Plaintiff’s Appeal Brief

DiCosolo v. Janssen Pharmaceutica Inc.

Description: This case was a wrongful death claim arising out of the death of Janice DiCosolo due to her use of a defective fentanyl pain patch designed, manufactured and marketed by Defendants.  After the DiCosolo family obtained an 418.5 judgment, the Defendants appealed.  They claims that the verdict was excessive, that Plaintiff’s counsel made an improper closing argument, that the trial court erred in excluding evidence of other drugs the decedent may have taken and that the Plaintiff failed to prove the existence of a non-specific defect.  The Court of Appeals rejected all of the Defendants’ argument and affirmed the judgment. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS
COUNTY DEPARTMENT, LAW DIVISION
JOHN DICOSOLO, as Administrator of the
Estate of Janice V. DiCosolo, Deceased,Plaintiff,

JANSSEN PHARMACEUTICA INC., a Foreign Corporation, et al.,

Defendants.

No. 04 L 5351

 

PLAINTIFF’S APPEAL BRIEF

 

NOW COMES the Plaintiff, John DiCosolo, as Administrator of the Estate of his deceased wife, Janice V. DiCosolo, through his attorneys, THE LAW OFFICES OF JOHN F. CUSHING, P.C., and HEYGOOD, ORR, REYES, PEARSON & BARTOLOMEI, and hereby files his Response to the Defendants’ Motion for Judgment Notwithstanding the Verdict or, in The Alternative, A New Trial or Remittitur (“the Motion”).

INTRODUCTION

Defendants have filed a 100-page Motion asking the Court for a new trial, judgment notwithstanding the verdict, or a remittitur.  With the exception of the Defendants’ request for a remittitur (which is without merit for the reasons discussed below), all of the arguments raised in the Motion have been briefed, argued at length, and correctly ruled on by the Court at trial.  Therefore, for the reasons discussed below, the Motion should be denied in its entirety.

SUMMARY OF ARGUMENT

First, Defendants contend that a new trial is warranted because the Court allegedly erred by excluding evidence that Janice was prescribed drugs that were never detected during her autopsy.  Defendants are not entitled to a new trial based on the exclusion of this evidence because the Defendants have failed to show that the Court’s exclusion of this evidence constituted an abuse of discretion.  Moreover, the Court properly excluded evidence concerning three medications—avinza, clonazepam and topamax—to which Ms. DiCosolo may have had access because (1) there was no testimony that she took these medications in the days leading up to her death and (2) no toxicological testing showing they were present in her blood at the time of death.  The Court properly restricted this evidence to prevent improper speculation that these drugs may have played a role in Janice’s death.

Second, Defendants argue that they are entitled to a new trial because the Court allegedly erred by excluding evidence that John discarded clonazepam pills after his wife’s death.  The Court did not abuse its discretion by excluding this evidence because:  (1) the fact that John discarded pills is not relevant because it does not make any pertinent fact more probable; (2) at the time he discarded the pills, John had no reason to believe that the number of remaining clonazepam pills—a drug not found in Janice’s system and not listed as a cause of her death—would have any relevance in a future lawsuit; (3) the absence of any test results or findings concerning a blood level of clonazepam made it impossible to determine whether the drug was even in her system at the time of death or whether the drug had any effect on her death; (4) Defendants were not prejudiced by the exclusion of this evidence because the Defendants brought to the attention of the jury the discarding of the pills on several occasions during the trial; and (5) the Defendants have not demonstrated the exclusion of this evidence probably resulted in an improper verdict.

Third, Defendants argue that a new trial is warranted because the Court prevented their expert, Gerhard Levy, from testifying that Janice was not tolerating her drug regimen.  The Court did not abuse its discretion by excluding this evidence because Levy, who is a “pharmaceutical scientist,” was not qualified to give medical opinions.  Moreover, Defendants failed to preserve error on this point because they neglected to make an offer of proof.

Fourth, Defendants maintain that they are entitled to a new trial because the Court did not allow defense expert Dr. Thomas Kearney to testify regarding an outdated toxicological screen from seven months before Janice DiCosolo’s death.  Defendants claim that the testimony should have been allowed because the toxicological screen showed a butalbital level eight times higher than it should have been.  The Court did not abuse its discretion by excluding this evidence because Janice’s butalbital level seven months before her death was not relevant to the cause of her death.  In fact, such evidence was particularly irrelevant – as well as prejudicial and misleading – because the postmortem toxicology report showed that Janice had a therapeutic level of butalbital at the time of her death.

Fifth, Defendants contend that a new trial is warranted because the Court allegedly erred by excluding evidence of Janice’s “erratic” behavior, including:  (1) in October 2003, Janice turned to another doctor after Dr. Neri refused her a prescription for Wellbutrin; (2) a DUI arrest (subsequently dismissed) in April 2003; (3) evidence of an alleged attempt by Mrs. DiCosolo to cut her wrists in April 2003; (4) an alleged episode of rage toward her doctor in 2001; and (5) Janice’s mental health records.  The Court did not abuse its discretion by excluding this evidence because each of these pieces of evidence was irrelevant and unfairly prejudicial, and Janice’s mental health records were protected from disclosure by statute.

Sixth, Defendants argue that the Court erroneously excluded evidence of Janice’s purported “psychological instability” and “erratic behavior” on the grounds that such evidence was relevant and admissible to rebut the presumption of loss of Janice’s society to her husband and children.  But the isolated and remote episodes Defendants point to were of not relevance in judging the family’s relationship at the time of Janice’s death.  The evidence at issue was irrelevant, highly prejudicial and statutorily privileged.

Seventh, Defendants contend that the Court erred by admitting evidence that the Defendants recalled Duragesic patches in 2004.  The Court did not abuse its discretion in admitting this evidence because:  (1) the 2004 recall was not “subsequent” for purposes of the subsequent remedial measure doctrine because it because it was instigated by Defendants before Janice DiCosolo’s death; (2) the 2004 recall was not “remedial” for purposes of the subsequent remedial measure rule because Defendants have not shown that the recall made the injury or harm less likely to occur; (3) the 2004 recall was relevant and probative evidence of the existence of a defect because the recall involved the same product (i.e., Duragesic) and Janice’s patch came from the recalled lot; and (4) Defendants were not prejudiced by the admission of evidence concerning the 2004 recall.

Eighth, Defendants contend that the Court erroneously admitted evidence of the label changes for Duragesic.  The Court did not abuse its discretion by its admitting evidence of the Duragesic label changes because the changes were admissible under various exceptions to the subsequent remedial measure rule, including impeachment and evidence of causation.  Moreover, Defendants failed to object to Plaintiff’s argument concerning the label changes in closing argument.  Therefore, any error was waived.

Ninth, Defendants argue that they are entitled to a new trial because this Court allegedly violated Supreme Court Rule 213(g) in allowing Drs. Anisfeld, Prausnitz, and Neri to proffer “new opinions” after discovery cutoff dates.  None of these supplemental matters constituted new opinions in violation of Rule 213(g).  Merely elaborating on a disclosed opinion does not violate Rule 213 where the additional testimony constitutes a logical corollary to the originally disclosed opinion.  With respect to Dr. Neri’s testimony regarding his continued prescription of Duragesic following Janice DiCosolo’s death, Defendants fail to explain how Plaintiff was responsible for the alleged change in testimony of a non-retained expert.  Moreover, the Court was not inconsistent in allowing Plaintiff’s experts to supplement their opinions, but denying Dr. Apple’s attempt to do the same.  The Court appropriately excluded Dr. Apple’s new study for an entirely different reason—his failure and refusal to provide counsel with the underlying data.

Tenth, Defendants argue that a new trial is warranted because the Court erred by allowing Dr. Downs to testify regarding 12 fentanyl-related autopsies at trial.  The Court did not abuse its discretion by allowing Dr. Downs to testify concerning the autopsies because:  (1) the Defendants created the need for such testimony by repeatedly asserting in that postmortem fentanyl levels cannot be used to determine cause of death and (2) testimony concerning the autopsies was properly admitted because both Dr. Downs and the Defendants’ expert on forensic pathology testified that medical examiners throughout the country routinely rely on postmortem fentanyl levels to establish cause of death.

Eleventh, Defendants contend that they are entitled to a new trial because the Court erroneously allowed Dr. Prausnitz to testify that leaking fentanyl gel could cause a fatal fentanyl overdose.  The Court did not abuse its discretion by allowing this testimony because:  (1) Dr. Prausnitz’ testimony was based on direct and circumstantial evidence that Janice used a leaking Duragesic patch and (2) the evidence Dr. Prausnitz relied on in forming his opinions was the type of evidence reasonably relied on by experts in his field.

Twelfth, Defendants argue that a new trial is warranted because evidence that they were less than candid, perhaps overtly deceitful, with the FDA was inadmissible under the Supreme Court’s decision in Buckman Company v. Plaintiff’s Legal Committee.  The holding in Buckman was limited to whether a cause of action for fraud on the FDA was preempted.  Unlike in Buckman, this case did not involve any fraud-on-the-FDA claims. Moreover, the Court did not abuse its discretion by admitting this evidence because (1) the defense opened the door to the e-mails at issue by stating repeatedly to the jury in opening statement that the Defendants were acting as a partner with the FDA and working in tandem with the FDA in developing a safe product and adequate labeling and (2) two of the emails at issue contained critical admissions that Defendants were unable to produce defect-free patches and that human inspection on a manufacturing line was essentially useless.

Thirteenth, Defendants maintain that they are entitled to a new trial because the Court erred in admitting evidence of the Vision System.  The Court did not abuse its discretion by admitting evidence concerning the Vision System because:  (1) John established the relevancy of the evidence though his manufacturing expert, Michael Anisfeld, who testified that the vision system “almost certainly” could have been used “to detect leaking patches like the patch that made it to Janice DiCosolo”; (2) evidence concerning the Vision System is not barred by the subsequent remedial measures doctrine because the Defendants deny that the Vision System would have detected the defects in Janice’s Duragesic patches; and (3) evidence concerning the Vision System did not mislead the jury because Bill Young, an ALZA reliability engineer, testified that the vision system project had begun even prior to the commencement of his employment at ALZA in 1999 and was capable of doing everything it was designed to do by September 2001.

Fourteenth, Defendants argue that a new trial is warranted because the Court erroneously admitted evidence concerning the matrix patch, an alternative design to the reservoir design used in the Duragesic patch.  The Court did not abuse its discretion by admitting evidence of the matrix design because:  (1) the evidence showed that the matrix design was safer than the reservoir design and (2) Defendants admitted in a Citizen Petition filed with the FDA that “matrix products do afford some advantages over reservoir products in terms of cosmetics, adhesion and in the elimination of possible gel leakage.”

Fifteenth, Defendants contend that they should be given a new trial because the Court erroneously admitted evidence of Janice’s postmortem fentanyl level.  The Court did not abuse its discretion by admitting Janice’s postmortem fentanyl level because:  (1) it is admissible by statute under 725 Ill. Comp. Stat. 5/115-5.1; (2) the phenomenon of postmortem redistribution does not make Janice’s fentanyl level inadmissible because it goes to the weight of the evidence, not its admissibility; and (3) the medical examiner and the pathology experts for both sides agreed at trial that postmortem fentanyl levels are routinely used to determine cause of death.

Sixteenth, Defendants claim that a new trial is warranted because the Court erred by admitting customer complaints and adverse event reports.  The Court did not abuse its discretion by admitting the reports and complaints because: (1) the reports and complaints were “substantially similar” to the adverse event experienced by Janice; (2) the reports were admissible under an exception to the hearsay rule that permits evidence of prior incidents to prove a design defect; (3) the reports and complaints were relevant to John’s negligence claim; and (4) their probative value was not outweighed by any prejudicial impact.

Seventeenth, Defendants ague that they are entitled to a new trial because the Court erred by refusing to give an adverse inference instruction, IPI Civil No. 5.01, that allegedly would have allowed the jury to infer that Janice consumed more than her prescribed number of clonazepam pills and that clonazepam contributed to her death.  The Court’s refusal to give the instruction does not warrant a new trial because:  (1) the decision not to give IPI No. 5.01 was within the trial court’s discretion; (2) Defendants failed to make a sufficient showing that a reasonable person would not have discarded the clonazepam pills and that there was no adequate excuse for the failure to produce the pills; and (3) the factors courts consider in determining whether an adverse inference instruction is warranted do not militate in favor of a such an instruction under the facts of this case.

Eighteenth, Defendants contend that a new trial is warranted because the Court erred by refusing to give proposed Instruction No. 10, a non-IPI instruction that added a “substantial factor” test to the language of the long form of IPI Civil 15.0.1.  The Defendants claim the instruction was warranted because other drugs played a role in Janice’s death.  The Court’s refusal to give Instruction No. 10 was proper and does not entitle the Defendants to a new trial because:  (1) the long form of IPI No. 15.01—the proximate cause instruction that the Court actually gave—was created for situations where there is evidence of concurring or contributing causes of an injury or death; (2) Defendants failed to show that IPI 15.01 does not accurately state Illinois law; and (3) Defendants were not prejudiced by the Court’s refusal to give proposed Instruction No. 10 because the jury determined that Janice was eight percent contributorily negligent.

Nineteenth, Defendants contend that they are entitled to a new trial because they were prejudiced by the Court’s refusal to give their proposed Instruction No. 25, their proffered jury instruction on design defect based on the Illinois Supreme Court’s opinion in Blue v. Environmental Engineering.  The Defendants were not prejudiced by the Court’s refusal to give Instruction No. 25 because:  (1) the Court gave a non-IPI design-defect instruction that used language taken from the Illinois Supreme Court’s opinion in Mikolajczyk v. Ford Motor Company, the court’s latest pronouncement on the holding in Blue, and (2) the Defendants’ proposed instruction utilized the disfavored practice of lifting sentences from court opinions and converting them into instructions.

Twentieth, Defendants also claim that a new trial is warranted because they were allegedly prejudiced by the Court’s refusal to give Defendants’ proposed Instruction No. 26, an argumentative, non-IPI instruction stating that the Defendants did not have a duty to warn of dangers that Dr. Neri or the medical community allegedly knew or should have known.  The Court’s refusal to give this instruction was not error nor does it entitle Defendants to a new trial because:  (1) under Supreme Court Rule 239(a), the Court had no obligation to give Defendants’ Proposed Instruction No. 26 because the Court gave IPI instructions that accurately stated the law and instructed the jury on the Defendants’ duty to warn and the learned intermediary doctrine; (2) the Court had no obligation to give the instruction because it is does not accurately state the law; (3) under Supreme Court Rule 239(a), the instruction was properly rejected because it was argumentative and constituted a negative instruction; and (4) Defendants were not prejudiced by the Court’s refusal to give the instruction because the Court gave the Defendants permission to raise Dr. Neri’s alleged awareness of Duragesic’s dangers in their closing argument.

Twenty-first, Defendants contend that they are entitled to a new trial because they were prejudiced by the Court’s refusal to give Defendants’ Proposed Instruction No. 27, a non-IPI instruction on their defense that the Duragesic patch is allegedly “unavoidably unsafe.”  The Court appropriately refused to give the instruction on the grounds that it is not an accurate statement of the law because (1) it would have improperly allowed the jury to conclude that the Defendants’ Comment k defense applied to John’s negligence claims and his strict liability claims for manufacturing defects and for failure to warn and (2) it failed to advise the jury that the Defendants had the burden of proof on their Comment k defense.

Twenty-second, Defendants argue that a new trial is warranted because the Court allegedly erred by refusing to give Defendants’ proposed Instruction  No. 28, an instruction consisting of an amalgam of language lifted from a variety of cases—none of it approved IPI language.  The instruction was properly refused because it was lengthy, rambling, confusing, thoroughly argumentative, and did not assist the jury in neutral language.  Moreover, contrary to the Defendants’ unsupported assertion, the Court’s refusal to give the instruction did not allow the jury to find that the Duragesic patch was defective based on Janice’s death alone.  The Court gave the jury a three-page jury instruction based on IPI No. 400.02.01 that explained John’s burden of proof on his strict liability counts.

Twenty-third, Defendants contend that they are entitled to a new trial because the Court allegedly erred by refusing to give Defendants’ proposed Instruction No. 29, which consisted of three paragraphs purporting to explain the meaning and effect of FDA approval.  The Court properly refused to give this instruction because:  (1) the instruction was not warranted by the evidence because there was no testimony at trial regarding the FDA approval process; (2) the instruction was an incorrect statement of the law in that it misleadingly omitted the fact that FDA regulations impose only minimum standards; and (3) under Supreme Court Rule 239(a), the instruction was properly refused because it was lengthy and argumentative.

Twenty-fourth, Defendants contend that they are entitled to a new trial because the Court refused to give proposed Instruction No. 30, an argumentative, negative instruction designed to tell the jury that they could not consider evidence of fraud on the FDA.  The Court properly refused to give this instruction because:  (1) there was no allegation of fraud on the FDA; therefore, the preemption of causes of action for fraud on the FDA discussed in Buckman Co. v. Plaintiff’s Legal Committee has no bearing on this case; (2) it was a negative, argumentative instruction; and (3) Defendants were not prejudiced by the Court’s refusal to give this proposed instruction because the Court gave Defendants permission to raise the issue in their closing argument.

Twenty-fifth, Defendants argue that a new trial is warranted because the Court erred by refusing their Proposed Instruction No. 31 that John’s failure-to-warn claims are allegedly preempted by federal law.   The Court properly refused to give this instruction because:  (1) preemption is an issue of law for the Court, not a question of fact for the jury and (2) the instruction is an incorrect statement of the law because FDA regulations impose only minimum standards that are open to supplementation by state law through a jury’s verdict enforcing a manufacturer’s common law duty to warn.

Twenty-sixth, Defendants argue that the Court should give them a new trial because the Court erred by refusing to give Defendants’ proposed Instruction No. 32, non-IPI limiting instruction regarding the 2004 recall.  The Court properly refused to give the instruction because:  (1) the 2004 recall was neither subsequent nor remedial and (2) a product recall is some evidence of a defect, even assuming the recall affects both defective and non-defective products.

Twenty-seventh, Defendants contend that a new trial is warranted because the Court allegedly erred by refusing to give their proposed Special Interrogatory No. 1, which would have asked the jury whether Janice’s contributory negligence was more than 50%.  The Court’s refusal to give the special interrogatory was appropriate and does not entitle the Defendants to a new trial because:  (1) it would not have controlled the general verdict because contributory negligence is not a defense to John’s strict liability claims; (2) the language of the special interrogatory was argumentative; and (3) the special interrogatory was unnecessary and duplicative because the jurors were told in other instructions to determine whether Janice was contributorily negligent and, if so, whether that contributory negligence was greater than 50% of the total proximate cause of her death.

Twenty-eighth, Defendants maintain that they are entitled to a new trial because John’s attorneys argued that Janice’s Duragesic patches could be regarded as defective because they came from a recalled lot.  The closing argument does not warrant a new trial because:  (1) the Defendants waived any error by failing to object to it at trial; (2) the Defendants opened the door to the argument by discussing the recall and, their relationship with the FDA, and the FDA’s post-recall investigation at trial; (3) John’s attorney did not state that Janice’s Duragesic patches were defective because they came from a recalled lot; (4) the 2004 recall was relevant to the existence of a product defect; and (4) Defendants failed to meet their burden of showing that John’s attorney’s statements regarding the recall were so prejudicial that they are entitled to a new trial.

Twenty-ninth, Defendants maintain that a new trial is warranted because Plaintiff’s counsel allegedly argued that the warnings in the 2003 Duragesic package insert were defective because they did not contain warnings that were added to new versions of the package insert.  This argument does not justify a new trial because:  (1) Defendants waived their objection to the statements concerning the label change by failing to object to it in closing argument or in their motion for mistrial; (2) contrary to Defendants’ assertion, John’s attorney did not argue that the 2003 package insert contained insufficient warnings because the warnings later changed; (3) John’s attorney’s statements concerning the language in the new package insert were also proper under the causation exception to the subsequent remedial doctrine; and (4) Defendants have not met their burden of showing that John’s attorney’s statements were so prejudicial that they are entitled to a new trial.

Thirtieth, Defendants contend that they are entitled to a new trial because John’s attorney stated that, at the time of her death, Janice was following the same drug regimen she had been on for months.  This argument does not warrant a new trial because:  (1) John’s attorney’s argument that Janice had been on the same drug regimen for several months was based on the evidence presented at trial and inferences drawn from that evidence; (2) the Court properly prevented Defendants from speculating that clonazepam might have been in Janice’s system based on the fact that a prescription for clonazepam was filled three days before she died; and (3) the Court heard the closing arguments and made a determination on the record that the argument was not unfairly prejudicial and would not prevent the jury from rendering a fair verdict.

Thirty-first, Defendants contend that they are entitled to a new trial because John’s attorney made “improper and inflammatory” remarks about Defendants’ profit motive.  The allegedly “inflammatory” closing argument does not warrant a new trial because:  (1) the Court heard the closing arguments and made a determination on the record that the arguments were not unfairly prejudicial and would not prevent the jury from rendering a fair verdict; (2) the Court’s denial of the Defendants’ motion for a mistrial was correct because the argument did not go beyond the wide latitude afforded to attorneys in closing arguments (3)  Defendants opened the door to the argument that the Defendants put profits over patient safety by repeatedly emphasizing Defendants’ alleged concern for patient safety in their opening statement and in trial; and (4) the size of the jury verdict demonstrates that it was not the result of prejudice, sympathy or passion resulting from allegedly inflammatory comments in closing argument.

Thirty-second, Defendants contend that they are entitled to a JNOV or, in the alternative, a new trial on John’s design-defect claim.  The Defendants’ motion should be denied because:  (1) there was sufficient evidence of a legally cognizable design defect (i.e., that Duragesic patches are inherent susceptibility to leakage); (2) there was sufficient evidence that the design of Duragesic patches is unreasonably dangerous under both the consumer expectation test and risk-utility test; (3) there was sufficient evidence that the faulty design of Janice’s Duragesic patches proximately caused her death; and (4) there was sufficient evidence that Defendants were negligent in designing the Duragesic patch.

Thirty-third,  the Defendant argue that they are entitled to a JNOV or, in the alternative, a new trial on John’s failure-to-warn claim.  The Defendants’ motion should be denied because:  (1) there was sufficient evidence that the warnings were inadequate; (2) there was competent expert and non-expert testimony supporting the failure-to-warn claim; and (3) there was sufficient evidence that the inadequacy of Duragesic’s warning label was a proximate cause of Janice DiCosolo’s death.

Thirty-fourth, Defendants argue that they are entitled to JNOV or a new trial on Plaintiff’s specific manufacturing defect claim.  This motion should be denied because there is sufficient evidence of a specific manufacturing defect because John actually saw a “shiny slick” film (which John’s experts believe is fentanyl gel) on Janice’s skin prior to her death.  Additionally, the patches used by Janice DiCosolo came from a recalled lot of defective, leaking patches that were manufactured under poor standards of quality control and contrary to Good Manufacturing Practices.  These facts provide ample evidence of a specific manufacturing defect.

Thirty-fifth, Defendants contend that they are entitled to JNOV or a new trial on Plaintiff’s non-specific manufacturing defect claim.  This argument is without merit because John offered evidence on all three elements of his non-specific manufacturing defect claim:  (1) Janice did not use her Duragesic patches in an abnormal manner; (2) one or both of her patches failed to perform as expected by giving Janice a blood fentanyl level sixteen times higher than expected; and (3) no reasonable secondary causes was responsible for the fatal fentanyl level found in Janice’s blood.

Thirty-sixth, Defendants contend that they are entitled to a new trial because this Court erred in refusing to grant their motion for a directed verdict.  Under Illinois law, verdicts ought to be directed only in those cases in which all of the evidence, when viewed in the light most favorable to the opponent, so overwhelmingly favors the movant that no contrary verdict based on that evidence could ever stand.  This case involves a substantial factual dispute involving conflicting evidence.  Therefore, the Court correctly denied the Defendants’ motion for a directed verdict.

Thirty-seventh, Defendants argue that they are entitled to JNOV or a new trial because Plaintiff’s design-defect and warning are preempted by federal law.  This is precisely the same preemption argument that the Court rejected in denying the Defendants’ motion for summary judgment.  This Court should reject the Defendants’ request for a JNOV or a new trial based on federal preemption for the same reasons.

Thirty-eighth, Defendants contend that a remittitur is warranted because the jury’s verdict was allegedly excessive.  The Defendants’ request for a remittitur should be denied because:  (1) the assessment of damages lies within the discretion of the jury and its collective judgment is rarely to be disturbed; (2) Illinois courts have rejected comparing awards in one case to those in other cases to determine if a remittitur is warranted; (3) there is no basis to reduce the loss of society award simply because Janice had been suffering pain in the years preceding her death; (4) the amount awarded by the jury was not outside the range of fair and reasonable compensation or so large as to shock the judicial conscience; (5) there is no basis for concluding that the damages awarded by the jury were the product of passion or prejudice; and (6) there is no basis for concluding that the damages awarded by the jury were “erroneous,” nor is an “erroneous” damage award a basis for remittitur.

For these reasons, discussed in detail below, the Defendants’ Motion should be denied in its entirety.

ARGUMENT AND AUTHORITIES

I.          Introduction.

 

The Defendants have moved for a judgment notwithstanding the verdict (“JNOV”) or a new trial.  Under Illinois law, a trial court should enter a judgment notwithstanding the verdict only when all of the evidence, viewed in the light most favorable to the opponent, so overwhelmingly favors the movant that no contrary verdict based on that evidence could ever stand. Pedrick v. Peoria & Eastern R.R. Co., 37 Ill. 2d 494, 510, 229 N.E.2d 504 (1967). As set forth more fully below, Defendants have wholly failed to meet this burden.  As for Defendants’ request for a new trial, “a court will weigh the evidence and set aside the verdict and order a new trial if the verdict is contrary to the manifest weight of the evidence.” Mizowek v. De Franco, 64 Ill. 2d 303, 310 (Ill. 1976).   A verdict is against the manifest weight of the evidence “where the opposite conclusion is clearly evident or where the findings of the jury are unreasonable, arbitrary and not based upon any of the evidence.” McClure v. Owens Coming Fiberglas Corp., 188 Ill. 2d 102, 132, 720 N.E.2d 242, 241 Ill. Dec. 787 (1999).  “The determination of whether a new trial should be granted rests within the sound discretion of the trial court, whose ruling will not be reversed unless it reflects an abuse of that discretion.” Snelson v. Kamm, 204 Ill. 2d 1, 36, 787 N.E.2d 796, 272 Ill. Dec. 610 (2003).  For the reasons discussed below, the verdict rendered by the jury herein was not contrary to the manifest weight of the evidence.  The Court should therefore deny the Motion to the extent it seeks a new trial.

The Defendants have moved for a JNOV or new trial on four grounds:  (1) that the court allegedly abused its discretion in its evidentiary rulings; (2) that Plaintiff’s counsel made allegedly improper arguments during the closing statement; (3) that the Defendants were allegedly prejudiced by the Court’s refusal to give their proffered jury instructions or special interrogatories; and (4) that there was insufficient evidence to support the jury’s verdict.  The Defendants are not entitled to a JNOV or new trial because:

  • Defendants have failed to show that the Court’s evidentiary rulings constituted an abuse of discretion;
  • Plaintiff’s closing argument was not improper and Defendants waived any objections to Plaintiff’s closing argument by failing to object to such arguments at trial;
  • The Court’s did not err by refusing to give certain non-IPI instructions and refusing to give special interrogatories that, if answered in the Defendants’ favor, would not have decided the entire case; and
  • There was sufficient evidence to support the jury’s verdict.

For these reasons, set forth more fully below, the Defendants’ Motion should be denied.

II.        Defendants are not entitled to a new trial based on the Court’s exclusion of evidence.

 

In their Motion, Defendants contend that they are entitled to a new trial because, according to Defendants, the Court erred in sustaining Plaintiff=s objections to certain evidence offered by Defendants.  In fact, nearly half of the Defendants= 100 page brief is devoted to alleged mistakes made by the Court relating to the admission or exclusion of evidence.  However, determinations regarding the relevance, speculative nature and prejudicial impact of evidence is left to the broad discretion of the trial court.  Such evidentiary rulings are to be disturbed only upon a showing of a clear abuse of the trial court=s discretion, meaning that no reasonable person would adopt the Court=s point of view.  Rose v. Mercedes-Benz USA, LLC, 378 Ill. App. 3d 615, 623 (1st Dist. 2007).  As set forth below, not only were the Court=s evidentiary rulings not an abuse of discretion, they were correct in every respect and required by Illinois law.

A.        The Court properly excluded evidence of Janice’s prescriptions for drugs that were never detected during her autopsy.

 

In their Motion, Defendants contend that the Court should have allowed unrestricted evidence of three medications (avinza, clonazepam and topamax) to which Ms. DiCosolo may have had access, even though there was no testimony that she took these medications in the days leading up to her death and no toxicological testing showing they were present in her blood at the time of death.  Defendants argue that a “jury could reasonably infer from the circumstantial evidence that Mrs. DiCosolo was taking the drugs in question” and that “experts could reasonably and permissibly opine that such usage … would have caused or contributed to her death.”  Motion at p.  4.  Essentially, Defendants argue that because Mrs. DiCosolo potentially had access to these medications that she must have taken them and they must have contributed to her death.  The Court properly restricted this evidence because to allow it would have involved rampant speculation.

  1. 1. The Court properly excluded evidence relating to clonazepam.

Mrs. DiCosolo was not even prescribed clonazepam at the time of her death.  Although a refill for clonazepam was picked up at the pharmacy two days before Mrs. DiCosolo=s death, there was no evidence that Mrs. DiCosolo was the one that picked up the refill or that she was even aware of it.  Defense expert Dr. Zumwalt admitted that the prescription of clonazepam might have been filled by her husband and Mrs. DiCosolo may not have even been aware that it was available in the house.  (11-12, a.m., Tr. 2323:11-2324:5).  It was not reported to the medical examiner=s office as a medication she was taking because it was not a medication which was prescribed for her at the time of her death.  Further, the evidence showed that two other prescriptions were filled at the same time and that Janice did not show any evidence of the presence of those medications (which were screened for during her autopsy), refuting any inference that she necessarily ingested prescriptions that were refilled shortly before her death. (10-27, a.m., Tr. 79-80).  Even if it is assumed she took clonazepam leading up to her death (which is a wild presumption), there was no evidence as to how much she would have taken, what the resulting concentration of clonazepam would have been in her blood stream or what role such resulting concentration would have played, if any, in Mrs. DiCosolo=s death.  Illinois law does not permit the piling of inference upon inference in this matter as a mode of proof. Rockett v. Chevrolet Motor Div., General Motors Corporation, 31 Ill. App. 3d 217, 223 (Ill. App. 1975) (probative force of inferences weakens with their increasing remoteness to reach intolerable level of speculation and conjecture).

In their Motion, Defendants claim that evidence of clonazepam should have been allowed because Dr. Middleberg allegedly agreed that information about Janice=s possible clonazepam use would have been significant in determining cause of death.  However, upon review of the testimony cited by Defendants (11-15, a.m., Tr. 1462-1465), no such admission was made.  To the contrary, Dr. Middleberg only indicated that as a “general rule, it’s nice to know whatever somebody is taking . . . .”@  (11-15, a.m., Tr. 1463:2-3).  Dr. Middleberg went on to note however that his office frequently gets “records where they’ll have 20, 30 different compounds available to them in terms of prescriptions and the bottles will be in the house and when we do our toxicological analyses for all 20 of those, rarely do we find 20 of them.” (11-15, a.m., Tr. 1463:5-9).  Dr. Middleberg continued by saying that he “has no way of assessing whether it was there or not at this point.”  (11-15, a.m., Tr. 1463:14-16).  Hence, Dr. Middleberg, rather than saying anything which supports Defendants= position, actually provided powerful testimony as to why any conclusion by a fact finder or witness that clonazepam had anything to do with Mrs. DiCosolo=s death would have involved a “flying leap” of speculation.  Just because she may have had it available (presuming she even knew it had been picked up from the pharmacy), is incompetent evidence that she consumed it or that it had anything to do with her death.

Dr. Middleberg=s testimony was also consistent with the testimony of Defendants= own experts.  For example, Dr. Kearney agreed that he did “not know one way or another whether she had clonazepam . . . in her blood.”  (11-10, a.m., Tr. 1940:4-7).  Likewise, defense expert Dr. Zumwalt agreed that he “can=t tell us one way or the other whether she took any clonazepam in the three days leading up to her death.”  (11-12, a.m., Tr. 2324:6-9).  For these reasons, the Court properly excluded this highly speculative and extremely prejudicial evidence.

Even if the Court should have admitted this testimony (which is clearly not the case), Defendants have not shown that the exclusion of this evidence probably resulted in an improper verdict.   Defendants could not have been prejudiced, because their counsel apprised the jury of the sought-after inferences about clonazepam.  In addition to counsel=s opening argument about an empty clonazepam bottle remaining after Janice=s death (10-29, a.m., Tr. 412-13), defense counsel was permitted to question Janice=s primary physician, Dr. Neri, about his discontinuation of clonazepam a few weeks prior to Janice=s death. (11-3, a.m., Tr. 1249, 1251).  Any inferences arising from the mere filling of a prescription were available to the jury.  Most significantly, the Defendants fully presented their “polypharmacy” theory through their expert, Dr. Zumwalt, who testified that his opinion as to cause of death, to a reasonable degree of medical probability, was “a mixed-drug intoxication.” (11-12, a.m., Tr. 2283-84, 2287).

4.         Defendants= arguments regarding synergistic effect do not render evidence of the other drugs admissible.

In their Motion, Defendants assert that evidence of clonazepam, topamax and avinza should have been allowed because multiple CNS depressants have a synergistic effect.  The fact that combining some CNS depressants may have synergistic effects does not render relevant evidence of medications where no competent evidence was presented they were ever  consumed.  Allowing the jury to speculate regarding whether Ms. DiCosolo took any clonazepam, topamax or avinza leading up to her death, how much she would have taken, what amount there would have been in her blood at the time of death and what, if any, synergistic effect they would have had with the other medications would have been, as the Court correctly pointed out, a “wild goose chase.”  (11-3, a.m., Tr. 1115:23).  Concluding anything based on such evidence would have involved a “flying leap of faith” on the part of the jury.  (11-3, a.m., Tr. 1115:14).  Thus, the Court properly exercised its discretion to exclude such evidence as irrelevant and/or because any possible relevance was outweighed by its prejudicial impact.

5.         The fact that Plaintiff was required to prove no abnormal use and no reasonable secondary cause in support of his defect claim likewise did not render evidence of the other drugs admissible.

Defendants contend that evidence of clonazepam, avinza and topamax was relevant to whether Mrs. DiCosolo was using Duragesic abnormally.  Essentially, Defendants argue that if Mrs. DiCosolo was using Duragesic along with clonazepam, avinza and topamax, the jury would have been entitled to find that she was not properly using Duragesic.  However, because Defendants were unable to present any competent evidence that she took any of these medications (as was the case at trial), they were clearly irrelevant to the issue of abnormal use.

Similarly, Defendants argue that evidence of clonazepam, avinza and topamax was relevant to prove a reasonable secondary cause.  Again, in order for evidence of clonazepam, avinza and topamax to be relevant as a possible reasonable secondary cause, there would have had to have been competent evidence that she actually had such substances in her system at the time of death.  As no such evidence was proffered, evidence of these drugs was not relevant.  Further, a claimed reasonable secondary cause which is based on speculation is not a reasonable secondary cause, and any conclusion by a fact finder that clonazepam, avinza and topamax played any role whatsoever would have been based on pure speculation.  Thus it could not have served as a reasonable secondary cause.

6.         While experts may testify to possibilities, they are not permitted to base their opinions on mere speculation and conjecture.

Defendants contend that the Court improperly excluded evidence of clonazepam, avinza and topamax based on the improper ground that Defendants= experts could not opine with a reasonable degree of certainty that Janice had taken the drugs or that they contributed to her death.  Defendants claim that evidence of these drugs should have been allowed because, according to Defendants, expert witnesses should be allowed to testify about “coulds” and “mights.” Motion at p. 8.  Hence, Defendants claim their experts should have been allowed to say that Mrs. DiCosolo: 1) might have taken clonazepam, avinza and topamax, 2) these substances might have been in her blood at the time of her death, 3) these substances might have been in her blood at the time of her death in sufficient quantities to cause respiratory depression and 4) they might have contributed to her death.  Illinois law clearly does not require admission of testimony based on “mights” upon “mights” upon “mights.”  See, e.g., People v. Le Shoure, 139 Ill. App. 3d 356, 363 (Ill. App. 1985) (“We concluded that the evidence was sufficient to show that she had constructive possession. However, participation by an accused in the commission of an offense by another is not necessarily a sufficient basis to infer that the accused had conspired with that person to commit the offense. To hold that Clendora’s possession gives rise to such an inference would be improper. It would constitute stacking that inference on top of the inference creating the constructive possession.”).

In Reed v. Fleming, 132 Ill. App. 3d 722 (Ill. App. 1985), the court reviewed a summary judgment granted by a trial court in a dramshop case.  In doing so, it compared the facts of its case to those of two other cases in which courts of appeal had upheld directed verdicts in dramshop cases.  The court distinguished those cases as involving a situation where the lack of evidence forced the jury to impermissibly stack one inference upon another:

Plaintiffs in both Reese and Rose failed to present sufficient facts from which a jury could reasonably conclude that the driver’s intoxication had reached a level from which they could infer that driving ability would be affected. In neither case was the driver’s blood alcohol content introduced into evidence. In neither case was there evidence of unusual conduct from which intoxication could be inferred. In both cases there was evidence only of some drinking of alcohol at the defendants’ establishments and a later fatal accident. To reach a verdict favorable to the plaintiffs in such cases, the jury would have to infer the fact of intoxication and then infer further that the subsequent accident was caused by intoxication. It is this stacking of inferences that rendered verdicts for the plaintiffs in Reese and Rose vulnerable to attack as being based upon “pure speculation or conjecture.

Id. at 738.  Similarly, in Sommers v. American Economy Insurance Company, 8 Ill. App. 3d 450 (Ill. App. 1972), the court held that the trial court properly struck testimony that there possibly could be a causal connection between an accident and decedent=s heart attack as conjectural and speculative.  In Simon v. Lumbermens Mutual Casualty Company, 53 Ill. App. 3d 380 (Ill. App. 1977), the court held that a medical statement that a heart attack could have been caused either by accident or hypertensive disease was not testimony about cause of death to reasonable degree of medical and scientific certainty but was instead mere speculation and conjecture that was properly stricken.  Lastly, in Gariti v. Karlin, 127 Ill. App. 2d 166 (Ill. App. 1970), the defendant’s expert witness testified that defendant suffered from a diabetic attack, which caused his car to swerve across the center line and collide with plaintiff’s car. The court held that although there was evidence that defendant was given insulin for a diabetic condition after the accident, there was no evidence that he was diabetic before the accident. The court also held there was no evidence to support the assumption that defendant’s car swerved across the center line before the collision. The court concluded that the expert’s testimony was highly speculative and improper.  Id. at 171-73.

Here, the evidence proffered by Defendants involved speculation upon conjecture upon speculation.  Clearly, the Defendants have not shown that Ano reasonable person would adopt the Court=s point of view@ that there were simply too many inferences stacked upon one another to make the proposed testimony reliable.  Rose v. Mercedes-Benz USA, LLC, 378 Ill. App. 3d 615, 623 (Ill. App. 2007).  The cases cited by Defendants do not change this conclusion.  For example, Defendants cite the case of Damron v. Micor Distrib., 276 Ill. App. 3d 901 (Ill. App. 1995).  The Damron case involved an expert who was testifying regarding the “only possibility” for the failure of the pipe wrench at issue in the case.  Id. at 911.  While the court held that the testimony at issue was not speculative, the court noted that when an expert bases their opinions “on what might have happened,” Illinois courts will properly hold that the opinions are based on mere speculation and conjecture.  Id. at 909.  In the instant case, the Defendants were attempting to introduce expert testimony on what Amight have happened@ based on highly prejudicial and speculative evidence.  The Court properly held that such opinions are based on mere speculation and conjecture just as the Damron case instructs.

Defendants= argument, presented for the first time after the verdict, regarding the half-life of avinza does not change this conclusion.  First, as this argument was not presented during the trial, it has been waived.  Further, assuming avinza has a short half-life, that means that it is eliminated by the body quickly.  Avinza having a short half life does not render evidence of avinza relevant, but instead explains why it was not found in Mrs. DiCosolo=s blood.  It was probably eliminated by her body before the fatal dose of fentanyl caused Mrs. DiCosolo=s demise.  It having already been eliminated by her body means that it was not in her blood and thus could not have contributed to her death.  Thus, such evidence was not relevant and any reference to avinza would have been prejudicial and confusing to the jury.  The Court properly excluded it.

7.         Evidence related to the other drugs was not admissible for impeachment of Plaintiff=s experts.

 

Defendants assert that evidence of clonazepam, avinza and topamax was admissible to demonstrate that facts existed which Plaintiff=s experts had not taken into account.  The problem with this argument is that Plaintiff=s experts did take clonazepam, avinza and topamax into account and concluded, as did the Court, that they were not relevant.  Further, Defendants waived any argument on these grounds by not conducting an offer of proof as to what the impeachment would have been and against which experts it would have been utilized.[1] Lastly, Defendants clearly have not established that the alleged impeachment evidence would have likely resulted in a defense verdict if it had been allowed.  For all of the foregoing reasons, Defendants are unquestionably not entitled to a new trial based on any alleged restriction on their impeachment of Plaintiff=s experts.

8.         Evidence of the other drugs was not admissible as circumstantial evidence from which a reasonable inference may be drawn.

Finally, Defendants contend that the Court improperly excluded evidence of clonazepam, avinza and topamax because the jury could have reasonably drawn the inference that Janice was taking these medications at the time of her death based on the fact that she had prescriptions for these medications and that someone refilled her clonazepam prescription two days before her death.  Motion at p. 9.  There are numerous problems with this argument.  First, the mere possession of medication does not reasonably infer that it has been taken. In State v. Ingraham, 966 P.2d 103 (Mont. 1988), the defendant’s negligent homicide conviction was overturned because the trial court erred in admitting evidence of bottles of prescription medicine found in his car after he struck and killed a woman in a head-on collision.  The court of appeals correctly concluded that “whether drug evidence was, in fact, relevant depended upon the State’s ability at trial to demonstrate a link between that evidence and the cause of the accident.”  Id. at 110.  Although toxicological testing revealed the presence of at least one of the prescription drugs, Librium, in his system, the amount was not enough to have impaired his driving.  As for another drug, buspar, none of the drug was found in any of the defendant’s blood or urine samples.  The court concluded that the trial court erred in admitting evidence of the prescription bottles found in defendant’s car:

As the State failed to demonstrate that any of the drugs detected in his blood and urine, or found in his car, were causally connected to the accident, we conclude that evidence of their presence was irrelevant to the question of Ingraham’s negligence, or negligent state of mind, and was inadmissible on that basis. Accordingly, we conclude the District Court abused its discretion in denying Ingraham’s motion in limine, and hold the court should have excluded all evidence of the librium, nordiazepam, caffeine, lithium, nicotine, cotinine, ephedrine, and phenylpropanolamine, found in Ingraham’s system. We similarly hold the court abused its discretion when it denied Ingraham’s motion to exclude evidence of the bottles of lithium and Buspar found by Officer Roth in Ingraham’s car.

966 P.2d at 111.

The cases cited by Defendants from other jurisdictions do not change this analysis.  In Roach v. State, 783 S.W.2d 376 (Ark. Ct. App. 1990), the defendant in a DWI case had in her possession at the time of her arrest two prescription pill bottles filled the previous day, she did not smell of alcohol, but yet she appeared intoxicated, and one of the bottles was almost empty and the other was half full.  Id. at 376-77.  Here, in contrast, not only was the pill bottle not in Mrs. DiCosolo=s possession, but there was no evidence she was even aware of its alleged availability.  In Roach, the defendant was available to deny (if she so chose) that she had taken the missing pills.  Here, in contrast, there was no evidence with respect to missing pills at the time of Mrs. DiCosolo=s death and Mrs. DiCosolo was not available to defend herself against speculation that she took a medication that had been discontinued.  In Roach, the DWI defendant appeared intoxicated without having consumed alcohol which was further evidence that the subject pills had been consumed.  Whereas here, Mrs. DiCosolo=s death was fully explained by her 28.2 ng/mL fentanyl level.  Clearly, as evidenced by the above, the facts and reasoning of the Roach case do not require a new trial in this case.

Similarly, Eschete v. Roy, 554 F. Supp. 2d 628 (E.D. La. 2008) does not support Defendants’ position.  Contrary to Defendants= assertions, the court in Eschete did not find that the mere refilling of a prescription created a fact question as to whether the medication was being taken.  Rather, the court in Eschete found that a fact question existed as to ingestion of the medication at issue based on numerous pieces of evidence that pointed to use of the medication.  Eschete does not support Defendants= motion for new trial.

The second problem with Defendants’ analysis is the fact that the inference that Mrs. DiCosolo took the medication at issue is not the only inference that Defendants sought to make.   In order to demonstrate the relevance of the medication, Defendants would have been forced to make additional inferences that were totally unsupported and, in one case, flatly contradicted by, the evidence.  In reality, Defendants would have to ask the jury to infer from the mere availability of such medication that:

  1. Janice DiCosolo was taking each of these drugs in the days leading up to her death;
  2. each of the drugs was in her blood at the time of her death;
  3. each of the drugs was in her blood at the time of her death at such a level as to cause respiratory depression;
  4. one or more of the drugs caused or contributed to her death.

These are not reasonable inferences but instead involve inferences upon inferences upon inferences without any facts to support them.  While the “evidence” touted by Defendants would involve multi-level inferences before it would even touch on an issue relevant to the case, it would also have been highly prejudicial to Plaintiff as it would have confused the jury and asked them to engage in unfettered speculation.  Furthermore, the jury might have found against the Plaintiff purely because a prescription was filled that had been discontinued, regardless of whether Mrs. DiCosolo ever took the mediation or even knew that the prescription had been filled.  The Court properly excluded the evidence.

9.         Defendants= argument that the prejudice to them of exclusion of the other drugs was compounded by the Plaintiff=s experts being allowed to testify that nothing in Mrs. DiCosolo=s drug regimen had changed is not well founded.

Finally, Defendants allege that Plaintiff=s experts were allowed to argue that a defective patch was the only reasonable explanation for Mrs. DiCosolo=s death because nothing with respect to her drug regimen had changed, and that Defendants in turn should have been allowed to introduce alleged changes in the drug regimen.  The fatal flaw in Defendants= argument is that there were no changes in Mrs. DiCosolo=s medications during the last few months of her life with respect to the drugs actually found in her system.  No witness during the trial suggested that medications not taken or not in Mrs. DiCosolo=s blood could have had any impact on her death.  Only the addition of or increase in a medication found in Mrs. DiCosolo=s system could have played any role in her death.  With respect to these medications, there were no changes.  Thus, Defendants= argument is purely a red herring and constitutes no valid basis for a new trial.

Further, the only change even claimed by Defendants at trial was that a prescription for clonazepam was filled a few days before Mrs. DiCosolo=s death.  In this regard, Mr. Dames stated “[t]he only solid evidence we have that something changed from her drug regimen was her obtaining [clonazepam] two days before her death.”  (11-10, a.m., Tr. 2084:7-9).  As discussed above, this alleged “change” would only be relevant if she actually consumed some of this drug near the time of her death.  Because any suggestion that Mrs. DiCosolo took clonazepam involved pure speculation, the Court properly exercised its discretion to exclude this evidence.

Similarly, Defendants complain about Plaintiff=s counsel=s questioning Dr. Kearney about whether one can die from a combination of medications that the person has been tolerating for a period of time unless there is a change.  First, counsel=s questions in this regard were stated purely as a hypothetical and thus, contrary to Defendants= assertions, there was no misrepresentation to correct.  Furthermore, even if counsel=s question had incorporated the facts of this case, with respect to all relevant drugs (drugs found in her system), it was completely accurate.  Clearly, there was no misrepresentation to correct and Defendants are not entitled to a new trial.   For all of the foregoing reasons, the court did not err in excluding evidence of clonazepam, topamax and avinza when there was no evidence that Janice DiCosolo took these medications, that they were in her system at the time of death, that they were in her system at such a level as to have caused respiratory depression and that they contributed to her death.  To have allowed the admission of the evidence would have been to encourage the type of inference stacking that Illinois courts have found improper.

11.       Because they cannot show prejudice from the excluded evidence, Defendants are not entitled to a new trial.

Finally, Defendants are not entitled to a new trial based on the exclusion of evidence of other drugs for the simple reason that they have failed to demonstrate that such exclusion caused them any prejudice.  Under Illinois law, the exclusion of evidence can form the basis for a new trial only when the exclusion is prejudicial.  See, e.g., Bartlett Bank & Trust Co. v. McJunkins (1986), 147 Ill. App. 3d 52, 63 (Ill. App. 1986) (“Errors in the exclusion of evidence may constitute grounds for a new trial, where the errors were serious and prejudicial.”);  Gold v. Ziff Comms. Co., 322 Ill. App. 3d 32, 70 (Ill. App. 2001) (“Ziff alleges that it is entitled to a new trial due to eight evidentiary errors. We disagree. Admission of evidence rests within the sound discretion of the trial court and will not be reversed absent an abuse of discretion to the prejudice of the appellant.”).  Here, there was no such prejudice.

Defendants claim that the exclusion of evidence regarding other drugs not found in the postmortem toxicological tests was prejudicial because “[h]ad the proffered evidence been admitted, jurors could reasonably have inferred that the Decedent was taking as many as seven central nervous system depressants that could have contributed to her hypoventilation and death.”  Motion at p. 5 (emphasis added); see also Motion at p. 6 (“the addition of clonazepam to Mrs. DiCosolo’s drug regimen shortly before her death may have significantly contributed to a lethal polypharmacy.”) (emphasis added); Id. (Dr. Kearney testified on proffer that topamax, if taken by Mrs. DiCosolo, “would have contributed to her death.”) (emphasis added).  Defendants’ argument overlooks the fact that a conclusion by the jury that these other drugs “contributed” to Mrs. DiCosolo’s death would not have altered the jury’s finding of liability against Defendants.  That is true because Plaintiff was only required to demonstrate that Defendants’ actions were a proximate cause of his wife’s death, and the Court properly informed the jury that to be a proximate cause, a cause “need not be the only cause” and is “sufficient if it concurs with some other cause acting at the same time, which in combination with it, causes the injury.” IPI Civil No.: 15.01.  Thus, even if the jury had determined from the excluded evidence that the other drugs “contributed” to Mrs. DiCosolo’s death, it would not alter their conclusion that a lethal dose of fentanyl was a proximate cause as well.

III.       Defendants are not entitled to a new trial based on the Court’s admission of evidence.

 

As stated above, a trial court’s decision regarding whether to admit evidence is reviewed for abuse of discretion. Gill v. Foster, 157 Ill. 2d 304, 312-13, 626 N.E.2d 190, 193 Ill. Dec. 157 (1993).  An abuse of discretion occurs only when no reasonable person would adopt the Court’s point of view. Rose v. Mercedes-Benz USA, LLC, 378 Ill. App. 3d 615, 623 (Ill. App. 2007).  Even when a trial court abuses its discretion in admitting evidence, a new trial should be ordered only when the improperly admitted evidence affected the outcome of the trial. Schmidt v. Ameritech Illinois, 329 Ill. App. 3d 1020, 1040-41 (Ill. App. 2002), citing Tzystuck v. Chicago Transit Authority, 124 Ill. 2d 226, 243 (Ill. 1988).  As set forth below, the Court did not abuse its discretion in admitting the evidence at issue and, in any event, the admission of such evidence did not affect the outcome of the trial.

A.        The Court properly admitted evidence of the 2004 recall.

  1. The Court properly held that the 2004 recall was not “subsequent”

for purposes of the subsequent remedial measure rule.

The Court properly admitted evidence of Defendants’ 2004 recall.  It did so because it held that the 2004 recall was neither “subsequent” nor “remedial” for purposes of the subsequent remedial measure doctrine. (10-28, p.m., Tr. 304:5-13).  Both conclusions were correct as a matter of law.  First, the Court correctly held that the 2004 recall was not “subsequent” because it because it was instigated by Defendants before Janice DiCosolo’s death.  Specifically, by February 13, 2004, two days before Janice DiCosolo’s death, Defendants stated in an internal memo that “[b]ecause of the potential medical risk, it was determined that we would initiate a Class I recall.”  (See February 13, 2004 memorandum (Ex. 24).)  On February 15, 2004, the day of DiCosolo’s death, Defendants published a Health Hazard Analysis Supporting the Recall of Duragesic 75 ug/hr Transdermal Systems that supported the recall.  (See February 15, 2004 Health Hazard Analysis (Ex. 25).)  Moreover, according to the FDA, Defendants “initiated a Voluntary Recall Class I of Pouched Lot # 0327192 on 2/15/04 due to the lot exhibiting a critical fold over defect.”  (See FDA Form 483 (Ex. 7).)  Clearly, the recall was planned and initiated prior to Janice DiCosolo’s death and could not possibly have been undertaken with knowledge of, or in reaction, to that death.  It was therefore not a subsequent remedial measure.  Van Gordon, 693 P.2d at 1288 (“The new signs cannot be considered remedial safety measures in response to the Van Gordon accident if PGE did not know of the injury or its circumstances. In other words, a defendant must know of the prior event in order to fashion a safety measure to remedy any hazard that caused the event.”).

The subsequent remedial measure rule was articulated by the Illinois Supreme Court in Herzog as holding that “[e]vidence of post-accident remedial measures is not admissible to prove prior negligence.”  Herzog v. Lexington Township, 167 Ill. 2d 288, 300 (Ill. 1995); (emphasis added); see also Worsley v. Farmington Pizza Co., Inc., 322 Ill. App. 3d 371, 373 (Ill. App. 2001) (emphasis added) (“Evidence of a defendant’s post-accident remedial measures is not admissible as proof of negligence”); Simich v. Edgewater Beach Apts. Corp., 368 Ill. App. 3d 394, 411 (Ill. App. 2006) (emphasis added) (“post-occurrence remedial measures are inadmissible to prove negligence”); Grubbs v. Illinois Terminal Co., 366 Ill. 330, 341 (Ill. 1937) (emphasis added) (“evidence of repairs made after the accident is not admissible”).  This rule is “comparable to Rule 407 of the Federal Rules of Civil Evidence.”  Davis v. International Harvester Co., 167 Ill. App. 3d 814, 822 (Ill. App. 1988).  That Rule states:

When, after an injury or harm allegedly caused by an event, measures are taken that, if taken previously, would have made the injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove negligence, culpable conduct, a defect in a product, a defect in a product’s design, or a need for a warning or instruction.

Fed. R. Evid. 407 (emphasis added).

Defendants disingenuously cite Smith v. Black & Decker (U.S.)., Inc., 272 Ill. App. 3d 451, 456 (Ill. App. 1995) for the proposition that post-manufacture but pre-injury remedial measures may be considered “subsequent” remedial measures.  Defendants’ Motion at pp. 23-24.  But Smith was a 1995 case.  Rule 407 was amended in 1997 to more clearly require that the remedial measure be one that was undertaken only after the plaintiff’s injury.  The Commentary to Rule 407 specifically states that:

[t]he 1997 amendment to the Rule limits exclusion to measures taken “after an injury or harm.” This clarifies that the rule applies only to changes made after the occurrence that produced the damages giving rise to the action. Evidence of measures taken by the defendant prior to the “event” causing “injury or harm” do not fall within the exclusionary scope of Rule 407 even if they occurred after the manufacture or design of the product.

Fed. R. Evid. 407, Commentary; see also 23 Wright & Graham, Federal Practice & Procedure: Evidence § 5283 (“[T]he word ‘after’ should be read to require some causal relationship between the event and the remedial measure.”).

Given the clear language of Rule 407 and its state statutory and common-law counterparts, nearly all courts applying the subsequent remedial measure rule have held that evidence of pre-accident measures – including measures approved or adopted pre-accident but implemented post-accident – is not covered by the rule.  For example, the First District in Millette held that a recall letter was admissible over an objection that it was a subsequent remedial measure “because the letter was not an aftermath of the accident.”  Millette, 84 Ill. App. 3d at 19; see also Chase v. General Motors Corp., 856 F.2d 17, 22 (4th Cir. 1988) (“The change in the brake design of the Citation occurred in July 1980, some two or three months after the plaintiffs’ car was manufactured and sold to them. That was a “measure” which was “taken” before the “event” mentioned in Rule 407. So Rule 407 does not exclude evidence with respect to that change.”); Trull v. Volkswagen of America, Inc., 187 F.3d 88, 96 (1st Cir. 1999) (“Although evidence concerning subsequent remedial measures generally is not admissible at trial, see Fed. R. Evid. 407, measures that take place before the accident at issue do not fall within the prohibition.”);  Arcenaux v. Texaco, Inc., Humphries v. Mack Trucks, Inc., No. 98-1970, 1999 U.S. App. LEXIS (4th Cir. Oct. 13, 1999) (“The trial judge did, indeed, fail correctly to apply Rule 407. The accident took place in 1974, but the changes were made beginning in 1971. Thus, they were not implemented in response to the “event.”); Raymond v. The Raymond Corp., 938 F.2d 1518, 1523 (1st Cir. 1991) (“Under 407, only measures which take place after the “event” are excluded.  The term “event” refers to the accident that precipitated the suit.  As the Model 76 modifications took place prior to the 1987 accident, Rule 407 cannot be applied.”); Straley v. U.S., 887 F. Supp. 728, 746 (D. N.J. 1995) (“Rule 407 is clearly not applicable to this case, however, as the “event” in question is the accident, and the warnings were mailed prior to the accident.”); Bogosian v. Mercedes Benz of North America, Inc., 104 F.3d 472, 481 (1st Cir. 1996) (“Although this circuit has recognized that Federal Rule of Evidence 407 applies to strict liability cases, it does not apply where, as here, the modification took place before the accident that precipitated the suit.”);  Dixon v. Jacobsen Mfg. Co., 637 A.2d 915, 918 (N.J. App. 1994) (“Hence, the Rule would not be a bar to admissibility of remedial measures, such as the warning labels or safety instructions . . . issued by defendant after the date of  manufacture, but prior to the date of the ‘event’ (plaintiff’s accident).”); Schmeck v. City of Shawnee, 651 P.2d 585, 600 (Kan. 1982) (installation of new traffic control devices after the accident was not a subsequent remedial measure because the city had already determined before the accident to place the devices at the intersection and the evidence thus “could not be characterized as subsequent remedial conduct.”); Myers v. Hearth Technologies, Inc., 621 N.W.2d 787, 792 (Minn. Ct. App. 2001) (“the changes were made well before the explosion that injured Richard Myers. . . . As a result, the changes were not subsequent remedial measures within the meaning of the rule.”); Uptain v. Huntington Lab, Inc., 723 P.2d 1322, 1328 (Colo. 1986) (“In this case, however, the new label was submitted to the EPA for approval in 1978, one year prior to the date of the plaintiff’s injuries. Thus, the new label cannot be deemed a “subsequent” remedial measure.  CRE 407 is expressly limited to measures taken “after an event.”).  There is simply no basis for the Court to have excluded evidence of pre-injury measures such as the 2004 recall.

2. The Court properly held that the 2004 recall was not “remedial” for

purposes of the subsequent remedial measure rule.

Moreover, the Court properly found that the 2004 recall was not “remedial” for purposes of the subsequent remedial measure rule.  Rule 407 of the Federal Rules of Civil Evidence defines subsequent remedial measures as measures “that, if taken previously, would have made the injury or harm less likely to occur.”  Fed. R. Civ. P. 407.  In other words, “remedial measures are those actions taken to remedy any flaws or failures.”  Dow Chemical Corp. v. Weeveil-Cide Co., 897 F.2d 481, 487 (10th Cir. 1990); see also Grubb v. Illinois Terminal Co., 366 Ill. 330, 341 (Ill. 1937) (emphasis added) (“evidence of repairs made after the accident is not admissible”); Patrick v. South Cent. Bell Tel. Co., 641 F.2d 1192, 1195-96 (6th Cir. 1980) (emphasis added) (Rule 407 “prohibits evidence of post-accident changes that make things different or better than they were at the time of an accident.”); Wilson v. Teagle, No. 81C-AU-14, 1985 Del. Super. LEXIS 1244 at *2 (Del. Super. Ct. 1985) (emphasis added) (purpose of rule “is to encourage repairs of potentially dangerous conditions by excluding remedial measures as evidence of negligence.”); Ranches v. City and County of Honolulu, 168 P.3d 592, 601 (Haw. 2007) (emphasis added) (rule “was designed to encourage defendants who are first notified of a dangerous conditions to make repairs”).

Typically subsequent remedial measures are things such as design changes, manufacturing changes or the addition of new safety features.  A product recall such as occurred here is not a subsequent remedial measure.  A recall does nothing to improve the safety of the recalled product.  It does nothing to “remedy any flaws or failures.”  Rather, it merely seeks to limit a product manufacturer’s future liability by removing from the market potentially dangerous products.  It is best seen as a self-serving attempt to limit liability rather than as the type of safety-enhancing remedial measure the rule is designed to encourage.  See, e.g., Schaffner v. Chicago & N.W. Transp. Co., 129 Ill. 2d 1, 11 (Ill. 1989) (emphasis added) (describing one of the two bases of the rule as the concern that “correction of unsafe conditions should not be deterred by the possibility that such an act will constitute an admission of negligence.”); Worsley v. Farmington Pizza Co., 322 Ill. App. 3d 371, 373 (Ill. App. Ct. 2001) (emphasis added) (“Evidence of a defendant’s post-accident remedial measures is not admissible as proof of negligence because 1) public policy encourages the adoption of safety improvements for unsafe conditions”).  Because the recalls did nothing to remedy or make safe Defendants’ dangerous Duragesic patches, they did not constitute a subsequent remedial measure.  See, e.g., Fasanaro v. Mooney Aircraft Corp., 687 F. Supp. 482, 487 (N.D. Cal. 1988) (“Post-event tests will not, in themselves, result in added safety. Rather, it is only if the defects revealed in those tests are remedied and changes implemented that the goal of added safety will be furthered. By its terms Rule 407 includes only the actual remedial measures themselves and not the initial steps toward ascertaining whether any remedial measures are called for.”).

The burden is on Defendants to demonstrate the facts necessary to bring the product recalls within the subsequent remedial measure rule.  See Olech v. Village of Willowbrook, No. 97 C 4935, 2002 U.S. Dist. LEXIS 19578 at *25 (N.D. Ill. Oct. 11, 2002) (“Whatever the context, the burden remains the same: the party wishing to exclude evidence of subsequent remedial measures has the burden of proving any preliminary facts necessary to bring the exclusionary rule into play.”).  Defendants cannot meet this burden for the simple reason that there is no evidence that the recalls were a measure “that, if taken previously, would have made the injury or harm less likely to occur.”  Fed. R. Evid. 407; Van Gordon v. Portland General Electric Co., 693 P.2d 1285, 1288 (Ore. 1985) (“In the present case, the posting of the new signs would not have prevented the Van Gordon accident, nor made it less likely to occur. Had the new signs with the new language been posted before Brock Van Gordon was burned, the new signs would not have made the accident less likely to occur because the uncontroverted evidence showed that the location of the signs made it impossible for Brock Van Gordon’s grandmother to read them. She was on a different path leading to the hot springs and would not have been able to read the signs. Thus, the posting of the new signs fails to qualify as a subsequent safety measure under the basic definition of OEC 407. The new signs were not a remedy at all as to the Van Gordon accident.”).  Here, there is no evidence that the recalls qualify as a remedial measure.  In fact, the need for the 2008 recall as a result of leaking patches belies any notion that the 2004 recall remedied the leak problem.  In truth, it did not.

In fact, Defendants claimed both before trial (Defendants’ Motion in Limine to Exclude Evidence of the 2004 Product Recall at p. 1) and during trial (11-14, a.m., Tr. 2834:17-2835:12) that the patch used by Mrs. DiCosolo did not contain the defect that prompted the 2004 recall.  They cannot then be heard to claim that the 2004 was somehow “remedial” in that they would have made Janice DiCosolo’s death less likely to occur.  Given Defendants’ insistence that DiCosolo’s patch “did not exhibit a breached seal defect, the specific defect that prompted the 2004 recall,” they cannot show that the recall was a subsequent remedial measure as to Janice DiCosolo. Id. The Court did not err in allowing evidence of the 2004 recall because it was not a subsequent remedial measure.

3. The Court properly held that the 2004 recall was relevant to the existence of a defect.

Contrary to Defendants’ argument, the 2004 recall was relevant and probative evidence of the existence of a defect.  See, e.g., Navarro v. Fuji Heavy Inds., 952 F. Supp. 1323, 1327 (N.D. Ill. 1996) (recall notice was admissible “for limited purpose of establishing that the car’s suspension system was defective”); Longenecker v. General Motors Corp., 594 F.2d 1283, 1286 (9th Cir. 1979) (“The recall letter recited that engine-mount separation would occur, if at all, during rapid acceleration.  Lustre was not accelerating when the mounts in his car allegedly separated. But the letter was relevant evidence that there was a flaw in the mounts, and the district court did not abuse its discretion in receiving the letter.”); Nevels v. Ford Motor Co., 439 F.2d 251, 258 (5th Cir. 1971) (“the recall campaign to correct a possible defect in the steering mechanisms of Mustangs manufactured by Ford was alluded to by witnesses for both parties and was the subject of extended comment by counsel. The evidence was relevant not only with respect to the statutory duty of Ford, but also in regard to plaintiff’s contention of negligent assembly in the manufacturing process.”).  This is particularly true where, as here, the recall notice involved the very same product the plaintiff alleges was defective.  Giglio v. Saab-Scania of America, No. 90-2465, 1992 U.S. Dist. LEXIS 17026 at *11 (E.D. La. 1992) (“The evidence of a product recall for a class of automobiles including the one involved in this lawsuit is extremely probative of whether the vehicle had a defect at that time.”).

The cases cited by Defendants are inapposite.  In Millette v. Chrysler Corp., 84 Ill. App. 3d 5, 20 (Ill. App. Ct. 1980), the court merely noted that a general recall letter could not, by itself, prove the existence of a defect.  The court did not, however, hold that such evidence was irrelevant to the existence of a defect; in fact, the court actually admitted the recall notice at issue.  As for the other two cases cited by Defendants, while they state that recall notices merely establish the possibility of a defect in a class of products, neither of them even addressed the admissibility of recall notices.  Perona v. Volkswagen of America, Inc., 292 Ill. App. 3d 59, 63 (Ill. App. Ct. 1997); Bagel v. American Honda Motor Co., 132 Ill. App. 3d 82, 88 (Ill. App. Ct. 1985).   And neither of them stand for the proposition that recall notices are per se irrelevant or inadmissible in a product liability case.

4.         Defendants suffered no prejudice from the introduction of the 2004 recall or the Court’s refusal to give Defendants’ jury instruction no. 32.

 

Finally, Defendants suffered no prejudice from the introduction of the 2004 recall or the Court’s refusal to give Defendants’ jury instruction no. 32.  As for evidence of the recall, Defendants claim that they were prejudiced because Plaintiff wrongly “inferred that the particular patches used by Mrs. DiCosolo were defective merely because they came from a recalled lot.”  Motion at p. 25.  There are two problems with this assertion.  First, the quote on which it is based – “The FDA said this lot was defective” – was not a reference to the 2004 recall, which was voluntary and not mandated by the FDA, but to the FDA’s inspection of Defendants’ manufacturing facility.  (11-14, a.m., TR. 2819).  Second, there is nothing prejudicial about the jury inferring a defect from a recall.  See, e.g., Navarro v. Fuji Heavy Inds., 952 F. Supp. 1323, 1327 (N.D. Ill. 1996) (recall notice was admissible “for limited purpose of establishing that the car’s suspension system was defective”).  Admission of the 2004 recall provides no basis for a new trial.

Nor does the Court’s refusal to give Defendants’ jury instruction no. 32 warrant a new trial.  As Defendants’ admit, failure to give a jury instruction is an abuse of discretion only when such failure “prejudice’s the party’s right to a fair trial.”  Mikolajczyk, 2008 Ill. LEXIS 1424 at *69.  Here, Defendants have offered no explanation as to how they were prejudiced by the Court’s refusal to give Defendants’ jury instruction no. 32.  Even if the instruction were an accurate statement of the law, which it is not, it is not automatically prejudicial to refuse to give it.  If the Court were required to inform the jury that each isolated piece of evidence alone was not by itself proof of a defect, the charge would be hundreds of pages long.  Defendants were free to argue to the jury that the 2004 recall by itself did not prove a defect, but they were not entitled to the jury instruction to the same effect.

E.        The Court properly allowed Dr. Prausnitz to testify regarding the effects of

fentanyl gel leakage.

The Court properly allowed Dr. Prausnitz to testify that fentanyl gel leakage could lead to a fatal fentanyl overdose.  First, to the extent Prausnitz relied on the affidavit of John DiCosolo, the court did not err in allowing him to do so.  While Defendants argue the affidavit was inadmissible, expert witnesses are entitled to rely upon evidence that may not be admissible in and of itself.  See, e.g., Wilson v. Clark, 84 Ill. 2d 186, 196 (Ill. 1981) (adopting Federal Rule of Evidence 703, which stated that “[t]he facts or data in the particular case upon which an expert bases an opinion or inference may be those perceived by or made known to the expert at or before the hearing. If of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject, the facts or data need not be admissible in evidence.”).  Moreover, although the Defendants claim the affidavit was unreliable, the sole basis for this claim is that the affidavit allegedly “contradicted Mr. DiCosolo’s sworn deposition testimony that he had never noticed any leakage from his wife’s Duragesic patches.”  Motion at p. 32.  But this supposed “contradiction” was entirely manufactured by Defendants.  In truth, Mr. DiCosolo merely stated in his deposition that he never observed that the patch had leaked.  Deposition at 96-97.  In his affidavit, he never claimed to have noticed a leak.  He merely stated that he observed a slick film upon removing his wife’s patch, something about which he was never asked in his deposition.   He never claimed this was evidence of a leak; that was a conclusion reached by Dr. Prausnitz as a result of additional evidence described below.  At trial, John DiCosolo even admitted that the slick film may simply have been sweat.  (11-7, a.m., Tr. 1737:7-11).  Clearly, he never stated that he saw a leaking patch.  There simply was no contradiction between the affidavit and his prior deposition testimony.

Defendants also assert that Prausnitz’ opinions were objectionable because there was no proof that any of the three things he testified could happen when gel leaks from a patch actually occurred in this case.  This assertion ignores the abundant circumstantial evidence that leaking gel caused Mrs. DiCosolo to suffer a fatal fentanyl overdose, including:

  • John DiCosolo’s affidavit;
  • the 28.2 ng/mL fentanyl blood level found at autopsy;
  • the conclusion of the Cook County Medical Examiner that Janice died from fentanyl-venlafaxine-gapapentin intoxication;
  • the fact that Defendant had poor manufacturing practices;
  • the fact that there were numerous instances of Defendants’ patches leaking;
  • the fact that Defendants’ 2004 recall notice stated that “[i]f the medication leaks from the patch, patients can get either too much or too little medication.  Exposure to too much medication can occur of the medicine leaks directly onto the skin and the body absorbs a higher than intended amount.”
  • the fact that Defendants’ 2004 recall notice stated that “[e]xposure to the Duragesic hydrogel contents could result in an increased absorption of the opiod component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications;” and
  • the fact that Janice’s patch come from a specific lot that had been recalled due to leaking patches.

Experts are certainly entitled to rely on circumstantial evidence and reasonable inferences therefrom.  See, e.g., Murphy v. General Motors Corp., 285 Ill. App. 3d 278, 282 (Ill. App. 1996) (“in product liability cases often rely on circumstantial evidence to form their opinions as to whether a product is defective.”).  The fact that Prausnitz could not say with certainty which of the three phenomena occurred is irrelevant.  Wojcik v. City of Chicago, 299 Ill. App. 3d 964, 978 (Ill. App. 1998) (“an expert can testify in terms of possibilities or probabilities so long as the opinion is based on a reasonable degree of medical probability.”). The Court did not err in allowing Prausnitz’ testimony.

F.         The Court properly admitted evidence of Defendants’ interaction with the FDA.

 

The Defendants argue that evidence that they were less than candid, perhaps overtly deceitful, with the FDA was inadmissible under Buckman Company v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001).  However, the issue in Buckman was whether a specific claim of fraud on the FDA was preempted.  The issue in McCutcheon v. Zimmer Holdings, 586 F. Supp. 2d 917 (N.D. Ill. 2008) was whether a plaintiff could allege fraud on the FDA as a means of avoiding the pre-emptive effect of FDA approval of a medical device; the court held that it could not.  Neither Buckman nor McCutcheon involved a state court negligence claim or a claim involving a prescription drug.  In fact, the court in Buckman went to great lengths to differentiate the case from such cases:

We must also reject respondent’s attempt to characterize both the claims at issue in Medtronic (common-law negligence action against the manufacturer of an allegedly defective pacemaker lead) and the fraud claims here as “claims arising from violations of FDCA requirements.” Notwithstanding the fact that Medtronic did not squarely address the question of implied pre-emption, it is clear that the Medtronic claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although Medtronic can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.

Buckman, 531 U.S. at 352-53.  As the Defendants acknowledge, the instant case did not raise a specific claim of fraud on the FDA. Motion at p. 35. Admission of the evidence at issue was therefore not precluded by Buckman or McCutcheon.

The evidence was not only admissible, it was highly relevant.  First, the defense opened the door to the e-mails at issue by stating repeatedly to the jury in opening statement that the Defendants were acting as a partner with the FDA, working in tandem with the FDA all along in developing a safe product and labeling that gave adequate information to the prescribing physician. (10-29, a.m., Tr. 392-93, 396, 406, 407, 408; 10-30, p..m., Tr. 658).  Defense counsel even told the jury in opening – before the evidence at issue had been admitted or even mentioned by Plaintiff’s counsel – that Defendants “were fully cooperating with the FDA” at the time of the plant inspections following the February 2004 recall.  (10-29, a.m., TR. 402:4-11).  And yet two of Hank Avallone’s e-mails, written during this exact time frame, March 2004, clearly demonstrated that Defendants were not accurately communicating with the FDA and were instead providing the FDA with “misinformation.”  PX 108, 120.  In a later e-mail, Avallone similarly stated that “it is very difficult to partner with the FDA if we keep deceiving them.”  PX 133.  These e-mails were clearly relevant to rebut Defendants’ argument, which began in opening statement, that they were honest partners with the FDA.

Finally, two of the four e-mails at issue contained critical admissions by Defendants that were highly relevant.  In a March 2004 e-mail, Hank Avallone admitted that the Defendants’ manufacturing process “is not capable of yielding zero defects for gel in the seal.”  PX 120.  In a December 2004 e-mail, Avallone stated that “human inspection on a line is essentially useless,” providing critical evidence that Defendants’ manufacturing processes and controls were wholly inadequate to prevent leaking patches like the one that killed Janice DiCosolo from being manufactured and released to the public.  PX 131.  The e-mails at issue were both admissible and highly relevant.  Defendants’ Motion should therefore be denied.

 

G. The Court properly admitted evidence of Janice’s postmortem fentanyl level.

The Court properly admitted evidence of Janice’s postmortem fentanyl level.  Defendants’ argument to the contrary is nothing more than rehash of claims the Court rejected at both the summary judgment and motion in limine stages of this case.  As set forth previously by Plaintiff, Janice DiCosolo’s postmortem fentanyl level was admissible as a matter of law under Illinois statute.  See 725 Ill. Comp. Stat. 5/115-5.1.   Defendants claim, however, that such evidence should have been excluded as unreliable because of the phenomenon of postmortem redistribution (“PMR”).  But courts have held that PMR merely goes to the weight of postmortem blood levels, not to their admissibility:

Here, there was nothing novel, suspect, or unreliable about Cohle’s testimony regarding the level of drugs in Sloan’s blood at the time of the autopsy. These data were scientifically determinable. Nor was there anything novel, suspect, or unreliable about Cohle’s conclusion that because of the absence of other causes of death and because of the drug levels in Sloan’s body, the likely cause of death was drug intoxication. Assuming, arguendo, that postmortem redistribution affected the level of drugs found in Sloan’s body at the autopsy as compared to the time of death, the effect of this redistribution was disputed at trial, and such evidence is relevant to the weight, not the admissibility, of Cohle’s testimony. The jury was adequately informed of the ramifications that postmortem redistribution, according to defendant’s experts, could have on a determination of the cause of Sloan’s demise. No error occurred.

People v. Stiller, 617 N.W.2d 697 (Mich. Ct. App. 2000), appeal denied, 626 N.W.2d 412 (Mich. 2001); see also State of Montana v. Bieber, 170 P.3d 444, 453-55 (Mont. 2007) (trial court did not err in allowing testimony regarding cause of death that was based on postmortem toxicology despite argument that levels were inflated due to postmortem redistribution); State of Ohio v. Aeh, No. 95APA11-1449, 1996 Ohio App. LEXIS 2774 at *5, 16 (Ohio Ct. App. June 27, 1996) (trial court did not err in admitting testimony from toxicologist that postmortem level of butalbital was within the toxic range despite argument that level was unreliable due to postmortem redistribution); McAlpine v. Midland Elec. Co., 634 P.2d 1166, 1171 (Mont. 1981) (“At most, appellant laid the basis for a suggestion that a change in the blood of the victims occurred between the time of death and the time the blood was drawn. Such a suggestion goes to weight, not admissibility.”).

Janice DiCosolo’s postmortem fentanyl level was clearly admissible as evidence that fentanyl caused her death.  Both Plaintiff’s experts and Defendants’ experts agreed at trial that postmortem fentanyl levels are routinely used to determine cause of death.  (10-29, p.m., 456:6-21) (Dr. Downs opined that PMR did not affect his conclusion that fentanyl caused Mrs. DiCosolo’s death); (11-12, a.m., 2289:16-2290:3) (Defense expert Dr. Zumwalt agreed that he routinely relies on postmortem fentanyl levels to determine cause of death).  Janice DiCosolo’s postmortem fentanyl level was also admissible as evidence of a defect.  While Dr. Middleberg testified that he could not identify a precise pre-death fentanyl level by extrapolating from Janice DiCosolo’s postmortem level, he testified that he could testify to a range based on the fact that PMR has an affect of no more than 2 times in fentanyl.  (11-5, a.m., Tr. 1362:6-1364:24).  Thus, even if extreme PMR occurred, Janice DiCosolo’s pre-death fentanyl level would have been at least 14.1 ng/mL (50% of her postmortem level of 28.2 ng/mL).  This level is significantly above the stated mean maximal concentration of 1.7 ng/mL for a 75 mcg/hr patch and provided ample evidence of a defect.  Defendants’ own expert, Dr. Zumwalt, admitted that a postmortem blood fentanyl level of 30 ng/mL (not much more than the 28.2 ng/mL level at issue here) would be evidence of a defect:

Q.    Okay.  I’m using a 75-microgram patch.  I’m not abusing it in any way.  I don’t have multiple patches on.  My level is 30.  What would be — I mean, if I came into your office and there is no other anatomic cause of death, I’ve got a 30.  The patch should be giving me a 1.7.  Now, maybe there’s some postmortem redistribution going on there, but that’s not going to explain the difference.  How would you think about that case?

A.   My answer is I would think that maybe the patch had too much drug put into it in the beginning or something, and there was something wrong with the patch.  I think you would have to consider that along with all the other possibilities.

(11-12, a.m., Tr. 2301:23-2302:14 ).  While defense counsel was free to, and did, cross-examine Plaintiff’s experts regarding PMR, Janice DiCosolo’s postmortem fentanyl level was clearly admissible.  See, e.g., In re Jacoby Plane Crash Litig., Civ. No. 99-6073, 2007 U.S. Dist. LEXIS 71012 at *51 (D. N.J. Aug. 27, 2007) (objection to postmortem methodology of extrapolating “from the butalbital concentrations in various parts of the body what level was present in the blood at the time of death” was “precisely the kind of argument that should be made at trial through proper cross-examination”).

V.        Defendants are not entitled to a new trial based on Plaintiffs’ closing argument.

Defendants maintain that they were prejudiced by comments made by Plaintiff’s attorney during closing argument.  Motion at p. 46.  They assert that John’s attorneys’ closing argument was improper because:  (1) the attorneys allegedly argued that Janice’s Duragesic patches could be regarded as defective because the patches came from a recalled lot; (2) the attorneys allegedly argued that the warnings in the 2003 Duragesic package insert were defective because they did not contain warnings that were added to new versions of the package insert; (3) the attorneys argued that, at the time of her death, Janice had been following the same drug regimen she had been on for months; and (4) the closing argument allegedly contained improper and inflammatory remarks.  For the reasons discussed below, John’s attorneys’ closing argument was not improper and does not entitle the Defendants to a new trial.

A. Counsel are afforded wide latitude in closing argument and allegedly prejudicial comments in closing arguments do not constitute reversible error unless they are so prejudicial that they deprive the other party of a fair trial.

Under Illinois law, “attorneys are afforded wide latitude in closing arguments and may comment and argue on the evidence and any inference that may be fairly drawn from that evidence.”  Clarke v. Medley Moving & Storage, Inc., 381 Ill. App. 3d 82, 95 (Ill. App. 2008); Black v. Laggren, 313 Ill. App. 3d 39, 44 (Ill. App. 2000) (same).  Improper comments by counsel constitute reversible error only where the comments are so prejudicial as to deprive the other party of the right to a fair trial.  Clarke, 381 Ill. App. 3d at 95; Balzekas v. Looking Elk, 254 Ill. App. 3d 529, 535 (Ill. App. 1993) (“A mistrial will generally be declared only as the result of some occurrence at trial of such character and magnitude that a party is thereby deprived of a fair trial.”); Compton v. Ubilluz, 353 Ill. App. 3d 863, 873 (Ill. App. 2004) (“Even where improper comments are made during closing argument, reversal is appropriate only where the comments substantially prejudiced the challenging party.”).

“Issues concerning the prejudicial effect of comments made during closing argument are within the discretion of the trial court, and determinations regarding such issues will not be reversed absent a clear abuse of discretion.”  Clarke, 381 Ill. App. 3d at 95; Compton, 353 Ill. App. 3d at 873 (same).  In determining whether there has been an abuse of discretion, an appellate court “may not substitute our judgment for that of the trial court, or even determine whether the trial court exercised its discretion wisely.”  Clarke, 381 Ill. App. 3d at 95; Simmons v. Garces, 198 Ill. 2d 541, 568 (Ill. 2002) (same).  Here, the Court heard the closing arguments and determined that the arguments were not unfairly prejudicial and would not prevent the jury from rendering a fair verdict.  (11-14, a.m., Tr. 2897:5-15).  The Court was in the best position to observe the arguments of counsel and the atmosphere of trial, and to make a determination about its effect on the jury.  Simmons, 198 Ill. 2d at 571 (The scope and character of closing argument are left to the discretion of the trial judge, who enjoys the best position to view the demeanor of counsel and the atmosphere of the trial.”); Compton, 353 Ill. App. 3d at 873 (concluding that the trial court did not abuse its discretion by denying a mistrial, the appellate court observed that the “trial court witnessed Walsh’s entire closing argument, including his objectionable conduct, and the court saw how Walsh’s behavior affected the jury.”)  Under these circumstances, Defendants cannot meet their heavy burden of showing that they are entitled to a new trial based on the allegedly improper closing argument.

Finally, a jury instruction stating that argument by counsel is not evidence cures any error that may have occurred.  Simmons, 198 Ill. 2d at 571 (plaintiffs were not entitled to a new trial based on allegedly improper closing argument because the trial court reminded the jury that closing arguments are not evidence); see also People v. Alksnis, 291 Ill. App. 3d 347, 358 (Ill. App. 1997) (“Error is cured by sustaining an objection, admonishments and jury instructions. The trial court sustained defendant’s objection to the prosecutor’s statement.   Before and after closing arguments, the trial court instructed the jury that what the lawyers said in closing arguments was not evidence and should not be considered as evidence.”)   In this case, this Court told the jurors that they should disregard any statement or argument of an attorney not supported by the law or the evidence.  IPI Civil No. 1.01.  Therefore, any alleged prejudice in John’s attorneys’ closing argument was cured by this instruction.

B. Defendants’ are not entitled to a new trial because John’s attorneys allegedly argued that Janice’s Duragesic patches could be regarded as defective because they came from a recalled lot.

Defendants contend that they are entitled to a new trial because John’s attorneys argued that Janice’s Duragesic patches could be regarded as defective because they came from a recalled lot.  Motion at p. 46 (citing 11-14, a.m., Tr. 2819:7-11).)[2] This argument is without merit for numerous reasons.  First, Defendants’ argument that John’s attorney stated that Janice’s Duragesic patches were defective because they came from a recalled lot is a gross mischaracterization of the attorney’s statement.  The statement was made near the end of the closing argument.  (11-14, a.m., Tr. 2819:7-11.)  John’s attorney argued that the evidence presented at trial and discussed during closing argument showed that Janice’s patches were defective and that the FDA determined that Lot 192 was defective:

This patch, as we talked about now for about 40 minutes, was absolutely manufactured with a defect.  We have talked about it.  There can be no dispute.  The FDA said this lot was defective.  We know that for sure.

(11-14, a.m., Tr. at 2819:7-11.)  John’s attorney did not, however, argue that every patch in Lot 192 was defective or that Janice’s patch could be regarded as defective simply because it came from a recalled lot.  Moreover, the comment about the FDA was not a comment about the recall itself, but about the FDA’s subsequent inspection of Defendants’ manufacturing facilities.  (See, e.g., FDA Establishment Inspection Report (PX 255) (containing an extensive discussion about the numerous defective patches found in Lot 192)).

Second, the 2004 recall was relevant to the existence of a product defect.  See, e.g., Navarro, 952 F. Supp. at 1327 (recall notice was admissible “for limited purpose of establishing that the car’s suspension system was defective”); Longenecker, 594 F.2d 1283, 1286 (9th Cir. 1979) (recall letter was relevant evidence on the issue of whether there was a flaw in the engine mounts and the district court did not abuse its discretion in receiving the letter); Nevels, 439 F.2d at 258 (recall to correct defect in steering assembling was relevant evidence on the issue of negligent assembly in the manufacturing process).  The recall evidence is particularly relevant in this case because the recall notice involved the very same product the plaintiff alleges was defective.  Giglio, 1992 U.S. Dist. LEXIS 17026 at *11 (“The evidence of a product recall for a class of automobiles including the one involved in this lawsuit is extremely probative of whether the vehicle had a defect at that time.”).  Moreover, as discussed above, Millette v. Chrysler Corp., 84 Ill. App. at 20, does not support the Defendants’ argument that the 2004 recall was not relevant to the existence of a defect.  In Millette, the court merely noted that a general recall letter could not, by itself, prove the existence of a defect.  The court did not, however, hold that such evidence was irrelevant to the existence of a defect; in fact, the court actually admitted the recall notice at issue.  See id.

Third, Defendants waived any error by failing to object to it at trial.  Defendants did not object to the comment during the closing argument and did not move for a mistrial based on that comment following closing arguments.  Failure to object to alleged errors during closing argument is deemed a waiver of those points. Hubbard v. Sherman Hospital, 292 Ill. App. 3d 148, 156-57 (Ill. App. 1997); Kenny Construction Co. v. Hinsdale Sanitary District, 111 Ill. App. 3d 690, 700 (Ill. App. 1982) (“a failure to object to alleged errors in an opponent’s closing argument is considered a waiver of objection.”).  “A party cannot sit on his hands and let perceived errors into the record and complain of those errors for the first time in a post-trial motion.”  Pharr v. Chicago Transit Authority, 220 Ill. App. 3d 509, 515 (Ill. App. 1991).

Fourth, Defendants waived any objection to closing arguments about the recall and the FDA’s investigation following the recall because Defendants discussed the recall, their relationship with the FDA, and the FDA’s post-recall investigation in opening statements (e.g., noting that they “were working cooperatively with the FDA”) and called Dan Michels to give expert testimony about those issues in their case in chief.  (10-29, a.m., Tr. 399:19 – 407:7); (11-7, a.m., Tr. 1831:13 – 188:24).  Defendants’ opening statements and the testimony of Dan Michels interjected the recall and the FDA’s investigation following the recall into the proceeding.  Therefore, the Defendants waived any objection to John’s attorney addressing those issues in his closing argument.  Jarmon v. Jinks, 165 Ill. App. 3d 855, 864 (Ill. App. 1987) (counsel cannot complain when he interjects an argument into the proceedings which invites rebuttal from opposing counsel); Lembeck v. Brady, 78 Ill. App. 2d 146, 152 (Ill. App. 1966) (same).

Finally, Defendants cannot meet their heavy burden of showing that John’s attorney’s statements regarding the recall were so prejudicial that they are entitled to a new trial.  Under Illinois law, “attorneys are afforded wide latitude in closing arguments and may comment and argue on the evidence and any inference that may be fairly drawn from that evidence.”  Clarke, 381 Ill. App. 3d 95.  Improper comments by counsel constitute reversible error only where the comments are so prejudicial as to deprive the other party of the right to a fair trial.  Id. Defendants’ Motion is devoid of any argument showing why the statements concerning the recall—which the Defendants did not object to at trial or raise in their motion for a mistrial—were so prejudicial that they supposedly warrant a new trial.

C. Defendants are not entitled to a new trial because John’s attorneys allegedly argued that the warnings in the 2003 Duragesic package insert were defective because they did not contain warnings that were added to new versions of the package insert.

Defendants also maintain that a new trial is warranted because Plaintiff’s counsel allegedly argued that the warnings in the 2003 Duragesic package insert were defective because they did not contain warnings that were added to new versions of the package insert.  Motion at pp. 46-7 (citing 11-14, a.m., Tr. 2820:12-20).  But the essence of John’s attorney’s comments was simply that the warning about potential hypoventilation in the 2003 package insert was insufficient to warn that Duragesic can kill patients:

Issue No. 3, ladies and gentlemen, it is pretty simple.  It is called a defective warning.  The defective warning you just saw, they now tell people, hey, this can kill you.  They didn’t do that to her on her patch, her insert.  They didn’t say, well, hypoventilation, and it is kind of the same thing.  Now it says fatal.  It didn’t say it before.  It was defective in the warning in the package insert.

(11-14, a.m., Tr. 2820:12-20.)  This statement does not warrant a new trial.

First, as discussed above, Defendants waived their objection to the statements concerning the label change by failing to object to it in closing argument or in their motion for mistrial.  Hubbard, 292 Ill. App. 3d at156-57.  Defendants also waived their objection to this argument by contending that the 2003 package insert contained sufficient warnings because the insert warned, inter alia, about the risk of “hypoventilation.”  (See 10-29, a.m., Tr. 392:19 – 394:19.)  By injecting the sufficiency of the 2003 package insert into the case, Defendants waived their complaint about John’s attorney rebutting that argument in his closing argument.  Jarmon, 165 Ill. App. 3d at 864.

Second, contrary to Defendants’ assertion, John’s attorney did not argue that the 2003 package insert contained insufficient warnings because the warnings later changed.  Instead, he used the new package insert to impeach the Defendants’ argument that the language in the 2003 package insert was sufficient.  Therefore, even if changes to the package insert constitute subsequent remedial measures, John’s attorney’s argument was proper for impeachment purposes.  Illinois courts have noted that Illinois’ subsequent remedial rule is “comparable to Rule 407 of the Federal Rules of Civil Evidence.”  Smith v. Black & Decker (U.S.)., Inc., 272 Ill. App. 3d 451, 456 (Ill. App. 1995).  That rule states that “[t]his rule does not require the exclusion of evidence of subsequent measures when offered for another purpose, such as proving ownership, control, or feasibility of precautionary measures, if controverted, or impeachment.”  Fed. R. Evid. 407.  As the Illinois Supreme Court has stated, “Illinois has long recognized that subsequent remedial measures may also be used for impeachment purposes.” Herzog v. Lexington Township, 167 Ill. 2d 288, 301 (Ill. 1995); see also Bulger v. Chicago Transit Authority, 345 Ill. App. 3d 103, 111 (Ill. App. 2003) (“evidence of a defendant’s post-accident remedial measures may be admissible for purposes such as . . . impeachment without inference of prior negligence.”).

Third, John’s attorney’s statements concerning the language in the new package insert was also proper under the causation exception to the subsequent remedial doctrine.  As trial, the Defendants repeatedly claimed that leaking fentanyl gel could not cause death.  In fact, one of the Defendants’ expert witnesses, Dr. Gerhard Levy, testified at length on that subject.  (11-12, p.m., Tr. 2336- 2425:16.)  Therefore, John’s attorney’s statements concerning the warnings in the new package inserts was proper not only for impeachment, but also to show that leaking fentanyl gel can cause death, as Defendants’ package insert now states.  “Because causation is analytically distinct from fault (‘negligence or culpable conduct’), it is plainly ‘another purpose’ for which evidence of subsequent remedial measures can be offered under Rule 407.”  Wetherill v. University of Chicago, 565 F. Supp. 1553, 1558 (N.D. Ill. 1983).

Finally, Defendants cannot—and have not attempted to – meet their burden of showing that John’s attorney’s statements were so prejudicial that they are entitled to a new trial.  See Clarke, 381 Ill. App. 3d 95.  The lack of any such argument shows that the statements concerning the language in the new package inserts do not entitle the Defendants to a new trial.

D. Defendants are not entitled to a new trial because John’s attorney allegedly argued that, at the time of her death, Janice had been following the same drug regimen she had been on for months.

Defendants contend that they are entitled to a new trial because John’s attorney stated that, at the time of her death, Janice was following the same drug regimen she had been on for months.  Motion at p. 47 (citing 11-14, a.m., Tr. 2877:1-6).  Defendants argue that this statement was unfairly because the Court prevented the Defendants from presenting evidence that a discontinued clonazepam prescription was refilled three days before Janice’s death.  This argument is fundamentally flawed for three reasons.

First, John’s attorney’s argument that Janice had been on the same drug regimen for several months was based on the evidence presented at trial and inferences drawn from that evidence.  The toxicology report, which showed the drugs found in Janice’s blood at the time of her death, was admitted into evidence and was discussed at length by the medical examiner and expert witnesses retained by Plaintiff and Defendants.  (See, e.g., Toxicology Report (PX. 19)); (10-29, p.m., Tr. 445:19 – 446:17); (11-05, a.m., Tr. 1337-1459).  That report showed nothing that would lead to the conclusion that Janice’s drug regimen had changed.  Attorneys are afforded wide latitude in closing arguments and may comment and argue on the evidence and any inference that may be fairly drawn from that evidence.  Clarke, 381 Ill. App. 3d at 95.  The argument that Janice had been on the same drug regimen for several months was firmly rooted in the evidence presented at trial and was a proper subject for closing argument.

Second, as discussed in detail above, the Court properly prevented Defendants from speculating that clonazepam might have been in Janice’s system based on the fact that a prescription for clonazepam was filled three days before she died.  None of the Defendants experts testified to a reasonable degree of medical certainty that clonazepam was in Janice’s blood at the time she died or that it was a cause of her death.  To the contrary, Defendants’ experts admitted that they did not know whether or not Janice had clonazepam in her system at the time of her death.  (11-10, a.m., Tr. 1940:4-7) (Dr. Kearney admitted that he did not know whether Janice had clonazepam in her blood); (11-12, a.m., Tr. 2324:6-9) (Dr. Zumwalt admitted that he could not testify with certainty whether Janice took any clonazepam in the three days before her death).  Given the inability of Defendants’ experts to link clonazepam to Janice’s death with any reasonable degree of certainty, there was nothing improper about John’s attorneys arguing about the drugs actually found in Janice’s system.  Without evidence that clonazepam was in Janice DiCosolo’s system at the time of her death, Defendants cannot possibly show that clonazepam played any role in her death. See Sommers v. American Economy Insurance Company, 8 Ill. App. 3d 450 (Ill. App. 1972) (testimony that there possibly could be causal connection between accident and decedent’s heart attack properly stricken as conjectural and speculative); Simon v. Lumbermens Mutual Casualty Company, 53 Ill. App. 3d 380 (Ill. App. 1977) (medical statement that heart attack could have been caused either by accident or hypertensive disease was not testimony about cause of death to reasonable degree of medical and scientific certainty but was instead mere speculation and conjecture that was properly stricken).   Therefore, Defendants cannot possibly have been prejudiced by John’s attorney’s statement that, at the time of her death, Janice was following the same drug regimen she had been on for months.

Finally, the Court heard the closing arguments and determined that the arguments were not unfairly prejudicial and would not prevent the jury from rendering a fair verdict.  Moreover, the Court has already denied a motion for mistrial based on the John’s attorney’s argument that Janice had been following the same drug regimen in the months leading up to her death:

MS. MAIMBOURG:  I just want to make another motion for a mistrial on the grounds that in his closing argument, at Page 110, as it was scrolling by me Mr. Orr said she didn’t have any problems on these drugs in the months before her death.  This goes right to the heart of the matter here about what these drugs mean.  We were not permitted to get into the drugs or the incidence of her falls and the thing in Dr. Neri’s records, and I think that saying that is unfairly prejudicial to the defendants.

COURT:  Well, I don’t think it is a basis for a mistrial.  It may well be that it was an — and this is a maybe — an advantage taken of a ruling that the Court made during the course of the trial by keeping certain evidence out, and I am not ruling that it is or it isn’t.  But I don’t think that it goes to the point of a mistrial, and I am convinced, having heard all of the arguments, that this jury is pretty well-focused on where the two sides are on this.

I feel that the arguments of both sides were very persuasive from their respective points of view, exceptionally good closing arguments, exceptionally good closing arguments.  I think this jury is tuned in to what they have to work on here, and I don’t think that some of the choice of words is going to be very deleterious either way with regard to getting this jury to the point.  I am aware of what you are arguing now, and I don’t think that rises to the level of a mistrial.

(11-14, a.m., Tr. 2896:8 – 2897:15).  The Court was in the best position to observe the arguments of counsel and the atmosphere of trial, and to make a determination about its effect on the jury.  Simmons, 198 Ill. 2d at 571 (The scope and character of closing argument are left to the discretion of the trial judge, who enjoys the best position to view the demeanor of counsel and the atmosphere of the trial.”); Compton, 353 Ill. App. 3d at 873 (concluding that the trial court did not abuse its discretion by denying a mistrial, the appellate court observed that the “trial court witnessed Walsh’s entire closing argument, including his objectionable conduct, and the court saw how Walsh’s behavior affected the jury.”)  Under these circumstances, Defendants cannot meet their heavy burden of showing that they are entitled to a new trial based on the allegedly improper closing argument.

E.        Defendants are not entitled to a new trial because John’s attorney allegedly made improper and inflammatory remarks about Defendants’ profit motive.

Defendants contend that they are entitled to a new trial because John’s attorney made “improper and inflammatory” remarks about Defendants’ profit motive.  Defendants maintain that remarks about Defendants’ greed and profit motive in John’s attorney’s closing argument were inflammatory and appropriate only in conjunction with a punitive damages claim.  Motion at pp. 47-48.  This argument is fatally flawed for several reasons.

First, the Court heard the closing arguments and determined that the arguments were not unfairly prejudicial and would not prevent the jury from rendering a fair verdict.  In fact, the Court has already denied a motion for mistrial based on the Defendants’ argument that John’s attorney’s comments about the Defendants’ greed and profit motive were unfairly prejudicial:

MS. MAIMBOURG:  I would like to make a motion for a mistrial on the grounds that Mr. Heygood basically argued a punitive damage case, not a compensatory damage case.  As the Court knows, punitive damages are not an issue in this case.  They are not an element of damages, and I think the argument was made to enflame the prejudice and passion of the jury, and for that reason I would move for a mistrial.

THE COURT:  I understand your motion.  I don’t think you quite got to that level of telling them to teach a lesson or something of that nature and to do and add onto under the punitive damages.

MR. DAMES:  I think virtually those words wore used.

THE COURT:  I don’t think so, but I mean they were being critical of the position of the defense, which I think is fair game.  So the motion is denied, but I understand your point.

(11-14, a.m., Tr. 2829:23-2830:17.)  In denying defense counsel’s motion for mistrial, this Court ruled that Plaintiff’s counsel had not reached the level of telling the jurors to punish the Defendants and therefore did not cross the line into impropriety. (11-14, a.m., Tr. 2830.)  As discussed in detail above, the Court was in the best position to observe the arguments of counsel and the atmosphere of tria, and to make a determination about its effect on the jury.  Ellington v. Riddle, 255 Ill. App. 3d 233, 238-39 (Ill. App. 1993) (“It is well established that the determination of whether argument not objected to was so pervasive as to deny a party a fair trial is a matter of sound trial court discretion, and that determination will not be disturbed on appeal absent a clear abuse of that discretion. . . .  [T]he trial court, having heard all of the comments and arguments, is in a superior position to assess the accuracy and prejudicial effect, if any, upon the jury of counsel’s statements.”).

Second, the Court’s denial of the Defendants’ motion for a mistrial was correct, as demonstrated by the very case cited by the Defendants.  Motion at p. 48.  In Johnson v. Hoover Water Well Service, Inc., 108 Ill. App. 3d 994 (Ill. App. 1982), counsel exhorted the jury that the defendant’s conduct “should not go unpunished” and that the jury had “an opportunity to right a wrong.” 108 Ill. App. 3d at 1007.  Even with the explicit reference to punishment, the Appellate Court declined to find any impropriety because punitive damages were not alluded to in the instructions and the jurors were specifically instructed on the proper factors to consider in assessing damages. 108 Ill. App. 3d at 1008; see also Goad v. Evans, 191 Ill. App. 3d 283, 310 (Ill. App. 1989) (“The statement suggesting the jury help Cole face his responsibility did not amount to a request the jury award damages for the sole purpose of punishing Cole.  Rather, that statement suggested the jury hold Cole responsible only for the damages which were caused by his negligent conduct on the night of the fatal accident and to which Goad is by law entitled.”)  In the instant case, Plaintiff’s counsel never referred to punishment but instead asked the jurors to “fix a wrong and make it right.” Motion at p. 47.  The jurors were correctly instructed on the proper elements of pecuniary damages that they could award, and no reference was made to punitive damages. IPI Civil No. 31.04, 31.11, 31.13, 31.07.  The jury was instructed, as well, to disregard any argument not supported by the law or the evidence. IPI Civil No. 1.01.  Thus, even if Plaintiff’s counsel exceeded the bounds of propriety, and he did not, the jurors could not have been led to believe that they could award punitive damages.

Third, the other cases cited by the Defendants for the proposition that John’s attorney’s statements are easily distinguishable.[3] In Cecil v. Gibson, 37 Ill. App. 3d 710, 712 (Ill. App. 1976), a judgment for the defense was reversed because defense counsel stated during closing argument that: (1) plaintiffs’ attorney was a “slick attorney from Chicago” and a “slick hired hand”; (2) plaintiffs’ expert medical witness was a “sidekick” and a “right hand man”; (3) plaintiffs’ counsel “manufactured” evidence, had a “wild imagination,” was not worthy of the jury’s trust, and was the “captain of (the) ship” who was “piloting” the testimony of his expert medical witness; (4) the relationship between plaintiffs’ counsel and his expert medical witness was comparable to that existing between the “Cisco Kid and Poncho” and “Matt Dillon and Chester”; and (5) plaintiffs’ expert medical witness was a “professional witness” whose “shiny black leather bag” contains instruments that “have never been used.”  Unlike in Cecil, the closing argument in this case did not involve any personal attacks on Defendants’ counsel.  Instead, John’s attorney’s arguments (e.g., that the Defendants put profit over safety and put on a frivolous defense) were proper arguments concerning the inferences the jury could draw from the evidence.  See Malatesta v. Leichter, 186 Ill. App. 3d 602, 626 (Ill. App. 1989) (plaintiff’s closing argument that a witness “lied like a rug” and that the defendant’s economist’s opinion that plaintiff’s expectancy would not have been profitable “were an absolute mystery” were fair comments on the evidence and did not warrant a new trial); Ellington, 255 Ill. App. 3d at 239-40 (distinguishing Cecil and concluding that the defense attorney’s use of the terms “polished” and “a performer” to describe the plaintiff’s attorney were not improper and were reasonable comments on the expert’s appearance and testimony at trial).

Fourth, Defendants’ waived any objection to John’s attorney’s argument that the Defendants put profits over patient safety by repeatedly emphasizing the Defendants’ alleged concern for patient safety in their opening statement and in trial:

What happened in 2004?  Complaints were trickling in about — with a complaint that looked, again, like a fold-over defect, and they were watching.  As the number grew higher, I think there were 20 something complaints, the decision was made to call a recall assessment committee together.  On the 11th of February, the defect was confirmed, and a recall assessment committee met on Friday.  They met by conference call, people in New Jersey, people in California, what are we going to do.  And the number-one thing you will hear about is the concern on that call patient safety first.  Let’s be conservative.  Let’s be safe than sorry.  Let’s not wait around and figure out if this is a problem.  Let’s recall this entire lot because all of their return patches were from lot 192.  So on Monday, which happened to be the President’s Day weekend that month, we voluntarily recalled 192.

Now, in the interim, obviously, we advised the FDA.  The FDA comes in the plant and begins an inspection, and we’re fully cooperating with the FDA.  And during that investigation, there were additional fold-over complaints of defects returned from another lot called 294.  And when those complaints came in, again, a decision was made, patient safety first.  Let’s be conservative.

We recalled not only 294, but three other lots that were made in what’s called the same campaign, the same time period.  So Alza and Janssen recalled four more lots for a total of five.  There were only defects found in the original one and one subsequent one, but again, we decided to be — to put patient safety first.

(10-28, a.m., Tr. 401:10 – 402:18 (emphasis added).)  Having argued that the Defendants put patient safety “first” and acted “conservatively,” Defendants cannot complain that John’s attorney rebutted that statement in closing by arguing that the evidence presented at trial showed that the Defendants put profits ahead of patient safety.  Jarmon, 165 Ill. App. 3d at 864 (counsel cannot complain when he interjects an argument into the proceedings which invites rebuttal from opposing counsel); Lembeck, 78 Ill. App. 2d at 152 (same).

Finally, the size of the jury verdict demonstrates that it was not the result of prejudice, sympathy or passion resulting from allegedly inflammatory comments in John’s attorney’s closing argument.  The jury awarded $16.56 million to four wrongful death beneficiaries.  This amount bears no relation whatsoever to the $280 million (the revenue from the patch that Defendants made between the time they discovered the lot was defective) or $25 million (the amount of damages that John’s counsel asked the jury to award) figures mentioned by counsel.  Moreover, the size of the award is comparable to jury awards in other wrongful death cases involving the Duragesic patch on a per beneficiary basis.  (See, e.g., Hendelson v. ALZA Corp., et al., 05-CV-81116 (S.D. Fla. June 25, 2007) ($5.5 million award to single wrongful death beneficiary for the death of his son due to a Duragesic patch).)   For these reasons, the allegedly inflammatory comments in John’s attorney’s closing argument do not warrant a new trial.  See, e.g., Goad v. Evans, 191 Ill. App. 3d 283, 310 (Ill. App. 1989) (“the size of the jury’s verdict does not convince us this portion of Goade’s closing argument caused the jury to disregard the evidence and return an excessive verdict in goad’s favor.”).

VI.       Defendants are not entitled to JNOV or a new trial based on the alleged insufficiency of the evidence.

 

Manufacturing defect.

Defendants argues that they are entitled to JNOV or a new trial on Plaintiff’s manufacturing defect claims because he failed to offer legally sufficient evidence in support of such claims at trial.  With respect to manufacturing (and design) defect claims, courts in Illinois have generally held that a plaintiff need not pinpoint the specific defect in a product in order to recover under strict liability.  Samansky v. Rush-Presbyterian Hosp., 567 N.E.2d 386, 394 (Ill. App. 1990) (“Illinois recognizes, as noted above, that a plaintiff may establish a case of strict product liability even though the plaintiff cannot prove the precise cause of his injury”).  Rather, under Illinois law, “a prima facie case for strict liability may be shown by evidence of either a specific defect or a non-specific defect.”  Allstate Ins. Co. v. Daimler Chrysler Corp., No. 03 C 6107, 2006 U.S. Dist. LEXIS 70686 at *6 (N.D. Ill. Sept. 26, 2006).  The evidence presented at trial demonstrated both types of defects in the Duragesic patch.  Defendants’ Motion should therefore be denied.

1. Plaintiff submitted sufficient evidence of a specific manufacturing defect.

 

During trial, Plaintiff presented sufficient direct and circumstantial evidence of a specific defect to the patch.  First, Plaintiff actually saw a “shiny slick” film (which Plaintiff’s experts believe is fentanyl gel) on Janice’s skin prior to her death.  Additionally, the patches used by Janice DiCosolo came from a recalled lot of defective, leaking patches that were manufactured under poor standards of quality control and contrary to Good Manufacturing Practices.  These facts provide ample evidence of a specific manufacturing defect.

a. Plaintiff’s testimony that he visibly witnessed the presence of a slick film of fentanyl gel on Janice DiCosolo’s skin is direct evidence that she used a leaking patch.

 

During trial, Plaintiff testified that, on the evening before her death, he removed Janice DiCosolo’s old patch and visibly observed a “shiny slick surface” underneath. (11-7, a.m., Tr. 1676:22-1677:6).  According to Plaintiff’s transdermal drug expert, the presence of this slick substance is “consistent with a patch leaking.”  (10-31, a.m., Tr. 839:17-840:1; 847:11-22 (Prausnitz)).  Defendants respond to this evidence by focusing on the fact that a physical examination of a different patch (i.e. the patch found on Janice’s body when she died) four years after the occurrence showed no visible defect.  Motion at p. 92.  But as explained by Michael Anisfeld, the condition of the patch was such that a physical examination years after Janice’s death could neither establish nor rule out a defect:

The patch was removed from her body four years ago, and it is impossible to say who has taken it off, what they have done with the patch, how they have handled it, how they have stored it, what they have done with it.  So I have no idea how this patch here would compare to how it was at the time it was manufactured.  It is impossible to say.

(10-30, p.m., Tr. 718:7-13).  Because Defendants did not show that the condition of the patch at the time of its examination was the same as the condition of the patch at the time of Janice’s death, its relevance is questionable at best.  And Defendants’ suggestion that the absence of a visible defect years later proves that there was no defect is belied by the undisputed fact that the patch did not perform as designed and intended—leading to an elevated fentanyl level 16 times higher than normal—and the fact that Plaintiff observed a slick film on his wife after removing the companion patch she wore prior to putting on her final patch.

b. The fact that Janice DiCosolo’s patches came from a recalled lot of defective, leaking patches that were made using poor manufacturing practices is circumstantial evidence that Plaintiff used a leaking patch.

 

The last two patches Janice used were among the lots included in a February 16, 2004, Urgent Class 1 Recall Notification issued by the Defendants after several patches in those lots were discovered to contain a defect known as a “fold-over defect” that caused affected patches to leak medication. (10-30, p.m., Tr. 624:7-627:11); (Urgent Class 1 Drug Recall Notification (PX 272)); (FDA EIR, pg. 5-7 (PX 255)).  Following the recall, the FDA conducted an inspection of Defendant’s manufacturing facility, which revealed numerous product defects in the Duragesic patches—including the fold-over defect, gel in the seal, seal breach, corners of the system cut off, holes in the drug reservoir, slit in pouches and system, air bubbles in the adhesive layer of the system, no gel in the system, and lack of adhesion.  PX 255.  As of June 8, 2004, there had been 97 reports from the field of leaking Duragesic patches in Lot 192—more than any other lot, including the four other recalled lots.  (See Id. at 7.)  One of the product defects was so common that it was termed the “classic stringer leaker.”  (See Id. at 6-10).  The fact that Plaintiff’s patches came from this recalled lot of defective, leaking patches is strong circumstantial evidence that her patch contained a specific defect.  See, e.g., Bramlette v. Hyundai Motor Co., No. 91 C 3635, 1992 U.S. Dist. LEXIS 17959 at *8-9 (N.D. Ill. 1992) (denying motion in limine to exclude evidence of recall because evidence was potentially probative of existence of defect and noting that “evidence of prior occurrences may be admissible to show the dangerousness of a product); Millette v. Radosta, 404 N.E.2d 823, 834 (Ill. App. 1980) (court found that recall letter was properly admitted as some evidence of defect); Hessen v. Jaguar Cars, Inc., 915 F.3d 641, 649 (11th Cir. 1990) (“Because Allstate met its burden of providing evidence that the defect alleged was the same defect involved in the recall campaign, the trial judge did not abuse his discretion in admitting the recall evidence, and the jury properly could have considered it.”).

Additional evidence that the Duragesic patches were defective includes the repeated quality control and quality assurance problems that Defendants experienced throughout 2003 and 2004, which were testified to at length by Plaintiff’s pharmaceutical manufacturing expert, Michael Anisfeld.  (See eg. 10-30, a.m., Tr. 609:18-610:3-12) (“[P]eople weren’t trained to follow these SOPs properly, and this reflects itself in poor quality patches that got out in the market”); (Id. at 622:9-623:13) (“[At the time lot 192 was made, ALZA’s sampling plan was not in compliance with GMP regulations]”); (Id. at 634:6-8) (“There were several observations where in the [FDA] inspector’s opinion ALZA did not follow GMPs”).  As a result of these problems, the FDA identified several manufacturing deficiencies and cited Defendant ALZA for numerous manufacturing problems.  (See generally Id. at 631:1-640:15); (PX 254); (PX 255).  This evidence is clearly sufficient to support the jury’s finding that Janice DiCosolo’s patch had a specific manufacturing defect.

2. Plaintiff submitted sufficient evidence of a non-specific defect.

 

Plaintiff also submitted substantial evidence of the existence of a non-specific defect at trial.  Specifically, Plaintiff offered evidence on all three elements of a non-specific defect: (1) Janice did not use the DiCosolo Patches in an abnormal manner; (2) one or both of her patches failed to perform as expected by giving Janice a blood fentanyl level sixteen times higher than expected; and (3) no reasonable secondary causes was responsible for the fatal fentanyl level found in Janice’s blood.  See, e.g., Sikora v. AFD Industries, Inc., 319 F.Supp.2d 872, 877 (N.D. Ill. 2004) (A plaintiff may establish a prima facie case for product liability by establishing facts showing that, despite no abnormal use and no reasonable secondary cause, the product failed to perform as could be expected); Rizzo v. Mr. Coffee, No. 94 C 5825, 1996 U.S. Dist. LEXIS 1745 at *20 (N.D. Ill. Feb. 15, 1996) (“a prima facie case that a product was defective and that the defect existed when it left the manufacturer’s control is established by proving the absence of abnormal use and reasonable secondary causes, and that the product failed to perform in a reasonable manner in light of its intended function.”).  For this reason, Defendants’ Motion should be denied.

a. There was no evidence Janice used the Duragesic patches in an abnormal manner

 

The undisputed evidence shows that Janice used the DiCosolo Patches in their normal and intended manner.  On February 9, 2004, Janice filled a prescription for ten 75 mcg/hour Duragesic patches.  She was to change patches every three days.  (11-3, a.m., Tr. 1205).  The patches came in two boxes of five patches each.  (11-7, a.m., Tr. 1737).  On or about February 12, 2004, her husband placed the first patch from the box on her back.  (11-7, a.m., Tr. 1717:18-1718:6).  About three days later, on the evening of February 14, 2004, he replaced this patch with the second patch from the box.  (11-7, a.m., Tr. 1675:15-19).  That was the patch she was wearing at the time of her death.  Following his wife’s death, John DiCosolo provided his attorneys with the remaining three patches from the opened box.  (11-7, a.m., Tr. 1737:17-1738:4).  He also provided them with the second box of five patches, which was unopened.  (11-7, a.m., Tr. 1738:10-20).  Janice DiCosolo clearly used her patches as prescribed and directed.  There is simply no evidence of any abnormal use or any product misuse or abuse.

b. The Duragesic patches failed to perform as expected.

 

There is also ample evidence that one or both of the Duragesic patches failed to perform in a reasonable manner in light of their intended function.  The patches’ malfunction is circumstantial evidence of a defect that caused the patch to not perform as expected.  As Chief Judge Posner has noted, while the doctrine of res ipsa loquitur is “not strictly applicable to a products liability case,” the doctrine “merely instantiates the broader principle, which is as applicable to a products case as to any other tort case, that an accident can itself be evidence of liability.”  Welge v. Planters Lifesavers Co., 17 F.3d 209, 211 (7th Cir. 1994); Hampton v. Sears Roebuck & Co., 625 N.E.2d 192, 195 (Ill. App. 1993) (“Like any fact, the defective nature of a product may be proved by circumstantial evidence.”); Hartford Ins. Co. v. Broan-Nutone, LLC, No. 02 C 6043, 2004 U.S. Dist. LEXIS 6765 at *12 (N.D. Ill. April 19, 2004) (“ A plaintiff in a product liability case may rely on circumstantial evidence to establish his case.”); Allstate Ins. Co., 2006 U.S. Dist. LEXIS 70686 at *6 (“A plaintiff may prove the inference of a non-specific defect through direct or circumstantial evidence.”); Klootwyck v. Daimler Chrysler Corp., No. 01 C 6127, 2003 U.S. Dist. LEXIS 7768 at *7 (N.D. Ill. May 7, 2003) (“All three elements of a strict liability claim can be established by circumstantial evidence.”).  Here, there is ample evidence that one or both of the patches malfunctioned by delivering Janice DiCosolo a higher-than-intended level of fentanyl.

The most obvious evidence that the patches failed to perform as expected is that one or both of them killed Janice DiCosolo.  (11-5, a.m., Tr. 1380:16-20 (Middleburg)); (11-6, a.m., Tr. 1591:4-7 (Cogan)); (11-29, p.m., Tr. 469:15-19 (Downs))).  For obvious reasons, reasonable consumers would not expect to be killed by their prescription medication.  For this reason alone, John has raised a fact issue that precludes summary judgment.  See, e.g., Garavalia v. Heat Controller, Inc., 570 N.E.2d 1227, 1232 (Ill. App. 1991) (“A product is considered to be unreasonably dangerous only when the product is dangerous to an extent beyond that which would be contemplated by the ordinary person with the ordinary knowledge common to the community as to its characteristics.  We believe that an ordinary consumer would not contemplate being killed by an air conditioner which is defective in that it leaked itself dry of Freon and failed to cool, which is precisely what is alleged to have happened here.  Accordingly, the complaint did adequately aver that the unit was unreasonably dangerous.”).

Other evidence that the patch failed to perform as expected came from the Defendants’ own package insert, which states that the “mean maximal concentration” for someone using a 75 mcg/hour Duragesic patch should be 1.7ng/mL. (11-5, a.m., Tr. 1344:15-20 (Middleburg)); (10-31, a.m., Tr. 790:20-791:17 (Prausnitz)); (2003 Duragesic Package Insert (PX 32)).  It is undisputed that the toxicological testing of Janice’s blood shortly after her death showed a blood concentration of fentanyl of 28.2 ng/mL.  (DiCosolo Toxicology Report (PX 19)); (10-29, p.m., Tr. 452:17-21 (Downs)); (11-6, a.m., Tr. 1583:22-1584:2 (Cogan)); (10-31, a.m., Tr. 839:4-11 (Prausnitz)). This level of fentanyl was much higher than would be expected if the Duragesic patch performed in a reasonable manner in light of its intended function.  According to Dr. Middleburg, a fentanyl blood level of 28.2 ng/mL is “somewhere between 15 and 20 times higher” than what would be expected to see from a properly functioning patch.  (11-5, a.m., Tr. 1346:21-24).  Dr. Prausnitz similarly testified that Janice DiCosolo’s fentanyl level “should have been as indicated in the package insert which is a level of 1.7.”  (10-31, a.m., Tr. 839:12-16).  In short, substantial evidence was submitted to the jury that Janice’s fentanyl level of 28.2 ng/mL was well outside the normal range expected for someone using a 75 mcg Duragesic patch.

Based on the foregoing, Plaintiff’s experts testified that Janice DiCosolo’s Duragesic patch failed to perform in a reasonable manner in light of its intended function.  As Dr. Middleburg testified, “[t]he concentration of fentanyl detected is not consistent with that expected from the prescribed use of a properly functioning 75 microgram per hour Duragesic patch.” (11-5, a.m., Tr. 1342:16-1343:10); (see also 10-31, a.m., Tr. 839:12-16 (Prausnitz)).  Taken together, this is clearly more than enough evidence to support the jury’s finding that the Duragesic patch failed to perform as expected and, thus, created a fact issue on the existence of a non-specific manufacturing defect.

c. PMR was not a reasonable secondary cause of Janice

DiCosolo’s elevated fentanyl level.

 

Defendants claim that Plaintiff “failed to rule out” postmortem redistribution as a reasonable secondary cause of Janice DiCosolo’s elevated postmortem fentanyl blood level. Postmortem redistribution is a well-recognized phenomenon in forensic toxicology.  It refers to changes in the concentrations of toxicants in various regions of the body that occur postmortem.  Specifically, after death, many substances will “leach” out of body tissues and pool in certain anatomical sites, the most common of which is the heart.  The result is that blood collected at or near the heart during autopsy may have concentrations of substances that exceed the concentrations that existed in circulating blood at the time of death.  (10-29, p.m., Tr. 456:1-16 (Cogan)).

To assess a particular drug’s propensity to redistribute postmortem, doctors and scientists compare the concentrations of the drug in the heart to concentrations of the drug in peripheral blood vessels (typically in the femur), where postmortem redistribution is assumed to occur only nominally or not at all.  (11-5, a.m., Tr. 1362:6-1364:2 (Middleburg)).  Studies on fentanyl demonstrate that it is subject to, at most, modest postmortem redistribution up to a range of 2 times the original antemortem level. (Id. at 1362:6-1364:24).  Thus, even if extreme PMR occurred, Janice DiCosolo’s pre-death fentanyl level would have been at least 14.1 ng/mL (50% of her postmortem level of 28.2 ng/mL).  This level is significantly above the stated mean maximal concentration of 1.7 ng/mL for a 75 mcg/hr patch and provided ample evidence of a defect.  Thus, while PMR might explain some variance between Janice DiCosolo’s antemortem and postmortem fentanyl levels, it would not at all undermine the fact that her patch gave her a much higher fentanyl level than intended.

Given the modest effect of PMR on fentanyl, Plaintiff’s expert, Dr. Claude Downs, opined that while he believes postmortem redistribution does occur, it did not significantly affect Janice DiCosolo’s antemortem blood level. (10/29/08 Trial Tr. at 497:18-24).  Similarly, Dr. Middleburg testified that while postmortem redistribution can explain an elevated fentanyl level, and while he can’t state with “certainty” that Janice DiCosolo’s antemortem fentanyl level was 28.2, he can state that “given the circumstances of this case, it’s not too far from 28.” (11-5, 11-5, a.m., Tr. 1416:6-22 (emphasis added)).  Again, viewed in its totality, the evidence is sufficient to support the jury’s finding that postmortem redistribution was not a reasonable secondary cause of Janice DiCosolo’s excessively and fatally high fentanyl level.

IX.       Defendants are not entitled to a remittitur.

A. The assessment of damages lies within the discretion of the jury and its

collective judgment is rarely to be disturbed.

 

“Illinois courts have repeatedly held that the amount of damages to be assessed is peculiarly a question of fact for the jury to determine.”  Snelson v. Kamm, 204 Ill. 2d 1, 36-37 (Ill. 2003); see also Lee v. Chicago Transit Authority, 152 Ill. 2d 432, 470 (Ill. 1992) (“The amount of a damage award is peculiarly an issue of fact for the jury to determine.”); Baird v. Chicago, Burlington & Quincy R.R. Co., 63 Ill. 2d 463, 472-73 (Ill. 1976) (“the amount of damages to be assessed is peculiarly a question of fact for the jury, and if the jury was properly instructed on the measure of damages, a reviewing court should not substitute its judgment for that of the jury as to the sum to be awarded.”).  Great weight must be given to the jury’s decision.  Hastings v. Gulledge, 272 Ill. App. 3d 861, 863-64 (Ill. 1995) (“The determination of the adequacy of the verdict is peculiarly within the province of the jury, and great weight is given to the jury’s decision.”); McMahon v. Richard Gorazd, Inc., 135 Ill. App. 3d 211, 230 (Ill. 1985) (same).  This is especially true in the context of a personal injury or wrongful death case such as this one.  See, e.g., Hastings, 272 Ill. App. 3d at 863-64 (“The very nature of personal injury cases makes it impossible to establish a precise formula to determine whether a particular award is excessive or inadequate.”); McMahon, 135 Ill. App. 3d at 230 (same).  For the foregoing reasons, courts are reluctant to tamper with damages awards:

Reviewing courts rarely disturb jury awards.  For good reason.  We are in no better position to judge the appropriate amount of a verdict than are the 12 people who see and hear the arguments and the evidence.  They use their combined wisdom and experience to reach fair and reasonable judgments.  We are neither trained nor equipped to second-guess those judgments about … familial losses incurred by other human beings.  To pretend otherwise would be sheer hubris.

Barry v. Owens-Corning Fiberglass Corp., 282 Ill.App.3d 199,207 (1996).

Judges are not free to reweigh the evidence simply because they may have arrived at a different verdict than the jury. Drews v. Gobel Freight Lines, Inc., 144 Ill. 2d 84, 97 (Ill. 1991); see also Hulke v. International Manufacturing Co., 14 Ill. App. 2d 5, 49 (Ill. 1957) (“the question of excessiveness is not to be determined by what we as judges think the damages should have been; the court has no right to substitute its judgment for that of the jury.”); Batterton v. Thurman, 105 Ill. App. 3d 798, 804 (Ill. App. 1998) (“a trial judge does not have the power to speculatively and gratuitously negate a jury’s verdict.”).  Even where the amount of a damage award seems excessive to the trial judge, “he cannot overturn such an award merely because he, for subjective and unknown reasons, would have computed damages differently.” Batterton, 105 Ill. App. 3d at 805.

A court reviewing a jury’s assessment of damages should not interfere unless a proven element of damages was ignored, the verdict resulted from passion or prejudice, or the award bears no reasonable relationship to the loss suffered. Gill v. Foster, 157 Ill. 2d 304, 315 (Ill. 1993).  As set forth below none of these descriptions applies to the jury’s damage award in this case.  For this reason, Defendants’ request for a remittitur should be denied.

B.        Illinois courts have rejected the comparative approach Defendants suggest.

While giving lip service to the notion that a comparison of awards in one case to the facts of another is improper, Defendants nonetheless urge the court to do just that.  In their Motion, Defendants suggest that “[w]hile Illinois courts have rejected a strictly comparative approach to assessing motion for remittitur, a benchmark is nonetheless useful for determining what is ‘fair and reasonable.’”  Motion at p. 97.   Defendants then offer as a “benchmark” the holding in Mikolajczyk v. Ford Motor Co., 374 Ill. App. 3d 646 (Ill. App. 2007), rev’d on other grounds, 2008 Ill. LEXIS 1424 (Ill. Oct. 17, 2008) in which the court reversed an award of $25 million in wrongful death damages awarded to a widow and her two children.

But the comparison approach advocated by Defendants was actually rejected by the court in Mikolajczyk, which stated that it “refuse[d] to compare the amount awarded in this case to the amounts awarded in other cases in determining whether the verdict was excessive” and “refuse[d] to deem the loss of society award excessive merely because it was larger than loss of society awards in other cases.”  Id. at 672, 673.  Other Illinois courts have likewise refused to compare awards in one case to those in another.  See, e.g., Velarde v. Illinois Central R.R. Co., 354 Ill. App. 3d 523 (Ill. 2004) (“Courts have traditionally declined to make comparisons when determining whether a particular award is excessive.”); Richardson v. Chapman, 175 Ill. 2d 98, 114 (Ill. 1997) (“The defendants urge us to compare Richardson’s damages with amounts awarded in other cases. Courts in this state, however, have traditionally declined to make such comparisons in determining whether a particular award is excessive and we do not believe that such comparisons would be helpful here.”); Barry v. Owens-corning-Fiberglas Corp., 282 Ill. App. 3d 199, 207 (Ill. App. 1996) (“Comparisons are difficult, if not impossible, because each award depends on the facts and circumstances of that particular case.”); Lawson v. Belt Ry. Co. of Chicago, 34 Ill. App. 3d 7, 27-28 (1975) (“One wrongfully injured by another should be permitted to secure a recovery based upon the evidence of his own particular loss, rather than by consultation of a schedule of previous awards”).  Illinois law clearly rejects the notion that a damage award in one case may be deemed excessive simply because it exceeds awards made in other cases.

C.        There is no basis to reduce the loss of society award simply because Janice

had been suffering pain in the years preceding her death.

 

Defendants take the absurd and unsupported position that the jury’s assessment of loss of society damages should be overturned simply because Janice DiCosolo had been suffering pain in the years preceding her death.  Motion at p. 96.  While Defendants agree that the jury was presented with “an array of damages evidence” and that Janice “was not estranged from her family” when she died (Motion at p. 96), they predicate their request for a new trial on the notion that Janice was “less and less capable of providing the companionship, consortium and personal services that constitute ‘society.’” Id. This contention is unsupported by either the evidence or by common sense.

John DiCosolo, Janice’s husband, testified that he and Janice had a close, committed marriage. (11-7, a.m. Tr. 1684)  Their oldest child, John, was interested in music, and Janice would encourage him by having him take music lessons, going to concerts with him, listening to music together, and talking about the songs and their meanings. (11-7, a.m., Tr. 1683).  John described his mother as his “rock.” (11-5, a.m., Tr. 1494).

Kristina, Janice’s daughter, testified that she had been teased in school and that her mother was the one who talked to her, helped her with her problems, and acted as her best friend when she was in elementary school. (11-5, a.m., Tr. 1496-97).  Her mother would cuddle with her on the couch, and she embroidered a blanket for Kristina with cute sayings and helpful messages. (11-5, a.m., Tr. 1499, 1501).  Kristina loved the outdoors and horseback riding, and Janice would take her to a ranch and on other special vacations and local overnights and getaways for just the two of them. (11-5, a.m., Tr. 1498; 11-7, a.m., Tr. 1683-84).

Anthony DiCosolo was in third grade when his mother died. (11-3, p.m., Tr. 1278-79).  He described her as a very caring person who treated him “with care and loving to the fullest extent.” (11-3, p.m., Tr. 1280).  She read books to Anthony, gave him pointers as he did his homework, and played video games with him. (11-3, p.m., Tr. 1284, 1287-88).  She encouraged Anthony to play soccer and came to his practices and games. (11-3, p.m., Tr. 1285-86).  Anthony said his mother was one of the first people to arrive at his first communion and school events so that she could get the best first-row seats to see him well. (11-3, p.m., Tr. 1283).  She would take Anthony and Kristina to pick up Plaintiff from guitar practice and then take all three children out to a restaurant. (11-3, p.m., Tr. 1289).  She surprised her children with cookies on Christmas morning, arranged Anthony’s birthday parties, and baked cookies and went trick-or-treating with her children on Halloween. (11-3, p.m., Tr. 1281-82, 1283-84). Anthony recalled that his mother would go to great lengths to persuade him to eat vegetables, including making trips to the store to get cheese to put on his broccoli to make it taste better. (11-3, p.m., Tr. 1279-80).

Tina Bielke had known Janice since they were both eighth-grade students. (11-3, p.m., Tr. 1266).  Ms. Bielke described Janice as “a good member” of her family. (11-3, p.m., Tr. 1269).  Despite Janice’s own discomfort, she was able and willing to nurse her mother through illness and pain. (11-3, p.m., Tr. 1270-71).  In the years prior to Janice’s death, Ms. Bielke noticed instances when Janice still thought first of other people’s needs and not her own. (11-3, p.m., Tr. 1273).  Nothing in the testimony of Ms. Bielke or Janice’s family members suggested that she had lost or was losing her capacity to provide companionship, consortium, and personal services, and the Defendants’ suggestion to the contrary is unsupported by evidence.

Rather than provide a reason to reduce the jury’s damage award, the fact that Janice DiCosolo suffered from extreme pain and yet was able to provide care, comfort and companionship to her husband and children stands as a testament to her strength of character and love for her family.  To suggest that the loss caused by her death is somehow lessened by the pain she endured during her life is to ignore her tremendous strength of spirit and to compound this needless tragedy by suggesting that Janice was less of a mother and wife simply because of her unfortunate condition.

Finally, Defendants’ argument should be rejected because there was no evidence that Janice’s condition would have continued or that her future life would have been marked by the pain and difficulties she was enduring at the time of her death.  Because of her premature death, we will never know.  To assume that her condition would never have improved is to engage in pure speculation and to award Defendants for the uncertainties created by their own wrongful conduct.  “[I]t is not the privilege of him whose wrongful act caused  the loss to hide behind the uncertainties inherent in the very situation his wrong has created.” Elliott v. Willis, 92 Ill. 2d 530, 540-41 (Ill. 1982).  Defendants’ request for a remittitur should be denied.

D.        There is no basis for concluding that the damages awarded by the jury herein were outside the range of fair and reasonable compensation or solarge as to shock the judicial conscience.

 

In Richardson v. Chapman, 175 Il1.2d 98, 113 (1997), the Illinois Supreme Court held that an award of damages will be deemed excessive if it falls outside the range of fair and reasonable compensation or is so large that it shocks the judicial conscience.  Contrary to Defendants’ arguments, there is no basis for concluding that the damages awarded by the jury herein were outside the range of fair and reasonable compensation or so large as to shock the judicial conscience.  The only “evidence” Defendants offer to the contrary is based on a comparison of the award in this case to the award made in Mikolajczyk.

But, as stated above, Illinois courts, including the court in Mikolajczyk, have rejected such a comparative approach.  And even if Defendants’ comparative approach were authorized by Illinois law, it would not support their request for remittitur.  For example, in Mikolajczyk v. Ford Motor Company, 374 Ill. App. 3d 646, 677 (1st Dist. 2007), the court held that a wrongful death award of $25 million was excessive and that it would find unreasonable any more than half of the jury’s award (or $12.5 million).  An award of $12.5M to the spouse and two children in that case amounts to an award of $4.17M per claimant.  Multiplying that amount by the four claimants in this case yields a damage award of approximately $16.6M, an amount almost identical to the $16.56M damage verdict entered by the Court herein.  Other courts have likewise affirmed damage awards in the same range as those awarded by the jury in this case.  See, e.g., Velarde v. Illinois Central R.R. Co., 354 Ill.App.3d 523, 540 (1st Dist. 2004) (court affirmed $54 million non-economic damage award in case involving a collision between a car and a train, noting that “the amount of a verdict is generally at the discretion of the jury.”); Anderson v. Alberto-Culver USA, Inc., 337 Ill.App.3.d 643 (Ill. App. 2003) (court of appeals affirmed gross award of $21,051,943 to widow and two children in wrongful death case arising from plane crash); Richardson v. Chapman, 175 Ill. 2d 98, 114 (Ill. 1997) (Illinois Supreme court affirmed non-economic damages of $10.2 million awarded to single individual injured in car wreck, holding that “[t]he determination of damages is a question reserved to the trier of fact.”); Donnellan v. First Student, Inc., 383 Ill. App. 3d 1040, 1064 (Ill. App. 2008) (While award of $6 million in non-economic damages “is a large sum, it is by no means so large as to shock the judicial conscience”).  There is simply nothing extraordinary about the $16.56 million in damages awarded herein that would support the conclusion that it “falls outside the range of fair and reasonable compensation” or is “so large that it shocks the judicial conscience.”

Illinois courts have long recognized that “damages for loss of society are difficult to estimate exactly and no standard of value applies; rather, their assessment is committed to the sound discretion of the jury as to what is reasonable under the circumstances of any given case guided by their observations, experience, and sense of fairness.”  Patch v. Glover, 248 Ill. App. 3d 562, 587 (Ill. App. 1993).  Here, there is no evidence that the jury abused its discretion or based its verdict on anything other than the evidence and its collective “observations, experience, and sense of fairness.”  As such, the Court would commit reversible error were it to grant Defendants’ request for a remittitur.  See, e.g., Dahan v. U.HS. of Bethesda, Inc., 295 Ill.App.3d 770, 782 (15t Dist. 1998) (appellate court reversed a trial court’s decision to remit a small portion of a substantial jury award, stating that: “[A] trial judge does not have the power to speculatively and gratuitously negate a jury’s verdict; rather, a basis in fact, evidenced by the record, must exist showing the award was erroneous or was the result of prejudice or passion before it can be reduced”); Medina v. City of Chicago, 238 Ill.App.3d 385, 396 (Ill. App. 1992) (remittitur reversed); Batterton v. Thurman, 105 Ill.App.3d 798, 804-5 (Ill. App. 1982) (remittitur reversed).

E.        There is no basis for concluding that the damages awarded by the jury herein were the product of passion or prejudice.

 

There is no basis for concluding that the damages awarded by the jury herein were the product of passion or prejudice.  Defendants attribute the jury’s award to passion and prejudice allegedly incited by Plaintiff’s counsel’s closing argument. (Motion at p. 98).  The Defendants focus particularly on remarks about evidence of the immense profitability of continued production of Duragesic patches in lieu of stopping production in order to investigate complaints and institute the computerized vision system. Id. However, the evidence supported these comments.  David Chullino testified that he believed there was increasing demand for Duragesic in 2002 and 2003. (10-31, p.m., Tr. 1062).  He said it was “probably a fair statement” that Defendant Janssen was not happy about downtime and lost production time due to an investigation of the product. (10-31, p.m., Tr. 1064).  Statements of counsel during closing argument that are supported by the evidence are perfectly proper. Thornhill v. Midwest Physician Center, 337 Ill. App. 3d 1034, 1053 (1st Dist. 2003).   And rather than object to such argument at the time it was made, counsel for Defendants actually argued in closing that the recall was done in a timely fashion, squarely placing the issue before the jury.  (11-14, a.m., Tr. 2854).

The Defendants also complain that Plaintiff’s counsel suggested “an extravagant award.” (Motion at p. 98).  However, Illinois has followed for at least the last one hundred years the rule that counsel may suggest to the jury in argument a total monetary award for noneconomic damages. Caley v. Manicke, 24 Ill. 2d 390, 394 (1962).  Moreover, Defendants did not objet to counsel’s request for $25 million in damages and said nothing in closing argument to rebut plaintiff’s suggestion that the jury award $25 million for loss of society.  Defendants did not suggest an alternative amount to the jury.  In fact, they did not even discuss damages at all during their closing argument.  Ultimately, of course, the jury did not award Plaintiffs the amount suggested by their counsel during closing argument; instead of the $25 million counsel suggested, the jury awarded $18 million (or 28% less than was suggested).   Defendants have utterly failed to demonstrate that the jury’s damage award was the result of passion or prejudice.  Their request for a remittitur must be denied.

F.         There is no basis for concluding that the damages awarded by the jury herein were “erroneous,” nor is an “erroneous” damage award a basis for

remittitur.

 

Finally, there is no basis for concluding that the damages awarded by the jury herein were “erroneous,” nor is an “erroneous” damage award a basis for remittitur.  Defendants cite the case of Batterton v. Thurman, 105 Ill. App.3d 798 (Ill. Ap. 1998) for the proposition that “a party is entitled to a remittitur when a jury’s verdict is erroneous.”  Motion at p. 99.  While the court in that case stated that “a basis in fact, evidenced by the record, must exist showing the award was erroneous or was the result of prejudice or passion before it can be reduced,” it did not explain how a court is to assess whether a jury verdict is erroneous.  Id. at 804.  Elsewhere, the court held that “a jury verdict should not be disturbed unless it is the product of passion or prejudice.”  Id. at 805.  Courts have found a damage award to be “erroneous” only when the award was excessive or the measure or method of calculating damages – not the mere amount of damages –

was “erroneous.”

Here, Defendants argue that the damages award was “erroneous” because the jury was denied certain evidence regarding Janice DiCosolo’s “drug-seeking behavior, reported suicide attempt, and uncontrollable rages.”  Motion at p. 99.  But Defendants concede that such evidence “did not pertain specifically to compensable losses.”  Id. Moreover, even if the excluded evidence was relevant to the jury’s damage assessment, no Illinois court has found a damage award to be “erroneous” simply because the trial court barred evidence that may have impacted the jury’s analysis.  Defendants’ attack is really an attack on the Court’s evidentiary rulings rather than on the amount of damages warded by the jury.  As set forth elsewhere in this Response, the Court’s evidentiary rulings were proper and provide no basis for a new trial.

CONCLUSION AND PRAYER

For the reasons set out more fully above, the Court should deny Defendants’ Motion for Judgment Notwithstanding the Verdict or, in The Alternative, A New Trial or Remittitur.

WHEREFORE Plaintiff John DiCosolo respectfully prays that the Court deny Defendants’ Motion for Judgment Notwithstanding the Verdict or, in The Alternative, A New Trial or Remittitur and grant him such other and further relief to which she may be justly entitled.


Law Offices of F. Plaintiff Cushing III, P.C.

By: ___________________________________

F. Plaintiff Cushing III, Esq.

29 South LaSalle Street, Suite 240

Chicago, Illinois 60603

Telephone No.: (312) 726-2323

Facsimile No.:  (312) 726-2344

Attorney No.: 02498

 

James Craig Orr, Jr., Esq.

Michael Heygood, Esq.

Charles Miller, Esq.

Eric D. Pearson, Esq.

John Pate, Esq.

Heygood, Orr, Reyes & Bartolomei

2331 West Northwest Highway, 2nd Floor

Dallas, TX 75220

Telephone No.: (214) 526-7900

Facsimile No.:   (214) 526-7910

 

Edward E. Angwin

Waller Law Office

2140 11th Avenue South, Suite 222

Birmingham, AL 35205

Telephone No.:  (205) 933-5421

Facsimile No.:   (205) 933-5451

 

ATTORNEYS FOR PLAINTIFF

 

 

 

CERTIFICATE OF SERVICE

 

I hereby certify that on the ___ day of February, 2009, I served the foregoing document on all counsel of record.

 

_________________________________

F. Plaintiff Cushing III, Esq.

29 South LaSalle Street, Suite 240

Chicago, Illinois 60603

Telephone No.: (312) 726-2323

Facsimile No.:  (312) 726-2344

Attorney No.: 02498


[1] Counsel for Defendants did not mention to the Court or seek to question Plaintiff=s experts Dr. Downs, Dr. Prausnitz or Dr. Middleberg regarding topamax or avinza either before the jury or outside the jury=s presence.  In fact, these words were not uttered at the trial by anyone on the days that these witnesses testified.  As to clonazepam, it was only mentioned during an offer of proof relating to Dr. Middleberg=s testimony.  This discussion appearing in pages 1461-1466 in the transcript clearly indicates that Dr. Middleberg did consider clonazepam and that he concluded he had “no way of assessing whether it was there or not at this point.”  (11-5, a.m., Tr. 1463:14-16).  Thus, because Dr. Middleberg did consider the issue, it carried no relevance from an impeachment standpoint.

[2] Defendants state that only a small fraction of patches in Lot 192 were defective.  Motion at p. 46.  This argument ignores the fact that the Defendants destroyed the recalled patches before they could be tested.  (Dep. of Sue Engle at 137:1-16.)  John raised this issue in a motion for an adverse inference based on the Defendants’ spoliation of evidence.

[3] The Los Amigos and Dooley cases cited in the Defendants’ Motion are completely inapposite to the issue of whether John’s attorney’s closing argument was unduly prejudicial.  Los Amigos Supermarket, 306 Ill. App. 3d at 128-29, involved a situation where an attorney misrepresented the evidence in closing argument.  Therefore, Los Amigos has no bearing on the issue of whether or not the closing argument in this case was unduly inflammatory.  Similarly, Dooley has no bearing on the propriety of John’s counsel’s closing argument.  In Dooley, the issue was not the propriety of closing argument, but whether the jury awarded excessive damages.  Dooley, 26 Ill. App. 3d at 357-58.  In Dooley, the court held that the size of the jury award was not so large to indicate that the jury acted from passion or prejudice.  Id. at 358.