Respondent’s Answer to Petitioner’s Petition for Leave to Appeal

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. Heygood, Orr & Pearson represented the husband and three children of Janice DiCosolo. After Heygood, Orr & Pearson obtained an $18.5 judgment for the DiCosolo family, the Defendants appealed. They claimed 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. The Defendants then appealed to the Illinois Supreme Court by filing a Petition for Leave to Appeal. This Brief was filed by Heygood, Orr & Pearson in response to that Petition. The Illinois Supreme Court subsequently denied the Petition for Leave to Appeal and the judgment in favor of the DiCosolo family became final.

No. 112807

______________________________________________________________________________

IN THE SUPREME COURT OF ILLINOIS

______________________________

JOHN DICOSOLO, as Administrator

of the Estate of Janice V. DiCosolo, Deceased,

Plaintiff/Appellee/Respondent

v.

Janssen Pharmaceutica Inc., et. al.,

Defendants/Appellants/Petitioners

______________________________

Petition for Leave to Appeal from the Appellate

Court of Illinois, First District, No. 1-09-3562,

Appeal from The Circuit Court of Cook County,

Illinois, County Department, Law

Division, Case No. 04 L 005351,

The Honorable Thomas Flanagan

RESPONDENT’S ANSWER TO PETITIONERS’

PETITION FOR LEAVE TO APPEAL

FACTS

Janice DiCosolo died on February 15, 2004 at the age of 38 in Cicero, Illinois as a result of a fatal overdose of fentanyl from Petitioners’ recalled Duragesic fentanyl pain patch.  PX 18; PX 19; PX 22; SR Vol. 3 C 588 (Tr. 451-52); SR Vol. 6 C 1078 (Tr. 1590-91).  She was survived by her husband, John, a Cicero Police Sergeant, as well as their three young children: John, Kristina and Anthony.  SR Vol. 5 C 1133-35 (Tr. 1673-74, 1680, 1682-83).  In the days leading up to her death, Janice was properly using a 75 mcg Duragesic fentanyl pain patch designed, manufactured and distributed by Petitioners that had been prescribed by her doctor.  SR Vol. 4 C 875 (Tr. 1126).   Fentanyl is a powerful pain killer 100 times stronger than morphine.  SR Vol. 3 C 1034 (Tr. 822).

When Janice’s blood was tested during an autopsy performed by the Cook County Medical Examiner’s office, it was found to contain a fentanyl level of 28.2 ng/mL.  PX 19.  According to Petitioners’ package insert, a properly functioning 75 mcg patch should have delivered a fentanyl level of approximately 1.7 ng/mL:

 

PX 62.  Thus, Janice’s fentanyl level was more than sixteen (16) times higher than the average level expected from a properly functioning 75 mcg patch.  PX 62

While decedent’s 28.2 ng/mL level was a post-mortem level, the forensic pathologist for the Cook County Medical Examiner’s office who conducted the DiCosolo autopsy testified that Janice’s postmortem fentanyl level was “an accurate assessment” of her blood fentanyl level at the time of death.  SR Vol. 5 C 1077 (Tr. 1585).  Forensic pathologist Dr. J.C. Upshaw Downs similarly testified that postmortem redistribution did not significantly affect the level of fentanyl found in Janice DiCosolo’s blood.  SR Vol. 3 C 599 (Tr. 497).  Dr. Mark Prausnitz testified that a post-mortem fentanyl level is “representative of the blood level at the time of death.”  SR Vol. 4 C 758 (Tr. 876).   And forensic toxicologist Dr. Robert Middleberg testified that Janice’s fentanyl level at the time of death was “not too far” from her 28.2 ng/mL post-mortem level.  SR Vol. 4 C 985 (Tr. 1416).  He further explained to the jury that studies have concluded that postmortem redistribution, when it occurs, has, at most, a doubling effect on the level of fentanyl.  SR Vol. 4 C 972 (TR. 1364).  This would mean that Janice’s level at the time of her death was at least 14.1 ng/mL, still far in excess of the 1.7 ng/mL level expected from a properly functioning 75 mcg patch.  SR Vol. 4 C 968 (Tr. 1345).[1]

Janice’s recalled 75 mcg patch came from a lot known to Petitioners as “Lot 192.”  Beginning on January 7, 2004, Petitioners received an extraordinary 21 “leaker complaints” and five “adverse event” reports from this lot.  SR Vol. 4 C 828 (Tr. 1058); SR Vol. 5 C 1186 (Tr. 1885-86); SR Vol. 39 C 9660 (Tr. 56-57), 9663 (Tr. 67), 9664 (Tr. 72-73); PX 254 at 13.  This was more than three times the highest number of complaints ever received by Petitioners from a similar-sized lot.  SR Vol. 39 C 9663 (Tr. 69).

Petitioners admitted that the receipt of even 5-7 complaints from Lot 192 should have triggered an investigation.  PX 91.  Instead, it was not until weeks later, when 21 complaints had been received, that Petitioners began an investigation into Lot 192.  Petitioners finally announced an “Urgent Class I Drug Recall” of Lot 192 on February 16, 2004, the day after Janice DiCosolo died.  PX 272.  Petitioners admit that “[i]t’s absolutely clear that Lot 192 had defective patches in that lot.”  SR Vol. 39 C 9683 (Tr. 149).  The recall notice itself stated that Lot 192 was being recalled because the fentanyl patches in that lot, including Janice’s patch, “may leak medication along one edge,” leading to “potentially life-threatening complications.” PX 272.  According to the Health Hazard Analysis Petitioners performed at the time of the recall, a leak in their fentanyl patches could “lead to drug overdose, the effects of which can include hypoventilation, respiratory depression, and at worst, death.” PX 171.

While the DiCosolo family first heard of defective, leaking patches when they received the 2004 recall notice, Petitioners had known of the problem for years.  As early as 2000, Petitioners learned that they had a manufacturing defect so prevalent it came to be called the “classic stringer leaker.”  SR Vol. 39 C 9650 (Tr. 14-17); PX 245 at 6.  Petitioners even knew that the “stringer leaker” defect was inherent in their chosen manufacturing process.  SR Vol. 4 C 811-12 (Tr. 993-996); SR Vol. 38 C 9475 (Tr. 107-08); SR Vol. 39 C 9651 (Tr. 19); PX 145.  By 2001, Petitioners also learned of another defect, the “fold-over” defect, which could lead to fentanyl gel leaking from the patch.  SR Vol. 4 C 807-08 (Tr. 975-81); SR Vol. 39 C 9679 (Tr. 132-33).  According to the FDA, the Petitioners did nothing to address these defects other than to “raise operator awareness” of their existence, a “remedy” the FDA found inadequate.  PX 245 at 39-40.

In the weeks following the 2004 recall, the FDA inspected Petitioners’ manufacturing facility.   In addition to the defects mentioned above, the FDA found numerous other defects in the Duragesic patches, including gel in the seals, seal breaches, corners of the patch cut off, holes in the drug reservoir and slits in pouches and systems. PX 254 at 11-12.  The FDA ultimately agreed with what Petitioners’ own engineers had told them the previous year, that their in-process and quality control checks were inadequate to prevent the release of defective patches.  PX 92, 254.

RESPONSE TO PETITIONER’S POINTS RELIED UPON FOR REVIEW

The Court should deny the Petition because, contrary to Petitioners’ claims, the Appellate Court did not alter, modify or ignore the law.  It merely applied longstanding Illinois product liability law to a case involving a prescription drug, as have numerous Illinois courts.  Petitioners attempt to create a conflict with prior case law by asserting that the Appellate Court failed to properly apply a bizarre reformulation of Illinois law Petitioners call the “malfunction doctrine” pursuant to which:

●          a product is unreasonably dangerous only if it suffered an obvious, observable physical malfunction;

 

●          a defect may be inferred from circumstantial evidence but a malfunction may not;

 

●          only certain types of malfunctions – “malfunctions that bespeak defect” – may be used to infer a defect; and

 

●          an inference of defect from a malfunction may not be found in a case involving pharmaceutical products or prescription drugs.

 

Petitioners do not cite a single Illinois case to support this newly-created doctrine and argue that prior Illinois decisions contrary to their position were wrongly decided.  In short, it is Petitioners who seek to change the law.

Petitioners also attempt to justify review by claiming that the Appellate Court created new law regarding what type of evidence may be used to rebut causation.  But the court merely held that where a defendant’s proffered causation evidence would be “based on sheer speculation,” the exclusion of that evidence can only be harmless error.

Lastly, Petitioners claim the Appellate Court’s finding that Petitioners waived any error in Respondent’s closing argument by failing to object at trial conflicts with its prior decision in Pleasance v. City of Chicago, 396 Ill. App. 32 821 (2009).  But that case merely held that certain comments can be so egregious as to constitute “plain error” and make a failure to object unnecessary.  Here, Petitioners never argued plain error below and the facts would not have supported such an argument.

ARGUMENT

  1. I. The Appellate Court followed well-established Illinois product liability law.
    1. A. The Appellate Court properly applied the Tweedy doctrine.

 

In Tweedy v. Wright Ford Sales, 64 Ill. 2d 570 (1976), this Court held that a plaintiff can prove a non-specific product defect by offering evidence that a product failed to perform as expected:

A prima facie case that a product was defective and that the defect existed when it left the manufacturer’s control is made by proof that in the absence of abnormal use or reasonable secondary causes the product failed “to perform in the manner reasonably to be expected in light of [its] nature and intended function.”

Tweedy v. Wright Ford Sales, 64 Ill. 2d 570, 574 (1976).  The doctrine this Court articulated in Tweedy is most accurately described as the “failure to perform” doctrine since it is a product’s failure to perform as reasonably expected that provides circumstantial evidence of a non-specific defect.  See Dunham v. Vaughan and Bushnell Mfrg. Co., 42 Ill. 2d 339, 342 (1969) (“Although the definitions of the term ‘defect’ in the context of products liability law use varying language, all of them rest upon the common premise that those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function.”); Gillespie v. R.D. Werner Co., Inc., 71 Ill. 2d 318, 322 (1978) (reversing grant of JNOV where “it was reasonable for the jury to conclude there was an absence of abnormal use and the ladder failed to perform in the manner reasonably to be expected”).

Petitioners claim that the Appellate Court “created a new doctrine of absolute liability that goes well beyond the Tweedy inference of non-specific defect” and somehow violated the premise that a defect cannot be established by the mere fact of an accident or injury.  Petition at 2, 9, 13.  But the court never inferred that Petitioners were liable solely because Janice DiCosolo died while using their product.  Rather, the court merely applied the Tweedy doctrine and properly concluded that Janice DiCosolo’s fentanyl patch failed to perform as expected and that such failure caused her death:

In addition to other evidence presented by plaintiff, the evidence showed that: the Duragesic® skin patch worn by DiCosolo was designed to deliver a blood fentanyl level of 1.7 ng/mL, which is a drastically lower level than the 28.2 ng/mL found in her system at the time of her death; the medical examiner concluded that DiCosolo died from an overdose of fentanyl; the source of the fentanyl was defendants’ product, the 75 mcg/hr Duragesic® skin patch; and the patch came from a lot that had been recalled by defendants due to the presence of a defect in some of the patches.  Although defendants have correctly noted that an accident or injury alone is not sufficient to establish a defect, as one court has explained: “Saying that the patch was defective because it delivered more fentanyl than intended is not the same as saying the patch was defective because [the patient] died . . . .”

Opinion at ¶30.

 

  1. B. Petitioners misstate Illinois law in an effort to convince this Court that this unremarkable product liability case merits review.

 

Petitioners assert that the Appellate Court ignored Illinois law and created a new doctrine of “absolute liability.”  Opinion at 9.  However, it is actually Petitioners who seek to create new law.    Ignoring the plain holding of Tweedy and thirty-five years of product liability law since, Petitioners seek to create out of whole cloth something they call the “malfunction doctrine” and a limitation that only certain types of product malfunctions that “bespeak a defect” can lead to an inference of a non-specific defect.  Although they accuse the Appellate Court of expanding Tweedy, in reality, the court merely applied Tweedy and it is Petitioners who seek to greatly restrict Tweedy in a manner unsupported by a single Illinois case.

In addition to seeking an unwarranted restriction on the application of the Tweedy doctrine, Petitioners also argue that while a defect can be inferred from a malfunction, a malfunction itself can never be inferred and must instead be shown by evidence of a clear, observable, physical malfunction of a product.  Lastly, they claim, citing as “authority” a Brooklyn Law Review article, that products like prescription drugs and medical devices do not lend themselves to application of the Tweedy doctrine.

In crafting their bizarre and unworkable reformulation of Illinois law, Petitioners ignore long-standing Illinois law that any fact, including the existence of a defect, can be inferred by circumstantial evidence.  They ignore Illinois case law applying the Tweedy doctrine to fentanyl pain patches and other pharmaceutical products.  And they ignore the fact that no reported Illinois case has ever recognized a so-called “malfunction doctrine,” held that a failure to perform can only be shown by a physical, observable malfunction or limited the Tweedy doctrine to malfunctions that “bespeak a defect.”

  1. 1. Illinois law does not recognize a “malfunction doctrine.”

Petitioners claim that review is proper because “the First District effectively eliminated ‘malfunction’ from the malfunction doctrine.”  Petition at 1.  While Petitioners rely on Tweedy to support this argument, Tweedy merely held that a plaintiff can prove a non-specific defect by offering evidence that a product failed to perform as expected.  No Illinois court has ever recognized or applied a so-called “malfunction doctrine” or held that an observable, physical malfunction must be present to prove a product was defective.  Opinion at ¶18 (after analyzing numerous Illinois product liability cases, Appellate Court noted that “[n]one of these cases, however, refer to a ‘malfunction doctrine’ or “malfunction theory.’”).  Rather, under the Tweedy doctrine, “a malfunction is only one type of proof that a product did not perform as expected.”  Opinion at ¶27; see also Bollmeier v. Ford Motor Co., 130 Ill. App. 2d 844, 851 (1970) (emphasis added) (“direct or circumstantial evidence which tends to prove that the product failed to perform in the manner reasonably to be expected in the light of its nature and intended function, such as proof of a malfunction which tends to exclude other extrinsic causes, is sufficient to make a prima facie case”).  Petitioners’ “malfunction doctrine” is a self-created reformulation of Illinois law that would fundamentally alter the way in which a plaintiff may prove a product liability claim.

  1. 2. Illinois law does not support the notion that a malfunction cannot be inferred from circumstantial evidence.

 

Petitioners also appear to argue that Tweedy permits a defect to be inferred from a malfunction but does not permit a malfunction to be inferred from circumstantial evidence.  Petition at 2.  But Illinois law clearly permits any fact – including a malfunction – to be inferred from circumstantial evidence.  See, e.g., Hampton v. Sears Roebuck & Co., 252 Ill. App. 3d 744, 748 (1993) (“Like any fact, the defective nature of a product may be proved by circumstantial evidence.”); Renfro v. Allied Ind’l Equipt. Corp., 155 Ill. App. 3d 140, 156 (1987) (“The existence of a defect may be proved inferentially by either direct or circumstantial evidence.”); Weedon v. Pfizer, 332 Ill. App. 3d 17, 22 (2002) (“[A] plaintiff may establish a non-specific defect claim by circumstantial evidence.”); Sikora v. AFD Industries, Inc., 319 F.Supp.2d 872, 877 (N.D. Ill. 2004) (“This method allows a plaintiff to prove a non-specific defect in the product through circumstantial evidence.”).

At trial, Respondent offered substantial circumstantial evidence of a malfunction, a defect and a failure to perform as reasonably expected, including the following:

●          Petitioners had known of the existence of defective, leaking patches since at least 2000, including defects inherent in their manufacturing process;

 

●          Janice DiCosolo’s fentanyl patch came from Lot 192, which was recalled by Petitioners on February 16, 2004 after numerous patches were discovered to contain a defect known as a “fold-over defect” that caused affected patches to leak medication, potentially leading to death;

 

●          When he changed his wife’s second to last patch, John DiCosolo observed a “slick film” on his wife’s skin that his experts testified was consistent with a leaking patch;

 

●          Janice DiCosolo’s fentanyl patch provided her with an excessive fentanyl level — a level of 28.2 ng/mL when the expected level from a properly functioning 75 mcg patch was 1.7 ng/mL;

 

●          All experts, Respondents’ and Petitioners’, agreed that fentanyl from Petitioners’ patch was a cause of Janice DiCosolo’s death; and

 

●          Respondent’s expert witnesses testified that Janice’s fentanyl patch was defective.[2]

 

Respondent clearly offered ample evidence that Janice DiCosolo’s fentanyl patch failed to perform as would reasonably be expected (and was therefore defective and unreasonably dangerous) because it gave her a fatal dose of fentanyl far in excess of the level expected from a properly functioning patch, most likely due to a leak.

  1. 3. Illinois law does not limit a Tweedy inference to malfunctions that “bespeak a defect.”

 

According to the Petition, “a Tweedy inference of non-specific defect [is] allowed when a product malfunction bespeaks defect.”  Petition at 9; see also Petition at 11 (“[m]ore recently, cases have improperly expanded the Tweedy inference to instances where there is no malfunction that bespeaks defect.”); Petition at 13 (plaintiffs may not prove a non-specific defect “without proof of a malfunction that bespeaks a defect.”).  The meaning of the unique phrase “bespeaks a defect,” a phrase unheard of in American product liability law, is not entirely clear.  Petitioners seem to argue that only observable, obvious, physical product malfunctions such as a broken ladder or exploding Coke bottle can support a Tweedy inference.  Petition at 10-11.

Of course, no Illinois court has ever recognized such a restriction on the Tweedy doctrine, which has been applied to a whole host of products.  Even if this were the law, a “malfunction that bespeaks defect” would certainly encompass a leaking patch that provided 16 times the expected fentanyl level.  See Opinion at ¶24 (noting that an “observable malfunction might be a markedly elevated blood fentanyl level such as 28.2 ng/mL when the only source of fentanyl is the patch that is designed to deliver a level of 1.7 ng/m” and that another “observable malfunction might be excessive gel on the skin” as supported by testimony from John DiCosolo “that he did observe a slick film on DiCosolo’s skin when he changed the penultimate patch.”).

  1. 4. Illinois law does not prohibit a Tweedy inference in cases involving pharmaceutical products.

 

Lastly, Petitioners claim that “pharmaceutical cases do not lend themselves to a Tweedy inference.”  Petition at 12.  But Illinois product liability cases do[E1] not limit a “Tweedy inference” to certain categories of products.  And several Illinois courts have applied the Tweedy doctrine to cases involving pharmaceutical products, including fentanyl pain patches.  See, e.g., Adams v. Johnson & Johnson, Civil No. 07-497-GPM (S.D. Ill. May 7, 2009) (in fentanyl patch wrongful death case against these same defendants, court cited Tweedy and held that “in the absence of evidence of abnormal use or reasonable secondary causes with respect to the overdelivery of fentanyl by the patch Mr. Adams was wearing at the time of his death, Respondent is entitled to present her products liability claim based on defective design and manufacture to the jury.”); Samansky v. Rush-Presbyterian-St. Luke’s Hosp., 208 Ill. App. 3d 377 (1990) (court applied Tweedy doctrine to case involving central venous pressure catheter); Kunnemann v. Janssen Pharmaceutica Products, L.P., No. 05 C 3211, 2008 U.S. Dist. LEXIS 101724 (N.D. Ill. Dec. 2, 2008) (in fentanyl patch wrongful death case against these same defendants, court denied summary judgment even though “Respondent admits she has no evidence of any specific defect in the patch” because evidence  the patch “delivered more fentanyl than intended” was some evidence that the patch was unreasonably dangerous); Weedon v. Pfizer, 332 Ill. App. 3d 17 (2002) (applying Tweedy to venous access device).

Courts in other jurisdictions have similarly held that a non-specific defect in a fentanyl patch can be inferred from circumstantial evidence of its failure to perform as expected.  See, e.g., Woodcock v. Mylan, 661 F, Supp. 2d 602, 610 (S.D. W. Va. 2009) (court denied motion to dismiss manufacturing defect claim in fentanyl patch wrongful death case where plaintiff alleged that the patch used by decedent “was manufactured defectively because it ‘can and does cause lethal levels of fentanyl in patients’ and ‘decedent had a lethal fentanyl blood concentration at the time of his death’”); Miller v. Alza Corp., Case No. 759 F. Supp. 2d 929, 941 (S.D. Ohio 2010) (“Plaintiff admits that there is no direct evidence of a leaking patch, but argues that the manufacturing defect claim is not limited to a claim of a leaking patch, and nevertheless, Plaintiff asserts that circumstantial evidence creates a genuine issue of material fact as to whether the patch leaked or was otherwise defective in its manufacture.  The Court finds that some circumstantial evidence of a leaking patch exists, thereby precluding summary judgment.”).  Rather than cite any case law, Petitioners rely solely on a Brooklyn Law Review article for the proposition that “pharmaceutical cases do not lend themselves to a Tweedy inference.”  Petition at 12.  This untenable position should be rejected.

  1. C. Petitioners agreed with the very rules of law they now attack until they lost at trial and on appeal.

 

Petitioners’ reformulation of Illinois product liability law conflicts not only with existing Illinois law but with Petitioners’ prior pleadings in this case as well.  In their summary judgment pleadings and post-trial pleadings, Petitioners repeatedly cited Tweedy as providing the applicable law and stated:

●          “an inference of non-specific defect is permissible when, among other things, the product fails to perform in the manner reasonably to be expected in light of its nature and intended function.”

 

●          “If a non-specific defect is alleged, a plaintiff must offer direct or circumstantial proof that in the absence of abnormal use or reasonable secondary causes, the product failed to perform in the manner reasonably to be expected in light of its nature and intended function.”

 

●          “Plaintiff is not limited to proving his manufacturing defect claims by direct evidence and can instead prove defect by circumstantial evidence.”

SR Vol. 22 at 5498; R Vol. 17 at 4229; R Vol. 9 at 2176.  They also agreed to a pattern jury charge that instructed the jury they could find in Respondent’s favor on his strict liability claim if he proved that “in giving Janice DiCosolo a dose of fentanyl that exceeded the does that properly functioning Duragesic patches were designed to give, one or more of the Duragesic patches failed to perform in a manner reasonably to be expected in light of its nature and intended function.”  R Vol. 17 at 4018.

Having lost at trial and had the judgment against them affirmed by the Appellate Court, Petitioners have apparently had an epiphany: “pharmaceutical cases do not lend themselves to a Tweedy inference” and the “failure to perform as reasonably expected” standard should be supplanted with a “malfunction that bespeaks defect” test.  Petitioners, however, are not permitted to challenge on appeal the very law they agreed applied to this case.  See, e.g., People v. Swope, 213 Ill. 2d 210, 217 (2004) (“a party cannot complain of error which that party induced the court to make or to which that party consented.”).

II.        The Appellate Court correctly applied Illinois law in finding no reversible error in the exclusion of evidence of a clonazepam refill.

 

  1. A. There was absolutely no evidence Janice ever took the clonazepam.

Several days before Janice DiCosolo’s death, her husband picked up a refill of clonazepam that the pharmacy mistakenly refilled even though the prescription had been discontinued by her doctor.  SR Vol. 6 C 1309 (Tr. 2113).  There was no evidence Janice even knew the prescription had been picked up by her husband.  And there was no evidence she ever took the discontinued drug.  In fact, her husband testified that his wife knew which medications to take and had previously refused to take medications that had been mistakenly refilled by the pharmacy after they had been discontinued.  SR Vol. 5 C 1137 (Tr. 1691-92), 1152 (Tr. 1750-52), 1154 (Tr. 1758-60).

Janice DiCosolo died on February 15, 2004.  That same day, while still under the stress and emotion of her death, her husband, John DiCosolo, prepared a “First Call Sheet” on which he listed ten different medications he understood she was taking at the time of her death.  SR Vol. 5 C 1152 (Tr. 1750); DX 4A.   Despite the fact they were specifically listed, the Medical Examiner chose not to test Janice’s blood for bextra or topamax.  SR Vol. 5 C 1080 (Tr. 1598).  Later, Respondent’s lawyer sent the M.E.’s office a letter identifying additional medications that had mistakenly been omitted from the First Call Sheet, including clonazepam.  SR Vol. 5 C 1081-82 (Tr. 1602-04).  Despite the fact that clonazepam was specifically listed, the Medical Examiner did not take any steps to test Janice’s blood for this drug.  Id. Nor did Petitioners, large pharmaceutical companies with the resources and equipment needed to test blood that had been retained by the toxicology lab and could have been tested.  CR 5 1067 (1547) (“NMS still had blood at this point and could have done this testing.”).

As a result of this failure to test the blood, there was simply no evidence as to whether Janice DiCosolo ever took the clonazepam or, if she did, when she took it, how much she took and what level of clonazepam, if any, was in her blood at the time she died.  In fact, Petitioners’ experts could not say whether Janice DiCosolo even took the discontinued clonazepam, whether clonazepam would have even been in Janice DiCosolo’s system at the time of her death if she took it the day it was filled, whether it would have contributed to her death or whether its addition would have even been a significant change to her existing drug regimen.  SR Vol. 6 C 1269 (Tr. 1950), 1311 (Tr. 2118).  The absence of these critical facts led Petitioners’ counsel to concede at trial regarding clonazepam and avinza that:

I’m not inferring that these were a cause of her death.  We know that because the blood wasn’t tested, that that’s a difficult hurdle to overcome.

 

SR 5: 1066 (Tr. 1540).

  1. B. The Appellate Court applied established law regarding reversible error.

 

On appeal, however, Petitioners asserted that they were entitled to a new trial because the Trial Court erred in excluding evidence of the clonazepam refill.  Under Illinois law, “a party is not entitled to reversal based upon evidentiary rulings unless the error was substantially prejudicial and affected the outcome of the case.” Taluzek v. Illinois Central Gulf R.R. Co., 255 Ill. App. 3d 72, 83 (1993).  In holding that any error in excluding the clonazepam evidence did not justify a new trial, the Appellate Court merely applied this well-established legal principle.  Opinion at ¶¶40-41.

Petitioners claim that the Appellate Court somehow “creat[ed] a new rule of law that requires defendants to develop direct evidence before they may present circumstantial evidence to rebut causation.”  Petition at 14.  This assertion appears to be based on Petitioners’ allegation that the court found that Petitioners “waived” any trial court error by not testing decedent’s blood for clonazepam.  Petition at 17.  But the Appellate Court held no such thing.  While the Appellate Court made note of the fact that Petitioners did not test the blood, it did not find that such conduct amounted to a “waiver” of any Trial Court error.  Petition at 17.  Instead, the Appellate Court merely stated that Petitioners’ failure to test the blood “belies their claim that the existence of clonazepam in DiCosolo’s blood was so crucial to their defense that the trial court’s exclusion of the evidence related to clonazepam ‘gutted’ their causation defense.”  Opinion at ¶44.

The true basis for the Appellate Court’s decision was not some unspoken finding of waiver, but rather the court’s observations that:

●          “even if the jurors could have inferred that DiCosolo ingested the clonazepam, it would not have changed the undisputed fact that no clonazepam was found in her system;” and

 

●          “any hypothetical question of causation and any expert testimony based upon the presence of clonazepam in DiCosolo’s blood would have been based on sheer speculation.”

 

Opinion at ¶¶41, 42 (emphasis added).  It is well-established under Illinois law that “regardless of how skilled or experienced an expert, the expert may not state a judgment or opinion based on conjecture.”  Rodrian v. Seiber, 194 Ill. App. 3d 504, 507 (1990).  It is equally well-established that to be admissible, causation evidence – whether offered by a plaintiff or defendant – must not be speculative.  See, e.g., Thacker v. UNR Inds., 151 Ill. 2d 343, 354 (1992) (“While circumstantial evidence may be used to show causation, proof which relies upon mere conjecture or speculation is insufficient.”).  Because “any hypothetical question of causation and any expert testimony based upon the presence of clonazepam in DiCosolo’s blood would have been based on sheer speculation” (Opinion at ¶42), Petitioners had no admissible evidence that clonazepam caused or contributed to Janice DiCosolo’s death.  Without such evidence, the clonazepam refill was irrelevant and more prejudicial than probative and its exclusion was, at most, harmless error.

Lastly, any error in the exclusion of clonazepam was harmless because the evidence would not have changed the jury’s finding of liability.  As set forth above, all experts agreed that fentanyl from Petitioners’ fentanyl patch was a cause of Janice’s death.  Moreover, the patch came from a lot recalled due to leaking defects, the decedent’s husband observed a slick film on her skin consistent with leaking fentanyl gel and decedent’s patch gave her a fentanyl level 16 times higher than reasonably expected from a properly functioning patch.  Speculative testimony that decedent may have taken clonazepam merely because she had “access” to it (SR Vol. 6 C 1269 (Tr. 1950-51)) would not alter any of these basic facts, facts which caused the Appellate Court to properly conclude that “[t]here was overwhelming evidence regarding the defective Duragesic skin patch causing DiCosolo’s death.”  Opinion at ¶41.  For all of the reasons set forth above, the Appellate Court properly determined that the exclusion of evidence of the clonazepam refill did not amount to reversible error.

III.       Respondent’s closing argument does not justify reversal of the jury’s verdict.

  1. A. The comments at issue did not justify a new trial.

“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 (2008).  Improper comments by counsel constitute reversible error only where the comments are so prejudicial as to deprive the other party of a fair trial.  Clarke, 381 Ill. App. 3d at 95.  In the instant case, the comments made by counsel were based on the evidence and were intended to refute Petitioners’ claims regarding the unavailability of a Vision System that would detect leaking patches and the timeliness of Petitioners’ 2004 recall.  SR Vol. 3 C 541 (Tr. 355), 553-54 (Tr. 401, 406); SR Vol. 5 C 1184-85 (Tr. 1880-81); SR Vol. 7 C 1698-1700 (Tr. 2806-11), 1710-11 (Tr. 2854-57).  No linkage was made between Petitioners’ profits and the damages sought by Respondent.  To the contrary, Respondent’s counsel repeatedly informed the jury that damages were totally within their discretion and discussed at length the proper evidence for the jury to consider in assessing damages: evidence relating to the specific losses the DiCosolo family had suffered.  SR Vol. 3 C 546 (Tr. 374); SR Vol. 7 C 1702 (Tr. 2824), 1719-20 (Tr. 2892-55).

  1. B. Petitioners waived any objection to the closing argument.

 

Petitioners failed to object to the allegedly improper comments of Respondent’s counsel during his closing argument.  Rather, Petitioners waited until his closing argument was complete to make their objection.  SR Vol. 7 C 1704 (Tr. 2829-30).  And when they did object, Petitioners merely stated that Respondent’s counsel had “basically argued a punitive damage case, not a compensatory damage case.”  SR Vol. 7 C (Tr. 1230).  No objection was made to any specific statements.  And despite now claiming the term was “inflammatory,” Petitioners never objected to the word “kill” or its variants, either in closing argument or during opening statement (when they were used 13 times).  Under Illinois law, Petitioners’ failure to timely object to the allegedly improper comments made during closing argument constitutes a waiver. See, e,.g., Hubbard v. Sherman Hospital, 292 Ill. App. 3d 148, 156-57 (1997); Opinion at ¶4.

Although Petitioners now claim that the Appellate Court’s finding of waiver is inconsistent with the “plain error” rule (Petition at 19), they never argued in their briefs before the Appellate Court that the comments at issue amounted to “plain error.”  Moreover, “plain error” is limited to those extreme circumstances, not present here, in which counsel’s comments are “so egregious that they deprived a litigant of a fair trial and substantially impaired the integrity of the judicial process itself.”   Spyrka v. County of Cook, 366 Ill. App. 3d 156, 170 (2006).  Both the Trial Court and Appellate Court properly held that the comments at issue did not rise to this level.  SR Vol. 7 C 1704 (Tr. 2829-30); R Vol. 26 C 6404-05; Opinion at ¶¶65-66.

Finally, the Appellate Court’s ruling was not based solely on a finding of waiver.  Rather, that court clearly stated that “waiver or forfeiture aside, we conclude that the comments do not warrant a new trial.”  Opinion at ¶64.  Petitioners have given this Court no basis to revisit this conclusion or the similar conclusion reached by the Trial Court.

  1. C. The Trial Court’s ruling is entitled to deference.

As numerous courts have held, a trial court is in the best position to observe the arguments of counsel and make a determination about their effect on the jury.  See e.g., Simmons v. Garces, 198 Ill. 2d 541, 571 (2002) (“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.”).  Here, the Trial Court carefully considered and rejected Petitioners’ arguments regarding closing argument both at trial and when denying Petitioners’ post-trial motions.  SR Vol. 7 C 1704 (Tr. 2829-30); R Vol. 26 C 6404-05.  And the Appellate Court properly deferred to the Trial Court’s considered judgment.  See, e.g., Mosser v. Fruehauf Corp., 940 F.2d 77, 83 (4th Cir. 1991) (appellate court held that a statement made during closing argument in a product liability case that “you can’t kill a man like that in the Ohio Valley” was intended to “inflame the passions of the jury” and was improper, but nonetheless deferred to the trial court’s judgment that the comments did not warrant a mistrial, stating that “we once again choose to credit the judgment of the trial court who heard the extended closing arguments in their entirety”);  Johnson v. Hoover Water Well Service, Inc., 108 Ill. App. 3d 994, 1007 (1982) (appellate court held that statements by counsel in negligence action that the defendant’s conduct “should not go unpunished” and that the jury had “an opportunity to right a wrong” were improper but deferred to the trial court’s ruling that they did not justify a mistrial since the trial court was “in the unique position of hearing the testimony and arguments and calculating the effect these matters have on the jury.”)

Petitioners now claim for the first time that the Trial Court’s ruling is not entitled to deference because the court “had no reason to gauge the effect of argument it considered to be permissible.”  Petition at 20.  In reality, however, the Trial Court never passed on whether the comments were “permissible.”  It merely held, after Petitioners belatedly moved for a mistrial, that the comments were not so unfairly prejudicial as to warrant a new trial.  Brief of Appellants at 41; SR Vol. 7 C 1706 (Tr. 2839); R Vol. 26 (6388, 6404-05).  It is simply a distortion of the record to claim that the Trial Court “did not even consider the argument to be improper.” Petition at 20.   Moreover, even if the Trial Court had so concluded, there is no Illinois case law supporting the proposition that its evaluation would therefore be entitled to little or no deference.  Petition at 20.

CONCLUSION AND PRAYER

Respondent respectfully prays that the Court deny Petitioners’ Petition for Leave to Appeal, affirm the judgment of the Appellate Court, and grant Respondent such other and further relief to which he may be justly entitled.

Respectfully submitted,
HEYGOOD, ORR & PEARSON
2331 W. Northwest Highway
Second Floor
Dallas, Texas 75220
(214) 237-9001 (Telephone)
(214) 237-9002 (Telecopier)


[1] Even the fourfold increase that Petitioners claim was possible would yield an ante-mortem level of 7.0 ng/mL, more than four times the expected level of 1.7 ng/ml.  And while Petitioners claim that a study showed an increase of up to “tenfold,” that was from a comparison between a blood level and a liver level, not between ante-mortem and postmortem blood levels.  SR Vol. 7 C 1544.  Lastly, while Petitioners cite a study showing a living patient with a 9.9 ng/mL fentanyl level, they fail to mention that this person was wearing three 100 mcg fentanyl patches, four times the dosage Janice DiCosolo was wearing.  SR Vol. 4 C 985.

[2] SR Vol. 3 C 589 (Tr. 455), 746-47 (Tr. 837-40); SR Vol. 4 C 749 (Tr. 847), 807-12 (Tr. 975-96); SR Vol. 5 C 1076 (Tr. 1582), 1133-48 (Tr. 1676-1735); SR Vol. 6 C 1078 (Tr. 1590-91); 1292 (Tr. 2042-43); 1430-32 (Tr. 2288-95); SR Vol. 7 C 1549 (Tr. 2514).; SR Vol. 38 C 9475 (Tr. 107-08); SR Vol. 39 C 9650-51 (Tr. 14-19), 9679 (Tr. 132-33); PX 25, 145, 272; DX 182.