Response to Defendants’ Motion for Summary Judgment

Kunnemann v. Janssen

Description: This brief was filed in Illinois federal court in response to a summary judgment motion filed by the defendants in a fentanyl pain patch case. The response generally addresses issues relating to manufacturing, design and marketing defects in terms of negligence and strict product liability. It also addresses the applicability and effect of Comment k to the Restatement (Second) of Torts, which generally applies to products that are “unavoidably unsafe.” Finally, the response addresses the application and import of the learned intermediary doctrine in relation to plaintiff’s warning claims. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
RANDI L. KUNNEMANN, as INDEPENDENT ADMINISTRATOR OF THE ESTATE OF KARIN K. KUNNEMANN,PLAINTIFFvs.JANSSEN PHARMACEUTICA PRODUCTS, L.P., a New Jersey Corporation; and ALZA CORPORATION, a Delaware Corporation,DEFENDANTS NO. 05-C03211Judge CastilloMagistrate Judge Keys

PLAINTIFF’S MEMORANDUM IN SUPPORT OF HER RESPONSE

TO DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Plaintiff Randi Kunnemann hereby files her Memorandum in Support of her Response to Defendants’ Motion for Summary Judgment.

INTRODUCTION

Defendants’ summary judgment motion in this product liability and negligence case should be denied. Plaintiffs have substantial and overwhelming evidence that Defendants were negligent in the design, manufacture and marketing of their Duragesic fentanyl pain patch. There is abundant evidence that the patch failed to perform as intended and expected when it delivered a fatal 5.8 ng/mL dose of fentanyl to 27 year-old Karin Kunnemann in June 2004, a dose more than double the stated mean maximal concentration of 2.5 ng/mL set forth in Defendants’ package insert. Following Kunnemann’s death, Dr. Jeff Harkey, a forensic pathologist with the DuPage County Coroner’s office, performed an autopsy and concluded that Kari Kunnemann died of “fentanyl toxicity due to delivery of fentanyl by means of a Duragesic 100 ug/hr patch.” This diagnosis has been confirmed by Dr. Michael Baden, one of the leading forensic pathologists in the country. The only reasonably probable explanation for this fatal dose of fentanyl was a manufacturing or design defect that caused the patch to perform other than was intended.

Defendants argue that there is no evidence of a manufacturing defect because an inspection of the patch more than two years after Kunnemann’s death showed no visible defect in the patch and because Plaintiffs have not identified a specific design or manufacturing defect. Defendants’ argument ignores the fact that the patch was in poor condition when it was examined and the fact that Illinois law allows a plaintiff to rely on a non-specific defect theory. As set forth below, the fact that Kunnemann’s Duragesic patch delivered a fatal, 5.8 ng/mL dose of fentanyl – more than twice the mean maximal does of 2.5 ng/mL – is circumstantial evidence of a manufacturing or design defect sufficient to defeat a motion for summary judgment.

Contrary to Defendants’ assertion, Plaintiff has also offered substantial evidence that a defective Duragesic patch caused Karin Kunnemann’s death. Both forensic pathologist Dr. Michael Baden and toxicologist Dr. Cheryl Blume have opined that Kunnemann died because her Duragesic patch delivered more fentanyl than it was designed to deliver. And although Defendants claim that the chart in their package insert showing a mean maximal fentanyl level of 2.5 ng/mL is applicable only to the first use of a Duragesic patch, another chart in that same insert shows a lower mean maximal level of fentanyl for repeat users of the patch. Moreover a study sponsored by Defendants showed a mean maximal fentanyl level of 2.6 ng/mL for repeat users, refuting the notion that long-term users like Kunnemann would have a substantially higher level of fentanyl in their system.

Plaintiff also has an abundance of evidence to refute the notion that the 5.82 ng/mL level of fentanyl found in Kunnemann’s blood was significantly higher than the level at the time of death due to postmortem redistribution. Both Drs. Baden and Blume have opined that there was no significant postmortem redistribution in this case. A study by Daniel Anderson found that postmortem redistribution of fentanyl accounted for an increase of no more than 20%. This same study found that in 43% of the cases, there was no postmortem redistribution at all. Finally, the source of the blood draw in this case, the level of drug found and the proximity in time between Kunnemann’s death and her autopsy militate against significant postmortem redistribution.

With respect to causation, Plaintiff also has ample evidence refuting Defendants’ argument that 5.82 ng/mL was a therapeutic – not lethal – level of fentanyl for Karin Kunnemann given her long-term use of Duragesic. As set forth below, a study by R.K. Portenoy that was sponsored by Defendants revealed steady state serum concentration of only 1.62 ng/mL and a mean maximum concentration of 2.6 ng/mL for long-term Duragesic users. Based on the results of the study, Portenoy concluded that “the kinetics of fentanyl did not change between single and multiple application of TSS (fentanyl).” Defendants’ “therapeutic level” argument is also refuted by numerous studies that have shown fentanyl to be lethal – not therapeutic – at levels as low as 3.0 ng/mL or even 2.2 ng/mL. Finally, the most telling evidence that 5.82 ng/mL was not a therapeutic level for Karin Kunnemann is the fact that such a level killed her according to her autopsy and the opinions of Drs. Harkey, Baden and Blume.

Defendants also contend that Plaintiff’s design defect fails under Comment k to the Restatement (Second) of Torts. Defendants’ argument fails for many reasons. First, Defendants have failed to meet their burden of proof of showing that Duragesic is “unavoidably unsafe” under Comment k. Second, case law holds that whether a product is unavoidably unsafe is a fact question for the jury. Third, Comment k does not shield a drug manufacturer from liability unless the evidence demonstrates that the manufacturer sufficiently warned of all known dangers. Here, Defendants have failed to provide such evidence and the uncontroverted evidence of the 2005 changes to Duragesic’s labeling, the product recalls, Janssen’s June 2005 “dear doctor” letters and the FDA’s July 2005 and December 2007 Public Health Advisories demonstrate that Defendants had not warned doctors of all of the known dangers of Duragesic at the time of Kunnemann’s death in June 2004.

Finally, Defendants argue that they are entitled to summary judgment on Plaintiff’s warning claims under the learned intermediary doctrine. But the doctrine only applies if a drug manufacturer has adequately warned the prescribing physician of all of the risks and dangers of its product. Defendants have failed to meet their burden in this regard and cannot as a matter of law make such a showing given the 2005 changes to Duragesic’s labeling, Janssen’s June 2005 “dear doctor” letters and the FDA’s July 2005 and December 2007 Public Health Advisories. In any event, under Illinois law, the issue of whether a manufacturer gave adequate warning of the known dangerous propensities of a drug so as to trigger the learned intermediary doctrine is one of fact.

As set forth more fully below, Plaintiffs have an abundance of evidence supporting each of their claims against Defendants under Illinois law. Because they have raised a fact issue on each challenged element of their causes of action, Defendants’ motion should be denied.

STATEMENT OF FACTS

Karin Kunnemann, 27 years old, was found dead in her bed in her parents’ house about 7:50 am on June 8, 2004. From June 2, 2004 through June 6, 2004, Ms. Kunnemann had been hospitalized at Central DuPage Hospital because of headaches and associated nausea. Declaration of Michael Baden (“Baden Declaration”) at ¶9. She had been prescribed one 100 mcg Duragesic patch every 48 hours for severe migraine-type headaches and chronic abdominal pain. Id. A patch was placed on Ms. Kunnemann by hospital staff at 6:06 am on the morning of discharge, June 6, 2004. Id. Her mother last saw her awake when she went to bed about 11:30 am on June 7, 2004 and last checked on her about 4:00 am at which time her mother perceived her daughter to be alive and sleeping. She found her to be lifeless a few hours later. Id.

During the above hospitalization, a chest X-ray showed her lungs to be normal and without any evidence of pulmonary edema. Baden Declaration. at ¶10. Her vital signs and heart sounds were normal. She appeared well nourished and reported a recent weight gain. Id. During the hospitalization, her pain medications primarily consisted of Roxicodone 15 mg QID, Duragesic 100 mcg and Demerol 50-75 mg IV q 3 to 4 hours (later changed to Dilaudid 1 to 2 mg q 2 hours IV). Id. In the hospital, she was given IV fluids for risk of dehydration (she was never dehydrated) which were gradually decreased until her discharge. Id. Her blood work was essentially normal, including indicators of hydration level. Upon discharge, Ms. Kunnemann’s medications, in addition to the Duragesic, were the following: Roxicodone (15 mg QID), Lexapro (30 mg QD) and Xanax (1 mg QID prn). The records indicate that the Roxicodone was actually being used as a break through pain medication on a prn basis. Id.

At the time of her death, Karin Kunnemann was wearing a 100 mcg Duragesic transdermal pain patch which contained the pain medication fentanyl. Fentanyl is a very potent narcotic drug more than 80 times stronger physiologically than morphine if not administered in a careful and controlled manner. Baden Declaration at ¶11. Fentanyl has a very narrow therapeutic band, meaning that the difference between a therapeutic dose and a fatal dose of Fentanyl is small. Deposition of Dr. Cheryl Blume (“Blume Depo.”) at p. 78. Therefore, any administration of Fentanyl must be done in a careful and controlled manner.

According to Dr. Cheryl Blume, Defendants failed to properly warn doctors about the risks and dangers of Duragesic.

The labeling should have been amplified to reflect that fatalities have been reported secondary to hypoventalative events in patients who were not misusing or abusing the drug and patients for whom the drug was properly indicated.

Blume Depo. at p. 65; Id. at p. 230 (“I think physicians need to know that patients have died from respiratory arrest or cardiovascular conduction difficulties or whatever it is when they’ve used the drug properly.”). Moreover, according to Blume, there should have been warnings regarding the “narrow therapeutic range” of Duragesic and the resulting “overlap in the ranges of drug – of plasma levels, blood levels of fentanyl between effective concentration and toxic concentration and lethal concentration.” Blume Depo. at pp. 78, 198. Blume contrasted her recommended warning with the warnings that existed in the package insert at the time of Karin Kunnemann’s death in June 2004:

My reading of the current insert suggests that the warnings are directed to those patients in which there has been an incorrect use of the product, and that hypoventilation should be a consideration in those patients.” Blume Depo. at p. 220. According to Blume, the warnings regarding hypoventilation were “watered down” by the continual references to problems associated with opiod naïve patients.

Blume Depo. pp. 220-21.

Although Defendants claim that Dr. Skaredoff, the doctor who prescribed Duragesic to Karin Kunnemann, was a “learned intermediary,” the evidence demonstrates that Defendants had not provided Dr. Skaredoff and other members of the medical community with adequate information regarding the risks and dangers of Duragesic. Following Karin Kunnemann’s death in June 2004, the FDA issued a Public Health Advisory in July 2005 which stated that it was “investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control.” See July 2005 FDA Public Health Advisory. This Public Health Advisory came on the heels of Janssen’s June 2005 “Dear Doctor” letter, which it captioned as an “IMPORTANT DRUG WARNING.” See Janssen June 2005 letter. In that warning letter, Janssen identified “important changes in the prescribing information for Duragesic.” Id.; see also July 2005 FDA Public Health Advisory (“In June 2005, the Duragesic product label was updated to add new safety information in several areas of labeling”). Subsequently, the FDA issued a second Public Health Advisory regarding the Duragesic patch in December 2007, in which it stated that “[d]espite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch.” December 2007 FDA Public Health Advisory. None of the information that prompted the changes to the Duragesic package insert, Jansenn’s “dear doctor” letters and the FDAs two Public Health Advisories had been provided to Dr. Skaredoff at the time he prescribed Duragesic to Karin Kunnemann.

On the day of her death, at 12 noon, an autopsy was performed on Karin Kunnemann. Baden Declaration at ¶12; Deposition of Dr. Jeffery Harkey (“Harkey Depo.”) at p. 63. A Duragesic patch was present on her left thigh and no injury or natural disease was found that could have caused or contributed to her death. Baden Declaration at ¶12. It was noted that Ms. Kunnemann had a tunneled coronary artery. This is a common benign normal anatomic variation and was not contributory to her death. Id. The pathologist who performed the autopsy, Dr. Harkey, also concluded that this was not contributory to her death. Id.

Although Ms. Kunnemann had no injury or natural disease which could have explained her death, she did exhibit pulmonary edema, confirmed by microscopic findings, with “foamy white secretions in the trachea and larynx.” Baden Declaration at ¶13. Toxicologic analyses showed a potentially lethal level of fentanyl – 5.82 ng/ml – in her blood. Baden Declaration at ¶13; Karin Kunnemann Toxicological Report at p. 1. They also showed a therapeutic level of acetaminophen and no other drugs. Id. Both Xanax and Roxicodone were prescribed on a prn basis but were not found at toxicological examination and therefore could not have caused nor contributed to her death. Id.

Dr. Harkey, the forensic pathologist who performed the autopsy and investigated the death, concluded that the cause of death was accidental fentanyl toxicity caused by the Duragesic patch. See Karin Kunnemann Postmortem Examination at p. 5; Harkey Depo. at pp. 98-99. At a subsequent Coroner’s Inquest, the jury also determined that the cause of Ms. Kunnemann’s death was fentanyl toxicity. Baden Declaration at ¶14. After reviewing all of the materials submitted, Plaintiff’s expert, Dr. Michael Baden agrees with this diagnosis. Baden Declaration at ¶15. He has testified that the heart, brain, liver, kidneys and other organs showed no evidence of disease which could have contributed to death. Id. He has also testified that the level of fentanyl (5.82 ng/ml) present was sufficient to cause death. Id. Fentanyl at lethal levels causes respiratory depression which causes the lungs to fill with fluid and the individual to gradually lose consciousness and, as the blood oxygen level diminishes, to become comatose and eventually die, which is what occurred with respect to Ms. Kunnemann. Id.

The lethal level for a particular drug is determined by looking at the level of the medication which has killed people in the past. Baden Declaration at ¶16. With respect to Fentanyl, the lethal level has been found to be as low as 2.2 ng/ml. Id. In one large series referenced in Baselt: Disposition of Toxic Drugs and Chemicals in Man, the primary text used by pathologists and health professionals for ascertaining the lethal level of medications (GL Henderson, Fentanyl-Related Deaths: Demographics, Circumstances and Toxicology of 112 cases), the fatal level of fentanyl averaged 3 ng/ml. Id.; see also. Additionally, Dr. Michael Baden has testified that he has reviewed 78 autopsies from across the country where the cause of death was assigned by many different forensic pathologists as fentanyl toxicity; several of these deaths involved fentanyl levels under 6 ng/ml. Baden Declaration at ¶16. Based on the foregoing, it cannot be disputed that 5.82 ng/ml is a potentially fatal level of fentanyl. Id.

Defendants contend that Ms. Kunnemann’s fentanyl level would have been less than 5.82 ng/ml at the time of death because of postmortem redistribution. But, according to Dr. Baden, under the circumstances of Ms. Kunnemann’s death and the relative time for autopsy, postmortem redistribution would not have occurred to any significant degree. Baden Declaration at ¶18. These opinions are consistent with his deposition testimony, in which he opined that there was no significant postmortem redistribution because of the rapidity with which the autopsy was performed, the fact the blood was drawn from the aorta and other circumstances of the autopsy. Baden Depo. at pp. 103-04. The testimony and opinions of Dr. Cheryl Blume are also supportive of the fact that the high level of fentanyl in Karin Kunnemann’s body cannot be explained away by postmortem redistribution. According to Dr. Blume, “the best and accurate estimate of Karin Kunnemann’s fentanyl level at the time of her death is 5.82 ng/mL.” Blume Declaration at ¶45; see also Blume Depo. at pp. 128-29 (“it’s unlikely that significant postmortem redistribution occurred subsequent to Ms. Kunnemann’s death.”). Finally, the largest data collection on the postmortem redistribution of fentanyl is from Daniel T. Anderson, a toxicologist with the LA County Coroner’s office. Anderson’s study demonstrates that in over 43% of cases, the heart or central blood (which was the specimen taken from Karin Kunnemann) is actually less than the femoral or peripheral blood. Baden Declaration at ¶18; see also Affidavit of Daniel T. Anderson at ¶20.

With a 100 mcg patch, according to a chart in the package insert for Duragesic, the mean maximum concentration should be 2.5 ng/ml with a standard deviation of 1.2 ng/ml. Baden Declaration at ¶20; see also Duragesic May 2003 Package Insert. Thus, according to the package insert, the maximum fentanyl level achieved by a large number of Duragesic 100 mcg patients should be lower than 2.5 ng/ml. Blume Declaration at ¶30. The lethal level of an opiod, such as fentanyl, depends on an individual’s tolerance to the substance. Baden Declaration at ¶19. Tolerance does not prevent death if a person receives a larger does than she is tolerant to. If Ms. Kunnemann were tolerant to a low level of fentanyl, then a level of 5.82 ng/mL could be and was, in fact, lethal in this case. Id. Defendants’ expert Yale Caplan agreed that if Ms. Kunnemann had been receiving for example 2.5 ng/ml from prior patches and then received 5.82 from the patch placed by the hospital on June 6th, it could be fatal. Deposition of Yale Caplan (“Caplan Depo.”) at pp. 15-56.

Defendants contend that the package insert chart containing a mean maximal fentanyl concentration of 2.5 ng/mL should be considered for first patch application only. However, there is another graph in the package insert related to multiple patch application and it demonstrates numbers similar to the chart related to first patch application. See Duragesic May 2003 Package Insert. Also, clinical trials conducted with respect to treating cancer patients with Duragesic confirmed similar numbers as the package insert for steady state serum concentrations from properly performing patches upon repeat applications. See R.K. Portenoy: Repeat Dose Pharmacokinetics of TTS (fentanyl) in Cancer Patients; Baden Declaration at ¶21.

Defendants’ experts have also asserted that the fentanyl level produced by the Duragesic patch with chronic use should be expected to be significantly higher than the figures in the package insert. Dr. Baden disagrees with this position. According to his Declaration, data shows that fentanyl levels of 6 ng/mL can be fatal to repeated users of the Duragesic patch. Baden Declaration at ¶22. Moreover, contrary to the contentions of Defendants’ experts, the inventor of the Duragesic patch himself testified in his deposition that Duragesic is intended and designed to produce fentanyl levels in patients as set forth in the package insert. Deposition of Robert Gale (“Gale Depo.”) at pp. 6-9. Also, clinical trials have confirmed that steady state serum concentrations are achieved by the second patch and are stable with repeat dosing. Based on these studies, Dr. R.K. Portenoy concluded that ““no significant changes occur in fentanyl kinetics between single and repeated application of TSS (fentanyl).” See R.K. Portenoy: Repeat Dose Pharmacokinetics of TTS (fentanyl) in Cancer Patients.

In the opinions of Dr. Harkey and Dr. Baden, Karin Kunnemann died from fentanyl toxicity. Further, in the opinions of Dr. Baden and Dr. Cheryl Blume, the cause of the fentanyl toxicity was a Duragesic patch delivering more fentanyl than it was designed or intended to deliver. Ms. Kunnemann had been using Duragesic for several years, and it had never proved to be fatal. The only reasonably probable explanation for her death is that the patch she was wearing malfunctioned due to a manufacturing or design defect. Anisfeld Declaration at ¶100 (“the malfunction was most likely due to a product defect.”).

ARGUMENT AND AUTHORITIES

I. Plaintiff has ample evidence to support her negligence claim.

Although Plaintiff’s negligence claim is based on the existence of a manufacturing, marketing or design defect in the Duragesic patch she was using at the time of her death, product liability claims and negligence claims are not one and the same. One difference is that negligence claims may be proven through the doctrine of res ipsa loquitur. A plaintiff seeking to rely on the res ipsa doctrine “must plead and prove that he or she was injured (1) in an occurrence that ordinarily does not happen in the absence of negligence, (2) by an agency or instrumentality within the defendant’s exclusive control.” Heastie v. Roberts, 877 N.E.2d 1064, 1076 (Ill. 2007); see also Kowalkowski v. Voris, 415 N.E.2d 397, 400 (Ill. 1980) (“For plaintiff to take advantage of this inference, he must show that he was injured (1) in an occurrence which would not have occurred in the absence of negligence, (2) by an instrumentality or agency under the management or control of the defendant, and (3) under circumstances which were not due to any voluntary act or negligence on the part of the plaintiff.”).

The res ipsa loquitur doctrine is a species of circumstantial evidence and may be rebutted by the opposing party. If contrary evidence is offered by defendants, the presumption of negligence will not dissolve. Rather, it will remain to be considered with all the other evidence in the case and must be weighed by the jury against the direct evidence offered by defendants. Heastie, 877 N.E.2d at 1081. The doctrine does not require the admission of expert testimony:

A preliminary flaw in defendants’ argument is that it presupposes that expert medical testimony is a prerequisite to invocation of the res ipsa doctrine. That is clearly not the case. To be sure, the determination as to whether the res ipsa loquitur doctrine should apply in a given case may be based on expert testimony. Nothing in Illinois law, however, makes expert testimony a prerequisite to reliance on the doctrine in every case.

Heastie, 877 N.E.2d at 1079.

A. Karin Kunnemann’s death occurred under circumstances which were not due to any voluntary act or negligence on the part of the plaintiff.

Karin Kunnemann’s death occurred under circumstances which were not due to any voluntary act or negligence on her part. There is no evidence of any abnormal use or any product misuse or abuse. See, e.g., Deposition of Dr. Michael Skaredoff (”Skaredoff Depo.”) at p. 33 (“When I did urine testing on her, I think its; in there somewhere, whatever was – whatever was in her was supposed to be in her.”); Id. at p. 34 (“She was a very integrated and very, very reliable individual.”). Defendant’s expert, Dr. Gerhard Levy, testified:

She has not abused fentanyl. She hasn’t put ten patches on. I believe she was found with one patch on her body, to the best of my recollection. So I don’t see any – any indication of – of abuse, putting all that together.

Deposition of Dr. Gerhard Levy (“Levy Depo.”) at pp. 160-61.

B. Karin Kunnemann’s death was caused by an instrumentality or agency under the management or control of Defendants.

In setting forth this second element, some authorities speak of “management and control” rather than “exclusive control,” but the terms have come to be viewed as interchangeable. In either case, the requisite control is a not a rigid standard, but a flexible one in which the key question is whether the probable cause of the plaintiff’s injury was one which the defendant was under a duty to the plaintiff to anticipate or guard against. Heastie, 877 N.E.2d at 1076; see also Samansky v. Rush-Presbyterian-St. Luke’s Medical Center, 567 N.E.2d 386, 394 (Ill. App. 1990) (”Nor must plaintiff eliminate all causes of his injuries other than the negligence of one or more of the defendants.”). Here, it is unquestioned that the Duragesic patch was manufactured and sold by Defendants. There are no allegations of misuse or abuse. Defendants have not alleged that the patch was tampered with, altered or otherwise modified after it was manufactured.

C. Karin Kunnemann’s death was caused by an occurrence which would not have occurred in the absence of negligence.

Finally, Karin Kunnemann’s death was caused by an occurrence which would not have occurred in the absence of negligence. The toxicological testing of Decedent’s blood within hours of her death found a level of fentanyl of 5.82 ng/mL. Defendant’s Statement of Undisputed Facts at ¶24 (“The fentanyl test was positive and was quantitated at 5.82 ng/mL.”). This level of fentanyl was much higher than would be expected if the Duragesic patch had properly performed. As Dr. Cheryl Blume testified, “the patch is designed to deliver certain drug levels and not to deliver certain drug levels; and her drug level was outside what the patch was intended to deliver.” Blume Depo. at p. 154.

The package insert as it existed in 2004 stated that the “mean maximal concentration” for someone using a 100 microgram patch would be 2.5ng/mL. Duragesic May 2003 Package Insert. For patients who have used several patches over an extended period of time, another chart in the package insert demonstrated a mean maximal fentanyl level of less than 2 ng/mL. Id. According to Dr. Cheryl Blume, “established levels in most laboratories I think are one to three or one to two and a half.” Blume Depo. at p. 63. According to Dr. Harkey, who performed the autopsy on Karin Kunnemann, the high end of the maximum concentration of fentanyl within 24 to 72 hours after application of a 100 microgram patch is 3.8 ng/ML. Harkey Depo. at p. 81. Kunnemann’s fentanyl level of 5.8 ng/mL was well outside the normal range expected for someone using a 100 microgram Duragesic patch.

Moreover, there is a great deal of evidence that the Duragesic patches manufactured and marketed by Defendants were susceptible to malfunctioning and delivering a lethal dose of fentanyl. As the FDA Medical officer who reviewed Defendant’s New Drug Application for Duragesic stated, “the proposed 75 & 100 ug/hr TTS fentanyl system sizes are capable of delivering toxic doses of fentanyl to a significant fraction of the clinical population.” FDA Medical Officer Review, Volume 2, at p. 25. These pre-approval concerns were borne out by the subsequent Public Health Advisory issued by the FDA in July 2005 which the FDA stated that it was “investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control.” FDA July 2005 Public Health Advisory. This Public Health Advisory came on the heels of Janssen’s June 2005 “Dear Doctor” letter, which it captioned as an “IMPORTANT DRUG WARNING.” In that warning letter, Janssen identified “important changes in the prescribing information for Duragesic.” Janssen’s June 2005 letter to health professionals; see also July 2005 FDA Public Health Advisory (“In June 2005, the Duragesic product label was updated to add new safety information in several areas of labeling”). Subsequently, the FDA issued a second Public Health Advisory regarding the Duragesic patch in December 2007, in which it stated that “[d]espite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch.” December 2007 FDA Public Health Advisory. Finally, additional circumstantial evidence that the Duragesic pain patches were defective comes from the 2004 recall of 75 microgram patches and the February 2008 recall of 25 microgram patches. Blume Declaration at ¶22. As Dr. Blume summarized in her declaration, “[t]here have been several problematic post-approval regulatory issues associated with Duragesic.” Blume Declaration at ¶21.

Based on the foregoing, and his review of batch records relating to the manufacture of Duragesic patches, Plaintiff’s expert Michael Anisfeld has opined that the patches released by Defendants to the market “were not safe and effective for consumer use” and should never have been released. Anisfeld Declaration at ¶98. Also, according to Anisfeld, the patch worn by Karin Kunnemann at the time of her death suffered a “malfunction” that “was most likely due to a product defect . . . .” Anisfeld Declaration at ¶100.

In the final analysis, in a negligence claim based on res ipsa loquitur, proximate cause is ordinarily a question of fact for the jury to decide. Heastie, 877 N.E.2d at 1083; see also Elliott v. Williams, 807 N.E.2d 506 (Ill. 2004). Because Plaintiff has satisfied each of the elements of her negligence claim under the doctrine of res ipsa loquitur, Defendants’ Motion for Summary Judgment should be denied. See, e.g., Berry v. American Cyanamid Co., 341 F.2d 14, 17 (6th Cir. 1965) (reversing trial court’s dismissal of res ipsa loquitur claims relating to defendant’s polio vaccine).

II. Plaintiff has ample evidence to support her product liability claims.

A. Introduction.

Illinois has adopted Section 402A of the Restatement (Second) of Torts. Kirk v. Michael Reese Hosp. and Medical Center, 513 N.E.2d 387, 391 (Ill. 1987). Section 402A imposes strict liability “on anyone who sells any product in a defective condition unreasonably dangerous to consumers, users, or their property.” Haddix v. Playtex Family Prods. Corp., 138 F.3d 681, 683 (7th Cir. 1998). “A product may be considered unreasonably dangerous for two reasons: 1) because of a design or manufacturing defect, or 2) because of a failure to warn consumers of a danger posed by the product of which the average consumer would not already be aware.” Id.; see also Clark v. Dial Corp., No. 90 C 524, 1993 U.S. Dist. LEXIS 9853 at *18 (N.D. Ill. 1993) (“Traditionally, the alleged defect may exist in one of three forms. The claim may be for injuries arising out of a defect in the design of a product, defect in the manufacture of a product, or a defect in the failure to provide adequate warnings in conjunction with the use of the product.”). Plaintiff herein has alleged each of these types of defect.

In rebutting Plaintiff’s claim of a manufacturing defect, Defendants contend that no visible defects were found when the patch was examined by Dr. Harkey and when it was inspected by Defendants’ representative, David Chullino, nearly two and a half years after Karin Kunnemann’s death. Defendants’ Memorandum at p. 11. According to Defendants, “the unrebutted testimony of Dr. Harkey and Mr. Chullino that their examinations revealed the absence of any defects in Kunnemann’s patch entitles defendants to judgment as a matter of law on plaintiff’s manufacturing defect claim.” Defendants’ Memorandum at p.12. This argument misses the mark for several reasons. First, it assumes that the patch was in the same condition when it was inspected in October 2006 as it was when it was removed from Karin Kunnemann at the time of her death in June 2004. This assumption ignores the testimony of Dr. Blume, who testified that when her colleague, Dr. Sirois “saw the condition of the patch as such, you can’t render an opinion either way regarding a leak that may – a stringer leaker that may have been present years before. Blume Depo. at pp. 148-9. Blume further testified about Sirois’ inspection of the patch as follows:

Q. Did he find any evidence of any defect in the patch?

A. He could not have, because the patch was not maintained. It was dried, it was crusted, and there was a paper towel scraped through it.

Blume Depo. at p. 150. Defendants’ argument ignores the fact that the patch was in poor condition when it was inspected in October 2006. It also ignores the testimony of Michael Anisfeld that the patch at issue “malfunction[ed] . . . due to a product defect.” Anisfeld Declaration at ¶100.

Defendants’ argument regarding the absence of a specific, visible manufacturing defect also ignores Illinois law. 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). In the case of a non-specific defect:

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. This method allows a plaintiff to prove a non-specific defect in the product through circumstantial evidence.

Sikora v. AFD Industries, Inc., 319 F.Supp.2d 872, 877 (N.D. Ill. 2004); see also 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.”).

The foregoing test, known as the “consumer expectation test,” requires that a plaintiff “establish what an ordinary consumer purchasing the product would expect about the product and its safety.” Winters v. Fru-Con, Inc., 498 F.3d 734, 744 (7th Cir. 2007). “This is an objective standard based on the average, normal, or ordinary experiences of the reasonable person; it is not dependent upon the subjective expectation of a particular consumer or user.” Id. Moreover:

The consumer expectation test usually does not require any evidence of ordinary consumer expectations, because the finder of fact may rely on its own experiences to determine what an ordinary consumer would expect.

Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1037 (Ill. App. 2004). In other words, “[w]hether a product is unreasonably dangerous is a question of fact to be determined by the jury” and in making this factual determination, “[t]he jury can draw their own reasonable conclusions as to the expectations of the ordinary consumer and the knowledge common in the community at large.” Id.

The jury should be permitted to assess whether the ordinary consumer would expect a Duragesic patch to provide its user with a lethal fentanyl level of 5.8 ng/mL, a level the FDA has defined as a toxic “dose dump.” Blume Declaration at ¶32. Under Illinois law, this is a clear question of fact. See, e.g., Renfro v. Allied Industrial Equip. Co., 507 N.E.2d 1213, 1226 (Ill. App. 1987) (“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 secondary causes, the product failed to perform in the manner reasonably to be expected in light of its nature and intended function. The issue of whether a product is defective under the foregoing standards is ordinarily a question of fact for the jury.”). Defendants’ Motion should be denied.

B. Plaintiff has ample evidence of a defect.

1. No abnormal use.

Plaintiff has ample evidence to support her claim of a non-specific defect under the consumer expectation test. First, there is no question but that the Duragesic patch was being subjected to its normal and intended use. Defendant’s Statement of Undisputed Facts at ¶22 (“On June 6, Kunnemann’s Duragesic® patch was replaced with a new patch pursuant to her usual prescription.”); Id. at ¶24 (“At an autopsy conducted on June 8, 2004, Dr. Jeffrey Harkey, the Medical Examiner for DuPage County, Illinois, found a single Duragesic® patch on Kunnemann’s thigh.”). There is no evidence of any abnormal use or any product misuse or abuse. See, e.g., Deposition of Dr. Skaredoff at p. 33 (“When I did urine testing on her, I think its; in there somewhere, whatever was – whatever was in her was supposed to be in her.”); Levy Depo. at pp. 160-61 (“She has not abused fentanyl . . . I don’t see any – any indication of – of abuse, putting all that together.”). Abnormal use is simply not an issue.

2. The Duragesic patch failed to perform as expected.

There is ample evidence that the Duragesic patch failed to perform in a reasonable manner in light of its intended function. Contrary to statements in Defendants’ brief, evidence of the Duragesic patch’s malfunction can provide 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.”).

The most obvious evidence that the Duragesic patch in this case failed to perform as expected, is that it killed Karin Kunnemann. Harkey Depo. at pp. 98-99; Baden Declaration at ¶¶8, 24; Blume Declaration at ¶49. Certainly a reasonable consumer would not expect to be killed by their prescription medication. For this reason alone, Plaintiff’s have 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 comes from Defendants’ own package insert, which states that the “mean maximal concentration” for someone using a 100microgram patch would be 2.5ng/mL. Duragesic May 2003 Package Insert. For patients who have used several patches over an extended period of time, another chart in the package insert shows a mean maximal fentanyl level of less than 2 ng/mL. Id. According to Dr. Cheryl Blume, “established levels in most laboratories I think are one to three or one to two and a half.” Blume Depo. at p. 63. Even looking at the maximum fentanyl level, as opposed to the mean maximal level, serum fentanyl concentrations in 10 patients treated with 100 ug/hr patch for 19 days showed a maximum fentanyl concentration of about 4.5ug/mL. Duragesic May 2003 Package Insert at p. 7. Further according to Dr. Blume, “FDA defined anything with a blood level over 5, they called it a patch dose dump in the FDA records. And anything over 5 they considered to be toxic.” Blume Depo. at p. 84.

It is unquestioned that the toxicological testing of Decedent’s blood within hours of her death found a level of fentanyl of 5.82 ng/mL. 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. As Dr. Cheryl Blume testified, “the patch is designed to deliver certain drug levels and not to deliver certain drug levels; and her drug level was outside what the patch was intended to deliver.” Blume Depo. at p. 154. According to Michael Anisfeld, the patch suffered a “malfunction” that “was most likely due to a product defect.” Anisfeld Declaration at ¶100. According to forensic pathologist Dr. Michael Baden, “the cause of the fentanyl toxicity was a Duragesic patch delivering more fentanyl than it was designed or intended to deliver” that occurred as a result of “a malfunction of the patch she was wearing.” Baden Declaration at ¶24. Based on all the evidence, it is irrefutable that Karin Kunnemann’s fentanyl level of 5.8 ng/mL was well outside the normal range expected for someone using a 100 mcg Duragesic patch.

Moreover, there is a great deal of evidence that the Duragesic patches manufactured and marketed by Defendants were susceptible to malfunctioning and delivering a lethal dose of fentanyl. As the FDA Medical officer who reviewed Defendant’s New Drug Application for Duragesic stated, “the proposed 75 & 100 ug/hr TTS fentanyl system sizes are capable of delivering toxic doses of fentanyl to a significant fraction of the clinical population.” FDA Medical Officer Review, Volume 2, at p. 25. These pre-approval concerns were borne out by the subsequent Public Health Advisory issued by the FDA in July 2005 which the FDA stated that it was “investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control.” FDA July 2005 Pubic Health Advisory. This Public Health Advisory came on the heels of Janssen’s June 2005 “Dear Doctor” letter, which it captioned as an “IMPORTANT DRUG WARNING.” In that warning letter, Janssen identified “important changes in the prescribing information for Duragesic.” Janssen June 2005 letter; see also July 2005 FDA Public Health Advisory (“In June 2005, the Duragesic product label was updated to add new safety information in several areas of labeling”). Subsequently, the FDA issued a second Public Health Advisory regarding the Duragesic patch in December 2007, in which it stated that “[d]espite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch.” FDA December 2007 Public Health Advisory. Finally, additional circumstantial evidence that the Duragesic pain patches were defective comes from the repeated quality control problems Defendants experienced throughout 2003 and 2004 as detailed in the Declaration of Michael Anisfeld. Anisfeld Declaration at ¶¶20-70. As Dr. Blume summarized in her declaration, “[t]here have been several problematic post-approval regulatory issues associated with Duragesic.” Blume Declaration at ¶21.

Finally, Plaintiff’s experts have also testified that Kunnemann’s Duragesic pain patch failed to perform in a reasonable manner in light of its intended function. As Dr. Cheryl Blume testified:

And within the abilities of my training and my experience, I would say that the patch that she was wearing at the time of her death led to unacceptably high levels, either by some problem with the patch or some problem with the design of the patch or the way that particular patch functioned; and that those high levels were responsible for respiratory arrest and her death.

Blume Depo. at p. 64. According to Dr. Blume, Defendants had been on notice for some time of possible problems with their manufacturing process:

my report clearly notes that they’ve had, your client has had problems with Duragesic manufacture for years; and that the problems resulting in the recalls in 2004, especially with the 75 and the 100 patches were actually evidenced as early as 2001. So I think I would say that they were on notice that they had problems with the manufacturing process, both in execution and control, that would have put them on notice that they had the potential for manufacturing problems.

Blume Depo. at p. 151; see also Id. at p. 154 (““I just know that her patch malfunctioned and she had a toxic level.”); Id. at pp. 178-79 (“They had problems with the manufacture and in some cases led to actual recalls of the product, and that put them on notice.”); Id. at p. 64 (“There has been an ongoing concern with the Duragesic manufacturer, especially the higher doses and . . . . [t]hose problems with the manufacturer could lead to unacceptably high levels. . . .”); Id. at p. 154 (““they were on notice that they had a manufacturing problem for years, especially with the higher strength patches.”).

Michael Anisfeld similarly testified that Karin Kunnemann’s patch suffered a “malfunction” that was “most likely due to a product defect.” Anisfeld Declaration at ¶100. He further opined that “released units” of Duragesic patches, including the batch containing Karin Kunnemann’s patch, “were not safe and effective for consumer use.” Anisfeld Declaration at ¶98. Dr. Baden testified that “the cause of the fentanyl toxicity was a Duragesic patch delivering more fentanyl than it was designed or intended to deliver” as a result of “a malfunction of the patch she was wearing.” Baden Declaration at ¶24. Dr. Blume has testified:

given that Ms. Kunnemann had used Duragesic for an extended period of time and there were no other medications found in her system at levels which would have contributed to her death, the level of fentanyl delivered to Ms. Kunnemann by her patch on June 7th and 8th 2004 must have been significantly more than Ms. Kunnemann’s level from prior use. The 100 mcg Duragesic patch is intended to produce a steady state of fentanyl and all 100 mcg Duragesic patches should produce the same fentanyl level. One patch should not produce a higher level than a previous patch. Because the patch on Ms. Kunnemann on June 7th and June 8th clearly delivered more fentanyl to her than she was accustomed to, in my opinion the patch malfunctioned and failed to perform as designed.

Blume Declaration at ¶33. The foregoing is more than enough evidence to create a fact issue on the existence of a non-specific defect which mandates the denial of Defendants’ Motion.

3. No reasonable secondary cause.

Finally, Plaintiff has excluded, to a reasonable degree of probability, reasonable secondary causes of the high fentanyl level found in Karin Kunnemann other than a defect in the patch. As set forth more fully below, postmortem redistribution is not a reasonable secondary cause of Ms. Kunnemann’s toxic level of fentanyl. Neither is the argument that the 5.8 ng/mL fentanyl level was a “therapeutic level” for Ms. Kunnemann. Rather, the only reasonable probability is that the 5.8 ng/mL level of fentanyl occurred as a result of a manufacturing or design defect in the Duragesic patch.

a. Postmortem redistribution is not a reasonable secondary cause of the high level of fentanyl found in Karin Kunnemann.

Defendants distort the record when they claim that Dr. Harkey “did not take postmortem redistribution into account when interpreting the 5.82 ng/mL result.” Defendants’ Memorandum at p. 15. What Harkey actually said was that there were many reasons why “I’m not sure I can say that [postmortem redistribution] was a factor in this case at these levels under these conditions and with this time frame between death and autopsy.” Harkey Depo. at p. 98. Among the reasons were the following:

1. “The references that I had at the time of this autopsy report did not have fentanyl as being one of those drugs that is subject to postmortem redistribution;”

2. His personal experience that at levels of fentanyl up to 25 ng/mL there did not “seem to be a difference between peripheral and central blood for postmortem redistribution;”

3. A review of literature indicating that a study “came to the conclusion that they did not see significant redistribution at lower levels of toxicity;”

4. The proximity between Karin Kunnemann’s death and her autopsy later that same day; and

5. The conclusion that “you would certainly believe that if a person was pronounced dead and then autopsied immediately, you don’t have much time for redistribution to take place.”

Harkey Depo. at pp. 82-87, 93. Dr. Harkey did not ignore the potential of postmortem redistribution as Defendants assert. Rather, he concluded that it did not alter his opinion that “the cause of death of Karin Kunnemann’s death was fentanyl toxicity due to delivery of fentanyl by means of a Duragesic 100 microgram patch.” Harkey Depo. at pp. 98-99.

Dr. Harkey’s opinion is corroborated by that of Dr. Michael Baden, a noted forensic pathologist. Based on his review of Karin Kunnemann’s medical records, pharmacy records, autopsy report, and toxicological findings, he is of the opinion that “Karin Kunnemann died from fentanyl toxicity delivered by a malfunctioning Duragesic 100 mcg patch.” Baden Declaration at ¶8. In reaching his opinion, Dr. Baden, like Dr. Harkey, considered the effects of postmortem redistribution. He stated in his Declaration that under the circumstances of Ms. Kunnemann’s death and the relative time for autopsy, postmortem redistribution would not have occurred to any significant degree. Baden Declaration at ¶18. These opinions are consistent with his deposition testimony, in which he opined that there was no significant postmortem redistribution because of the rapidity with which the autopsy was performed, the fact the blood was drawn from the aorta and other circumstances of the autopsy. Baden Depo. at pp. 103-04.

The testimony and opinions of Dr. Cheryl Blume are also supportive of the fact that the high level of fentanyl in Karin Kunnemann’s body cannot be explained away by postmortem redistribution. According to Dr. Blume, “the best and accurate estimate of Karin Kunnemann’s fentanyl level at the time of her death is 5.82 ng/mL.” Blume Declaration at ¶45; see also Blume Depo. at pp. 128-29 (“it’s unlikely that significant postmortem redistribution occurred subsequent to Ms. Kunnemann’s death.”). According to Dr. Blume:

In my opinion, Ms. Kunnemann’s fentanyl level at the time of her death was at least 5.82 ng/ml and that post mortem redistribution did not occur to any significant degree. . . . .

Fentanyl is not considered a drug that is subject to high levels of post mortem redistribution. . . . Karin Kunnemann’s death presented none of the factors which exacerbates post mortem redistribution, such as, extremely high levels of drug, significant delay between death and autopsy or body exposed to elevated temperatures post death. . . . Based on the foregoing, it is my opinion that the best and accurate estimate of Karin Kunnemann’s fentanyl level at the time of her death is 5.82 ng/ml.

Blume Declaration at ¶¶44-45.

Dr. Blume’s opinions were based, in part, on the Affidavit of Daniel T. Anderson. Blume Depo. at p. 120; Blume Declaration at ¶¶45. Anderson is a forensic toxicologist for Los Angeles County who has studied the effects of postmortem redistribution in patients using the Duragesic pain patch. His analysis indicated that 43% of the time there was no postmortem redistribution and that, when their was, “the ratio of postmortem concentrations of fentanyl between central blood and femoral blood will be, on average, approximately 1.2.” Affidavit of Daniel T. Anderson at ¶¶20, 21. Thus, the effects of postmortem redistribution would be either non-existent or minimal.

Finally, Defendants state that Dr. Michael Evans, a forensic toxicologist and the director of laboratories for the company that performed the toxicological testing on Karin Kunnemann’s blood, testified that postmortem redistribution occurred in her case and that the level of fentanyl in her body at the time of death was less than the 5.8 ng/mL found by the toxicological testing after her death. Defendants’ Memorandum at p. 7. But Evans actually stated, twice, that he could not testify as to whether postmortem redistribution occurred in this case:

Q. You believe that postmortem redistribution does occur with fentanyl?

A. Yes, I believe – first of all, it does occur. It’s been demonstrated to occur. I can’t tell you in this particular case it occurred, but I recognize it can occur.

* * * * *

Q. Well, if this blood was drawn from the heart and the result from the laboratory is 5.82, would you believe that the result has been affected by PMR?

A. I don’t know that. I can’t state that with certainty. . . .

Evans Depo. at pp. 47-48 (emphasis added). When he was asked the question for a third time, he changed his answer, but admitted that he had no evidence to support it:

Q. Do you believe that the 5.82 fentanyl level that your laboratory reported is higher than the level of fentanyl in her blood when she died?

A. I do believe that. I have no evidence to support that, just knowledge of fentanyl, the nature of the drug, the nature of postmortem redistribution and that phenomenon. Yes, I do believe it.

Evans Depo. at p. 50 (emphasis added). Clearly, at the most, postmortem redistribution presents an issue of fact for the jury.

b. The argument that Kunnemann’s fentanyl level was actually a “therapeutic level” for her given her prolonged use of Duragesic is not a reasonable secondary cause of the high level of fentanyl found in her body post-mortem.

Defendants argue that it is possible that Karin Kunnemann’s 5.8 ng/mL level of Duragesic was actually a “therapeutic level” given her prolonged use of the drug. They clams that the 2.5 ng/mL mean maximal concentration level stated in their own package insert applies only to the first use of a Duragesic patch and assert that a patient with a prolonged history of Duragesic use would have a significantly higher steady state serum level and mean maximal level of fentanyl due to their increased tolerance for the medication. This theory, however, is refuted by Defendants’ own package insert, which shows a mean maximal concentration of less than 2.0 ng/mL after several sequential applications of a 100 microgram Duragesic patch. See Duragesic May 2003 Package Insert. In other words, patients who used several patches sequentially actually had a lower mean maximal concentration of fentanyl than first-time users. This result is supported by the opinions of Dr. Charles Laurito, one of Defendants’ own experts, who testified that he would expect the fentanyl level of a patient using Duragesic to actually decrease over time, not increase:

Q. But if someone is taking a one hundred microgram patch, that should produce the same level of Fentanyl in their blood after they’ve been taking it for three months versus after they’ve been taking it for three years, right?

A. I don’t think so. I think that the liver becomes more adept at breaking down the Fentanyl so the level declines after a period of time.

Deposition of Charles Laurito at pp. 121-22.

Defendants’ “therapeutic level” theory has also been refuted by a study by Russell K. Portenoy that Defendants sponsored. In that study, ten opiod tolerant patients were given 100 microgram Duragesic patches at 72-hour intervals. After the application of five patches, the patients had reached a steady state serum concentration of only 1.62 ng/mL and a mean maximum concentration of 2.6 ng/mL. See R.K. Portenoy: Repeat Dose Pharmacokinetics of TTS (fentanyl) in Cancer Patients, Final Report, at p. iv; Portenoy Abstract. This compares to the mean maximal concentration of 2.5 ng/mL as set forth in the Duragesic package insert. The data from the Portenoy study refutes the notion that there is a significant difference in steady state serum level between new patients and patients who have used a Duragesic patch repeatedly. In fact, in the study, Portenoy concluded that “the kinetics of fentanyl did not change between single and multiple application of TSS (fentanyl).” R.K. Portenoy: Repeat Dose Pharmacokinetics of TTS (fentanyl) in Cancer Patients, Final Report, at p. iv (emphasis added). Portenoy’s conclusions are also supported by the testimony of Bob Gale, the inventor of the Duragesic patch, who testified that “after the first two applications, steady state was achieved in the blood levels.” Gale Depo. at pp. 4-9.

Moreover, the fact that levels well below 5.8 ng/mL have been found to be fatal in other patients contradicts the possibility that 5.8 ng/mL was “therapeutic” for Karin Kunnemann. According to Dr. Baden, studies by Baselt and others have found lethal levels as low as 2.2 ng/mL and average lethal levels as low as 3.0 ng/mL:

The lethal level for a particular drug is determined by looking at the level of the medication which has killed people in the past. Fentanyl has been found at levels as low as 2.2 ng/mL in persons who were determined to have died of fentanyl overdoses. In one large series referenced in Baselt (GL Henderson, Fentanyl-Related Deaths: Demographics, Circumstances and Toxicology of 112 cases), the fatal level of fentanyl averaged 3 ng/ml. Many other referenced studies confirm that death from fentanyl can occur at levels of 5.82 ng/mL or less, including my review of 78 autopsies from across the country where the cause of death was assigned by many different pathologists as fentanyl toxicity. Based on the foregoing, it is clear that 5.82 ng/mL can be a fatal level for a fentanyl overdose.

Baden Declaration at ¶16 (citations omitted). Dr. Blume similarly cited to a number of studies that have shown fentanyl to be lethal at levels far below Kunnemann’s 5.82 ng/mL level:

Tharp et al, Fatal Intravenous Fentanyl Abuse: Four Cases Involving Extraction of Fentanyl from Transdermal Patches, Am J. Forensic Med. Pathology, 25(2), pg. 178 (2004) studied four cases in which death was attributed to the intravenous injection of fentanyl extracted from transdermal patches. In one case in which the attributed cause of death was fentanyl poisoning, the aortic blood fentanyl level was 5 µg/L. Marquardt, et al, Inhalation Abuse of Fentanyl Patch, J. Toxicol. Clin. Toxicol., 32(1), pg. 75 (1994) reported one case of inhalation abuse of a fentanyl patch in which the decedent had a femoral blood fentanyl level of 2.66 ng/mL. . . . . Henderson . . . stated that “…clinical studies with … fentanyl have shown that plasma levels above 2 to 3 ng/mL are associated with respiratory depression.”

A review of 30 fentanyl fatalities in Maryland (Smialek, et al, A Fentanyl Epidemic in Maryland, J. Forensic Science, 39(1), pg. 159-64 (1994)) found fentanyl blood concentrations in the range of 2.2 to 100 µg/L with 13 cases having concentrations less than 10 µg/L. . . . In another case report describing an accidental death attributed to fentanyl, the blood level was 4.9 ng/mL, a level the author described as being “consistent with those reported in fentanyl fatalities.”

Blume Declaration at ¶¶28-29 (citations omitted). The fact that levels of 3.0 ng/mL — levels just half the level found in Karin Kunnemann — have proven fatal further undercuts the argument that Kunnemann’s level of 5.8 ng/mL was a “therapeutic” level. See Blume Declaration at ¶31 (“I am not aware of any reliable evidence to support 5.82 ng/ml being a therapeutic level.”)

Finally, the strongest evidence that a fentanyl level of 5.8 ng/mL was not “therapeutic” for Karin Kunnemann is the fact that such a level killed her. Harkey Depo. at pp. 98-99; Baden Declaration at ¶¶8, 24. As a matter of common sense, a certain dose is not “therapeutic” if it is fatal. According to Defendants’ own package insert, “[a]fter several sequential 72-hour applications, patients reach and maintain a steady state serum concentration . . . .” Duragesic May 2003 Package Insert. If Karin Kunnemann’s normal therapeutic steady state serum concentration was 5.8 ng/mL, then that level would not have proven fatal for her. The only probable explanation for the high level of fentanyl is that there was a manufacturing or design defect in the Duragesic patch which caused Ms. Kunnemann to receive a much higher than normal fentanyl level at the time of her death. As Dr. Baden has explained:

In my opinion, Karin Kunnemann died from fentanyl toxicity. Further, in my opinion, the cause of the fentanyl toxicity was a Duragesic patch delivering more fentanyl than it was designed or intended to deliver. Ms. Kunnemann had been using Duragesic for several years. Something had to change on the day of her death. In my opinion, the only reasonable explanation for what changed is a malfunction of the patch she was wearing.

Baden Declaration at ¶24. Dr. Blume has similarly explained how and why a level of 5.82 ng/mL was lethal – not therapeutic – for Karin Kunnemann:

Because Karin Kunnemann died from a fentanyl level of 5.82 ng/ml, in my opinion, her normal fentanyl level from past usage of properly functioning patches was probably below the mean maximum concentration of 2.5 ng/ml. Thus, 5.82 ng/ml clearly could have been a fatal dose because the doubling or tripling of a patient’s fentanyl level can cause death.

Blume Declaration at ¶30. Defendants’ “therapeutic level” argument completely ignores the evidence that a level of 5.8 ng/mL was fatal – not therapeutic – for Karin Kunnemann.

For the reasons set forth above, the argument that 5.8ng/mL was a therapeutic level for Karin Kunnemann is not a reasonably probable explanation for her high fentanyl level. The only reasonable inference is that the patch malfunctioned due to a manufacturing or design defect.

III. Plaintiff has ample evidence that Karin Kunnemann’s death was caused by fentanyl toxicity as determined by Dr. Harkey’s autopsy.

A. The testimony of Drs. Harkey, Baden and Blume provides ample evidence of causation sufficient to defeat Defendants’ summary judgment motion.

Plaintiff has ample evidence that Karin Kunnemann’s death was caused by fentanyl toxicity. First, this is the conclusion reached by Dr. Jeffery Harkey, the independent forensic pathologist that performed her autopsy. Harkey Depo. at pp. 98-99. A subsequent Coroner’s Inquest reached the same conclusion. So did Dr. Cheryl Blume:

A toxic level of fentanyl delivered from a Duragesic patch was the cause of Ms. Kunnemann’s death. Specifically, the coroner noted that Ms. Kunnemann “…died of fentanyl toxicity due to delivery of fentanyl by means of a Duragesic 100 µg/hr patch.”. A postmortem drug screen revealed no other pharmaceutical products listed as possible cause or contributors to her death. No other diseases or injuries were noted that could have caused her death. In addition, Ms. Kunnemann was a long-term, opioid-tolerant user of Duragesic who utilized the patch according to the manufacturers’ instructions. Despite meeting all criteria for appropriate, and presumed safe, use of the product, Ms. Kunnemann ultimately received a toxic dose of Duragesic resulting in her death, from in my opinion, a patch that malfunctioned.

Blume Declaration at ¶49. Finally, this same opinion has been rendered by Dr. Michael Baden. As he has testified:

Dr. Harkey concluded, after his autopsy and investigation, that the cause of Ms. Kunnemann’s death was accidental fentanyl toxicity caused by the Duragesic patch. At a subsequent Coroner’s Inquest, the Coroner’s Jury also determined that the cause of Ms. Kunnemann’s death was fentanyl toxicity.

After reviewing all of the materials submitted, I must agree with the conclusion that Ms. Kunnemann died as the result of a fentanyl overdose. The heart, brain, liver, kidneys and other organs showed no evidence of disease which could have contributed to death. The level of fentanyl (5.82 ng/ml) in her blood can cause death. Fentanyl at lethal levels causes respiratory depression, pulmonary edema and focally white secretions to fill the air passages and the individual gradually loses consciousness and dies as the blood oxygen level diminishes.

Baden Declaration at ¶¶14-15.

Defendants attack Dr. Harkey’s opinion because they claim that the PDR section he relied upon in determining that the maximum fentanyl blood level following application of a 100 microgram patch was 1.9-3.8 ng/mL applied only to the first 72 hours of patch use. Defendants’ Memorandum at p. 14. But Defendants fail to mention that a chart included in their own package insert shows a maximum fentanyl concentration in repeat users of the 100 microgram patch of approximately 4.0 ng/mL and a mean maximal concentration among the group of less than 2.0 ng/mL. Duragesic May 2003 Package Insert. They also fail to mention that a study by RK Portenoy found a mean maximal fentanyl level of repeat patch users of only 2.6 ng/mL. See Portenoy Abstract.

Defendants also contend that the opinions of Drs. Harkey and Baden are unreliable because they failed to take into account postmortem redistribution. As set forth in Section II.B(3)(a), however, each of them considered postmortem redistribution but concluded that it did not affect their ultimate conclusion that Ms. Kunnemann died from a lethal dose of fentanyl. Harkey Depo. at pp. 98-99; Baden Declaration at ¶24. Defendants’ challenges to the opinions of Dr. Harkey and Dr. Baden should be rejected.

B. Defendants’ “morphine equivalent” and “three standard deviation” arguments should be rejected.

Defendants contend that a fentanyl level of 5.8 ng/mL could not have been fatal to Karin Kunnemann because she survived a higher “morphine equivalent” when she was in the hospital. The fallacy of this theory is the assertion that Karin Kunnemann was subjected to an opiate exposure in the hospital “that was three times higher per day than at home.” Defendants’ Memorandum at p. 19. According to Dr. Baden:

Defendant’s expert Dr. Levy contends that Ms. Kunnemann could not have died from the 5.82 ng/mL level of fentanyl because she was on high doses of pain medication in the hospital. I disagree. A fentanyl level of 5.82 ng/mL can cause death even if higher narcotic levels and pain had been tolerated in the hospital. To arrive at a cause of death – and only a physician is given that responsibility – must evaluate past medical history, clinical findings, circumstances of death, autopsy findings and toxicology results and then determine what could have caused the death and eliminate all other causes of death. In this instance, the fentanyl level could have caused death, all the findings are consistent with fentanyl causing death, and there is no evidence for a competing cause of death.

Baden Declaration at ¶23.

Defendants also contend that 5.82 ng/mL “was not in a lethal range, but rather in the expected range of distribution, as it was within 3 standard deviations of 2.5 ng/mL or 6.1ng/ml.” Defendants’ Memorandum at p. 15. This argument is nonsensical for a variety of reasons. First,

The very table they use for this argument is the one they claim does not apply to repeat patch users. Memorandum at pp. 14-15. Second, there is no evidence that any test subject ever obtained a fentanyl level of 5.8 ng/mL. In fact, in the Portenoy study referenced above, the highest level attained by any test subject was 4.2 ng/mL.

According to Defendants, because Karin Kunnemann’s fentanyl level of 5.8 ng/mL fell within three standard deviations of the mean on a typical bell curve, “it was not in a lethal range, but rather in the expected range of distribution.” Defendants’ Memorandum at p. 15. But Defendants fail to explain the legal or factual significance that the 5.8 ng/mL was within three standard deviations of the norm. In fact, in other contexts, courts have repeatedly found results greater than 2 standard deviations from the norm to be statistically significant evidence of some abnormal event. See, e.g., Adams v. Ameritech Services, Inc., 231 F.3d 414, 424 (7th Cir. 2000) (in an age discrimination case, the court held that “two standard deviations is normally enough to show that it is extremely unlikely (that is, that there is less than a 5% probability) that the disparity is due to chance”); Chavez v. Illinois State Police, 251 F.3d 612, 642 (7th Cir. 2001) (in case involving alleged discriminatory practices by drug interdiction squad, court held that evidence that the number of field reports issued to Hispanic and African-American motorists was more than two standard deviations from the expected norm “would be statistically significant.”); Keys. v. Barnhart, 347 F.3d 990, 994 (7th Cir. 2003) (applying definition of “disabled” that is “two or three standard deviations” below the mean in terms of domain of functioning); EEOC v. American Nat’l Bank, 652 F.2d 1176, 1192 (4th Cir. 1981) (“well short of three standard deviations the probability levels for chance as explanation have already dropped far below the point at which courts of law concerned with proof by the ‘greater weight’ or ‘preponderance’ of the evidence would presumably have discarded the hypothesis of chance.”). There is simply nothing “magic” about three standard deviations and certainly nothing that would support Defendants’ summary judgment motion.

Even if Defendants could show that a fentanyl level of 5.8 ng/mL was “in the expected range of distribution,” this would not prove that such level was not fatal for Karin Kunnemann. As Dr. Blume explained, fentanyl has a “narrow therapeutic range.” Blume Depo. at p. 78. As a result, there is an “overlap in the ranges of drug – of plasma levels, blood levels of fentanyl between effective concentration and toxic concentration and lethal concentration.” Blume Depo. at p. 198. In other words, what might be therapeutic for one patient could be lethal to another.

Moreover, Defendants’ assumption that a result within three standard deviations of the norm could not have been lethal is refuted by the numerous studies that have found levels far below Karin Kunnemann’s level of 5.8 ng/mL – a level Defendants claim is both “therapeutic” and “within the expected range of distribution” – to have been lethal. As stated in Dr. Baden’s Declaration and the documents cited therein, studies have found fentanyl to be lethal at levels as low as 2.2 ng/ml. Baden Declaration at ¶16. In one large series referenced in Baselt, the fatal level of fentanyl averaged 3 ng/ml. Id. Furthermore, more recent studies confirm that the fatal range of fentanyl starts at 3 ng/ml. Id. And at least 10 autopsies from around the country have listed fentanyl toxicity as the cause of death when the fentanyl level was 6.0 ng/mL or lower. See Appendix at Exhibit E. The fact that autopsies and studies have found fentanyl to be lethal at levels as low as 2.2 ng/mL contradicts Defendants argument that 5.8 ng/mL cannot be lethal simply because it is within three standard deviations of the mean maximal level of 2.5 ng/mL.

C. Defendants have failed to demonstrate that something other than fentanyl was the probable cause of Ms. Kunnemann’s death.

Finally, Defendants have failed to demonstrate that something other than fentanyl was the probable cause of Ms. Kunnemann’s death. Their own expert, Dr. Stephen Factor, testified that “there were no anatomical findings that were sufficient to explain her death” and that he “can’t say with a reasonable degree of medical certainty that anything in her history was the specific single cause of her death.” Deposition of Stephen Factor at pp. 63-65. Rather than offer an alternative cause of death other than fentanyl toxicity, Factor merely opined that the cause of Karin Kunnemann’s death was “indeterminate.” Id. at p. 63. Factor also testified that he could not absolutely rule out fentanyl toxicity as the case of her death and that “if this were presented to a completely neutral panel of pathologists that there very well might be disagreement” as to whether fentanyl was the cause of death. Id. at pp. 90, 93-4. Clearly, Plaintiff has offered sufficient evidence to create a fact issue on causation. See, e.g., Rosenburg v. Cottrell, Inc., No. 05-545-MJR, 2007 U.S. Dist. LEXIS 25770 at *5-6 (S.D. Ill. April 6, 2007) (“The issue of proximate causation is only proper for disposition in a motion for summary judgment where no material issue of fact remains or only one clearly evident which can be reached; it is, otherwise, best left to the trier of fact.”).

IV. Defendants are not entitled to summary judgment on Plaintiff’s design defect claim.

A. Comment k does not bar Plaintiff’s design defect claim.

Defendants contend that Plaintiff’s design defect claims are barred because Duragesic is an “unavoidably unsafe product” under Comment K to Section 402A of the Restatement (Second) of Torts. Defendants are wrong for several reasons. First, Illinois courts have not held that all drugs are unavoidably unsafe as a matter of law. Rather, the decision on whether a particular drug constitutes an unavoidably unsafe product is determined on a case-by-case basis. “[N]ot all prescription drugs per se fall under comment k, and comment k’s applicability must be decided on a case-by-case basis.” Glassman v. Wyeth Laboratories, Inc., 606 N.E.2d 338, 342 (Ill. App. 1992); see also Toner v. Lederle Laboratories, 732 P.2d 297, 308 (Idaho 1987), aff’d, 828 F.2d 510 (9th Cir. 1987), cert. denied, 485 U.S. 942 (1988) (“We do not believe comment k was intended to provide nor should it provide all ethical drugs with blanket immunity from design defect claims. . . . Not all drugs are so perfectly designed that they cannot be made more pure or more safe, or that there are not safer, suitable alternatives.”); also Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1496 (D. Kansas 1987) (“Neither comment k nor Johnson stands for the rule that all prescription drugs are unavoidably unsafe as a matter of law.”).

“[A] defendant has the burden to demonstrate that a product comes under comment k’s protection.” Glassman, 606 N.E.2d at 343. To meet this burden, Defendants must show that Duragesic is “incapable of being made safe for its intended use.” Restatement (Second) of Torts § 402A, Comment k. Defendants have wholly failed to meet this burden. In fact, they have not even attempted to do so. Instead, they have miscast the test for an “unavoidably unsafe” product. In their Brief, Defendants assert that:

While the risk of respiratory depression can be managed through proper use of Duragesic – e.g., through proper supervision by the prescribing physician, selection of appropriate does, and adjustment of concurrent medications – it cannot be eliminated as respiratory depression is an inherent side effect of all opioid medication and their mechanism of action. In other words, the only way to eliminate the risk of respiratory depression for drugs like Duragesic is to eliminate their use altogether.

Defendants’ Memorandum at p. 20 (emphasis added). But this misses the point. Plaintiff has not alleged that all opioids are unreasonably dangerous or even that Duragesic is unreasonably dangerous because it contains fentanyl, a powerful opioid that may cause respiratory depression. Rather, Plaintiff has alleged that Duragesic is unreasonably dangerous because it does not provide a steady and reliable dose of fentanyl but is instead subject to sudden, fatal overdosing as a result of a manufacturing or design defect. In other words, it is the delivery mechanism of Duragesic that renders it unreasonably dangerous, not the mere properties of the drug it is delivering. Defendants’ comments about “all opioid medications” and “drugs like Duragesic” completely miss the point.

As set forth above, the mere fact that Duragesic is a prescription drug does not mean that it is an unavoidably unsafe product subject to Comment k. Instead, “[w]hether a product is unavoidably unsafe within the meaning of comment k is an issue of material fact. . . . .” Glassman, 606 N.E.2d at 343; see also Graham, 666 F. Supp. at 1497 (“In our view, the decision as to whether a drug, vaccine, or any other product triggers unavoidably dangerous product exemption from strict liability design defect analysis, poses a mixed question of law and fact and can be made only after evidence is first taken, out of the jury’s presence, on the relevant factors to be considered.”). At most, then, Defendants have raised a fact issue as to whether Duragesic is an “unavoidably unsafe” product that must be resolved by the trier of fact.

Even if the Court assumed that Duragesic was “unavoidably unsafe’ and that Comment k therefore applied, it would not have the preclusive effect Defendants claim. Comment k does not shield a drug manufacturer from liability unless the evidence demonstrates that the manufacturer sufficiently warned of all known dangers. See, e.g., Martinkovic v. Wyeth Laboratories, 669 F. Supp. 212, 216 (N.D. Ill. 1987) (“Since Wyeth has not established that its warnings were adequate, we need not determine whether the vaccine was unavoidably unsafe within the meaning of comment k.”); Needham v. White Laboratories, 639 F.2d 394, 402 (7th Cir. 1981) (“A comment k defense is available only where the manufacturer warned of the danger, yet the product remains dangerous even if the warning is followed.”). As set forth more fully in Section V below, a clear issue of fact exists as to whether Defendants properly warned prescribing doctors of the risks and dangers associated with the Duragesic patch. See, e.g., Giles v. Wyeth, 500 F. Supp.2d 1063, 1067 (S.D. Ill. 2007) (“The trier of fact must judge a warning by whether it sufficiently apprised physicians of the risks associated with the use of the drug.”); Proctor v. Davis, 682 N.E.2d 1203, 1215 (Ill. App. Ct. 1997) (“the adequacy of warnings is a question of fact, not law, for the jury to determine”); Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 43 (Ill. 2002) (“the adequacy of warnings is a question of fact, not law, for the jury to determine.”). These issues of fact preclude the granting of Defendants’ Motion.

B. Plaintiff is not required to provide expert testimony in support of her design defect claim.

In Lamkin v. Towner, 563 N.E.2d 449, 457 (Ill. 1990), the Illinois Supreme Court stated that a design defect claim may be proven in one of two ways:

A plaintiff may demonstrate that a product is defective in design, so as to subject a retailer and a manufacturer to strict liability for resulting injuries, in one of two ways: (l) by introducing evidence that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner or (2) by introducing evidence that the product’s design proximately caused his injury and the defendant fails to prove that on balance the benefits of the challenged design outweigh the risk of danger inherent in such designs.

The first method is commonly referred to as the consumer expectation test while the second is called the risk-utility or risk-benefit test. Winters v. Fru-Con, Inc., 498 F.3d 734, 744 (7th Cir. 2007). Here, there is ample evidence that an ordinary consumer would not expect the Duragesic patch to provide them with a lethal level of fentanyl when used properly and according to instructions.

Contrary to Defendants’ argument, there is no requirement of expert testimony to meet the consumer expectation test. See, e.g., Tweedy v. Wright Ford Sales, Inc., 357 N.E.2d 449, 451 (Ill. 1976) (court upheld jury verdict against car manufacturer finding defective brakes even though “Plaintiff offered no expert testimony concerning the presence of a specific defect in the automobile’s brake system.”); Hill v. Int’l Harvester Co., 798 F.2d 256, 259 (7th Cir. 1986) (“With respect to the existence of a defect, the Hills were only required to prove that the truck ‘failed to perform in the manner reasonably to be expected . . . .’ In this case, the truck veered sharply off the road and collided with a culvert after something snapped in the truck’s cab. . . . While this is far from conclusive proof of what specific defect caused the truck’s malfunction, it certainly was sufficient to establish that the truck did not ‘perform in the manner reasonably to be expected.’ The jury could reasonably conclude that, in the normal course of events, trucks do not veer sharply off the road and steering wheels do not lock.”); Eberle v. Brenner, 475 N.E.2d 639, 643-44 (Ill. App. 1985) (“In his complaint, Eberle alleged that the spray gun was negligently designed and was not reasonably safe in that it was not equipped with adequate guards or other safety devices. In our opinion, it would be within the realm of knowledge and experience of laymen to determine whether a spray gun without adequate guards or other safety devices might be unreasonably dangerous. The testimony of experts is therefore not required. We conclude that genuine issues of material fact exist as to Eberle’s claims against defendants Binks and Garrolts and that the trial court erred in granting summary judgment.”). As the court stated in Millette v. Radosta, 404 N.E.2d 823, 835 (Ill. App. 1980):

Chrysler and Des Plaines cite no case for their assumption that a case in strict tort liability can, absent the Tweedy doctrine, be established only through expert testimony. This is not the rule. The plaintiff may rely on direct or circumstantial evidence to establish his case or on expert testimony indeed, expert testimony is merely one kind of circumstantial evidence.

Id.; see also Rizzo, 1996 U.S. Dist. LEXIS 1745 at *12 (emphasis added) (“Under Tweedy, 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. Plaintiffs do not need to present expert testimony to establish a prima facie case; they may rely on their own testimony.”).

Even if expert testimony were required, Plaintiffs have offered expert medical testimony from two of Karin Kunnemann’s prescribing physicians about their reasonable expectations of Duragesic. Dr. Skaredoff, Kunnemann’s treating physician at the time of her death, testified that he believed that “the whole trick of using Duragesic is that it has to be a constant inflow of narcotic into the – into the skin and then into the bloodstream.” Skaredoff Depo. at p. 52. Similarly, Dr. Gruft, a chronic pain specialist who treated Karin Kunnemann up until April 2000, testified that he prescribed Duragesic when “having a continuous amount of medication being delivered to the patient is well-served in that patient.” Gruft Depo. at p. 41. Thus, both prescribing doctors testified that their primary expectation for Duragesic patches was that they would provide a continuous level of fentanyl to the patient. Here, Defendants have alleged that Karin Kunnemann’s Duragesic patch did not give her a continuous level of fentanyl but instead gave her an unexpected “dose dump” of fentanyl that was much greater than was intended and much greater than she was accustomed to. Blume Depo. at p. 154 (“the patch is designed to deliver certain drug levels and not to deliver certain drug levels; and her drug level was outside what the patch was intended to deliver.”); Baden Declaration at ¶24 (“In my opinion, Karin Kunnemann died from fentanyl toxicity. Further, in my opinion, the cause of the fentanyl toxicity was a Duragesic patch delivering more fentanyl than it was designed or intended to deliver.”); Anisfeld Declaration at ¶98, 100 (the patches released by Defendants to the market “were not safe and effective for consumer use” and the patch worn by Karin Kunnemann at the time of her death suffered a “malfunction” that “was most likely due to a product defect . . . .”).

Plaintiff has clearly raised an issue of fact regarding whether Karin Kunnemann’s Duragesic patch “failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner.” Defendants’ Motion as to Plaintiff’s design defect claim should therefore be denied.

V. Plaintiff has ample evidence in support of her warnings claim.

A. Plaintiff has not abandoned her failure to warn claim.

Defendants contend that Plaintiff “abandoned” her failure-to-warn claim in her First Amended Complaint. Defendants’ Memorandum at p. 22 Contrary to Defendants’ assertion, Plaintiff has a viable failure-to-warn claim because: (i) the complaint is sufficient to state a failure-to-warn claim under the notice pleading standard; (ii) the alleged failure of Plaintiff’s complaint to state a failure-to-warn claim is irrelevant because the issue has been pre-tried by the consent of the parties; and (iii) even if amendment of the complaint is necessary, such an amendment would be proper under Rule 15(b)(1) because it would aid in presenting the merits of the case and would not prejudice Defendants.

Defendants’ argument that Plaintiff abandoned her failure-to-warn claim is presumably based on the fact that Plaintiff did not use the phrase “failure to warn” in her First Amended Complaint. This argument is inconsistent with Rule 8 and controlling Seventh Circuit law. Under Rule 8, a pleading need only contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8. The Seventh Circuit has “repeatedly stated that Rule 8 does not require plaintiffs to plead facts or legal theories. Marshall v. Knight, 445 F.3d 965, 968 (7th Cir. 2006); see also Higgs v. Carver, 285 F.3d 437, 439 (7th Cir. 2002); Kirksey v. R.J. Reynolds Tobacco Co., 168 F.3d 1039, 1041 (7th Cir. 1999). Instead, the “notice pleading system requires complaints to contain a short and plain statement of the claim sufficient to file an answer.” Marshall, 445 F.3d at 968. Plaintiff’s complaint clearly meets this standard.

In the First Amended Complaint, Plaintiff alleges that “Defendants had a duty to design, manufacture, distribute and sell the patch so that it was not unreasonably dangerous for the purpose for which it was designed, manufactured, distributed, or sold.” Plaintiff’s First Amended Complaint at ¶ 19; see also Id. at ¶ 25. Plaintiff further contends that the Defendants breached this duty with respect to the Duragesic patch worn by the Decedent (see id. ¶¶ 20, 26), and that neither the Decedent nor her family knew or could have discovered that the patch was defective. Id. at ¶¶ 14, 20, 26. The Defendants had a duty to provide adequate warnings concerning Duragesic in connection with their distribution and sale of the product. Woodill, 402 N.E.2d at 198. Therefore, Plaintiffs’ allegations concerning manufacturing and sale are sufficient to state a failure-to-warn claim and provided enough information to enable Defendants to respond to the complaint. See Salgado-Santiago v. Am. Baler Co., 394 F. Supp. 2d 394, 406-07 (D. P.R. 2005) (general allegations concerning a defective hay baler were sufficient to state a product liability claim because the allegations provided sufficient information for the defendant to respond).

Moreover, Plaintiff designated Dr. Cheryl Blume as a warnings expert fourteen months ago. See Blume Expert Report dated Apr. 27, 2007. If the Defendants believed that the complaint did not include a warnings claim, the Defendants should have objected to the designation or moved for judgment on the pleadings. They did neither of these things. Instead, they deposed Dr. Blume on two different occasions and designated their own warnings expert, Karen Kaplan. The fact that the Defendants waited until the eve of trial, and after engaging in full expert discovery on the warnings issue, to argue that the pleadings are insufficient to raise a warnings claim demonstrates that they had sufficient notice of the claim to respond. Therefore, the Court should reject the Defendants’ argument that the complaint did not sufficiently plead a warnings claim. Marshall, 445 F.3d at 968 (under the notice pleading system, a complaint only needs to contain enough information to allow a defendant to respond).

Even if Plaintiff’s Complaint were insufficient to state a failure-to-warn claim, the Court should treat the issue as raised by the pleadings because the warnings issue has been pre-tried by consent. Rule 15(b)(2) provides: “When an issue not raised by the pleadings is tried by the parties’ express or implied consent, it must be treated in all respects as if raised by the pleadings.” See, e.g., Torry v. Northrop Grumman Corp., 399 F.3d 876, 878-79 (7th Cir. 2005), (Seventh Circuit rejected Defendant’s summary judgment motion on Plaintiff’s racial discrimination claim on the grounds that the plaintiff’s complaint did not mention racial discrimination, holding that the issue was tried by consent and stating that “the defendant went through four years of discovery and pretrial maneuverings without objecting to the fact that its opponent was patently engaged in endeavoring to prove racial as well as age discrimination. No more was required to satisfy Rule 15(b).”); Hartzol v. McDonald’s Corp., 437 F. Supp. 2d 805, 813 (N.D. Ill. 2006) (considering two unpled discrimination claims because the claims were tried by express or implied consent); 3 Moore’s Federal Practice § 15.18 (if an issue has been tried by implied consent, it does not matter whether the issues were raised by the pleadings—the court must treat the issues as though they were raised by the pleadings).

Here, as in Torry, the parties have engaged in years of discovery on the failure-to-warn issue, including fourteen months of expert discovery. Plaintiff and the Defendants have designated warnings experts who prepared reports, and Plaintiff’s expert has been deposed twice. Before the Defendants moved for summary judgment, they never objected to discovery on the warnings issue, moved for judgment on the pleading, or did anything else to indicate that the warnings issue was not in the case. Instead, they waited—negligently or perhaps tactically—until the eve of trial to contend that the pleadings are insufficient to raise the warnings issue. Therefore, under Rule 15(b)(2), the Defendants have tried the warnings issue by implied consent and the warnings claim is in the case whether or not it has been sufficiently pled.

Finally, even if the Defendants had not impliedly consented to try the failure-to-warn claim, the Court should permit the pleadings to be amended, if necessary, to conform to the evidence in the case. Under Rule 15(b), amendment of pleadings to include an unpled issue to conform to the evidence is appropriate if it will aid in presenting the merits and the objecting party fails to establish that it would be prejudiced. Fed. R. Civ. P. 15(b)(1); 3 Moore’s Civil Practice § 13.18. The Court should freely permit such amendments, despite objection, when it is in the interest of justice and there is no prejudice to the objecting party. See id. A party may move to amend at any time, even after the judgment is rendered. See id. In this case, the parties have litigated the warnings issue for years. Critically, plaintiffs have designated a warnings expert, which the Defendants have deposed twice, and the Defendants have designated a rebuttal expert. Therefore, permitting Plaintiff to amend her complaint, if necessary, to plead her failure-to-warn claim (which has been litigated for years and was sufficiently pled) more explicitly would aid in presenting the merits of the case at trial and would not prejudice the Defendants.

B. Plaintiff has ample evidence to support her failure to warn claim.

Under Illinois law, a drug manufacturer has a duty to warn adequately of any risks about which it knew or should have known at the time it sold the product; failure to warn exposes the manufacturer to strict liability. Woodill v. Parke-Davis & Co., 402 N.E.2d 194, 198 (Ill. 1980). The manufacturer’s warnings are deemed adequate if they: are in a form likely to catch a physician’s attention; contain language clearly conveying the dangers; and are intense enough to provoke a physician to proceed cautiously. Mahr v. G.D. Searle & Co., 390 N.E.2d 1214, 1230, (Ill. 1979). A drug manufacturer is strictly liable under products liability law if it distributes a drug without providing physicians with adequate warnings regarding possible adverse reactions to the drug. Woodill, 402 N.E.2d at 198; Eldridge v. Eli Lilly & Co., 485 N.E.2d 551 (Ill. 1985).

Here, there is ample evidence that Defendants failed to properly warn doctors about the risks and dangers of Duragesic. According to Dr. Cheryl Blume:

The labeling should have been amplified to reflect that fatalities have been reported secondary to hypoventalative events in patients who were not misusing or abusing the drug and patients for whom the drug was properly indicated.

Blume Depo. at p. 65; Id. at p. 230 (“I think physicians need to know that patients have died from respiratory arrest or cardiovascular conduction difficulties or whatever it is when they’ve used the drug properly.”). Moreover, according to Blume, there should have been warnings regarding the “narrow therapeutic range” of Duragesic and the resulting “overlap in the ranges of drug – of plasma levels, blood levels of fentanyl between effective concentration and toxic concentration and lethal concentration.” Blume Depo. at pp. 78, 198. According to Blume, the warnings regarding hypoventilation were “watered down” by the continual references to problems associated with opioid naïve patients and references to patients not properly using the patch. Blume Depo. at pp. 220-21. As she explained, “Alza should have provided information in the professional product labeling related to sudden death (and other serious adverse events) associated with proper use of the patch.” Blume Declaration at ¶47.

Dr. Blume’s opinions are reliable. In Crisostomo v. Stanley, 857 F.2d 1146 (7th Cir. 1988), the Defendants in a pharmaceutical case argued that the opinions of one of the plaintiff’s experts regarding the adequacy of warnings were inadmissible because the expert was “a pharmacist, not a pharmacologist or a medical doctor.” Id. at 1153, n.18. The court rejected this argument, noting that “there is no reason why a witness who is not a medical doctor should be automatically disqualified as a medical expert, if he is otherwise well schooled in the field.” Id.

Here, Plaintiff’s expert on warnings is a pharmacologist; she has a Ph.D in pharmacology and toxicology. The fact that she is not a medical doctor is irrelevant and does not disqualify her from rendering opinions regarding the adequacy of Defendants’ warnings. See, e.g., Martin v. Ortho Pharmaceuticals, 645 N.E.2d 431, 437 (Ill. App. 1994), rev’d on other grounds, 661 N.E.2d 352 (Ill. 1996) (“The record before us contains the affidavits of the plaintiffs’ expert witnesses, Dr. Nancy Lord and James P. O’Donnell, a pharmacologist, which state that the defendant’s patient warnings were inadequate to explain the known risks of birth limb reductions with the use of oral birth contraceptives in the first trimester of pregnancy. These affidavits create a genuine issue of fact on the adequacy of the defendant’s patient warnings which precludes summary judgment on the question.”); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1168 n.6 (S.D. Fla. 1996) (“the Court acknowledges that an expert need not be a medical doctor to testify as to the adequacy of a drug’s warning”).

C. Plaintiff’s warning claims are not barred by the learned intermediary doctrine.

The learned intermediary doctrine is a defense on which Defendants bear the burden of proof. Defendants have not met their burden of proof because they have not brought forth sufficient evidence that Dr. Skaredoff, Decedent’s prescribing physician, was fully aware of all of the risks and dangers associated with the use of Duragesic patches. Moreover, because Defendants cannot demonstrate that they adequately warned Dr. Skaredoff of the dangers of Duragesic, they cannot even show that the doctrine applies. For these reasons, Defendants’ Motion for Summary Judgment must be denied.

1. Because Defendants cannot demonstrate that they adequately warned Dr. Skaredoff of the dangers of Duragesic, they cannot even show that the learned intermediary doctrine applies.

Because Defendants cannot demonstrate that they adequately warned Dr. Skaredoff of the dangers of Duragesic, they cannot even show that the learned intermediary doctrine applies. As many courts have held, “[d]octors who have not been sufficiently warned of the harmful effects of a drug cannot be considered ‘learned intermediaries’.” Proctor v. Davis, 682 N.E.2d 1203, 1215 (Ill. App. Ct. 1997); McNichols v. Johnson & Johnson, 461 F.Supp.2d 736, 740 (S.D. Ill. 2006) (“the learned intermediary doctrine is not a bar to liability where a manufacturer never communicated an adequate warning to physicians.”); Riddle v. Merck & Co., Civil Action No. 06-172-GPM, 2006 U.S. Dist. LEXIS 22085 at *13 (S.D. Ill. 2006) (”the learned intermediary doctrine is not a bar to liability where a manufacturer never communicated an adequate warning to physicians.”). Where the manufacturer has failed to provide adequate warnings, the learned intermediary doctrine is inapplicable as a matter of law. See, e.g., AMF, Inc. v. Victor J. Andrew High Sch., 526 N.E.2d 584, 588 (Ill. App. Ct. 1988) (“In the present case, however, … AMF failed to give adequate warnings to the defendants in the first instance, . . . and, therefore, the learned intermediary doctrine is, if for no other reason, inapplicable.”).

After Decedent’s death in June 2004, Defendants sent a “dear doctor” letter to the medical community providing new information about the risks of Duragesic. They also substantially modified the “black box” warning in their package insert. Given that the new warnings provided in 2005 had not been provided prior to Decedent’s death, Defendants cannot possibly show that Dr. Skaredoff had all of the pertinent information about the risks of Duragesic. Where, as here, a prescribing physician has not been properly warned of all of the dangers of the drug at issue, the manufacturer is not entitled to the learned intermediary defense:

While the evidence in the record does indicate some awareness on the part of Dr. Mateo of the potential adverse reaction from Haldol, there were several features of NMS that he may not have known — or at least did not recall — at the time he prescribed the drug. For example, conspicuously omitted from the warnings was any indication of altered mental status as part of a syndrome of symptoms — including hyperpyrexia, muscle rigidity, and autonomic instability — associated with NMS. Dr. Mateo’s failure to perform a mental status examination on plaintiff when plaintiff returned to his office after the drug was first prescribed creates some question as to the extent of his awareness of this risk.

Noyola v. Johnson & Johnson, No. 85 C 2184, 1986 U.S. Dist. LEXIS 31007 at *6 (N.D. Ill. Dec. 16, 1986). Defendants’ Motion should be denied.

2. Defendants cannot demonstrate that Dr. Skaredoff was aware of all of the risks and dangers associated with the use of Duragesic patches.

Defendants have not met their burden under the learned intermediary defense because they have not demonstrated that Dr. Skaredoff was aware of all of the risks and dangers associated with the use of Duragesic patches. In their brief, Defendants state that Dr. Skaredoff “testified that the package insert gave him adequate information about the risks of using Duragesic . . . .” Defendants’ Memorandum at p. 22. This is misleading. In response to the question of whether the package insert gave him “adequate information about the risks associated of using Duragesic, his non-responsive answer was that “[i]t tells me what I need to know about handling this drug.” Skaredoff Depo. at pp. 97-8. Not only did Dr. Skaredoff fail to specifically testify that the package insert sufficiently apprised him of all known risks of Duragesic, his testimony is unreliable. The question and answer quoted above came after Skaredoff had glanced at the package insert during his deposition; he hardly had time to read the lengthy insert to determine whether all known risks were mentioned. Id. at pp. 95-98. And as for his prior experience with the package insert, he testified:

Q. And at some point in time did – over the years, have you reviewed the package insert or information regarding the product on the Internet?

A. Probably.

Skaredoff Depo. at pp. 95-6. Without evidence that Dr. Skaredoff carefully reviewed the product insert and unequivocally stated that it apprised him of all known risks and dangers associated with Duragesic, Defendants cannot invoke the learned intermediary defense.

Moreover, Defendants never informed Dr. Skaredoff in his deposition of the new warnings they added to the package insert in June 2005, after Karin Kunnemann’s death. Nor did they ask him whether he would have acted differently had he been given those new warnings or the warnings suggested by Plaintiff’s expert, Dr. Cheryl Blume. The burden was on Defendants to offer such evidence:

Defendants apparently do not dispute the necessity for giving adequate warnings to treating physicians under Illinois law, but argue only that plaintiff’s failure to submit an affidavit of Dr. Lemus indicating that he was unaware of the proper treatment of NMS, and that he would have used different treatment if he had more information, establishes that summary judgment in their favor should be granted. This argument, however, misconstrues the burden of proof on a motion for summary judgment. It is not plaintiff who must show the existence of genuine issues of material fact, but rather defendants who must demonstrate the absence of any such issues.

Noyola, 1986 U.S. Dist. LEXIS 31007 at *10. Without such evidence, Defendants cannot meet their burden of proof on the learned intermediary defense. See, e.g., Batteast v. Wyeth Laboratories, 560 N.E.2d 315, 323 (Ill. 1990) (“judgment notwithstanding the verdict was improperly granted in drug warning case where “an issue exists whether proper warnings would have caused him not to prescribe the drug.”); Giles v. Wyeth, Inc., 500 F. Supp. 2d 1063, 1070 (S.D. Ill. 2007) (“Clearly, his testimony is sufficient to create a fact issue as to whether he would have changed his conduct in light of the warning.”). Even with such evidence, “under Illinois law the issue of whether a manufacturer gave adequate warning of the known dangerous propensities of a drug so as to trigger the learned intermediary doctrine is one of fact.” See, e.g., Riddle, 2006 U.S. Dist. LEXIS 22085 at *13.

Not only is there no evidence that Dr. Skaredoff knew of all of the risks associated with Duragesic based on the 2004 package insert, the uncontroverted evidence proves the contrary. After Decedent’s death in June 2004, Defendants sent a “dear doctor” letter to the medical community providing new information about the risks of Duragesic. They also substantially modified the “black box” warning in their package insert. Given that the new warnings provided in 2005 had not been provided prior to Decedent’s death, Defendants cannot possibly show that Dr. Skaredoff had all of the pertinent information about the risks of Duragesic. And it is only when a defendant can show that the prescribing physician knew about all of the risks that the learned intermediary doctrine shields them from liability. Giles, 500 F.Supp.2d at 1066, n. 3 (“In failure to warns cases, courts regularly grant summary judgment when ‘the physician’s testimony shows unequivocally that s/he knew at the relevant time all the information which would have been included in a proper warning.”) (emphasis original).

Finally, many courts have refused to find the learned intermediary doctrine satisfied even when the prescribing physician clearly and unequivocally testified he had all the information he needed to make a prescribing decision. These courts have reasoned that “unless a physician’s claim that she would have prescribed a drug even if adequately warned is self-disserving, the credibility of such a claim is generally a jury question not to be resolved on a motion for summary judgment.” Golod v. LaRoche, 964 F. Supp. 841, 857 (S.D. N.Y. 1997); see also In re Prempro Products Liab. Litig., MDL Docket No. 4:03CV1507-WRW, 2006 U.S. Dist. LEXIS 47472 (E.D. Ark. July 13, 2006) (“I’m not convinced that a physician’s testimony regarding what he or she would have done in 20/20-hindsight should be considered absolute. It appears to me that such testimony may well hinge on credibility, which is for the jury to decide.”). For the foregoing reasons, Defendants’ Motion for Summary Judgment should be denied.

D. Whether Defendants’ warnings were adequate is a fact question for the jury.

In the final analysis, whether Defendants’ warnings were adequate is a fact question for the jury. Under Illinois law, in order to determine whether or not warnings are adequate, the trier of fact must:

look to whether the warnings are sufficient in form, content and intensity. The adequacy of the warning is measured not only by what is stated, but also by the manner in which it is stated. Warnings may be inadequate if they (1) do not specify the risk presented by the product; (2) are inconsistent with how a product will be used; (3) do not provide the reason for the warnings; or (4) do not reach the foreseeable user.

Woodbury v. Janssen Pharmaceuticals, No. 93 C 7118, 1997 U.S. Dist. LEXIS 5282 at *20 (N.D. Ill. 1997); Mahr, 390 N.E.2d at 1230 (“Implicit in the duty to warn is the duty to warn with a degree of [i]ntensity that would cause a reasonable [physician] to exercise . . . the caution commensurate with the potential danger . . . . A clear cautionary statement setting forth the exact nature of the dangers involved would be necessary to fully protect the seller.”). This fact-intensive inquiry necessitates a review of the full record:

Illinois law clearly contemplates that the case-dispositive defense of the learned intermediary doctrine is one to be resolved on a full record and, in all but those instances where there is no genuine issue for trial as to the doctrine’s applicability in a given case, by a jury.

Brooks v. Merck & Co., 443 F.Supp.2d 994, 1005 (S.D. Ill. 2006); Kirk v. Michael Reese Hosp. & Med. Ctr., 483 N.E.2d 906, 911 n.2 (Ill. App. Ct. 1985), rev’d on other grounds, 513 N.E.2d 387 (Ill. 1987) (sufficiency of warnings “is not resolved judicially by pointing to a single document or act, but remains a question to be resolved by the trier of fact in light of all the information provided by the manufacturer and all the information that it was reasonably possible to provide.”).

For this reason, the adequacy of warnings under the learned intermediary doctrine is a fact question inappropriate for disposition on summary judgment. See, e.g., Giles, 500 F. Supp.2d at 1067 (“The trier of fact must judge a warning by whether it sufficiently apprised physicians of the risks associated with the use of the drug.”); Proctor, 682 N.E.2d at 1215 (“the adequacy of warnings is a question of fact, not law, for the jury to determine”); Hansen, 764 N.E.2d at 43 (“the adequacy of warnings is a question of fact, not law, for the jury to determine.”); Noyola, 1986 U.S. Dist. LEXIS at *10 (“[U]nder Illinois law, the adequacy of warnings is ordinarily a question of fact which is inappropriate for resolution on a motion for summary judgment.”); Mahr, 390 N.E.2d at 1230 (“[T]he sufficiency of form, content and intensity [of a manufacturer’s warning to physicians] is not resolved by pointing to a single document, but remains a question to be resolved by the trier of fact in the light of all the information provided by the manufacturer and all that was reasonably possible to provide.”). Defendants’ summary judgment motion should be denied.

VI. Plaintiff’s claims are not pre-empted.

Defendants argue that they are entitled to summary judgment on Plaintiff’s design defect and warnings claims because they are preempted by federal law. Specifically, Defendants contend that under the Food, Drug and Cosmetic Act, 21 § 301, et. Seq. (the “FDCA”), FDA approval of pharmaceutical drugs such as Duragesic and their labeling preempt all state law damages actions and absolve pharmaceutical manufacturers and/or distributors of liability for injury or death caused by dangerous or defective drugs irrespective of the merits of Plaintiff’s state law claims. The FDA approved the sale of Duragesic in August, 1990. Defendants contend that such approval entitles them to summary judgment on Plaintiff’s state law claims by virtue of preemption. It does not.

The United States Constitution provides that the laws of the United States “shall be the supreme Law of the Land…any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. This provision gave rise to the doctrine of preemption, under which federal statutes and agency regulations may preempt state law. See Louisiana Pub. Serv. Comm’n v. F.C.C., 476 U.S. 355, 369 (1986). Federal preemption of state law can occur in three scenarios. First, where Congress explicitly preempts state law; second, where preemption is implied from the depth and breadth of a congressional scheme that occupies the legislative field and; third, where preemption is implied because there is an actual conflict between federal and state law. Pokorny v. Ford Motor Co., 902 F.2d 1116, 1120 (3rd Cir. 1990). The latter is known as “implied conflict preemption,” and is the version of preemption relied upon by Defendants in the present case.

Implied conflict preemption occurs when a state law makes it “impossible for a private party to comply with both state and federal requirements” or where state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2000). However, there is a strong basic presumption against implied preemption, particularly in areas that states have traditionally occupied such as the regulation of public health and safety. See Maryland v. Louisiana, 451 U.S. 725, 726 (1981); Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1018, 1032 (S.D. Ill. 2001) (“this court starts its analysis with an anti-preemption assumption.”). Courts must presume “that the historic police powers of the states were not to be superseded by a Federal Act unless that was the clear, manifest purpose of Congress.” Geier v. American Honda Motor Co., 529 U.S. 861, 869-874 (2000). The need for a clear statement from Congress is imperative where a finding of preemption will foreclose a remedy that was traditionally available and for which federal law provides no substitute. Perry v. Novartis Pharm. Corp., 456 F. Supp. 2d 678, 685 (E.D. Pa. 2006).

Protecting health and safety is an area traditionally occupied by the states, and “Illinois’ duty that manufacturers of dangerous products warn individuals as to the product’s dangers falls within the states traditional role of protecting the health and safety of its citizens.” Caraker, 172 F. Supp. 2d at 1032. The Supreme Court has further noted that the case for federal preemption is particularly weak where, as here, Congress has indicated its awareness of the operation of state law in a field of interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there is between them. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 166-67 (1989).

Applying these principles, the majority of courts have found that state law claims against prescription drug manufacturers are not preempted by FDA approval of a drug application. See, e.g., Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230 (E.D.N.Y. June 11, 2007); Weiss v. Fujisawa Pharm. Co., 464 F. Supp. 2d 666 (E.D. Ky. 2006); In re Vioxx Prods. Liab. Litig., 501 F. Supp. 2d 776 (E.D. La. 2007). Rather, these courts have recognized that FDA regulations pertaining to design and warning standards “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.” Caraker, 172 F. Supp. 2d at 1033; Orso v. Bayer, No. 04 C 0114, 2006 U.S. Dist. LEXIS 73647 at *13 (N.D. Ill. Sept. 27, 2006) (“FDA labeling requirements should be viewed as minimum thresholds.”). For these reasons, set forth more fully below, Plaintiff’s state law claims are not preempted.

A. Plaintiff’s claims do not conflict with federal law.

Since the parties agree that the FDCA does not expressly preempt state law damage claims, the relevant question is whether Plaintiff’s claims are impliedly preempted because they actually conflict with federal law; that is, whether Plaintiff’s recovery renders Defendants’ compliance with state and federal law “impossible” or whether Defendants’ compliance with state law would erect an “impermissible obstacle” to the accomplishment of federal objectives.

First, it would not be impossible to comply with the Illinois state law duties pertaining to design defect and warning claims because a finding that Duragesic is “unreasonably dangerous” does not require Defendants to alter their conduct but only to pay damages to Plaintiffs. FDA regulations and common law product liability claims have existed harmoniously for nearly 70 years since the enactment of the FDCA. See In re. Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d at 230. If a jury were to find Defendants liable for defects in the Duragesic patch, it would not compel Defendants to do anything, as jury verdicts do not impose mandatory design or labeling requirements on drug manufacturers. As explained in Bates v. Dow Agrosciences LLC, a “requirement is a rule of law that must be obeyed; an event, such as a jury verdict, that merely motivates an optional decision is not a requirement.” Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005).

Moreover, it would not have been impossible to comply with Illinois’ duty to warn because FDA requirements expressly give manufacturers the right to revise drug labeling, after FDA approval, to include contraindications, warnings, and instructions that enhance patient safety. See 21 C.F.R. § 314.70(c)(6)(iii)(A). FDA regulations contemplate that information may arise after application approval that calls into question the current safety of the drug. Additional or more forceful warnings may, in the drug manufacturer’s judgment, be added to labeling without prior FDA approval and on the drug manufacturer’s own initiative. See 21 C.F.R. § 314.70; see also Caraker, 172 F. Supp.2d at 1034 (“Even after approval, additional or more forceful warnings may, in the drug manufacturer’s judgment, be added to labeling without prior FDA approval and on the drug manufacturer’s own initiative.”); Osburn v. Anchor Lab., 825 F. 2d 908, 912 (5th Cir. 1987) (“Of special significance is the fact that the FDA regulations specifically permitted Rachelle to add additional warnings to a previously approved label as soon as it became aware of the necessity to do so — without any need to first obtain FDA approval of the supplemental warnings.”). Liability may attach if drug manufacturers do not request FDA approval of an additional warning as soon as new hazards or elevated risk associations are discovered. See In re Tetracycline Cases, 747 F. Supp. 543, 550 (W.D. Mo. 1989); cf. Sterling Drug, Inc. v. Yarrow, 408 F. 2d 978, 991-92 (8th Cir. 1969).

A conflict does not exist for the additional reason that FDA regulations provide only a minimum standard on drug manufacturers, not a conclusive standard. In other words, the regulations of the FDA provide a floor, not a ceiling. Caraker, 172 F. Supp. 2d at 1035 (“it is reasonable to find that the FDA has imposed a minimum – as opposed to conclusive – standard of safety.”). Although the FDA has taken a different approach, the majority of courts continue to find that state law claims against prescription drug manufacturers are not preempted, affording little to no deference to the FDA’s recent statements. See, e.g., Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230; Weiss, 464 F. Supp. 2d 666; Perry, 456 F. Supp. 678.

B. Congress has not manifested an intent to preempt state law warning and design defect claims.

Congress has not manifested an intent to preempt state law warning and design defect claims. As already shown, there is a strong fundamental presumption against implied preemption, particularly in areas that states have traditionally occupied such as the regulation of public health and safety. See N.Y. State Conference of Blue Cross Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 654-55 (1995). To overcome this presumption, Defendants rely, in part, on dicta in the Supreme Court decision in Riegel v. Medtronic, Inc., — U.S. —, 128 S. Ct. 999, 1009, L. Ed. 2d 892 (2008) to argue that Plaintiff’s claims are preempted by the FDCA. In Riegel, the Court held that the Medical Device Amendments Act of 1976, 21 U.S.C. § 360(c) (“MDA”) preempted design defect and breach of implied warranty claims that were “different from or in addition to” federal requirements. Defendants acknowledge that the MDA contains an express preemption clause and is, therefore, not dispositive of the issues in the present case. But Riegel is significant in it speaks to an instance where Congress has expressly preempted the states’ regulation of public health. In-so-doing, Riegel underscores why Defendants cannot overcome the “strong fundamental presumption” against preemption in the present matter.

In clear contrast to the MDA, the FDCA does not contain any express statement that Congress intended to displace state law claims in the prescription drug context.

Congress has not spoken on the issue of preemption as related to prescription drugs, and this silence is telling. While a direct statement of legislative intent is not essential for preemption, it would be odd for Congress to include express preemption provisions in amendments to the FDCA regarding state-law tort claims in certain contexts (i.e. for medical devices) if it intended all FDCA claims to be preempted.

In re. Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d at 230; Orso, 2006 U.S. Dist. LEXIS 73647 at *14 (“While the FDA Act restricts states from regulating drugs falling within its ambit, it does not bar recovery for actions in tort.”). In fact, when Congress amended the FDCA in 1962, it stated that “[n]othing in the amendments…shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of state law.” Drug Amendments of 1962, Pub. Law No. 87-781, § 202, 76 Stat. 780, 793.

To summarize, Congress has already acknowledged the operation of state law in the area of prescription drugs and “tolerates the tension,” to the extent it exists, between state and federal law. In that setting, the case for preemption is “particularly weak.” Bonito Boats, Inc., 489 U.S. at 166-67. A “clear statement from Congress” is imperative where a finding of preemption will foreclose a remedy that was traditionally available and for which federal law provides no substitute. See Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230. Not only is a “clear statement” of intent to preempt lacking in this case; there is an acknowledgement of the operation of state law in the area of pharmaceutical drugs, an area Congress has thus far declined to expressly preempt despite having done so in other fields related to public safety and health.

At its core, preemption is fundamentally a question of Congressional intent. English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). Congress clearly did not intend for the FDA to preempt of state law claims against prescription drug manufacturers and distributors:

there is no “clear evidence” of intent to preempt by means of a conflict. First, Congress expressly preempted other areas in Title 21, but it chose not to with respect to prescription drugs. Second, as stated, it is not clear whether FDA approval meant a drug manufacturer was meeting minimum standards of safety or conclusive standards on safety. Third, the FDA’s specific position on implied preemption of products liability cases like these is not clear. Fourth, Sandoz may unilaterally strengthen a warning without prior FDA approval and the FDA has cited without criticism cases that have found such a duty. Fifth, it rather difficult to believe that Congress or the FDA would, without comment, remove all means of judicial redress for those injured.

Caraker, 172 F. Supp.2d at 1038. Defendants have failed to show that it would be impossible for Defendants to comply with both state law and FDA requirements. Defendants have also failed to show that Plaintiff’s state law claims stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress when it enacted the FDA. For the foregoing reasons, the claims asserted by Plaintiffs are not preempted as a matter of law. Defendants’ Motion for Summary Judgment should be denied.

CONCLUSION AND PRAYER

Plaintiffs have offered substantial evidence in support of each of their stated causes of action. For this reason, as set out more fully above, the Court should deny Defendants’ Motion for Summary Judgment.

WHEREFORE Plaintiff Randi Kunnemann respectfully prays that the Court deny Defendants’ Motion for Summary Judgment and grant her such other and further relief to which she may be justly entitled.

By:

_________________________________

James Craig Orr, Jr.

Texas Bar No. 15313550

Charles W. Miller

Texas Bar No. 24007677

Heygood, Orr, Reyes, Pearson & Bartolomei

2331 W. Northwest Highway, 2nd Floor

Dallas, TX 75220

214-526-7900 Telephone

214-526-7910 Facsimile

 

ATTORNEYS FOR PLAINTIFFS