Response to Defendants’ Motion for Summary Judgment

DiCosolo v. Janssen

Description: This brief was filed in Illinois state 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 availability of a “non-specific defect” claim under Illinois law. Finally, the response addresses issues relating to the learned intermediary doctrine and the applicability and effect of Comment k to the Restatement (Second) of Torts, which generally applies to products that are “unavoidably unsafe.” The court denied the defendants’ motion for summary judgment, and the firm thereafter obtained a $16.5 million jury verdict for the plaintiffs. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

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

Janssen Pharmaceutica Inc., a Foreign Corporation; ALZA Corporation, an Illinois Corporation.

Defendants.

No. 04 L 5351

 

PLAINTIFF’S RESPONSE TO DEFENDANTS’ MOTION FOR

SUMMARY JUDGMENT AND MEMORANDUM IN SUPPORT

John DiCosolo (“John”), as Administrator of the Estate of his deceased wife, Janice V. DiConsolo (“Janice”), hereby files his Response to the Motion for Summary Judgment and Memorandum in Support filed by Janssen Pharmaceutica Inc., and Alza Corporation (collectively, “the Drug Companies”).

PRELIMINARY STATEMENT

John’s wife Janice was killed by one or both of the 75 mcg/hour Duragesic prescription pain patches (the “DiCosolo Patches”) that she used on the night she died. One or both of the DiCosolo Patches killed Janice by giving her a lethal fentanyl level that was sixteen times higher than a properly functioning patch should have given her. The evidence in this case demonstrates that the Drug Companies responsible for Janice’s death used substandard manufacturing and quality control practices, failed to use safer alternative designs, ignored internal whistleblowers, and failed to warn doctors and their patients of the known dangers associated with the numerous leaking and otherwise defective patches they manufactured and sold.

John sued the Drug Companies that caused his wife’s wrongful death and asserted claims against them for manufacturing defects, design defects, failures to warn, and negligence. The Drug Companies have urged seven grounds for summary judgment, and are asking this Court to dismiss all of John’s claims against them, with prejudice.

First, the Drug Companies argue that they are entitled to summary judgment on John’s manufacturing-defect claim because there is allegedly no evidence that the DiCosolo Patches suffered from a non-specific manufacturing defect. To the contrary, the toxic amount of fentanyl in Janice’s body (approximately sixteen times higher than expected) is evidence that one or both of the DiCosolo Patches failed to perform as expected—especially since it is undisputed that Janice did not use the defective patches in an abnormal or unintended manner. Moreover, John has produced evidence negating any secondary causes of the fatal fentanyl level found in Janice’s blood.

Second, the Drug Companies argue that they are also entitled to summary judgment on John’s manufacturing-defect claim because there is allegedly no evidence that the DiCosolo Patches suffered from a specific manufacturing defect. To the contrary, there is both direct and circumstantial evidence that a specific manufacturing defect caused at least one of Janice’s patches to leak. For example, it is undisputed that the patches Janice used on the night she died came from one of five lots recalled by the Drug Companies after they learned that several defective Duragesic patches in those lots leaked fentanyl gel. Moreover, the night Janice died, John actually saw a slick film on her skin underneath the area previously covered by another patch. John’s experts have testified that the film he saw was most likely fentanyl gel from a defective Duragesic patch, and that the most reasonable explanation for Janice’s fatal fentanyl level is a leaking patch.

Third, the Drug Companies argue that they are entitled to summary judgment on John’s design-defect claim under comment k to the Restatement (Second) of Torts § 402A because Duragesic is allegedly “unavoidably unsafe.” Comment k, however, is an affirmative defense, which shifts the burden of proof to the Drug Companies. They have not produced any evidence or expert testimony demonstrating that Duragesic is “unavoidably unsafe” within the meaning of comment k. Moreover, even if they had offered some evidence on this defense, the Drug Companies would not be entitled to summary judgment because: (a) the issue of whether a product is unavoidably unsafe is a fact question for the jury; (b) the Drug Companies failed to sufficiently warn of all known dangers—an essential element of a comment-k defense; and (c) John has produced expert testimony showing that, by using an available alternative design and by improving their manufacturing and quality control practices, the Drug Companies could have easily made Duragesic safer.

Fourth, the Drug Companies argue that they are also entitled to summary judgment on John’s design-defect claim because (a) there is allegedly no evidence that Janice used a leaking patch; (b) an alternatively designed patch (known as a “matrix” patch) was not sold in the United States at the time of Janice’s death; and (c) leaks are a manufacturing defect rather than a design defect. But, as described above, John has produced evidence showing that a leaking patch caused Janice’s death. And it is undisputed that the only reason a matrix patch was not available in the United States at the time Janice was killed was because the Drug Companies abandoned their efforts to obtain FDA approval for a matrix patch and blocked its sale by a competitor. (More specifically, a matrix patch was available outside the United States, but the Drug Companies abandoned their efforts to obtain FDA approval for the matrix patch and sued Mylan, Inc., the manufacturer of the competing matrix patch, to prevent it from selling the matrix patch in the United States.) Finally, John has produced evidence that the Duragesic patch’s “reservoir” design is inherently susceptible to patch rupture and fentanyl-gel leaks, which could have been prevented by using a safer alternative design, such as the matrix patch.

Fifth, the Drug Companies argue that they are entitled to summary judgment on John’s failure-to-warn claim because John has not produced an expert witness on warnings. Contrary to the Drug Companies’ assertion, Illinois law does not require a “warnings” expert in failure-to-warn cases. Instead, the issue is whether the failure to warn is of a type that would allow a jury to reach an intelligent conclusion about the adequacy of the warning without the aid of an expert’s specialized knowledge. In this case, John has designated six different experts to testify about every conceivable aspect of Duragesic (e.g., that leaking patches are inherent in the manufacture of Duragesic, that leaking patches are dangerous and potentially fatal, that a properly functioning should not give patients a fentanyl level higher than 4 ng/ML, etc.) and how it caused Janice’s death. Janice’s treating doctor has also opined that the warnings were inadequate. Therefore, to the extent expert testimony is necessary to establish the inadequacy of the Drug Companies’ warnings (the need for warnings about the dangers of leaking patches and wildly excessive fentanyl doses are obvious), John’s experts will provide the jury with ample information to reach an intelligent decision on the warnings issues.

Sixth, the Drug Companies argue that they are entitled to summary judgment on John’s failure-to-warn claim under the learned-intermediary doctrine because Janice’s doctor allegedly received sufficient warnings concerning Duragesic. But, like the Drug Companies’ comment k defense, the learned-intermediary doctrine is an affirmative defense that shifts the burden of proof to the Drug Companies—and it only applies when a drug manufacturer has adequately warned the prescribing physician of all of the risks and dangers of its product. The Drug Companies have not cited to any conclusive, undisputed evidence that they warned Janice’s doctor about the dangers of Duragesic (e.g., that leaking patches are inherent in the manufacture of Duragesic, that Duragesic patches can leak fatal dose of fentanyl, that Duragesic can give patients wildly excessive fentanyl levels, or that the combination of drugs found in Janice’s blood was dangerous). In fact, Janice’s prescribing doctor signed an affidavit indicating that the Drug Companies did not warn of these dangers. And given the undisputed fact that Duragesic’s labeling was changed after Janice died to warn of the danger of leaking patches, the Drug Companies cannot meet their burden of proof on this affirmative defense. In any case, 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.

Finally, the Drug Companies argue that they are entitled to summery judgment on John’s negligence claim because there is allegedly no evidence that the patches Janice used on the night she died were defective. For the reasons discussed above, John has substantial and overwhelming evidence that the design, manufacture and marketing of the Duragesic patch was defective. Moreover, contrary to the Drug Companies’ assertion, the existence of a defect may be established through the res ipsa loquitur doctrine because Janice’s death: (a) occurred under circumstances which were not due to any voluntary act or negligence on her part; (b) was caused by an instrumentality or agency under the management or control of the Drug Companies; and (c) was caused by an occurrence that would not have occurred in the absence of negligence.

As set forth more fully below, John has an abundance of evidence supporting each of his claims against the Drug Companies under Illinois law. Because he has raised a fact issue on each challenged element of his causes of action, the Drug Companies’ motion should be denied.

 

STATEMENT OF FACTS

The Duragesic patches that killed Janice in February 2004 came from lot number 0327192 (“Lot 192”), one of five lots included in an February 2004 “Urgent Drug Recall” initiated by the Drug Companies because several patches contained a defect known as the “fold-over defect,” which causes a leak along one edge of the patch.

REDACTED

Following the recall, the Drug Companies prepared a new package insert warning patients that fentanyl gel from cut or damaged Duragesic patches “can lead to the rapid release of the contents of the Duragesic patch and absorption of a potentially fatal dose of fentanyl.” (See 2005 Duragesic Package Insert (Ex. 33); Prausnitz Aff. ¶ 6 (Ex. 2).)

The FDA later inspected ALZA’s manufacturing facility and cited the company for numerous manufacturing problems.

REDACTED

The Drug Companies’ poor GMPs, combined with their production and distribution of defective, leaking patches, ultimately led to Janice’s death. Janice was a chronic sufferer of neck and arm pain, and was treated at various medical facilities and pain centers over the years. (DiCosolo Aff. ¶ 2 (Ex. 1).) One of the medications she was prescribed for her condition was a Duragesic pain patch, which she used as prescribed since 2002. (Nath Dep. at 75, 78 (Ex. 59).) Duragesic patches are transdermal patches applied to the patient’s skin that administer the active ingredient fentanyl. (See 2003 Package Insert (Ex. 32).) Fentanyl is a very potent narcotic drug with a narrow therapeutic band (i.e., the difference between a therapeutic dose and a fatal dose of fentanyl is small). (Middleburg Aff. ¶ 7(c) (Ex. 6); Downs Aff. ¶ 8 (Ex. 4); Lekin Aff. ¶ 11 (Ex. 3).) Accordingly, Duragesic must be administered in a careful and controlled manner. (Downs Aff. ¶ 8 (Ex. 4); Lekin Aff. ¶ 11 (Ex. 3).) Janice’s customary practice was to apply one patch at a time, change her patch every three days, and keep track of this schedule on a calendar. (DiCosolo Aff. ¶ 3 (Ex. 1).) Her husband John, a Cicero Police Sergeant, frequently helped Janice remove the used patch from her skin and replaced it with a new patch to another area of her body. (See id. ¶ 4.) On the evening of February 14, 2004, John removed Janice’s used patch. (See id. ¶ 12.) The patch came off with unusual ease, and John noticed a slick film on Janice’s skin where the patch was located. (See id. ¶13.) John replaced the old patch with a new one and, shortly thereafter, left for his second job as an all-night security officer. John returned home at approximately 6:30 a.m. the next morning to find his wife’s lifeless body in bed where he had left her the night before. (Id. ¶16.)

The day after her death, Cook County Medical Examiner J. Lawrence Cogan performed an autopsy on Janice’s body. (See DiCosolo Autopsy Report (Ex. 25).) A 75 mcg/hour Duragesic patch was present on her left clavicle and the toxicology tests revealed a fentanyl blood level of 28.2 ng/mL. (See id.); DiCosolo Toxicology Report (Ex. 26).) Fentanyl has proven lethal at concentrations as low as 3.0 ng/mL and, according to the primary text used by pathologists and health professionals to ascertain lethal levels of medications, the fatal level of fentanyl averages 8.3 ng/ml. (Prausnitz Aff. ¶ 5 (Ex. 2); Downs Aff. ¶ 20 (Ex. 4); Leikin Aff. ¶ 18 (Ex. 3) (citing R. Baselt, Disposition of Toxic Drugs and Chemicals in Man, pg. 452 (7th Ed. 2004).) The package insert accompanying the DiCosolo patches indicates that Janice’s fentanyl level should have only been approximately 1.7 ng/mL. (See 2003 Package Insert (Ex. 32); Middleberg Aff. ¶ 7(c); Downs Aff. ¶ 12 (Ex. 4).) In other words, Janice’s level of fentanyl was more than sixteen times higher than it should have been had her patch functioned properly. (See Middleberg Aff. ¶ 7(a), (k) (Ex. 6); Downs Aff. ¶ 13 (Ex. 4).)

After his examination and autopsy, Dr. Cogan concluded that the cause of death was accidental fentanyl-venlafaxine-gapapentin intoxication. (See DiCosolo Autopsy Report (Ex. 25); Cogan Dep. at 6:11-18 (Ex. 21).) After reviewing all of the evidence in this case, several of John’s experts have concluded that Janice’s excessively high fentanyl level was the cause of her death. (Downs Aff. ¶¶ 25, 26 (Ex. 4); Middleburg Aff. ¶ 6(a) (Ex. 6); Leikin Aff. ¶¶ 28, 31 (Ex. 3); Sims Dep. at 41:2-11 (Ex. 12).) The Drug Companies’ medical expert, Dr. Richard Blonsky, also agrees the 28.2 ng/mL fentanyl level was the primary cause of Janice’s death. (Blonsky Dep. at 193:2-8 (Ex. 15).) John’s experts have opined that this fentanyl level was the result of a defective Duragesic patch that did not perform as intended. (See, e.g., Prausnitz Aff. (Ex. 2); Middleburg Aff. ¶ 19 (Ex. 6)Downs Aff. ¶¶ 13, 26 (Ex. 4); Leikin Aff. ¶¶ 15-18 (Ex. 3).)

ARGUMENT AND AUTHORITIES

I. There Is Ample Evidence of a Non-Specific Defect to Create a Fact Issue for Trial.

 

A. Under Illinois law, John does not need to pinpoint the defect in the DiCosolo Patches.

 

Under Illinois law, John can create a fact issue for trial on the existence of a defect by pointing out the specific defect in the product or simply by showing that the product failed to perform as expected during normal use. 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., July 19, 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.”). The evidence in this case demonstrates both types of defects.

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).

A plaintiff may establish a prima facie case for product liability through a 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 through the use of 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. In this case, a 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 28.2 ng/mL. 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.”).

B. There is sufficient evidence of each element of John’s non-specific defect claim to create a fact issue for trial.

 

John has raised a fact issue for trial on the existence of a non-specific defect by producing summary judgment evidence on all three elements of a non-specific defect: (1) Janice did not use the DiCosolo Patches in an abnormal manner; (2) one or both of the DiCosolo Patches failed to perform as expected by giving Janice a blood fentanyl level sixteen times higher than expected; and (3) secondary causes were not responsible for the fatal fentanyl level found in Janice’s blood.

1. Janice did not use the DiCosolo Patches in an abnormal manner

The undisputed evidence shows that Janice used the DiCosolo Patches in their normal and intended manner. On February 9, 2004, Janice filled a prescription for ten 75 mcg/hour Duragesic patches. (See DiCosolo Aff. ¶ 8 (Ex. 1); DiCosolo Prescription Records (Ex. 28).) She used one of the patches as directed and for the prescribed period of time, and then changed to the second patch. (See DiCosolo Aff. ¶¶ 3, 8-13; 2003 Duragesic Package Insert at 27-28 (Ex. 32).) The remaining eight Duragesic patches that Janice bought on February 9, 2004, were unopened and unused when she died. (DiCosolo Dep. at 109:12-20 (Ex. 22).)

There is no evidence of any abnormal use or any product misuse or abuse. The Drug Companies’ own forensic toxicologist, Dr. Graham Jones, concedes as much:

Q: And sitting here today are you aware of any evidence that the patch was used improperly in this case?

A: No, I have no evidence to that.

(Jones Dep. at 58:12-16 (Ex. 16).) The Drug Companies’ forensic pathologist, Dr. Ross Zumwalt, agreed:

Q: So sitting here today, you don’t have any reason to believe that Ms. DiCosolo was abusing the fentanyl patch at the time of her death, do you, Doctor?

A: I don’t have any information that she used more than the usual number of patches.

Q: Okay. And you don’t have any reason to think that she was abusing the patch in any other way, do you, Doctor?

A: There is no information that I got that would lead me to that, no.

(Zumwalt Dep. at 45:18-46:9 (Ex. 17); see also Prausnitz Aff. ¶ 3(i) (Ex. 2) (“[T]here is no evidence of abuse, misuse or altered fentanyl clearance.”).) Abnormal use is simply not an issue.

2. The DiCosolo Patches failed to perform as expected.

 

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

a. One or both of the DiCosolo Patches killed Janice.

The most obvious evidence that the DiCosolo Patches failed to perform as expected is that one or both of them killed Janice. (Downs Aff. ¶ 25, 26 (Ex. 4); Middleburg Aff. ¶¶ 6(a), 7(d) (Ex. 6); Leikin Aff. ¶¶ 28, 31 (Ex. 3).) For obvious reasons, reasonable consumers would not expect to be killed by their prescription medication. For this reason alone, John has raised a fact issue that precludes summary judgment. See, e.g., Garavalia v. Heat Controller, Inc., 570 N.E.2d 1227, 1232 (Ill. App. 1991) (“A product is considered to be unreasonably dangerous only when the product is dangerous to an extent beyond that which would be contemplated by the ordinary person with the ordinary knowledge common to the community as to its characteristics. We believe that an ordinary consumer would not contemplate being killed by an air conditioner which is defective in that it leaked itself dry of Freon and failed to cool, which is precisely what is alleged to have happened here. Accordingly, the complaint did adequately aver that the unit was unreasonably dangerous.”).

b. One or both of the DiCosolo Patches gave Janice a fatal blood fentanyl level that was far higher than a properly functioning 75 mcg/hour Duragesic patch should provide.

Other evidence that the patch failed to perform as expected comes from the Drug Companies’ own package insert, which states that the “mean maximal concentration” for someone using a 75 mcg/hour Duragesic patch should be 1.7ng/mL. (2003 Duragesic Package Insert (Ex. 32); see also Middleburg Dep. at 82:3-8 (Ex. 10); Middleburg Aff. ¶ 7(c) (Ex. 6) (“The expected peak concentration of fentanyl following the proper use of a 75 ug/lu Duragesic® Patch is approximately 1.7 ng/mL (SD=0.7), but may be as high as approximately 3 ng/mL.”); Prausnitz Aff. ¶ 4(g) (Ex. 2) (“A properly functioning 75 mcg/hour Duragesic patch should produce a fentanyl blood level between 1.0 and 2.4 ng/mL.”).) This information is corroborated by a Medical Officer Review carried out by the FDA, which found that just 3% of properly functioning 75 mcg/hour Duragesic patches produced fentanyl concentrations greater than 3.0 ng/mL, and that none exceeded 5.0 ng/mL—a level the FDA referred to as “dose dumping.” (Prausnitz Aff. ¶ 5 (Ex. 2).)

It is undisputed that the toxicological testing of Janice’s blood shortly after her death showed a blood concentration of fentanyl of 28.2 ng/mL. (See DiCosolo Toxicology Report (Ex. 26); Chen Dep. at 85:9-86-4 (Ex. 23); Middleburg Dep. at 31:24-32:6 (Ex. 10); Middleburg Aff. ¶ 7(c) (Ex. 6).) This level of fentanyl was much higher than would be expected if the Duragesic patch performed in a reasonable manner in light of its intended function. According to Dr. Mark Prausnitz, a fentanyl blood level of 28.2 ng/mL “should never be achieved . . . a patch that produces this high level of fentanyl is most probably defective.” (Prausnitz Aff. ¶¶ 4(g), 5 (Ex. 2); see also Middleburg Aff. ¶ 21 (Ex. 6).) (“[I]t can be stated with a reasonable degree of scientific certainty that Janice had a concentration of fentanyl in her blood in excess of that expected from a properly functioning 75 ug/hr Duragesic patch.”); see also Middleburg Dep. at 81:12-22 (Ex. 10); Leikin Aff. ¶ 15 (Ex. 3) (“A properly functioning 75 mcg/hour Duragesic patch should produce a fentanyl level concentration between 1 ng/ML and 2.4 ng/ML. A properly functioning 75 mcg/hour Duragesic patch should not produce a fentanyl level greater than 4 ng/ML.”).) In short, it is irrefutable that Janice’s fentanyl level of 28.2 ng/mL was well outside the normal range expected for someone properly using a 75 mcg Duragesic patch.

As a very potent opioid analgesic, fentanyl has a narrow therapeutic index; the difference between therapeutic levels of fentanyl in the blood versus toxic levels is very small. (Leikin Aff. ¶ 11; (Ex. 3); Downs Aff. ¶8 (Ex. 4); (Middleburg Aff. ¶ 7(c) (Ex. 6).) Lethal fentanyl concentrations have been found to range from 3.0 to 28 ng/mL, with an average value of 8.3 ng/mL. (Prausnitz Aff. ¶ 5 (Ex. 2); Downs Aff. ¶ 20 (Ex. 4); Leikin Aff. ¶ 18 (Ex. 3).) Janice’s fentanyl blood concentration was well in excess of levels sufficient to cause death.

Based on the foregoing evidence, John’s experts have testified that Janice’s Duragesic patch failed to perform in a reasonable manner in light of its intended function. Dr. Mark Prausnitz, a Professor of Chemical and Biomedical Engineering and an expert on transdermal drug delivery for the last 20 years, stated:

A properly functioning Duragesic Patch should produce a fentanyl blood level between 1.0 and 2.4 ng/mL. A fentanyl blood level of 28.2 ng/mL should not be achieved using a properly functioning patch. A patch that produces this high level of fentanyl is most probably defective.

In this case, I conclude that the high level of fentanyl found in the blood of Janice DiCosolo was the result of a leak or other defect in one of the Duragesic patches she was wearing prior to her death. That is because the fentanyl concentration in her blood was 28.2 ng/mL, which is more than 16 times larger than the average maximum concentration from a properly functioning Duragesic-75 patch, i.e. 1.7 ng/mL.

(Prausnitz Aff. ¶ 4(g), (i) (Ex. 2); see also Middleburg Aff. ¶ 6(c) (Ex. 6) (“The concentration of fentanyl detected is not consistent with that expected from the prescribed use of a properly functioning 75 ug/hr Duragesic® patch.); see also Middleburg Dep. at 81:12-22 (Ex. 10).) These opinions were echoed by Dr. J.C. Upshaw Downs, a physician and medical examiner for the State of Georgia, who opined that:

The only reasonable explanation for Janice DiCosolo’s death is that one or both of the Defective Patches delivered a greater than intended dose of fentanyl that caused her death. In my opinion, Janice DiCosolo died as the result of a fentanyl overdose caused by one or both of the Defective Patches, which administered a higher dose of fentanyl than they were designed to deliver.

(Downs Aff. ¶ 26 (Ex. 4); see also Leikin Aff. ¶31 (Ex. 3) (“The only reasonable explanation for Janice’s death is that one or both of the Defective Patches delivered a greater than intended dose of fentanyl that caused her death. In my opinion, Janice DiCosolo died as the result of a fentanyl overdose caused by one or both of the Defective Patches, which administered a higher dose of fentanyl than they were designed to administer.”).)

Michael Anisfeld, John’s pharmaceutical manufacturing expert, similarly testified that Janice’s patch suffered a “malfunction” that was “most likely due to a product defect.” (Anisfeld Aff. ¶ 72 (Ex. 5).) He further opined that “released units” of Duragesic patches, including the recalled lot containing Janice’s patch, “were not safe and effective for consumer use.” (Id. ¶ 71.) Further, according to Mr. Anisfeld, the Drug Companies were on notice of problems with their manufacturing process:

The company knew that the production process was incapable of consistently producing product but they kept trying to minimize the problems by inspecting and segregating pockets of each lot rather than stopping production and re-designing the process.

(Id. ¶ 55; see also id. at 60 (“the manner in which the product was manufactured in the period was unacceptable, and breached compliance with GMP regulations.”); id. ¶ 62 (“The process…was prone to regular and repeated break down; and was a process that produced an unacceptably high level of critical or major defects.”); id. ¶ 37 (“[i]t is my firm opinion that the batches of Duragesic manufactured were not safe and were not effective, and were manufactured under conditions that were noncompliant with GMP regulations…and must be considered adulterated as defined by the FDA.”).) The foregoing is more than enough evidence to show that the Duragesic patch failed to perform as expected and, thus, create a fact issue on the existence of a non-specific manufacturing or design defect.

3. John has produced evidence negating alleged secondary causes of Janice’s fatal postmortem fentanyl level.

 

The Drug Companies argue that Janice’s 28.2 ng/mL postmortem fentanyl blood level cannot serve as credible circumstantial evidence of a manufacturing defect because that level is not representative of her fentanyl level at the time of death. The Drug Companies cite to their pharmacology expert, who opines that Janice’s aspiration of stomach contents and postmortem rupture of her stomach “could” have increased the levels of fentanyl found in her blood above the level that existed at death. (The Drug Companies’ Mot. at 12.) As set forth more fully below, however, the evidence shows that neither the rupture of Janice’s stomach nor her aspiration of stomach contents is a reasonable secondary cause of the toxic fentanyl levels found at autopsy. Nor can the Drug Companies argue that Janice’s excessive fentanyl level was caused by postmortem redistribution or the combination of drugs in her system. Finally, the presence of the patch on Janice’s body from the time of death until her autopsy did not operate to increase her postmortem fentanyl level. Rather, the only reasonable explanation is that the 28.2 ng/ML level of fentanyl was caused by a manufacturing and design defect in the Duragesic patch.

a. The rupture of Janice’s stomach, and the aspiration of its contents, do not explain the fatal level of fentanyl found in Janice’s blood.

 

The Drug Companies argue that Janice’s stomach ruptured before her autopsy was performed and that this stomach rupture could have significantly increased the fentanyl levels in Janice’s blood above the levels that existed when she died. (Drug Companies’ Mot. at 12-13.) In support of this argument, the Drug Companies cite to their own expert, Gerhard Levy, who testified that a stomach rupture could increase postmortem fentanyl levels because gastric contents of fentanyl have been noted to be higher than blood fentanyl levels. (Levy Dep. 120-126 (Ex. 18).) The Drug Companies’ claim that John’s experts do not dispute that a stomach rupture could have a “possible impact” on postmortem findings; however, the Drug Companies conveniently ignore the testimony of Dr. Robert Middleburg, John’s toxicology expert, who stated that the rupture of Janice’s stomach had no measurable impact on her postmortem fentanyl levels.

Q: Did you consider, when analyzing this case, any effect that the postmortem rupture of the stomach and the fentanyl content in the stomach would have on the drug concentration?

A: I certainly considered the rupture of the stomach . . . the amount of fentanyl that I would expect to be circulating through what we would call backwash from circulating blood in the stomach contents would be very, very small. And if it were to enter the blood, I think the amount of increase in fentanyl you might see in that blood in the heart would probably not even be measurable.

(Middleburg Dep. at 96:6-97:2 (Ex. 10).) Dr. Middleburg’s deposition testimony is supported by the Affidavit testimony of John’s other experts. For example, John’s forensic pathology expert, Dr. J.C. Upshaw Downs, testified:

The fact that Janice DiCosolo’s stomach ruptured after death does not affect my opinion that Ms. DiCosolo received a much higher dose of fentanyl than a properly functioning 75 mcg/hour patch should provided. I do not believe that fentanyl was present in Janice DiCosolo’s stomach in any significant amount because Ms. DiCosolo received fentanyl from a transdermal patch. Therefore, unlike medications she took in pill form, I would not expect to see a significant amount of fentanyl in her stomach.

(Downs Aff. ¶16 (Ex. 4.)

The Drug Companies also cite to Dr. Levy, their own expert, in support of the argument that Janice’s aspiration of stomach contents at death also could have resulted in increased fentanyl levels. (Drug Companies Mot. at 13.) Yet Dr. Middleburg expressly refuted the idea that this could have measurably increased Janice’s postmortem fentanyl blood concentrations:

Q: If it is true that the aspiration affected the levels of the venlaxafine [sic] and the gabapentin . . . wouldn’t it be true that it would also affect the fentanyl level, since we’ve already said that fentanyl is in the gastric contents?

A: But, again…the amount of fentanyl in the stomach contents would be very, very minimal, and, again, perhaps not even measurable. . . . the only way it gets there is through [the] transfer of stuff flowing in and around the stomach, the blood flow, and whatever is able to get across the membrane and into the gastric contents, and then it gets diluted even further. That itty-bitty amount gets diluted even further in the gastric contents. So, ultimately, the amount [of fentanyl] that gets in there is very, very small.

(Middleburg Dep. at 143:18-144:24 (Ex. 10); see also Middleberg Aff. ¶ 10 (Ex. 6).)

The Drug Companies’ argument that Janice’s aspiration of stomach contents and rupture of her stomach caused an increase in her fentanyl blood levels is not supported by any concrete, dispositive evidence. But even if these events did in fact cause a postmortem increase Janice’s blood fentanyl levels, “the amount of increase . . . would probably not even be measurable.” (Id. at 96:23-97:2.) This is significant given that Janice’s fentanyl concentration of 28.2 ng/mL was 16 times higher than the normal range expected for someone properly using a 75 mcg/hour Duragesic patch. The only reasonable inference is that the patch malfunctioned due to a manufacturing or design defect, as stated by John’s experts.

b. Postmortem redistribution is not a reasonable secondary cause of the fatal level of fentanyl found in Janice.

 

The Drug Companies have also theorized that Janice’s blood fentanyl level at autopsy (28.2 ng/ML) is higher than her level was at the time of her death because of post-mortem redistribution (“PMR”). The Drug Companies have waived the PMR issue (for summary judgment purposes) by failing to raise it in their summary judgment brief. But, even if the Drug Companies had raised PMR, John’s experts have testified that PMR had no effect on their opinions that Janice’s fentanyl level was much higher than a properly functioning 75 mcg/hour Duragesic patch should have given her.

PMR is a well-recognized phenomenon in forensic toxicology. It refers to changes in the concentrations of toxicants in various regions of the body that occur postmortem. Specifically, after death, many substances will “leach” out of body tissues and pool in certain anatomical sites, the most common of which is the heart. The result is that blood collected at or near the heart during autopsy may have concentrations of substances that exceed the concentrations that existed in circulating blood at the time of death. (Leikin Aff. ¶ 24 (Ex. 3); Downs Aff. ¶ 15 (Ex. 4); (Middleburg Aff. ¶ 11 (Ex. 6); Middleburg Dep. at 97:11-99:1, 106:15-112:2 (Ex. 10).)

To assess a particular drug’s propensity to redistribute postmortem, doctors and scientists compare the concentrations of the drug in the heart to concentrations of the drug in peripheral blood vessels (typically in the femur), where PMR is assumed to occur only nominally or not at all. (Middleburg Dep. at 111:1-112:3 (Ex. 10).) Studies on fentanyl demonstrate that it is subject to, at most, modest postmortem redistribution. (See, e.g., Leikin Aff. ¶ 24 (Ex. 3) (“the amount of PMR that occurs with fentanyl is relatively small compared with other drugs, such as antidepressants.”); see also Leikin Dep. at 109:14-16 (Ex. 14) (wherein Leikin testifies that postmortem redistribution of fentanyl occurs only to a “minor extent,” if at all.).) This opinion is shared by Dr. Downs:

There is no evidence that PMR occurred in this case. Even if PMR occurred, data on the ratio between postmortem heart blood (which is thought to be susceptible to PMR) and femoral blood (which is thought to be much less susceptible to PMR) suggest that the ratio between postmortem and antemortem fentanyl levels is, on average, 1.2. Therefore, the possibility that PMR may have occurred in this case does not affect my opinion that Janice DiCosolo received a much higher dose of fentanyl than a properly functioning 75 mcg/hour patch should have provided.

(Downs Aff. ¶ 15 Ex. 4) (; see also Leikin Aff. at ¶25 (Ex. 3) (“Data on the ratio between postmortem heart blood (which is thought to be susceptible to PMR) and femoral blood (which is thought to be much less susceptible to PMR) suggests that the ratio between postmortem and antemortem fentanyl levels is, on average, 1.2. Therefore, PMR does not affect my opinions that Janice DiCosolo received a much higher dose of fentanyl than a properly functioning 75 mcg/hour patch should have provided or that she died from fentanyl poisoning. As I stated in my deposition, Janice DiCosolo’s fentanyl level was far too high to be explained by PMR.”).)

According to other experts, a close scrutiny of the clinical data regarding PMR with fentanyl reveals a “mean ratio close to unity, i.e. 1.0” (Middleburg Aff. ¶ 13 (Ex. 6).) As such, one cannot state with any reasonable degree of scientific certainty that PMR of fentanyl actually occurred in the case of Janice. According to Dr. Middleburg, “the concentration of fentanyl found in peripheral blood (considered an accurate reflection of circulating concentrations at or around the time of death) is actually greater than the concentration found in heart blood.” (Id.) But even if a 1.6 PMR ratio were applied to Janice’s fentanyl level of 28.2 ng/mL, it would yield a hypothetical antemortem (pre-death) fentanyl level of 17.6 ng/mL—which is still over five times higher than a fatal level, and over ten times higher than a properly functioning 75 mcg/hour Duragesic patch should provide. The evidence shows that postmortem redistribution is simply not a reasonable secondary cause of Janice’s excessively and fatally high fentanyl level.

c. Postmortem diffusion of fentanyl is not a reasonable secondary cause of Janice’s postmortem fentanyl level.

 

The Drug Companies have also speculated that Janice’s elevated fentanyl levels were caused by postmortem diffusion of fentanyl from the Duragesic patch to the central compartments of her body (where the blood was drawn at autopsy) after her death. The Drug Companies have waived the patch diffusion issue (for summary judgment purposes) by failing to raise it in their summary judgment brief. But, even if the Drug Companies had raised patch diffusion, John’s experts disagree, creating a disputed fact issue for trial.

John’s toxicology expert, Dr. Middleburg, testified that postmortem patch diffusion would have had no measurable effect on the level of fentanyl found in Janice’s blood:

Q: Do you believe that the fentanyl patch, the Duragesic patch, continues to diffuse fentanyl into the body after death?

A: I think there might be some local diffusion. But I think it’s a self-limiting process.

Q: So you don’t believe that it makes its way to any capillaries in the tissue and can then make its way to larger blood vessels?

A: I haven’t seen any reports of that…I would think it’s difficult for that to happen, since there is no active blood flow whisking the blood away or whisking the concentration of the stuff and taking it to the general circulation.

(Middleburg Dep. at 46:7-47:6 (Ex. 10); see also Middleburg Aff. ¶15 (Ex. 6) ([There is] no independent means of confirming such postmortem movement of the fentanyl…. [P]ostmortem, there would be no active blood flow to carry fentanyl from the subcutaneous tissues to the general circulation, including the heart.”).) Dr. Middleburg’s opinions are echoed by Dr. Downs:

Moreover, the fact that a 75 mcg/hour Duragesic patch remained on Janice DiCosolo’s body until the autopsy does not affect my opinion that Janice DiCosolo received a much higher dose of fentanyl than a properly functioning 75 mcg/hour patch should have provided. Even if some of the fentanyl remaining in the patch could have diffused out of the patch after death into the subcutaneous tissues (something not established by scientific data or studies I am aware of), any such diffusion would have had no measurable effect on the fentanyl level measured in Janice DiCosolo’s heart blood because there would have been no blood circulation to carry it there.

(Downs Aff. ¶ 17 (Ex. 4).) The expert opinions of Drs. Downs and Middleburg constitute sufficient evidence that postmortem diffusion is not a reasonable secondary cause of Janice’s elevated fentanyl levels.

d. The combination of drugs found in Janice’s blood did not cause her fatal fentanyl level.

 

The Drug Companies also speculate that the combination of drugs found in Janice’s body contributed to her death by inhibiting her ability to metabolize fentanyl, thereby raising her blood fentanyl to lethal levels and causing her death. John, however, has sufficient evidence to the contrary. According to Dr. Middleburg “there is no evidence that [Janice] suffered from any deficiency in her ability to metabolize fentanyl.” (Middleburg Aff. ¶ 17 (Ex. 6).) “There is no reported issue with any of the drugs [Janice] was taking as inhibiting the metabolism of fentanyl. The package insert for Duragesic references several medications which potentially may inhibit the metabolism of fentanyl, but none of the medications found in Ms. DiCosolo’s system are among them.” (Id.); see also Middleburg Dep. at 60:1-61:13, 73:20-81:7 (Ex. 10).)

Janice had been prescribed the medications found in her system for at least one year prior to her death, and other drugs for an even greater period of time. During this period, there is no indication that she suffered significant adverse pharmacokinetic or pharmacodynamic interactions. Thus, it is unlikely that, at and around the time of her death, such interactions would have occurred spontaneously. (Id.) Dr. Leikin agrees:

I do not believe that Janice DiCosolo’s metabolism had anything to do with her excessive fentanyl level because such a metabolism issue is very rare and would have occurred right away. Janice DiCosolo had been taking the drugs found in her system together for some time, as indicated above. If she had a problem metabolizing the drugs, any problems would have occurred right away. The fact that such problems did not occur early on (or, for that matter, at any point) leads me to believe that metabolism problems did not have any impact on Janice DiCosolo’s excessive fentanyl level or her resulting death.

(Leikin Aff. ¶ 26 (Ex. 3); Leikin Dep. at 114:6-15 (Ex. 14); see also (Downs Aff. ¶ 23 (Ex. 4) (“The other medications found in Janice DiCosolo’s blood were all safe medications and it was not dangerous for Ms. DiCosolo to take these medications together.”).) These opinions constitute sufficient summary judgment evidence that the other medications found in Janice’s blood are not a reasonable secondary cause of Janice’s excessive fentanyl level.

e. Janice’s 28.2 ng/mL fentanyl level is both reliable and admissible as evidence of a defect.

 

As a last resort, the Drug Companies contend that Janice’s 28.2 ng/mL fentanyl level cannot serve as circumstantial evidence of a product defect because it cannot be regarded as an accurate measure of Janice’s postmortem fentanyl level until the parties “settle” the reliability of the toxicology calibration records. (Drug Companies’ Mot. at 14.) By “settle,” the Drug Companies surely mean that they need more time to collect testimony from their hired experts, which they hope will undermine the reliability of the toxicology data and enable the Drug Companies to proffer some colorable basis for arguing that Janice’s 28.2 ng/mL level should be disregarded. Yet the Drug Companies have thus far failed to do so; and, in any case, they already raised this issue in a Motion to Exclude the fentanyl toxicology results, which they withdrew (after John moved to strike it) because it is factually and legally baseless for the reasons set forth below.

First, the Drug Companies are in full possession of the calibration and control data for the fentanyl testing performed on Janice’s blood at the Cook County Medical Examiner’s Office (“M.E.”), as well as the SOPs that were in effect at the time the tests were conducted. (See Business Records Aff. (Ex. 9) (attaching the relevant calibration, controls, and SOPs).) John has also produced expert testimony that records provided by the Medical Examiner’s office are sufficient for a reasonable toxicologist to rely on the Medical Examiner’s toxicology report with a reasonable degree of scientific certainty. (See Middleberg Aff. ¶ 19 (Ex. 6); Leikin Aff. ¶ 17 (Ex. 3).) As such, John has provided foundational evidence concerning the reliability of the fentanyl testing results, and 28.2 ng/mL can be regarded as an accurate measure of Janice’s postmortem fentanyl levels.

Second, under 725 Ill. Comp. Stat. 5/115-5.1, the Medical Examiner’s records relating to medical examinations and/or autopsies of deceased persons—including toxicology reports—must be received as competent evidence and are admissible as prima facie evidence of the facts stated therein:

In any civil or criminal action the records of the coroner’s medical or laboratory examiner summarizing and detailing the performance of his or her official duties in performing medical examinations upon deceased persons or autopsies, or both, and kept in the ordinary course of business of the coroner’s office, duly certified by the county coroner or chief supervisory coroner’s pathologist or medical examiner, shall be received as competent evidence in any court of this State, to the extent permitted by this Section. These reports, specifically including but not limited to the pathologist’s protocol, autopsy reports and toxicological reports, shall be public documents and thereby may be admissible as prima facie evidence of the facts, findings, opinions, diagnoses and conditions stated therein.

725 Ill. Comp. Stat. 5/115-5.1. (emphasis added). Put simply, the toxicology report and Janice’s fentanyl level are admissible because 725 Ill. Comp. Stat. 5/115-5.1 requires admission of toxicology reports as public records. Steward v. North American Van Lines, Inc., 289 Ill. App. 3d 66, 72-74, 681 N.E.2d 1040, 10443-45 (Ill. App. Ct. 1997).

Finally, even if the fentanyl results were not admissible by statute, any alleged deficiencies in the toxicology report would go to the weight—not the admissibility—of the evidence. See Woolley v. Hafner’s Wagon Wheel, Inc., 22 Ill. 2d 413, 419, 176 N.E.2d 757, 760 (Ill. 1961) (any alleged discrepancies in the testimony about the adequacy of a blood alcohol test “goes to the weight to be accorded to the evidence, not its admissibility”); Przislicki v. City of Chicago, 212 Ill. 3d 661, 669-70, 571 N.E.2d 762, 767-68 (Ill. App. Ct. 1991) (same). If the Drug Companies believe that there are any problems with the Medical Examiner’s fentanyl testing, they can raise their concerns through the normal cross-examination process at trial.

II. There Is Evidence of a Specific Defect.

As seen above, John has substantial evidence of a non-specific defect. John also has direct and circumstantial evidence of a specific defect to the patch. As stated above, Janice’s husband actually saw a slick film (which John’s experts believe is fentanyl gel) on Janice’s skin prior to her death. Additionally, the patches Janice used came from a recalled lot of defective, leaking patches that were manufactured under poor standards of quality control and contrary to Good Manufacturing Practices. These facts provide ample evidence of a specific manufacturing and/or design defect to defeat the Drug Companies’ motion for summary judgment.

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

 

The fact that John saw a slick film on Janice’s skin under the patch he removed from Janice the night she died (which the Drug Companies fail to address in their brief) is direct evidence that Janice used a leaking patch, which, according to John’s experts, is the most reasonable explanation for her death. According to John, Janice’s customary practice was to apply one patch at a time, change her patch every three days and keep track of this schedule on a calendar. (DiCosolo Aff. ¶ 3 (Ex. 1).) Janice frequently received the assistance of her husband, who helped remove and discard used patches, replacing them with new patches to various areas on Janice’s body. (See id. ¶ 4.) On the evening before Janice’s death, John removed Janice’s used patch. (See id. ¶¶ 12-13.) He observed that the patch was unusually easy to remove and noticed a slick film on Janice’s skin underneath the area that had previously been covered. (See id.)

According to John’s transdermal drug expert, Dr. Mark Prausnitz, the presence of this slick substance is “consistent with a leaking patch.” (Prausnitz Aff. at ¶ 26 (Ex. 2).) John’s pharmaceutical manufacturing expert, Michael Anisfeld, agreed:

In light of the fact that leaking patches were regularly being produced by the Drug Companies during this timeframe, the “sticky substance” stated by her husband as being on her skin, was in my opinion most likely the result of a leaking patch. As such, the patches manufactured during this timeframe could hardly be considered safe, and thus were not in accord with GMPs.

(Anisfeld Aff. at ¶ 73 (Exhibit 5).) The foregoing constitutes direct evidence that Janice’s patch was “leaking” fentanyl onto her skin in the hours prior to her death. Based on this evidence, John’s transdermal expert, Dr. Mark Prausnitz, has opined that the most reasonable explanation for Janice’s death is a leaking patch. (Prausnitz Aff. at ¶ 4(i) (Ex. 2); see also Leiken Aff. ¶¶ 18, 31 (Ex. 3) (Janice’s fentanyl poisoning is consistent with a leaking patch); REDACTED.

Instead of addressing John’s direct evidence of a leaking patch, the Drug Companies focus on the fact that a physical examination of a different patch (i.e. the patch found on Janice’s body when she died) years after the occurrence showed no visible defect. But as explained by Michael Anisfeld, the condition of the patch was such that a physical examination years after Janice’s death could neither establish nor rule out a defect:

I reviewed a picture of the patch worn by Janice DiCosolo at the time of her death. The condition of the patch appeared to have been negatively affected by the passage of time and manipulation by individuals involved in the autopsy and/or who inspected the patch. Therefore, in my opinion, it is not possible to state with a reasonable degree of scientific certainty whether or not the patch found on Ms. DiCosolo’s body suffered from a physical defect at the time of Ms. DiCosolo’s death.

(Id. ¶ 74.) Because the Drug Companies have not shown that the condition of the patch at the time of its examination was the same as the condition of the patch at the time of Janice’s death, the relevance of their argument is questionable at best. And the Drug Companies suggestion that the absence of a visible defect years later proves that there was no defect when the patch killed Janice is belied by the undisputed fact that the patch did not perform as designed and intended—leading to an elevated fentanyl level 16 times higher than normal—and the fact that John observed a slick film on his wife after removing the companion patch she wore prior to putting on her final patch.

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

 

The last two patches Janice used were among the lots included in an February 17, 2004, Urgent Class 1 Recall Notification issued by the Drug Companies after several patches in those lots were discovered to contain a defect known as a “fold-over defect” that caused affected patches to leak medication. (See Urgent Class 1 Drug Recall Notification Patient Level (Ex. 29).

REDACTED

The fact that Janice’s patches came from this recalled lot of defective, leaking patches is circumstantial evidence that her patch contained a specific defect. See, e.g., Bramlette v. Hyundai motor Co., No. 91 C 3635, 1992 U.S. Dist. LEXIS 17959 at *8-9 (N.D. Ill. 1992) (denying motion in limine to exclude evidence of recall because evidence was potentially probative of existence of defect and noting that “evidence of prior occurrences may be admissible to show the dangerousness of a product); Millette v. Radosta, 404 N.E.2d 823, 834 (Ill. App. 1980) (court found that recall letter was properly admitted as some evidence of defect); Hessen v. Jaguar Cars, Inc., 915 F.3d 641, 649 (11th Cir. 1990) (“Because Allstate met its burden of providing evidence that the defect alleged was the same defect involved in the recall campaign, the trial judge did not abuse his discretion in admitting the recall evidence, and the jury properly could have considered it.”).

Additional evidence that the Duragesic pain patches were defective includes the repeated quality control and quality assurance problems the Drug Companies experienced throughout 2003 and 2004, which are discussed in detail by John’s pharmaceutical manufacturing expert, Michael Anisfeld. (See, e.g., Anisfeld Aff. ¶ 60 (Ex. 5) (“the manner in which the product was manufactured in the period was unacceptable, and breached compliance with GMP regulations”); (Id. at ¶ 62) (“The process…was prone to regular and repeated break down; and was a process that produced an unacceptably high level of critical or major defects.”); (Id. ¶ 37) (“The inspection process and sampling plans were not valid in preventing units with critical defective units from being released to consumers.”).) Anisfeld further opined that the patches released to the market by the Drug Companies “contain[ed] critical and major defects in product quality” and were not safe and effective for consumer use. (Id. ¶ 71.) “The sampling and inspection process[es] utilized by the company were unable to prevent elimination of these patient health-threatening deficiencies and these batches should never have been released.” (Id. ¶ 71.) According to Anisfeld, the patch on Janice at the time of her death suffered a “malfunction” that “was most likely due to a product defect . . . .” (Id. ¶ 72.)

III. The Drug Companies Are Not Entitled to Summary Judgment on John’s Design-Defect Claim.

 

A. There is sufficient evidence of a design defect.

The Drug Companies argue that John has no evidence to support a design defect. 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). For the reasons discussed below, John has sufficient evidence to create a fact issue for trial under both tests.

1. There is ample evidence to create a fact issue for trial on John’s design-defect claim under the consumer expectation test.

 

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 “John 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 the 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. Johns do not need to present expert testimony to establish a prima facie case; they may rely on their own testimony.”).

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. (See supra at pp. 14-18.) Janice received a dosage of fentanyl that was over sixteen times higher than would be expected if the Duragesic patch performed in a reasonable manner in light of its intended function. A fentanyl blood level of 28.2 ng/mL “should never be achieved . . . a patch that produces this high level of fentanyl is most probably defective.” (Prausnitz Aff. ¶¶ 4(g) (Ex. 2); see also Middleburg Aff. ¶19 (Ex. 6) (“[I]t can be stated with a reasonable degree of scientific certainty that Janice had a concentration of fentanyl in her blood in excess of that expected from a properly functioning 75 ug/hr Duragesic® patch.”); Middleburg Dep. at 81:12-22 (Ex. 10); Downs Aff. ¶12 (Ex. 4) (“A properly functioning 75 mcg/hour Duragesic patch should not produce a fentanyl level higher than 3 ng/ML.’); Leikin Aff. ¶ 15 (Ex. 3) (a properly functioning 75 mcg Duragesic patch should not produce a fentanyl level higher than 4 ng/ML).) This is compelling evidence that Janice’s fentanyl level of 28.2 ng/mL was well outside the normal range expected for someone properly using a 75 mcg/hour Duragesic patch. It is also irrefutable that it killed her. John has clearly raised an issue of fact regarding whether Janice’s Duragesic patch “failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner.”

2. There is ample evidence to create a fact issue on John’s design-defect claim under the risk-utility test.

John also has sufficient evidence to create a fact issue for trial under the risk-utility test. Under the risk-utility test, a plaintiff may demonstrate that a product is unreasonably dangerous because of a design defect by presenting evidence of an alternative product design that would have prevented the injury and is “feasible” in terms of cost, practicality and technological possibility. Hansen v. Baxter Healthcare Corp., 198 Ill. 2d 420 (2002); Mikolajczyk v. Ford Motor Co., 369 Ill.App.3d 78 (2006). To be feasible, the alternative product design must be economical, practical, and effective. Moss v. Wolohan Lumber Co., 1995 U.S. Dist. LEXIS 8854 (N.D. Ill. 1995). The inquiry should be whether the alternative design would eliminate the product’s usefulness; whether its costs would be prohibitive; and the balancing of these factors against the seriousness of the potential harm. Lease by Lease v. Int’l Harvester Co., 174 Ill. App. 3d 897 (Ill. App. 4th Dist. 1988). Evidence of feasibility is not limited to economy, effectiveness and practicality, but it also includes “technological possibilities under the state of the manufacturing art at the time the product was produced.” Kerns v. Engelke, 76 Ill. 2d 154 (1979). Evidence of alternative designs is therefore admissible “if the design alternative was available at the time the defendant’s product was manufactured and sold.” Id. at 164. John has presented more than sufficient evidence of a safer alternative design to Duragesic.

John’s expert, Dr. Mark Prausnitz, has testified that the Drug Companies could have manufactured Duragesic Patches using the “matrix” system, in which fentanyl is actually incorporated into the adhesive of the patch instead of being encased in a gel reservoir. Under normal operation, the reservoir and matrix designs are equally good. (Prausnitz Aff. ¶ 31 (Ex. 2).) REDACTED. Yet, according to Dr. Prausnitz, the matrix-type patch is a safer alternative design to the reservoir-type patch.

The reservoir system of the Duragesic patch is dangerous, because drug can leak if the patch malfunctions, which can cause a drug overdose. Similar fentanyl patches that utilize the matrix design cannot leak and therefore do not pose this risk. Such safer designs have been under development at ALZA for many years, represented a feasible commercial alternative at the time of the Janice’s death, and would have eliminated the risk of catastrophic patch failure due to leakage.

(Prausnitz Aff. ¶ 4(h) (Ex. 2).) The advantage of the matrix design is widely recognized. In fact, in Defendant ALZA’s very own Citizen Petition to the FDA, they stated that “matrix products do afford some advantages over reservoir products in terms of cosmetics, adhesion and eliminating the possibility of gel leakage.” (Id. ¶ 29 (emphasis added).)

Furthermore, the matrix design has been in existence for many years and is in widespread use for fentanyl delivery in the United States and around the world. Many drugs are delivered using matrix-design patches and the system has been available in the United States since the 1980s. (See id. ¶ 30.)

REDACTED

The Drug Companies filed a patent application for a matrix-type fentanyl patch on March 16, 2001 (Id. at 116:12-119:20). In their application for a patent, the Drug Companies stated that they had developed a matrix-type fentanyl patch that worked. (Id. at 139:4-140:24). At the time the application was filed, the matrix patch was already in the “pilot stage”—meaning that the Drug Companies had manufactured fentanyl patches with a matrix system of delivery. (Id. at 120:10-121:8). REDACTED.

A competitor of the Drug Companies, Mylan, developed their own matrix fentanyl patch in 2002, but before Mylan could sell the patch, they had to overcome the Drug Companies patent. (Id. at 168:16-169:2; 171:17-172:6) As soon as the Drug Companies became aware of plans to develop and sell a fentanyl matrix patch, they filed suit alleging, inter alia, patent infringement. (Id. at 172:10-17). The Drug Companies were successful in their suit, and Mylan was prohibited from selling the matrix fentanyl patch until 2005. (Id.) Taken together, this clearly constitutes sufficient, reliable evidence that a safer alternative design was available as an alternative to the reservoir-type patch that killed Janice.

The Drug Companies argue that Prausnitz’s testimony regarding the safety of the matrix patch is “irrelevant” because the FDA did not give final approval for a matrix-design fentanyl patch for use in the United States until 2005, after Janice died. In a strict-liability setting, if the plaintiff introduces evidence that a reasonable alternative design could have been practically adopted, a trier of fact may conclude that the product was defective—even if the proposed design was not adopted by any manufacturer, or even considered, at the time of sale. Blue v. Envtl. Eng’g, Inc., 215 Ill. 2d 78, (2005) citing Restatement (Third) of Torts: Products Liability Sec. 2, Comment d, at 19. As seen above, John has substantial evidence that the matrix fentanyl patch could have been practically adopted by the Drug Companies. The matrix design was available—and in use—at the time Duragesic was manufactured and sold to Janice. The Drug Companies had intellectual property rights in the design of (and the equipment needed to manufacture) matrix fentanyl patches. The Drug Companies had actually manufactured thousands of matrix fentanyl patches in 2001 and filed lawsuits to prevent others from doing the same. The simple fact that the Drug Companies chose not to seek FDA approval (and instituted litigation to prevent their competitor Mylan from selling a matrix patch) has no bearing on whether the matrix delivery system was, in fact, a safer alternative design. (See id. ¶ 30.)

The Drug Companies also argue that Prausnitz’s testimony is insufficient evidence of a design defect because he “does not dispute that an intact, sealed reservoir patch is safe and effective.” (See The Drug Companies’ Mot. at 18.) This entirely misses the point of Prausnitz’s opinion, which is that, even assuming that a perfectly intact patch would not leak, the reservoir patch design is inherently subject to leakage and, therefore, inherently unsafe.

Q: So would you agree with me . . . that the criticism about reservoir patches being inferior under the situation of a leak has nothing to do with the actual patch design?

A: I wouldn’t agree with that. And the reason I wouldn’t agree is because, as we have seen based on recalls of lots, that this patch design seems to be inherently difficult to manufacture and is apparently inherently prone to having defects.

(Prausnitz Dep. at 193:21-194:7 (Ex. 11).) Elsewhere in his deposition, Prausnitz testified that “[t]he reservoir design itself is going to lend itself to the possibility of leakage . . . . So, in a sense the design of the device has set the manufacturing folks up for failure because, as hard as they may try, the manufacturing process is going to be susceptible to failure.” (Id. at 198:4-25.)

B. Comment k does not bar John’s design-defect claim.

 

The Drug Companies contend that John’s design-defect claim is barred because Duragesic is an “unavoidably unsafe product” under Comment k to Section 402A of the Restatement (Second) of Torts. (Drug Companies’ Mot. at 14-16.) The Drug Companies are wrong for several reasons. First, Illinois courts have not held that all prescription 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.”).

Second, comment k is an affirmative defense. Therefore, the Drug Companies have the burden to prove on this defense. Glassman, 606 N.E.2d at 343 (“[A] defendant has the burden to demonstrate that a product comes under comment k’s protection.”) To meet this burden, the Drug Companies must show that Duragesic is “incapable of being made safe for its intended use.” Restatement (Second) of Torts § 402A, Comment k. The Drug Companies have wholly failed to meet this burden. In fact, they have not even attempted to do so. The Drug companies have not designated a single expert on this issue and their motion is devoid of any evidence that Duragesic is “unavoidably unsafe.” (See generally Drug Companies’ Mot.)

Third, the Drug Companies have misstated the test for an “unavoidably unsafe” product. In their brief, the Drug Companies assert that:

Although the risk of respiratory depression when using Duragesic® can be managed through the proper medical management – proper supervision by the prescribing physician, selection of appropriate does, and adjustment of concurrent medications – it cannot be entirely eliminated. Respiratory depression is an inherent side effect of all opioid medication. Stated differently, the only way to eliminate the risk of respiratory depression for drugs like Duragesic is to eliminate their use altogether.

(The Drug Companies’ Mot. at 15 (emphasis added).) But this misses the point. John 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, John has alleged that Duragesic is unreasonably dangerous because it does not provide a steady and reliable dose of fentanyl but, rather, is 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 fentanyl itself. The Drug Companies’ comments about “all opioid medications” and “drugs like Duragesic” conflate the two and misstate the fundamental basis of John’s design-defect claim.

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.”). Here, John has offered expert testimony that Duragesic is not an unavoidably unsafe product because the Drug Companies could take various steps to make it safe:

I understand that the manufacturer contends that Duragesic is an “unavoidably unsafe” product. This statement needs to be analyzed at two levels. The first question is whether a properly functioning Duragesic patch (i.e, one producing blood fentanyl levels as indicated in the package insert) is unavoidably unsafe. The second question is whether the intermittent occurrence of an improperly functioning Duragesic patch, such as due to gel leakage from the patch, is also unavoidably unsafe. Clearly the risks associated with the second scenario are much greater and, in my opinion, are avoidable. For example, they can be avoided by better manufacturing processes and quality control that prevent production of defective patches and prevent their release to patients, as discussed in the FDA’s post-recall findings and in Mr. Anisfeld’s expert report. They can be avoided by an improved patch design that would avoid leakage of gel. They can be avoided by an improved patch design that does not contain gel and therefore is incapable of leaking, such as in a matrix design patch. Thus, the Duragesic patch, with its demonstrated susceptibility to defective operation, is not unavoidably unsafe.

(Prausnitz Aff. ¶33 (Ex. 2).) At most, then, the Drug Companies have raised a fact issue as to whether Duragesic is an “unavoidably unsafe” product that must be resolved by the trier of fact.

Fourth, even if the Court assumed that Duragesic was “unavoidably unsafe” and that Comment k therefore applied, it would not have the preclusive effect the Drug Companies 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 IV below, there are disputed issues of fact as to whether the Drug Companies 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 fact issues preclude summary judgment on the Comment k defense.

IV. There is Ample Evidence to Support John’s Warnings Claims.

A. The evidence supports John’s 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).

1. The adequacy of the Drug Companies’ warnings is an issue of fact for the jury.

The Supreme Court of Illinois has instructed that “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 (2002); See also 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.”). Here, a clear issue of fact exists to preclude the granting of the Drug Companies’ Motion. As set forth below, there is ample evidence that the Drug Companies knew or should have known about the risks and dangers of Duragesic, yet failed to properly warn about those risks.

a. The Drug Companies knew of the risks of using Duragesic when ithey sold the patch to Janice.

 

The Drug Companies were aware of the risks associated with using defective and non-defective patches at the time they sold Duragesic to Janice. First, the evidence shows that the Drug Companies knew or should have known that users of a non-leaking 75 mcg/hour Duragesic patch would receive doses of fentanyl that would significantly diverge from the stated mean maximal concentration (“MMC”) of 1.7 ng/mL due to normal variations in skin permeability and/or the presence of fissures or abrasions in the skin. A 1990 study at the University of Michigan found that human skin’s permeability to fentanyl varied 5.8 fold. (Prausnitz Aff. ¶13 (Ex. 2).) Another study at the University of Southern Denmark in 2003 showed a 5.0-fold variability in skin permeability to fentanyl. Id. Finally, a 1994 study from the University of Michigan showed that human skin lacking a stratum corneum (outermost skin layer) has a 67-fold higher permeability to fentanyl compared to intact skin. (Prausnitz Aff. ¶14 (Ex. 2).) These variations in permeability result in the administration of fentanyl in amounts significantly above the stated MMC of 1.7 ng/mL.

The Drug Companies also knew (or should have known) that probable excessive fentanyl doses resulting from variations in skin permeability could cause death. Fentanyl is a highly toxic substance that is approximately 80 to 100 times stronger than morphine by weight. Leikin Aff. ¶9 (Ex. 3); Downs Aff. ¶6 (Ex. 4).) As such a powerful narcotic, fentanyl has a narrow therapeutic band, which means that the difference between a therapeutic dose and lethal dose of fentanyl is very small. (Leikin Aff. ¶11 ; (Ex. 3); Downs Aff. ¶8 (Ex. 4).) Fentanyl has proven lethal at concentrations as low as 3.0 ng/mL and, according to the primary text used by pathologists and health professionals to ascertain lethal levels of medications, the fatal level of fentanyl averages 8.3 ng/ml. (Prausnitz Aff. ¶ 5 (Ex. 2); Downs Aff. ¶ 20 (Ex. 4); Leikin Aff. ¶ 18 (Ex. 3) (citing R. Baselt, Disposition of Toxic Drugs and Chemicals in Man, pg. 452 (7th Ed. 2004) (Ex. 40).) Variations in skin permeability can therefore cause increased fentanyl absorption in some individuals that may result in death. (Prausnitz Affidavit ¶16 (Ex. 2) (“The lethal threshold [of fentanyl] may be achieved by an above-average skin permeability due to inherent skin variability [or] due to a nick or abrasion to the stratum corneum.”).)

REDACTED

The Drug Companies also knew (or should have known) that use of a leaking patch would be more likely to result in death of the patch user. There is substantial evidence showing that a leaking patch will result in increased fentanyl absorption. According to Dr. Prausnitz,

The stratum corneum is the outer layer of the skin that controls the rate of dermal absorption of fentanyl in the absence of the rate-controlling membrane. In the case of a defective Duragesic patch, the fentanyl formulation can come out of the patch housing and make direct contact with the skin…. Simply removing the rate controlling membrane should at least double the fentanyl delivery rate for skin with average permeability…loss of the rate-controlling membrane significantly increases the fentanyl delivery rate.

(Prausnitz Aff. ¶¶10-12 (Ex. 2); see also Prausnitz Aff. ¶8 (“…the rate controlling properties of a non-defective patch can be significant and a loss of those properties can dramatically increase the fentanyl delivery rate.”); Prausnitz Aff. ¶ 15 (Ex. 2) (“Upon leaking out of the patch, fentanyl gel can spread over skin areas…which would increase fentanyl absorption by 3.3 to 33-fold relative to delivery from a 30 cm2 patch.”).) Dr. Leikin also testified, “[o]ne possible way for a Duragesic fentanyl patch to administer more fentanyl than intended is a leaking patch.” (Leikin Aff. ¶ 13 (Ex. 3).) There is also substantial evidence that increased absorption of fentanyl can cause death. If the Duragesic patch administers more than the intended dose of fentanyl, the excess dose can cause fentanyl toxicity and/or poisoning, which can lead to death. (Leiken Aff. ¶¶ 10, 12 (Ex. 3); Downs Aff. ¶¶ 7, 9 (Ex. 4).)

It is my opinion, to a reasonable degree of medical certainty, that fentanyl gel on the skin can lead to a fentanyl overdose. In my practice as a medical toxicologist, if a patient told me that she had a gel-like substance on her skin from a fentanyl patch, I would suspect that the patient received a toxic dose of fentanyl. In fact, I have treated patients as a clinical toxicologist who reported getting fentanyl gel on their skin and exhibited signs of fentanyl toxicity. This further supports my belief that a patient can receive a toxic dose of fentanyl by getting fentanyl gel on their skin.

(Leiken Affidavit ¶ 13 (Ex. 3); see also, Prausnitz ¶ 4(h) (Ex. 2) (“The reservoir design of the patch is dangerous, because drug can leak if the patch malfunctions, which can cause drug overdose.”).)

Finally, and most importantly, the Drug Companies themselves claim that Duragesic is an “unavoidably unsafe” drug because it “carries a risk of respiratory depression that can lead to respiratory failure and death.” (The Drug Companies’ Mot. at 14-16 (emphasis added).) The Drug Companies’ own expert, Dr. Gerhard Levy, testified that the risk of death from using powerful opioids is the management of chronic pain is “substantial.” (Levy Dep. at 30:17-25) (Ex. 18).) Based on all of the above, the Drug Companies clearly had knowledge that the use of Duragesic carried with it a risk of death.

b. The Drug Companies failed to warn of the risk of death in using Duragesic when they sold the patch to Janice.

 

It is undisputed that the Drug Companies did not warn of the risk of death associated with Duragesic’s use at the time they sold the offending patches to Janice. It was not until after Janice’s death that Defendants modified the warnings in the package insert to warn that fentanyl gel from cut or damaged Duragesic patches “can lead to the rapid release of the contents of the Duragesic patch and absorption of a potentially fatal dose of fentanyl.” (See 2005 Duragesic Package Insert (Ex. 33) (emphasis added).) This warning was placed in the “black box” section of the revised package insert, as well as the “Description,” “Warnings,” “Precautions,” “Drug Abuse and Addiction,” “Dosage and Administration,” and “How Supplied” sections of the insert. Furthermore, in June, 2005, Janssen issued a “Dear Doctor” letter, which it captioned as an “IMPORTANT DRUG WARNING.” (See Janssen June 2005 letter (Ex. 39).) In that warning letter, Janssen identified “important changes in the prescribing information for Duragesic. (Id.); see also July 2005 FDA Public Health Advisory (Ex. 38) (“In June 2005, the Duragesic product label was updated to add new safety information in several areas of labeling.”).) In December 2007, the FDA issued a second Public Health Advisory regarding the Duragesic patch, 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 (Ex. 38a).)

None of this information pertaining to the risk of death associated with the use of Duragesic was included in any warning issued by the Drug Companies when they sold the patch to Janice. Because the evidence shows that the Drug Companies knew of the risk of death and, yet, completely failed to warn of that risk, summary judgment on John’s failure to warn claims should be denied.

2. Expert testimony is not needed to prove John’s failure-to-warn claims because the adequacy of The Drug Companies’ warnings are within the comprehension of a lay person.

 

The Drug Companies argue that they are entitled to summary judgment on Plaintiff’s “failure to warn” claims because the adequacy of a warning must be established by expert testimony and Plaintiff lacks expert testimony that Duragesic’s warnings were inadequate. In support, the Drug Companies cite to Northern Trust Co. v. The Upjohn Company, 213 Ill. App. 3d 390 (1991). Northern Trust Co. was a products liability case where a woman was given a prescription medication called “Prostin” at the hospital during an abortion procedure. The drug caused her to fall into cardiac arrest and suffer a brain injury. In addressing the question of whether expert testimony is necessary to support a claim for failure to warn, the Court reasoned that:

Expert testimony shall be necessary and proper in a case, such as the one at bar, where a drug manufacturer’s liability for a prescription drug is based upon its failure to provide adequate warnings. We note, however, that our decision, as in the cases cited above, is limited to those instances where the inadequacy of the warning is not so obvious that a lay person could not so readily understand the insufficiency of the warning. [We must] consider whether expert testimony [is] required …or whether the alleged failure to warn was of a type that would allow a jury to reach an intelligent conclusion about the adequacy of the warning without the aid of an expert’s specialized knowledge. Id. at 399 (emphasis added).

This “lay person” standard is also employed in other jurisdictions in determining the adequacy of evidence of failure to warn in product liability cases. See e.g., Dion v. Graduate Hospital of Pennsylvania, 360 Pa. Super 416 (1987) (“Where a layperson can understand the insufficiency of a warning, expert testimony is not needed.”); Howertson v. Blitz U.S.A., Inc., 2007 U.S. Dist. LEXIS 94937 (2007) (holding that an expert is not necessary to support a failure to warn claim because the warning issue is within the layperson’s knowledge). Applying this standard, the Court in Northern Trust Co. concluded that expert testimony was necessary to establish a duty to warn because, under the facts of that case, whether the manufacturer had knowledge of the risk sufficient to trigger such duty was a complex scientific question.

[T]he question of whether Upjohn’s knowledge of reported cases of cardiac arrest was tantamount to knowledge of an “association” between the drug and cardiac arrest which obligated it to include cardiac arrest as a possible side effect, was a complex question which required expert testimony.”

Id at 401. In the case at bar, no such question exists. It is undisputed that, when they sold the offending patches to Janice, the Drug Companies were aware of the risk of a fold-over defect and that a rapid release of Duragesic’s contents could result in a potentially fatal dose of fentanyl. The Drug Companies were also aware that some users of 75 mcg/hour Duragesic patches without leaks would achieve potentially lethal levels of fentanyl due to the variable nature of skin permeability. The Drug Companies’ knowledge of the risk of death associated with Duragesic’s use can be readily understood by a layperson and, therefore, Plaintiff does not require expert testimony to establish the existence of the Drug Companies’ duty to warn.

Similarly, the facts of this case are such that Plaintiff does not require expert testimony to prove the inadequacy of Duragesic’s warning. As seen above, the Drug Companies knew that some users of Duragesic will experience a potentially lethal delivery of fentanyl from a non-defective patch. Defendants also had knowledge of the fold-over defect and that patches with fold-over defects are more likely to leak fentanyl gel directly onto the skin, increasing the rate of fentanyl absorption and the likelihood of death. Despite these facts, the Drug Companies failed to provide any warning about the increased risk of death from use of the patch. The inadequacy of this warning is so obvious that a lay person can easily understand the insufficiency. Common sense would dictate that the apparent and obvious risk of death from using a Duragesic patch would call for a warning that death might result through normal use. As such, expert testimony is not necessary to prove that Duragesic’s warnings were inadequate.

3. John has competent expert and medical expert testimony showing that the Drug Companies warnings were inadequate.

 

Even if the Court concludes that the adequacy of Duragesic’s warning in 2003 is beyond the comprehension of an ordinary lay person, John has sufficient expert testimony that the warnings in the 2003 Package Insert were inadequate. John has retained six different experts to testify about every conceivable aspect of Duragesic (e.g., leaking patches are inherent in the manufacture of Duragesic, leaking patches are dangerous and potentially fatal, that a properly functioning should not give patients a fentanyl level higher than 4 ng/ML, etc.) and how it caused Janice’s death. (See generally, Middleburg Aff.; Downs Aff.; Prausnitz Aff.; Anisfeld Aff.; Sims Dep.) These experts will provide the jury with ample information to enable them to reach an intelligent decision on the adequacy of the Drug Companies’ warnings.

Additionally, John has competent medical expert testimony—from Janice’s own prescribing physician—that the warnings accompanying the DiCocolo Patches were inadequate. Dr. Neri’s opinions on the adequacy of the warnings are set forth below:

  • Cut, damaged or leaking Duragesic patches: As already seen, the evidence shows that use of a cut, damaged or leaking Duragesic patch can give the patch user a lethal dose of fentanyl. (Prausnitz Aff. ¶¶ 8, 10-12 (Ex. 2).) Dr. Neri opines that “if cut, damaged, or leaking patches can give patients a toxic, potentially fatal dose of fentanyl, the 2003 Package should have warned about that danger.” (Neri Aff. ¶ 8 (Ex. 7).)

REDACTED

  • Duragesic patches without leaks can cause death: There is substantial evidence that, even in the absence of a leak, Duragesic patches manufactured in 2003 and 2004 could give some users lethal doses of fentanyl greatly in excess of the levels listed in the Package Insert. (Prausnitz Aff. ¶¶ 5, 13-14, 16 (Ex. 2); Downs Aff. ¶¶ 6, 8, 20 (Ex. 4); Leikin Aff. ¶¶ 9, 11, 18 (Ex. 3).) According to Dr. Neri, “if Duragesic patches manufactured in 2003 and 2004 that did not have a leak could give patients toxic, potentially fatal fentanyl levels that far exceed the mean maximal levels listed in the package insert, the 2003 Package Insert should have warned this could happen.” (Neri Aff. ¶ 10 (Ex. 7).)
  • Using Duragesic in combination with other medications: The Drug Companies claim that the combination of other drugs found in Janice’s body contributed to her death by inhibiting her ability to metabolize fentanyl. Dr. Neri opines that if this is true, the Duragesic Package Insert should have warned about the dangers of using that combination of drugs. (Neri Aff. ¶ 16 (Ex. 7).)

Dr. Neri ultimately concludes that if proper use of Duragesic can cause death, as Defendants admit, “the 2003 Package Insert should have warned about that danger.” (Neri Aff. ¶ 10 (Ex. 7).) All of these opinions are given by Dr. Gene Neri, a licensed physician board certified in psychiatry and internal medicine. (Neri Aff. ¶ 2 (Ex. 7).) Clearly, John has competent expert testimony countering the Drug Companies’ claims of warning adequacy. The Drug Companies Motion for Summary Judgment on John’s claims for failure to warn should therefore be denied.

B. John’s warning claims are not barred by the learned-intermediary

doctrine.

 

The learned-intermediary doctrine is an affirmative defense on which the Drug Companies bear the burden of proof. The Drug Companies have not met their burden of proof because they have not brought forth sufficient evidence that Dr. Neri, Janice’s prescribing physician, was fully aware of all of the risks and dangers associated with the use of Duragesic patches. Moreover, because the Drug Companies cannot demonstrate that they adequately warned Dr. Neri of the dangers of Duragesic, they cannot even show that the doctrine applies.

1. Because the Drug Companies cannot demonstrate that they adequately warned Dr. Neri of the dangers of Duragesic, they cannot show that the learned-intermediary doctrine applies.

 

Because the Drug Companies cannot demonstrate that they adequately warned Dr. Neri 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 Drug Companies in the first instance, . . . and, therefore, the learned-intermediary doctrine is, if for no other reason, inapplicable.”).

After Janice’s death in February 2004, the Drug Companies substantially modified the warnings in their package insert warning that fentanyl gel from cut or damaged Duragesic patches “can lead to the rapid release of the contents of the Duragesic patch and absorption of a potentially fatal dose of fentanyl.” (See 2005 Duragesic Package Insert (Ex. 33).) Also after Janice’s death, 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 (Ex. 38).) 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 (Ex. 39).) In that warning letter, Janssen identified “important changes in the prescribing information for Duragesic.” (Id.; see also July 2005 FDA Public Health Advisory (Ex. 38) (“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, (Ex. 38a).) 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. Neri at the time he prescribed Duragesic to Janice.

Because the new warnings provided in 2005 were not provided before Janice’s death, the Drug Companies cannot possibly show that Dr. Neri 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 invoke 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).

2. The Drug Companies cannot demonstrate that Dr. Neri was aware of all of the risks and dangers associated with the use of Duragesic patches.

 

Even if one assumes the learned-intermediary doctrine applies, the Drug Companies have not met their burden under the learned-intermediary defense because they have not demonstrated that Dr. Neri was aware of all of the risks and dangers associated with the use of Duragesic patches. In their brief, The Drug Companies state that Dr. Neri “testified that the warnings accompanying Duragesic were adequate and sufficiently apprised him of all he needed to know to make a prescribing decision.” (The Drug Companies’ Mot. at 21.) This is misleading. In response to the question of whether the package insert gave him “adequate information to make a prescribing decision for his patients,” his non-responsive answer was that “Well, all it said is don’t use it in the three things, and he didn’t have any of those three things that we illucidated on further in the—so I don’t think this had added anything or subtracted anything from anything we’ve said so far.” (Neri Dep. at 68:19-69:3 (Ex. 24).) Defense counsel followed up by asking Dr. Neri if, “as a general matter, the information about the risks” in the package insert is adequate for him to make prescribing decisions. Dr. Neri’s response to this non-specific question was, “Sure.” (Id. at 69:4-8.) Yet, Dr. Neri did not specifically testify that the package insert sufficiently apprised him of all known risks of Duragesic:

Q: Now you said you did look at the package insert at some point. Have you periodically reviewed it or do you review it if a patient would raise something about it?

A: No, I don’t think I need to re-review it. You know, the basics of narcotics, you can look at the same package insert for morphine or Fentanyl or – generally the pain clinics like.

(Id. at 63:5-12.) In fact, Dr. Neri did not know whether these questions were directed to the warnings given on the 2003 Package Insert or the Current Package Insert. (Neri Aff. ¶ 6 (Ex. 7).) Without evidence that Dr. Neri carefully reviewed the 2003 product insert and unequivocally stated that it apprised him of all known risks and dangers associated with Duragesic, the Drug Companies cannot invoke the learned-intermediary defense.

Moreover, the Drug Companies never informed Dr. Neri in his deposition of the new warnings they added to the package insert in February 2004, after Janice’s death. Nor did they ask him whether he would have acted differently had he been given those new warnings. The burden was on the Drug Companies 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 the Drug Companies who must demonstrate the absence of any such issues.

Noyola, 1986 U.S. Dist. LEXIS 31007 at *10. Without such evidence, the Drug Companies 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.”).

In fact, the evidence specifically shows that Dr. Neri would not have prescribed Duragesic to Janice if the Package Insert had contained proper warnings of the risk of death associated with its use. Dr. Neri testified,

  • If the 2003 Package Insert had warned that cut/damaged patches can lead to rapid release of the contents of Duragesic and that leaking patches were inherent in the manufacture of Duragesic, he would not have prescribed Duragesic to Janice or, at least, have warned Janice to closely examine patches for leaks before applying them to her skin. (Neri Aff. ¶ 13 (Ex. 13).)
  • If the 2003 Package Insert had warned that Duragesic patches manufactured in 2003 and 2004 could give patients fentanyl levels greatly in excess of the MMC listed in the insert, he would not have prescribed Duragesic to Janice. (Neri Aff. ¶ 14 (Ex. 13).)
  • If the 2003 Package Insert had warned that the combination of drugs found in Janice’s blood could cause death, he would not have prescribed that combination for her. (Neri Aff. ¶ 16 (Ex. 13).)
  • If the 2003 Package Insert had warned that proper use of Duragesic can cause death, he would not have prescribed it to her. (Neri Aff. ¶ 17 (Ex. 13).)

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.”).

3. Whether The Drug Companies’ warnings were adequate is a fact question for the jury.

 

In the final analysis, whether the Drug Companies’ 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:

[L]ook 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.”).

V. There Is Sufficient Evidence to Create a Fact Issue for Trial on John’s Negligence Claims.

 

Although John’s negligence claim is predicated 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. In order to prevail on a claim of common law negligence, John must show the existence of a duty, a breach of that duty, and injury to the plaintiff proximately caused by the breach. Ziemba v. Mierzwa, 142 Ill. 2d 45 (1991). The Drug Companies argue that John’s negligence claims fail because in order to prevail on a negligence theory, there must be proof that the product was actually defective and no such proof exists in this case. (Drug Companies’ Mot. at 11.) As set forth in detail above, however, John has substantial and overwhelming evidence that the Drug Companies were negligent in the design, manufacture and marketing of the Duragesic, which resulted in Janice’s death from a defective, leaking Duragesic patch and that Janice’s death was caused by a leaking patch. (See § I, supra.) Accordingly, the evidence is more than sufficient to withstand The Drug Companies’ Motion for Summary Judgment on John’s negligence claims.

Additionally, a claim for negligence 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. However, if contrary evidence is offered by the Drug Companies, the presumption of negligence will not dissolve. Instead, 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 the Drug Companies. Heastie, 877 N.E.2d at 1081. The doctrine does not require the admission of expert testimony:

A preliminary flaw in the Drug Companies’ 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. Janice’s death was involuntary and not due to negligence on her part.

 

Janice’s death occurred under circumstances which were not due to any voluntary act or negligence on her part. The evidence shows that there was no abnormal use or misuse or abuse of Duragesic by Janice. On February 9, 2004, Janice filled a prescription for ten 75 mcg/hour Duragesic patches. She used one patch as directed and then changed to a second patch. (Aff. of John DiCosolo ¶¶ 3, 8-13 (Ex. 1); DiCosolo Prescription Records (Ex. 28).) The Drug Companies own expert, Dr. Graham Jones, concedes as much:

Q: And sitting here today are you aware of any evidence that the patch was used improperly in this case?

A: No, I have no evidence to that.

(Jones Dep. at 58:12-16 (Ex. 16); See also, Zumwalt Dep. at 45:18-46:9 (Ex. 17); Prausnitz Aff., ¶ 3(i) (Ex. 2).) (“[T]here is no evidence of abuse, misuse or altered fentanyl clearance by the Janice.”). There is simply nothing to indicate that Janice died from any act of negligence on her own part.

B. Janice’s death was caused by an instrumentality or agency

under the management or control of the Drug Companies.

 

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 Drug Companies.”). Here, it is unquestioned that the Duragesic patch was manufactured and sold by the Drug Companies. There are no allegations of misuse or abuse. The Drug Companies have not alleged that the patch was tampered with, altered or otherwise modified after it was manufactured.

C. Janice’s death was caused by an occurrence that would not

have occurred in the absence of negligence.

Finally, Janice’s death was caused by an exceedingly high level of fentanyl that would not have been delivered in the absence of negligence on the part of the Drug Companies. The toxicological testing of Janice’s blood shortly after her death found a level of fentanyl of 28.2 ng/mL. This level of fentanyl was much higher than would be expected if the Duragesic patch had properly performed. According to Dr. Mark Prausnitz, a fentanyl blood level of 28.2 ng/mL “should never be achieved…a patch that produces this high level of fentanyl is most probably defective.” (Prausnitz Aff. ¶¶ 4(g), 5 (Ex. 2).)

The package insert, as it existed in 2004, stated that the “mean maximal concentration” for someone using a 75 microgram patch would be 1.7ng/mL. (2003 Duragesic Package Insert (Ex. 32); see also Middleburg Dep. at 82:3-8 (Ex. 10); Middleburg Aff. ¶ 7(c) (Ex. 6) (“The expected peak concentration of fentanyl following the proper use of a 75 ug/lu Duragesic® Patch is approximately 1.7 ng/mL (SD=0.7), but may be as high as approximately 3 ng/mL.”); Prausnitz Aff. ¶ 4(g) (Ex. 2) (“A properly functioning Duragesic-75 patch should produce a fentanyl blood level between 1.0 and 2.4 ng/mL.”).) REDACTED Janice’s fentanyl level of 28.2 ng/mL was well outside the normal range expected for someone using a 75 microgram Duragesic patch.

Moreover, there is a great deal of evidence that the Duragesic patches manufactured and marketed by the Drug Companies were susceptible to malfunctioning and delivering a lethal dose of fentanyl. The patches used by Janice came from lot number 192, which was among several lots recalled by the Drug Companies in 2004 after they discovered patches were released containing a “fold-over defect.” (See Urgent Class 1 Drug Recall Notification Patient Level (Ex. 29); FDA EIR at 5-7 (Ex. 30).) REDACTED Following the recall, the Drug Companies prepared a new package insert warning patients that fentanyl gel from cut or damaged Duragesic patches “can lead to the rapid release of the contents of the Duragesic patch and absorption of a potentially fatal dose of fentanyl.” (See 2005 Duragesic Package Insert (Ex. 33); Prausnitz Aff. ¶ 6 (Ex. 2).)

REDACTED

John’s pharmacological manufacturing expert, Michael Anisfeld, has opined that the patches the Drug Companies released to the market “contain[ed] critical and major defects in product quality” and were not safe and effective for consumer use. (Anisfeld Aff. ¶ 71 (Ex. 5).) “The sampling and inspection process utilized by the company were unable to prevent elimination of these patient health-threatening deficiencies and these batches should never have been released.” (Id.) According to Anisfeld, the patch worn by Janice at the time of her death suffered a “malfunction” that “was most likely due to a product defect . . . .” (Id. ¶ 72.)

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 John has satisfied each of the elements of his negligence claim under the doctrine of res ipsa loquitur, the Drug Companies’ 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).

CONCLUSION AND PRAYER

John has offered substantial evidence in support of each of his stated causes of action. For this reason, as set out more fully above, the Court should deny the Drug Companies’ Motion for Summary Judgment.

WHEREFORE Plaintiff John DiCosolo respectfully prays that the Court deny the Drug Companies’ Motion for Summary Judgment and grant him such other and further relief to which he may be justly entitled.

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