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John Dicosolo, As Administrator of the Estate of v. Janssen Pharmaceuticals

June 30, 2011


Appeal from the Circuit Court of Cook County No. 04 L 005351 Honorable Thomas E. Flanagan, Judge Presiding

The opinion of the court was delivered by: Judge Epstein

JUDGE EPSTEIN delivered the judgment of the court, with opinion. Justices Joseph Gordon and Howse concurred in the judgment and opinion.


¶ 1 Defendants, Janssen Pharmaceuticals, Inc., and ALZA Corporation, appeal from an $18 million judgment in favor of plaintiff, John DiCosolo, as administrator of the estate of Janice V. DiCosolo, deceased, for non-economic damages entered in a wrongful death product liability case involving the Duragesic® prescription transdermal patch that they manufactured and distributed. Defendants raise several arguments on appeal: (1) they were entitled to a judgment notwithstanding the verdict because plaintiff presented insufficient evidence that the product "malfunctioned" to permit the legal inference of a "nonspecific" defect; (2) in the alternative, multiple errors in evidentiary rulings entitle them to a new trial; (3) an improper and inflammatory closing argument resulted in a grossly excessive verdict that requires reversal; and (4) if the judgment is not reversed, the case should be remanded for a substantial remittitur. We affirm.


¶ 2 On February 15, 2004, 38-year-old Janice DiCosolo died while using a Duragesic® skin patch designed, manufactured, and distributed by defendants. DiCosolo was survived by her husband, John DiCosolo (plaintiff) and three children: John, Kristina, and Anthony. The active ingredient in Duragesic® is fentanyl, a strong narcotic painkiller. The fentanyl is mixed with a gel and ethanol and sealed within the patch. The patch is placed on the skin and the fentanyl travels through a rate-controlled membrane into the skin. Once through the skin, the fentanyl collects just beneath the skin and then enters the bloodstream through capillaries.

¶ 3 The Duragesic® skin patch is prescribed for chronic, severe pain that is otherwise unrelieved. DiCosolo suffered from a nerve root problem in her neck that was "exceedingly painful." After numerous painkillers and a spine stimulator implant failed to manage her pain, DiCosolo began treatment with Dr. Gene Neri. In July 2003, Dr. Neri prescribed a 50 micrograms per hour (mcg/hr) Duragesic® patch and increased the prescription to a 75 mcg/hr patch in September 2003. In addition to using the Duragesic® skin patch, DiCosolo was taking several other medications prescribed by her physician.

¶ 4 An autopsy performed by Dr. Lawrence Cogan of the Cook County Medical Examiner's office on February 16, 2004, which was more than 24 hours after DiCosolo's death, showed that DiCosolo's blood contained a fentanyl level of 28.2 nanograms per milliliter (ng/mL). A properly functioning 75 mcg/hr Duragesic® patch, according to defendants' package insert, should have delivered a fentanyl level of approximately 1.7 ng/mL.

¶ 5 Although DiCosolo had access to11 central nervous system (CNS) depressants immediately prior to her death, plaintiff provided only eight of these for the "First Call List" that the Cicero police department provided to the medical examiner. Plaintiff did not list Avinza (an opiate), clonazepam (a sedative), or butalbital (a barbiturate). The medical examiner did not test DiCosolo's blood for the presence of Avinza or clonazepam, but he did test for butalbital, which was present in the blood. Although plaintiff listed Bextra (a sedative) and Topamax (a sedative) on the First Call List, the medical examiner decided not to test for those drugs. The medical examiner concluded that DiCosolo's cause of death was from "Fentanyl and Gabapentin and Venlafaxine" and that the manner of death was "suicide."

¶ 6 On February 16, 2004, the day after DiCosolo died, defendants announced an "Urgent Class I Drug Recall" of lot control No. 0327192 (Lot 192). DiCosolo's patch came from this lot. The recall notice stated, in part, that "[a] small percentage of these patches may leak medication along one edge." The notice further stated that exposure to the patch's gel "could result in an increased exposure to the active opioid component, fentanyl" and that "[s]uch increased exposure can lead to increased drug effect including nausea, sedation, drowsiness, or potentially life-threatening complications."

¶ 7 Plaintiff received a letter regarding the recall shortly after DiCosolo's death. After receiving information from plaintiff's attorney that DiCosolo's patch had come from the recalled lot, the medical examiner changed his conclusions regarding DiCosolo's manner of death from "suicide" to "accident."

¶ 8 On May 12, 2004, plaintiff filed a complaint alleging strict products liability against defendants and asserting defects in the manufacture, design, and labeling of Duragesic®. On March 28, 2005, plaintiff amended his complaint. Both complaints alleged that the patch that DiCosolo was wearing at the time of her death caused her respiratory arrest and death.

¶ 9 On June 21, 2006, the director of process engineering for defendant ALZA Corporation examined the preserved patch that DiCosolo had been wearing at the time of her death and determined that it did not leak and contained no defect. On December 28, 2006, plaintiff filed a second amended complaint that deleted the allegation regarding the patch she was wearing at the time of her death. With respect to the patch that had been removed and discarded on February 14, 2004, the day before DiCosolo's death (the penultimate patch), in an affidavit dated November 17, 2007, plaintiff stated that when he removed the penultimate patch from his wife's back, he "noticed that it slid from her skin, and almost fell off, almost as if all the adhesive material from the patch and large adhesive overlay bandage was gone, leaving a slick film behind on [her] skin." Plaintiff filed a third amended complaint on July 18, 2008 alleging negligence and strict products liability, and further alleging that "one or more of the two" patches worn by DiCosolo prior to her death contained a manufacturing defect. At trial, plaintiff's theory was that the penultimate patch was defective and the sole cause of DiCosolo's death. The jury returned a verdict in favor of plaintiff. The trial court denied defendants' posttrial motions. This appeal followed.


¶ 10 I. Judgment Notwithstanding the Verdict

¶ 11 Defendants argue that the trial court erred in denying their motion for judgment notwithstanding the verdict. Specifically, they contend that plaintiff presented insufficient evidence of product "malfunction" to support a jury verdict based on inferences of a "nonspecific" product defect.

¶ 12 A judgment notwithstanding the verdict (judgment n.o.v.) presents a question of law that we review de novo. Knauerhaze v. Nelson, 361 Ill. App. 3d 538, 547 (2005). A judgment n.o.v. should be "entered only in those cases in which all of the evidence, when viewed in its aspect most favorable to the opponent, so overwhelmingly favors movant that no contrary verdict based on that evidence could ever stand." Pedrick v. Peoria & Eastern R..R. Co., 37 Ill. 2d 494, 510 (1967); accord Maple v. Gustafson, 151 Ill. 2d 445, 452 (1992). A trial court should not "enter a judgment n.o.v. if there is any evidence, together with reasonable inferences to be drawn therefrom, demonstrating a substantial factual dispute, or where the assessment of credibility of the witnesses or the determination regarding conflicting evidence is decisive to the outcome." Maple v. Gustafson, 151 Ill. 2d at 454. "[T]he standard for obtaining a judgment notwithstanding the verdict is a very difficult standard to meet and limited to extreme situations only. [Citation.]" (Internal quotation marks omitted.) Knauerhaze v. Nelson, 361 Ill. App. 3d 538, 548 (2005). As the Illinois Supreme Court has explained:

"A trial court cannot reweigh the evidence and set aside a verdict merely because the jury could have drawn different inferences or conclusions, or because the court feels that other results are more reasonable. [Citations.] Likewise, the appellate court should not usurp the function of the jury and substitute its judgment on questions of fact fairly submitted, tried, and determined from the evidence which did not greatly preponderate either way." Maple v. Gustafson, 151 Ill. 2d at 452-53.

Additionally, where a jury is presented with the testimony of experts with conflicting opinions, "our task is not to reweigh the evidence and make our own determinations." Knauerhaze v. Nelson, 361 Ill. App. 3d 538, 550 (2005).

¶ 13 A plaintiff in a products liability case, must prove three elements: (1) the injury resulted from a condition of the product; (2) the condition was an unreasonably dangerous one; and (3) the condition existed at the time it left the defendant's control. Suvada v. White Motor Co., 32 Ill. 2d 612 (1965). A plaintiff is not required to present expert testimony that the product contained a specific defect. Tweedy v. Wright Ford Sales, Inc., 64 Ill. 2d 570, 574 (1976). In Tweedy, our supreme court held that "[a] prima facie case that a product was defective and that the defect existed when it left the manufacturer's control is made by proof that in the absence of abnormal use or reasonable secondary causes the product failed 'to perform in the manner reasonably to be expected in light of [its] nature and intended function.' [Citations.] " Tweedy v. Wright Ford Sales, Inc., 64 Ill. 2d 570, 574 (1976); see also Erzrumly v. Dominick's Finer Foods, Inc., 50 Ill. App. 3d 359, 363 (1977) (noting that Tweedy eased plaintiff's burden of proof in a strict liability case).

¶ 14 The Tweedy doctrine has been analogized to the res ipsa loquitur doctrine in negligence cases. Id.; St. Paul Fire & Marine Insurance Co. v. Michelin Tire Corp., 12 Ill. App. 3d 165, 177 (1973). "After Tweedy, courts in this State have generally held that a plaintiff need not pinpoint the specific defect in a product in order to recover under strict liability." Doyle v. White Metal Rolling & Stamping Corp., 249 Ill. App. 3d 370, 377 (1993) (and cases cited therein).

¶ 15 Defendants contend that the Tweedy doctrine does not apply to the facts of the instant case because plaintiff did not present sufficient evidence of a product "malfunction," i.e., that the penultimate Duragesic® patch did not perform in the manner reasonably expected in light of its nature and intended function. Defendants contend that the questions on appeal are: "(1) what is the nature and quantum of evidence required for a Tweedy inference of nonspecific defect when there is no clear evidence of malfunction; and (2) did plaintiff's evidence meet that threshold standard?" Plaintiff does not address defendants' specific argument that he failed to present the required evidence of a "malfunction" but, instead, contends that he presented sufficient evidence of a "nonspecific defect."

¶ 16 At the outset, we note that the product alleged to be defective here, the penultimate patch worn by DiCosolo, was not available because it was discarded by plaintiff. Nonetheless, Illinois courts have acknowledged that the unavailability of the product does not preclude a plaintiff from proving that a product was defective through circumstantial evidence. See, e.g., Samansky v. Rush-Presbyterian-St.Luke's Medical Center, 208 Ill. App. 3d 377, 389 (1990) ("the absence of the product at trial is not fatal to the plaintiff's [claim for strict liability]"); Ralston v. Casanova, 129 Ill. App. 3d 1050, 1059 (1984) ("it may indeed be possible to introduce sufficient evidence to establish a prima facie case of strict liability even in the absence of the allegedly defective product itself"); Weedon v. Pfizer, Inc., 332 Ill. App. 3d 17, 19 (2002) (involving case where physician explanted the allegedly defective device, discarded it before any tests could be conducted for extravasation, i.e., leakage, and the device was never recovered); Mateika v. La Salle Thermogas Co., 94 Ill. App. 3d 506, 510 (1981) (noting generally that "[i]t is possible to introduce sufficient evidence to establish a prima facie case of strict liability even in the absence of the allegedly defective product"); Neighbors ex rel. American States Insurance Co. v. City of Sullivan, 31 Ill. App. 3d 657, 659 (1975) ("there are numerous cases holding that failure of a machine may be shown by circumstantial evidence and that the machine itself need not be produced at trial"). None of these cases, however, refer to a "malfunction doctrine" or "malfunction theory."

¶ 17 Other jurisdictions have addressed the situation where the actual product is unavailable and have made direct reference to a "malfunction." Under Pennsylvania law "a plaintiff pursuing a case under the malfunction theory can assert a successful strict product liability claim based purely on circumstantial evidence in cases where the allegedly defective product has been destroyed or is otherwise unavailable." (Emphasis added) Barnish v. KWI Building Co., 980 A.2d 535, 539 (Pa. 2009); see also Cassisi v. Maytag Co., 396 So. 2d 1140, 1150 (Fla. Dist. Ct App. 1981) (noting that the inference has been applied to cases in which the malfunction was such as to cause the product's disappearance); Living &nd Learning Centre, Inc. v. Griese Custom Signs, Inc., 491 A.2d 433, 436 (Conn. App. Ct. 1985) (defect may be circumstantially proved from the fact of the malfunction).

¶ 18 Defendants argue that Tweedy did not change fundamental product liability law or the rule that a defect "cannot be established by the mere fact that an accident or injury has occurred" and contend also that the Tweedy doctrine allows an inference of defect from a malfunction, but does not allow an inference of the malfunction itself. Defendants note that "[h]ere, there is no exploding coffee pot, collapsed ladder, or brake pedal that goes all the way to the floor to show malfunction." Defendants assert that, absent this threshold requirement that there be direct evidence of a malfunction in the product at issue, the Tweedy doctrine did not apply and the trial court should not have allowed circumstantial evidence of the nonspecific defect. They further argue that plaintiff conflates the distinct concepts of malfunction and inferred nonspecific defect. They assert that "[p]laintiff's formulation of the malfunction doctrine eliminates 'defect' from a prima facie product liability case." As noted earlier, plaintiff has not addressed defendants' argument that he failed to meet the threshold requirement of showing that the patch "malfunctioned" and was, therefore, not entitled to any inference of nonspecific defect.

¶ 19 In Weedon v. Pfizer, Inc., 332 Ill. App. 3d 17 (2002), a case involving summary judgment, the plaintiff had a venous access device surgically implanted in his chest for the administration of chemotherapy. The site became inflamed and physicians explanted the device and discarded it before any tests could be conducted for extravasation (leakage). The plaintiff's condition continued to deteriorate and he was left with a large hole in his chest. The plaintiff alleged that the device improperly leaked and allowed the chemotherapy drugs to come in contact with tissues in his chest. The plaintiff did not present evidence of a specific "malfunction" or a specific defect and the circuit court granted summary judgment in favor of the defendants. The plaintiff appealed claiming that he produced "sufficient circumstantial evidence to create a reasonable inference that the product was defective." Weedon, 332 Ill. App. 3d at 19. The appellate court agreed.

ΒΆ 20 The appellate court noted that "[a] plaintiff may establish a nonspecific defect claim by circumstantial evidence." Weedon, 332 Ill. App. 3d at 22. The court, although not using the term "malfunction," addressed the defendants' argument that the plaintiff had failed to "demonstrate that the device failed to perform in a manner reasonably expected in light of its nature and intended function." Weedon, 332 Ill. App. 3d at 30. Acknowledging that the plaintiff had not produced any expert witness to testify "regarding any specific defect in the venous access device," the court reviewed the evidence presented by each party and ...

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