Wolfe v McNeil-PPC, Inc. A current application of the failure-to-warn doctrine.

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1 Wolfe v McNeil-PPC, Inc. A current application of the failure-to-warn doctrine. By Charles J. Crooks, Esquire, a member of Jackson Kelly PLLC For: Law360 s May 2011 Product Liability Guest Column New products are constantly being developed to meet modern needs and expectations. The law evolves to regulate the development, marketing and use of these products. Tort law governs claims for damages. This yields decisional law, referred to as case precedent. Whereas legislative enactments produce a distillation of a broad consensus, case precedent comes from individualized, interpretive applications of law to facts. Each such precedent is then either applied or rejected in subsequent cases, producing a body of decisions known as the common law. Products liability cases are usually complex and costly to litigate. The rules encourage pleading alternative theories and lawyers are trained against omission so products liability complaints typically contain an array of alternate legal theories against not only the product manufacturer but everyone involved in the product s distribution and sale. A recent federal court decision from the Eastern District of Pennsylvania, Wolfe v. McNeil-PPC, Inc., 2011 WL (E.D.Pa. March 30, 2011), affords a current example of the judicial paring of liability theories using the process of summary judgment. Kiley Wolfe was nine years old in 1996 when she complained of headache pain. Her mother gave her an over-the-counter (OTC) medicine, Children s Motrin, generically known as ibuprofen. After a couple of days of worsening symptoms, she was taken to the pediatrician who recommended continued use of the OTC ibuprofen as needed. Symptoms persisted and rashes began to appear on Kiley s cheeks. In response to calls to the pediatrician s office the nurses advised her mother to continue the ibuprofen. Symptoms persisted and when blisters appeared on Kiley s ears, her mother took her to the hospital where she was diagnosed with Stevens - Johnson syndrome, a rare and painful condition that affects the skin and mucous membranes, caused by an allergic reaction to medication or infection. In this instance, Kiley Wolfe also suffered severe liver damage, requiring a transplant. Wolfe, 2011 WL at *1. Product liability litigation was filed in 2007, presumably in reliance on the tolling of the statute of limitations owing to Kiley s minority when her injuries occurred. Her complaint pleaded six distinct counts as well as a claim for punitive damages: (1) negligence, (2) strict liability under Restatement (Second) of Torts 402A, (3) strict liability under Restatement (Second) of Torts 402B, (4) breach of express warranty, (5) breach of implied warranty of merchantability, (6) violation of consumer protection law and (7) punitive damages. The first two counts each assert multiple theories of liability. In

2 Count I, plaintiff alleges defendants were negligent in their failure to warn of the dangers of Children's Motrin, and in their testing, marketing and design of the product. In Count II, plaintiff claims defendants are strictly liable for her injuries for their failure to warn of the dangers of Children's Motrin, and design and manufacturing defects in the product. Wolfe, 2011 WL at *2. During the fourth year of litigation, some 15 years after the operative events occurred, Federal District Judge Jan Ely DuBois, appointed to the federal bench by President Reagan in 1988, entered a summary judgment ruling on March 30, Judge DuBois dismissed all but two theories of liability: (1) negligence resulting in a failure to warn the consumer of inherent dangers that rendered the product defective; and (2) strict liability arising from the failure to warn. The claim for punitive damages also survived summary judgment. Wolfe, 2011 WL at *12. As a result of this summary judgment ruling, the two failure-to-warn claims as well as the claim for punitive damages may be presented to a jury. In a fairly typical fashion, Kylie Wolfe s complaint alleged negligence as well as strict liability theories against the manufacturer. These claims were dismissed either for lack of evidence or there was no legal duty to support the claim; there must be a breach of a legal duty before the law will afford a remedy. In dismissing the negligent-design claim, Judge DuBois applied the following five factors to determine there was no legal duty to design a safer version of Children s Motrin: (1) the relationship between the parties; (2) the social utility of the actor's conduct; (3) the nature of the risk imposed and foreseeability of the harm incurred; (4) the consequences of imposing a duty upon the actor; and (5) the overall public interest in the proposed solution. Citing Althaus ex rel. Althaus v. Cohen, 756 A.2d 1166, 1169 (Pa.2000). [A] duty will be found to exist where the balance of these factors weighs in favor of placing such a burden on a defendant. Phillips, 841 A.2d at Wolfe, 2011 WL at *6. Only the first factor weighed in favor of imposing a duty; the product at issue was intended for use by children. The remaining factors weighed heavily against imposing a duty to design a safer form of ibuprofen. Under the second factor, the annual sale of six billion doses of ibuprofen demonstrated the social utility of the product. Third, while Stevens-Johnson syndrome was obviously a serious adverse reaction, it was found to be extremely rare, one to six cases per every million people per year. Fourth, the absence of

3 any alternative forms of FDA-approved ibuprofen meant that requiring a safer form would remove a widely-used OTC medicine from the market. Judge DuBois ruled that removing ibuprofen from the market would on balance adversely affect the public interest. Wolfe, 2011 WL at *7. A similar seven-factor test was applied to deny the claim that strict liability should be imposed because ibuprofen is unreasonably dangerous. Judge DuBois noted the wide use of ibuprofen, the lack of any safer alternative form and the rarity of Stevens-Johnson syndrome as preponderating factors. Wolfe, 2011 WL at *8. The strict-liability claim for defective manufacture was dismissed for lack of evidence. On the manufacturing defect claim, plaintiff has presented no evidence that the Children's Motrin plaintiff ingested deviated from defendants' design specifications or was otherwise improperly manufactured. Wolfe, 2011 WL at *7. As for the negligent-testing claim, the court found this was not a distinctly recognized legal theory. Courts have held that such a claim is logically subsumed within plaintiff's defective design or defective manufacture claims. Wolfe, 2011 WL at *6, citing Shires v. Celotex Corp., No , 1988 WL , at *2 (E.D.Pa. Mar. 30, 1988). The negligent-marketing theory was summarily dismissed because the plaintiff s facts developed in discovery did not make out a claim for negligence in the promotion of an otherwise adequately labeled product. The allegation in this case, however, is not that an otherwise-adequate warning was nullified but that the warning itself was insufficient. Wolfe, 2011 WL at *6. The claim for breach of the implied warranty of merchantability was summarily dismissed based on a judicial determination that there was no legally-implied duty to warrant against the occurrence of Stevens-Johnson syndrome. Such a duty would have imposed an impossible burden. Plaintiff may have been entitled to a better warning about the dangers of ibuprofen an issue that, as the Court has already ruled should be reserved for the jury but [i]t can't be argued seriously that McNeil implicitly warranted that Children's Motrin will not cause SJS... That would imply that the company had a duty to guarantee against every conceivable adverse consequence of taking the drug, however remote, esoteric, or even conjectural; and that is not the law. Wolfe, 2011 WL at *10, citing Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir.2010). The claim for misrepresentation was summarily dismissed because there was no evidence of reliance on the manufacturer s representations in the purchase or use of the product. Wolfe, 2011 WL at *9. Likewise, there was no evidence to support the claim for breach of express warranty. In this case, plaintiff does not point to any specific

4 description of Children's Motrin that formed the basis of the bargain between plaintiff and defendants, nor does she cite to any evidence that she read, heard, saw or knew of such a statement when she purchased the product. Id. The claim that the defendants violated Pennsylvania s consumer protection law was also summarily dismissed. Some of the defendants maintained their principal places of business in Pennsylvania, but the plaintiff had no residential connection with that commonwealth. The court ruled that this was an insufficient nexus to justify the application of a statute designed to protect Pennsylvania consumers. Wolfe, 2011 WL at *10. Judge DuBois found the plaintiff did articulate a jury-worthy case for failure to warn. There were two versions of this claim. One required proof of negligence. The plaintiff would have to prove that the manufacturer knew of a particular danger associated with the intended use of the product, a danger that consumers likely would not appreciate, and the manufacturer failed to exercise reasonable diligence in warning of that danger. The other version of the failure-to-warn claim relied on the strict liability doctrine. To successfully invoke that doctrine, the plaintiff must prove: (1) that the product was defective, (2) that the defect existed when it left the hands of the defendant, and (3) that the defect caused the harm. Wolfe, 2011 WL at *3, citing Schindler v. So-famor, Inc., 774 A.2d 765, 771 (Pa. Super. Ct. 2001) (citation omitted). A product is defective due to a failure-to-warn where the product was distributed without sufficient warnings to notify the ultimate user of the dangers inherent in the product. Donoughe v. Lincoln Elec. Co., 936 A.2d 52, (Pa.Super.Ct.2007). The defendants unsuccessfully argued that the FDA exercised exclusive jurisdiction when it approved the sufficiency of the warning used for Children s Motrin and the Commonwealth of Pennsylvania could not apply a different standard; this is a preemption defense. They likewise argued that the discovery record failed to raise a triable issue of causation, that is, the plaintiff did not read or rely on the labeling, so no warning however written could have made any difference. Wolfe, 2011 WL at *3. In denying the preemption argument, Judge DuBois applied the standard articulated in Wyeth v. Levine, 129 S.Ct. 1187, 1199 (2009). The Supreme Court in Levine broadly and unequivocally held that state law complemented federal law to ensure that drug makers market and sell only safe and effective drugs. To the contrary, such claims are only preempted where defendant adduces clear evidence that the FDA would not have approved the change that was necessary to comply with state law. Levine, 129 S.Ct. at This is an exacting burden that cannot be met simply by showing that the FDA approved the label which was in place at

5 the time of the plaintiff's injury. Citing Forst v. Smithkline Beecham Corp., 639 F.Supp.2d 948, (E.D.Wis.2009). Wolfe, 2011 WL at *3. In this regard, the defendants argued that the FDA in fact considered and rejected a warning label that specifically identified the risk of Stevens-Johnson syndrome. In reviewing that action the court noted the FDA drew a distinction that defeated summary judgment in Kylie Wolfe s case: In this case, defendants assert that plaintiff's failure-to-warn claims are preempted because, in 2006, the FDA declined a citizen petition's request to require manufacturers to include a specific reference to SJS on the warning label. (See Defs.' Mot. for Summ. J., Ex. 7 at 8 9.) In the very same document, however, the FDA agreed with the citizen petition that labeling for drugs like Children's Motrin should be improved to warn consumers about the risks of severe skin reactions associated with [over-the-counter] ibuprofen products. (Id. at 8.) In other words, the FDA agreed that the ibuprofen label in place prior to 2006 should be strengthened but believed that a description of symptoms including skin reddening, rashes and blisters of SJS and related ailments would be more helpful to consumers than the names of the diseases themselves. (Id. at 9.) Wolfe, 2011 WL at *4. The lawyers for Kylie Wolfe must have pleaded their client s complaint with this 2006 FDA finding in mind. They alleged that the label should have warned users to stop using ibuprofen and seek medical assistance if rashes, blisters or mucosal-reaction symptoms appeared. This pleaded claim tracked the sort of warning the FDA endorsed in Defendants have thus failed to adduce clear evidence that the FDA would have rejected the stronger labeling plaintiff believes was required. As defendants have not met their exacting burden, the Court rejects defendants' preemption argument. Wolfe, 2011 WL at *4. It appears the tolling of the statute of limitations afforded Kylie Wolfe s attentive lawyers the time and opportunity to use the FDA finding in 2006 and use it to plead around the federal preemption defense. The defendants causation defense was rejected based on the facts developed in discovery. The court noted that the evidence was conflicting but the deposition testimony given by Kylie s mother was sufficient to raise a triable issue on whether a stronger warning label would have been heeded. Whenever the discovery evidence on a material issue is disputed, summary judgment is denied on that issue in deference to a jury trial. Wolfe, 2011 WL at *5-6.

6 Finally, the court ruled that the claim for punitive damages could be presented to the jury. The plaintiff developed evidence in discovery showing that the defendants found two cases of Stevens-Johnson syndrome in a study of ibuprofen use, yet these were not mentioned in a subsequent report of the study. This evidence met the threshold for admissibility for implied malice under applicable law. Wolfe, 2011 WL at *11. The summary judgment ruling in Wolfe did not resolve all issues before the court, but it trimmed the action down to a single theory, failure-to-warn, as well as a claim for punitive damages. The parties will next decide whether to settle or try those remaining parts of the case. If the case is tried, the summary judgment ruling as well as the verdict on the surviving claims will be ripe for appeal. Whatever the final resolution to the Wolfe case, Judge DuBois published decision now adds precedent to the common law on all the forgoing points.

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