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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 theseproducts. Tort law governs claims for damages. This yields decisional law, referred to ascase precedent. Whereas legislative enactments produce a distillation of a broadconsensus, case precedent comes from individualized, interpretive applications of law tofacts. 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 soproducts liability complaints typically contain an array of alternate legal theories againstnot only the product manufacturer but everyone involved in the product’s distribution andsale. A recent federal court decision from the Eastern District of Pennsylvania, Wolfe v.
McNeil-PPC, Inc.
, 2011 WL 1157927 (E.D.Pa. March 30, 2011), affords a currentexample of the judicial paring of liability theories using the process of summaryjudgment.
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, genericallyknown as ibuprofen. After a couple of days of worsening symptoms, she was taken to thepediatrician 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 tothe 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 tothe hospital where she was diagnosed with Stevens - Johnson syndrome, a rare andpainful condition that affects the skin and mucous membranes, caused by an allergicreaction to medication or infection. In this instance, Kiley Wolfe also suffered severeliver damage, requiring a transplant. Wolfe, 2011 WL 1157927 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. Hercomplaint 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 merchantability, (6) violation of consumer protection law and (7) punitivedamages. The first two counts each assert multiple theories of liability. In Count I, plaintiff alleges defendants were negligent in their failure to warnof the dangers of Children's Motrin, and in their testing, marketing anddesign of the product. In Count II, plaintiff claims defendants are strictlyliable for her injuries for their failure to warn of the dangers of Children'sMotrin, and design and manufacturing defects in the product.
Wolfe, 2011 WL 1157927 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 byPresident Reagan in 1988, entered a summary judgment ruling on March 30, 2011. JudgeDuBois dismissed all but two theories of liability: (1) negligence resulting in a failure towarn the consumer of inherent dangers that rendered the product defective; and (2) strictliability arising from the failure to warn. The claim for punitive damages also survivedsummary judgment. Wolfe, 2011 WL 1157927 at *12. As a result of this summaryjudgment ruling, the two failure-to-warn claims as well as the claim for punitive damagesmay 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 forlack of evidence or there was no legal duty to support the claim; there must be a breach ofa 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’sMotrin: ‘(1) the relationship between the parties; (2) the social utility of the actor'sconduct; (3) the nature of the risk imposed and foreseeability of the harmincurred; (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 foundto exist where the balance of these factors weighs in favor of placing such aburden on a defendant.” Phillips, 841 A.2d at 1008–09.
Wolfe, 2011 WL 1157927 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 aduty to design a safer form of ibuprofen. Under the second factor, the annual sale of sixbillion doses of ibuprofen demonstrated the social utility of the product. Third, whileStevens-Johnson syndrome was obviously a serious adverse reaction, it was found to beextremely rare, one to six cases per every million people per year. Fourth, the absence of any alternative forms of FDA-approved ibuprofen meant that requiring a safer formwould remove a widely-used OTC medicine from the market. Judge DuBois ruled thatremoving ibuprofen from the market would on balance adversely affect the publicinterest. Wolfe, 2011 WL 1157927 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 wideuse of ibuprofen, the lack of any safer alternative form and the rarity of Stevens-Johnsonsyndrome as preponderating factors. Wolfe, 2011 WL 1157927 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 thatthe Children's Motrin plaintiff ingested deviated from defendants' design specifications orwas otherwise improperly manufactured.” Wolfe, 2011 WL 1157927 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 subsumedwithin plaintiff's defective design or defective manufacture claims.” Wolfe, 2011 WL1157927 at *6, citing Shires v. Celotex Corp., No. 85–7141, 1988 WL 1001970, 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 ofan otherwise adequately labeled product. “The allegation in this case, however, is not thatan otherwise-adequate warning was nullified but that the warning itself was insufficient.”Wolfe, 2011 WL 1157927 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 towarrant against the occurrence of Stevens-Johnson syndrome. Such a duty would haveimposed an impossible burden. “Plaintiff may have been entitled to a better warningabout the dangers of ibuprofen—an issue that, as the Court has already ruled should bereserved for the jury—but “[i]t can't be argued seriously that McNeil implicitly warrantedthat Children's Motrin will not cause SJS. That would imply that the company had aduty 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 WL1157927 at *10, citing Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7thCir.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 theproduct. Wolfe, 2011 WL 1157927 at *9. Likewise, there was no evidence to support theclaim for breach of express warranty. “In this case, plaintiff does not point to any specific description of Children's Motrin that formed the ‘basis of the bargain’ between plaintiffand defendants, nor does she cite to any evidence that she ‘read, heard, saw or knew’ ofsuch 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 placesof business in Pennsylvania, but the plaintiff had no residential connection with thatcommonwealth. The court ruled that this was an insufficient nexus to justify theapplication of a statute designed to protect Pennsylvania consumers. Wolfe, 2011 WL1157927 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. Theplaintiff would have to prove that the manufacturer knew of a particular dangerassociated with the intended use of the product, a danger that consumers likely would notappreciate, and the manufacturer failed to exercise reasonable diligence in warning ofthat danger. The other version of the failure-to-warn claim relied on the strict liabilitydoctrine. To successfully invoke that doctrine, the plaintiff must prove: “‘(1) that theproduct 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 1157927 at *3, citingSchindler 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 distributedwithout sufficient warnings to notify the ultimate user of the dangers inherent in theproduct. Donoughe v. Lincoln Elec. Co., 936 A.2d 52, 61–62 (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 Motrinand the Commonwealth of Pennsylvania could not apply a different standard; this is apreemption defense. They likewise argued that the discovery record failed to raise atriable issue of causation, that is, the plaintiff did not read or rely on the labeling, so nowarning however written could have made any difference. Wolfe, 2011 WL 1157927 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 statelaw complemented federal law to ensure that drug makers market and sellonly safe and effective drugs.’ To the contrary, such claims are onlypreempted where defendant adduces ‘clear evidence that the FDA wouldnot have approved the change’ that was necessary to comply with state law.
Levine, 129 S.Ct. at 1198. This is an ‘exacting burden’ that cannot be met‘simply by showing that the FDA approved the label which was in place at the time of the plaintiff's injury.’” Citing Forst v. Smithkline BeechamCorp., 639 F.Supp.2d 948, 953–54 (E.D.Wis.2009).
Wolfe, 2011 WL 1157927 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. Inreviewing that action the court noted the FDA drew a distinction that defeated summaryjudgment in Kylie Wolfe’s case: In this case, defendants assert that plaintiff's failure-to-warn claims arepreempted because, in 2006, the FDA declined a citizen petition's request torequire manufacturers to include a specific reference to SJS on the warninglabel. (See Defs.' Mot. for Summ. J., Ex. 7 at 8–9.) In the very samedocument, however, the FDA agreed with the citizen petition that labelingfor drugs like Children's Motrin ‘should be improved to warn consumersabout the risks of severe skin reactions associated with [over-the-counter]ibuprofen products.’ (Id. at 8.) In other words, the FDA agreed that theibuprofen label in place prior to 2006 should be strengthened but believedthat a ‘description of symptoms’—including skin reddening, rashes andblisters—of SJS and related ailments would be more helpful to consumersthan the names of the diseases themselves. (Id. at 9.) Wolfe, 2011 WL 1157927 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 stopusing ibuprofen and seek medical assistance if rashes, blisters or mucosal-reactionsymptoms appeared. This pleaded claim tracked the sort of warning the FDA endorsed in2006. “Defendants have thus failed to adduce ‘clear evidence’ that the FDA would haverejected the stronger labeling plaintiff believes was required. As defendants have not mettheir ‘exacting burden,’ the Court rejects defendants' preemption argument.” Wolfe, 2011WL 1157927 at *4. It appears the tolling of the statute of limitations afforded KylieWolfe’s attentive lawyers the time and opportunity to use the FDA finding in 2006 anduse 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 testimonygiven by Kylie’s mother was sufficient to raise a triable issue on whether a strongerwarning label would have been heeded. Whenever the discovery evidence on a materialissue is disputed, summary judgment is denied on that issue in deference to a jury trial.
Wolfe, 2011 WL 1157927 at *5-6.
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 foundtwo cases of Stevens-Johnson syndrome in a study of ibuprofen use, yet these were notmentioned in a subsequent report of the study. This evidence met the threshold foradmissibility for implied malice under applicable law. Wolfe, 2011 WL 1157927 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 forpunitive damages. The parties will next decide whether to settle or try those remainingparts of the case. If the case is tried, the summary judgment ruling as well as the verdicton the surviving claims will be ripe for appeal. Whatever the final resolution to the Wolfecase, Judge DuBois’ published decision now adds precedent to the common law on allthe forgoing points.

Source: http://www.jacksonkelly.com/jk/pdf/Law360%20Product%20Liability%20May%202011,%20Crooks2.pdf

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