Brown v. Johnson

64 F. Supp. 3d 717, 2014 U.S. Dist. LEXIS 173800, 2014 WL 6979262
CourtDistrict Court, E.D. Pennsylvania
DecidedDecember 9, 2014
DocketCiv. No. 12-4929
StatusPublished
Cited by11 cases

This text of 64 F. Supp. 3d 717 (Brown v. Johnson) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Brown v. Johnson, 64 F. Supp. 3d 717, 2014 U.S. Dist. LEXIS 173800, 2014 WL 6979262 (E.D. Pa. 2014).

Opinion

ORDER

PAUL S. DIAMOND, District Judge.

Plaintiffs allege that Riley Brown, a three-year-old child, contracted Stevens-Johnson Syndrome and/or Toxic Epidermal Necrolysis — severe skin conditions— from her use of Children’s Motrin. Plaintiffs bring claims against Defendants, the producers of Children’s Motrin, for failure to warn consumers, failure to warn physicians, design defect, manufacturing defect, negligent marketing or testing, breach of warranty, fraudulent or negligent misrepresentation, punitive damages, and breach of the Pennsylvania Unfair Trade Practices and Consumer Protection law. The Parties have cross-moved for summary judgment. Defendants seek summary judgment on all Plaintiffs’ claims. Plaintiffs seek partial summary judgment on all Defendants’ affirmative defenses.

I. DISCUSSION

A. Failure to Warn Consumers

Plaintiffs argue that Defendants should have included more specific warnings on the Children’s Motrin label. (Am. Compl., Doc No. 51 at ¶ 83r.) Defendants argue that because the FDA approved their labels, any state law requiring different labels is preempted by this federal action. (Doc. No. 106 at 25); Farina v. Nokia, Inc., 625 F.3d 97, 122 (3d Cir.2010) (“Conflict preemption exists ... ‘where it is impossible for a private party to comply with both state and federal requirements....’” (internal citation omitted)); see also Wyeth v. Levine, 555 U.S. 555, 573, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (“Impossibility pre-emption is a demanding defense.”).

Defendants have not adduced “ ‘clear evidence that the FDA would not have approved the change’ that was necessary to comply with state law.” Wolfe v. McNeil-PPC, Inc., 773 F.Supp.2d 561, 568 (E.D.Pa.2011) (internal citation omitted); see also id. (“This is an ‘exacting burden’ that cannot be met ‘simply by showing that the FDA approved the label....’” (internal citation omitted)). Typically, a drug manufacturer may strengthen its warnings through a “Changes Being Effected” process without FDA approval. 21 C.F.R. § 314.70(c)(6)(iii)(A); see also Levine, 555 U.S. at 568, 129 S.Ct. 1187 (changes being effected regulation precluded conflict preemption defense). Defendants have failed to show that they could not have modified the 2005 Children’s Motrin label through the Changes Being Effected process in light of evolving information about the connection between Motrin and SJS/TEN. See, e.g., Hunt v. McNeil Consumer Healthcare, 6 F.Supp.3d at 701-02 (FDA’s response to the 2005 Citizen Petition is not “clear evidence” that the FDA would have rejected stronger warnings, including blindness warning); Newman v. McNeil Consumer Healthcare, No. 10-1541, 2012 WL 39793, at *7 (N.D.Ill. Jan. 9, 2012) (“[T]he FDA should not have to reject every possible formulation of a particular warning.... Here, however, the FDA’s response does not even address the petitioners’ references to the more serious consequences of SJS and TEN.”); see also Wolfe v. McNeil-PPC, Inc., 773 F.Supp.2d 561, 568-69 (E.D.Pa.2011) (no preemption for an earlier version of the Motrin label). The FDA’s approval in 2013 of the same SJS/TEN warnings for acetaminophen is [721]*721not “clear evidence” strong enough to meet the “exacting burden” for this defense. Wolfe, 773 F.Supp.2d at 568; Hunt, 6 F.Supp.3d at 701-02 (rejecting acetaminophen argument). Accordingly, I will deny Defendants’ Motion.

B. Failure to Warn Physicians

Plaintiffs allege that Defendants should have warned physicians about Stevens-Johnson, Syndrome and Toxic Epidermal Necrolysis. (Am. Compl., Doc No. 51 at ¶¶ 71, 83g-h, 98.) Defendants had no duty to inform physicians, however, because Children’s Motrin is an over-the-counter drug. See Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 751 (E.D.Pa.2007) (“[A] manufacturer will only be held liable where it fails to exercise reasonable care to inform the one for whose use the product is supplied of the facts that make the product likely to be dangerous. In a case involving a prescription medical device, the intended user is the prescribing physician.” (internal citation omitted)); LaBarre v. Bristol-Myers Squibb Co., No. 06-6050, 2013 WL 144054 (D.N.J. Jan. 11, 2013) (“Pharmaceutical companies then, who must warn the ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician .... ” (quoting Buckner v. Allergan Pharms., 400 So.2d 820, 822 (Fla.Dist.Ct. App.1981))), aff'd, 544 Fed.Appx. 120 (3d Cir.2013). Accordingly, I will grant Defendants’ motion for summary judgment on Plaintiffs’ claims for failure to warn physicians.

C. Design Defect

Proceeding under strict liability and negligence theories, Plaintiffs allege that Children’s Motrin was defectively designed. (Am. Compl., Doc. No. 51 at ¶¶ 82, 92.) Defendants argue that federal law preempts these claim and that Children’s Motrin was safe according to state law. (Defs.’ Mot. Summ. J. at 41-48.)

Preemption

Defendants have not made out federal preemption. See Wyeth v. Levine, 555 U.S. 555, 565, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (“[I]n all pre-emption cases, ... we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” (internal citation and quotation marks omitted)). The Supreme Court has not addressed whether federal law can preempt state law design defect claims brought against manufacturers of brand-name or non-prescription drugs. I cpnclude that its preemption cases do not extend to the manufacturers of these products. See Mut. Pharm. Co. v. Bartlett, — U.S. -, 133 S.Ct. 2466, 2475, 186 L.Ed.2d 607 (2013) (preempting claims against generic drug manufacturers because generic drugs are required to have the same design as their brand-name counterparts); id. at 2480 (emphasizing that the federal statute governing prescription drugs “includes neither an express preemption clause ... nor an express non-pre-emption clause (as in the over-the-counter drug context)”); Hunt v. McNeil Consumer Healthcare, 6 F.Supp.3d 694, 704 (E.D.La.2014) (“Congressional intent to preserve products liability actions against manufacturers of nonprescription drugs could not be more clear.”).

Defendants have also failed to demonstrate that the FDA would have rejected a proposed change to Children’s Motrin’s chemical composition. {See Steffey Decl., Ex. 42 at 12; Ex. 10 at 109 (suggesting that the FDA’s initial rejection of dexibu-profen was based on the lack of clinical trials).) In these circumstances, Defen[722]*722dants have failed to meet their “exacting burden.”

Choice of Law

Defendants suggest that Florida and Pennsylvania design defect laws differ: there is a presumption under Florida law — but not .Pennsylvania law — that a product is safe if it complies with regulatory provisions. (Defs.’ Supplemental Br., Doc. No.

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Cite This Page — Counsel Stack

Bluebook (online)
64 F. Supp. 3d 717, 2014 U.S. Dist. LEXIS 173800, 2014 WL 6979262, Counsel Stack Legal Research, https://law.counselstack.com/opinion/brown-v-johnson-paed-2014.