United States District Court, E.D. Pennsylvania
KRISTIN L. BROWN and PAUL L. BROWN individually, and RILEY J. BROWN, by and through her natural parents and guardians, Plaintiffs,
JOHNSON & JOHNSON, MCNEIL-PPC, INC. MCNEIL CONSUMER PRODUCTS COMPANY, MCNEIL CONSUMER HEALTHCARE, a division of MCNEIL-PPC, INC., MCNEIL CONSUMER & SPECIALTY PHARMACEUTICALS, a division of MCNEIL-PPC, INC., Defendants
[Copyrighted Material Omitted]
For KRISTIN L. BROWN, PAUL L. BROWN, INDIVIDUALLY, RILEY J. BROWN, BY AND THROUGH HER NATURAL PARENTS AND GUARDIANS, Plaintiffs: BRANDON H. STEFFEY, LEAD ATTORNEY, PRO HAC VICE, JENSEN & ASSOCIATES, FORT WORTH, TX; JOHN BRADLEY MCDERMOTT, ROSEMARY PINTO, FELDMAN & PINTO PC, PHILADELPHIA, PA; LAURA A. FELDMAN, FELDMAN & PINTO, PHILA, PA.
For JOHNSON & JOHNSON, MCNEIL-PPC, INC., F/K/A MCNEIL CONSUMER PRODUCTS COMPANY, MCNEIL CONSUMER HEALTHCARE, A DIVISION OF MCNEIL-PC, INC., McNEIL CONSUMER & SPECIALTY PHARMACEUTICALS, A DIVISION OF MCNEIL-PPC, INC, Defendants: MATTHEW P. SMITH, PRO HAC VICE, DAVID F. ABERNETHY, KENNETH P. CONOUR, THOMAS W. PULLIAM, JR., VERNON I. ZVOLEFF, DRINKER BIDDLE & REATH LLP, PHILADELPHIA, PA.
Paul S. Diamond, 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.
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 (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 694, 2014 WL 1116358, at *5 (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
not " clear evidence" strong enough to meet the " exacting burden" for this defense. Wolfe, 773 F.Supp.2d at 568; Hunt, 6 F.Supp.3d 694, 2014 WL 1116358, at *5 (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 F.App'x 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 ...