Hunt v. Mcneil Consumer Healthcare

• Decision Date: 11 March 2014
• Docket Number: Civil Action No. 11–457.
• Parties: Keisha HUNT v. McNEIL CONSUMER HEALTHCARE, et al.
• Court: U.S. District Court — Eastern District of Louisiana

6 F.Supp.3d 694

Keisha HUNT

v.McNEIL CONSUMER HEALTHCARE, et al.

Civil Action No. 11–457.

United States District Court,

E.D. Louisiana.

Signed March 11, 2014.

Patty Ann Trantham, Robert Lyle Salim, Salim–Beasley, LLC, Natchitoches, LA, Jay Hodges Henderson, Jay Henderson, PLLC, Joseph C. Melugin, Kenneth Thomas Fibich, Russell S. Briggs, Fibich, Hampton, Leebron, Briggs & Josephson, LLP, Sara J. Fendia, Law Offices of Sara J. Fendia, Houston, TX, Val Patrick Exnicios, Liska, Exnicios & Nungesser, New Orleans, LA, for Keisha Hunt.

James B. Irwin, Douglas J. Moore, Kelly E. Brilleaux, Timothy Farrow Daniels, Irwin Fritchie Urquhart & Moore, LLC, New Orleans, LA, Charles Coleman Lifland, O'Melveny & Myers, LLP, Los Angeles, CA, Kari L. Sutherland, Paul Victor Cassisa, Jr., Butler, Snow, O'Mara, Stevens & Cannada, Oxford, MS, Kenneth P. Conour, Preuss, Shanagher, Zvoleff & Zimmer, Matthew P. Smith, Vernon I. Zvoleff, Drinker, Biddle & Reath, LLP, San Francisco, CA, for McNeil Consumer Healthcare, et al.

ORDER AND REASONS

JANE TRICHE MILAZZO, District Judge.

Defendants have raised the affirmative defense of preemption. The question presented is whether Plaintiff's product liability claims are preempted by federal law. For the following reasons, the Court finds Defendants have failed to carry their burden of demonstrating preemption.

BACKGROUND

This a pharmaceutical products liability action. Plaintiff Keisha Hunt suffered personal injury on February 4, 2010 after ingesting Children's Motrin—a non-prescription drug manufactured by Defendants McNeil Consumer Healthcare ¹(“McNeil”) and Johnson & Johnson. The active ingredient in Children's Motrin is ibuprofen. Plaintiff alleges Children's Motrin caused her to contract Stevens–Johnson Syndrome and/or Toxic Epidermal Necrolysis (“SJS/TEN”).² Plaintiff subsequently filed suit under the Louisiana Products Liability Act(“LPLA”), La.Rev.Stat. § 9:2800.54 et seq., alleging Children's Motrin is defectively designed and contains inadequate warnings of potential health problems. Defendants answered the complaint and asserted the affirmative defense of federal preemption, on which they carry the burden of proof. See Fisher v. Halliburton, 667 F.3d 602, 609 (5th Cir.2012) (“Federal preemption is an affirmative defense that a defendant must plead and prove.”).

LEGAL STANDARD

The doctrine of preemption derives from the Supremacy Clause, which provides that federal law “shall be the supreme Law of the Land; ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. Accordingly, “state laws that conflict with federal law are ‘without effect.’ ” Altria Grp., Inc. v. Good, 555 U.S. 70, 76, 129 S.Ct. 538, 172 L.Ed.2d 398 (2008) (quoting Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981)).

Whether state law is preempted by federal law vel non is a question of congressional intent. Medtronic, Inc. v. Lohr, 518 U.S. 470, 494, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (“[T]he purpose of Congress is the ultimate touchstone in every pre-emption case.”) (internal quotation marks omitted). Congress may manifest preemptive intent in three ways. English v. Gen. Elec. Co., 496 U.S. 72, 78–79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990).³ “Express preemption” occurs when a federal law contains an express preemption clause. See Altria Grp., 555 U.S. at 76, 129 S.Ct. 538. “Field preemption” occurs when a federal regulatory scheme is so pervasive or a federal interest so dominant that Courts may presume Congress intended to occupy the legislative field exclusively. English, 496 U.S. at 72, 110 S.Ct. 2270. Finally, “conflict preemption” occurs when state law conflicts with a federal statute. Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000). The Supreme Court recognizes two separate, albeit interrelated, forms of conflict preemption. See id. at 372–73, 120 S.Ct. 2288. Courts will find “impossibility preemption” where “it is impossible for a private party to comply with both state and federal law.” See id. at 372, 120 S.Ct. 2288. “Obstacles preemption,” on the other hand, occurs “where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” English, 496 U.S. at 79, 110 S.Ct. 2270 (internal quotation marks omitted).

In undertaking the preemption analysis—whether express, field, or conflict—courts must heed “the assumption that the historic police powers of the States [are] not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Altria Grp., 555 U.S. at 77, 129 S.Ct. 538 (alteration in original) (internal quotation marks omitted). This assumption applies with “particular force” when Congress legislates in a field traditionally occupied by the States. Id.

LAW AND ANALYSIS

Defendants contend Plaintiff's LPLA claims that Children's Motrin is defectively designed and contains inadequate warnings are preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. Specifically, Defendants invoke the doctrine of impossibility preemption, arguing that it was impossible to comply with both state-law duties under the LPLA and federal duties imposed by the FDCA. The Court addresses each of Plaintiff's LPLA claims separately.⁴

I. Whether Plaintiff's Inadequate–Warning Claim Is Preempted by Federal Law

Defendants contend the Supreme Court's decision in Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), preempts Plaintiff's inadequate-warning claim under the LPLA. As explained more fully below, the Court disagrees for two reasons. First, Wyeth is inapposite. Second, even if Wyeth is on point, Defendants fail to provide “clear evidence,” as required by Wyeth, that it was impossible to comply with both the LPLA and the FDCA.

Wyeth involved the brand-name prescription drug Phenergan—an antihistamine administered intravenously by the “IV-push” method or the “IV-drip” method. 555 U.S. at 559, 129 S.Ct. 1187. The IV-push method presented a higher risk of the drug entering an artery, thereby causing gangrene. Id. at 559–61, 129 S.Ct. 1187. The plaintiff received an IV-push injection of Phenergan and developed gangrene in her right arm, which was eventually amputated at the forearm. Id. at 559, 129 S.Ct. 1187. The plaintiff brought a products liability action against the manufacturer of Phenergan, alleging the drug label failed to adequately warn of the dangers associated with the IV-push method. See id. at 560, 129 S.Ct. 1187. The manufacturer argued both forms of conflict preemption—that is, “impossibility preemption” and “obstacles preemption.” Id. at 563–64, 129 S.Ct. 1187. The Supreme Court rejected both.

In addressing the first, the Court began by noting the general rule that a manufacturer may not alter a drug label absent the Food and Drug Administration's (“FDA”) approval of a supplemental application. Id. at 568, 129 S.Ct. 1187. There is, however, a “changes being effected” (“CBE”) regulation that allows manufacturers to supplement a drug label immediately upon filing a supplemental application, i.e., without first receiving FDA approval. Id. The Court interpreted the FDCA and its complementing regulations (such as the CBE) to require that manufacturers ensure drug warnings “remain adequate as long as the drug is on the market.” Id. at 571, 129 S.Ct. 1187. Thus, when the risk of gangrene from an IV-push injection became apparent, the manufacturer had a duty to update its warning absent “clear evidence” the FDA would not have ultimately approved such a warning. Id. Because the manufacturer in Wyeth failed to offer clear evidence the FDA would have rejected the proposed change, the Court concluded that it was not impossible for the manufacturer to comply with both federal and state-law requirements. Id. at 572–73, 129 S.Ct. 1187.

Defendants contend Wyeth preempts Plaintiff's inadequate-warning claim because there is “clear evidence” the FDA would not have approved Plaintiff's proposed changes to the Children's Motrin label. But this argument erroneously presupposes its legal predicate—that Wyeth is on point. There is a crucial distinction between Wyeth and the case at bar: whereas Wyeth involved a prescription drug, Children's Motrin is available over the counter.⁵

Non-prescription drugs are regulated by a special statute—21 U.S.C. § 379r. While this statute contains an explicit preemption clause, 21 U.S.C. § 379r(a), it also contains a savings clause, which “expressly preserve[s] product liability actions.” Wyeth, 555 U.S. at 575 n. 8, 129 S.Ct. 1187; see also Mut. Pharm. Co. v. Bartlett, ––– U.S. ––––, 133 S.Ct. 2466, 2480, 186 L.Ed.2d 607 (2013). The savings clause—entitled “No effect on product liability law”—provides as follows: “Nothing in [21 U.S.C. § 379r] shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.” 21 U.S.C. § 379r(e). Congress' intent to preserve state-law product liability actions with respect to non-prescription drugs could not be more clear. This conclusion is underscored by the axiom that courts should assume Congress did not intend to displace state law, especially when Congress legislates in a field traditionally regulated by the states such as health and safety. See PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 2586, 180 L.Ed.2d 580 (2011) (Sotomayor, J., dissenting). Given that Congressional intent is the “ultimate touchstone” in any preemption analysis, Altria Grp., 555 U.S. at 76, 129 S.Ct. 538 (internal quotation marks omitted), and that “[i]mpossibility preemption is a demanding defense,” Wyeth, 555 U.S. at 573, 129 S.Ct. 1187, the Court cannot find Plaintiff's inadequate-warning claim preempted.

Even assuming arguendo that Wyeth is on point, Defendants' preemption argument still fails. As Wyeth makes clear,...