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Marvin v. Zydus Pharmaceuticals USA Inc.

United States District Court, W.D. Wisconsin

August 23, 2016



          BARBARA B. CRABB District Judge

         Plaintiffs have brought state law claims of negligence and wrongful death against defendants Zydus Pharmaceuticals (USA) Inc. and Wyeth Pharmaceuticals, Inc. for injuries sustained by Shirley Johns, who died as a result of taking a drug commonly known as Amiodarone. Defendant Zydus Pharmaceuticals (USA) Inc. moved to dismiss the complaint on grounds that (1) plaintiffs’ claims for wrongful death, gross negligence and off-label marketing are barred by the applicable statute of limitations; and (2) plaintiffs’ claim that defendant was negligent per se in not providing federally-required medication guides for the Amiodarone it manufactured is impliedly preempted by the Food, Drug and Cosmetic Act, 21 U.S.C. § 337. (All further references to “defendant” will be to defendant Zydus only.)

         During the course of the parties’ briefing, it became apparent that they also disputed whether Wisconsin would recognize a claim of negligence per se. On April 28, 2016, I denied defendant’s motion to dismiss plaintiff’s claims as barred by the statute of limitations but reserved ruling on the negligence per se claim to allow the parties to submit further briefing on the preemption and state law issues. Dkt. #71.

         Having reviewed the parties’ supplemental briefing, I conclude that Wisconsin would recognize a claim of negligence per se and that the claim is not subject to implied preemption. In reaching this conclusion, I have accepted as true the allegations of fact in plaintiffs’ first amended complaint, dkt. #16, which I set forth in my previous order and incorporate by reference in this opinion.


         Regulations promulgated by the Food and Drug Administration require that drug manufacturers issue medication guides with certain prescribed drugs and biological products when the agency determines that (1) information is necessary to prevent serious adverse effects; (2) patients should be informed about a known serious side effect; or (3) patients’ adherence to directions for the use of a product is essential to the product’s effectiveness. 21 C.F.R. § 208.1. Any manufacturer who ships a container of the drug product must insure that medication guides are available for each patient receiving a prescription by providing (or providing the means to produce) a sufficient number of medication guides for authorized distributors, packers and dispensers. 21 C.F.R. § 208.24(b).

         In this case, plaintiffs allege that defendant Zydus failed to provide medication guides for the Amiodarone it manufactured to any of the pharmacies from which Shirley Johns obtained defendant’s drug. As defendant points out, the Food, Drug and Cosmetics Act does not allow private litigants to enforce its provisions. 21 U.S.C. § 337(a) (enforcement proceedings “shall be by and in the name of the United States”). See also Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4 (2001) (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with [its] provisions.”). Although plaintiffs are not attempting to enforce the medication guide regulations directly, they are relying on them to establish the standard of care for their claim that defendant was negligent per se in failing to warn Johns about the side effects of Amiodarone. In other words, plaintiffs contend that defendant was negligent because it violated a federal statute related to public health and safety.

         As discussed in the previous order, there is some confusion about whether the limitation on enforcement actions in § 337(a) prohibits plaintiffs from basing a negligence per se claim on defendant’s alleged violation of the federal medication guide provisions. In order to bring their claim, plaintiffs must show that (1) it is not subject to implied preemption under the doctrine announced in Buckman; and (2) it meets the requirements for negligence per se claims under Wisconsin law. I will address these two issues separately.

         A. Implied Preemption

         In Buckman, 531 U.S. at 347, the Supreme Court held that the Food, Drug, and Cosmetic Act as amended by the Medical Devices Amendments “impliedly preempted” state law fraud claims because the claims conflicted with federal law. In that case, the plaintiffs alleged that a manufacturer of bone screws made fraudulent representations to the Food and Drug Administration in the course of obtaining federal approval to market the screws. In dismissing their claim, the Court reasoned that the Act empowers the Food and Drug Administration to deter and punish fraud and that the “balance [of statutory objectives] sought by the [Food and Drug] Administration can be skewed by allowing fraud-on-the-FDA claims under state tort law.” Id. at 348. It specifically noted that “[t]he FDA . . . has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud, ” id. (citing enforcement limitation in 21 U.S.C. § 337(a)). It distinguished claims based on traditional state law tort principles that had predated the federal statute from claims for “fraud-on-the-agency” claims, that is, those in which the existence of federal requirements was a critical element. Id. at 353.

         Defendant contends that permitting plaintiffs to rely on a federal regulation as a substitute for key elements of a state law cause of action (i.e., duty and breach) “effectively deputizes private plaintiffs to enforce federal law” and violates the holding in Buckman. Dkt. #74 at 4. Plaintiffs distinguish Buckman on the ground that it involved a “fraud on the agency” claim that did not exist under state law. Buckman, 531 U.S. at 347 (“[T]he relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”). They argue that, unlike the claim in Buckman, their failure to warn claim arises under state law and falls within a field traditionally occupied by the states-the labeling of prescription drugs.

         As noted in the previous order, courts have resolved the implied preemption issue in negligence per se cases in conflicting and often muddled ways, at times confusing it with the express preemption provision in 21 U.S.C. § 360(k) applicable to medical devices. Dkt. #71 at 11-12. Defendant cites a few cases in which federal district courts have held that imposing liability because the defendant violated the Food, Drug and Cosmetics Act or its regulations amounts to the private enforcement of federal law and is therefore subject to implied preemption under Buckman. E.g., Perdue v. Wyeth Pharmaceuticals, Inc., ___ F.Supp.3d. ___, 2016 WL 3951091 (E.D. N.C. Jul. 20, 2016) (negligence per se claim impliedly preempted because it arose solely under federal law); Kapps v. Biosense Webster, Inc., 813 F.Supp.2d 1128, 1151-52 (D. Minn. 2011) (“A negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by definition, a claim that would give rise to liability under Minnesota law only because of the FDCA’s enactment. Such a claim is preempted under Buckman.”). See also Mitaro v. Medtronic, Inc., 23 Misc.3d 1122(A), 886 N.Y.S.2d 71 (Sup. Ct. 2009), aff'd, 73 A.D.3d 1142, 900 N.Y.S.2d 899 (2010) (intentional misrepresentation and fraud claims premised on false representations to the Food and Drug Administration are impliedly preempted under Buckman). (Although defendant cites other federal and state cases for the same proposition, those cases either do not address implied preemption or dispose of the negligence per se claim on state law grounds.) In Perdue, the district court addressed the same claim at issue in this case: the allegation that a manufacturer of a generic version of Amiodarone was negligent per se under North Carolina law for failing to adhere to the medication guide requirements. Perdue, 2016 WL 3951091, at *5. The court was persuaded that implied preemption applied because North Carolina had never required the provision of medication guides. Id. at *4-6 (citing several cases holding that test for implied preemption is whether state claim would exist in absence of Food, Drug and Cosmetic Act).

         Plaintiffs point out, however, that a number of federal circuit courts considering the issue have held or noted in dicta that state claims based on violations of the Food, Drug and Cosmetics Act are not impliedly preempted. McClellan v. I-Flow Corp., 776 F.3d 1035, 1041 (9th Cir. 2015) (“Where the plaintiff in Buckman alleged that the defendant made fraudulent representations during the market approval process, to the FDA, [] McClellan's requested [jury] instructions [on negligence per se] have little to do with direct regulatory interaction with the FDA.”); Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 586-87 (6th Cir. 2013) (failure to warn claim based on defendant’s violation of federal duty to include an updated warning in its labeling of drug not impliedly preempted because claim based on traditional state tort law principles); Hughes v. Boston Scientific Corp., 631 F.3d 762, 775 (5th Cir. 2011) (allowing plaintiffs to show that defendant’s violations of Food and Drug Administration regulations breached its duty to warn under state law and finding that “plaintiffs in Buckman were attempting to assert a freestanding federal cause of action based on violation of the FDA’s regulations. . . [and] did not assert violation of a state tort duty.”); Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010) (explaining that state law claim arising solely from violation of federal requirements is impliedly preempted but one alleging “breach of a well-recognized duty owed to [plaintiff] under state law” survives implied preemption); In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999) (affirming dismissal of state law negligence claims alleging conspiracy to violate the Federal Food, Drug, and Cosmetic Act but noting in dicta that some courts have allowed plaintiffs to use federal statutory violations to prove liability for separate state tort claim). Most instructive is the decision of the Court of Appeals for the Seventh Circuit in Bausch, which is binding on this court.

         Bausch involved state law negligence and product liability claims based on allegations that the defendant had manufactured a hip replacement medical device in violation of federal law. Bausch, 630 F.3d at 548. Defendant tries unsuccessfully to distinguish the case, arguing that the court of appeals held that plaintiff’s claims were state law “parallel claims” that successfully threaded the gap between § 360 express preemption and implied preemption under Buckman. Bausch, 630 at 552-53, ...

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