Health Law Daily Generic manufacturer has ‘duty of sameness’ on drug label
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Thursday, March 12, 2020

Generic manufacturer has ‘duty of sameness’ on drug label

By Jeffrey H. Brochin, J.D.

Because the generic manufacturer of amiodarone hydrochloride could not have disseminated post-marketing warnings inconsistent with the warnings and labeling approved by the FDA for the brand drug, the patients’ claims were preempted.

A federal district court in New York has dismissed the state strict liability and negligence claims brought by heart arrhythmia patients against Taro Pharmaceutical USA, Inc. (Taro), the generic manufacturer of amiodarone hydrochloride, because the claims were preempted by federal law, after a finding that the brand manufacturer, Wyeth Pharmaceuticals, Inc’s. (Wyeth’s) Cordarone® labels were approved by the FDA and Taro’s were consistent with the approved labels (Frei v. Taro Pharmaceuticals, Inc., March 9, 2020, Briccetti, V.).

Drug of last resort. In 1985, Wyeth received FDA approval to market and sell Cordarone® (amiodarone hydrochloride) for the treatment of ventricular fibrillation and ventricular tachycardia. However, the FDA approved the use of amiodarone only where other treatment options were unsuccessful or were otherwise not appropriate for a particular patient. In other words, the FDA approved amiodarone as a "drug of last resort." A group of patients who used Taro’s generic version of the drug alleged that notwithstanding that proviso, Wyeth aggressively and successfully marketed Cordarone for inappropriate off label use as a first-line anti-arrhythmic therapy. The patients further alleged that the FDA repeatedly warned Wyeth to stop marketing Cordarone in a manner which downplayed safety risks and promoted off-label use. Also, that the FDA promulgated a regulation requiring manufacturers of amiodarone to make available to distributors a medication guide explaining the drug’s safety information.

Taro moved to dismiss the patients’ state law strict liability, negligence, and failure to warn claims, which for the reasons stated below, the court granted.

Variations of pre-emption. The court began its analysis by reviewing the difference between express pre-emption and implied pre-emption: Express preemption is present when Congress’s intent to preempt state law is explicitly stated in the statute’s language; and, implied preemption arises when, in the absence of explicit statutory language, Congress intended the federal government to occupy a field exclusively, or when state law actually conflicts with federal law, the latter pre-emption also being known as "conflict pre-emption."

Duty of sameness upon generic manufacturers. The court found that in the instant case, the failure to warn claims were not expressly pre-empted by federal law, but rather that they impliedly pre-empted. The Supreme Court has held that with respect to brand-name, or "innovator," manufacturers, state law failure to warn claims are not preempted by federal law, but, that such suits cannot go forward against generic drug manufacturers, as it is impossible for them to comply simultaneously with their state duty to adequately warn and their federal duty of sameness. That duty requires that a generic manufacturer’s ingredients, safety, efficacy, and warning labels must remain identical to its branded equivalent.

Because Taro could not have disseminated post-marketing warnings inconsistent with Wyeth’s warnings and labeling—approved by the FDA—without violating federal law, and also could not have disseminated alternative post-marketing warnings without violating federal law, the patients’ claims were preempted in those respects. The failure to warn claims against Taro were also preempted inasmuch as they concerned Taro’s alleged failure to provide medication guides to amiodarone distributors and patients. When the FDA has made a conclusive determination, positive or negative, as to the existence of a link between the drug at issue and some adverse health consequence, state law cannot mandate that a manufacturer include additional warnings beyond those that the FDA has determined to be appropriate to the risk.

For the foregoing reasons, the court granted Taro’s motion to dismiss the state claims.

The case is No. 7:19-cv-02939-VB.

Attorneys: Alan M. Mansfield (Consumer Law Group of California) and Edward K. Wood, Jr. (Wood Law Firm LLC) for Judith Frei. Arthur J. Liederman (Morrison Mahoney, LLP) for Taro Pharmaceutical U.S.A., Inc.

Companies: Taro Pharmaceutical U.S.A., Inc.; ABC Corp. or Entities 1-50

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