Frei v. Taro Pharmaceutical U.S.A., Inc.

Background

Sixty-seven plaintiffs brought claims against Taro Pharmaceuticals U.S.A., Inc., and unnamed defendants concerning Taro’s manufacture, sale, and promotion of generic amiodarone hydrochloride, an anti-arrhythmic heart medication. The plaintiffs alleged that they, their spouses, or related decedents were injured after taking Taro’s amiodarone to treat atrial fibrillation.

The plaintiffs alleged that the Food and Drug Administration had approved amiodarone as a “drug of last resort” for certain dangerous heartbeat irregularities, but that the brand-name manufacturer, Wyeth Pharmaceuticals, Inc., promoted it for first-line treatment of atrial fibrillation. They alleged that Taro benefited from that promotion, failed to correct information promoting off-label use, failed to provide medication guides to distributors and patients, and failed to warn about the drug’s risks and inappropriate first-line use.

The amended complaint asserted strict-products-liability and negligence failure-to-warn claims, claims concerning off-label promotion, negligence per se, violations of New York General Business Law Sections 349 and 350, fraud, and wrongful death. Taro moved to dismiss under Federal Rule of Civil Procedure 12(b)(6). The court accepted well-pleaded factual allegations as true for purposes of the motion but required the complaint to contain enough facts to make the claims plausible.

Failure-to-Warn Claims

The court dismissed the strict-liability and negligence failure-to-warn claims as impliedly preempted by federal law. Federal preemption means that federal law overrides a conflicting state-law requirement. The court concluded that generic manufacturers have an ongoing federal duty to keep their ingredients, safety information, effectiveness information, and warning labels the same as those of the brand-name drug.

The plaintiffs’ claims would have required Taro to provide stronger or different warnings than those approved for the brand-name drug. The court ruled that Taro could not comply with both that proposed state-law duty and its federal duty to keep the generic labeling the same. The court also rejected the plaintiffs’ argument that Taro could have asked the Food and Drug Administration to help obtain a stronger label, explaining that such a request would not satisfy a state-law duty to provide adequate labeling.

The court separately ruled that the claims based on medication guides were preempted. The applicable federal regulation required manufacturers to make medication guides, or the means to produce them, available to distributors. It required authorized dispensers to provide the guides to patients, but did not require manufacturers to provide them directly to patients. The court also concluded that the plaintiffs were effectively trying to enforce federal drug-law requirements through state tort claims, even though the federal statute did not create a private right to sue for those violations.

Off-Label Promotion

The court dismissed the claims concerning off-label promotion. The claims were based on allegations that Taro benefited from Wyeth’s marketing, failed to correct promotional information in third-party materials, and failed to seek stronger medication-guide and labeling information. The court ruled that these theories were preempted because they would require Taro to change the labeling or design, leave the market, or accept state-law liability for not doing so. The court also stated that the alleged duties concerning off-label promotion existed only under federal drug law and therefore were preempted for that additional reason.

Negligence Per Se

Negligence per se is a theory that treats violation of a qualifying statute as negligence. The plaintiffs based this claim on the medication-guide allegations and on New York Education Law provisions concerning adulterated or misbranded drugs.

The court dismissed the claim because the federal medication-guide regulation was not privately enforceable and did not require manufacturers to provide guides directly to patients. The court also found that the plaintiffs had not plausibly alleged that Taro engaged in the conduct prohibited by the New York statute. In addition, Taro could not unilaterally change the federally approved warnings and information for its generic drug.

New York General Business Law Claims

The court dismissed the claims under New York General Business Law Sections 349 and 350. Section 349 concerns consumer-oriented unfair or deceptive business practices, while Section 350 concerns false advertising. The court found that the plaintiffs had not plausibly alleged the required elements.

The court explained that prescription-drug warnings are directed to prescribing doctors rather than directly to drug users for purposes of Section 349. It also found that the plaintiffs alleged only that Taro failed to counteract a decades-old marketing campaign by the brand-name manufacturer and failed to correct information in third-party materials for which Taro was not responsible. The court concluded that these allegations did not state a plausible claim under either section.

Fraud

The court dismissed the fraud claims. Under Federal Rule of Civil Procedure 9(b), fraud must be pleaded with particularity by identifying the allegedly fraudulent statements, who made them, where and when they were made, why they were fraudulent, and how they caused injury.

The court found that the plaintiffs did not identify what information their doctors relied on when prescribing amiodarone for atrial fibrillation. It also found that the allegations about Taro’s marketing and promotional activities were conclusory and lacked the specific facts required by Rule 9(b). The court stated that these claims might not have been preempted because they appeared to rely on state law, but dismissed them for insufficient pleading.

Wrongful Death and Disposition

The court dismissed the wrongful-death claim because the plaintiffs had not plausibly pleaded a wrongful act by Taro that caused the deaths of related decedents.

The court granted Taro’s motion to dismiss. It instructed the Clerk to terminate the motion and close the case. The provided case metadata lists March 10, 2020 as the filing date, while the opinion itself is dated March 9, 2020.