The Second Circuit on Tuesday affirmed a Southern District of New York dismissal of a case brought by 71 individuals against Taro Pharmaceutical U.S.A. Inc. lodging claims of strict liability, negligent failure to warn, negligent marketing and sale, negligence per se, fraud, and wrongful death stemming from the plaintiffs’ use of Taro drug Amiodarone.
The original complaint against generic pharmaceutical manufacturer Taro alleged that the drug company was complicit in the injuries of the plaintiffs, some purportedly resulting in death, by failing to make “medication guides” noting proper use and risks of Amiodarone available to patients and failing to ensure that the drug information promulgated to physicians was accurate. The plaintiffs also claimed that Taro “concealed” records of adverse effects of the drug in treating atrial fibrillation.
Sixty-seven individuals appealed the dismissal by the district court, which reasoned that the claims of failure to warn and negligent marketing and sale were preempted under the Federal Food, Drug, and Cosmetic Act, and the remaining causes of action were not plausibly pleaded. The Second Circuit agreed with the district court.
The circuit panel reasoned that the plaintiffs conclusorily asserted their claims, meaning that they made a causational link from the defendant to the injuries of the plaintiffs without properly detailing the specific ways Taro was at fault. For example, noting the plaintiffs’ allegations over the lack of access to medication guides, the court said they did not plead the particulars of how Taro violated its purported duty to provide the guides. On the allegation that Taro did not conduct proper quality assurance in providing accurate prescribing reference materials, the court concluded similarly, citing that the plaintiffs did not give specific examples for how physicians were led astray or not given access to the proper materials.
Further, any allegation related to the labeling of the drug necessarily cannot survive here because generic drug manufacturers “do() not have control over this labeling,” the court explained.
The allegation that Taro did not disclose adverse effects from using Amiodarone also was not sufficiently pleaded and instead manifested in a “broad statistical allegation” not necessarily tied to Taro’s own conduct, according to the Second Circuit. The complaint had reasoned that because there are millions of people diagnosed with atrial fibrillation every year, there should be tens of thousands of people who experience adverse events annually — but because there are not nearly that many adverse event reports submitted to the Food and Drug Administration each year, Taro must be concealing reports, the plaintiffs alleged.
“This allegation merely posits that all entities in the Amiodarone market should have collectively reported more adverse events of pulmonary toxicity in light of the frequency of these events in the general population,” the court said. “We cannot draw from this allegation an inference that Taro itself concealed information in its possession.”