From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021 that further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices and other FDA regulated products, it is often helpful to review holdings that have affected the industry and may shape the years ahead.

Pharmaceuticals

In Frei v. Taro Pharmaceutical U.S.A., 844 F. Appx. 444 (2d Cir. 2021) cert. denied No. 21-654 2022 U.S. LEXIS 12 (U.S. Jan. 10, 2022), plaintiffs appealed from the FRCP 12(b)(6) dismissal of their first amended complaint alleging injuries from taking Amiodarone, a generic drug manufactured by Taro Pharmaceutical. The Second Circuit affirmed the dismissal because none of the claims were plausibly pled, and as such did not reach the questions of whether certain claims were preempted or barred by the learned intermediary doctrine.

Plaintiffs alleged that Taro concealed information regarding adverse events that had occurred from the off-label use of the drug to treat atrial fibrillation. The court found this allegation was not plausible, as it was based upon a broad statistical allegation, and one not specifically tied to Taro's conduct. Plaintiffs complained that Taro failed to make medication guides available to patients. The Second Circuit found that simply because plaintiffs did not receive medication guides did not mean Taro had committed any wrongdoing. Plaintiffs also allege that Taro failed to ensure the accuracy of prescribing information relied on by physicians, such as in the PDR, but the complaint did not explain how Taro, as a generic manufacturer, contributed to the inaccuracy or had authority to correct such reference materials.