![]() ![]() As the drug’s manufacturer, Janssen had no duty to warn plaintiff directly of the potential side effects or risks of taking Invega-that was the responsibility of plaintiff’s physician, the learned intermediary. Plaintiff claimed that defendant failed to “provide proper informed consent about ultimate outcome as well as important side effects from taking their medicine Invega” but plaintiff’s lack of informed consent claim against a manufacturer is non-cognizable under New York law, and was dismissed with prejudice. While a court is required to read a plaintiff’s pro se complaint liberally and interpret it as raising the strongest arguments it suggests, a pro se plaintiff must still plead enough facts to state a claim for relief that is plausible on its face. Manufacturer of the schizophrenia drug Invega moved to dismiss complaint alleging pro se plaintiff suffered numerous side effects, including hypertension, diabetes, and stroke, which led to the end of her career as a primary care physician. Thus, these failure to warn claims were not plausibly pled. 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. The Second Circuit found that simply because plaintiffs did not receive medication guides did not mean Taro had committed any wrongdoing. Plaintiffs complained that Taro failed to make medication guides available to patients. ![]() 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 alleged that Taro concealed information regarding adverse events that had occurred from the use of the drug to treat atrial fibrillation. 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 appealed from the FRCP 12(b)(6) dismissal of their first amended complaint alleging they suffered injuries from taking Amiodarone, a generic drug manufactured by Taro Pharmaceutical, for the off label treatment of atrial fibrillation.
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