Products Liability Law Daily Wrap Up, WARNINGS ISSUES—DRUGS—E.D.N.Y.: Conclusory allegations result in dismissal of failure to warn suit against drug manufacturer, (Dec 3, 2021)

By Susan L. Smith, J.D., M.A.

Nearly all of the side effects that a woman allegedly suffered as a result of taking an antipsychotic medication were listed on the drug’s FDA-approved package insert.

A woman who filed an amended complaint against a pharmaceutical company for its failure to warn her about the possible side effects of a drug it manufactured failed to plead sufficient facts to support her claim, a federal district court in New York held. The woman alleged that the manufacturer’s failure to warn about the possible side effects of Invega-an antipsychotic medication-caused her to perform poorly on medical board examinations and, as a result, she was ineligible for a medical residency program. She asserted that, among other things, she suffered from subclinical hypothyroidism, facial nerve damage, motor and vocal tics, memory issues, neuropathy, and metabolic syndromes. The court determined that the allegations in her amended complaint were conclusory and that her allegations of the side effects from which she suffered were almost all the same as the side effects identified in the medication’s Food and Drug Administration (FDA)-approved package insert. The court concluded that the woman had not pleaded sufficient facts to state a plausible claim against the manufacturer. Therefore, her amended complaint was dismissed (Gioia v. Janssen Pharmaceuticals, November 22, 2021, Azrack, J.).

Prior proceedings. In a previous decision, the court dismissed the woman’s original complaint after determining that she failed to allege any facts to support her allegation that her treating physician was not informed of the risks of the drug. The court stated that the complaint provided only conclusory allegations that were not sufficient to plead a failure to warn claim. The court, however, allowed the woman to amend her claim, cautioning her to provide nonconclusory allegations as to why the pharmaceutical company failed to provide adequate warnings to her physician.

Duty to warn. In the instant case, the court explained that under New York law, a pharmaceutical manufacturer satisfies its duty to warn of a product’s risks by providing information to the prescribing physician, not directly to the patient. The court found that the woman’s amended complaint failed to plead a sufficient claim against the pharmaceutical manufacturer because her amended allegations failed to allege any facts to indicate that her physician was not informed of the side effects of the drug. Furthermore, the court pointed out that the drug’s FDA-approved package insert identified almost all of the side effects the woman experienced. The court dismissed the amended complaint and denied the woman permission to replead her claim because she’d had the opportunity to correct the deficiencies of the original complaint but failed to do so.

The case is Nos. 19-CV-04629 (JMA)(SIL), 19-CV-05377 (JMA)(SIL).

Attorneys: Maria Gioia, pro se. John D. Winter (Patterson Belknap Webb & Tyler LLP) for Janssen Pharmaceuticals.

Companies: Janssen Pharmaceuticals

Cases: CourtDecisions WarningsNews DrugsNews NewYorkNews