Products Liability Law Daily Wrap Up, WARNINGS ISSUES—DRUGS—E.D.N.Y..: District court dismisses vexatious failure to warn action and precludes further litigation, (Mar 18, 2026)

By Sara Cracau, J.D.

District court granted consumer’s motion to proceed in forma pauperis (IFP) but dismissed failure to warn action and barred her from filing further litigation relating to injuries allegedly resulting from her use of Invega without prior leave of court.

A district court in New York granted a consumer’s motion to proceed in forma pauperis (IFP) but dismissed her failure to warn action in its entirety and barred her from filing further litigation relating to injuries which she allegedly sustained arising from her use of Invega without prior leave of court. The court found that because the failure to warn claim was already litigated and decided on the merits, any further litigation is precluded by res judicata and collateral estoppel. The court found that the consumer’s additional claims failed as a matter of law and were dismissed. The court barred the consumer from filing any new complaint relating to the same subject matter as Gioia I-X, including allegations either arising from or relating to Ivega without first securing leave of court. Although, ordinarily, a pro se plaintiff is given the opportunity to amend at least once, in this case, granting leave would be futile. Therefore, the court denied the consumer leave to amend (Gioia v. Johnson and Johnson, No. 2:25-cv-2810 (NJC) ( SIL) (E.D. N.Y. Mar. 11, 2026)).

A pro se consumer filed her tenth complaint against a pharmaceutical company alleging that she sustained injuries resulting from her use of Invega that was manufactured by a wholly owned subsidiary of the pharmaceutical company and prescribed to her by a psychiatric health provider. According to the longstanding litigation history, the consumer, invoking diversity subject matter jurisdiction, alleged that she sustained injuries because of taking Invega without being informed of various important side effects which allegedly caused her subclinical hypothyroidism and poor scholastic achievement on board exams. She sought damages of between $12-17 million. She alleged violations of the New York Privacy Act as well as allegations of lack of transparency and accountability in connection with the company’s data collection practices. Her complaint was replete with various allegations claiming that various individuals impersonated lawyers and took information from her about her personal experience with Invega

Preclusion. The court found that because the failure to warn claim was already litigated and decided on the merits, any further litigation is precluded by res judicata and collateral estoppel. Under New York’s transactional approach, the res judicata bar extends to all claims arising out of the same transaction or series of transactions. Therefore, any other claims that may liberally be construed to arise from the consumer’s use of the drug Invega are similarly precluded.

The Penal Law, failure to warn, and Privacy Act claims. The court found that the consumer’s additional claims failed as a matter of law and were dismissed. Under the New York Penal Law, there is no private right of action. The failure to warn claim was not plausible because the very warning that was allegedly missing was included in the Invega labelling.

Litigation injunction. The court barred the consumer from filing any new complaint relating to the same subject matter as Gioia I-X, including allegations either arising from or relating to Invega without first securing leave of court. The court found that the consumer’s ten cases illustrated a pattern of duplicative, vexatious, and harassing lawsuits. Considering the consumer’s litigation history in both federal and state court, the court noted that her continued filing of new complaints against the pharmaceutical company or those in privity with it, was not acceptable. Furthermore, it clarified that the court has an obligation to protect the public from those who interfere with the proper administration of justice and have a history of litigation involving vexation, harassment, and needless expense. Her repetitive and incoherent submissions have resulted in an unnecessary burden on the court, consumed the court’s resources, and her continued filing of frivolous complaints has been an abuse of the judicial process. Her filings reveal a lack of a good faith expectation that she will prevail. Furthermore, the court has repeatedly warned the consumer about the vexatious, harassing, and duplicative nature of her litigation with no effect. Although the court was particularly sensitive to the consumer’s pro se status and has considered her position in the most favorable light, she has been afforded notice and an opportunity to be heard on the propriety of a litigation injunction.

Leave to amend. Although, ordinarily, a pro se plaintiff is given the opportunity to amend at least once, in this case, granting leave would be futile. Therefore, the court denied the consumer leave to amend.

The case is No. 2:25-cv-2810.

Judge: Choudhury, N.

Attorneys: Anderson Shackelford (K&L Gates LLP) for University of North Carolina Hospitals at Chapel Hill. Caitlin C. Van Hoy (Alston & Bird LLP) for UnitedHealthcare of North Carolina, Inc.

Companies: University of North Carolina Hospitals at Chapel Hill; UnitedHealthcare of North Carolina, Inc.

Cases: CourtDecisions WarningsNews DrugsNews NewYorkNews