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Plaintiffs’ Claims Against Gilead Permitted to Proceed in HIV Drug Lawsuits

Gilead Sciences, Inc. (“Gilead”) manufacturers the HIV drugs: Truvada, Atripla, Viread, Stribild, and Complera. After being named as a defendant in multiple lawsuits in 2018, Gilead filed a motion to dismiss all of the plaintiffs’ claims in the lawsuits, arguing that they were preempted by federal law, including the design defect allegations. Plaintiffs allege that these HIV drugs, which contain tenofovir disoproxil fumarate (“TDF”), cause kidney damage, such as chronic kidney disease, and bone damage, such as osteoporosis or osteopenia.

U.S. District Judge, Jon S. Tigar, recently held that “Gilead could have independently complied with both state and federal law prior to submitting the TDF drugs for FDA approval. Because Gilead has not presented ‘clear evidence’ that the [U.S. Food and Drug Administration] would not have approved the allegedly safer versions of the drugs that plaintiffs contend would have complied with state law, plaintiffs’ pre-approval design-defect claims are not preempted.” The judge also allowed plaintiffs to proceed with any of their fraud and consumer protection claims, based on Gilead’s alleged omissions.

However, Judge Tigar did grant a portion of Gilead’s motion, dismissing claims related to plaintiffs’ claim that Gilead had failed to warn them and their doctors about the risks associated with the HIV drugs insofar as those claims are based on assertions that Gilead could have made a required label change after 2008. Judge Tigar advised that plaintiffs could amend their Complaints with additional information to try to revive the claim. Claims related to fraud and consumer protection claims were also dismissed insofar as the claims were based on alleged misrepresentations Gilead made about the HIV drugs.

With Judge Tigar’s recent ruling, additional complaints are expected to be filed in the near future with an application for official consolidation to follow.

COPYRIGHT © 2023, STARK & STARKNational Law Review, Volume IX, Number 134

About this Author

Stefanie Colella Walsh, Pharmaceutical Litigation Attorney, Stark Law Firm

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She also handles litigation related to nursing home negligence and abuse claims, elder abuse, and assisted living facility litigation.

Recently, Ms. Colella-Walsh was a member of the national trial team involved the first trial in the country of a TVT-Secur transvaginal...

Martin P. Schrama, Stark Law, Intellectual Property and Litigation Law Attorney

Martin P. Schrama is a Shareholder in Stark & Stark's Commercial Litigation, Mass Tort, Intellectual Property and Green Litigation Groups. Mr. Schrama has extensive experience litigating on both the trial and appellate levels of the federal and state courts of New Jersey and New York, as well as numerous other jurisdictions throughout the nation in a pro hac vice capacity. This experience also extends to regular practice before AAA, JAMS and various other alternate dispute resolution fora.

The primary focus of Mr. Schrama’s practice is...