On March 26, Judge Kevin McNulty of the U.S. District Court for the District of New Jersey rejected a dismissal motion filed by Gilead Sciences over a Truvada lawsuit, stating that the failure-to-warn claim is not preempted as the company was not barred from seeking FDA's approval for an enhanced warning.
Truvada is one of the five different Tenofovir Disoproxil Fumarate (TDF) brand name drugs sold in the U.S. TDF is an orally administered prodrug of tenofovir and is similar to Adefovir, which is used for the treatment of HIV and chronic hepatitis B virus infections. Truvada was approved by the FDA on August 2, 2004, for the treatment of HIV-1 infection in adults.
The lawsuit was filed by a man who started taking Truvada daily in 2005, and at the same time, he was diagnosed with kidney diseases. Five years later he started experiencing pain and the pain continued until 2018 when he was diagnosed with chronic pain related to musculoskeletal disorders.
Gilead was sued in the New Jersey Superior Court over allegations that the medication was defective because it caused kidney and bone damage, and Truvada’s label failed to warn about the risks associated with it.
Gilead filed a motion to dismiss, arguing that all of the claims are preempted and that the failure-to-warn claim is precluded by New Jersey law.
According to the latest opinion, Judge McNulty stated that the lawsuit alleges Gilead acquired new information about the side effects of its HIV drugs and did not pass on to federal regulators, which is the reason for dismissal as it is clear that the risks Gilead allegedly failed to warn about did not meet the definition of newly acquired information.
The lawsuit also noted that the company had conducted studies from October 2001 through May 2007, indicating that healthy individuals were experiencing adverse kidney events while taking Truvada, which the company failed to warn doctors to monitor patients for kidney problems after this new information became available.
