Centralization for TDF Drug Lawsuits Sought With JPML

With a growing number of product liability lawsuits being pursued that allege Truvada, Viread, and certain other HIV drugs are too toxic, a group of plaintiffs have filed a petition asking for the centralized management of claims filed throughout the federal court system over the potential side effects of tenofovir disoproxil fumarate (TDF), which is the active ingredient contained in the drugs. 

Gilead Sciences currently faces at least five complaints in different U.S. District Courts, which involve a total of about 150 plaintiffs, each raising similar allegations that consumers and the medical community have not been adequately warned about the potentially toxic side effects of TDF drugs used for treatment of HIV.

On December 19, some plaintiffs filed a motion to transfer (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for the cases to be centralized for pretrial proceedings before one judge in the Northern District of California, where Gilead is headquartered.

Given similar questions of fact and law raised in the TDF drug lawsuits, the motion claims that consolidation as part of a federal multidistrict litigation (MDL) will help prevent duplicative discovery, avoid contradictory rulings by different judges, and serve the convenience of the courts, parties and witnesses.

Gilead manufactures, markets and sells Viread, Truvada, Atripla, Complera and Stribild; all of which are HIV drugs that contain the active ingredient TDF. Viread was the first on the market in 2001.

Plaintiffs say that the company has been accumulating data on the toxicity of the drugs ever since, and by the time it released Stribild 10 years later, it had plenty of evidence of the drugs’ effects on kidneys and bones.

However, the lawsuits claim Gilead also had another drug, tenofovir alafenamide fumarate (TAF), which it knew was less toxic than TDF because it could be administered at a lower dose with the same effectiveness. The lawsuits claim that, despite that knowledge, Gilead sat on TAF for years, so that it could profit from TDF-based drugs before releasing a safer and improved version once its patent protections ran out.

“All plaintiffs allege that Gilead intentionally designed its TDF drugs to be unreasonably and unnecessarily toxic to patients’ kidneys and bones, while it purposefully withheld a safer design of the drugs for more than a decade in order to make more money,” the motion states. “All plaintiffs also challenge the inadequate warnings Gilead gave to physicians and consumers about the risks and safe use of the TDF drugs. Because the cases involve numerous common questions of fact and law, transfer for centralized proceedings in one federal district court will achieve efficiencies in discovery and motion practice, preserve judicial resources, and alleviate the risk of inconsistent pretrial rulings.”

The company shelved TAF in 2004, and did not begin to sell TAF-designed drugs until 2015, plaintiffs point out, which gives them patent protection until 2032. TDF drug patents began expiring last year.