Appeals Court Weighs Gilead Challenge to Lawsuits Over Delaying HIV Drug Development

Gilead claims it had no duty to develop safer TAF-based HIV drugs to replace its older TDF-based medications, including Truvada, Viread, Stribild and others, which have been linked to bone fractures, kidney injuries and other side effects.

Gilead has asked a California appeals court to rule that it had no duty to develop and market safer versions of it’s medications, as part of a defense to thousands of HIV drug lawsuits that claim the manufacturer withheld less harmful formulations to maximize profits, putting patients at risk of kidney and bone damage.

Last week, the California Appellate Court for the First District questioned attorneys from both plaintiffs and defendants about the company’s duty regarding the sale of tenofovir disoproxil fumarate (TDF) based HIV drugs, including Viread, Truvada, Atripla, Complera and Stribild, which have been linked to reports of renal failure, kidney injury, bone loss, fractures and other complications associated with bone deterioration.

Gilead faces about 24,000 product liability lawsuits brought by former users of the HIV drugs in California state court, alleging that the company knew about a safer alternative formulation, involving the antiviral tenofovir alafenamide fumarate (TAF). However, the drug maker continued to sell the more toxic versions without adequate warnings, until it faced the prospect of diminished sale from generic equivalents, which the lawsuits indicate was part of a scheme to increase profits at the expense of patient safety and health.

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Kidney and bone injuries linked to the HIV drugs Truvada, Viread, Atripla, Complera and Stribild may have been avoided.

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The litigation has been delayed as Gilead pursues an interlocutory appeal, seeking to have the lawsuits dismissed on the grounds that it was not required to develop the TAF drugs any earlier than it did. The manufacturer argues that it had paused development of the drug for some time before clinical trials had been conducted, and that it was not required to continue working on it in order to replace the TDF drugs faster.

The drug maker has suggested that a ruling against it would stifle innovation, but plaintiffs assert that the company should be held responsible for intentionally withholding the safer, less toxic versions. They argue that Gilead owed consumers a duty to make sure its products are reasonably safe, and that it failed to do so.

The decision could determine whether tens of thousands of HIV drug lawsuits in that state move forward to trial.

While some cases have been filed in federal court, the majority of the claims have been brought in the state courts of California, where Gilead’s U.S. headquarters are located.

Given common questions of fact and law presented in claims filed throughout the state court system, the litigation has been consolidated before one judge for coordinated discovery and pretrial proceedings. Unless Gilead succeeds appealing this issue, it is expected that the court will hold a series of early “bellwether” trials, to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the of claims.


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