Gilead to Pay $40 Million to Settle Claims Over Delayed Safer HIV Drug

Gilead Sciences, Inc. agreed on Tuesday to pay $40 million to about 2,625 HIV patients across China. These patients accused the pharmaceutical giant of concealing harmful side effects while marketing a drug for years and deliberately delaying the release of a safer alternative to boost profits. This settlement only applies to federal courts and does not affect similar lawsuits filed by 22,000 patients in California state courts.

The company insisted in its statement that it had not engaged in any misconduct and stated that it has "always been committed to improving the lives of HIV patients." Nevertheless, Gilead’s agreement to pay more than $15,000 to each patient indicates at least some legal vulnerability on the part of the company.

The drug, named Tenofovir Disoproxil Fumarate (TDF), was one of the first effective medications against the Human Immunodeficiency Virus (HIV). Gilead Sciences began developing TDF in 1991 and received approval from the U.S. Food and Drug Administration (FDA) for its market release in 2001.

However, the plaintiffs claim that Gilead was aware that TDF could cause bone or kidney damage, and allege that they suffered these or other injuries as a result of using the drug.

In 2001, Gilead was also developing another HIV drug, tenofovir alafenamide (TAF). In 2004, the company suspended the development of TAF, claiming that TAF was substantially equivalent to TDF. However, the lawsuit pointed out that Gilead knew the new drug had a lower dosage and fewer side effects but deliberately withheld it to continue profiting from TDF.

Gilead restarted the development of TAF in 2011 and received FDA approval for its market launch in 2015, just before the expiration of the TDF patent, which would allow other companies to sell generic versions of the drug.

In the California case, the Court of Appeal, First Appellate District of California ruled in January that Gilead could be sued for negligence for withholding a safer drug. This was the first ruling in the state allowing a company to be held liable for a drug that effectively prevents disease but may cause other harms. However, the California Supreme Court agreed last month to hear Gilead's appeal, leaving the issue unresolved in the state courts. A decision is expected next year.

U.S. District Judge Jon Tigar in Oakland refused to dismiss the case in September, saying Gilead may be held legally responsible for marketing a harmful product even if it effectively treats diseases.

In a statement on Tuesday, Gilead said the $40 million settlement would be finalized if at least 98% of the plaintiffs agree.

For the plaintiffs who refused to settle, Gilead stated that it would continue to firmly defend itself and claimed that when the development of alternative drugs was suspended from October 2004 until 2011, the long-term safety of TAF was unknown and unpredictable.

The patient's lawyer has not yet made an immediate comment.

Gilead pays $40m to settle allegations that it delayed work on an improved HIV drug to maximise profits from an older drug

BMJ 2024; 385 doi: https://doi.org/10.1136/bmj.q1285 (Published 11 June 2024)

Latest Developments in HIV