Court certifies class action against drug giant

A class-action lawsuit alleging a U.S. pharmaceutical giant marketed an HIV drug in Canada after it had discovered a safer alternative has been certified by a B.C. Supreme Court judge.

The lawsuit's two representative plaintiffs alleged Gilead Life Sciences and its Canadian affiliate, Gilead Sciences, sold a drug that causes kidney and bone damage — instead of a newer, safer version — in an attempt to increase profits.

The plaintiffs allege Gilead was negligent because it sold drugs referred to as TDF and marketed under five brand names “to maximize profits from TDF-based drugs while they were still patent-protected from competition, needlessly depriving HIV/AIDS patients from earlier access to the less harmful” drugs referred to as TAF-based.

Gilead had asked the court to dismiss the lawsuit, saying drugs with TDF, or tenofovir disoproxil fumarate, and those with TAF, or tenofovir alafenamide fumarate, both effectively treated HIV/AIDS even though they had different risks and benefits, and both were approved by the Canadian government.

“Their development occurred on different timelines for legitimate reasons,” Justice Jan Brongers quoted Gilead as saying.

Gilead also said the two drugs are “still marketed and safely used today” and TDF is not defective and included warnings about side-effects.

But after a three-day court hearing in September, Brongers has ruled the proposed class action raises “a reasonable cause of action for negligent design that raises genuine issues for trial.”

He said it may eventually be dismissed, but deserves to go to trial.

One of the two plaintiffs, identified only as I.F., tested positive for HIV in the early 1990s and was prescribed a TDF drug called Truvada in 2007, according to the judgment.

He took it until early 2020, when his prescription was switched to a TAF drug called Biktarvy because of concerns about his long-term kidney health, it said.

Gilead, which obtained the patent rights to TDF in 1997, marketed five different brands: Truvada, Viread, Atripla, Complera and Stribild. It had exclusive rights to make TDF drugs until 2017, when generic drug manufacturers were also allowed to make and sell them, the judgment said.

Gilead began developing TAF in 1998. It said in 2004 it was discontinuing its research on TAF, but then announced it was going ahead with TAF in 2010. It released four brands of TAF drugs in Canada, one a year from 2015 to 2018, the decision said.

Internal Gilead documents that came out during a similar U.S. lawsuit against it last year suggested the company may have stopped developing TAF drugs in the early 2000s to avoiding hurting sales of its TDF drug, Viread, the judgment said.