Four Californians living with HIV, including one in Marin County, are suing the pharmaceutical company Gilead Sciences over its continued distribution of what they say is a toxic HIV medicine while it kept a safer version of the drug on its lab shelf to turn a higher profit.
Los Angeles-based AIDS Healthcare Foundation announced the lawsuits in a news release last week.
Two separate lawsuits were filed May 8 in a Los Angeles County Superior Court by patients living with HIV who say Gilead knew that the drug tenofovir disoproxil fumarate, known as TDF, was "highly toxic" and could cause possibly fatal damage to kidneys and bones.
The suits also allege that the Foster City-based drug maker "deliberately and maliciously" withheld its safer and newer alternative HIV drug, TAF, from consumers "in order to extend the patent life, and sales, of its existing medications that included TDF." And that it used deceptive marketing strategies to promote TDF to health professionals and consumers.
One of the cases is a personal injury lawsuit that was filed by two Californians living with HIV who suffered bone and kidney damage.
The second is a class action lawsuit filed by two other HIV-positive Californians on behalf of all Californians who were prescribed or have taken the company's drugs: Viread, Truvada, or Atripla from October 26, 2001 through the present.
Truvada is widely used for HIV prevention known as PrEP. AHF has long questioned what the consequences of its longtime usage may be.
Both cases claim the company failed to warn patients of the damaging side effects of the drug and misrepresented the medication as a "miracle drug." The complaint says Gilead knew as far back as 2001 from its own research that TDF was highly toxic in the doses prescribed and risked permanent injury.
"A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the 'miracle drug' and using other deceptive marketing strategies," Michael Lujano, from Los Angeles, one of two plaintiffs in the personal injury suit, said in a statement. "Gilead shelved a far safer drug called tenofovir alafenamide fumarate simply to increase its long-term profits."
Marin County plaintiff Ricardo Wohler, 52, a gay man who lives in Sausalito, spoke with the Bay Area Reporter over the phone about the serious side effects he experienced after 12 years of taking TDF. He first started taking TDF in 2005 and slowly began losing teeth almost 10 years later, having never been informed of the potential side effects.
"I didn't know, but I had a suspicion it could be from the medication," said Wohler, who is a real estate agent. "I talked with my doctor, and he said there was no way it was the medicine and that there was no hard data to support that."
In three years, Wohler lost 17 teeth and suffered severe bone loss in his jaw, an experience he said changed his life.
"Losing my teeth was one of the most traumatizing things to ever happen to me," he said.
Wohler said he lost a tremendous amount of time, having to get substantial dental work, unearned income, and still owes money for his dental work. He decided to enter the lawsuit when he was informed of Gilead's knowledge of the potential side effects of TDF that it withheld from the public.
Although Wohler does not have kidney or other bone loss, he is not confident that it won't be discovered down the road.
The personal injury suit claims that the federal Food and Drug Administration issued warning letters to Gilead over its TDF marketing practices in 2002 and 2003. The letter, according to the suit, reprimands Gilead, saying it violated the law by giving doctors and patients false and misleading information regarding TDF's side effects. The warning letter states that salespeople falsely claimed TDF had "no toxicities," was "benign," and was "extremely safe," according to the suit.
The second FDA letter required Gilead to retrain its salespeople to give accurate information about the side effects associated with TDF, the suit states.
AHF filed both lawsuits with co-counsel Michelle Rutherford of Rutherford Law and says it is funding the litigation but will not accept any financial recovery in excess of its actual costs.
"For far too long Big Pharma has been abusing the financial and legal benefits they've been given under the guise of fostering research and development," said Liza Brereton, an attorney for AHF representing the plaintiffs, in a statement. "These lawsuits, however, make clear that Gilead's perverse motive of outsized profits and increased market share is not in line with patient health and safety. Under these circumstances, the laws must be read to protect public health from corporate greed."
Gilead had no comment.
Ryan McKeel, associate director for public affairs for the company, wrote in an email, "We are thoroughly reviewing the complaints and will not provide comment until that process is complete."
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