March 6, 2019 at 1:13 pm PDT | by Arti Bhimani
OPINION: Gilead continuously placed profits over patient health

Arti Bhimani was the Arti Bhimani was the litigation attorney on the case. (Photo courtesy Bhimani)

Last month, a ruling by a California court gave HIV/AIDS patients—and potentially thousands of others—new hope, and a path toward justice for grave physical harm some may have suffered at the hands of Gilead for simply taking what should have been lifesaving medicine made by the company to manage their disease and prevent it from advancing.

Gilead, a greedy Bay Area drug company, produces many of the most effective and widely prescribed antiretroviral drug therapies used by HIV and AIDS patients today.

Last summer, with help and guidance from HIV Litigation Attorneys, who are funded by AHF, several individual patients filed personal injury lawsuits seeking to hold Gilead accountable for serious physical harm they suffered: debilitating and potentially fatal kidney and bone damage. They also sued over actions around Gilead’s failure to address or fix a known defect in one of its key AIDS drugs: tenofovir disoproxil fumarate or ‘TDF’ knowing full well that a safer alternate, tenofovir alafenamide or ‘TAF’ existed.

Gilead knew this safer drug existed because TAF was also one of its drugs.

Unsurprisingly, Gilead petitioned the court to try and have the cases dismissed.

However, in a February ruling, a judge from the Superior Court of the State of California for the County of Los Angeles, rejected all but one of Gilead’s arguments in its legal pleading seeking to have all the HIV/AIDS patients’ legal theories dismissed. The judge ruled that the plaintiffs’ allegations were sufficiently pled to move forward with all their legal claims, aside from one cause (strict liability).

In their lawsuits, the patients assert that Gilead recklessly and deliberately kept TAF off the market and out of the reach of patients for a decade or more in order to squeeze every last penny of profit from TDF.

They assert that Gilead’s zeal to maintain and maximize its corporate profits came at the considerable expense of the health and wellbeing of its customers who were prescribed and taking TDF, which, according to the patients’ lawsuits, the company knew as far back as 2001 from its own studies and other research was, “…highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.”

Meanwhile, Gilead’s own studies showed that the TAF formulation of tenofovir was far less toxic. Their studies also confirmed that TDF’s low absorption, high dosage requirements, and potential bone and renal toxicity were real risks. Yet, Gilead did not publish that research.

Instead, over the years and as TAF remained on the laboratory shelf, the FDA twice issued warning letters to Gilead over its marketing practices for TDF. The FDA stated that Gilead’s sales representatives had violated the law by giving doctors and patients false and misleading information regarding TDF’s side effects. According to a 2002 FDA Warning Letter, Gilead salespeople falsely stated that TDF had “no toxicities” was “benign” and was “extremely safe.”

A 2003 FDA Warning Letter even took the uncommon step of requiring Gilead to retrain its sales representatives to provide accurate information regarding the significant side effects associated with TDF and comply with the law (Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352).

So, Gilead knew years ago that continuing to sell TDF risked permanent and possibly fatal damage to the kidneys and bones in patients prescribed and taking the drug. It also knew that its newer, alternate version, TAF, would reduce the risk of toxicity and damage to kidney and bones.

What did Gilead do?

Surprisingly, in October 2004, Gilead’s then CEO John C. Martin—who made $187 million from Gilead in just one year (2014)—announced that, “the company is discontinuing its development program” for TAF.

However, Gilead did NO such thing.

Instead, between October 2004 and May 2005, Gilead applied for seven patents associated with TAF.

To be clear, not every patient taking TDF has had complications or such extreme or harmful physical side effects and no one should stop taking prescribed medication without consulting with a doctor on what may be the best option for them.

Nevertheless, Gilead continued to wring profits off the backs—and wreak havoc in the kidneys and bones—of many of its HIV/AIDS patients taking TDF knowing that a better alternative existed in its own labs.

The February court ruling is a groundbreaking victory for these HIV/AIDS patients in their quest for justice for the life-threatening physical harm that Gilead has caused. It is a victory that also paves the way for potentially thousands of other patients to seek their day in court for harm caused by Gilead’s greed.

As Michael Lujano, one of the initial plaintiffs said at the time of the ruling: “Gilead has shown a disregard for its patients’ health in order to reap outsized profits from its TDF medications. I am happy the judge has allowed our cases against Gilead to proceed.”

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Anyone interested in joining the Gilead lawsuit should visit www.hivlitigation.com or call HIV Litigation Attorneys at (833) HIV-SUIT (866-524-1210).

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