Gilead faces personal injury suit for not rectifying HIV-drug’s alleged defect

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Forty-one patients from 12 states in the US who are living with HIV or Aids or were on PrEP have filed a personal injury lawsuit against Gilead Sciences Inc seeking to hold the drug maker accountable for actions around its failure to rectify an alleged known defect in the drug formulation of one of its most widely prescribed medications: tenofovir disoproxil fumarate (TDF) knowing that a safer alternate, tenofovir alafenamide (TAF) existed in its own laboratory; its failure to warn patients of the damaging side effects of TDF; and the company’s active misrepresentation of TDF’s efficacy and substantial risks.

The legal action, prepared by HIV Litigation Attorneys, was filed in Superior Court of the State of California for the County of Los Angeles, as personal injury claims and demands a jury trial. Aids Healthcare Foundation (AHF) is funding the litigation and will not receive any financial recovery from the lawsuit in excess of its actual legal costs.

The lawsuit was filed by 41 individuals who suffered bone and/or kidney damage as a result of taking Gilead’s TDF despite the fact that the company knew as far back as 2001 that it was ‘…highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones,’ AND that Gilead had a safer alternate tenofovir alafenamide (TAF) that it deliberately and maliciously suppressed from the market for nearly fifteen years in order to extend its profits.

Plaintiffs in the case against Gilead hail from California, Florida, New York, Pennsylvania, Alabama, Arkansas, Iowa, Maryland, Michigan, New Mexico, Ohio and Virginia.

TDF is prescribed and sold by Gilead under the brand name Viread. TDF is also a component of Gilead’s Truvada, an HIV/Aids treatment medication that is also used to prevent HIV acquisition in the prevention protocol known as pre-exposure prophylaxis or PrEP. TDF is also a component of Gilead’s all-in-one combination antiretroviral therapies Atripla, Complera and Stribild for use by people living with HIV or Aids.

As such, thousands and thousands of HIV/Aids patients may have been unwittingly exposed to significant kidney and bone damage from TDF as a component of their ostensibly lifesaving antiretroviral drug regimens – all manufactured and sold by Gilead. In addition, many HIV-negative individuals seeking to prevent HIV acquisition may have suffered similar harm to their kidneys or bones from taking Truvada as part of their PrEP protocol.

The case filing asserts that Gilead’s zeal to maintain and maximise its corporate profits came at the expense of the health and wellbeing of its customers who were prescribed and taking TDF. The case also asserts that Gilead deliberately and maliciously suppressed from the market its alternate and newer formulation of the drug, TAF, in order to extend the patent life, FDA exclusivity, and sales of its existing medications that included TDF. Gilead earned over $18bn in net profit in 2015.

“I contracted HIV through my work as a nurse serving others and then learned that my kidneys and bones were damaged from taking Gilead’s TDF based drugs for HIV. I am glad that my voice and the voices of others who have been taken advantage of for more profits will finally be heard,” said Rachelle Lyons, one of the Plaintiffs in the new lawsuit.

“More and more plaintiffs are coming forward to tell their stories of how they have been harmed by Gilead’s practice of putting profits over patient health. We look forward to working with this new group of plaintiffs from around the country to hold Gilead accountable and seek justice for the people it has harmed. We will continue filing lawsuits against Gilead regarding its TDF medications,” said Liza Brereton of HIV Litigation Attorneys, attorney for the plaintiffs, and also counsel for AHF.

“I am privileged to be a part of this important and ground-breaking litigation. These plaintiffs have suffered greatly at the hands of Gilead we will continue to fight to hold Gilead accountable for its horrendous actions,” added Courtney Conner of HIV Litigation Attorneys, attorney for the plaintiffs, and also counsel for AHF.

The legal action against Gilead asserts claims for: 1) Strict Products Liability – Failure to Warn; 2) Negligence and Gross Negligence – Design Defect and Failure to Warn; 3) Fraud, and 4) Breach of Express and Implied Warranty.

Regarding the potential harm caused by TDF, the fraud claim asserts that: “…the real reason Gilead abandoned its TAF (tenofovir) design in 2004 was not because TAF could not be sufficiently differentiated from TDF; (d) Gilead purposefully withheld the TAF design, which it knew was safer than TDF, to make more money; and (e) Gilead knew to warn doctors to frequently monitor all patients for the adverse effects of TDF toxicity using more than one marker of kidney function even though it did not do so in its warnings to doctors in the US.”

It also noted that: “Gilead intentionally omitted from its prescriber and patient labelling an adequate warning regarding the need for doctors to monitor all TDF patients, on a frequent, specific schedule, for the adverse effects of TDF-associated bone and kidney toxicity. Gilead intentionally omitted an adequate monitoring warning in order to conceal the true risk of its TDF Drugs, and to inflate sales by inducing doctors to prescribe, and patients like Plaintiffs to consume, its TDF Drugs. By providing inadequate warnings that were contrary to those it gave with respect to the exact same drugs in the EU, Gilead partially disclosed material facts. Gilead had a duty of complete disclosure once it began to speak.”

HIV Litigation Attorneys previously filed lawsuits in May 2018 on behalf of HIV patients from Los Angeles, San Diego and Marin Counties in California state court for similar personal injury claims and also for a California consumer class action case against Gilead. AHF is also funding that litigation.

Aids Healthcare Foundation material

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