California Judge Allows TDF HIV Anti-Viral Drug Lawsuits to Proceed Against Gilead

Published on February 20, 2019 by Laurie Villanueva

Personal injury and class action lawsuits involving Gilead Sciences, Inc.’s TDF HIV-AIDS medications are moving forward in California, after a Los Angeles Superior Court judge found that nearly all of the Plaintiffs’ claims were sufficiently plead.

Gilead Allegedly Hid TDF Side Effects

The U.S. Food & Drug Administration (FDA) approved Gilead’s Viread – the first tenofovir disoproxil fumarate (TDF) HIV-AIDS medication — in October 2001.

The company eventually obtained FDA approval for several other TDF-based HIV-AIDS medications, including:

  • Truvada (emtricitabine/TDF)
  • Atripla (efavirenz/emtricitabine/TDF)
  • Complera (emtricitabine/rilpivirine/TDF)
  • Stribild (elvitegravir/cobicistat/emtricitabine/TDF)

Last May, several California HIV patients filed personal injury (Case No. BC702302) and consumer class action lawsuits (Case No. BC 705063) in Los Angeles Superior Court seeking to hold Gilead accountable for alleged misconducted related to the promotion of its TDF-based HIV-AIDS medications.

Specifically, the lawsuits claimed the drug maker:

  • Suppressed a safer alternate, tenofovir alafenamide (TAF), to protect the profits derived from its valuable TDF patents.
  • Failed to warn patients of the serious side effects associated with TDF, including the drugs’ potential to damage the kidneys and bones.
  • Actively misrepresented the efficacy and risks of its TDF HIV-AIDS medications.

Gilead filed a Demurrer seeking to have the lawsuits dismissed on various grounds. But Los Angeles Superior Court Judge Carolyn B Kuhl rejected nearly every one the company’s arguments on August 13th, allowing all but the Plaintiffs’ claims of Strict Products Liability to proceed.

Gilead TAF HIV/AIDS Medications

Gilead brought its first TAF HIV-AIDS medication, Genvoya, to market in November 2015. The company subsequently launched two additional TAF-based drugs, and currently promotes the franchise as a safer alternative to TDF medications.

Gilead’s TDF HIV-AIDS medication patents expire in 2021, while its TAF patents will remain in effect until 2032. The company currently monopolizes the market for HIV-AIDS treatments and has made billions of dollars from both franchises.

However, a growing number of  plaintiffs throughout the United States claim Gilead knew TDF was toxic to the bones and kidneys when the FDA approved Viread nearly two decades ago. They further assert that the company was also aware by then that TAF did not pose the same risks.

“After learning that TAF had a higher absorption rate and largely avoided the bone and kidney toxicity associated with TDF, Gilead shelved its development of TAF and instead kept HIV infected patients and their doctors in the dark about the true risks associated with TDF, along with the solution to those risks, for over a decade,” the lawsuits charge.” In 2014, as Gilead’s patent on TDF approached its expiration and Gilead faced a sharp decrease in profits that would result from competition entering the market for TDF-containing drugs, Gilead decided to release the results of the TAF studies it began conducting in 2001.”

The alleged delay tactics allowed Gilead to “reap outsized profits” from the high costs of its TDF HIV-AIDS medication franchise. However, plaintiffs claim they also “limited patient access either through exorbitant out-of-pocket costs or co-pays, limitations in existing insurance, and rationing of these high-priced pills.”

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