Truvada TDF Manufacturer - Gilead as a Lawsuit Defendant

(Please note that as of May 6, 2020, Shouse Law Group has stopped accepting new Truvada or TDF cases. The discussion below is for public information purposes only.)

Truvada and other TDF drugs are manufactured by Gilead Sciences, Inc., an American pharmaceutical company based in California. These drugs are used to treat HIV, but have been linked to severe side effects including kidney failure, lactic acidosis, and bone loss.

The lawyers at the Shouse Law Office have been filing Truvada lawsuits on behalf of victims who have suffered from these drugs. Here, we discuss:

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1. History of Gilead Sciences, Incorporated

Gilead Sciences, Inc. is the company that designed and manufactures Truvada and other TDF-based drugs to treat HIV.

The company was founded in 1987 by a 29-year-old doctor and businessman, Michael Riordan. Riordan had contracted dengue fever, an untreatable viral disease, while working in the Philippines and wanted to start a medical and pharmaceutical business that would focus on antiviral medicine.

During the early years of Gilead's existence, it attracted some big names to its list of advisors and its board of directors, including:

  • Jack Szostak, who would become a Nobel Prize winner in 2009,
  • Harold Varmus, a Nobel laureate who served as the Director for the National Institute of Health from 1993 through 1999, and
  • Donald Rumsfeld, who served on the board of directors from 1988 until 2001, including a stint as the company's Chairman from 1997 until 2001, when he left to become the U.S. Secretary of Defense.

Gilead Sciences, Inc. became a publicly-traded company in January 1992, raising $86.25 million in investment. The company continued to focus on antiviral drugs and cancer treatments until the early 2000s.

In 2001, Gilead received approval from the U.S. Food and Drug Administration (FDA) for their HIV treatment made of the drug tenofovir disoproxil fumarate (TDF) and sold under the brand name Viread.1 In 2002, Gilead sold off its body of cancer research to focus solely on HIV treatments.

Since then, Gilead has released a handful of other HIV treatments based on TDF, including:

  • Truvada, which was approved in 2004,2
  • Atripla, approved in 2006,3
  • Complera, which was approved in 2011,4
  • Stribild, which was approved by the FDA in 2012,5
  • Symfi-Lo, approved in 2018,6 and
  • Cimduo, which was FDA approved in 2018.7

These drugs are combination, or “cocktail” drugs that have a central active ingredient – in this case, TDF – plus other drugs that maximize the effect of that ingredient.

Controversially, Gilead pivoted to HIV treatments that are based on another, safer drug called tenofovir alafenamide fumarate, or TAF, in 2015.8 These newer treatments include:

  • Genvoya, a TAF-based replacement for Stribild,
  • Odefsey, the TAF version of Complera, and
  • Descovy, the TAF version of Truvada.

Together, these lines of HIV treatment drugs have net Gilead Sciences, Inc. up to $18 billion per year in revenue and have effectively cornered the market in HIV treatment.

2. Gilead Sciences, Inc., today

Gilead Sciences, Inc. has numerous offices across the U.S., but has seen a drop in the net revenue as its HIV drugs face lawsuits and lose their market protection from generic versions.

While Gilead is headquartered in Foster City, a planned community just outside San Francisco, it has numerous satellite offices in:

  • San Dimas, California,
  • El Segundo, California,
  • Oceanside, California,
  • Santa Monica, California,
  • Emeryville, California,
  • Washington, D.C.,
  • Seattle, Washington, and
  • Miami, Florida.

Altogether, Gilead has around 11,000 employees interspersed throughout these offices.

2.1 Lawsuits against Gilead Sciences, Inc.

In the past few years, Gilead has faced some severe legal accusations. Some of them concern the side effects of its HIV treatments and claim that Gilead withheld safer versions of the drugs from the market to extend their protection from generic drugs. Other lawsuits claim that Gilead broke antitrust laws by conspiring with other pharmaceutical companies to keep the prices of their HIV drugs as high as possible.

The lawsuits against Gilead over the side effects caused by its HIV treatments all claim that Gilead failed to adequately warn doctors and patients of the severity of the risks of taking TDF-based drugs. Perhaps more importantly, though, these TDF lawsuits also claim that Gilead had developed safer HIV drugs that were based on TAF, but had kept them from the market for nearly a decade in order to extend Gilead's protection from generic versions.9

Both of these claims are being made in lawsuits over side effects caused by a host of Gilead HIV drugs, including:

Another class-action lawsuit claims that Gilead artificially inflated the prices of its HIV drugs.10 Most of these HIV treatments are “cocktail” drugs – they include TDF of TAF, plus other drugs to maximize the effectiveness of the active ingredient. As the protection from generic versions on those other drugs expired, though, their manufacturers conspired with Gilead to continue using the brand name version in Gilead's HIV treatments. The result was an HIV cocktail drug made by Gilead that included all brand name ingredients, rather than TDF or TAF and generic versions of the other drugs. By using only brand names, the price for Gilead's drugs doubled.11

Together, these lawsuits pose a significant threat to Gilead's roaring business. However, the lawsuits aim to right the wrongs done by Gilead against consumers who have had to buy overpriced drugs and suffer needlessly from their severe side effects.

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