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Gilead Sciences and other drug makers face a growing number of class action lawsuits over HIV drugs sold in recent years, alleging that the companies have engaged in a long-running scheme to restrain competition for some of the most important treatments for the serious and life-threatening disease.
Two separate lawsuits have been filed this month against Gilead, Bristol-Myers Squibb, Johnson & Johnson, it’s Janssen subsidiary, Akros Pharma, and Japan Tobacco, Inc., including one complaint (PDF) brought by Teamsters Local 237 Welfare Fund and Retiree’s Benefit Fund on June 6, and a separate complaint (PDF) filed by Pipe Trades Services MN Welfare Fund on June 12.
Each of the lawsuits seek class action status to pursue damages against the pharmaceutical companies for all individuals or entities that purchased HIV drugs for use in a cART regimen, alleging that the companies conspired to control the market for the critical medications that individuals with HIV need to survive.
The anticompetitive and unlawful conduct resulted from Gilead’s control of tenofovir disoproxil fumarate (TDF) drugs, which includes Viread and HIV “cocktail” drugs like Truvada, Atripla, Complera and Striblid; also known as “combination antiretroviral therapy” (cART).
“By controlling the market for Tenofovir, and through its collusive agreements with its coconspirators, Gilead now dominates the market for cART,” the lawsuits state. “Today more than 80% of patients starting an HIV regimen in the United States, and more than 80% of continuing patients, take one or more of Gilead’s products every day. Gilead’s sales of these products in the United States alone are more than $11 billion annually.”
If left untreated, human immunodeficiency virus (HIV) is a disease that leads to the development of AIDs, and eventually to death. As individuals with HIV are leading longer and longer lives, the drug treatments have become some the highest grossing pharmaceutical products, and Gilead has acquired and maintained an essential monopoly on modern HIV treatments, according to the class action complaints.
The lawsuit indicates that the drug makers entered a series of joint development schemes, which combined TDF with other drugs into a single pill, known as fixed-dose combination drugs (FDCs), preventing other drug makers from creating or selling generic equivalents after Gilead’s patent on TDF expired, thus ensuring its ability to charge high prices for the drugs.
In 2015, Gilead began to introduce a new type of HIV drug, involving the use of tenofovir alafenamide fumarate (TAF), which is less toxic than TDF, since it can be taken at a much lower dose. The lawsuits allege that Gilead then “returned the favor” to their co-conspirators, by agreeing not to market combinations with their newer treatment after patents on the other portions contained in the FDCs expired.
“[T]he high cost of these life-saving medications prevents many patients from gaining access to the drugs at all,” according to the HIV drug class action. “Half of those in this country living with HIV are not accessing the required medications, and fully 400,000 more Americans should be on HIV treatment. The high prices of cART regimens contribute to that problem.”
The lawsuits also alleges that Gilead intentionally delayed development and approval of TAF drugs, waiting until after the TDF drugs were about to face generic competition to ensure the maximum profit was generated from the older and more dangerous treatment.
The allegations are similar to those presented in a growing number of HIV drug injury lawsuits filed against Gilead by individuals who suffered kidney problems or bone density loss following use of TDF drugs, indicating that the injuries may have been avoided if TAF drugs had been introduced earlier.
The proposed class action excludes individuals who are pursuing damages for personal injuries caused by the drugs through Viread lawsuits, Truvada lawsuits, Atripla lawsuits, Complera lawsuits or Stribild lawsuits, alleging that the company knew that TAF would reduce the risk of chronic kidney disease, kidney failure, bone fractures and other serious injuries, yet withheld warnings and intentionally delayed development of the safer alternative to increase profits. Those claims are being investigated and pursued by lawyers as individual claims.