A class of medications used to treat HIV and Hepatitis B has been linked to serious side effects that may cause permanent damage to users’ bones and kidneys, and lawsuits allege that the drug maker not only knew about these side effects and concealed them from the public, but intentionally kept a safer alternative off the market to protect its bottom line. If you or a loved one took Viread, Truvada, Complera, Stribild or Atripla for HIV or Hepatitis B and subsequently suffered kidney disease, bone loss or another serious side effect, contact a knowledgeable product liability lawyer today to discuss your legal options. You may have grounds to file a lawsuit against drug maker Gilead Sciences for financial compensation.
A growing number of lawsuits have been brought against Viread and Truvada maker Gilead Sciences recently, alleging that the drug manufacturing company knew about the problems with its tenofovir disoproxil fumarate (TDF)-based HIV drugs for years, and intentionally downplayed the potential for the drugs to cause irreversible damage to the bones and kidneys of users. The lawsuits also allege that Gilead intentionally delayed the production of what the company knew to be a safer version of the HIV medication, tenofovir alafenamide (TAF), in an effort to protect the company’s profits, thereby allowing patients to continue taking an HIV drug that Gilead was aware could permanently damage their kidneys and bones.
In May 2018, two California men living with HIV filed a lawsuit against Gilead, alleging that the company’s TDF drugs caused them to suffer severe kidney and bone damage. According to the lawsuit, Gilead knew as early as 2001 that TDF was “highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.” On the same date, a separate class action lawsuit was also filed against Gilead by two other California residents living with HIV who suffered kidney and bone damage from TDF. The class action was filed on behalf of “All persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.”
Lawsuits brought against Gilead seek to hold the company accountable for its failure to warn patients about the problem with its TDF drug formula and for failing to develop a safer version of the drug sooner, despite knowing that TAF was less toxic to the kidneys and bones of people living with HIV. In February 2019, the Superior Court of California paved the way for future lawsuits against Gilead, indicating that the company may be held accountable for bone and kidney injuries suffered by patients who took the company’s antiretroviral medications.
• Chronic kidney disease
• Severe renal deficiency
• Fatal renal insufficiency
• End-stage renal disease
• Bone loss
• Loss of bone density
• Low bone mineral density
• Breaks or fractures
• Bone necrosis
• Tooth loss
• Fanconi syndrome
• Osteoporosis with pathological fracture
• Osteomalacia (softening of the bones)
“More than 25,000 people with HIV have been diagnosed with serious side effects after taking TDF-based antiretroviral medication, including kidney disease and bone density loss, according to attorneys for the plaintiffs. TDF stands for tenofovir disoproxyl fumurate.”
Viread (tenofovir disoproxil fumarate) is a prescription oral antiretroviral drug commonly used in combination with other drugs to manage HIV and Hepatitis B. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2001 for use in people living with HIV and has been shown to slow the progress of HIV and prolong the lives of users.
Viread belongs to a class of drugs known as nucleotide reverse transcriptase inhibitors (NRTIs), which are designed to prevent the HIV virus from replicating and stop the transmission of AIDS, and Viread is currently available as a single drug or in the all-in-one, fixed-dose combination drugs Complera, Truvada, Stribild and Atripla. According to reports, Gilead Sciences originally developed two separate delivery systems for tenofovir, TDF and TAF.
Compared to TAF, TDF delivered the drug in a much higher dose, which allegedly caused users to suffer severe kidney issues, including chronic kidney disease and end-stage renal disease, as well as severe bone density loss, breaks or fractures, and bone necrosis.
Lawsuits against Gilead allege that the company:
• Knew about the problems with its TDF drugs as early as 2001
• Failed to adequately warn users about the bone and kidney risks of Viread
• Misrepresented TDF’s efficacy and risks
• Knew that a safer alternative to TDF existed (TAF)
• Deliberately delayed the production of a safer medication
• Protected its profits at the expense of the health and well-being of customers taking TDF
The FDA sent several warning letters to Gilead regarding the company’s allegedly misleading promotion of tenofovir generally and Viread specifically. In 2002, the FDA issued a warning letter to Gilead instructing the company to stop making what the agency said were misleading and illegal statements to promote tenofovir, which Gilead representatives claimed was a “miracle drug.” The following year, the FDA requested that Gilead retrain its Viread sales representatives, whom the agency said were making misleading statements about the safety and efficacy of the HIV drug. According to the FDA letter, Gilead representatives at a promotional exhibit booth during an HIV/AIDS conference made statements that “minimized the important risk information and broadened the indication for Viread,” despite the fact that the company “had previously been warned not to engage in such activities.”
Gilead representatives’ depiction of tenofovir as a “miracle drug” occurred around the same time the company was developing a new, alternate version of TDF, known as TAF, which was found to have a higher absorption rate than the older version of the drug and delivered the drug at a much lower dose than TDF. The company announced in 2004 that it was discontinuing its development program for TAF, despite knowing that the newer version would reduce the risk of toxicity and cause less damage to users’ kidneys and bones. It wasn’t until 2014, when Gilead’s patent on TDF was nearing its expiration and the company faced a dramatic decline in profits due to competition for TDF drugs entering the market, that Gilead finally released the results of the TAF studies the drug maker first began conducting in 2001.
