Mass Tort- Gilead TDF Lawsuit

TDF has caused damage, sometimes permanent and sometimes fatal, to the kidneys and bones of patients who took the drug.

In 2001, Gilead’s first TDF-based (tenofovir disproxil fumarate) medication came to market. That same year, Gilead began development of less toxic alternative to TDF known as TAF (tenofovir alafenamide fumarate). In 2003, Gilead placed a label on its TDF medications warning of the possible side effects and a year later the drug manufacturer stopped development of the less toxic TAF altogether. Arguably to extend its profits on the production on the less safe TDF. TDF was a key drug used for the treatment of patients with HIV or AIDS and was also used under the brand name "Truvada" by uninfected individuals as part of the HIV prevention strategy known as PrEP (pre-exposure prophylaxis). In 2010, Gilead resumed its development of TAF and by 2015 the first TAF drug "Genvoya" was released to the public. The patent on Gilead’s TDF drugs expired in 2018, but the company will still be able to profit until at least 2031, when Gilead’s TAF patent expires.

Gilead’s TDF medications belong to a class of antiretroviral drugs known as nucleoside reverse-transcriptase inhibitors that are prescribed to treat HIV/AIDS. These medications inhibit the activity of reverse-transcriptase, an enzyme that is crucial in the replication and progression of HIV/AIDS. In combination with other drugs, TDF medications were shown to slow the progression of HIV and keep HIV-positive people healthy for many years, according to the Centers for Disease Control. Not taking antiretroviral drugs isn’t an option for HIV-positive individuals, even if taking the drug resulted in serious side effects.

At this time, there are five Gilead TDF medications available to people infected with HIV/AIDS:

  • Viread
  • Truvada
  • Atripla
  • Complera
  • Stribild

Legal actions against Gilead over its promotion and distribution of HIV/AIDS medication are premised on Gilead’s knowledge of producing and promoting an inferior drug (TDF) with harmful side effect while it shelved a safer and superior alternative drug TAF. TDF has caused damage, sometimes permanent or fatal to the kidneys and bones of patients who took the drug. It is alleged that TDF drug users were exposed to up to an additional 10 years of toxicity because Gilead stopped production of its safer alternative, TAF. 

If you took one or more of Gilead’s TDF drugs, Viread, Truvada, Atripla, Complera, or Stribild and you were diagnosed by a physician or other healthcare provider with kidney issues and/or bone density loss, you may be eligible for compensation from Gilead. Balaban's Law experienced Mass Tort attorneys have helped victims of other corporate misdeeds and we may also be able to help you.

Contact Balaban Law’s team to discuss your case. We represent injured parties throughout the Denver metro area and we welcome the opportunity to be of assistance to you. Feel free to complete a Free Case Evaluation form on our website or call our office for a complimentary, confidential discussion regarding your case.

 

Bone tissue never stops growing because new tissue is necessary to replace older tissue. When old tissue deteriorates faster than new tissue can grow, or new tissue stops growing altogether, people can develop osteoporosis. Osteoporosis is a condition in which bones are so weak that minor falls or stresses can cause them to fracture. TDF users have alleged they developed osteopenia after taking the HIV drug, a precursor condition to osteoporosis in which bone density levels fall below their peak levels. Common symptoms for osteoporosis and osteopenia include:

  • Back pain
  • Bone density loss, bone demineralization, or weakening of the bones diagnosed by a physician or other healthcare provider
  • Bone fractures with physician or healthcare provider diagnosis of bone weakening or demineralization 
  • Loss of height
  • Stooped posture

Since 2009, there have been nearly 6,000 reports of bone breaks allegedly connected to TDF usage. Shortly after Gilead released Viread, its first TDF medication, studies began correlating its use to bone density loss. One 2010 study found that a “strong correlation between loss of bone density in HIV- infected individuals, particular in conjunction with the antiretroviral drug tenofovir.” A more recent study, published in 2016 announced similar findings, stating “Several studies have demonstrated an approximately 1-3 percent greater bone mineral density loss with TDF compared with other agents.”

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Kidneys are one of the body’s most important organs because they filter electrolytes, fluids, and waste from the bloodstream into urine and out of the body. Chronic kidney disease prevents the kidneys from effectively filtering the bloodstream and waste can build up to dangerously high levels if left unaddressed. In the most severe cases of chronic kidney diseases, people will need to undergo dialysis or have a kidney transplant. Common symptoms of kidney failure include: 

  • Abnormal protein levels in the urine
  • Abnormal glomerular filtration rate (GFR) levels (15 to 90 as determined by tests and blood work
  • Death due to renal failure
  • Fatigue
  • Frequent urination
  • High blood pressure 
  • Itchy skin
  • Loss of appetite

Since Gilead’s first TDF medication came to market nearly 20,000 people taking one or more of the drug manufacturer’s TDF medications have been diagnosed with kidney disease by a physician or other healthcare provider. Kidney damage is a particularly dangerous side effect of taking TDF because under normal circumstances, the kidneys are resilient and adapt easily when damaged. However, for TDF users kidney symptoms began appearing once irreversible damage had already occurred.

Aside from chronic kidney disease, individuals taking Gilead’s TDF medications are at risk for developing several other kidney-related conditions including:

  • Acute kidney injury (AKI) or acute renal failure (ARF): A kidney disorder in which the kidneys have suddenly have difficulty filtering waste from the blood.
  • Fanconi syndrome: A kidney tubule disorder that causes excess levels of glucose, potassium, and bicarbonate to be excreted in the urine. 
  • Renal tubular acidosis: A kidney condition involving the build-up of acid in the bloodstream due to the kidneys failure to filter it out.

Other serious side effects of taking TDF drugs include high creatine levels, renal failure, renal dysfunction and Fanconi Syndrome (kidney tubules function disorder). 

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There is no question that Gilead’s TDF drugs Viread, Truvada, Atripla, Complera, or Stribild have improved the lives of people living with HIV/AIDS. However, allegations that Gilead knew about potential harmful side effects of these drugs, had a safer alternative (TAF) that they pulled from the market in order to maximize TDF profits are deeply troubling. Gilead resumed production and development of the safer TAF drug in 2010 and in 2015, released the first TAF drug, Genvoya. If the allegations of failing to warn about risks in order to increase profits are true, Gilead must be held responsible! 

If you were diagnosed by a physician or other healthcare provide with kidney issues or experienced bone density loss after starting or using a TDF Drug (Viread, Truvada, Atripla, Complera, or Stribild) or if a kidney or bone density ailment has been exacerbated after starting a TDF medication, you may be eligible for compensation. If you have incurred medical expenses or need future medical expenses, have lost wages or reduced your earning capacity or if you are in physical pain or suffering from mental anguish, contact one of Balaban Law's experienced mass tort attorneys today to discuss how we may be able to help you file a lawsuit and recover the compensation you deserve! Time is limited so please submit your information online today or call us for a free and confidential case review.

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