A number of lawsuits have been filed against Gilead related to its TDF Drugs. This includes a class action lawsuit filed by California patients of Truvada. The claims are complex and it will probably take years to gather evidence. Gilead has denied any wrongdoing.
Gilead failed to warn patients of serious side effects
TDF drugs, which are used in the treatment of HIV/AIDS, are known to cause kidney failure, bone fractures, and other health problems. Because these drugs do not cure the disease, patients should be informed of the risks and side effects before they begin taking them. If you or someone you love has been affected by TDF-related side effects, you may be entitled to financial compensation.
Many people who have become ill because of TDF drugs are turning to the legal system to demand justice. Gilead knew about the side effects of TDF, and the company was working to find safer alternatives. In 2001, Gilead discovered that tenofovir alafenamide fumarate (TAF) produced lower levels of active tenofovir in the kidneys, and was less likely to cause bone and tooth loss.
In California, plaintiffs have filed lawsuits alleging that Gilead failed to warn patients of the severe side effects of TDF drugs. Gilead also withheld TAF from patients, despite the fact that it was superior to TDF in terms of targeting HIV. Vanessa L. Naisha filed a lawsuit against Gilead on July 11, 2019. She was diagnosed with HIV in 1986 and began taking Truvada in 2004.
According to the lawsuits, Gilead failed to warn patients of the serious side effects of TDF drugs, including the development of a safer alternative drug. Gilead intentionally delayed the release of a safer alternative drug, TAF, because it wanted to maximize its profits. It also allegedly failed to adequately train salespeople about the dangerous side effects of TDF drugs.
It misrepresented the drug’s efficacy
A federal investigation into Gilead’s TDF drugs found that the company failed to adequately warn patients about the risks and side effects of TDF. The company also failed to inform physicians about a safer alternative known as TAF. The FDA also found that Gilead’s marketing and advertising of TDF drugs misrepresented the drug’s safety and efficacy.
Despite these concerns, Gilead marketed its TDF-based HIV drug regimens despite knowing that the TAF-based regimens were safer. The company’s alleged misrepresentations forced patients to take more powerful TDF drugs that could result in serious side effects. Attorneys for the plaintiffs have said Gilead manipulated the market by denying patients adequate information about the drug’s side effects.
TDF-based medications are life-saving HIV medications. However, studies have shown that TDF may cause bone and kidney damage in patients. Several lawsuits have been filed against Gilead for failing to warn patients about these risks. While Gilead has continued to market TDF-based drugs, the FDA has repeatedly warned the company about the risks of TDF and other TDF-based drugs.
Gileads TDF-based HIV drugs are at the center of a patent-infringement lawsuit. The lawsuit has been filed by the United States on behalf of the Department of Health and Human Services. Among the drugs involved in the lawsuit are Truvada, Complera, and Stribild. These drugs contain the same active ingredient.
It withheld the release of a safer version
A new lawsuit alleges that Gilead Sciences intentionally withheld the release of a safer version of its HIV medication Tenofovir Disoproxil Fumarate, or TDF. TDF is used to control viral load and is included in routine HIV medications. The lawsuit claims that Gilead knew that TDF was linked to side effects such as bone density loss and kidney damage, but failed to release a safer version. As a result, patients in Canada needlessly suffered from the side effects.
When TDF’s patent expired in 2021, Gilead began development of a safer version. This new drug, known as TAF, was approved by the FDA. However, Gilead delayed the release of TAF until the patent on TDF expired. The delayed release was likely an effort to maintain profit margins during the exclusivity period and encourage prescribers to switch patients from TDF to the safer TAF drug.
Gileads TDF drugs were on the market for nearly a decade before the lawsuits were filed. The drug was marketed to improve the lives of HIV patients. However, the company knew about the risk of adverse side effects of TDF, and purposefully withheld the release of a safer version in order to increase profits.
The lawsuit alleges that Gilead purposely hampered the development of an alternative TDF drug for more than a decade, and then failed to provide adequate warnings for the dangerous drug. As a result, the company faces tort, strict liability, fraud by omission, and state consumer protection laws.