Truvada Injuries

You may have seen an uptick in advertisements for Florida Truvada injury lawyers, Truvada injury lawsuits and TDF drug injuries.

Truvada and other medications containing TDF (short for tenofovir disoproxil fumarate) have been hailed as a breakthrough in hepatitis B and HIV/AIDS treatment. They claim to slow the progression of the HIV virus, extend patients’ lives and even lower the risk of HIV transmission between sexual partners. Available by mouth as a tablet or powder, the antiviral prescription drug became a staple treatment for many patients with HIV.

However, since the U.S. Food and Drug Administration approved TDF prescriptions in 2001, numerous red flags have been raised indicating serious patient health risks. Medical studies and clinical trials began to note kidney problems and bone fractures soon after the first TDF drug hit the market.

Here, our Florida Truvada injury lawyers provide patients with a straightforward explanation about why the drug has come under such intense scrutiny, the basis for legal action in these cases and how one might determine if they should seek legal counsel.

Truvada is one of the TDF brand names manufactured by Gilead Sciences, Inc. to treat HIV/AIDS, a condition affecting roughly 1.1 million Americans, with nearly 39,000 people newly infected each year, according to HIV.gov. Some other TDF drugs can also be used to treat hepatitis B.

Truvada and other TDF drugs are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by halting a key HIV enzyme from multiplying, thereby reducing the amount of virus in one’s body.

Truvada is one of the few medications that may help prevent HIV infection. Doctors refer to this use as “PrEP,” short for pre-exposure prophylaxis (an FDA-approved use since 2012).

The problem, as noted by the U.S. Department of Health and Human Services’ AIDS Info page, is that TDF drugs “can cause serious, life-threatening side effects,” often from a buildup of lactic acid in the blood (known as lactic acidosis). These include:

• Severe liver problems.
• New or worsening kidney problems (including chronic kidney disease and kidney failure).
• Lactic acidosis (potentially fatal buildup of acid in the blood).
• Aggravation/flare up of hepatitis B virus infection.
• Bone demineralization (reduced bone density increasing the risk of fractures and osteoporosis).

Although Truvada is probably the best-known TDF medication, others include:

• Atripla
• Complera
• Stribild
• Viread

While any drug carries some possibility of risk, warning labels on these medications are what physicians consider before making any decision about whether to prescribe medications like Truvada to patients. It’s critical that these warning labels are accurate so that doctors have the best information about drug safety and how it might affect each individual patient.

Drug makers owe consumers a duty of care to make sure these medications are as safe as possible. That means every drug undergoes rigorous testing during development (before release to the public) and that safety is continuously monitored once it’s on the market. Any credible evidence of possible health risks must be communicated with health care professionals and the public.

The reason Gilead and other TDF drug manufacturers are facing litigation is because plaintiffs allege:

• Drug makers knew about these harmful side effects of TDF drugs like Viread and Truvada yet failed to adequately warn doctors and patients.
• Drug makers had already developed safer HIV/AIDS drugs (“TAF” medications, short for tenofovir alafenamide) yet delayed putting them on the market to maximize profits made off the TDF medications.

Gilead has repeatedly been reprimanded by the FDA for marketing these medications without mentioning the serious side effects. For example, the FDA reported in March 2001 that the company’s communications division engaged in false and misleading promotional activities by marketing Viread as “extremely safe,” extremely well-tolerated” and a “miracle drug” containing “no toxicities” – thus downplaying the black box warning and offering information inconsistent with known risks.

A 2019 analysis of initial data gathered from seven separate studies found that TAF drugs given to cisgender women were just as effective as TDF medications, but with fewer side effects to the kidney and bones.

In Lujano and Gary v. Gilead Sciences, Inc., filed in the Los Angeles County Superior Court, plaintiffs alleged that by the time Gilead designed, manufactured and sold Truvada in 2004 and Atripla in 2006, the company knew or should have known TDF drugs were highly toxic in the prescribed doses – possibly causing fatal damage to the kidneys and bones. Further, before the company began selling drugs with the TDF compound in 2001, it discovered the TAF compound, which was a safer alternative that could reduce the risk of damage to internal organs and bones.

“But because Gilead enjoyed monopoly profits on its TDF-containing drugs, including Truvada and Atripla, resulting from its patent on TDF, Gilead chose to withhold TAF as the product design for Truvada and Atripla (until the patents on its TDF drugs was set to expire),” plaintiffs asserted.

Amid a wave of TDF injury lawsuits filed against Gilead over the last several years, the AIDS Healthcare Foundation filed an antitrust action (citing unfair competition) against Gilead, asking it to establish a $10 billion fund for affected patients and surviving families. That claim was later dismissed without prejudice by the U.S. District Court for the Northern District of California, which found the company owed no duty to competitors to release a product earlier. Plaintiffs in that case were given leave to amend. But as noted by the same court in a 2019 ruling in Holly v. Gilead Sciences, Inc., “Concluding that Gilead owed no duty to its competitors says nothing about any duties Gilead might owe consumers under state tort law.”

That means those injured by TDF drugs before Gilead released its TAF medications may have a fair shot at recovering damages for TDF injuries.

Dangerous and defective drug lawsuits against drug manufacturers fall under the umbrella of injury law known as product liability.

Patients who took these drugs and suffered one of the known serious side effects should consult with an experienced product liability attorney – the sooner the better. The risk in waiting is the possibility of running into a statute of limitations, which could forever bar a claim.

In Florida, the statute of limitations for product liability injuries is four years, but it’s shortened to two years if the claim involves wrongful death. There is a 12-year statute of repose, but that may only apply in rare circumstances.

Statutes of limitations vary by state, and product liability claims are frequently handled in federal U.S. courts. To reduce your risk of missing a filing deadline, contact a Florida Truvada injury lawyer as soon as possible.

For information on legal action, contact Fort Lauderdale Truvada injury lawyers at The Ansara Law Firm by calling (954) 761-4011 or (954) 761-3641.