Truvada Lawsuit in 2024 (Get the Latest Updates)

What is Truvada?

As claimed by the manufacturer, Truvada (tenofovir disoproxil fumarate TDF) is one of several pre-exposure prophylaxis medications that are currently used to treat human immunodeficiency virus (HIV) and hepatitis B virus infection [1].

The drug is sometimes considered a safer HIV drug for some people who do not have HIV infection (for example, those who do not always use condoms or who have a sex partner that has HIV infection) to help reduce their chances of getting an HIV infection. Truvada was approved by the U.S. Food and Drug Administration in 2012.

How Does it Work?

Truvada blocks important pathways that HIV viruses use to set up infection. In patients who take Truvada as PrEP daily, the presence of the medication in their bloodstream can sometimes stop the virus from establishing itself and slow the spread of HIV in the body.

By itself, PrEP with Truvada does not work all the time so patients should also use condoms during sex for the most protection from HIV infection.

What’s the Difference Between TDF Drugs and TAF Drugs?

TDF drugs have been found to cause serious side effects that can cause kidney and bone injuries to individuals already suffering from HIV.

TAF has been known to be a safer alternative that does not pose the same risks. TAF drugs possess a smaller concentration of the main ingredient, tenofovir, in the blood. The smaller concentration can prevent it from accumulating in the blood and kidneys.

What’s the Problem with HIV Treatment Drugs?

According to the Clinicalinfo.HIV.gov research from 2023 [2], Truvada side effects can be:

• Acute or chronic kidney disease – When damage to the kidneys prevents them from filtering blood properly. Anything below 90 GFR (glomerular filtration rate) is abnormal. Truvada‘s “poor bioavailability” keeps the body from efficiently absorbing the drugs. This leads to kidney problems and kidney injuries.
• Kidney failure – occurs when kidney disease is left untreated. Patients would then need a kidney transplant or dialysis to filter waste from their blood. Kidney function failure can be acute or chronic.
• Fanconi Syndrome – Occurs when impaired kidney tubule function affects the urine’s chemical makeup. This includes abnormal protein levels in the urine, called proteinuria. Fanconi Syndrome can lead to kidney damage and bone loss.
• Osteopenia – Medical condition characterized by weakened bone mineral density (including teeth). If left untreated, it could lead to breaks and fractures.
• Osteoporosis – occurs when bones become brittle and fracture easily.
• Osteomalacia – When bones break down more quickly than they can re-form.

Judge Clears Suit Alleging Gilead HIV Drugs Defectively Designed

U.S. District Judge Jon S. Tigar has greenlighted a dangerous drug lawsuit filed by a group of patients accusing Gilead Sciences Inc. of negligence, product liability, and a host of other allegations surrounding its tenofovir disoproxil fumarate-containing HIV drugs, but agreed to narrow the scope of the case by tossing allegations that Gilead Sciences Inc. hid knowledge that the medicines are “unreasonably and unnecessarily unsafe.” Tigar cleared various other claims made in the suit, including design defect, negligence, and product liability claims.

In one recent study, it was found that the bone mineral density (BMD) of patients treated with Truvada declined 2-6% within 2 years of initiating the regimen.

As claimed by a study from the University of San Francisco, which examined the outcomes of 10,000 patients, it was found that Truvada increases the risk for proteinuria (abnormal protein levels in urine), rapid decline in kidney function, chronic kidney disease (CKD), and kidney failure [3].

In iPrEx, there were no significant differences in urine α1m, albuminuria, or proteinuria by treatment arm. In iPrEx-OLE, after 24 weeks on PrEP, urine α1m and proteinuria increased by 21% [95% confidence interval (CI): 10 to 33] and 18% (95% CI: 8 to 28), respectively.

According to this 2019 study by the National Library of Medicine, the prevalence of detectable α1m increased from 44% to 65% (P < 0.001) and the estimated glomerular filtration rate declined by 4 mL/min/1.73 m2 (P < 0.001). There was no significant change in albuminuria (6%; 95% CI: −7% to 20%) [4].

Among the 200 participants included in the cross-sectional iPrEx substudy, the median age was 23 years and 18% of participants were transgender. Persons of black race comprised 11% of participants, whereas Asians and Latinos comprised 27% and 54% of participants, respectively. – Stated the National Center for Biotechnology Information.

Which Other HIV Medications Have Been Linked to These Side Effects?

In addition to Truvada, other similar TDF drugs that may cause these side effects include:

• Atripla
• Stribild
• Complera
• Viread

Are Truvada Lawsuits Being Filed?

Only a qualified attorney can determine whether you are eligible to file a dangerous drug lawsuit against Gilead Sciences Inc., the maker of Truvada, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now to see if you qualify for Truvada Lawsuit Settlements.

Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect.

In the case of a Truvada Lawsuit, our attorneys suspect that patients may be able to take legal action in light of claims that Gilead failed to adequately warn consumers about the risk of kidney disease and bone loss.

Truvada Litigation

Truvada lawsuits have been consolidated in the Northern District of California in multidistrict litigation (MDL). This is where similar lawsuits are consolidated to speed up litigation and a settlement.

The Truvada Lawsuit MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881. Currently, the first Bellwether trial is scheduled for June 2022.

Failure to Warn and Defective Design Claims

The bulk of the lawsuits deal with the claim that Gilead Sciences knew that Truvada carried serious design defects that caused severe side effects. Gilead also failed adequately to warn doctors or patients of those risks in its disclaimers.

The lawsuits claim that Gilead knew that the drug TDF was very toxic in the prescribed doses. The company even sought a safer version of it right after TDF was approved by the FDA in 2001. Nevertheless, Gilead continued to tout TDF and Truvada as “risk-free.”

The FDA reprimanded Gilead in 2002 and 2003 for false claims that TDF did not put a patient’s bone density or kidneys in jeopardy. Truvada continued to be marketed as a safe drug to maximize profits. This happened despite a growing body of scientific evidence to the contrary.

Claims that Gilead Withheld a Safer Drug

The lawsuits also allege that Truvada manufacturer Gilead concealed the development of another drug, tenofovir alafenamide, or TAF.

An alternative to TDF, TAF is more easily absorbed in the body. This makes TAF more efficacious, even at significantly lower doses. Gilead had been investigating TAF even before Truvada was approved in 2004. Those studies revealed not only that TAF was far less toxic. But also that TDF carried a much greater risk profile.

However, TDF had only recently been patented. It still had years of protection against generic brands. TDF was also the dominant drug in HIV treatment. This allowed Gilead to charge extremely high prices per dose.

Therefore, rather than release the studies that found TAF was a less toxic alternative to TDF, Gilead covered them up. In 2004, Gilead even announced that it would stop researching TAF. It then promptly applied for and received seven patents related to TAF in the span of the next several months.

Finally, in 2010, the patent on TDF was running out. Gilead announced the discovery of a new drug that would revolutionize HIV treatment – TAF.

Gilead began unveiling the results of its studies on TAF, which had been done years earlier, as proof that it was a better drug for HIV treatment. One with fewer risks of bone density problems and kidney damage than TDF. Gilead urged patients on TDF medications to switch to newer, TAF-based drugs like Genvoya, Odefsey, and Descovy.

The lawsuits allege Gilead delayed the introduction of TAF – a safer alternative – for business reasons. This came at the expense of HIV patients taking high-risk TDF-based HIV medications.

For nearly a decade, they were put at severe risk of osteoporosis, bone fractures, kidney damage, renal failure, and potentially fatal lactic acidosis. All because Gilead wanted to pad their bottom line. Profits came before people.

Kidney Failure Symptoms

• Decreased urine output, although occasionally urine output remains normal
• Fluid retention, causing swelling in your legs, ankles or feet
• Shortness of breath
• Fatigue
• Confusion
• Nausea
• Weakness
• Irregular heartbeat
• Chest pain or pressure
• Abdominal pain
• Seizures or coma in severe cases

AIDS Healthcare Foundation Files Truvada Class Action Lawsuit

AIDS Health Foundation (AHF), the largest global AIDS organization, helped file the class action lawsuit on behalf of Devin Martinez, Ricardo Wohler, and others who purchased Truvada and other TDF drugs in May 2018.

This California class action lawsuit is separate from the individual injury lawsuits filed by people who suffered injuries from TDF, but it deals with similar issues.

According to the complaint, Gilead misrepresented TDF’s safety profile as early as 2001. The FDA even reprimanded Gilead in 2002 and 2003 for claiming the drug had no toxicities and would not cause bone or kidney damage, but the company continued to downplay the risks.

Allegations against Gilead in the class action include:

• Failing to disclose that TDF had a significant risk for toxicity and bone and kidney damage
• Failed to warn of the kidney and bone risks in all patients, not just those with preexisting kidney and bone problems
• Gilead misrepresented the risks and benefits of its TDF drugs to sell them

Has There Been a Recall?

Truvada is still available and has yet to be taken off the market. Despite the evidence linking the drug to several serious injuries, the FDA has not mandated a recall of the product.

If you are currently taking Truvada, talk to your doctor about other treatment options. Before stopping use, consult with your doctor to make sure that it is safe.

How Can Filing a Lawsuit Help Me?

By filing a lawsuit against the maker of Truvada, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering.

Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.

Related Article: What is a Design Defect?

See all related dangerous drugs lawsuits our lawyers covered so far.

Get a Free Truvada Lawsuit Evaluation With Our Personal Injury Lawyers

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Truvada lawsuits. We are handling individual litigation nationwide and currently accepting new kidney injury and bone fracture cases in all 50 states.

Free Case Evaluation: Again, if you suffered bone loss or another injury after taking Truvada or other dangerous drugs, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and a Truvada Lawsuit Attorney can help.

References:

1. https://www.cdc.gov/hiv/pdf/prep_gl_patient_factsheet_truvada_english.pdf
2. https://clinicalinfo.hiv.gov/en/drugs/emtricitabine-tenofovir-disoproxil-fumarate/patient
3. https://www.ucsf.edu/news/2012/09/98692/study-underscores-truvadas-potency-preventing-transmission-hiv
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6071417/