Tenofovir Disoproxil Fumarate (TDF) Lawsuits
Gilead Sciences Inc. faces lawsuits that claim its tenofovir disoproxil fumarate HIV medications Truvada, Viread, Atripla, Complera and Stribild led to kidney problems and bone loss. Several lawsuits are pending, including individual cases in state and federal courts and a class action lawsuit in California.
People who filed tenofovir disoproxil fumarate (TDF) lawsuits against Gilead Sciences Inc. claim the manufacturer failed to warn that its HIV drugs Truvada, Viread, Atripla, Complera and Stribild can cause serious kidney problems, low bone density and related health problems.
HIV products are big money makers for Gilead. They make up about 67 percent of the company’s revenue. The company made $14.6 billion from HIV drugs in 2018, an increase from $13 billion in 2017.
Lawsuits also claim the drug maker purposely delayed releasing a more effective, safer version of the drug called tenofovir alafenamide fumarate (TAF) to maximize profits from TDF. Releasing TAF sooner could have prevented patients from experiencing as many side effects, lawsuits allege.
So far, lawsuits against Gilead are pending in five federal courts in Louisiana and California as well as California state court, according to Gilead’s 2018 annual report. The drug maker said it intends to vigorously defend itself but expressed concern that a plaintiff win could mean financial losses.
“While we believe these cases are without merit, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages.”
“While we believe these cases are without merit, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages,” Gilead said in the report.
The drug maker sought to have the California state case dismissed. Then, in February 2019, the Superior Court of California in Los Angeles allowed plaintiffs’ claims to move forward.
“This ruling is a tremendous victory for HIV/AIDS patients in their quest for justice regarding the life-threatening physical harm that Gilead has caused and we thank Judge Kuhl and the court for allowing these cases to proceed,” attorney for plaintiffs Arti Bhimani said in a statement.
Lawyers expect more people to come forward and file claims.
Injury Claims: Kidney Problems & Bone Density Loss
Lawsuits claim that Gilead knew or should have known that TDF was “highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.” However, instead of conducting further studies and informing the public, the drug maker ignored and misrepresented the risks, according to the combined lawsuit of Michael Lujano and Jonathan C. Gary.
Gilead hid the risks from doctors and patients so it could continue to raise its market share with TDF, according to lawsuits.
Over the years, several studies have linked TDF to kidney and bone problems.
The first documented instance of kidney toxicity in relation to TDF occurred in the United States the same year the drug hit the market in 2001, according to Willem D.F. Venter and the coauthors of a 2018 study in Southern African Journal of HIV Medicine. The patient suffered acute kidney injury (AKI), nephrogenic diabetes insipidus and Fanconi syndrome.
“Since then, many studies have described the nephrotoxic potential of the drug,” the authors wrote.
- Acute kidney injury or acute renal failure
- Chronic kidney disease or declining kidney function
- Fanconi syndrome
- Kidney tubular dysfunction
Bone Density Loss
A 2018 study by Grace A. McComsey and colleagues published in AIDS stated, “Loss of [bone mineral density] in patients with HIV is associated with many contributing factors including antiretroviral therapy (ART), particularly regimens including tenofovir disoproxil fumarate.”
Researchers found switching to a combination of two other antiretroviral drugs, dolutegravir and rilpivirine, continued to suppress the virus while improving bone mineral density.
Gilead’s ‘Bald-Faced Greed’ and ‘Disregard for Patient Safety’
The TDF litigation began when AIDS Health Foundation (AHF), the largest global AIDS organization, sued Gilead in 2016. The foundation accused the company of manipulating the patent system by withholding from patients a more potent, less toxic drug called TAF.
Media coverage of the topic has “exposed Gilead’s bald-faced greed, patent manipulation and disregard for patient safety,” AHF said in a press release.
As early as 2002, Gilead was paying doctors to research TAF in patients around the country while at the same time it was making profits on TDF, the lawsuit alleges. The company quietly applied for patents on TAF but kept its research secret.
“The delay in conducting clinical trials deprived those suffering from HIV of TAF for more than a decade,” the lawsuit said. “It is possible that HIV patients suffered from 10 years of additional accumulated kidney and bone toxicity using TDF while TAF stayed on the shelf.”
Gilead’s lawyers denied the allegations and said the company “had no duty to develop, test, seek approval of, or launch its new product on any particular timetable,” the Los Angeles Times reported.
Then, AHF helped patients file a class action lawsuit against Gilead in May 2018. This action filed in California is separate from the individual injury lawsuits filed by people who claim TDF caused kidney or bone injuries, but it raises similar issues.
- Failure to disclose that TDF had significant risk for toxicity and bone and kidney damage
- Failure to warn of the kidney and bone risks in all patients, not just those with preexisting kidney and bone problems
- Misrepresentation of the risks and benefits of Gilead TDF drugs to sell them
People Who Filed Lawsuits
Plaintiffs filed the first individual TDF injury lawsuits in California in May 2018, and others followed. Like in the class action, the common assertion in these claims is that Gilead failed to warn about TDF side effects and purposely withheld the reportedly safer drug, TAF, from the market in order to make more money.
Gilead’s sales reps and CEO claimed TDF was “a ‘miracle drug,’ had ‘no toxicities,’ was ‘benign’ and ‘extremely safe,’” according to lawsuits. But in as early as 1997, studies had shown the medication could cause significant bone toxicity and kidney damage.
Michael Lujano and Jonathan C. Gary
Michael Lujano and Jonathan C. Gary took Truvada for several years. Lujano also took Atripla. In May 2018, they filed their lawsuit in California state court.
Lujano took Truvada from 2004 to 2009. Then, he took Atripla from 2009 to 2015. In 2016, when Lujano was 35 years old, doctors diagnosed him with osteopenia and osteoporosis of the spine, neck and hip.
Gary took Truvada from 2001 until 2011. Doctors diagnosed him with Fanconi syndrome in 2010, and osteopenia and osteoporosis in 2017.
Gilead tried to have the case dismissed, but in February 2019, the court allowed the claims to continue on all actions except strict liability. The case will proceed on negligence and breach of warranty claims.
“Gilead has shown a disregard for its patients’ health in order to reap outsized profits from its TDF medications.”
“Gilead has shown a disregard for its patients’ health in order to reap outsized profits from its TDF medications. I am happy the judge has allowed our case against Gilead to proceed,” plaintiff Michael Lujano said in a statement.
Christopher Pierot filed his case July 2018 in Louisiana federal court. He took Truvada to manage his HIV from 2008 through late 2009.
Pierot was 26 years old when he started taking Truvada. By 30 years old, he suffered bone necrosis and bone loss so severe that he needed to have both hips replaced. He suffered a great deal of pain after each surgery.
Pierot’s lawsuit claimed Gilead’s studies showed levels of tenofovir in target cells were about 10-fold and 30-fold greater with TAF than with TDF. TAF was also more efficient and barely detectable after the body used it. But TDF remained in blood plasma, a marker that it could be toxic to non-target cells.
Despite this knowledge, Gilead continued to sell the less effective, more toxic TDF medication and withhold TAF from patients.
Please seek the advice of a medical professional before making health care decisions.