Truvada — emtricitabine and tenofovir disoproxil fumarate — lawsuits claim that the pre-exposure prophylaxis, or PrEP, drug causes kidney problems and bone loss. Lawsuits also claim that Gilead withheld a safer alternative, tenofovir alafenamide, or TAF, in order to maximize profits from Truvada and other drugs containing TDF including Viread, Atripla, Complera, and Stribild.
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So far, hundreds of Truvada lawsuits against Gilead are pending in state and federal court in California, according to Gilead’s quarterly report ending June 30, 2019. The company also faces one class action in the state.
While the majority of cases are in California, there a handful of cases in other states including Delaware and Louisiana.
Gilead said it intends to vigorously defend itself against lawsuits 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,” Gilead said in the 2018 annual report.
Truvada and other 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.
“The lawsuits, which are pending in state or federal court in California, Delaware, Florida, New Jersey and Missouri, involve more than 21,000 plaintiffs. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss.”
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.
So far, there have been no Truvada lawsuit settlements or trials because the litigation has just begun.
Lawyers expect more people to come forward and file claims. People who took Gilead’s other HIV drugs containing TDF — Viread, Atripla, Complera, and Stribild — may also file lawsuits for compensation.
Injury Claims: Kidney Problems & Bone Density Loss
Truvada lawsuits claim that Gilead knew or should have known that Truvada and its active ingredient TDF were “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.”
Over the years, several studies have linked TDF to side effects that include 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, 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’s syndrome — a disorder where certain substances normally absorbed into the blood are excreted in urine instead
- 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.
- Bone fractures
People Who Filed Lawsuits
People filed the first individual Truvada injury lawsuits in California in May 2018, and others followed. Like the class action, the common assertion in these claims is that Gilead failed to warn about the drug’s side effects and purposely withheld the safer drug tenofovir alafenamide (TAF), now marketed as Descovy, 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. In fact, as early as 1997, studies already showed it had significant bone and kidney toxicity.
Michael Lujano and Jonathan C. Gary
Michael Lujano and Jonathan C. Gary took Truvada and Atripla for several years. 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. At the age of 35, 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 and osteopenia and osteoporosis.
Gilead tried to have the case dismissed, but in Feb 2019, Judge Carolyn B. Kuhl 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 an AP statement.
Christopher Pierot filed his case July 2018 in Louisiana federal court. He took Truvada to manage his HIV from 2008 to 2009.
Pierot was 26 when he started taking Truvada. By age thirty, 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 TAF in target cells were about 10-fold and 30-fold greater than with TDF. It 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 and withhold TAF from patients.
Vanessa L. Naisha
Vanessa L. Naisha filed a Truvada lawsuit against Gilead in Delaware on July 11, 2019. Doctors diagnosed Naisha with HIV in 1986, and she began taking Truvada as soon as the drug hit the market in 2004.
By 2009, Naisha experienced severe pain in her hips and loss of balance. In 2010, she had to use a wheelchair after her hips failed.
She had two hip replacement surgeries in 2011 and suffered complications during the second surgery. She had to go to the Intensive Care Unit for a blood transfusion and did not regain consciousness until hospital staff ran electricity through her body seven times.
Doctors said her bone mineral density was osteopenic. It wasn’t until 2018 that she discovered Truvada might be to blame.
“[Naisha] put her trust in [the] Defendant with hopes of getting treatment for HIV. She was oblivious to the fact that all these years she was ingesting poison,” the complaint said.
AIDS Health Foundation Files Truvada Class Action
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 action is separate from the individual injury lawsuits filed by people who claim kidney or bone 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 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
Gilead’s ‘Bald-Faced Greed and Disregard for Patient Safety’
Before the class action, AHF had already sued Gilead in April 2016. The foundation accused the company of manipulating the patent system by withholding TAF from patients.
Media coverage on the topic has “exposed Gilead’s bald-faced greed 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 at the same time that it was making profits on TDF, the lawsuit alleges. The company quietly applied for patents on TAF but kept its research secret.
In response to the allegations, Gilead’s lawyers denied lawsuit claims 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.
“The delay in conducting clinical trials deprived those suffering from HIV of TAF for more than a decade,” the class action 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.”
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