So far, there have been no Truvada lawsuit settlements or trials because the litigation is relatively new. In its 2018 annual report, Gilead said it believes these cases are without merit. However, the company expressed concern that losing these lawsuits could result in “significant monetary damages.”
Cases against Gilead are pending in state and federal courts and involve hundreds of plaintiffs, according to the company’s quarterly report ending June 30, 2019. In addition to the large group of lawsuits in California, people from other states including Delaware and Louisiana have filed individual injury claims.
The company also faces a Truvada and Descovy PrEP patent infringement lawsuit filed by the United States on behalf of the Department of Health and Human Services.
People who say Truvada injured them filed the first lawsuits in 2018. Complaints also name other Gilead HIV drugs: Viread, Atripla, Complera, and Stribild. These drugs contain the same active ingredient as Truvada — tenofovir disoproxil fumarate, or TDF — and may cause kidney and bone damage on rare occasions.
Gilead’s perverse motive of outsized profits and increased market share is not in line with patient health and safety and we are grateful that patients will now get their days in court.
Several of the people who filed lawsuits took Truvada along with other TDF drugs. Lawyers are also accepting cases for people injured after taking Gilead’s other TDF drugs.
Gilead tried to have the California cases dismissed, but Judge Carolyn B. Kuhl of the Superior Court of California in Los Angeles permitted plaintiffs’ claims to move forward in Feb. 2019.
“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.
Lawsuits Say PrEP Drug Causes Kidney & Bone Damage
When Gilead began selling Truvada in 2004, the drug maker knew or should have known that the drug and others that contained TDF were “highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones,” according to Michael Lujano and Jonathan C. Gary’s May 2018 lawsuit.
Plaintiffs’ complaints further claim that instead of warning the public, Gilead ignored and misrepresented the risks. Even after the U.S. Food and Drug Administration reprimanded the company in 2002 and 2003 for claiming TDF had no toxicities and did not endanger kidneys and bones, Gilead continued to downplay the risks.
At the same time that it was getting ready to seek FDA approval for Truvada, Gilead was developing a safer alternative called tenofovir alafenamide, or TAF. Lawsuits claim that the company withheld the safer drug from the market in order to extend the patent life and moneymaking power of Truvada.
Injuries claimed in lawsuits may include:
- Acute Kidney Injury
- Acute Renal Failure
- Bone fractures
- Chronic Kidney Disease
- Declining kidney function
- Fanconi’s syndrome
- Kidney tubular dysfunction
First Case of TDF-related Kidney Disease in United States
Willem D.F. Venter and the coauthors of a 2018 study in Southern African Journal of HIV Medicine wrote about the first documented TDF kidney damage case in the United States. Researchers reported the case the same year Gilead’s Viread HIV drug hit the market in 2001.
Venter and colleagues said the patient suffered nephrogenic diabetes insipidus, acute kidney injury and Fanconi syndrome.
“Tenofovir disoproxil fumarate (‘tenofovir’; TDF) is the major antiretroviral implicated in renal disease in first-line antiretroviral therapy … the fact that tens of millions of people in both resource-rich and resource-limited countries are on TDF translates into large numbers of patients potentially at risk of kidney disease,” authors wrote.
Studies Find TDF May Lower Bone Density
Low bone mineral density that leads to osteopenia or osteoporosis affects about 40 to 90 percent of people with HIV, according to researchers Phillip M. Grant and Aoife G. Cotter.
In their 2016 article, Grant and Cotter say multiple studies have shown that TDF causes 1 to 3 percent more bone mineral density loss than other antiretroviral drugs.
Though there may be multiple reasons why people with HIV have lower bone mineral density, “antiretroviral toxicity, in particular from tenofovir disoproxil fumarate (TDF), contributes significantly,” Grant and Cotter said.
Examples of Truvada Injury Lawsuits
People who filed Truvada lawsuits are seeking compensation for different types of kidney and bone injuries. Some people suffered bone fractures that required painful and risky hip replacement surgery. Compensation for damages may include lost wages and medical bills, as well as past and future pain and suffering.
Gilead has made billions off its HIV medications, and lawsuits accuse the company of putting their profits before patients’ safety. The lawsuits allege that not only did Gilead fail to warn the public about the risks of Truvada and TDF, it also purposefully delayed the release of TAF — a drug that would have put patients at less risk for kidney and bone problems.
Michael Lujano and Jonathan C. Gary were the first plaintiffs to file a joint Truvada lawsuit for kidney and bone damage in May 2018, and dozens more people have filed since then.
Christopher Pierot Files His Lawsuit in Louisiana
Louisiana resident Christopher Pierot was 26 when he started taking Truvada. By age thirty, he underwent painful hip replacement surgery because of severe bone necrosis and bone loss. He filed his lawsuit in July 2018.
Pierot’s lawsuit claimed Truvada’s low bioavailability meant higher doses of the drug were required to fight HIV infection. But the high dose exposed bones and kidneys to more toxicity.
Delaware Resident Vanessa Naisha Sues Gilead
Vanessa L. Naisha began taking Truvada as soon as the drug hit the market in 2004. By 2009, Naisha began to lose her balance and develop severe pain in her hips. After her hips failed because her bones were osteopenic, she had two hip replacement surgeries in 2011.
[Naisha] put her trust in [the] Defendant with the hopes of getting treatment for HIV. She was oblivious to the fact that all these years she was ingesting poison.
She had to go to the Intensive Care Unit for a blood transfusion and only regained consciousness once hospital staff ran electricity through her body seven times.
She filed her lawsuit in Delaware Superior Court in July 2019.
“[Naisha] put her trust in [the] Defendant with the hopes of getting treatment for HIV. She was oblivious to the fact that all these years she was ingesting poison,” the complaint said.
Forty-One People File a Group Complaint in California
In Sept. 2019, 41 people filed Truvada and TDF drug lawsuits against Gilead. The complaint alleges that Gilead developed its TDF drugs from 1990 to 2012 and that, throughout their development, the company knew TDF was extremely toxic to kidneys, bones and teeth.
The complaint also alleges that, at the same time and as early as 1997, Gilead knew that TAF was more potent and less toxic than TDF, but instead promoted TDF as the miracle drug and withheld the safer, more effective TAF.
Only when the first TDF drug patent for Viread became close to expiring did Gilead release its first TAF drug, Genvoya, in 2015.
Injuries in this combined lawsuit include: chronic kidney disease, renal failure, renal deficiency, fatal renal insufficiency, loss of bone density, bone loss, bone necrosis, osteoporosis, low bone mineral density, tooth loss and bone fractures.
Truvada Class Action Lawsuit
In May 2018, Devin Martinez, Ricardo Wohler and others who purchased Truvada and other TDF drugs filed a class action lawsuit with the help of the AIDS Health Foundation.
Unlike individual injury lawsuits that seek damages for physical injuries, this California class action seeks to hold Gilead accountable for violating the California Consumer Legal Remedies Act by misleading consumers about the safety and effectiveness of the drug.
It demands reimbursement for costs associated with buying the drug such as co-pays, money paid to insurance companies and other out-of-pocket costs related to purchasing the drug.
But it makes many of the same allegations against Gilead. For example, the drug maker misrepresented TDF’s safety profile as early as 2001, according to the complaint. It failed to warn the public, withholding the superior and safer drug TAF.
In Nov. 2019, the United States sued Gilead on behalf of the Department of Health and Human Services, according to a press release. HHS alleges Gilead infringed on its patent for PrEP to prevent HIV infection.
The government says the Centers for Disease Control and Prevention originally designed and patented PrEP regimens with hundreds of millions in taxpayer dollars. Now Gilead makes billions using taxpayer-funded research and markets Truvada and Descovy for PrEP without licensing from HHS.
HHS demands Gilead obtain the proper licensing from the government to continue to sell its medications.
14 Cited Research Articles
- Abrams et al. v. Gilead Sciences. (2019, September 10). Complaint for Damages and Demand for Jury Trial. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-09-10-Complaint.pdf
- AIDS Healthcare Foundation. (2019, February 13). Victory over Gilead! California Court Rules HIV Drug Personal Injury Cases May Proceed. Retrieved from https://www.apnews.com/4db956edccff42d7b869cf311b3e5b0d
- Department of Health and Human Services. (2019, November 6). United States Files Patent Infringement Lawsuit Against Gilead Related to Truvada and Descovy for Pre-exposure Prophylaxis of HIV. Retrieved from https://www.hhs.gov/about/news/2019/11/06/us-files-patent-infringement-lawsuit-against-gilead-pre-exposure-prophylaxis-hiv.html
- Gilead Sciences, Inc. (2018). Form 10-K, Annual Report. Retrieved from http://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_GILD_2018.pdf
- Gilead Sciences, Inc. (2019, June 30). Form 10-Q, Quarterly Report. Retrieved from http://investors.gilead.com/static-files/439a64ce-41c7-4e4f-866c-f0aba54751e2
- Grant, P.M. & Cotter, A.G. (2016). Tenofovir and Bone Health. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4844450/#:~:targetText=TDF%20use%20results%20in%20a,with%20TDF%20is%20largely%20reversible.
- Lujano et al v. Gilead Sciences, Inc. (2018, May 8). Superior Court of the State of California for the County of Los Angeles. Complaint for Damages. Case No. BC702302. Retrieved from https://www.aidshealth.org/wp-content/uploads/2018/05/gilead-personal-injury-final.pdf
- Martinez et al. v. Gilead Sciences, Inc. (2018, May 8). Superior Court of the State of California for the County of Los Angeles. Class Action Complaint for Injunctive Relief and Damages. Case No. BC705063. Retrieved from https://www.aidshealth.org/wp-content/uploads/2018/05/class-action-complaint-final.pdf
- McComsey, G.A. et al. (2018, February 20). Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. Retrieved from https://journals.lww.com/aidsonline/Fulltext/2018/02200/Switch_from_tenofovir_disoproxil_fumarate.8.aspx
- Naisha v. Gilead Sciences. (2019, July 11). Complaint Under Delaware Superior Court Civil Rule 17 for Damages. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-7-11-truvada-naisha-complaint.pdf
- Petersen, M. (2018, May 9). Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine. Retrieved from https://www.latimes.com/business/la-fi-gilead-hiv-drug-lawsuit-20180509-story.html
- Pierot v. Gilead Sciences, Inc. (2018, July 27). United States District Court Western District of Louisiana. Complaint and Demand for Jury Trial. Case No. 3:18-cv-00975. Retrieved from https://www.aidshealth.org/wp-content/uploads/2018/07/pierot-v-gilead-filed-complaint.pdf
- Silverman, E. (2016, February 1). Gilead accused of manipulating HIV patents. Retrieved from https://www.statnews.com/pharmalot/2016/02/01/gilead-patents-hiv/
- Venter, W.D.F. et al. (2018, July 17). An overview of tenofovir and renal disease for the HIV-treating clinician. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6111387/