A Truvada lawsuit is a claim against the pharmaceutical company Gilead Sciences, Inc. for the dangerous side effects of Truvada.
- Gilead delayed a safer drug for a decade in order to boost profits from Truvada‘s patent, and
- Truvada had a design defect.
What medications are subject to the litigation?
- Truvada, Gilead’s original TDF (tenofovir disoproxil fumarate) medication for HIV treatment as well as pre-exposure prophylaxis “PrEP” for HIV-negative people.
- Atripla, which is used only for HIV treatment, not HIV prevention. Also goes by the name Efavirenz.
- Complera, which is used only for HIV treatment, not prevention. Also goes by the name Rilpivirine.
- Stribild, which is used for HIV treatment, not prevention. Also goes by the name Elvitegravir, Cobicistat, and Emtricitabine.
- Viread, which treats Hepatitis B in addition to HIV. Also goes by the name Tenofovir DF.
Common Injuries from Truvada and similar TDF drugs
- Acute or chronic kidney disease, which is when damage to the kidneys prevents them from filtering blood properly. Anything below a 90 GFR (glomerular filtration rate) is abnormal. Truvada‘s “poor bioavailability” keeps the body from efficiently absorbing the drugs. This leads to kidney problems.
- Kidney failure is kidney disease 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, which is 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, which is weakened bone mineral density (including teeth). Left untreated, it could lead to breaks and fractures.
- Osteoporosis is when bones become brittle and may fracture easily.
- Osteomalacia occurs when bones break down more quickly than they can re-form.
The current litigation
Presently, we are bringing suit in the Northern District of California (federal court) through an MDL (multidistrict litigation). This is where similar lawsuits are consolidated to speed up litigation and a settlement. The Truvada MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881.
In this article, we will discuss:
- 1. What is Truvada?
- 2. What are the health risks associated with Truvada?
- 3.3. What is the current state of the Truvada litigation?
- 4. What compensation can victims recover?
- 5. What you can do if you have been hurt
- 6. Contact our defective drug lawyers
1. What is Truvada?
Truvada is an antiretroviral drug that treats and prevents HIV and AIDS. It combines the chemicals emtricitabine and tenofovir disoproxil fumarate (TDF). The drug stops HIV cells from multiplying once in the body.
One of the drugs in Truvada, TDF, has been around since the 1980s. However, its use for HIV had been limited because it could only be taken intravenously. When Gilead Sciences, Inc. bought the rights to sell TDF, they modified it so it could be taken orally, in the form of a pill. That oral medication was approved by the U.S. Food and Drug Administration (FDA) in 2001. This initially came under the brand name Viread.1 Truvada was approved by the FDA in 2004.2
2. What are the health risks associated with Truvada?
Truvada has been linked to a number of serious severe side effects. These include:
- Decreased bone density and osteoporosis,3
- Kidney damage and renal failure,4 and
- Lactic acidosis.5
2.1. Decreased bone density and osteoporosis
One of the serious side effects of Truvada is a decrease in bone density. These bone problems can occur after taking the HIV drug for just a few weeks. Bone loss significantly increases the risks of:
- Bone fractures,
- Broken bones,
- Osteopenia, and
This loss of bone density stems from the kidney damage Truvada causes. Not easily absorbable by the body, Truvada pools in the renal tubules. This inhibits the kidneys from regulating phosphate levels. This, in turn, compromises bone density.
2.2. Kidney damage and renal failure
Truvada was designed to be taken in high doses for such a long time. It is up to the kidneys to expel the drug from a patient’s system. Therefore Truvada puts stress on the kidneys as well. This strain can lead to kidney damage and even kidney failure. It can create numerous other medical problems.
2.3. Lactic acidosis
Kidney damage from prolonged use of Truvada can lead to lactic acidosis. This is the accumulation of lactate in the bloodstream. Without the kidneys working at full function, they fail to remove enough lactate acid from the blood. This leads to the following symptoms:
- Vomiting, and
- Difficulties breathing.
3. What is the current state of the Truvada litigation?
Numerous lawsuits have been filed against drug maker Gilead Sciences, Inc.6 This includes a class action lawsuit representing victims in the state of California.7 These lawsuits include allegations that Gilead Sciences, Inc. had developed a drug that was safer than Truvada. But the company kept it out of production until Truvada’s patent was set to expire.
3.1. Failure to warn and Defective design claims
The bulk of the lawsuits deal with the claim that Gilead knew that Truvada carried serious design defects that cause severe side effects. Gilead also failed adequately to warn doctors or patients of those risks.
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 2001.8 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.9 Truvada continued to be marketed as a safe drug. This happened in spite of a growing body of scientific evidence to the contrary.10
3.2. 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 2004.11 Those studies revealed not only that TAF was far less toxic. But also that TDF carried a much greater risk profile.12
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.13
Therefore, rather than release the studies that found TAF was a less toxic alternative to TDF, Gilead covered them up.14 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.15
Finally, in 2010, the patent on TDF was running out. Gilead announced the discovery of a new drug that would revolutionize HIV treatment – TAF.16 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.17 Gilead urged patients on TDF medications to switch to newer, TAF-based drugs like:
- Odefsey, and
The lawsuits allege Gilead delayed 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.
4. What compensation can victims recover?
Victims of Truvada are likely to have suffered injuries and amassed steep medical bills and other losses. A drug lawsuit against Gilead can recover the compensation for the losses, pain, and suffering that they have sustained through no fault of their own.
These compensatory damages can come in a variety of forms, including:
- The costs of medical treatment,
- Lost income,
- Pain and suffering, and
- The loss of consortium suffered by a victim’s family.
Moreover, lawsuits pending against Gilead have sought punitive damages.19 These damages seek to punish the makers of defectively advertised drugs for their egregious and dangerous conduct.
5. What you can do if you have been hurt?
Are you taking or have you taken a Truvada-based drug? If so, talk with your doctor about diagnostic tests. Kidney disease can be diagnosed by way of blood or urine test, imaging or biopsies. The first step in diagnosing bone loss is a DEXA scan. A DEXA scan is a dual-energy x-ray that measures bone loss.
It is important to diagnose and treat these injuries as early as possible. If the tests reveal kidney or bone damage, you may qualify to bring a lawsuit. Contact a lawyer as soon as possible. There is a statute of limitations (deadline) for filing a Truvada lawsuit or claim. In some cases this may be as short as one year from the onset of the injuries.
6. Contact our defective drug lawyers
The lawyers at the Shouse Law Office represent people injured by big pharma throughout the United States. Call our law firm for a free case evaluation.
- FDA Approval Letter for TDF.
- FDA Approval Letter for Truvada.
- Iwen F Grigsby, Lan Pham, Louis M Mansky, Raj Gopalakrishnan, and Kim C Mansky. “Tenofovir-associated bone density loss,” Therapeutics and Clinical Risk Management 6:41-7 (2010).
- Willem D.F. Venter, June Fabian, and Charles Feldman. “An overview of tenofovir and renal disease for the HIV-treating clinician,” South African Journal of HIV Medicine 19(1):817 (2018).
- Pablo Rivas, Jorge Polo, Miguel de Górgolas, Manuel L Fernández Guerrero. “Drug points: Fatal lactic acidosis associated with tenofovir,” British Medical Journal 327:711 (2003).
- See Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).
- Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).
- Complaint at 1, Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018); also see Gilead Tenofovir Cases and Coordinated Actions, JCCP No. 5043.
- Id. at 2.
- Id. at 2-4.
- Id. at 3.
- The yearly cost of Truvada was $18,456 (Id. at 5).
- Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).
- See Id. and Complaint at 4.
- Petersen, supra note 14.
- Complaint at 17, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).