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 for HIV infection treatment, not HIV prevention. Also goes by the name Efavirenz.
- Complera, which is 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 and kidney injuries.
- 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, Shouse Law Group is bringing legal action 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 In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881. Currently, the first bellwether trial is scheduled for October of 2022.
In this article, we will discuss:
- 1. How bad is Truvada?
- 2. What is the lawsuit against Truvada?
- 3. How much can you get from Truvada lawsuit?
- 4. How long do I have to file a lawsuit?
- 5. What evidence do I need to win a Truvada lawsuit?
- 6. What you can do if you have been hurt
- 7. Contact our defective drug lawyers
1. How bad is Truvada?
Truvada has been linked to a number of serious severe side effects. Truvada side effects include:
- Decreased bone density and osteoporosis,1
- Kidney damage and renal failure,2 and
- Lactic acidosis.3
1.1. 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.
Signs of bone problems include back pain, hip pain, and joint pain.
1.2. Kidney damage and renal failure
Truvada was designed to be taken in high doses for 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.
1.3. 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:
- Weakness and fatigue,
- Vomiting, and
- Difficulties breathing.
1.4. Other side effects
Truvada patients have reported many other side effects that negatively impact their well-being, such as:
- Abdominal pain
- Bizarre dreams
- Hyperpigmentation of the skin
- Itching and rashes
- Loose stools (diarrhea)
- Losing weight
- Respiratory infections
- Trouble sleeping (insomnia)
2. What is the lawsuit against Truvada?
All of the Truvada lawsuits across the U.S. are consolidating into a federal MDL out of the Northern District of California. Each plaintiff’s case remains separate, but the MDL – similar to a class action lawsuit – helps to expedite the litigation process and speed up settlements. The name of the Truvada MDL against drug manufacturer Gilead Sciences, Inc. is In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881.
The Truvada MDL is still in the pretrial phase. Eventually, the judge will allow a few “bellwether cases” to go to trial – the first one is set to start in October of 2022.
How these bellwether trials turn out will set the stage for negotiations with the tens of thousands of remaining plaintiffs in the MDL. There will likely be no Truvada lawsuit settlements until all the bellwether cases finish, which may take until 2023 or later.
2.1. Failure to warn and Defective design claims
The bulk of the lawsuits deals with the claim that Gilead knew that Truvada carried serious design defects that – in turn – cause severe side effects. Gilead also failed adequately to warn doctors or patients of those risks in its disclaimers.
Each lawsuit claims 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 as an oral medication by the U.S. Food and Drug Administration (FDA) in 2001.4 Nevertheless, Gilead continued to tout TDF and Truvada as “risk-free.”5
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. This happened in spite of a growing body of scientific evidence to the contrary.6
2.2. Claims that Gilead withheld a safer drug
The lawsuits also allege that Truvada manufacturer Gilead concealed the development of another drug, tenofovir alafenamide (TAF).
The body absorbs TAF better than TDF. This makes TAF more efficacious at significantly lower doses. Gilead had been investigating TAF even before Truvada gained approval in 2004.7 Those studies revealed that TAF was far less toxic and that TDF carried a greater risk profile.8
However, TDF had only recently received a patent. 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.9
Therefore, rather than release the studies that found TAF was a less toxic alternative to TDF, Gilead covered them up.10 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.11
Finally, in 2010, the patent on TDF was running out. Gilead announced the discovery of a new drug that would revolutionize HIV treatment – TAF.12 Gilead unveiled the results of its earlier TAF studies as proof that it was a better drug for HIV treatment and caused less bone density problems and kidney damage than TDF.13 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 and at the expense of HIV patients taking high risk TDF-based HIV medications.
For nearly a decade, patients were 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.
3. How much can you get from Truvada lawsuit?
Truvada victims may be able to recover the following economic and non-economic damages from Gilead:
- Past and future anticipated costs of medical treatment and other medical expenses
- Medical expenses to treat previous injuries aggravated by the TDF-related injuries
- Lost income from being too ill to work
- Loss of future earnings from being too ill to work
- Cost of disability accommodations
- Pain and suffering, including mental distress and losing quality of life
- The loss of consortium suffered by a victim’s family
- Funeral expenses and loss of support if the victim died (“wrongful death”)
- Any other compensatory damages caused by TDF-related injuries
Moreover, lawsuits pending against Gilead have sought punitive damages for plaintiffs.15 These damages seek to punish the makers of defectively advertised drugs for their egregious and dangerous conduct.
Ultimately, the amount each plaintiff may settle for depends on their specific case and the extent of their Truvada-triggered injuries. Plaintiffs who are too injured to work and with reduced life expectancy will likely recover more money than plaintiffs who recovered from their injuries and can still earn a living.
4. How long do I have to file a lawsuit?
Every state has its own statute of limitations for filing dangerous drug claims. The average is two or three years following the injury, but there may be ways to get around this time limit. An attorney can help victims determine by what time they need to file suit.
In any case, TDF victims should consult a lawyer as soon as possible. It takes a while to work up a winnable case, and attorneys want as much time as possible to craft the best lawsuit possible.
5. What evidence do I need to win a Truvada lawsuit?
TDF victims and their attorneys would compile the following documentation to show that Gilead caused their injuries:
- Pharmacy records to show the dates that the victim took Truvada or other TDF medications
- Medical records to show that the victim’s doctor prescribed him/her TDF
- DEXA scans that show the victim has osteoporosis or osteopenia
- Medical records – including blood tests – that show the victim has kidney damage
- Medical records of all the medications and treatments (including surgeries) that the victim needs
- Dialysis records
- Receipts of medical bills and expenses, including therapy and medical equipment (such as walkers)
- Financial records (such as bank records and pay stubs) to show time missed from work and lost wages
- Diaries indicating the extent of the victim’s physical pain and mental anguish
- Doctors’ notes indicating future anticipated medical treatments and costs
Depending on the case, plaintiff’s attorneys may also hire expert medical witnesses to help show the link between the TDF medications and the plaintiffs’ injuries.
6. 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 or other healthcare provider about diagnostic tests. A blood or urine test, imaging, or biopsies can diagnose kidney damage. 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 Truvada injuries as early as possible. If the tests reveal kidney or bone damage, you may qualify to bring a product liability lawsuit.
- 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 also et al, Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns, Drug Saf. (April 2017).
- 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. See also Lujano v. Gilead Sciences, Inc., (Cal. filed May 18, 2018) No. BC 702302. Also see Martinez v. Gilead Sciences, Inc., (Cal. filed May 8, 2018) No. BC 705063. See also FDA Approval Letter for TDF. See also FDA Approval Letter for Truvada.
- Id. at 2.
- See note 6 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 12.
- Complaint at 17, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018). See also Kenslea, G. AHF Calls on Gilead to Set Up $10 Billion Fund for Victims Harmed by its TDF-based Drugs, AHF (July 17, 2019). See also Gilead Agrees To Pay $97 Million To Resolve Alleged False Claims Act Liability For Paying Kickbacks, US Department of Justice (September 23, 2020)(re. the drug Letairis).