- Kidney damage and renal failure, resulting from the body’s inability to filter out the Viread’s toxins;
- Osteoporosis and broken bones, caused by the damaged kidneys filtering calcium out of the bones and reducing the body’s ability to make phosphate (poor bone mineral density); and
- Lactic acidosis, a metabolic imbalance that is also caused by damaged kidneys and can be life-threatening
Despite the dangerous side effects, Gilead not only sold the defectively designed drug. Gilead also withheld selling a safer alternative to milk TDF’s patent for all it was worth. In short, Gilead put profit over the well-being of its consumers. Our 2022 Viread lawsuits are pursuing the maximum compensation possible under the law.
1. What are the grounds for a Viread lawsuit?
Viread lawsuits make two main claims against TDF manufacturer Gilead:
- Gilead negligently created a defective design; and
- Gilead purposely withheld a safer drug to increase TDF’s profits
1.1 Negligent defective design
To win a product liability defective design claim, Viread plaintiffs need to prove the following two elements:
- Gilead knew of the risk associated with taking Viread; and
- Viread caused the plaintiff’s kidney failure, other kidney problems, and/or bone damage
As for the first element, there is ample documentation that indicates Gilead knew that the HIV drug had poor “bioavailability.” In other words, that the body did a poor job of absorbing the HIV medication.
As for the second element, there is also ample evidence that Viread was a substantial factor in causing patients to get kidney injuries and bone injuries. Plaintiffs’ attorneys would compile medical records and the testimony from medical experts to show the connection between the drug and its serious side effects.1
Depending on the particular case, plaintiffs may also have a viable claim against Gilead for failing to warn physicians and patients about TDF’s dangers. There is evidence that Gilead sales representatives touted Viread as “risk-free.” Even the U.S. Food and Drug Administration (FDA) has reprimanded the drugmaker for misleading the public on Viread’s side effects.2
1.2. Gilead withheld a safer drug
Plaintiffs claim that Gilead invented a safer version of TDF called TAF (tenofovir alafenamide fumarate) as early as 2000. But Gilead refused to release this alternative treatment of HIV for another 15 more years.
TAF had a higher absorption rate than TDF. This meant a low dose of TAF would have the same impact as a high dose of TDF. Consequently, TAF posed less of a strain on kidneys and bone density.
However, it was more profitable for the drugmaker to sell TDF drugs exclusively until its patent protection expired. So that is exactly what Gilead did. It was not until 2015 that the drugmaker finally presented TAF to the FDA for approval.
When TDF drugs were finally about to lose their market protection, the drugmaker announced a major breakthrough in HIV treatment. It released studies it had done years earlier proving that TAF was more effective and less risky than TDF. All of a sudden, Gilead was admitting that TDF was not “risk-free” after all.3
In summary, Gilead was earning billions from a dangerous, inferior product while keeping a safer, superior drug on the back-burner. Meanwhile, hundreds of thousands of HIV patients were put at risk of developing devastating injuries from TDF’s toxicity. And many did.
2. Who qualifies to be a plaintiff?
People may be able to sue Gilead if they developed any of the following conditions after taking Viread:
- Osteoporosis, osteopenia, or osteomalacia
- Bone fractures which a doctor attributed to bone weakening or demineralization
- Bone density loss, bone demineralization, or weakening/thinning/softening of the bones
- Chronic kidney disease
- Renal failure, which requires hospitalization and/or dialysis
- Low kidney function which requires dialysis or has been diagnosed by a doctor
- High creatinine levels
- Abnormal glomerular filtration rate (GFR), from levels 15 to 90
- Abnormal protein levels in urine
- Fanconi Syndrome/ proximal renal tubule dysfunction4
If a Viread user passed away from renal failure, his/her estate would be able to file a wrongful death suit.
Note that having kidney stones, bone fractures, or bone pain alone is not grounds for a 2022 Viread lawsuit. They would need to be a symptom of one of the above conditions.
Also note that Viread use can lead to such side effects as Immune Reconstitution Syndrome and liver problems.
3. Where are the lawsuits being filed?
2022 Viread lawsuits and a class action have been filed in state courts throughout California, where Gilead is headquartered. However, the plaintiffs are from all over the United States.
In order to speed up the litigation and settlement process, these California lawsuits have been joined into an MDL (multidistrict litigation) out of the Northern District of California (federal court). An MDL is where similar lawsuits are joined together to expedite litigation and a settlement. It is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881.
4. When are settlements expected?
Settlement talks will begin after a few of the Viread cases go to trial. This probably will not occur for another year or so since the lawsuits are still in the evidence-gathering (“discovery”) stage.
The results of these first “bellwether trials” will give both sides a starting point for negotiations. If the juries find Gilead liable and impose large punitive damages, Gilead may be willing to pay a large settlement to avoid further lawsuits.
During settlement negotiations, the plaintiffs’ lawyers would seek compensation for:
- Medical bills (such as surgeries, hospital bills, diagnostic tests, medical equipment, and medications)
- Anticipated future medical expenses (such as rehabilitation, dialysis, long-term nursing care)
- Professional setbacks like lost wages and lowered earning potential,
- Pain and suffering (including depression, anxiety, mental anguish, loss of enjoyment of life, chronic pain, reduced mobility, disabilities, and insomnia)
- Loss of consortium for the victim’s family
If the victim passes away, a wrongful death lawsuit would seek compensation for medical expenses, funeral expenses, and loss of support.
5. How do I prove I was injured?
Viread victims should compile all relevant evidence including:
- Medical records showing when the Viread was prescribed and resulting injuries
- Photographs and scans of injuries
- Receipts for Viread purchases
- Financial records indicating lost wages
- A diary documenting pain and suffering
- Names and contact information of potential witnesses who can attest to the pain and suffering
Plaintiffs’ attorneys may also call upon medical experts to connect a victim’s Viread usage and his/her injuries.
6. Is there a class action lawsuit against Viread?
For the most part there are individual 2022 Viread lawsuits. These individual lawsuits are temporarily consolidated into an MDL. But every case remains separate and gets individually evaluated.
MDLs function to make the litigation and settlement process more efficient while maintaining the integrity of each lawsuit.5
7. What is the drug Viread used to treat?
Viread is prescribed to treat HIV and hepatitis B.
8. What is the statute of limitations?
The time limit to bring a Viread lawsuit depends on the state, but it can be as short as one year after the injury occurs. An attorney can help victims determine their timeframe to file a lawsuit.
8. Do I need an attorney?
It is highly recommended that Viread victims hire an attorney to handle the entire litigation process while they concentrate on healing. A mass torts lawyer will file all the paperwork, manage all the communications with opposing counsel and the court, and finally negotiate the case (it is very rare for these cases to go to trial). And in practice, victims of dangerous drugs tend to receive much higher settlements if they have a private attorney fighting for them.
- See Berrier v. Simplicity Mfg., Inc., (3d Cir. 2009) 563 F.3d 38, 61.
- See Sample Jury Instructions CACI No. 1222. Negligence—Manufacturer or Supplier—Duty to Warn—Essential Factual Elements.
- See Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018); Melody Petersen, “FDA’s second warning letter to Gilead, Los Angeles Times,” (May 29. 2016); note that Viread is part of a class of anti-HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It is antiretroviral; some TAF brand names include Genvoya, Descovy, and Odefsey.
- 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); FDA Approval Letter for TDF.
- There is a class action regarding TDF medications: Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).