- 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 public health.
1. What are the grounds for a Viread lawsuit?
Viread lawsuits make two chief 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 defective design claim, Viread plaintiffs need to prove the following two elements:
- Gilead knew of the risk associated with 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 develop kidney injuries and bone problems. 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 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 drug maker 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 to TDF called TAF (tenofovir alafenamide fumarate) as early as 2000. But Gilead refused to release this alternative treatment of HIV for another 15 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 drug maker to sell TDF drugs exclusively until its patent protection expired. So that is exactly what Gilead did. It was not until 2015 that the drug maker finally presented TAF to the FDA for approval.
When TDF drugs were finally about to lose their market protection, the drug maker 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. Suddenly, 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 product on the back-burner. Meanwhile, hundreds of thousands of HIV-patients were put at risk of developing devastating injuries. 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 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 suit.
Note that having kidney stones or bone fractures alone is not grounds for a lawsuit. They would need to be a symptom of one of the above conditions.
3. Where are the lawsuits being filed?
Viread lawsuits are largely being 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’ attorneys would seek compensation for:
- Medical bills,
- Anticipated future medical expenses,
- Professional setbacks like lost wages and lower earning potential,
- Pain and suffering, and
- Loss of consortium for the victim’s family
5. Is this a class-action lawsuit or individual lawsuits?
Individual lawsuits. As discussed above in section 3, 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
- See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 61 (3d Cir. 2009).
- 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).