Settlements of TDF lawsuits are likely to resolve the mass tort claims against Gilead Sciences, Inc. for the side effects caused by Truvada and their other HIV treatment drugs. However, because the Truvada lawsuits are still very new, settlements are still a long way away. When they do finally happen, these settlements would aim to compensate TDF victims for their losses, including:
- Past medical bills,
- Future medical expenses associated with side effects of TDF (tenofovir disoproxil fumarate) or Truvada,
- Lost wages and reduced earning capacity,
- Pain and suffering, and
- The loss of companionship suffered by the victim’s family.
In this article, we will discuss:
- 1. Have there been any settlements of TDF lawsuits yet?
- 2. What is the likely timeline for settlements with Gilead Sciences?
- 3. What is the Truvada lawsuit payout expected to be?
1. Have there been any settlements of TDF lawsuits yet?
There have not yet been any settlements with drug manufacturer Gilead in Truvada cases or TDF lawsuits. In fact, it is unlikely that settlement negotiations have started yet because of how new the lawsuits are.
On May 8, 2018, the first batch of lawsuits was filed against Gilead for the side effects of Truvada and other TDF-based HIV prep and treatment antiretroviral drugs (such as Complera, Atripla, Stribild, and Viread). Some of these lawsuits were filed by individual victims.1 One was filed as a class action representing TDF victims in the state of California.2
These lawsuits, which are being brought on behalf of victims by AIDS Healthcare Foundation (AHF), quickly created a stir in the news media, starting with an in-depth exposé in the Los Angeles Times the very next day.3
As is often the case with mass tort claims, the media attention served to notify other victims that the side effects they were experiencing were widespread and that other people were taking legal action for the injuries they have suffered. Other victims soon followed suit.4 The number of TDF lawsuits has since spread into the hundreds.
2. What is the likely timeline for settlements with Gilead Sciences?
Based on similar mass tort claims that are based on defective drugs and a pharmaceutical company’s failure to warn people about serious risks, it could still be several years before settlements are made in Gilead lawsuits.
Because there are likely thousands of people who have suffered from the serious side effects of Truvada or other TDF drugs, courts have consolidated them into multidistrict litigation, or MDL. The Truvada MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881. It is out of the Northern District of California (federal court).
MDLs combine all similar cases for the pretrial procedures in front of one federal district court, including:
- Evidence gathering,
- Motions to dismiss,
- Motions to exclude evidence,
- Expert testimony, and
- Summary judgment motions.
Similar to class action lawsuits, MDLs streamline the process and allow victims to share evidence with one another, rather than having to discover it independently in each claim for compensation.
In theory, MDLs end by sending each lawsuit back to the court from which it came, where it would then go to trial.
Increasingly, though, MDLs have included settlement negotiations. To further those negotiations, MDLs conduct bellwether trials. These trials take representative cases from the MDL and take them through a jury trial. The success or failure of the bellwether trials then influences the settlement negotiation.5
3. What is the Truvada lawsuit payout expected to be?
If the claims made by the victims in TDF lawsuits are true, the Truvada lawsuit payout is likely to be substantial. This is because of the profits that TDF drugs have made Gilead Sciences, Inc. and the potential for punitive damages being assessed against the company.
According to lawsuits filed by the victims, Gilead both failed to warn doctors and patients of the increased risks and toxicity of their HIV medications and withheld a safer alternative from the market called TAF (tenofovir alafenamide fumarate). By not adequately warning people of the severe side effects that TDF and Truvada could cause, victims could not make informed decisions about their health that could have avoided their injuries. And by withholding safer TAF drugs such as Genvoya and Descovy from the market for ten years, the drug maker forced victims to needlessly continue to experience those TDF side effects, including:
- bone mineral density loss / bone density loss,
- bone injuries,
- bone fractures,
- lactic acidosis,
- osteopenia – osteoporosis’s precurser where bone density is below peak level as signaled by shorter height, stooped over posture, back pain, and bone demineralization,
- osteoporosis – where old bone tissue dies, and new tissue stops growing or grows too slowly to replace it, which may result in fractures from small movements or falls,
- acute kidney injury (AKI) – where waste is not filtered well from blood,
- kidney damage and kidney problems,
- reduced kidney function,
- acute renal failure (ARF) / kidney failure,
- Renal tubular acidosis – a renal condition where the blood contains increased acid that the kidneys fail to filter out,
- Fanconi Syndrome – a tubule disorder where the urine contains increased levels of glucose, potassium, and bicarbonate,
- chronic kidney disease – a disorder where waste may build up to dangerous levels, and/or
- other kidney injuries.6
The Gilead lawsuits allege that this course of conduct allowed the company to reap around $18 billion per year on its HIV drugs, all while putting patients at risk so it could extend the market protection for its brand name Truvada and TDF-based drugs.7
If these claims are proven true, the threat of being taken to court where they could be penalized with punitive damages could increase Gilead’s willingness to settle TDF lawsuits outside the courtroom. This willingness would be reflected in payouts that go beyond the compensatory damages. Instead, these settlements would reflect Gilead’s interest in settling the case before too much evidence was made public about their business decisions.
- See for example, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 8, 2018).
- Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).
- Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018). TDF drugs are antiretroviral nucleoside reverse-transcriptase inhibitors which stop an enzyme necessary for HIV to replicate and progress. Antiretroviral medications are necessary for HIV-positive patients.
- See for example, Pierot v. Gilead Sciences, Inc., No. 3:18-cv-00975 (La. Filed July 27, 2018).
- See for example, In Re: Proton-Pump Inhibitor Products Liability Litigation, MDL No. 2789 (D. N.J.) (formed on August 2, 2017, and still gathering evidence) and In re: Roundup Products Liability Litigation, MDL No. 2741 (N.D. Cal.) (formed October 4, 2016, and now conducting bellwether trials).
- See Complaint at 1-4 Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018). The same year Gilead released TDF (2001), it began developing the safer TAF medications. But it stopped developing TAF in 2004 and did not resume until 2015. Instead, Gilead put a warning label on the TDF meds in 2003 and continued profiting off of it until the patent lapsed in 2018. Now Gilead is profiting from TAF, the patent of which expires in 2031. The purpose of kidneys are to filter out fluid, waste, and electrolytes from the blood and release them into urine. Typical symptoms of kidney failure are itchy skin, frequent urination, hypertension, swollen ankles and feet, tiredness, inability to concentrate, lack of appetite, high protein levels in urine, high creatinine levels, and/or abnormal GRE (glomerular filtration rate) levels from 15 to 90. Kidney failure may require a transplant or dialysis. It can also lead to death. See also Iwen F Grigsby, Lan Pham, Louis M Mansky, Raj Gopalakrishnan, and Kim C Mansky, Tenofovir-associated bone density loss, Ther. Clin. Risk Manag. (Feb 2, 2010)(“a strong correlation between loss of bone density in HIV-infected individuals, particularly in conjunction with the antiretroviral drug tenofovir”). Philip M. Grant and Aoife G. Cotter, Tenofovir and Bone Health, Curr Opin HIV AIDS. (2016 May; 11(3): 326–332)(“Several studies have demonstrated an approximately 1–3 percent greater bone mineral density loss with TDF compared with other agents)”.
- Id. at 5.