Truvada and TDF lawsuits have been filed against Gilead Sciences, Inc., seeking compensation for the losses sustained by victims of their drugs' side effects. These side effects can include bone loss and osteoporosis, kidney failure, and lactic acidosis. The lawsuits claim that the warning labels on TDF drugs failed to warn doctors and patients of the risks of taking the drugs. They demand compensation for:
- Medical expenses,
- Lost wages,
- Reduced earning capacity,
- Pain and suffering, and
- Loss of consortium for the victims' families.
- 1. What are TDF or Truvada lawsuits?
- 2. Compensation available in TDF lawsuits
- 2.1. Medical expenses
- 2.2. Professional ramifications
- 2.3. Pain and suffering
- 2.4. Loss of consortium or companionship
- 3. Punitive damages
- 4. TDF lawsuit settlements and payout
1. What are TDF or Truvada lawsuits?
TDF lawsuits are mass tort claims that have filed against the manufacturer Gilead Sciences, Inc. for the side effects of the company's pill-based prophylactic treatments for HIV. The active ingredient in many of these drugs is tenofovir disoproxil fumarate, or TDF. Different treatments also include other drugs, and include:
- Cimduo, and
Therefore, Truvada lawsuits are just one example of the larger group of TDF lawsuits, which include:
All of these lawsuits claim that TDF can cause some severe side effects, including:
- Osteoporosis and a decreased bone density,1
- Kidney damage and renal failure,2 and
- Lactic acidosis.3
Despite the risks, though, Gilead failed to warn doctors and patients of the true potential for these side effects. Worse, the lawsuits claim that Gilead withheld a drug that would have been safer for people to take.
2. Compensation available in TDF lawsuits
The TDF lawsuits against Gilead all demand compensation for the victims who have needlessly suffered from the side effects of TDF-based HIV drugs like Truvada. This compensation would cover a victim's:
- Medical expenses,
- Professional ramifications,
- Pain and suffering, and
- Loss of companionship for their family.
2.1. Medical expenses
The core element to the compensation sought after in TDF lawsuits is for the victim's medical expenses. Importantly, this includes both the medical expenses that have been paid in the past, as well as the cost of reasonably anticipated medical care in the future.
Because the side effects of TDF drugs are so severe and potentially life-threatening, these medical expenses are likely to be significant for each person who has suffered from them.
2.2. Professional ramifications
Many of the people who take TDF drugs like Truvada to treat their HIV or to avoid contracting the disease have jobs or earn an income. Both the recovery process and the long-term impact of TDF's side effects can cause severe professional ramifications.
TDF lawsuits aim to recover compensation for those repercussions, including:
- Wages that have been lost by salaried workers while they recover from the serious side effects of Truvada,
- Business opportunities that have been missed by non-salaried workers, like those who run their own business, freelance, or earn a significant portion of their income on a commission basis,
- Earning capacity that has been lost by people who were not working at the time of their injuries, but who could have entered the workforce in the future at a level that they no longer can, due to their injuries.
2.3. Pain and suffering
Bone loss and kidney failure, along with renal failure's often fatal complication, lactic acidosis, are all painful and extremely debilitating medical conditions. TDF lawsuits aim to compensate victims by providing them with financial payments for what they have been put through.
Compensation for the physical pain suffered by a victim of TDF drugs aims to cover the physical discomfort and anguish that are related to the side effects of the drugs. For people who have suffered bone loss and broken numerous bones because of Truvada, this can be quite significant.
Meanwhile, compensation for suffering aims to compensate TDF victims for the mental and emotional distress of having to deal with a life-threatening medical complication through no fault of their own. This includes the feelings of disappointment that accompany a victim's knowledge that their debilitation might prevent them from doing what they most like to do.
2.4. Loss of consortium or companionship
Finally, victims of Truvada's side effects are likely to have families or loved ones who suffer along with them. Because these family members are being put through a difficult ordeal because Gilead failed to warn patients and doctors of the risks of Truvada and TDF, these lawsuits demand compensation for their loss of consortium or companionship, as well.
3. Punitive damages
In addition to compensatory damages, Truvada lawsuits also seek punitive damages to punish Gilead Sciences, Inc. for their egregious conduct in covering up the dangers of TDF and withholding a safer alternative.
Many mass tort claims demand punitive damages. However, the claims against Gilead seem especially likely to succeed if the lawsuits uncover evidence that the pharmaceutical company did, in fact, deliberately withhold safer drugs to extend their market protection of its HIV treatments.
4. TDF lawsuit settlements and payout
Because TDF lawsuits have only recently begun to be filed and are still gathering evidence, none of them have ended with a publicly-disclosed settlement, yet. However, if the claims against Gilead are true, the payout of these settlements could be substantial.
4.1. No settlements, yet
The earliest batch of TDF lawsuits against Gilead were filed in mid-May, 2018.4 A class action TDF lawsuit was filed on the same day, representing Truvada victims who lived in California.5 Because of the complexity of these claims, it will likely be years before enough evidence has been gathered for settlement negotiations to even begin.
To add to the complexity of these Truvada lawsuits, there are potentially thousands of people who have been hurt across the country by Gilead's alleged conduct. All of these victims are likely to have suffered similar injuries. As a result, all of the potential lawsuits that they could file would benefit from consolidation into multidistrict litigation, or MDL. Such an MDL would streamline the compensation process by allowing all victims to share evidence.
However, an MDL has not yet been formed.
4.2. Likelihood of a significant payout in TDF lawsuits
TDF lawsuits are still in their preliminary stages. However, if they prove to be successful, it does seem like there will be a significant payout, considering the nature of the claims against Gilead and the huge amounts of money that Gilead's TDF drugs have made.
According to the complaints in the TDF class action, Gilead was making $18 billion every year around 2015, largely on the backs of its line of TDF-based HIV drugs.6 Much of that profit comes because of the exorbitantly high prices Gilead has charged for its HIV treatments – nearly $20,000 per year for one person.7 That profit relies on the period of market protection that Gilead was granted with its approval by the U.S. Food and Drug Administration (FDA): Without market protection, generic versions of the drug could compete and drastically lower prices.
If victims are able to prove that Gilead manipulated the market by withholding a safer version of its TDF drugs in order to maximize its period of market protection, the threat of punitive damages being assessed could dramatically increase the payout of TDF lawsuits, even if they do end up settling out of court.
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).