A Stribild lawsuit is a mass tort claim against Gilead Sciences, Inc., the manufacturer of the HIV medication Stribild. Stribild contains the drug TDF, which has been known to cause serious side effects such as kidney failure and bone fractures, as well as lactic acidosis.
However, Gilead failed to warn people about these risks on the TDF drug’s warning label. Moreover, there is growing evidence that Gilead covered up a safer drug in order to maximize its profits. Stribild and other TDF lawsuits seek compensation for:
- Medical bills to treat these side effects,
- Anticipated medical expenses for ongoing medical care,
- Pain and suffering,
- Loss of consortium suffered by the victim’s family, and
- Professional setbacks like lost wages and reduced earning capacity.
The statute of limitations for filing a claim varies by state, but generally is two years from the injury.
In this article, we will discuss:
- 1. What is Stribild?
- 2. What are the side effects?
- 3. Are there lawsuits pending against the manufacturer?
- 4. What compensation might a victim obtain?
- 5. Is there litigation as to the other HIV drugs made by Gilead?
1. What is Stribild?
Stribild is a brand name for an HIV treatment antiretroviral pill. This pill contains a mixture of four different drugs:
- Emtricitabine, and
- Tenofovir disoproxil fumarate, or TDF.
The TDF works with the elvitegravir and the emtricitabine to prevent HIV cells already in the body from multiplying and spreading. The cobicistat in Stribild prevent the body from metabolizing the elvitegravir in Stribild.
Because Stribild only prevents HIV cells from spreading, it is not a cure for HIV. Rather, it is a treatment that needs to be continued for as long as a patient is at risk of developing HIV. Many of the people who take Stribild work with HIV-infected patients or are in intimate relationships with people who are HIV-positive or who have AIDS.
However, the TDF drug used in Stribild is very toxic and has to be taken in high doses because not much of it gets absorbed in the body.
2. What are the side effects?
Stribild comes with a host of common side effects, including:
- Skin discoloration and rash,
- Muscle pain,
- Stomach pain and discomfort,
- Vivid dreams and hallucinations,
- Breathing problems, and
Stribild has also been known to cause some far more severe side effects, as well:
- Kidney problems, including acute kidney injury and acute renal failure,1
- Lactic acidosis, or the accumulation of lactic acid in the blood,2 and
- A decrease in bone mineral density that can lead to osteopenia, osteoporosis, broken bones, and other bone injuries and bone problems.3
Each of these severe side effects can have a significant impact on an HIV patient’s quality of life. In some cases, they can even be fatal.
2.1. Kidney damage and renal failure caused by Stribild
Most of the TDF in Stribild does not get absorbed in the body. Instead, it passes through the kidneys on its way out of the organ. The toxicity of the drug can cause significant kidney damage. Because Stribild is a long-term treatment for HIV rather than a cure, the kidney damage it causes builds up over time.
One study monitored the kidney health of 10,841 people in the San Francisco area with HIV. All of them were taking a TDF drug to treat their condition. One thing the study monitored was the protein level in their urine – a telltale sign of kidney damage. After controlling for factors like age and health, the study found that there is a 34 percent increase in signs of kidney damage for every year the patient was taking a TDF drug. Additionally, there were 33 percent increases in developing chronic kidney disease and an 11 percent increase in a sudden and rapid decline of kidney function.4
As the kidney damage gets worse, it can lead to renal failure, a potentially fatal medical condition.
2.2. From kidney failure to lactic acidosis
One of the worst complications of kidney failure caused by Stribild is lactic acidosis.
Because the kidneys are responsible for controlling the body’s lactic acid, decreased kidney performance can lead to lactate accumulating in the blood. If enough lactic acid builds up, it can alter the acidity of the entire bloodstream, lowering its pH level. As the blood becomes more acidic, it can cause medical complications throughout the rest of the body. Some of them, like organ failure, can be fatal.
2.3. Stribild can cause a reduction in bone density
The toxicity of the TDF in Stribild is also a problem for a patient’s bone structure. When combined with the usual effects that the HIV virus has on a victim’s bone density, Stribild can lower bone mass considerably. Because Stribild is a permanent treatment, the effect that the TDF has on a victim’s bone density accumulates over time.
As the bone density decreases, the risks of breaking or fracturing a bone increase accordingly. Stribild can lower bone mass so much that the density could fall below the level of osteoporosis, a medical condition often reserved for the elderly.
3. Are there lawsuits pending against the manufacturer?
Hundreds of lawsuits have been filed against Gilead Sciences, Inc. for the side effects of Stribild. These lawsuits claim that victims are entitled to compensation because Gilead did two things:
- They developed a safer drug than Stribild, but kept it off the market to maximize company profits, and
- They failed to warn doctors and patients about the risks of Stribild.
Some victims in California have joined together to file a class action lawsuit against Gilead.5 Most, though, are proceeding through the court system individually.6 But because these lawsuits involve victims with similar injuries, they are presently being consolidated 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.
3.1. Gilead withheld a safer alternative to Stribild
One of the claims made in the Stribild lawsuits is that Gilead had developed a drug that did not pose such a high risk to patients, but refused to release it until Stribild was about to lose protection from generic drug makers.
Gilead first began releasing its TDF-based HIV treatment pills in 2001.7 According to the lawsuits, Gilead was already developing another drug, tenofovir alafenamide fumarate, or TAF at that point. Research into TAF quickly discovered that TAF was absorbed in higher rates in the body than TDF. This meant TAF had the same effect as TDF, but at much lower doses, reducing the dangers of its toxicity.8
Gilead’s TDF-based drugs were just being released, though, and still had years of market protection from generic alternatives. They were also dominating the HIV treatment market. Gilead realized that they could continue to make billions of dollars every year on their TDF drugs until their market protection expired, and then release its TAF-based drugs to get a whole new period of market protection from generics. In 2004, Gilead patented its formula for TAF, announced that it would stop the development of TAF, and then hid all of the medical studies that it had conducted about the drug.9
In 2010, when the market protections for its earliest releases of TDF-based HIV drugs were expiring, Gilead made a major announcement. It had made a major breakthrough in HIV research and created a new drug: TAF. To support their announcement, Gilead released the medical studies that it had done years earlier. These studies showed that TDF could cause osteoporosis, broken bones, kidney damage and failure, and lactic acidosis, making it a very dangerous drug to take. TAF, on the other hand, drastically reduced those risks, so patients should switch to the new drug immediately.10
The lawsuits claim that Gilead should be held accountable for injuries suffered by people taking Stribild during the time between Gilead’s development of TAF-drugs and its release of them to the public.
3.2. Gilead failed to warn people of the dangers of taking Stribild
The Stribild lawsuits also claim that Gilead should be held accountable for their failure to warn doctors and patients of the risks of taking Stribild.
Drug companies have a legal duty to disclose the known risks and side effects of their products. The law requires these disclosures because it understands that doctors need them to write prescriptions and because patients use them to make informed healthcare decisions.
Victims filing Stribild lawsuits claim that Gilead failed to uphold this legal duty. They claim that Gilead knew of the risks of Stribild and other TDF-based HIV drugs, and point to much of the same evidence that supports their claim that Gilead withheld a safer HIV drug.
Throughout Stribild’s time on the market, Gilead representatives had claimed that it was “risk-free” and posed no threat to kidney health or bone density.11 Not only was the U.S. Food and Drug Administration (FDA) reprimanding Gilead for these claims; Gilead had known of TDF’s risks through its research and development of TAF. This research and development had revealed the absorption rates of the two drugs and the much higher risks of TDF. In fact, Gilead had begun emphasizing those risks as soon as it announced its discovery and subsequent release of TAF-based HIV drugs.12
Stribild lawsuits claim that, by withholding information on the risks of Stribild and the TDF in it, Gilead had caused victims to suffer terrible injuries from Stribild’s side effects.
4. What compensation might a victim obtain?
Victims who have taken Stribild and who have suffered its severe side effects have filed lawsuits that seek compensation for the:
- Medical expenses they have already accumulated,
- Medical expenses they are likely to accrue in the future as they recover,
- Wages they have lost during their recovery from Stribild’s side effects,
- Reduced earning capacity from the health effects of Stribild’s side effects,
- Physical pain and emotional and mental suffering of those side effects, and
- Loss of companionship suffered by the victim’s family and loved ones.
Many lawsuits also demand punitive damages be awarded against Gilead for their egregious conduct in withholding a safer drug from the market.13
5. Is there litigation as to the other HIV drugs made by Gilead?
In addition to Stribild, Gilead Sciences, Inc. has also produced other HIV drugs that contain TDF, creating numerous other lawsuits for causing serious side effects:
- Cimduo lawsuit,
- Atripla lawsuits,
- Truvada lawsuits,
- Complera lawsuits,
- Symfi-Lo lawsuit, and
- Viread lawsuits.
The HIV drugs that Gilead has released more recently have been based on TAF, rather than TDF. While TAF is likely a safer alternative, it can still cause significant side effects, as well. Gilead’s TAF-based line of HIV medication includes:
- Genvoya, the TAF-based pill that Gilead has urged Stribild users to switch to, and which has spawned its own set of Genvoya lawsuits,
- Vemlidy, and
- 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).
- 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).
- Scherzer R, Estrella M, Li Y, Choi AI, Deeks SG, Grunfeld C, Shlipak MG, “Association of tenofovir exposure with kidney disease risk in HIV infection,” AIDS 26(7):867-75 (April 24, 2012) and Steve Tokar, “Tenofovir, Leading HIV Medication, Linked with Risk of Kidney Damage,” University of California – San Francisco News Report (February 10, 2012).
- Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).
- See e.g., Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).
- FDA Approval Letter for TDF.
- See Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018) (complaint).
- Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).
- See note 9.
- See note 8.
- See notes 8 and 9.
- Complaint at 17, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).