Complera lawsuits are mass tort claims that have been filed against Gilead Sciences, Inc. for the side effects caused by their HIV drug, Complera, and one of its ingredients, TDF. These side effects can be devastating, and include kidney damage, lactic acidosis, and osteoporosis. Gilead, however, failed to warn doctors of the risks by disclosing them on the warning label. Worse, there is evidence that Gilead withheld a safer version of Complera in order to bolster its profits. As a result, numerous lawsuits have been filed against Gilead, seeking compensation for:
- Medical expenses,
- Lost wages and other professional setbacks,
- Pain and suffering, and
- Loss of companionship suffered by the victim's family.
- 1. What is Complera?
- 2. HIV drugs similar to Complera
- 3. Complera's side effects
- 3.1. Kidney problems and renal failure
- 3.2. Lactic acidosis caused by kidney failure
- 3.3. Bone problems and osteoporosis
- 4. Lawsuits against Gilead over side effects of Complera
- 4.1. Failure to warn claims in Complera lawsuits
- 4.2. Claims that a safer alternative to Complera was withheld
- 5. Compensation for Complera victims
1. What is Complera?
Complera is the brand name for a pill-based HIV treatment. Complera is comprised of three drugs:
- Emtricitabine, and
- Tenofovir disoproxil (TDF).
The major component in Complera, as with many other Gilead-produced HIV treatments, is TDF. TDF is a very toxic drug that prevents cells of the HIV virus from replicating. Importantly, this prevents HIV from spreading in the body, but does not kill the virus – TDF treats HIV but does not cure it.
The other two drugs in Complera, rilpivirine and emtricitabine, work as antiretroviral drugs. In combination with TDF, these drugs can reduce the risk of contracting HIV. Many people who are in intimate relationships with someone who is HIV-positive use Complera as a prophylactic.
While Complera can prevent the spread of HIV in the body and keep it from getting out of control, its reliance on TDF poses a threat to the people who take it: TDF is very toxic and does not absorb well in the body. TDF can cause severe side effects in people who take it, and it has to be taken in high doses to be effective.
2. HIV drugs similar to Complera
Complera is just one in a line of HIV drugs produced by Gilead that uses TDF as a main ingredient. Others include:
Recently, Gilead has stopped using TDF in its HIV drugs. Instead, it has replaced TDF with a safer alternative, a drug called tenofovir alafenamide, or TAF. Gilead has since released a handful of drug mixtures to replace its old line of TDF-based drugs:
- Odefsey, the TAF-based replacement for Complera,
- Genvoya, and
3. Complera's side effects
Complera can cause a handful of common side effects:
- Vivid dreams,
- Discolored skin,
- Muscle pain,
- Stomach pain,
- Breathing problems and shortness of breath, and
- Skin rashes.
Most people who take Complera, however, deal with these common and relatively light side effects to keep their HIV infection in check.
The more severe side effects of Complera include some life-threatening conditions:
- Kidney damage, kidney failure, and renal failure,1
- Lactic acidosis,2 and
- Decreased bone density, osteoporosis, and an attendant increase in bone fractures.3
3.1. Kidney problems and renal failure
One of the most severe side effects associated with Complera is kidney damage.
Most of the TDF in Complera does not get absorbed in the body. Instead, it passes to the kidneys, which then have to work far more than normal to distill the drug and expel it from the body. This extra work, together with the high level of toxicity in TDF, damages the kidneys over time. Because Complera is designed to be a long-term treatment for HIV, and cannot cure the disease, the ongoing damage to the kidneys accumulates. As kidney function eventually drops, the deterioration becomes quicker and quicker and eventually leads to kidney failure.
3.2. Lactic acidosis caused by kidney failure
The stress on a patient's kidneys can cause a life-threatening complication: Lactic acidosis.
Lactic acidosis is the accumulation of lactate acid in the bloodstream. As kidney function decreases from the overwork caused by the TDF in Complera, the kidneys cannot keep lactate levels in check. Increased lactate in the blood can cause a host of symptoms, including:
- Muscle pain, cramps, and weakness,
- Shortness of breath,
- Stomach pain and discomfort,
- Loss of appetite,
- Diarrhea, and
The most severe problem caused by lactic acidosis, however, is an altered pH level in the blood. When the blood gets too acidic, it can create life-threatening medical complications including organ failure.
3.3. Bone problems and osteoporosis
The toxicity in TDF is especially dangerous for a Complera patient's bone structure. The drug causes a significant drop in bone density over time. Because Complera is a long-term treatment for HIV, the decrease in bone density grows exponentially worse over time, eventually reaching the level of osteoporosis.
With a lower bone density, people taking Complera have a substantially higher risk of suffering a broken bone than others do. Even lightly traumatic events can cause a fracture.
4. Lawsuits against Gilead over side effects of Complera
The serious side effects of Complera have led to hundreds of lawsuits being filed against its maker, Gilead Sciences Inc. These lawsuits claim that Gilead failed to warn people about the serious dangers of taking their HIV medication. They also make the very serious allegation that Gilead developed a safer drug but withheld it from people who could benefit from it in order to bolster the company's profits.
So far, these lawsuits have not been consolidated into multidistrict litigation (MDL). There is a class action lawsuit filed by Complera and TDF victims in California,4 though, and numerous lawsuits filed by individual victims.5
4.1. Failure to warn claims in Complera lawsuits
Victims who took Complera and suffered the severe side effects of the drug have filed lawsuits claiming that Gilead did not uphold its legal duty to disclose the risks of taking their drug.
Drug companies have an obligation to warn doctors and patients about the severe or especially common side effects that their drugs can cause. Doctors use this information to make professional recommendations and prescriptions, while patients use it when they perform due diligence before making an important healthcare decision. However, drug companies have learned that these disclosures can deter patients, and often try to avoid making them.
Victims of Complera claim that Gilead knew of the risks of the TDF in Complera – this knowledge of TDF's danger was what led them to develop a safer alternative to TDF, the drug TAF, even as Complera was just being released.6 Nevertheless, Gilead representatives touted its TDF drugs as “risk-free,” even as the U.S. Food and Drug Administration (FDA) was reprimanding them for false claims that TDF did not cause bone density of kidney problems.7
4.2. Claims that a safer alternative to Complera was withheld
The lawsuits against Gilead also claim that the company had developed an HIV drug that was safer than Complera, but kept it off the market in order to extend its protection from generic replicas of the drug. This decision came at the expense of the thousands of people who were suffering from the potentially lethal side effects of Complera.
The lawsuits claim that Gilead's studies revealed TDF's high toxicity and its threat to a patient's bone density and kidneys, but also that TAF was less dangerous because more it was absorbed in the body. However, because Gilead's TDF drugs had just received legal protection from generic drugs, the lawsuits claim that Gilead aggressively patented TAF and then covered up the studies that found it was more effective than TDF.8
It was only when Gilead's TDF-based HIV drugs were about to lose their protection from generic alternatives that Gilead announced a breakthrough in HIV treatment – TAF-based drugs.9 Gilead supported the announcement with the studies it had done years before, showing how TAF was far safer than TDF because it was better absorbed and so could be taken in lower doses.10
Gilead urged people taking TDF-based HIV drugs like Complera to switch immediately to its new TAF-based versions, citing the side effects like renal failure and osteoporosis that it had previously insisted did not exist.11
5. Compensation for Complera victims
The lawsuits against Gilead for injuries caused by Complera demand compensation for losses suffered by the victims of the drug, including:
- Past and future medical bills and anticipated expenses,
- Lost wages,
- Reduced earning capacity,
- Pain and suffering, and
- Compensation for the loss of companionship suffered by the victim's family.
Victims are also asking for punitive damages, as well, to punish Gilead Sciences, Inc. for putting innocent people in danger so it could increase its profits.
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).
Complaint at 1, Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).
Id. at 2.
See Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).
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