Atripla® Lawsuit - Legal Claims for Bone Loss and Kidney Damage

An Atripla lawsuit is a mass tort claim filed against the pharmaceutical company Gilead Sciences, Inc. for side effects caused by TDF, one of the drugs in Atripla. While Atripla was designed to treat HIV, it can also cause serious side effects such as kidney failure, bone loss and fractures, and lactic acidosis. Despite the risks, Gilead failed to warn doctors and patients about the risks of TDF on Atripla's warning label. There is even evidence that Gilead withheld a safer version of the drug. Thousands of TDF lawsuits have been filed, seeking compensation for victims to cover their:

  • Past and future medical expenses,
  • Lost wages,
  • Pain and suffering, and
  • Loss of consortium.
atripla tablet

1. What is Atripla?

Atripla is the brand name for a pill that contains three different drugs:

  1. Efavirenz,
  2. Emtricitabine, and
  3. Tenofovir disoproxil (TDF).

TDF is a highly-toxic drug that can treat, but not cure, HIV/AIDS by preventing HIV cells from spreading once they are in the body. TDF does not eliminate HIV cells that have already entered the body, though. The other drugs in Atripla are antiretroviral drugs that help treat complications arising from HIV.

Atripla comes in a pill form, and is meant to be taken once per day. The concentration of drugs in this dose is considered to be very high. People who are in an intimate relationship with someone who is HIV positive frequently take Atripla so they do not contract the disease.

While TDF was first used in the 1980s, it was not popular in HIV treatment until Gilead Sciences, Inc. bought the rights to it and modified it so it did not have to be administered intravenously.

2. Drugs that are related to Atripla

There are several other drug combinations that rely heavily on TDF to treat HIV that have also caused problems for people taking them. These include:

Because all of these other drugs also use TDF, they have also created the same set of severe side effects.

3. Side effects of Atripla

Atripla has been known to cause a host of common side effects, including:

  • Fatigue,
  • Muscle pain,
  • Stomach pain and distress,
  • Nausea,
  • Diarrhea,
  • Headache,
  • Dizziness,
  • Skin discoloration,
  • Depression,
  • Insomnia or sleeplessness,
  • Hallucinations,
  • Difficulties breathing, and
  • Skin rash.

Because Atripla reduces the risk of developing HIV, though, most people who take the drug think these common side effects are worth it.

However, Atripla has also been linked to far more severe side effects:

  • Osteoporosis and a decreased bone density,1
  • Kidney damage and renal failure,2 and
  • Lactic acidosis.3

3.1. Osteoporosis, decreased bone density, and fractures

The high level of toxicity in the TDF in Atripla has been known to cause a significant decrease in the density of the bones of the people who take the drug. The decrease is severe enough to cause osteoporosis in otherwise young and healthy individuals.

To make matters worse, Atripla is a treatment for HIV, but not a cure. Therefore, Atripla is intended to be taken for a long period of time. The high degree of toxicity in TDF, together with the high dosage levels of Atripla needed to make the drug an effective treatment for HIV, takes a significant toll on a patient's bone density.

As time wears on, Atripla causes an increasingly high risk of suffering bone fractures and broken bones.

3.2. Kidney damage and renal failure

The toxicity of TDF and the standard dosage of Atripla also severely strain the kidneys, which are responsible for eliminating most of the drug from the patient's system. This stress also builds over time, as weakened kidneys struggle to continue to work at such a high pace. Eventually, the chance of developing kidney damage becomes significant. As the kidney damage gets worse, it can lead to kidney failure and other medical complications like lactic acidosis.

3.3. Lactic acidosis

As Atripla's toxicity hampers the ability of a patient's kidneys to function, lactate acid can build up in the patient's bloodstream. The accumulation of lactate acid can create lactic acidosis. The symptoms of lactic acidosis are relatively minor, and include:

  • Decreased appetite,
  • Abdominal and stomach pain and discomfort,
  • Vomiting,
  • Nausea,
  • Diarrhea,
  • Weakness,
  • Fatigue,
  • Muscle pain,
  • Cramping, and
  • Breathing problems.

However, too much lactate acid can change the pH level of a patient's blood. As the blood becomes more and more acidic from the buildup of lactate acid, it can create a host of medical complications that can be life-threatening.

4. Lawsuits against Gilead over side effects of Atripla

Hundreds of lawsuits have been filed against Gilead Sciences, Inc. for side effects caused by their HIV drug, Atripla. These lawsuits claim that Gilead not only failed to warn doctors and patients about the risks of developing serious medical conditions by taking Atripla, but also that Gilead had developed a safer drug, but withheld it from the market to maximize their profits.

Many of these lawsuits are proceeding on an individual basis.4 However, there is one class action lawsuit in California representing many of the victims, there.5

4.1. Claims that Gilead failed to warn people about the risks associated with Atripla

The core claim in these lawsuits is that Gilead knew that Atripla – and all other HIV drugs based on TDF – could cause severe and life-threatening side effects but failed to warn anyone about them.

The law requires drug makers like Gilead Sciences, Inc. to report any potential side effects that their drugs can cause on their warning label. These disclosures are critically important: Doctors rely on them when they prescribe drugs, and patients rely on them when they perform due diligence before making important decisions about their health. However, drug companies understand that disclosing the risks of taking their product can hurt its sales. History has shown that, when possible, pharmaceutical companies tend to lean towards nondisclosure.

In the Atripla lawsuits against Gilead, victims have claimed that Gilead knew that one of the drugs in Atripla – TDF – posed a threat to patients in high doses. The evidence the victims have presented includes Gilead's rapid development of a safer alternative to TDF – a drug called tenofovir alafenamide, or TAF – right after TDF was approved by the FDA in 2001.6 Despite the ongoing development of TAF, Gilead continued to tout TDF as “risk-free.”

4.2. Claims that Gilead developed a safer drug but withheld it

The lawsuits also make a novel argument: That Gilead had developed an HIV drug that was safer than Atripla, but refused to release it. The lawsuits claim that Gilead's decision to cover up the safer drug put thousands of people at risk of developing severe medical conditions and entitle those victims to compensation.

The lawsuits allege that Gilead quickly found the alternative drug, TAF, was far less toxic than TDF because much more of it was absorbed in the body, rather than expelled by the kidneys. As a result, lower doses of TAF accomplished the same results as high doses of TDF.7

However, Gilead had only just gotten approval for its line of TDF-based HIV drugs by the U.S. Food and Drug Administration (FDA). If Gilead quickly replaced those TDF-based drugs with safer TAF-based drugs, all of those years of protection from competition by generic drugs would be lost.

So Gilead patented TAF in 2004, putting obstacles in the way of other drug companies developing HIV drugs, and covered up the studies it had written on the drug.8 Gilead even announced that it was no longer researching TAF – possibly in an attempt to convince other drug companies that there was no reason to develop the drug.9

In 2010, though, Gilead's patents for TDF-based drugs, like Atripla, were expiring. So Gilead rolled out a new line of “revolutionary” HIV drugs based on TAF, complete with extensive medical studies that showed it was more effective, less toxic, and safer than TDF-based drugs.10 Gilead then urged patients to switch to the new HIV treatments to avoid the side effects of TDF – like osteoporosis and kidney failure – that it had earlier denied.11

5. Compensation for victims of Atripla

Victims who have been taking Atripla – one of Gilead's highly toxic TDF-based treatments for HIV – have filed lawsuits that seek compensation for their:

  • Medical bills associated with treating complications caused by Atripla,
  • Anticipated future medical expenses for ongoing care,
  • Wages and other income that has been lost while they recover from Atripla's side effects,
  • Any reduced earning capacity that is associated with Atripla's side effects,
  • Pain and suffering, and
  • Loss of consortium and companionship felt by the victim's family and loved ones.

Additionally, victims have claimed that they are entitled to punitive damages from Gilead Sciences, Inc., as well. These punitive damages are meant to punish Gilead for their especially disturbing conduct in releasing a safer alternative to Atripla.

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References:

  1. 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).

  2. 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).

  3. 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).

  4. See e.g., Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).

  5. Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).

  6. Complaint at 1, Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).

  7. See Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).

  8. See note 7.

  9. See note 7.

  10. See note 7.

  11. See note 7.

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