Viread® Lawsuit - HIV Drug Causing Bone and Kidney Injuries

A Viread lawsuit is a mass tort claim against the pharmaceutical company Gilead Sciences, Inc. for side effects of Viread, one of their drugs that treat HIV. Viread, like other HIV drugs made by Gilead, uses the drug TDF. The toxicity of TDF can cause kidney damage and renal failure, osteoporosis and broken bones, and even life-threatening lactic acidosis. Despite the side effects of TDF, Gilead failed to warn doctors by mentioning them on the Viread's warning label, and allegedly withheld a safer alternative to TDF. Viread and other TDF lawsuits seek compensation for:

  • Medical bills,
  • Anticipated future medical expenses,
  • Professional setbacks like lost wages and lower earning potential,
  • Pain and suffering, and
  • Loss of consortium for the victim's family.

1. What is Viread?

Viread is the brand name for the drug tenofovir disoproxil, or TDF. TDF is a highly-toxic chemical that keeps HIV cells from spreading once they are in the body. TDF, however, does not eliminate HIV cells that have already infected someone – this makes TDF a treatment for HIV, but not a cure for the disease.

The toxicity of TDF is compounded by the fact that relatively little TDF is absorbed in the body. Because most of it is excreted, TDF has to be taken in high doses to be effective at treating HIV.

Many of the people who take Viread consider themselves to be at high risk for contracting HIV. Many of them take Viread as a prophylactic because they are either in contact with people who have AIDS, or because they are in intimate relationships with people who are HIV-positive.

While TDF has been around since the 1980s, it had to be administered intravenously. It was not until Gilead bought the rights to the drug and modified it to be taken in a pill that it became a viable treatment for HIV and a prophylactic for AIDS. Viread was the first HIV drug by Gilead that was approved by the U.S. Food and Drug Administration (FDA). It was approved for medical use in the U.S. in 2001.1

2. Gilead's other HIV drugs that use TDF

Since releasing Viread in 2001, Gilead has created several other drugs to treat HIV. These other drugs are combinations of Viread and other antiretroviral drugs into one pill. However, because they also use TDF, they have led to lawsuits, as well, including

Recently, Gilead released a new line of HIV drugs that replaced TDF with another, safer alternative called tenofovir alafenamide, or TAF. This line of HIV drugs includes the brand names:

  • Vemlidy,
  • Odefsey,
  • Genvoya, and
  • Descovy.

The release of these drugs was controversial, and lies at the heart of the lawsuits that have been filed against Gilead over the side effects caused by Viread. Additionally, studies have suggested that TAF is not as safe as it was anticipated, leading to a handful of Genvoya lawsuits being filed.

3. Side effects caused by Viread

Viread has been known to cause a handful of common side effects. Because the drug treats HIV, though, patients who take Viread frequently consider these side effects relatively minor and worth the risk:

  • Skin rashes,
  • Muscle pain,
  • Fatigue,
  • Stomach pain and discomfort,
  • Nausea,
  • Diarrhea,
  • Discolored skin,
  • Vivid dreams,
  • Headaches,
  • Dizzy spells,
  • Depression, and
  • Problems breathing.

However, Viread has also been medically linked to some far more severe side effects:

  • A decrease in bone density, which can lead to osteoporosis, and an increase in broken bones,2
  • Kidney damage and renal failure,3 and
  • Lactic acidosis.4

While people who suffer from HIV already have bone density issues and kidney problems, taking Viread can drastically increase these risks.

3.1. Viread and bone density problems

Viread is known to cause bone density problems because of the high toxicity of TDF. The bone erosion caused by TDF exacerbates the bone density problems that are already a consequence of many HIV infections. Worse, TDF is a long-term treatment for HIV, not a cure. Because TDF has to be taken continually to keep HIV cells in check, the bone density problems that it causes get worse over time.

Eventually, Viread can reduce a patient's bone density by so much that it amounts to osteoporosis. At the onset of osteoporosis, the risk of bone fractures and broken bones increases substantially. As a result, people who take Viread to treat their HIV are far more likely to suffer broken bones than those who do not.

3.2. Viread and kidney problems

Because most of Viread's TDF drug gets expelled from the body, taking Viread puts extra strain on a patient's kidneys. As this strain builds over time, the kidney damage gets worse and can lead to renal failure.

According to one study, the risks of developing kidney damage are disturbingly high. That study tracked 10,841 HIV-positive people who were taking TDF drugs and monitored them for the presence of protein in their urine – a strong indication of kidney damage. Even when controlling for other factors, the study found that each year of TDF exposure led to a 34 percent increase in this sign of kidney damage. The risk of a rapid decline in kidney function rose 11 percent, and the risk of chronic kidney disease rose 33 percent.5

If left unchecked, this kidney damage can lead to renal failure.

3.3. Viread and lactic acidosis

One of the biggest medical complications of the kidney problems and renal failure that TDF and Viread can cause is lactic acidosis.

Lactic acidosis is the potentially fatal medical complication of having too much lactic acid in the bloodstream. Because the kidneys are responsible for distilling and expelling lactate, compromised kidneys and renal failure are a precursor to lactic acidosis.

Lactic acidosis can cause some serious symptoms:

  • Breathing difficulties,
  • Loss of appetite,
  • Stomach discomfort and pain,
  • Nausea,
  • Vomiting,
  • Diarrhea,
  • Fatigue,
  • Weakness,
  • Cramping, and
  • Muscle pain.

The most severe consequence of high levels of lactic acid, though, is a change to the pH level of a patient's blood. Acidic blood can cause a host of potentially fatal medical complications, including organ failure.

4. Gilead facing lawsuits over Viread's side effects

Numerous lawsuits, including a class action of victims in the state of California,6 have been filed against Gilead Sciences, Inc. for the side effects caused by Viread.

These lawsuits make two chief claims:

  1. Gilead had a legal duty to warn people about the dangerous side effects Viread could cause, but did not do so, and
  2. Gilead developed a safer alternative to Viread, but delayed its release in order to extend its market protection and maximize the company's profits.

They claim that Gilead's conduct entitles victims to compensation for their losses.

Because so many people have been hurt by a single course of conduct by a single defendant, these Viread lawsuits are ripe for consolidation in multidistrict litigation (MDL). However, an MDL has not yet been formed.

4.1. The failure to warn claim

The main argument in the lawsuits against Gilead for injuries caused by the side effects of Viread is that Gilead failed to warn people about the risks of taking their drug.

The law in the U.S. recognizes that doctors rely on the warning labels on drug packaging for information about when a medication could pose a threat to a patient's health. Patients also rely on this information when they research their health options to make an informed decision about their future. To facilitate this, the law requires drug companies to disclose the risks that are associated with their products. However, drug companies know that disclosing these risks could deter patients from using their drugs.

Victims in pending Viread lawsuits have claimed that Gilead knew about the risks of Viread and TDF, but failed to disclose them. Victims point to Gilead representatives claiming that Viread was “risk-free” while being reprimanded repeatedly by the FDA for making false claims that Viread did not imperil bone density or kidney health. Additionally, victims point to Gilead's early development of an alternative drug to TDF, the drug TAF, as a safer option than TDF.7

4.2. The claim that Gilead withheld a safer drug

The Viread lawsuits also claim that Gilead put hundreds of thousands of patients at risk by developing a safer alternative to TDF, but refused to release it until TDF's patent protection was set to expire.8

Soon after the development of Gilead's TDF-based drugs and the release of Viread in 2001, Gilead investigated other ways of treating HIV. Its researchers discovered another drug, TAF, which absorbed in the body far better than TDF. The higher absorption rate meant a low dose of TAF would have the same impact as a high dose of TDF, reducing strain on the kidneys and lowering the treatment's effect on bone density.

However, Gilead's line of TDF-based HIV drugs was dominating the market, and had years of FDA protection from generic versions to go. Gilead was making billions of dollars every year, and could extend that market domination by rolling out TAF only when the protection for its TDF-based drugs was set to expire. So Gilead patented TAF but did not present it to the FDA. Gilead also covered up the medical studies that showed TAF was safe – and that TDF could cause osteoporosis and kidney failure.9

When its TDF drugs were about to lose their market protection, Gilead announced a major breakthrough in HIV treatment, got its TAF drugs approved by the FDA, and released the studies it had done years ago, proving that TAF was far more effective and less risky than TDF. Gilead urged people taking TDF drugs to switch to its newer lines of HIV treatment plans that were based on TAF, instead, suddenly claiming that its TDF drugs were no “risk-free” at all.10

5. Compensation for victims of Viread's side effects

People who have taken Viread, suffered bone density loss or kidney problems, and who have filed lawsuits are seeking compensation for their:

  • Medical expenses,
  • Pain and suffering,
  • Lost wages and reduced earning capacity, and
  • Family's loss of companionship.

Additionally, victims are seeking punitive damages to punish Gilead for withholding a safer drug from the market.11

Legal References:

  1. FDA Approval Letter for TDF.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

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

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

  8. Id. at 3.

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

  10. See note 9.

  11. Complaint at 17, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).

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