Gilead Sciences, a drug manufacturer, is in the middle of multiple lawsuits because of the TDF drugs it has developed for the treatment of HIV. AIDS patients and those diagnosed with HIV or people who have been exposed have been treated with these drugs since 2001, when the first medication was approved by the Food and Drug Administration (FDA).
What are TDF Drugs?
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Gilead developed tenofovir disoproxil fumarate (TDF) drugs as early as 1984, but it wasn’t until 1997 that they were recognized for their value in treating HIV. The FDA approved the first drug in this classification in 2001. In total, there are five drugs labeled as TDF: Viread, Atripla, Complera, Stribild, and Truvada.
Truvada was the first drug to prevent transmission of HIV from one person to another, effectively preventing the disease. In fact, almost 80 percent of Americans diagnosed with HIV have taken one of these drugs as part of their treatment plan.
TDF drugs are designed to treat HIV infection, and they are used along with other medications for HIV. While this medication doesn’t cure HIV, it does block the enzyme that multiplies the amount of HIV in a person’s body. Secondary use of TDF drugs is to treat chronic hepatitis.
These drugs come in multiple dosages.
- 150 mg
- 200 mg
- 250 mg
- 300 mg
Along with the tablets, this drug can be dispensed as an oral powder.
Risks of TDF Drugs
As with any medication, there are side effects of taking TDF. These medications may cause nausea and vomiting, as well as dizziness. More serious side effects can occur in some patients.
There is a warning of the possibility of lactic acidosis, which is a buildup of lactic acid in the blood. Severe liver problem is another concern as well as kidney problems. It can change the immune system and cause bone problems.
Two of these side effects have caused a great deal of concern from patients, to the point they are blaming Gilead for their medical conditions. The more severe is kidney damage, which can lead to death. The other is bone density loss or bone softening. The results of this condition include fractures.
It is advised that the patient disclose their full medical history before the doctor prescribes a TDF drug. They will determine if the patient is a good candidate for treatment with these medications or if the risks outweigh the benefits.
Lawsuits Against Gilead
While the TDF drugs have been shown to help patients with HIV, they come with serious risks. Many patients have filed lawsuits against the manufacturer for failure to disclose the risks and for negligence.
Gilead began research on the second type of HIV drug known as TAF or tenofovir alafenamide fumarate. These drugs were safer than the TDF medications because they required a lower dosage for treatment. However, Gilead discontinued research in 2004 on the TAF drugs until 2010. The first of these medications went to market in 2015, just three years before the first of the patents on TDF were set to expire.
Plaintiffs in the lawsuits claim that Gilead shelved the TAF research to maximize profits instead of providing a safer drug to patients. According to claims, the manufacturer was able to charge a higher price since no other alternatives were available, and no other drug manufacturers would be allowed to create a generic version of the TDF drugs until the patent expired.
According to these claims, Gilead maximized the opportunity to continue to monopolize the market on HIV medications. It currently has 80 percent of the market. In this scenario, Gilead could charge a high price for the TDF drugs allegedly because no alternative existed. Once it came close to the time that generics would be produced, the manufacturer released the TAF drugs at a lower price. They marketed them to doctors as a safer, less expensive alternative to TDF drugs to convince medical professionals to switch before generic versions of the TDF drugs became available.
A separate lawsuit was filed alleging that Gilead conspired with Johnson & Johnson and Bristol-Myers to keep competition away from the HIV drug market. According to allegations made, the three manufacturers agreed to continue to use the specific ingredients in the medications rather than using generics even when the patents had expired. The complaint states that Gilead and the other companies devised the plan to prevent competition at the cost of patient safety.
Gilead has denied the claims and said everything it did was for the safety of patients. However, the company agreed to provide free drugs to people as part of an agreement with the federal government.
The manufacturer tried to have one lawsuit dismissed in California on the basis that it followed the federal requirements for the drugs. However, the plaintiffs argued that it could have met both state and federal requirements. The judge ruled to continue the lawsuit even though a few specific cases were dismissed. They were given time to reform their claims and continue the lawsuit with new evidence.
Should You File a Lawsuit?
If you have taken TDF drugs and suffered from bone density loss or kidney damage, you may be eligible for a personal injury lawsuit against Gilead. The AIDS Healthcare Foundation has reported of multiple lawsuits against the manufacturer, and more plaintiffs are expected to come forward. Contact us today to speak with an experienced attorney to determine if your case has merit. Qualifying injuries include:
- Bone fractures
- Bone density loss or bone demineralization
- Chronic kidney disease
- Renal failure
- Low kidney function which requires dialysis
- High creatinine levels
- Abnormal glomerular filtration rate
- Death due to renal failure
- Abnormal protein levels in the urine
- Fanconi Syndrome/proximal renal tubule dysfunction
If you have experienced one or more of these conditions, you may be eligible for a class action drug lawsuit against Gilead Sciences for their TDF-based drugs, which patients claim they provided rather than the drug TAF, a safer alternative. Our firm is holding Gilead accountable for failing to warn patients and physicians about serious side effects and we are seeking maximum compensation on behalf of our clients.