A TDF lawsuit is a mass tort claim against Gilead Sciences, Inc., the maker of several types of HIV pills. HIV drugs based on TDF can cause side effects such as kidney damage and renal failure, as well as a decrease in bone density, osteoporosis, and broken bones. Despite the risks, the lawsuits claim that Gilead Sciences, Inc. failed to warn doctors and patients of the drug's dangers, and even withheld a safer drug from the market in order to lengthen their patent protection and maximize their profits. The lawsuits seek punitive damages, as well as compensation for:
- Medical expenses,
- Lost wages,
- Pain and suffering, and
- Loss of consortium.
- 1. What are TDF HIV drugs?
- 2. Side effects of TDF drugs
- 3. The development of TAF HIV drugs
- 4. Lawsuits over side effects from TDF HIV drugs
- 4.1 Claims that Gilead failed to warn patients and doctors of TDF's dangers
- 4.2 Claims that Gilead suppressed TAF
- 5. Compensation for victims of TDF HIV drugs
- 6. What to do if you have been hurt by a TDF HIV drug
1. What are TDF HIV drugs?
TDF is the drug tenofovir disoproxil fumarate. TDF helps to treat, but not cure, HIV by preventing HIV cells from multiplying once they are inside the body. For people who are HIV-positive, TDF drugs can prevent the disease from getting out of control and becoming AIDS. People who are not HIV-positive, on the other hand, can use a TDF drug to be intimate with someone who has HIV without contracting the disease. This prophylactic use is called pre-exposure prophylaxis, or PrEp.
TDF is found in several brands of HIV drugs, including:
Each of these brand name drugs contains a dose of TDF, along with another antiretroviral drug.
The first TDF drug made by Gilead Sciences, Inc. was Viread. Viread was a breakthrough drug because, unlike other HIV drugs at the time, Viread could be taken orally in a pill form, rather than intravenously. The U.S. Food and Drug Administration (FDA) approved Viread in 2001.1
2. Side effects of TDF drugs
TDF drugs come with lots of side effects. Because they treat HIV, though, patients have little choice but to live with the adverse effects of the drug. Some of the most common side effects include:
- Abdominal pain,
- Stomach pain,
- Weight loss,
- Liver problems,
- Sleeping problems,
- Vivid dreams,
- Fatigue or chronic weakness,
- Muscle pain,
- Shortness of breath, and
- Skin rashes.
There are more severe side effects, though, including:
- Kidney damage and renal failure,2
- Lactic acidosis,3 and
- A decrease in bone density, which can lead to broken bones and even osteoporosis.4
2.1 Kidney damage and renal failure
A hallmark of TDF drugs is that they are very potent, and rely on the kidneys to expel the drug from the patient's bloodstream. The stress that TDF drugs put on the kidneys, therefore, is not small. Over long periods of time excreting TDF from the patient's system, the kidneys can get damaged. In some cases, this damage can be so severe that it leads to renal failure, which comes with a host of other complications, as well.
2.2 Lactic acidosis
One serious side effect of the kidney damage caused by TDF drugs is a buildup of lactate in the blood. When the kidneys are damaged, they are unable to eliminate as much lactate acid as before. This can lead to the following symptoms:
- Shortness of breath,
- Vomiting, and
Additionally, lactate is an acid. When it builds up in the patient's blood, it can reach a point where the lactate acid can alter the pH levels in the bloodstream. Numerous medical complications follow from this condition, some of which can be fatal.
2.3 Decreased bone density and osteoporosis
The toxicity of TDF drugs can also cause bone problems by killing bone tissue faster than the human body can replace it. This reduces a patient's bone density, and can lead to the following medical conditions:
- Broken bones and fractures,
- Osteopenia, and
Worse, because TDF treats, but does not cure, HIV, it is supposed to be taken for a long period of time. Over the course of the treatment, therefore, the bone density problems that a patient is likely to suffer will get worse. As bone density deteriorates, the chances for suffering a broken bone or osteoporosis increase dramatically.
3. The development of TAF HIV drugs
Even though Gilead Sciences, Inc. had just released its first TDF drug, Viread, in 2001, later that year the company started developing another HIV drug that was less toxic. This new drug was called tenofovir alafenamide fumarate, or TAF.
TAF is far less toxic than TDF because more of the drug is absorbed by the body. The increased absorption rate means that TAF is equally as powerful of an antiretroviral drug as TDF, even when taken in a fraction of the dosage. The lower toxicity means that there are far less severe repercussions on a patient's kidneys or bone density.
However, in 2001, Gilead's patent for TDF drugs had only just begun. With years to go before generic versions of TDF HIV drugs could enter the market, Gilead stopped developing TAF.5 They made this decision even though they had realized not only that TAF was less dangerous than TDF, but also that TDF posed serious risks to those who took the drug over the long term. Instead, Gilead wanted to maximize their profits by selling TDF drugs for as long as possible, and then switching to TAF drugs right before generic versions of TDF could compete.6
It was not until 2010, when Gilead's patent for TDF HIV drugs was running out, that Gilead announced a revolutionary breakthrough in antiretroviral medication – TAF. Gilead supported this announcement with studies that showed TAF was less toxic than TDF, caused fewer kidney problems, and was less of a risk to a patient's bone density – studies that had been conducted years earlier.7 Gilead urged patients taking TDF drugs to switch immediately to its new TAF drugs, including:
- Genvoya, and
4. Lawsuits over side effects from TDF HIV drugs
Numerous personal injury and defective drug lawsuits have been filed against Gilead Sciences, Inc. for the serious side effects of TDF HIV drugs,8 including a class action for victims in California.9 These lawsuits claim that Gilead failed to warn doctors and patients of the dangers associated with its TDF HIV drugs, and also that Gilead had an obligation to release the safer TAF drugs on the market. Settlement of Truvada claims is likely to happen in the coming years.
4.1 Claims that Gilead failed to warn patients and doctors of TDF's dangers
The core claim of the lawsuits against Gilead for its TDF HIV drugs is that Gilead completely failed to warn doctors and patients of the drug's dangers.
Pharmaceutical companies have a legal obligation to warn people of the adverse effects that their drugs can cause. This legal duty comes from the fact that doctors rely on these disclosures to prescribe drugs that will benefit their patients. Patients also rely on these disclosures so they can weigh the pros and cons of taking a drug and make an informed decision about their health.
However, pharmaceutical companies try to avoid these disclosures because they know that warnings about the risks a drug creates can deter consumers and hurt their bottom line.
The lawsuits against Gilead claim that the company knew of the toxicity of its TDF drugs.10 They claim that Gilead's research into the safer version of the drug, TAF, highlights the concerns that Gilead had with the side effects of TDF, and shows that Gilead knew of the risks posed by TDF.11
Despite this knowledge that TDF was toxic at the prescribed doses, though, Gilead marketed TDF HIV drugs as “risk-free.”12 They continued to do so even after scientific studies connected TDF HIV drugs with bone density issues and kidney problems, and even after the FDA scolded Gilead for making false claims about the drug's toxicity in 2002 and 2003.13 In fact, the lawsuits claim that, while Gilead was touting its TDF drugs as “risk-free,” they were paying doctors to test TAF, rather than TDF, on patients because of the dangers posed by TDF.14
According to the lawsuits, Gilead never warned patients about these risks. Instead, the TDF warning label only recommended bone mineral assessments for patients who already had a high risk of bone fractures or osteoporosis.15
4.2 Claims that Gilead suppressed TAF
The lawsuits also claim that Gilead suppressed the development of TAF, and that victims who suffered from TDF deserve to be compensated for the extra years of risk that they were put through, because of this suppression.
This aspect of the lawsuits against Gilead is more novel than the claim that Gilead failed to warn consumers of the dangers associated with TDF. There is little precedent that pharmaceutical companies can be held liable for not bringing a safer alternative to the market.
Typically, defective drug claims against pharmaceutical companies use one of three legal doctrines to hold the company accountable:
- The company designed the drug defectively, making the drug dangerous even when used for its intended purpose,
- The drug was manufactured defectively, and the differences between the drug's design and the end product caused harm to people, and
- The drug's marketing was defective, and the failure to warn patients of the risks of serious side effects put innocent people in danger.
The claim that Gilead Sciences, Inc. had an obligation to send a safer drug to market to replace TDF does not fall neatly within any of these recognized drug defects.
Gilead claims that it has no legal obligation to create a safer drug. Victims claim that suppressing a safer drug could be a design defect because it meant there was a known alternative that was less risky for patients. They also claim that it could be a marketing defect because it meant Gilead knew there was a safer drug, but refused to warn about the dangers of the existing one.
Whether courts are willing to expand the notion of a defective drug to include situations where safer alternatives are suppressed is one of the big questions about this case.
5. Compensation for victims of TDF HIV drugs
People who take TDF-based HIV drugs deserve to be compensated for all of the losses they have sustained through no fault of their own. This includes compensation for:
- Medical expenses, both in the past and the future,
- Lost wages and professional setbacks,
- Pain and suffering, and
- A family's loss of consortium and companionship with the victim.
Additionally, lawsuits against Gilead have demanded punitive damages for the pharmaceutical company's attempts to cover up TAF, which would have alleviated many of the risks of TDF. These damages are meant to punish Gilead for especially egregious conduct that put innocent people at risk. The statute of limitations (deadline) for filing a TDF lawsuit varies by state, and can be from one to six years from the point of injury.
6. What to do if you have been hurt by a TDF HIV drug
If you have taken a TDF-based HIV drug and worry that you have developed osteoporosis or kidney problems, you should talk to your doctor, first. Only with a proper diagnosis can you receive the proper medical care that you need to minimize the damage.
If you have developed one of these medical conditions, you should consider talking to a lawyer. The defective drug lawyers at the Shouse Law Office can help you raise your rights and fight for the compensation that you need and deserve. Call them at 855-LAWFIRM to schedule a consultation and learn your legal rights and options.
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).
Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).
Complaint at 1, Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).
Id. at 2.
Id. at 2-4.
Id. at 3.
Id. at 9.