The human immunodeficiency virus (HIV) has been a public health crisis for nearly 40 years. From the early days labeling it the gay plague to the realization it was a blood-borne disease transmitted through the exchange of bodily fluids, HIV has been a politicized, serious disease that meant a death sentence for millions of people. The virus baffled doctors for about the first decade of its discovery. It took as many years before effective treatment was found that prolonged the life of those infected by the virus. Early medications often meant terrible side effects that made life difficult anyway. Truvada was one of the first medication’s introduced to the market that reduced an HIV patient’s viral load. But recently a Truvada lawsuit has taken center stage for serious bone and kidney damage that Gilead failed to warn patients of.
The Truvada lawsuit alleges that drugmaker Gilead Sciences Inc. deliberately delayed development of a safer version of the crucial HIV medicine. This delay led to serious harms in high-risk populations that may have been taking the medication to prevent infections, prolong their lives or prevent the infection of others. These harms include kidney issues, low bone density and other health problems.
The Carlson Law Firm has been protecting the rights of all communities for more than 40 years. We can help you navigate the complex American legal system with no upfront costs.
Call us today if you or a loved one have been affected by Gilead Sciences harmful practices to schedule a free consultation for a Truvada lawsuit.
Who is Gilead Sciences Inc.?
Gilead Sciences Inc. is an American biotechnology company. The company focuses the bulk of its efforts on antiviral drugs used in the treatment of HIV, hepatitis B and C and the flu. Gilead has been under intense scrutiny for its high pricing of some of its patented drugs. The company launched Truvada in 2004. Its studies later proved its theory that a fixed-dose combination of tenofovir and emtricitabine could be used to prevent HIV transmission.
The company’s HIV treatments account for nearly 70% of its total product sales. The company expects for its HIV treatments to account for a higher percentage of its total product sales by the end of 2019.
Why is Gilead being sued for Truvada
People who have filed tenofovir disoproxil fumarate (TDF) lawsuits against Gilead claim that the manufacturer failed to warn that its HIV drugs caused serious kidney problems, low bone density and related health problems. Further, the lawsuits say that Gilead failed to disclose TDF’s significant risk for toxicity in relation to bone and kidney damage. And finally, the lawsuit states that the company misrepresented the risks of benefits of Gilead TDF drugs to sell them.
What is Truvada?
Truvada is an antiretroviral medication that contains a combination of emtricitabine and tenofovir disoproxil fumarate. This combination of drugs prevents HIV from multiplying in a person’s body. The emtricitabine reduces the ability of the HIV RNA cells to turn in to HIV DNA—preventing the cells from becoming viral.
The medication is not a cure for HIV or AIDS, but can be used to treat the condition in adults and children who are at least 12 and weigh at least 37 pounds. Generally, there are two uses for Truvada in the fight against HIV/AIDS.
- The FDA approved Truvada in 2004 as a treatment in those infected with HIV to lower the viral count in a person’s blood.
- In 2012, the FDA approved Truvada for pre-exposure prophylaxis (PrEP). In other words, the drug was approved as a means to prevent HIV infection in those who were HIV negative, but at high risk of being infected.
Truvada doesn’t completely prevent HIV transmission. However, according to the Centers for Disease Control and Prevention, it is sometimes prescribed to those who do not always use safer sex practices to help reduce the chances of HIV infection.
Since its approval, Truvada has been sold under other names including:
Who took Truvada?
In its early uses, Truvada was almost exclusively for people with a positive HIV diagnosis. Today, the drug is recommended as a prevention method for those who HIV negative but are at a higher risk of contracting the disease. For example, the FDA recommends pre-exposure prophylaxis (PrEP) for the following high-risk groups:
- Gay or bisexual men who either have anal sex without a condom or have been diagnosed with an STD in the past 6 months
- Heterosexual men and women who do not regularly use condoms with sexual partners who have an unknown HIV status
- Injection drug users who share equipment
- Sero-discordant heterosexual and homosexual partners where one partner is HIV-positive and the other is HIV-negative
Truvada is currently the only drug FDA-approved for pre-exposure prophylaxis (PrEP). If you or a loved one took Truvada and suffered bone or kidney damage, contact a Truvada Lawsuit Attorney from The Carlson Law Firm. We can help you get the compensation you deserve.
Why is a non-toxic antiretroviral so important in the fight against HIV/AIDS?
HIV works by hijacking a subset of white blood cells called T cells. T cells are the body’s first line of defense against foreign invaders that cause illnesses. Essentially, HIV uses the DNA in T cells to make copies of itself and in the process, the T cells are destroyed. The medications on the market today, and even in the past, have been to prevent the virus from destroying these important cells.
To truly understand the importance of alternate, less toxic versions of antiretrovirals, and the negligent actions of Gilead, it’s important to look at the history of HIV/AIDS treatment up until the first Truvada lawsuit was filed against Gilead.
1980s – AZT
In the early 1980s, the world watched as healthy young men and transwomen became stricken with an illness that was robbing them of their lives at an alarming rate. At the time, scientists and doctors had few answers as to what was causing the deaths of young men and women in communities ostracized by the mainstream. In addition, the U.S. government was slow to move in recognizing the disease or appropriate funding for research.
This slowly began to change in 1983 when a French scientist discovered HIV and in 1985, the first HIV test became available. However, the number of people dying from AIDS continued to grow.
AZT was the first antiviral medication to reduce the viral load in an HIV positive person. It was FDA approved in March 1987, with only one trial on the humans instead of the standard three.
AZT is not without controversy. The side effects were harsh, and there are countless stories of children dying from taking AZT. The drug, while powerful, was also said to be toxic and created debilitating side effects in many who took it as prescribed.
This period of time was also the subject of the Matthew McConaughey-led film Dallas Buyers Club that showed the underground market of experimental drugs imported from Mexico, Japan and Europe.
The 1980s and early 1990s saw the deaths of legendary icons like movie star Rock Hudson and Queen frontman Freddie Mercury from AIDS. In 1991, NBA legend Earvin “Magic” Johnson announced that he was HIV positive. Johnson, a heterosexual athlete, gave a new face to the disease. Many activists cite these notable names as the catalyst behind the invigorated efforts in the 1990s to raise awareness around HIV/AIDS and discover better treatments.
d4T has been around since the late 1960s, however, it became available for treatment in HIV-1 infection in 1992 prior to receiving FDA approval. The drug essentially works by inhibiting HIVs ability to replicate.
By today’s guidelines, both AZT and d4T are no longer recommended for most people as HIV treatment.
Mid-1990s – Combination drugs
The fight against HIV/AIDS turned for the better in 1996 at the International AIDS Conference in Vancouver. At the conference, researchers reported that people who had been deathly ill with AIDS had seen their health improve by taking at least three antiretroviral drugs. The drugs came from at least two different classes that can include transcriptase inhibitors and including a new class of drugs called protease inhibitors. It was the first time since the virus’ discovery that people’s CD4 counts were rising and staying up.
These potent medications were eventually called highly active antiretroviral therapy (HAART). These medications carried with them severe side effects including explosive diarrhea, nausea, sensory loss and painful nerve injuries. In addition, people had to take a fistful of pills two to three times a day.
2000s – Tenofovir disoproxil fumarate drugs
Tenofovir was patented in 1996 and was approved by the FDA in 2001. In the last two decades, HIV treatment has come a long way. In fact, Truvada was one of the first drugs that could reduce an infected person’s viral load and prevent infection. Since that time, Gilead has manufactured several tenofovir disoproxil fumarate (TDF) drugs in combination with other anti-HIV medications. It is also used in the treatment of hepatitis B. The company’s current TDF drugs include Viread (the first brand name), Truvada, Atripla, Complera and Stribild.
TDF works by blocking the enzyme that allows HIV to replicate and multiply in an infected person’s body. It is not a cure for HIV/AIDS, but is used as part of a treatment regiment that can help infected people live longer. Several studies have found the drug to be incredibly effective at reducing the amount of HIV or HBV in the blood.
Tenofovir is on the World Health Organizations List of Essential Medicines. A Gilead spokesperson once referred to Viread as a “miracle drug.”
TDF combined with emtricitabine make Truvada.
Truvada’s effect on HIV
As mentioned before, the communities and populations most devastated by HIV are the same communities who have been harmed by Gilead’s actions. This includes gay or bisexual men, transwomen, intravenous drug users, and heterosexual Latinx and African Americans—particularly Black women. For this reason, a drug that curbs the transmission of HIV and extends the life of an infected person is crucial in the fight against HIV/AIDS. Truvada, and other drugs containing TDF, filled that void in those battling the disease. The drug was valuable in that it eliminated the handful of drugs that HIV patients had to take in the 1990s and meant that the disease was no longer a death sentence, but rather a manageable disease.
The drug also changed the way health agencies like the World Health Organization looked at HIV prevention. This meant that more people went on the drug to prevent infection. With consistent and correct use, the drug could prevent infection and make viral loads in HIV positive people undetectable.
Patients may have opted to take Truvada over other drugs because its makers hailed it as a “miracle drug.”
While TDF in combination with other antiretroviral drugs helped HIV patients from developing full-blown AIDS, the medication also had serious side effects that Gilead failed to warn about. These side effects include:
- Brittle bones
- Broken bones
- Kidney failure
- Kidney disease
Lawsuits claim that Gilead knew or should have known that TDF was highly toxic in the doses prescribed. In fact, the lawsuit claims that the TDF manufacturers should have known that the drug could risk permanent and possibly fatal damage to the kidneys and bones. Rather than conduct further studies to properly inform the public, Gilead ignored and misrepresented the risks of the drugs.
The lawsuit further alleges that the drug maker hid the risks from doctors so it could continue to raise its market share with TDF.
If you or a loved one suffered from the above disease, contact a qualified Truvada Lawsuit Attorney.
Truvada’s links to kidney disease
The first documented kidney toxicity in relation to TDF occurred in the United States the same year the drug hit the market in 2001. The first patient suffered acute kidney injury AKI, nephrogenic diabetes insipidus and Fanconi syndrome. In the last 18 years, there have been many studies that examine the drug’s toxicity.
Kidney problems claimed in Truvada lawsuits include:
- Acute kidney injury
- Acute renal failure
- Chronic kidney disease
- Declining kidney function
- Fanconi syndrome
- Kidney tubular dysfunction
Truvada and bone density loss
In 2018, studies found the loss of bone mineral density in patients with HIV was particularly high among patients that use antiretrovirals containing tenofovir disoproxil fumarate. Researchers found that by switching to a combination of other antiretroviral drugs, the virus would continue to be suppressed while improving bone mineral density.
Bone injuries claimed in Truvada lawsuits include:
Osteopenia. A condition that occurs when bones are weaker than normal, but not too weak that break easily.
Osteoporosis. Literally translated to porous bone. Osteoporosis is a disease which the density and quality of bone are reduced. As bones become more fragile, the risk of fracture greatly increases.
Bone fractures. Occurs when a bone actually breaks because of weakened bones, or significant force.
If you are an HIV patient or have a loved one who suffered from the above conditions, contact The Carlson Law Firm. We have a qualified Truvada Lawsuit attorney ready to assist you through the legal process. Our compassionate legal staff will help you get the justice you deserve.
Gilead’s disregard for patient safety
Litigation over TDF began when the AIDS Health Foundation sued Gilead in 2016. In its filing, the foundation alleged that Gilead manipulated the patent system by witholding a less toxic drug called tenofovir alafenamide (TAF) from patients.
The lawsuit alleges that as early 2002, Gilead was paying doctors to research TAF in patients around the country. At the same time, it was making profits on TDF. The company quietly applied for patents on TAF, however, it kept its research on the less toxic drug secret.
This delay deprived those suffering of HIV more than a decade of exposure to TDF and its toxic symptoms.
What is TAF?
Tenofivir alafenamide is the replacement for TDF, the original tenofovir formulation. The drug does the same viral suppression as TDF. But studies have shown that it does not carry the same bone and renal damage side effects. It was approved by the FDA is 2016.
Why should I file a Truvada Lawsuit?
If you’ve suffered any life-altering injuries because of any drug, you have a legal path toward justice. Gilead hid, or understated the seriousness of the side effects of its drug while doing research on a safer drug in secret. The biomedical company then quietly patented the drug to keep other companies from offering TAF as an alternative.
If you took Truvada and have suffered from any of the following conditions, contact a Truvada Lawsuit Attorney immediately:
- Brittle bones
- Broken bones
- Kidney failure
- Kidney disease
Other medical alternatives may have saved you from these conditions. Gilead may have blocked you from those alternatives by failing to properly inform you about the conditions. This is in addition to hiding its development of a less toxic drug. This boils down to greed. The law entitles you to hold companies that put profits over people accountable for their actions.
A Carlson Law Firm Truvada Lawsuit Attorney can help
We understand that lawsuits aren’t easy on anybody. However, filing a Truvada lawsuit may be the only way that you can get the financial compensation you deserve after suffering from Gilead’s negligent actions. You don’t have to be on the hook for medical bills that are not your fault. Gilead failed to warn patients of the risks associated with TDF. The Carlson Law Firm has a diverse legal staff that is ready to assist you through your recovery.
If you’ve suffered from renal disease or bone disease after using Truvada, contact us to discuss your next steps. We are available 24/7. We care and we can help.