Gilead Sciences is the leading manufacturer of HIV drugs worldwide, having earned combined sales of $14.6 billion in 2018 alone. Despite their successes, they face serious allegations from the U.S. Food & Drug Administration, plaintiff counsel, and consumer advocate groups for downplaying the serious side effects of their medications and suppressing research of safer alternatives until their patents expired.
If you or a loved one developed bone or kidney failure after taking one of Gilead’s TDF drugs for the treatment of HIV or Pre-Exposure Prophylaxis (PrEP), then you may consider a Gilead lawsuit. No matter where you are located in the United States, you can count on Showard Law Firm to build a winning case on your behalf.
What Drugs Are Involved in the Gilead Lawsuits?
Tenofovir Disoproxil Fumarate (TDF) antiretroviral drugs are associated with adverse side effects. They include:
- Viread (tenofovir disoproxil fumarate) – 2001
- Truvada (tenofovir) – 2004
- Atripla (efavirenz/emtricitabine/tenofovir) – 2006
- Complera (emtricitabine/rilpivirine/tenofovir) – 2011
- Stribild (elvitegravir/cobicistat/tenofovir/emtricitabine) — 2012
All of these medications have been developed by Gilead for the treatment and prevention of HIV infection. The nucleotide analog reverse-transcriptase inhibitor class of drugs work by inhibiting a vital enzyme in HIV replication. TDF is absorbed by the gut quickly (within two hours) and excreted by the kidneys, so it must be administered in high doses, which puts undue stress on the kidneys. Renal tubular damage and phosphate wasting side effects disrupt vitamin D and calcium absorption, leading to bone loss.
What Are the Most Serious Truvada Side Effects?
The most dangerous Truvada side effects are also the most serious side effects for all drugs containing TDF:
- Bone injuries – Studies show patients taking TDF drugs lose an average of 1-2% of their bone density each year. The bones become thin, brittle, and Men in their forties have presented to their doctors with bones similar to women in their eighties. Most people don’t know they have suffered bone loss until they break a bone. Of those who progress to osteoporosis, 1 in 2 women and 1 in 4 men will suffer a fracture. It can take more than a year to fully recover from this type of “hard” injury, and some people’s mobility will never be the same.
- Kidney injuries –Many different types of kidney injuries have been associated with TDF drugs. Tubular Dysfunction is a renal disorder causing a disruption in the body’s homeostasis that can lead to kidney stones, painful urination, fatigue, vomiting, and muscle weakness. Patients with Fanconi Syndrome inadvertently lose essential nutrients into the urine before they can be absorbed by the bloodstream, leading to pain, weakness, and bone fracture. When waste products build significantly up in the blood, Acute Kidney Injury can progress to Chronic Kidney disease or Acute Renal Failure, requiring emergency care and possibly dialysis or transplant in order to survive.
- Liver dysfunction – A type of liver failure known as lactic acidosis is rare but potentially fatal. When the liver cannot remove excess acid from the blood, the patient may suffer a fast heartbeat, dizziness, shortness of breath, nausea, vomiting, fatigue, cold hands and feet, yellowed eyes, loss of appetite, darkened urine, and light-colored stools. Up to 75 percent of patients die from shock, particularly if they are not treated within 28 hours.
Truvada Lawsuit Centers on False Advertising and Suppression of Safer Alternatives
“Failure to warn” is one of the allegations against HIV Medication Manufacturer Gilead. While the safety labels reflect the risks now, it took the company two years to include these risks under the “warnings” section. Even after they updated the label, FDA officials had to repeatedly remind Gilead sales reps – who were claiming Viread and other drugs were safe with “no toxicities” and were “miracle drugs” — that they were violating the law by providing doctors and their patients with false and misleading information. In fact, in 2003, the FDA took the rare step of mandating that sales reps be retrained “due to the significant public health and safety concerns” raised by their repeated false statements.
In 2006, the large number of kidney injuries prompted European drug regulators to ask Gilead to remind doctors to monitor renal function while patients were taking the drug.
It’s worth asking a qualified lawyer about the possibility of filing a Truvada lawsuit if you have suffered bone or kidney loss after taking one of Gilead’s drugs. At the heart of the TDF lawsuits is the contention that Gilead knowingly and intentionally put profits over people by suppressing the development of a less toxic drug while they were enjoying a monopoly on HIV / PrEP treatments. Internal studies dating back to as early as 2001 show that Gilead was aware that tenofovir disoproxil fumarate (TDF) was highly toxic, while tenofovir alafenamide (TAF) could be administered in lower doses and did not carry the same risks of adverse effects. However, they ceased development after “an internal business review” and only began working on these “revolutionary new drugs” after their original TDF patents expired almost a decade later, in 2010.
TAF drugs made it to market in 2017, after countless patients had broken bones and went on dialysis for TDF’s harmful effects.
Gilead Lawsuit Settlements
The litigation is still in its early stages, so no settlements have been reported as of December 2019. Plaintiffs have recently sought centralization into MDL proceedings, which would streamline early discovery and explore the common strengths and weaknesses of the claims against Gilead. If you are part of the Gilead lawsuit settlement, your case will be heard individually in the court where it was filed, but you can still benefit from the research presented and early decisions made in federal courts.
Contact Showard Law Firm for a free case review. If you choose us to represent your claim, you pay nothing upfront and only pay a legal fee after we recover compensation on your behalf. Litigation is one of the best ways to put pressure on regulators and pharmaceutical manufacturers to prevent greater harm from happening to others. Call today for a no-pressure consultation and get all the information you need to decide if filing a lawsuit is the right decision for you at this time.