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Florida Viread Lawsuit Attorneys
Pharmaceutical companies have a legal duty to make safe products and to warn physicians and patients about the potential for adverse side effects. When they do not, they can be held accountable in court.
Drug manufacturer Gilead Sciences, Inc. is facing legal action over its breakthrough HIV and hepatitis B drug Viread, the first of five containing a substance called tenofovir disoproxil fumarate, or TDF.
The company is accused of downplaying the serious bone and kidney risks and withholding safer formulations of this drug for more than a decade to maximize its TDF profits for as long as it held exclusive rights under patent law to sell them.
What is Viread?Viread is an expensive antiretroviral drug, taken as either pill or powder, that prevents both HIV (human immunodeficiency virus) and hepatitis B from multiplying in the body.
Both HIV (a virus that attacks the body’s immune system) and hepatitis B (a virus that attacks the liver) can be fatal if not treated. It’s not a cure for HIV/AIDS or chronic hepatitis B, but it is used to treat both and can prolong the life of the patient for many years. Approved by the U.S. Food & Drug Administration in 2001, it was the first of five TDF medications produced by Gilead.
Although Viread is effective at controlling these dangerous viral infections, it must be taken at high doses, and it’s highly toxic. Taken in large quantities over time, it’s known to cause kidney damage and renal failure, osteoporosis and broken bones and a condition called lactic acidosis, a dangerous build-up of lactic acid in the blood. Some patients have had to undergo kidney transplants or go on kidney dialysis as a result. Some have even died.
Why Gilead is Being Sued Over VireadAs our Florida Viread injury attorneys can explain, Gilead is accused of selling a defectively-designed, dangerous drug, delaying the release of a safer alternative and downplaying the potential risks to doctors and patients.
It wasn’t long after Gilead began selling Viread that researchers learned the alternative form of the drug, tenofovir alafenamide, or TAF, was both safer and more effective. Yet the drug wasn’t released
Although marketed as “new,” according to one class action lawsuit, the company was paying physicians around the country to conduct studies on TAF as early as 2002. Those early findings indicated TAF was not only just as effective but safer, as it could be administered at lower doses. Yet rather than explore this clearly safer alternative, the company abruptly discontinued its research. It did so even as it quietly applied for seven different patents for TAF medications in 2004 and 2005.
Why? If you ask the plaintiffs in the class action lawsuit:
“If Gilead had chosen to develop tenofovir in the safer and more effective TAF version, TDF would lose marketability - it was less effective and had fair higher risks - and Gilead’s profits from TDF would decrease. By holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in 20 years.”In other words, it came down to greed. The company is accused of putting the profits it raked in from TDF drugs like Viread ahead of the people with life-threatening conditions they claimed to help. By refusing to release TAF drugs and continuing promotion of TDF drugs, the company’s actions resulted in thousands of people developing bone and kidney injuries.
Among the condition reportedly suffered by Viread lawsuit plaintiffs:
- Acute kidney injury or acute renal failure
- Chronic kidney disease or declining kidney function
- Fanconi’s syndrome (a condition where substances normally absorbed into the blood are instead excreted through urine)
- Kidney tubular dysfunction
- Osteopenia
- Osteoporosis
- Bone fractures
Some patients ended up with multiple hip replacements or even in wheelchairs because of the severity of bone injuries. Those with kidney failure ended up on dialysis or requiring kidney transplants. These are very serious and life-threatening complications. Plaintiffs say it could all have been prevented had Gilead been upfront with patients about the risks and followed through on its development of a known safer alternative.
Gilead’s lawyers deny these claims, and assert the company did not have a duty to develop, test, seek approval for or launch the TAF drugs on any particular timetable.
It is believed thousands of HIV/AIDS patients may have unknowingly been exposed to serious kidney and bone damage while taking TDF medications made by Gilead. If you suspect you may be one of them, our Fort Lauderdale Viread attorneys can help.
Contact Florida Viread injury lawyers at The Ansara Law Firm by calling (954) 761-4011 or (954) 761-3641.
