Florida Atripla Lawsuit Attorneys
Filing a Florida Atripla lawsuit involves seeking damages against pharmaceutical company Gilead Sciences Inc. for the serious or fatal side effects caused by HIV medication Atripla. This is a brand name for one of the drugs containing tenofovir disoproxil fumarate (TDF for short). TDF drugs have been shown to cause injuries such as:
- Bone damage, including osteoporosis or weakening resulting in fractures or breaks.
- Kidney damage, chronic kidney disease and kidney failure, in some cases requiring dialysis or a kidney transplant.
- Lactic acidosis, a potentially fatal metabolic condition stemming from kidney damage.
Atripla is one of several medications produced and marketed by Gilead that contains the TDF compound. Others include:
Atripla, which also contains a substance called efavirenz, was approved for production and sale by the U.S. Food and Drug Administration in 2006. Unlike Truvada, Atripla is only prescribed for treatment - not prevention - of HIV/AIDS.
As Florida Atripla injury lawyers can explain, there are two primary claims against Gilead in relation to these medications:
- That Gilead purposely delayed for years the release of alternative HIV/AIDS drugs containing a compound called tenofovir alafenamide (TAF for short) known to be safer and just as effective as TDF drugs like Atripla because to do so would be to risk profit losses while Gilead still held a monopoly on TDF drugs, thanks to its patents.
- That Gilead failed to adequately warn patients and doctors about the serious health risks posed by TDF drugs like Atripla. Plaintiffs say the company downplayed these dangers repeatedly, and it is a fact that the FDA issued several warnings to the company about this.
Both pertain to product liability claims of negligent defective design. To establish this, plaintiffs need to show the drug maker was aware of the risk associated with the drug and that the drug itself caused plaintiff’s injuries.Withholding a Safer Alternative
Although it is yet to be proven in court, there is strong evidence that Gilead had the ability to release the safer versions of the HIV pills much sooner than it did.
It’s fairly common knowledge that Gilead first began researching and developing drugs containing tenofovir in the 1990s. These included both TDF and TAF compounds.
In 2001 - months before the FDA received approval for Viread, its first TDF drug - Gilead’s own researchers published a study indicating TAF compounds were far less toxic in animals. TAF medications were found to be just as effective, yet could be given in lower doses (and thus were less dangerous). Between 2002 and 2003, Gilead conducted clinical trials that underscored these earlier findings. However, those TAF-positive results were not published until 2014, as noted by The Los Angeles Times.
In 2004, Gilead abruptly announced it was discontinuing TAF research and development after an “internal business review.” It went on raking in billions of dollars on TDF medications - including Atripla - until the patent life on those drugs began to wind down. It began applying for patents for TAF drugs in 2005 and 2006.
In 2010, the company announced its discovery of an “interesting new molecule” - TAF - to treat HIV/AIDS. The company unveiled two other TDF drugs (Complera and Stribild) before obtaining FDA approval for Genvoya - its first TAF-based HIV medication - in late 2015. Immediately, the company began urging physicians to switch their patients to the safer TAF alternative. It unveiled two other TAF alternative drugs over the next year. In 2017, the first of Gilead’s patents expired, and the TDF drugs became available in generic form. Gilead no longer had a monopoly.
By 2018, we started to see the first product liability lawsuits filed against Gilead for allegedly withholding safer TAF alternatives while patients suffered from the serious side effects of TDF drugs like Atripla.Atripla Injury Lawsuits
Gilead’s quarterly reports indicate that hundreds of TDF injury lawsuits were pending against the company by mid-2019.
One primary plaintiff in a California class action lawsuit against Gilead was prescribed Atripla. According to the complaint in Martinez and Wohler v. Gilead Sciences, Inc., plaintiff was prescribed Atripla for more than a decade.
Plaintiff alleges that when Gilead started marketing and selling Atripla, it provided prescribing information that contained misrepresentations nearly identical to the Viread and Truvada marketing materials for which the FDA had issued previous warnings. Namely, these materials limited the risk to those with a history of bone and kidney problems, plaintiffs alleged. Even current prescribing information and patient information for Atripla makes little mention of risks associated with long-term TDF drug use for patients who don’t have a prior history of these problems - even with evidence that these risks are present for all patients, regardless of prior bone or renal health issues.
This lends itself to claims of defective design, failure to warn, as well as failure to provide a safer reasonable alternative.
Contact Florida Atripla injury lawyers at The Ansara Law Firm by calling (954) 761-4011 or toll-free at (888) ANSARA-8.