Florida Complera Lawsuit Attorneys
A Florida Complera lawsuit is a legal action against Gilead Sciences, Inc., the maker of HIV drug Complera. This compounded medication is made with tenofovir disoproxil fumarate, better known as TDF, and a substance called rilpivirine. Numerous studies indicate TDF-based drugs like Complera can cause serious and sometimes fatal side effects, including:
- Lactic acidosis. This is a potentially fatal condition characterized by a buildup of lactic acid in the blood. It’s caused by damage to the kidneys.
- Renal failure. Damage to the kidneys resulting in the need for dialysis or transplant.
- Bone density loss. This can include conditions like osteoporosis that weaken the bone tissue, making it susceptible to fractures and breaks.
- Possible liver damage.
Complera was approved by the U.S. Food & Drug Administration in 2011 to treat HIV/AIDS. It is one of five TDF medications manufactured by Gilead. The others are Truvada, Viread, Stribild and Atripla. Truvada is the only one approved for preventing contraction of the HIV virus. Some are also prescribed to treat hepatitis B.
Complera is a once-a-day, single-dose medication intended for adults with HIV and children over the age of 12 who meet certain medical requirements. It does not cure HIV, but rather is considered an antiretroviral therapy. It increases CD4+ cell counts while decreasing the amount of HIV in one’s bloodstream.Why is Gilead Being Sued for Complera?
Drug manufacturers have a legal duty to design, manufacture and market HIV medications that are safe for the intended purpose. If there are potential risks, pharmaceutical companies have an obligation to issue adequate warnings about those risks.
Gilead started development of tenofovir medications - TDF and one other, tenofovir alafenamide, or TAF - in the 1990s. The FDA approved the first TDF medication, Viread, in 2001. Months prior to that (and years before Complera was approved), Gilead’s own researchers had concluded TAF drugs were less toxic and just as effective, primarily owing to the fact that TAF drugs could be administered at much lower doses than TDF drugs.
Clinical trials conducted in 2002 and 2003 supported researchers’ earlier findings about TAF compared to TDF, but those results weren’t published until more than a decade later.
So why did Gilead not release TAF drugs for HIV patients sooner? As our Florida Complera lawsuit attorneys can explain, the assertion by plaintiffs is that the company tried to maximize profits by running down the clock on its patents for TDF drugs. So long as it held the patent on TDF medications, the company could charge premium prices. Pharmaceutical drug patents, which imbue the patent holder with exclusive rights to produce a medication, typically last 20 years. When the patent expires, other drug companies can begin making generic versions.
This withholding of a reasonable, safer alternative is the basis for a number of these claims. Others include:
- Design defects
- Strict product liability - failure to warn
- Breach of implied and express warranties
- Fraudulent concealment
- Marketing defects
Plaintiffs allege Complera caused their kidney and/or bone damage and that Gilead was aware of these risks. Many patients say that had they been fully informed of the dangers of taking TDF, they’d never have taken it.
In addition to the peer-reviewed research linking TDF drugs like Complera to kidney and bone conditions, medical experts can testify about the link. Patients’ medical records will be key evidence in these cases.Gilead Faces Mass Tort, Class Action Litigation for TDF Drugs Like Complera
Gilead is facing both class action lawsuits and mass tort litigation for the purported harm caused by TDF-based drugs like Complera.
Mass tort litigation is a type of civil action that involves numerous plaintiffs against one or a handful of defendants in either state or federal court. These involve many injuries caused by the same or similar act of harm. Many of the plaintiffs are often from the same geographic region. Certain matters early on in mass torts are decided all at once, but each plaintiff is still considered an individual, required to prove certain facts in order to prevail.
In class actions, one or a few individuals represent the entire class, wherein all members must meet certain criteria. Where the factual basis for the claims of each plaintiff varies too widely, class action may not be ideal.
Both types of claims are intended to reduce the burden on the court system.
Those who suffered renal or skeletal injuries after taking Complera should consult with an experienced Florida product liability attorney to determine whether they may have grounds to file a claim.
Contact Florida Complera injury lawyers at The Ansara Law Firm by calling (954) 761-4011 or toll-free at (888) ANSARA-8.