AdvaMed Files Amicus Brief with California Court Opposing New Liability Theory for Products in California Courts
WASHINGTON, DC—The Advanced Medical Technology Association (AdvaMed) urged California’s First District Court of Appeal to overturn an erroneous decision by the trial court that has the potential to impose unfair and unwarranted liability upon companies that engage in research to move science forward.
The litigation arises out of Gilead’s tenofovir-based medications for treating and preventing HIV. In the 1990s, Gilead began investigating various forms of tenofovir, including the primary compound at issue in this litigation: tenofovir disoproxil fumarate (TDF). After years of study and extensive review by FDA, Gilead’s first TDF-based medication to treat HIV (Viread®) was approved by FDA in October 2001, followed by Truvada® in 2004, Atripla® in 2006, Complera® in 2011, and Stribild® in 2012. Gilead’s TDF medications have been an enormous success, playing a central role in transforming HIV from the death sentence that it was to the chronic, treatable illness that it has now become.
The brief highlights the fact that the medicines plaintiffs complain about were developed and approved in full compliance with all FDA requirements. Compliance with the FDA’s extensive testing and approval process means that, in exercising the care deemed necessary by the FDA’s expert scientists, Gilead necessarily exercised reasonable care. By allowing plaintiffs to proceed toward trial on this theory, the Superior Court’s decision has the potential to impose unfair and unwarranted liability upon the companies that engage in research to move science forward and treat patients.
AdvaMed joined the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the California Life Sciences Association (“CLS”), and the Biotechnology Innovation Organization (“BIO”) on the amicus brief.
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AdvaMed is the world’s largest medical technology association, representing device, diagnostics, and digital technology manufacturers that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments.