Two sets of California patients living with HIV filed a personal injury lawsuit and a separate class action lawsuit against Gilead Sciences Inc. seeking to hold the Bay Area drug maker accountable for actions around its failure to rectify a known defect in tenofovir disoproxil fumarate’s (TDF’s) drug formulation, knowing a safer alternate, tenofovir alafenamide (TAF) existed; failure to warn patients of the damaging side effects of TDF; and active misrepresentation of TDF’s efficacy and risks. Each lawsuit was filed on behalf of two patients.
The legal actions, prepared by Rutherford Law attorney Michelle M. Rutherford and in-house counsel for AHF (Aids Healthcare Foundation) , were filed in Superior Court of the State of California for the County of Los Angeles, [Case No. BC702302, Personal Injury Claims; and Case No. BC 705063, Class Action Status], and each demands a jury trial. AHF is funding the litigation and providing pro bono counsel and will not receive any financial recovery from the lawsuit in excess of its actual costs.
Both civil cases assert that Gilead’s zeal to maintain and maximize its corporate profits came at the expense of the health and wellbeing of its customers who were prescribed and taking TDF, which, according to the pleadings, the company knew as far back as 2001 from its own studies and other research was, ‘…highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.’
“For far too long big pharma has been abusing the financial and legal benefits they've been given under the guise of fostering research and development. These lawsuits, however, make clear that Gilead’s perverse motive of outsized profits and increased market share is not in line with patient health and safety. Under these circumstances, the laws must be read to protect public health from corporate greed,” said Liza Brereton of AHF, attorney for plaintiffs.
This is not the first time AHF has sued Gilead over TDF. In January of 2016 AHF filed a lawsuit that claimed Gilead had illegally manipulated the US patent system by intentionally delayed research on the safer form of the medicine in order to keep out competition and preserve its high prices. Judge William Alsup in the U.S. District Court in Northern California dismissed the case last week, ruling that Gilead's patents were valid. The company, he said, "had no obligation to introduce the improved product at an earlier date."
The previous lawsuit was referenced in an article in the LA Times published in May of 2016 “A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner”