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.
The legal actions, prepared by Rutherford Law attorney Michelle M. Rutherford and in-house counsel for AHF, 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.'
The cases also assert that Gilead deliberately and maliciously suppressed from the market its alternate and newer formulation of the drug, TAF, in order to extend the patent life - and sales - of its existing medications that included TDF. Gilead earned over $18 billion in net profit in 2015.
"A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the 'Miracle Drug' and using other deceptive marketing strategies. Gilead shelved a far safer drug, TAF, simply to increase its long term profits. I'm bringing this lawsuit to try to hold Gilead responsible for their reckless focus on profits over patient safety," said Michael Lujano, one of the plaintiffs in the personal injury action.
"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.
"Plaintiffs bring these lawsuits today because Gilead should be accountable for making misrepresentations about the significant side effects of its key HIV drug, TDF, while it shelved a safer alternative in TAF for many years simply to increase profits," said Michelle M. Rutherford of Rutherford Law, attorney for plaintiffs.
The lawsuit asserts:
"After learning that TAF had a higher absorption rate and largely avoided the bone and kidney toxicity associated with TDF, Gilead shelved its development of TAF and instead kept HIV infected patients and their doctors in the dark about the true risks associated with TDF, along with the solution to those risks, for over a decade. In 2014, as Gilead's patent on TDF approached its expiration and Gilead faced a sharp decrease in profits that would result from competition entering the market for TDF-containing drugs, Gilead decided to release the results of the TAF studies it began conducting in 2001."
It also asserts:
"Viread's original prescribing information and patient information sheet said little about the severe risk of toxicity in kidneys and concomitant risk of bone mineral density loss. The boxed warning for Viread has never mentioned TDF toxicity, bone, or kidney risks. And, the current label still only recommends assessment of bone mineral density for patients with a history of fracture or other risk factors for osteoporosis or bone loss."
"Gilead's prescribing information and patient information sheets for Truvada did little to correct the tide of misrepresentations unleashed by its sales force and CEO only months before Truvada's launch into the market in 2004. Truvada's prescribing information failed to correct prior misrepresentations regarding the safety and efficacy of TDF and continued to misrepresent and minimize the risk of toxicity and bone and kidney damage. Where Gilead did list potential patient concerns, it misrepresented the risks as primarily for already-renally impaired or bone-compromised patients."
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 894,000 individuals in 39 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe.