LOS ANGELES--(BUSINESS WIRE)--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.
Personal Injury Claims Against Gilead
The personal injury action against Gilead asserts claims for: 1) Strict Products Liability – Design Defect and Failure to Warn; 2) Negligent Products Liability – Design Defect and Failure to Warn; 3) Breach of Implied Warranty, and; 4) Breach of Express Warranty.
Regarding the potential harm caused by TDF, the personal injury claim asserts that:
“FDA twice issued warning letters to Gilead over its TDF marketing practices, stating that their sales representatives had violated the law by giving doctors and patients false and misleading information regarding TDF’s side effects. According to a 2002 FDA Warning Letter, Gilead salespeople falsely stated that TDF had 'no toxicities' was 'benign' and was 'extremely safe.' A 2003 FDA Warning Letter took the uncommon step of requiring Gilead to retrain its sales representatives to provide accurate information regarding the significant side effects associated with TDF and comply with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352.”
It also noted that:
“Gilead had a duty to share its exclusive knowledge of the risks associated with TDF. Gilead failed to do this. Instead, Gilead misrepresented the safety and benefits of TDF and failed to provide prescribing physicians and their patients with the information they needed to safely and reasonably prescribe and take Gilead’s drugs.”
“… studies showed that TAF was far less toxic and confirmed that TDF’s low absorption, high dosage, and potential bone and renal toxicity were real risks. But, Gilead did not publish this research, did not conduct clinical trials of TAF, did not change its prescribing information, and did not instruct its sales representatives to begin informing doctors that the toxicities associated with TDF could be eliminated with a new, better drug.”
Surprisingly, in October 2004, Gilead’s CEO John C. Martin announced, “the company is discontinuing its development program for TAF.” However, “… Gilead did not discontinue development of TAF. Instead, between October 2004 and May 2005, Gilead applied for seven patents associated with it.”
Gilead knew that continuing to sell TDF risked permanent and possibly fatal damage to the kidneys and bones in patients prescribed and taking the drug. It also knew that its newer, alternate version, TAF, would reduce the risk of toxicity and damage to kidney and bones.
California Class Action Claims Against Gilead
Two other Californians living with HIV—each of whom has taken TDF for many years with subsequent and related health deficits—have filed a class action lawsuit against Gilead on behalf of:
“All persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.”
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.”
Previous Federal Lawsuit on Gilead and Tenofovir TDF/TAF
AHF filed a separate and previous legal action in federal court in 2016 seeking to hold Gilead accountable for its misdeeds and misrepresentations regarding TDF and TAF. That lawsuit is currently pending in the Federal Circuit Court of Appeals in Washington D.C. as Case No. 16-2475.
In May 2016, the Los Angeles Times published a front-page article, “A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner” by reporter Melody Petersen that was prompted in part by the lawsuit.
In an astounding revelation in her 2016 article, Petersen reported:
“In stark language contained in a recent court filing, the company's (Gilead) lawyers said the firm ‘had no duty to develop, test, seek approval of, or launch its new product on any particular timetable.’"
About AIDS Healthcare Foundation
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. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare