NEW ORLEANS--(BUSINESS WIRE)--Two Louisiana patients living with HIV filed personal injury lawsuits against Gilead Sciences Inc. seeking to hold the San Francisco Bay Area drug maker accountable for actions around its failure to rectify a known defect in tenofovir disoproxil fumarate’s (TDF’s) drug formulation. Plaintiffs allege their severe physical injuries, kidney damage and bone density loss were caused by Gilead’s TDF medications and that Gilead developed but withheld a safer alternative, tenofovir alafenamide (TAF), that could have prevented their injuries. Both plaintiffs allege Gilead failed to warn them of the damaging side effects of TDF and actively misrepresented TDF’s efficacy and risks.
Plaintiff Willie Hills, Jr. claims the medication caused him to develop chronic kidney disease. Plaintiff Christopher Pierot claims the medication caused severe bone density loss and necrosis in both hips, resulting in a double hip replacement when he was only 30 years old.
The two separate, but similar legal actions, prepared by Rutherford Law attorney Michelle M. Rutherford, Louisiana lawyer John Adcock, and in-house counsel for AHF, were filed in two United States District Courts, the Western and Middle Districts of Louisiana, (Case No. 3:18-cv-00718-SDD-EWD) on behalf of Mr. Willie Hills, Jr., in the Middle District, and (Case 3:18-cv-00975) on behalf of Mr. Christopher Pierot in the Western District of Louisiana. Both plaintiffs demand jury trials. AHF is funding the litigation and will not receive any financial recovery from the lawsuit in excess of its actual costs.
The case follows earlier, similar cases filed in Superior Court of for the State of California County of Los Angeles [Case No. BC702302, Personal Injury Claims; and Case No. BC 705063, Class Action Status], against Gilead over Tenofovir. Both sets of 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 current pleadings, the company knew as far back as 2001:
“Gilead knew that TDF toxicity led to kidney and bone damage, even in patients without pre-existing kidney or bone issues. Gilead had a duty to share its exclusive knowledge of the risks and adequately warn of any known or scientifically knowable risks associated with the use of TDF. Instead, Gilead misrepresented the safety and benefits of TDF and failed to provide prescribing physicians and their patients, including Plaintiff and his doctors, with the information they needed to safely and reasonably prescribe and take Gilead’s drugs.”
"Gilead should be held responsible for not putting out a better alternative drug knowing all along they hand one on hand. I do not understand the rationale behind their decision, but I will be feeling the effects of their decision for the rest of my life," said plaintiff Willie Hills Jr.
“The fact that Gilead knowingly gave an inferior version of their product that they knew caused kidney damage and bone loss to patients in order to make more money and extend their patent is despicable,” said Michael Weinstein, President of AHF.
"These two actions in Louisiana, similar to the claims filed in California, seek justice for individuals who now suffer severe health issues after taking TDF based HIV drug regiments, which Gilead marketed and sold, when it knew that a safer alternative existed in TAF based regiments," said Arti Bhimani, Attorney for Plaintiffs.
"I am honored to represent Messrs. Hills and Pierot in their efforts to obtain justice for being the collateral damage caused by Gilead's strategy of continuously placing profits over patient health,” said Michelle Rutherford, Attorney for Plaintiffs.
The case(s) 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.
Personal Injury Claims Against Gilead
The personal injury action against Gilead asserts claims for: 1) Louisiana Products Liability Act– Design Defect LSA RS 9:2800.56 2) Louisiana Products Liability Act– Breach of Implied Warranty LSA RS 9.2800.57, 3) Louisiana Products Liability Act– Breach of Express Warranty LSA RS 9.2800.58 and 4) Breach of Warranty in Redhibition, a claim for violation of Louisiana’s consumer protection laws.
Regarding the potential harm caused by TDF, Mr. Hills’ personal injury claim asserts that:
“… at the time the Viread used by Plaintiff left Defendant’s control, there were other practical and feasible alternative designs that would have prevented and/or significantly reduced the risk of Mr. Hills’ injuries without impairing the reasonably anticipated or intend function of the product. These safer alternatives designs were economically and technologically feasible, and also would have prevented or significantly reduced the risk of Ms. Hills’ injuries without substantially impairing the product’s utility.”
It also noted that:
“Defendant (Gilead) expressly warranted that Viread was safe for its intended use and as otherwise described in this Complaint. Viread did not conform to these express representations, including, but not limited to, the representation that it was well accepted in patient and animal studies, the representation that it was safe, and the representation that it did not have high and/or unacceptable levels of permanent or chronic side effects like kidney disease, and that it would improve health, maintain health, and potentially prolong life.”
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 (7) 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.
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. The Federal Circuit Court of Appeals in Washington D.C. recently issued an unjust ruling and AHF intends to seek review by the Supreme Court of the United States. The case is 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 950,000 individuals in 41 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