Another two lawsuits were filed last week in California against the U.S. pharmaceutical company Gilead Sciences, Inc. by several dozen patients who claim the company withheld from the market for more than a decade a drug for treating HIV that it knew was safer and more effective than the drug it promoted during that period.
The two personal injury lawsuits accuse Gilead of intentionally continuing to promote the HIV medication tenofovir disoproxil fumarate (TDF), which was known to cause serious kidney and bone damage, so it could profit from the drug before its patent on the medication was to expire in 2015.
At the same time, the lawsuits charge, Gilead withheld from the market a far safer version of the drug called tenofovir alafenamide (TAF), which it knew would more effectively treat HIV without causing any of the serious side effects caused by TDF.
The lawsuits charge that many patients taking one of five Gilead HIV drugs for which TDF was a key component needlessly suffered debilitating and sometimes fatal kidney and bone damage as well as damage to their teeth. Also adversely impacted by TDF, the lawsuits claim, were HIV-negative people taking the Gilead drug Truvada, which contained TDF, as part of the HIV prevention regimen known as PrEP.
In response to these and as many as a dozen or more similar lawsuits filed by HIV patients and PrEP users in state and federal courts in California over the past two years, the AIDS Healthcare Foundation on Monday called on Gilead to create a $10 billion fund “for victims harmed by its TDF-based drugs.”
Michael Weinstein, executive director of AHF, the nation’s largest AIDS advocacy and HIV/AIDS patient care organization, said a large compensation fund would benefit both Gilead and the more than 1,000 patients that are plaintiffs in the multiple lawsuits against Gilead over the TDF issue.
“We had two goals in putting this out,” said Weinstein. “One was to underline the significance of the liability that they are facing based on their conduct,” which could amount to billions of dollars, he said referring to Gilead.
“And second of all is simply to plant the idea in Gilead’s mind that ultimately the best resolution of this is to compensate the people who were harmed,” Weinstein said.
“For years, Gilead represented its TDF-based medications as safe and effective, misleading Plaintiffs, their doctors, and the medical community into believing that no safer alternative design existed that would have saved Plaintiffs from TDF’s dangerous effects,” says one of the two lawsuits filed July 12 in Alameda County, Calif., Superior Court.
“Indeed, it was Gilead that discovered and helped develop the safer design around the same time it developed TDF in the mid to late 1990s,” the lawsuit says. “Gilead, however, shelved TAF, the safer design, in 2004. Gilead marketed and sold only the dangerous and less effective design – TDF and TDF-based combination pills – for approximately 15 years,” the lawsuit continues.
“Then, when its monopoly on those TDF drugs was about to expire, Gilead sought and received approval from the U.S. Food and Drug Administration to sell, and market TAF-based drugs, allowing it to extend its exclusivity on tenofovir and keep its HIV drugs branded and priced high to increase its profits,” the lawsuit says.
A spokesperson for Gilead Sciences didn’t immediately respond to an email and phone message from the Blade asking the company to comment on this and other similar lawsuits filed against it during the past two years over the TDF and TAF drug allegations.
Gilead’s attorneys disputed the allegations that the company failed to adequately alert patients and doctors of the adverse side effects of TDF in a July 10 motion filed in the U.S. District Court for the Northern District of California in a motion calling for the court to dismiss yet another lawsuit filed against it over the TDF-TAF issue.
That case, Adrian Holley, et al vs. Gilead Sciences, Inc., was filed in March 2018 and is one of several TDF-related cases filed against Gilead in federal court in California.
In its motion to dismiss, Gilead argues that plaintiffs have failed to provide sufficient evidence that “newly acquired information” surfaced to that would have allowed Gilead to “strengthen warnings contained in TDF medication labeling after 2008.”
Gilead has stated in the past it has included warnings about possible harmful side effects of TDF for people who have a history of kidney or bone related ailments. The lawsuits, however, have charged the company with failing to issue an alert that TDF could cause serious kidney and bone damage for people who did not have a history of kidney or bone related problems.
‘Plaintiffs still have not alleged, inter alia, facts supporting when they or their doctors were exposed to any alleged misrepresentations, what misrepresentations they or their doctors were exposed to, or if or how their or their doctors’ conduct changed based on any such misrepresentations, as required by the Federal Rules of Civil Procedures 8(a) and 99(b),” Gilead attorneys state in their motion to dismiss the federal lawsuit.
The motion to dismiss makes no mention of the other key allegation in this and the other lawsuits – that Gilead withheld the release of the safer HIV drug TAF to enable it to reap its profits from TDF until its patent on that drug expired in 2015.
The lawsuit filed on July 12 in Alameda County, entitled Gary Smith, et al vs. Gilead Sciences, Inc. includes 41 plaintiffs who are seeking financial compensation for damages of an as yet undeclared amount on grounds that Gilead violated “Strict Products Liability – Failure to Warn” requirements; engaged in “Negligence and Gross-Negligence—Design Defect and Failure-to-Warn” related to the harmful effects of TDF; Fraud; and “Breach of Express and Implied Warranty.”
The Smith v. Gilead lawsuit was filed five days after a separate lawsuit accusing Gilead of the same allegations of failing to adequately alert patients to the harmful side effects of TDF and withholding the release of the safer drug TAF was filed in San Diego County Superior Court under the case name Timothy Williams, et al vs. Gilead Sciences, Inc., et al.
“This case is a shocking example of corporate greed,” said Elizabeth Graham, one of the lead attorneys with Grant & Eisenhofer, an Oakland, Calif.-based law firm that filed the San Diego case on behalf of the plaintiffs it is representing.
“Gilead owed its consumer patients the safest possible drug, but opted to withhold that drug from the market in the name of profit,” Graham said in a statement.
Liza Brereton, an attorney with HIV Litigation Attorneys, a law firm created to focus on personal injury and class action lawsuits filed against Gilead related to TDF, said judges with the multiple California state courts in which the pending lawsuits against Gilead have been filed have scheduled a hearing in Los Angles for July 30 in which the cases were expected to be consolidated into one large case.
“So it’s taken a while but pretty soon we’ll be all in front of one judge in one court and things will be moving pretty quickly,” Brereton said.
She said the cases in federal courts will continue as separate cases.