CORPUS CHRISTI, Texas, May 10, 2019 /PRNewswire/ — In a ruling issued earlier today, the Honorable Judge Jon S. Tigar of the United States District Court for the Northern District of California overwhelmingly rejected Gilead’s bid to have the claims of 165 Plaintiffs from 31 states dismissed—allowing all of the Plaintiffs’ claims to move forward, although slightly narrowing only two of the Plaintiffs’ twelve claims.
In a major victory for people living with HIV/AIDS, Judge Tigar ruled that Gilead “has cited no federal law that restricts a brand-name drug manufacturer from designing a reasonably safe product prior to FDA approval” and, in particular, has identified no federal law that would have prevented it from developing and submitting for approval drugs that contained [safer]TAF rather than TDF…” and that Gilead did not present “‘clear evidence’ that the FDA would not have approved the allegedly safer versions of the drugs that Plaintiffs contend would have complied with state law.”
Bob Hilliard, attorney for the plaintiffs, states, “Gilead’s conduct in knowingly providing a drug that causes such terrible side effects, while having the safer drug sitting in their corporate office and intentionally delaying making that safer drug available just so as to enjoy more years of making billions without Generic competition, is evil.”
“A San Francisco jury will now have an opportunity to determine the cost to Gilead of doing business in such a callous and uncaring way—preying on some of the country’s most vulnerable, those living with HIV.”
From the Opinion:
“Although choosing not to prescribe a particular medication or device is one way that a physician might have acted differently, it is not the only adequate means of demonstrating causation on a failure-to-warn claim. To the contrary, as the first case cited by Gilead demonstrates, the relevant question is whether the plaintiff’s physician would have “prescribed the drug in the same manner.””
“[Plaintiffs’] allegations are sufficient to allege a plausible causal link between Gilead’s alleged failure to warn and Plaintiffs’ alleged injuries. To the extent Gilead argues the complaint is deficient because it does not allege specific treatment that would have lessened Plaintiffs’ kidney and bone damage, the Court disagrees; the contours of what Plaintiffs’ physicians might have done differently if Gilead had provided different warnings can be explored during discovery.”
“Likewise, here, as Plaintiffs observe in their opposition: “The ‘who’ is Gilead, the ‘what’ is an adequate warning about the risks and safe use of TDF and the fact that Gilead was withholding safer designs of the TDF Drugs, the ‘when’ is prior to Plaintiffs’ doctors’ prescribing and monitoring decisions, and the ‘where’ is in Gilead’s drug labeling, marketing, and promotional materials.””
Plaintiffs are represented by Bob Hilliard, Steve Berman, Ben Crump, and Morgan & Morgan Law Firm.
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