Rehearing urged for 'bad Ninth Circuit Decision' on Gilead case

In July, the USA’s Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against US biotech major Gilead Sciences (Nasdaq: GILD), relating to its selling of HIV drugs.

Not surprisingly, writes Anne Walsh on legal experts Hyman, Phelps & McNamara’s FDA Law Blog, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted briefs in support of Gilead, including Pharmaceutical Research and Manufacturers of America, Biotechnology Innovation Organization, the US Chamber of Commerce, and the Washington Legal Foundation.

In its July ruling, the Ninth Circuit determined that the complaint alleged sufficient facts to show “materiality” of the underlying violations to the reimbursement decision. Unlike other appellate courts, the Ninth Circuit did not find the Food and Drug Administration’s continued approval of Gilead’s drugs determinative that the alleged violations were not material to reimbursement, notes Ms Walsh.