Court Evades US Concern Over False Claims And Side Effect Reports

Here is a ruling that is nothing but anticlimactic. After a few months of anticipation, a federal appeals court decided not to rule on an issue raised last summer by the US Department of Justice in a whistleblower case against a drugmaker – whether the failure to report adverse events can form the basis for filing a lawsuit citing the False Claims Act. Here is the background, all of which is from our earlier story: A year ago, a federal court judge tossed a pair of whistleblower lawsuits that were filed by a former safety consultant, Helen Ge, who alleged Takeda misrepresented or altered descriptions of adverse events for the Uloric gout pill. She also maintained Takeda failed to report instances of bladder cancer and congestive heart failure concerning the Actos diabetes pill to the FDA (back stories here and here). In her lawsuits, Ge contended the drugs, including the Prevacid heartburn treatment, would not have been as widely prescribed had adverse events been reported properly to the FDA in the belief that the agency might have ordered updated labeling or issued safety alerts. Consequently, she charged federal healthcare programs paid for more prescriptions than might otherwise have been dispensed (see the lawsuits here and here). But US District Court Judge F. Dennis Saylor had ruled that Ge failed to provide specific details of any false claims – another way of referring to bills for drugs – that might have prompted overpayment by federal or state healthcare prog...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs