The First Circuit recently affirmed the dismissal of a closely watched False Claims Act (FCA) suit in United States ex rel. Ge v. Takeda Pharmaceutical Co. because the relator’s complaint failed to identify any examples of actual false claims presented to the federal government. The relator Helen Ge, alleged that Takeda, a pharmaceutical company, failed to inform the U.S. Food and Drug Administration (FDA) of adverse events associated with its drugs Uloric, Kapidex/Dexlant, Prevacid, and Actos. Federal law requires Takeda to inform the FDA of such adverse events. According to Ge, claims for the reimbursement of Takeda drugs under federal Medicare and state Medicaid programs must have been false because Takeda failed to inform the FDA of adverse events associated with those drugs. The First Circuit held that such allegations do not rise to the level of particularity required by the federal rules.
The Takeda case has been closely watched since the district court dismissed the case in November 2012. The district court’s dismissal order stated that compliance with the FDA’s reporting requirements was not a material condition of payment. Although the FDA has the discretion to remove drugs that are marketed in violation of the adverse-event reporting requirement, it is not required to do so. Thus, in the district court’s view, claims such as Ge’s would always be subject to dismissal. Continue reading “First Circuit Ends Closely Watched Takeda Suit With Limited Ruling”
Two recent regulatory actions by the Department of Labor will impose significant new affirmative action and data collection requirements on federal contractors and subcontractors. The final rules will impact many federal prime and subcontracts performed in the United States and warrant close attention by contractors of all sizes. This alert highlights key provisions in those rules, which are presently set to go into effect on March 24, 2014.
False Claims Act (FCA) suits against health care providers have dramatically risen during the last three years. However, recent decisions indicate that courts are becoming increasingly skeptical of suits which allege that technical violations of Medicare regulations are actionable FCA violations. The most recent decision indicating such increasing skepticism was issued by the Eighth Circuit Court of Appeals last week in U.S. ex rel. Ketroser v. Mayo Foundation, 2013 WL 4733986, No. 12-3206 (8th Cir. Sept. 4, 2013). In that case, relators brought a qui tam action under the FCA against the Mayo Clinic and several related entities (Mayo). Relators asserted that Mayo falsely billed Medicare for surgical pathology services when it did not submit written reports for each surgical pathology service billed, which was allegedly required by Medicare regulations. The Eighth Circuit found that the regulations at issue did not require such written reports. However, the Eighth Circuit also signaled that even if Mayo was noncompliant with Medicare’s rules and requirements, the relators had not established the “scienter” necessary to show that Mayo “knowingly” submitted false or fraudulent claims for Medicare payment in violation of the FCA. The court concluded that because Mayo’s interpretation of the applicable requirements was at least reasonable, it did not violate the FCA even if it did make a technical mistake under the rules, because it did not act “with the knowledge that the FCA requires before liability can attach…” 
On November 8, 2012, the U.S. Department of Justice (DOJ) announced its intention to continue expanding the False Claims Act’s (FCA) reach by intervening in a lawsuit against Fluor Hanford Inc. and its parent company, Fluor Corporation (collectively Fluor), in the U. S. District Court for the Eastern District of Washington. In this case, DOJ is using the rarely invoked Byrd Amendment as the hook to pursue FCA claims. The complaint alleges that Fluor used federal contract funds to pay for lobbying services in violation of the Byrd Amendment and therefore, violated the FCA and subjected itself to treble damages. 31 U.S.C. § 3729 et seq. (FCA); 31 U.S.C. § 1352 (Byrd).
The Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) jointly issued a new guidance entitled “