Today, the district court in the AseraCare case delivered the coup de grace to the Department of Justice, granting summary judgment for AseraCare after previously vacating a jury’s verdict in favor of DOJ. In so doing, the court’s brief order emphasizes that disagreements over medical necessity, standing alone, provide no basis for an FCA claim. See Order in United States v. AseraCare Inc., No. 12-cv-00245 (N.D. Ala. Mar. 31, 2016). The district court’s holding that “contradiction based on clinical judgment or opinion alone cannot constitute falsity under the FCA as a matter of law” buttresses potential defense arguments in suits involving issues of medical necessity or other judgment calls, including alleged upcoding.
On March 8, 2016, Amarin Pharma, Inc., advised Judge Paul Engelmayer of the United States District Court for the Southern District of New York that the company had reached agreement with the Government on the resolution of the parties’ dispute over Amarin’s entitlement to engage in certain types of communication to physicians regarding the health benefits of the company’s drug, VASCEPA. Judge Engelmayer signed the proposed stipulation and order later that day.
The settlement is noteworthy for the obvious reason that it continues the Government’s string of losses in First Amendment cases involving the Federal Food, Drug, and Cosmetic Act. But it also matters because it entitles Amarin to use a special advisory comment process for off-label materials, and did not condition resolution of the litigation on Amarin’s agreement to vacate the court’s powerful August opinion finding the FDA’s rejection of Amarin’s proposed claims unconstitutional. It is also important, however, because it appears to qualify Amarin’s victory somewhat, by holding the company accountable for the continued accuracy of its claims and permitting the Government to proceed against Amarin based on shifts in the science supporting those claims.