WLF Urges Supreme Court Review of Ortho Biotech Decision; Argues that the False Claims Act is Intended to Combat Fraud, not Legitimate Product Promotion

January 11, 2010

By Peter M. Jaensch –

On January 4, 2010, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in support of Ortho Biotech Products’ petition for a writ of certiorari in the Supreme Court of the United States, urging review of the decision in United States, ex rel. Mark Eugene Duxbury v. Ortho Biotech Products, L.P., 579 F.3d 13 (1st Cir. 2009).

As discussed in our earlier post, the underlying case asserted qui tam claims under the False Claims Act (“FCA”) against Ortho Biotech that were based on certain of the company’s product promotion activities, alleging promotion of off-label use, marketing the “spread” and providing “kickbacks” to providers in the form, among others, of free product samples.  The District Court dismissed all of the claims, citing multiple grounds.  On appeal, the First Circuit reversed in part, reviving only those claims attributable to Duxbury based on kickbacks.  Ortho Biotech petitioned for certiorari to the Supreme Court on December 3, 2009.  Such petitions are formal pleadings requesting the Court to exercise its discretion to review a lower court's decision, and are rarely granted.

As an amicus in support of Ortho Biotech’s petition, WLF argues that the FCA is meant to combat fraud, not legitimate product promotion, and that it cannot have been Congress’ intent to permit private suits against pharmaceutical and medical device companies for their truthful promotional activities absent the identification of any fraudulently-filed claim.  Ultimately, WLF argues the specific allegation of an actual false claim is a “threshold issue” without which Federal Rule of Civil Procedure 9(b) is dispositive, and requires dismissal of Respondent’s claims.  This argument is buttressed with a warning that, if unreviewed, the Duxbury decision threatens the ability of drug and medical device manufacturers to discuss freely and truthfully their products’ off-label uses and to distribute drug samples – activities which are beneficial to doctors and their patients.