First Circuit: First-to-File Bar Derails Later-Filed Off-Label Marketing Qui Tam That Alleged Different Off-Label Uses

In recent years, court has increasingly read the False Claims Act’s First-to-File Bar quite broadly, precluding later-filed qui tam actions that, at times, seem quite different from the earlier-filed qui tam actions. The most recent example comes out of the First Circuit Court of Appeals, in United States ex rel. Wilson v. Bristol-Myers Squibb, No. 13-1948 (1st Cir. April 30, 2014).

In Wilson, a former Bristol-Myers Squibb (BMS) sales representative filed a qui tam action in October 2006, alleging that his former employer had off-label marketed its drugs for specific off-label uses. The government intervened and settled a portion of this case in August 2007 for over $317 million. Mr. Wilson decided to go forward with the non-intervened claims.

However, an earlier-filed qui tam whistleblower lawsuit included off-label marketing allegations involving the same drug; it alleged that these promotions cause providers to use the drugs for different off-label uses than the ones identified in Mr. Wilson’s complaint.

After the District of Massachusetts cited the First-to-File bar in dismissing Mr. Wilson’s qui tam complaint, he appealed to the First Circuit. Mr. Wilson argued that the First-to-File Bar did not apply, for his action was not substantially similar to the earlier-filed qui tam suit.

In affirming the lower court’s decision, the First Circuit determined that the “essential facts” were present in the earlier-filed suit, so the government was put on notice, triggering the FCA First-to-File bar. While recognizing that Mr. Wilson supplied the government with different information, the Court quoted its earlier decision in stressing, “the first-to-file bar ‘still bar[s] a later claim’ even if that claim incorporates somewhat different details.”

Reduced to its core, the Court emphasized that the First-to-File bar will apply when the two complaints involve the same essential facts, such as: “the same defendants, the same drugs, the assertion of nationwide schemes, and the allegations of specific mechanisms of promotion common to both…”