Potential False Claims Act violation justifies retaliation suit

A federal court has given a saleswoman the go-ahead for her retaliation claim against her former employer. The case is unusual, because the judge allowed the claim under the False Claims Act, even though the employee did not report the company to the government.

In her complaint, the saleswoman alleges that she questioned the company’s decision to market a medical device for off-label use. The Food and Drug Administration had approved the device for removal of soft cardiac tissue during surgery. In a training session, however, the company asked its sales force to promote the device to treat atrial fibrillation.

Regulators have been concerned about off-label use of medications and medical devices for some time. A drug may be designed and approved to treat migraines, for example, but a scientist or physician discovers that it reduces acid reflux, too. What should happen is that the drug go through clinical trials for effectiveness and safety testing of the acid reflux use — the same rigorous testing that the drug ostensibly went through for use on migraines. Without that testing, the off-label use could end up being harmful to patients.

The saleswoman questioned the legality of the off-label marketing plan twice. The response each time was a reprimand. In a short period of time, the employer manufactured reasons to fire her and followed through just three months after she was hired. The complaint states that she has not been able to secure employment in the medical device industry since that time; her former employers have blacklisted her.

She claims retaliatory discharge in violation of the False Claims Act. The court knew that the plaintiff had not filed a complaint against the company alleging it had defrauded or attempted to defraud the U.S. government. Still, the plaintiff’s questions about the off-label use alerted the employer to the “distinct possibility” that she or any other employee in the room at the time could accuse the company of fraud under the False Claims Act.

This decision in no way signals whether the plaintiff will prevail. It does, though, allow her to move forward with her retaliation claim.

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Alan Olson practices employment law throughout the United States from his offices in New Berlin, Wisconsin. Attorney Olson may be contacted at [email protected] with questions about the information posted here or for advice on whistleblower claims.

Source: Courthouse News Service, “Doubting Off-Label Use May Have Led to Firing,” Bonnie Barron, April 2, 2012

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