On April 6, the United States District Court for the Western District of Missouri ruled that a relator may proceed with a qui tam action against a medical device company related to off-label marketing of a medical device.
The medical device company markets and sells Auragen, a medical device used by physicians for brain mapping and approved by the FDA for monitoring electrical activity during surgery. However, Auragen has not been approved by the FDA for post-operative monitoring.
In the motion to dismiss phase, the relator and the company’s key contention centered around whether the relator had stated with sufficient particularity that the company’s conduct was intended to and caused the United States to pay out money it was not obligated to pay; merely alleging improper off-label marketing is not sufficient. The District Court found that the relator had provided facts with sufficient particularity. Two factual allegations in particular strongly supported the relator’s position: (1) The company repeatedly provided reimbursement codes for post-operative use that is not approved by the FDA; and (2) 90% or more of the company’s product line was for unauthorized off-label uses, including implantation and post-operative monitoring.