A federal court in Chicago has dismissed a federal False Claims Act, or qui tam, lawsuit filed by former Aventis sales rep, who charged the drugmaker with off-label promotion of its Lovenox blood thinner and, in doing so, induced and doctors and hospitals to submit fraudulent Medicare claims.
In their 2003 suit, Katy Kennedy, who also filed a retaliation claim, and Frank Matos, allege Aventis, now owned by Sanofi, prompted docs to prescribe Lovenox for atrial fribillation, acute myocardial infarction, mechanical heart valve replacement and other conditions for which the FDA had not approved use.
They also charged Aventis paid $34,000 to one pharmacist for speaking engagements and hiring him to keep Lovenox on hospital formularies under his control. In addition, Aventis allegedly gave various organizations grants ranging from $5,000 to $30,000 in hopes of inducing them to use or promote Lovenox for off-label purposes. Two years ago, however, the government, declined to join the suit.
However, Matthew Kennelly, a US District Court Judge in Chicago, ruled that Medicare claims filed as a result of the alleged off-label scheme were not “material” to the amount the government paid for treatment of any patient. That's because Medicare reimbursement was based on a diagnosis group code tied to a patient diagnosis and age, and was not tied to services given a patient. As a result, the Medicare claims could not have been false (here is his ruling).
The former sales reps also contended there false claims for additional payments above and beyond the diagnosis code rate, also known as outlier claims. A hospital may submit outlier claims to receive additional payments from Medicare for inpatient hospital services when its operating and capital costs exceed the payment by a specified amount. However, the Kennelly ruled they failed to identify any particular instance of an outlier claim that included a Lovenox prescription or off-label use.
Hat tip to FDA Law blog