Implanting Defective Cardiac Devices Compromised Patient Safety, Says DOJ
Thanks to yet another qui tam action under the False Claims Act, the U.S. Department of Justice (DOJ) is working to recoup federal dollars from a medical device manufacturer for implanting defective devices in Medicare patients.
A recipient of one of the defective devices sued Guidant and Boston Scientific (who bought Guidant in 2006) in a whistleblower lawsuit filed in 2008. The complaint alleges that Guidant concealed problems with its defibrillators from the Food and Drug Administration (FDA), patients and doctors. The medical device manufacturer paid $296 million in a settlement with the FDA in February 2010, pleading guilty in Minnesota federal district court for submitting misleading reports to the FDA and failing to report a medical device correction.
The DOJ has filed a related lawsuit, claiming that Guidant knew as early as 2002 that it was implanting cardiac devices with potentially life-threatening defects. According to the DOJ's complaint, Guidant "knowingly caused approximately 2,000 false or fraudulent claims to be submitted to the Medicare program." Citing 10 specific examples of Medicare reimbursements ranging from $20,000 to $46,000, the DOJ is seeking triple damages for all of the fraudulent Medicare claims.
An attorney with DOJ noted, "Patients with serious heart conditions who depend on these devices should not have to second-guess whether they are safe and effective. Concealing the problems wasted taxpayer money and put lives at risk."