Any individual with original information about fraudulent Medicaid or Medicare claims may come forward as a whistleblower under the federal False Claims Act (“FCA”). Under the FCA, it is considered against the law for a doctor to offer or implant a medical device that is known to be faulty and thereafter seek reimbursement for the procedure from a government healthcare program. It is similarly problematic under the FCA for a device manufacturer to offer faulty equipment or misrepresent the features of a product to a healthcare professional who, in turn, prescribes or uses the device with a Medicare or Medicaid patient.
Between 2002 and 2005, Boston Scientific Corp. and its subsidiaries Guidant LLC, Guidant Sales LLC and Cardiac Pacemakers Inc. allegedly manufactured and marketed faulty pacemakers to doctors who then implanted the devices in their Medicaid and Medicare patients. Pacemakers are small devices, usually implanted near the shoulder, which help regulate a patient’s heartbeat who is at an increased risk of cardiac arrest. Also known as an implanted defibrillator, the device is vital to save the life of patients with irregular heartbeats. Upon sensing an unstable heart rhythm, the pacemaker exerts an electric pulse to shock the heart back to a regular rhythm.
Boston Scientific Urges Doctors to Implant Faulty Devices
The DOJ’s allegations center around Boston Scientific’s decision to continue marketing pacemakers it knew to be faulty. Beginning in 2002, Boston Scientific allegedly began to realize that two of its models, the Prizm 2 and the Renewal 1 and 2, were plagued with a defect known as “arcing.” This flaw refers to a chain of events wherein the pacemaker detects an irregular heartbeat, emits an electric pulse and, instead of the pulse heading to the heart, it arcs backward and strikes the pacemaker itself. This issue causes the device to short circuit and renders it completely useless in helping patients defeat the effects of an irregular heartbeat.
The DOJ further alleges that Boston Scientific not only went to great lengths to hide this fact from its customers and the FDA, but continued to market and sell the products. The defendants eventually took corrective action and began manufacturing safe and effective pacemakers, but, according to the Department of Justice, not before unloading its remaining faulty products to unsuspecting doctors and healthcare professionals. It wasn’t until the New York Times ran a front page article about the cover-up that Boston Scientific finally decided to issue a recall.
DOJ Committed to Saving Patients From Fraud
In its most recent statements, the DOJ commended investigators for their efforts in putting a stop to this behavior. Assistant Attorney General for the DOJ’s Civil Division stated: “Medicare patients who depend on cardiac defibrillators should not have to worry about whether their devices will work when they are needed….This settlement, along with the prior criminal prosecution of Guidant, demonstrates that there will be significant consequences when companies engage in conduct that threatens health and safety and violates the law.”
The FCA permits whistleblowers to receive a percentage of any amount recovered. In this case, pacemaker recipient James Allen received $2.25 million for coming forward against the medical device manufacturer. If you have original information similar to that described in this article regarding your medical device, you are encouraged to speak to a whistleblower attorney right away.