Medical Device Fraud

Becoming a Whistleblower, and exposing medical device fraud, helps ensure that often expensive, increasingly complex medical devices, are used as intended. Highly invasive, or as a precursor to determining treatment, medical device fraud can cause significant patient harm, often to our most vulnerable of citizens. Innovative medical devices, and their significant cost to develop, seem to dramatically increase the risk for medical device fraud, as aggressive marketing leaps over the bounds of legality.

Whistleblowers have uncovered schemes between medical device companies, healthcare institutions and physicians that create illegal incentives to increase the use of medical devices. Whether illegal kickbacks to inappropriately increase the use of a medical device, marketing medical devices fraudulently for unintended and illegal uses, knowingly selling a defective medical device, or a host of other schemes, whistleblowers have helped to correct these unacceptable behaviors through their actions. Quality patient care dictates that such actions must be stopped.

Medical device fraud typically involves some combination of the following:

  • offering kickbacks to healthcare institutions or physicians;
  • off-label marketing of a medical device for uses other than those approved by the FDA; knowingly marketing a defective medical device; and
  • charging prices to the Government that are higher than allowable by law.

Medical Device fraud whistleblower rewards include:

Quest Diagnostics to Pay U.S. $302 Million to Resolve Allegations It Sold Misbranded Test Kits

The relator in the case received $45 million for helping the government to uncover allegations that Quest Diagnostics manufactured, marketed and sold parathyroid hormone test kits despite knowing that some of these kits produced results that were materially inaccurate and unreliable.

Medical Device Makers Enter $310 Million Kickback Settlement

Biomet Orthopedics, DePuy Orthopaedics, Smith & Neephew, Stryker Corp. and Zimmer Holdings settled allegations that they gave illegal kickbacks to surgeons as incentives to use their products.

“With these settlements in place, we expect doctors to make decisions based on what is in the best interest of their patients, not the best interest of their bank accounts.”

Dialysis Provider to Pay $486 Million to Settle Charges

The relator in the case received more than $65.8 million for helping the government to uncover allegations that Fresenius Medical Caree A.G.: conspired to defraud government payers by charging for disputed intravenous feeding of dialysis patients; charged for blood tests deemed unnecessary; and violated anti-kickback laws by providing payments, discounts, yacht trips and bear-hunting excursions in Alaska to attract potential customers for the LifeChem blood-testing business.

Boston Scientific Pays $22 Million To Settle Claims It Used Post-Market Studies To Pay Kickbacks To Physicians

Settled allegation that it used post-market studies as vehicles to pay kickbacks to induce physicians to implant Guidant pacemakers and defibrillators.

“Patient safety should be the top priority, and cardiologists and electro physiologists should make their decisions on which pacemaker or defibrillator to implant in a patient based on their independent medical judgment, not based on how much the manufacturer is paying them.”