Medical Device Manufacturers

Medical device manufacturers face temptations to try to influence physicians’ treatment decisions in order to benefit their bottom lines, including by knowingly:

  • Paying kickbacks to physicians or hospitals to boost sales and use of devices or implants
  • Marketing their products for uses not approved by the U.S. Food and Drug Administration (“off label” uses)
  • Counseling healthcare providers to use improper codes to increase reimbursement rates
  • Forging or altering certificates of medical necessity or other physician documents
  • Waiving patient co-payments

Case Examples

A number of successful False Claims Act cases have been brought against medical device manufacturers. By way of example:

In 2013, Baxano Surgical Inc. agreed to pay $6 million to settle whistleblower claims that it had violated the False Claims Act by counseling health care providers to submit claims with incorrect diagnosis or procedure codes for spine surgeries performed using the company’s devices, in order to increase reimbursement rates, as well as by paying kickbacks to physicians to induce them to use the company’s products. The whistleblower in this case was a former sales manager for Baxano. He received $1,020,000 as his share of the settlement. Read more 

In 2012, Orthofix Inc., a Texas-based manufacturer of medical devices, agreed to pay $34 million to settle whistleblower claims that it had violated the False Claims Act, by waiving patient co-payments; paying kickbacks to physicians and their staffs to induce them to use Orthofix products; and failing to advise patients of their right to rent rather than purchase Orthofix products. The whistleblower in this case was an ex-sales manager for the company. She received $8 million as her share of the settlement. Read more

In 2007, four companies accounting for the lion’s share of the market in hip and knee surgical implants — Zimmer, Inc., Depuy Orthopaedics, Inc., Biomet Inc., and Smith & Nephew, Inc. —agreed to pay $311 million to resolve claims that they had violated the False Claims Act by paying illegal kickbacks to surgeons in exchange for exclusively using their hip and knee replacement products. Read more

In 2006, Medtronics agreed to pay $40 million to resolve claims that it violated the False Claims Act by paying kickbacks to doctors to induce them to use the company’s spinal products, including by providing the doctors with sham consulting gigs, sham royalty payments, and lavish trips. Read more

If you have knowledge and solid evidence of fraud or false claims by a medical device manufacturer, please contact our Chicago whistleblower attorneys.
Consultations are free and confidential.