Practice Areas

Medical Device Fraud

Medical device fraud occurs when manufacturers, distributors, or healthcare providers submit false claims to Medicare or Medicaid for devices that were unnecessary, defective, or never delivered, or when they conceal known defects in devices that have already been implanted or prescribed. If you work in the medical device industry or in a healthcare setting and have witnessed any of these practices, you may have the basis for a qui tam case. Reach out for a confidential conversation. There is no obligation.

Practice Areas

Medical Device Fraud

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WHAT IS MEDICAL DEVICE FRAUD?

Medical devices covered by Medicare and Medicaid range from durable medical equipment such as wheelchairs and oxygen equipment to implantable devices such as orthopedic implants, cardiac devices, and neurostimulators. Medical device fraud occurs when manufacturers, distributors, or healthcare providers submit false or inflated claims for these devices, bill for devices that were not delivered or were not medically necessary, or conceal known defects in devices that continue to be sold and implanted in patients.

Because medical device claims are submitted to Medicare or Medicaid, false claims in this area fall within the scope of the False Claims Act. Healthcare insiders, device company employees, and others with direct, first-hand knowledge of device fraud may be eligible to file a qui tam lawsuit on behalf of the government and receive a share of any financial recovery.

Aesculap Implant Systems agreed to pay $38.5 million in November 2025 to resolve False Claims Act allegations that it sold a line of knee replacement implants while knowing the devices would fail prematurely at a higher than acceptable rate, rendering the claims submitted to Medicare for those implants false.

Source: U.S. Department of Justice, November 17, 2025 | justice.gov

Legal basis: 31 U.S.C. § 3729 (False Claims Act) | 42 U.S.C. § 1395 et seq. (Medicare) | Source: uscode.house.gov

TYPES OF MEDICAL DEVICE FRAUD THIS PRACTICE HANDLES

Medical device fraud takes several forms. The following are the most common types handled by this practice.

Defective Device Concealment: Selling or continuing to sell a medical device that the manufacturer knows to be defective, unreliable, or likely to fail, while concealing that information from physicians, patients, and the government programs paying for the device. When a device is not reasonable and necessary because it is known to be defective, claims submitted to Medicare or Medicaid for that device may be false claims under the False Claims Act. Quality, regulatory affairs, and clinical employees who are aware of internal knowledge of device failures that were not disclosed may have direct knowledge of this type of fraud.

False Reimbursement Claims: Billing Medicare or Medicaid for medical devices using incorrect procedure codes that result in higher reimbursement than the device actually qualifies for, billing for devices that were not delivered to the patient, or submitting claims for devices that were reused in violation of FDA single-use requirements. Billing staff, sales representatives, and compliance employees may be in a position to observe discrepancies between what was delivered and what was billed.

Unnecessary Prescriptions: Writing or facilitating prescriptions for medical devices that are not medically necessary in order to generate Medicare or Medicaid claims. This includes prescribing devices to patients who do not meet the clinical criteria for coverage, or prescribing devices in connection with kickback arrangements that influence the prescribing decision rather than the patient’s clinical need.

Legal basis: 31 U.S.C. § 3729(a)(1)(A) and § 3729(a)(1)(B) (False Claims Act) | 42 U.S.C. § 1395 et seq. (Medicare) | Source: uscode.house.gov

WHO CAN REPORT MEDICAL DEVICE FRAUD?

The strongest medical device fraud qui tam cases come from current or former employees who have direct, first-hand knowledge of the fraudulent conduct from inside the organization. This includes quality assurance and regulatory affairs employees who are aware of device defects that were not disclosed to the FDA, physicians, or government programs, sales and distribution staff who know that devices billed to Medicare were not delivered or were not the devices actually used, billing and coding personnel who process claims they know to be inaccurate, clinical staff who observe devices being prescribed or implanted in patients who do not meet the medical necessity criteria, and compliance officers who have identified billing or disclosure practices that do not comply with federal law.

You do not need all the documentation before contacting us. If you have credible, first-hand knowledge of what you believe constitutes false claims to Medicare or Medicaid in connection with medical devices, that is enough to start a confidential conversation. We investigate thoroughly before asking for any commitment.

In fact, many former employees come forward with knowledge of fraudulent practices by their former employers after they have been demoted or terminated for complaining to their supervisors about the fraudulent practices or leaving their employment because they refuse to participate in the fraud.

Legal basis: 31 U.S.C. § 3730(b) (qui tam provisions) | Source: uscode.house.gov

YOUR PROTECTIONS AS A WHISTLEBLOWER

When you file a qui tam complaint, it is submitted under seal and served on the Department of Justice and any state agencies that have been impacted by the alleged fraud. During the time the case is under seal, your employer is not notified and does not receive a copy of the complaint. Your identity remains protected throughout the government’s investigation.

The False Claims Act prohibits your employer from firing, demoting, suspending, harassing, or otherwise retaliating against you for reporting fraud or participating in a qui tam case. These anti-retaliation protections apply to both current and former employees.

If your employer retaliates against you, you have legal remedies that include reinstatement, two times the amount of back pay owed, interest on that back pay, and compensation for special damages including litigation costs and attorney fees.

Legal basis: 31 U.S.C. § 3730(h) (anti-retaliation) | 31 U.S.C. § 3730(b) (under seal filing) | Source: uscode.house.gov

WHISTLEBLOWER REWARDS

When a qui tam lawsuit results in a financial recovery, the False Claims Act entitles the relator to receive a percentage of the total amount recovered by the government. If the government intervenes and takes over the case, the relator may receive between 15% and 25% of the recovery. If the government declines to intervene and the relator proceeds independently, the share can rise to between 25% and 30%. There is no cap on the dollar amount of the reward. We work on a contingency fee basis. There is no upfront cost, and if there is no recovery, you owe us nothing.

Legal basis: 31 U.S.C. § 3730(d)(1) and § 3730(d)(2) | Source: uscode.house.gov

About This Practice

Arvind Bob Khurana has over 27 years of experience in qui tam and False Claims Act litigation, complex commercial litigation, and class action matters. He began his career at a top international defense firm and joined a national class action firm in 2005, becoming partner in 2009, where he worked on ERISA actions, qui tam cases, securities fraud, and antitrust matters. He is admitted to the New York State Bar and represents whistleblowers in federal courts nationwide.

We are selective. Before we ask for any commitment, we investigate the claim, explain the facts and the risks, and give you a complete picture of what you are facing. We never ask you to sign a retainer agreement until you have the full picture and have decided, on your own terms, that you want to move forward. You remain in control throughout.

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Arvind Bob Khurana has over 27 years of experience in complex litigation. We work on contingency. There is no upfront cost and no obligation to proceed.