Medical Device Manufacturer Fraud under the False Claims Act

Do you have information that a medical device manufacturer is breaking the law? Medicare and Medicaid may be losing millions as a result of the company’s fraud.  You can help stop it by reporting the violation of the law through a whistleblower lawsuit under the False Claims Act.  You may also be entitled to receive a reward if the U.S. Government recovers money because of your information.

Medical device fraud poses a serious risk to the U.S. Government’s regulation of health care.  The FDA rules are put in place to protect patients from potentially dangerous devices.  When companies don’t do the right thing and report problems to the government, the responsibility often falls on the shoulders of whistleblowers.  The government simply doesn’t have enough resources to police every aspect of the health care industry without someone pointing them in the right direction.

Potential Violations by Medical Device Manufacturers

Off-Label Marketing

Medical devices are only approved or cleared by the FDA for certain uses.  Although doctors can prescribe them for additional uses, the manufacturer must limit its marketing to the approved uses.  If the company violates the regulations for marketing its device by encouraging its use for off-label purposes, the device will be considered adulterated or misbranded.  This may also be a violation of the False Claims Act.

Defective Medical Devices

A medical device manufacturer that knowingly provides defective devices to Medicare and Medicaid patients may have caused the submission of false claims for payment by physicians and hospitals.  If the company does not fully disclose the problem to the FDA, or continues selling defective devices after it has discovered the problem, then it may have violated the law.

Kickbacks & Referrals

The Anti-Kickback Statute and the Stark Law prohibit improper payments for referrals of Medicare and Medicaid patients. Violations may happen when the manufacturer pays improper fees to physicians and their staff, improper rebates to induce future business, or the prescribing physician is an owner of the device company.

Unnecessary Billing

On occasion, medical device companies have violated the law by encouraging doctors to use an inappropriate treatment protocol or billing code for the procedures involving its device. For example:

The device manufacturer advised the hospital that a procedure could be billed under a more complicated diagnosis related group than was warranted by Medicare guidelines.

On the advice of the device manufacturer, the hospital charged Medicare for an inpatient stay when the device could have been implanted using an outpatient procedure.

This is health care fraud.

Medical Device News

The False Claims Act

The False Claims Act imposes substantial penalties on doctors, hospitals and other health care companies engaged in fraud while rewarding whistleblowers for providing evidence of the misconduct to the Justice Department through a qui tam lawsuit.

Our Federal False Claims Act lawyers have guided whistleblower cases to several significant settlements on behalf of relators. Our largest unsealed cases are currently focused on kickbacks in violation of the Anti-Kickback Statute, but we have a broad base of experience across other types of Medicaid and Medicare fraud. In the pursuit of suspected frauds, we have brought cases to the attention of the government in many states, including New York, Florida, California and here in Philadelphia. In 2016, for example, we helped the federal and state governments recover $54 million from a Valeant subsidiary for kickbacks paid through speaker programs.

The law rewards whistleblowers for information with between 15 and 30 percent of the proceeds from the litigation, subject to numerous terms and conditions specified in the law. During President Obama's Administration, the U.S. paid out more than $4 billion to whistleblowers. For those not familiar with whistleblower cases, we have written a quick guide to the process.

Our False Claims Act attorneys undertake a thorough review of whistleblower evidence up front during the case evaluation process. We confirm that there is sufficient evidence of both inappropriate government billings as well as evidence of intentional or reckless conduct by the individuals in charge. We understand that no one person needs to have every piece of the puzzle and we have evaluated thousands of potential cases while honing our judgment. We also answer any questions that a whistleblower has in order to ensure that you can make an informed judgment about whether to proceed with a qui tam lawsuit.

To begin the process and get your questions answered, use our contact form or call 1-800-590-4116 for a free, confidential and no-obligation initial legal consultation from our whistleblower attorneys.