Reporting FDA fraud by failing to report adverse events
This article addresses how to get a whistleblower reward for reporting a medical device company that concealed or failed to report an adverse event for a medical device.
Why report fraudulent concealment of adverse events relating to medical devices (FDA fraud)
It is estimated that 10% of Medicare bills are inflated or fraudulent. Cheating on medical devices is one culprit. When you report a medical device company for concealing adverse events you not only help the Medicare program, but you also help ensure that the medical devices are safe and effective.
Concealing adverse events is a form of Medicare fraud against the government. In fact, a medical device manufacturer must keep track of and report all adverse events relating to their medical devices to the FDA within 30 days of becoming aware of an adverse event.
An adverse event is defined as any incident in which the medical device may have caused or contributed to serious injury. An adverse event also includes any malfunctions that might cause or contribute to any serious injury if the malfunction were to occur again in the future. In addition, a medical device manufacturer is required to conduct an investigation of each adverse event and report its findings to the FDA, including the likely cause of the adverse event.
Rewards for reporting a medical device manufacturer that conceals or fails to report adverse events
The government is offering significant monetary whistleblower rewards to report a medical device manufacturer that commits fraud associated with medical devices due to concealing or failing to report adverse events. To be eligible for a reward, the failure to report adverse events must be so significant that it taints the eligibility of billing Medicare for the device. In other words, the government is not paying rewards for mere technical violations, such as a few days late or an oversight in submitting an adverse event. Rather, to rise to the level of fraud, the undisclosed adverse event must casts doubt on the safety or effectiveness of the medical device. Because it involves a legal standard, you should contact an attorney experienced with the government whistleblower reward program and FDA/Medicare fraud to help you decide whether your allegations might be eligible for a reward. The rest of this article provides some guidance on how to receive a reward for reporting a medical device company that failed to report adverse events, but again you should contact an attorney for specific advice.
Tips for reporting adverse event fraud
Below are just two important tips for how to report a medical device company that concealed or failed to report adverse events.
First, it is not sufficient to call a hotline or inform the FDA of the failure to report a required adverse event to get a reward. In fact, the government whistleblower reward program prohibits paying rewards based on tips. Rather, you must hire an attorney (often on a contingency basis) to file a qui tam suit under the False Claims Act to be eligible for a reward.
Second, your attorney must show why the failure to report an adverse event amounts to a false claim for payment under the False Claims Act. Therefore, you will need specific and detailed information regarding the allegation that the adverse event was a reportable incident and how and why it may affect safety or effectiveness of the medical device. That is why it is key that you select an attorney with experience with the government reward program and handling FDA and Medicare fraud cases.
How much reward for reporting fraudulent concealment of an adverse event
The size of any whistleblower reward is determined by the amount the government, such as Medicare, recovers based on your allegations that a medical device company failed to report an adverse event. Specifically, the reward is between 15% and 25% of what Medicare gets back from the medical device manufacturer. If there was only one adverse event that was concealed and it was not likely to cause the government much concern, it is not likely to result in a large repayment. On the other hand, if the medical device manufacturer concealed adverse events because it was concerned that the FDA might revoke approval, then the size of the case can be large. The government has required medical device manufacturers to repay the entire cost of medical devices sold during the period of time that it concealed information that led to a recall or withdrawal of FDA approval.
How to report fraudulent concealment of an adverse event
This rest of this website (plus the whistleblower books authored by Mr. Hesch) take you step-by-step through the process of reporting fraud against government for concealing adverse events by medical device manufacturers, and how to report adverse event fraud against the FDA or Medicare to get a whistleblower reward.
Mr. Hesch is experienced investigating fraud against both the FDA and Medicare and cases involving failure to report adverse events by medical device manufacturers. He worked over 15 years in the Civil Fraud Section of the U.S. Department of Justice in Washington, D.C. handling FDA/Medicare fraud cases. He is available to review your case and help determine whether you should and how to report fraud against the FDA and Medicare by failing to report adverse events.
The link below “Do I have a case” shows you how to ask Mr. Hesch to review your FDA/Medicare fraud case and how to get a reward for reporting a medical device manufacturer for concealing or failing to report adverse events.