Each year, the U.S. Food and Drug Administration pursues countless allegations of malfeasance on behalf of medical device manufacturers and marketers for violations of the nation’s regulations. For each allegation that is successful prosecuted, though, there are untold numbers that never reach the agency because they’re never reported.
Seeking to change the landscape and make it easier for people to report regulatory violations, the FDA launched a new portal on its website titled “Reporting Allegations of Regulatory Misconduct”. This portal gives anyone the ability to report any allegation of misconduct from a medical device manufacturer and/or the companies that market or distribute medical devices.
These potential violations range from hiding or obscuring vital information from the FDA to failing to properly register medical devices and promoting a product that has not been cleared by regulators. For example, in September 2015, the FDA won an agreement to recover $32.5 million from the Genzyme Corporation for its alleged unlawful distribution of Seprafilm, a surgical device.
Of course, many cases go unresolved because they’re never reported. The FDA has made significant strides in uncovering fraud, misconduct, and other violations as a result of whistleblowers taking action and reporting wrong-doing – much of the $650 million recovered in 2015 came as a result of qui tam cases – but there is still plenty of illicit activity that goes on without the agency being aware. Oftentimes, whistleblowers want to report bad conduct without bringing a whistleblower suit.
For this reason, the new website has been created. The hope is that the online portal will make it easier and less dangerous for whistleblowers to initiate complaints. Since people can submit reports anonymously, there is less of a chance of reprisal for those willing to come forward.
Potential Impact of the FDA’s New Website
The steps the FDA is taking to make it easier for whistleblowing are steps in the right direction toward protecting consumers and the public.
Medical devices that haven’t been approved or cleared for distribution can endanger the public and cause not just monetary damages, but physical ones as well. Every year, Americans are injured, disabled, and even killed by defective medical devices that shouldn’t have made it onto the market or shouldn’t have been marketed in the way they were. Yet, the drive to make more and more profit encourages medical device makers to ignore regulations and skirt the law – resulting in harm.
As an attorney who pursues defective medical device cases and also helps whistleblowers with qui tam cases, I think there is potential for the website to provide additional information to the FDA from insiders with knowledge concerned about protecting the public from the malfeasance of medical device companies. Even the strongest regulations are ineffective if wrongdoing goes undetected and unreported. But blowing the whistle can be difficult, intimidating, and impractical. Hopefully, the FDA’s initiative will make stepping forward easier and more productive.
How to Report an Allegation
If you have information about a potential regulatory violation that you want to bring to the FDA’s attention, you can do so on their online portal via this form. You can also speak with a whistleblower attorney who is experienced with pursuing dangerous or defective medical device cases.
When making a report, it helps to provide the following information, per the FDA:
- Name of the company
- Address and phone number of the company (if known)
- Name and model of the device
- Lot numbers, serial numbers, part numbers
- The device’s Unique Device Identifier (UDI)
- Recall numbers (if applicable)
- Detailed description of your allegation with any documentation that supports your claim
Don’t worry if you don’t have all this information. The goal is to give the FDA and your attorney as much information and documentation as you can. This will enable the agency to investigate further and uncover any evidence that may be necessary to pursue the case.
It always helps to talk things over with a qualified attorney who specializes in medical device and whistleblower cases. You’ll get a better idea of your options and what the process will look like once you take the next step. Many whistleblowers feel more comfortable taking action after they’ve partnered with an attorney, and that very well may be the case for you as well.
If you know of a potential violation of existing laws or regulations covering medical devices, or have a serious complaint about any medical device or product you have used, reach out to an attorney and contact the FDA. Your action could help protect others from harm.