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Advertising Medical Devices In the US
The biggest single source of information tips probably originates with your competitors. By their nature the FDA will seek out the truth and may investigate the claim. Other “informants” include employees who are concerned that the new indications may cause harm, as well as disgruntled ones who only want to get back at management (or stand to profit by participating as “whistleblowers”).
The incredible monetary rewards that result from whistleblower cases has prompted a pseudo-vigilant watchdog over the device and pharmaceutical industry.
THE CONSEQUENCES OF PROMOTING OFF LABEL USES
The risks that your organization faces for the mislabeling/promotion of devices are substantial. Criminal charges can and have been brought before executive managers, including: CEOs, Regulatory Affairs Managers (VPs), Legal and Sales personnel.
The monetary fines that can be given are again incredible with manufacturers being ask to pay in the hundreds of millions. The fines are given on a per false claim basis and have been as high as $11000 per instance. Whistleblowers who testify against the organization are ‘rewarded’ up to 30% of the eventual recovery – which can earn them tens of millions to the hundreds of millions of dollars!
Ultimately, prosecution against an organization can have dire consequences as a result of a negative reputation. Stock prices have been know to nose dive as a