Medical Device – Adverse Events
Substantial Noncompliance with Reporting Requirements by a Medical Device Manufacturer may lead to a FCA Lawsuit
Improper complaint handling may get a device manufacture in hot water. FDA inspectors often focus first on compliance with medical device reporting obligations by looking at a manufacturer’s systems first. The lack of a sound quality assurance system leaves cracks in the armor of assuring that products are safe and effective. This, in turn, may lead to increased scrutiny. When a manufacturer knows or should have known about certain facts that adversely and materially effect it’s product, and fails to report it, False Claims Act liability may follow. These include:
- Failure to disclose adverse events to the FDA.
- Failure to report changes to the design, manufacture, or labeling have been made are associated with medical device reporting requirements.
- Hiding the results and conclusions of internal clinical investigations that adversely impact the known safety and effectiveness profile of the device.
Devices subject to pre-market approval under are also subject to periodic reports imposed by the pre-market approval application (PMA) approval. FDA typically specifies that an applicant submit a report 1 year from the date of approval of the original PMA and annually thereafter. False Claims Act liability may result from failure to disclose these items in a manufacturer’s annual report.