Medical Device – Adverse Events

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Substantial Noncompliance with Reporting Requirements by a Medical Device Manufacturer may lead to a FCA Lawsuit

FDA inspectors often focus on compliance with medical device reporting obligations by first looking at a manufacturer’s systems. The lack of a sound quality assurance system leaves cracks in the armor of assurance that products are safe and effective. Moreover, when a manufacturer knows or should have known about certain facts that adversely and materially affect its 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 that 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.

Pursuant to federal regulations, manufacturers must report adverse events associated with a medical device to the FDA within 30 days after the manufacturer becomes aware that a device may have caused or contributed to serious injury, or that a device has malfunctioned and would be likely to cause or contribute to serious injury if the malfunction was to recur. In addition, manufacturers are responsible for conducting an investigation of each adverse event, and must evaluate the cause of the adverse event. The failure to do so may constitute Medical Equipment Fraud, serving the basis for whistleblower initiation of a qui tam lawsuit.