Healthcare Compliance Attorneys

Nolan Auerbach & White are experienced Medical Equipment Fraud Lawyers helping courageous whistleblowers.

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.

Kathleen Hawkins

Dignity Health
$37 million

Kathleen Hawkins, RN MSN, had been employed by Defendant, Catholic Healthcare West (CHW) for approximately 6 years when she decided she had had enough of trying to change the hospital system from within.

CHW, a California not-for-profit corporation that operated hospitals in California, Arizona, and Nevada, was at the time the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California.


Joe Strom

Johnson & Johnson
$184 Million

Joe Strom contacted us in 2005. We were very grateful that he did. We immediately formed an all-star legal team and a process to stop a very harmful pharmaceutical marketing strategy. It was this process we set into motion that ultimately returned hundreds of millions of dollars to the U.S. Treasury, and a portion of that, very well-deserved, into Joe’s bank account.

Joe told us a very troubling story about the off-label promotion of a pharmaceutical drug for patients who already suffered from chronic heart failure.


Bruce A. Moilan Sr.

$27 Million

Bruce Moilan was a seasoned hospital systems expert by the time he contacted our Firm. At the time he decided to file his qui tam lawsuit, he was employed by South Texas Health System as a System Director for Materials Management. In this position, he oversaw $24 million in annual purchases of supplies and equipment and helped determine budget, reduction and cost analysis throughout the contract bidding and negotiations process. His job was to insure proper implementation for purchasing, receiving and management of inventory, for McAllen Hospitals, L.P.


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