Would You Fire an Employee for Contacting FDA?

A former employee at SpineFrontier claims she was fired for contacting FDA after learning the company was not engaging in proper lot tracking and safety procedures.

Nancy Crotti

An accountant is suing a Massachusetts spinal-device manufacturer, claiming it fired her after she reported the company to FDA for allegedly failing to track its devices implanted in patients.

Beverly Katz wants her job back and back pay from her former employer, SpineFrontier (Beverly, MA), according to the lawsuit filed in U.S. District Court in Massachusetts.

In a separate court filing, SpineFrontier denied the suit's allegations.

In her suit, Katz maintains she noticed the company was not complying with federal regulations requiring lot tracking and safety procedures, and that she notified her immediate supervisor. After taking compliance classes offered by her employer, Katz opened a Corrective and Preventative Action (CAPA) regarding SpineFrontier's alleged lot-recording deficiencies, the suit says.

After the company's chief innovation officer allegedly closed the CAPA, Katz asked FDA, without naming her employer, about requirements concerning medical device lot tracking and tracing, the lawsuit says. Upon learning that SpineFrontier had allegedly failed to comply with federal regulations, Katz forwarded her emails to and from FDA to company officials.

Those officials held a meeting to discuss her actions while Katz was away, caring for her ailing father in Florida, the suit maintains. When she returned, Katz's lawsuit says, she was fired, despite previous positive work performance evaluations and bonuses.

Following a 2012 inspection, FDA issued a warning letter to SpineFrontier for allegedly violating regulations governing lot tracing and tracking, and for failing to notify or delaying notification to FDA regarding adverse events, including a patient's death. FDA also found that the company's devices were misbranded, and were adulterated for failing to comply with federal current good manufacturing practice. Later that year, the agency wrote SpineFrontier a letter that said the company had largely complied with the warning letter's requirements.

Nancy Crotti is a contributor to Qmed and MPMN.

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