A former accountant for SpineFrontier sued the company this month for wrongful termination, alleging that the spinal implant maker fired her for raising concerns about manufacturing processes later flagged by the FDA in a warning letter.
Patricia Katz was hired by Beverly, Mass.-based SpineFrontier as a senior accountant in February 2011, according to court documents. But soon after her employment began, "Katz voiced concern about SpineFrontier’s lot tracking and tracing procedures, which involved little to no tracking," she alleged in a lawsuit filed in the U.S. District Court for Massachusetts.
After her immediate supervisor dismissed her concerns, and with a pair of compliance classes under her belt, Katz allegedly "learned that SpineFrontier’s lot tracking and tracing procedures violated federal safety regulations for medical devices" and subsequently opened a Corrective & Preventive Action report documenting the deficiencies.
"But when Katz opened a CAPA for SpineFrontier’s lot recording deficiencies, the company’s chief innovation officer promptly closed it," the lawsuit alleged.
After confirming her suspicions with the FDA, without naming SpineFrontier, Katz forwarded her correspondence with an FDA agent to company officials, she alleged. After a meeting scheduled while she was out of the office to attend to her ill father, she alleged, she was fired on her 1st day back at work.
"Soon after her termination, Katz contacted the FDA by phone to report the violations, later following up with a letter. When the FDA investigated, it found rampant problems with tracking, tracing, design and inspection safeguards, and handling of adverse event investigation and reporting, leading to a formal, public warning letter that designated the company’s devices as adulterated and misbranded for 9 types of violations," according to the lawsuit.
"SpineFrontier knew that its devices were misbranded and adulterated, but marketed and sold them anyway despite the prohibitions of federal law," Katz alleged. "When it became clear to SpineFrontier that Katz would not let the matter drop and that she was willing to speak with the FDA about it, she was immediately terminated."
SpineFrontier denied the accusations, according to the documents, and argued that the case should be dismissed for failure to state a claim, lapsed statute of limitations, laches and the doctrine of unclean hands.
"The claim is barred by the plaintiffs’ own negligence, fraud, or unfair and deceptive conduct," SpineFrontier alleged.
