The Pursuit of Civil Money Penalties – An Important Weapon in FDA’s Enforcement Arsenal

The Food and Drug Administration (FDA) has a variety of weapons in its enforcement arsenal, including seizures, injunctions, criminal prosecutions, and civil money penalties. On July 6, 2007, FDA reminded regulated industry that it still uses the latter, civil money penalties, when Administrative Law Judge (ALJ) Daniel Davidson found TMJ Implants Inc. and two employees, President Robert Christensen, and Regulatory Affairs and Quality Assurance Manager Maureen Mooney (collectively, TMJI), liable for civil money penalties for failing to submit Medical Device Reports (MDRs). The decision is the latest milestone in a five-year old dispute that centers on TMJI’s interpretation of FDA’s device adverse event reporting requirements as they relate to TMJI’s temporomandibular joint (TMJ) implants and accessories.