Medical device regulation is under the jurisdiction of the FDA’s Office of Criminal Investigations. In this space, federal law mandates that hospitals and manufacturers “self-report” deadly hazards to the FDA’s public health experts.
But in the case of a dangerous medical device, known as a power morcellator, a vast number of women were harmed without a single physician, hospital or manufacturer bothering to “self-report” the problem to FDA. In fact, it is quite clear from publicly available information that several major hospitals had clear knowledge of the deadly complication associated with morcellation but failed to comply with the law.
Read Full Article »