Three of the four former Synthes executives who pled guilty to charges under the Park Doctrine were sentenced to jail time and large fines recently. The four men were charged for training and supplying doctors with bone cement to repair fractured vertebrae in spinal surgery, an indication that was off-label according to FDA.
Former Synthes company president Michael Huggins and former senior vice president Thomas B. Higgins were sentenced to nine months in prison. John J. Walsh, the former director of regulatory and clinical affairs, received a five-month sentence, while Richard Bohner, former vice president, will be sentenced at a later date. In addition to the jail time assigned, all four executives agreed to pay fines of $100,000 each. The charges were misdemeanor violations, but the nine-month sentences for Huggins and Higgins are the longest jail terms yet handed down using the Park Doctrine. Higgins has already filed an appeal based constitutionality of the length of the sentence.
This is the first time that the DOJ and FDA has worked with local DA offices (Philadelphia in this case) to use the Park Doctrine to send responsible corporate officers to jail. The investigation certainly uncovered greater transgressions than off-label marketing as there were patient deaths involved and ensuing cover ups during the FDA investigation that led to these convictions.
There could be more cases like this out there that will come to light, but certainly fines are not enough when so much is at stake. Prosecution now means personal fines and personal jail time in light of these off-label marketing practices.
Executives need to be asking, how are your promotional practices being monitored?
- Top Three Off-Label Marketing Strategies and Tactics (goodpromotionalpractices.com)
- 3 Tips to Keep Your Reps On-Message vs. Off-Label (goodpromotionalpractices.com)