Federal prosecutors are seeking jail time for four former executives of Pennsylvania-based medical device manufacturer, Synthes. The four have pleaded guilty to a misdemeanor involving the off-label use of a bone cement product made by the company. The cement was used in surgeries involving the hip and spine, for which it was not approved, and three patients died during surgery. According to the Philadelphia Inquirer, Synthes and Norian Inc., a wholly owned subsidiary, pleaded guilty to charges related to introducing adulterated and misbranded bone cements into interstate commerce and paid fines totaling $23.6 million. Synthes sold Norian to obtain funds to comply with the plea. In late April, Johnson & Johnson agreed to buy Synthes for $21.3 billion.
At issue is intent. According to the Philadelphia Inquirer, prosecutors believe the off-label use was promoted by the company and was, in essence, unapproved clinical research. Lawyers for the defense are seeking leniency, agreeing in principal that executives are culpable for wrong-doing committed by the company, but questioning how much the executives knew about it or what they could have done to prevent it.
If the four executives receive jail time, they would be the first receive such a sentence under the Park Doctrine, named for a Supreme Court ruling in 1975. In January of this year, FDA updated its guidelines on prosecutions under the Park Doctrine. According to the guidelines (section 6.5.3),
“The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (“the Act”) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.”
“When considering whether to recommend a misdemeanor prosecution against a corporate official, consider the individual’s position in the company and relationship to the violation, and whether the official had the authority to correct or prevent the violation. Knowledge of and actual participation in the violation are not a prerequisite to a misdemeanor prosecution but are factors that may be relevant when deciding whether to recommend charging a misdemeanor violation.”
The ability, and willingness, of FDA go beyond fines in punishing corporate officers for violation of federal law send a clear signal that The Buck Stops Here.