If anything 2011 could be the beginning of a new legal era in spine. Michael Huggins, Tom Higgins, Richard Boehner, and John Walsh could become the first white collar defendants sent to jail under the 1975 Park Doctrine which would hold them responsible as corporate officers whether they intended to break the law or not. On Tuesday, November 30th, 2010 Synthes put closure by pleading guilty to dozens of crimes related to their unauthorized tests on some 200 spinal surgery patients, three of whom died on the operating room table.
In 1975 the SOTUS upheld the conviction of John Park, the President of Acme Markets Incorporated, on the theory that people that manage businesses that make and sell products that are regulated by the FDA have an affirmative duty to ensure the safety of the product. The Court concluded that the government can criminally prosecute a corporate officer who is in a responsible relationship to some illegal activity by the company even though that officer did not personally engage in, or even know about that activity.
In the past 15 years there have been very few pure Park cases in which the government solely charged a misdemeanor against a company official on the ground that due to the official's position of responsibiltiy, within the company, the official should have prevented or corrected the deficiency. But the question must be asked, is this an opportunity for the Department of Justice to prove to the industry, once and for all, that the Park Doctrine is not a paper tiger? Recent changes to the Sentencing Guidelines could spell some jail time for Mssrs. Huggins, Higgins, Boehner and Walsh. Considering that Synthes/Norian had documented violations harsh penalties could await those that have already plead guilty to misdemeanor charges.
But the bigger question that must be asked is why didn't the government go after Mr. Famous (#7)? After consulting with attorneys regarding this case, the consensus seems to be that all four individuals will in all likelihood do some time. Judges and prosecutors frown upon cases where innocent people die.
Maybe Wyss will get some Judge out of retirement to cut these boys a break, but then, maybe not. You know what TSB says, it's a new dawn, a new day.