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.
Suggestion for the Judge in their sentencing. Rather than send them to jail, please make them walk the floor of AAOS, NASS, CNS, AANOS, with a T-Shirt with a tee-shirt and placard that says "I was complicit in killing three people because of my greed." Rather than fine Synthes $23 million they should have mandated that they sponsor a class on medical ethics at NASS, etc.......you would think you yanks would learn something by now.
ReplyDeleteWow, I like that idea. Also, how about going after POD's?? From what I hear, they are popping up like wild fire. No question, it is a conflict of interest.
ReplyDeleteLove the creative sentencing! But in addition to walking the halls of our meetings, send them down the halls of some insurance industry meetings, or plaintiff lawyer meetings for a real beatdown.
ReplyDelete(BTW 8:08, we've had plenty of POD discussions already, why bring this thread there?)
Back to the topic, you raise a very good point TSB. I'm ignorant of the law and the specifics of this case, but I can see the question raised of whether a corporate culture or structure existed that was complicit in this crime being committed. But I have to believe that's a very high threshold to say that a company executive at a well established company like Synthes so negligently exercised their job functions that they were complicit in a crime even though they knew nothing about it occurring. (Presuming that's the case.) I'm inclined to think the law you're citing would be more applicable in a situation where a rogue company or individual unknowingly encourages someone to commit a crime by intentionally creating an environment that's inconsistent with the rules and conventions of the industry. So while they didn't know about the crime itself, they were complicit by violating accepted standards in their own roles. I'd be surprised if that was the case here, but as I said, I'm ignorant of both the law and specifics in this case. BTW, how much of this event was Synthes, and how much of this was pre-synthes Norian?
Google Park Doctrine 1975 and you will be able to read a legal interpretation of the law. Thanks
ReplyDeleteI think it's clear this crime was committed by Synthes back in 2004, after Norian's acquisition. To answer TSB's question, I'd like to pose it to the SE PA District Attorney. Did Wyss, a foreign national, threaten to move Synthes, which must bring in tens of millions in tax revenue, out of PA if he were prosecuted? Why hasn't an investigative reporter followed up on the reasons why?
ReplyDeleteAnother interesting question... Is the regional DA worried about pursuing jail sentences for the corporate officers as it might have a backlash on the state's other corporate residents in pharma, biotech and med devices, especially considering the number of these firms in PA and the often-available tax incentives in other states for relocating?
ReplyDeleteMany years ago Wyss was in a unlawful termination suit with one of his big distributors. Supposedly, he leveraged his relationship with a member of the Board of the Philadelphia Museum to have them influence the outcome. It wouldn't surprise me if he is dipping into his magic bag of tricks like Felix the Cat to see what he can do to make Christmas at the HHBW homes tolerable. TSB can see the Soggy Mountain Boys, Ulysses, Pete, Delmar and the Blind Man attempting to escape on their manual rail car looking for redemption through baptism.
ReplyDeleteAs I went down to the Schuylkill River to pray, Study about that good 'ol way, And who shall wear the robe and crown, Good Lord show me the way." 'em boys will have plenty of time to listen to Allison Krause while their doing their community service.
I think a side door agreement must have been reached where Wyss accepted relinquishment of his CEO position, which is a big deal for someone of his stature in the industry, albeit his leadership continues as principal owner of the company.
ReplyDeleteThanks for the ref TSB. Interesting, and the context is definitely not as I described. (in 11:16)
ReplyDeleteAny idea when the 4 individuals are to be sentenced?
ReplyDeleteACME sucks.
ReplyDeletevery sad that 3 innocent people died because executives at $ynthe$ decided it would be o.k. to use norian for vertebroplasty. $23M is a slap on the wrist and no one is talking about how the product was sold by other divisions after the fact and was an utter failure, but the ultimate irony that should scream out loud is this is from the company built on the not for profit AO Foundation! No wonder Weber and Mueller exited the AO!
ReplyDeleteThere were not just three patients affected.
ReplyDeleteEven long after Norian-XR was pulled off the market, there were still all wise and arrogant surgeons that thought they knew better. There were some that continued to use regular Norian in spinal applications...even after express warning (verbal, written and email) to their facilities AND them NOT to do so.