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Is Federal Preemption of Medical Device Claims Backfiring?

Posted by Andrew J. Barovick | May 14, 2009 | 0 Comments

Today, we revisit the story of a West Virginia orthopedist who has injured and killed numerous residents of his state with his unmatched incompetence. reports that Biomet, Inc. , parent company of EBI, the manufacturer of bone stimulators used by Dr. John King during many failed surgeries, has settled 24 out of 27 claims by plaintiffs.  Based on a regulatory filing by Biomet, it expects to pay out $39 million dollars on the claims.  EBI has denied that it improperly marketed its devices through an illegal kickback scheme centering on Dr. King, which scheme was also alleged to have defraued federal healthcare programs.

Of course, this is not the first time Dr. King has been covered by this blog.  I wrote about the kickbacks he seemingly enjoyed from the makers of devices he implanted here.    And before that, I wrote , in awe, about how a man facing 124 medical malpractice suits still had the time and the chutzpah to sue the good lawyers who had defended him in court.

Meanwhile, in yesterday's NY Times , we learned that an Army surgeon at Walter Reed Medical Center who was a paid “consultant” for Medtronic, concocted a fraudulent study, using nonexistent subjects, to support his glowing praise for Medtronic's bone-growth product.  He even forged the signatures of four other Walter Reed doctors when submitting his study for publication in a British medical journal, which has since retracted the related article at the Army's request.  And this is where it almost gets personal.  Dr. Timothy Kuklo , the doctor who masterminded this fraud, is also a lawyer, having graduated from Georgetown University's Law School.  Ethics? Professional Responsibility? Differences between right and wrong?  Are these no longer part of the law school curriculum?  Do they really have to be?

But the bigger problem here is, because these physician-criminals have so bastardized the process of using medical devices and products, they have effectively muddied the waters surrounding their quality.  We cannot know how effective these devices are, since they were used in a manner dictated not by what was best for the patient, but what was best for the pocketbook.

And, the unfortunate victims of these scams will never be able to seek redress in the courts when these products fail, due to the federal preemption doctrine.  Ironically, the federal preemption case that enabled big business to avoid its responsibilities to the medical consumer involved this very company, Medtronic (Riegel v. Medtronic).

Let's hope that the current efforts in Washington to undo that ill-advised decision will bear fruit, and quickly.

About the Author

Andrew J. Barovick

Mr. Barovick is a graduate of Columbia College and Cardozo School of Law. He began his legal career at the Queens District Attorney’s Office, where he tried over 20 felonies to verdict, and argued an equal number of appeals before the Appellate Division, Second Department, the New York Court of Appeals and the United States Court of Appeals for the Second Circuit.


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