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Update on Backfiring of Federal Preemption Due to Manufacturer Fraud

Posted by Andrew J. Barovick | May 19, 2009 | 0 Comments

In my last post , I addressed the dangers and senselessnes of FDA preemption in the wake of Riegel v. Medtronic , given the reality that some doctors continue to test and use medical devices in ways that can only be described as corrupt.  Combine that with the FDA's well-documented history of poorly run trials that are hurriedly performed so that the product can be rushed to market, and you have untold disasters waiting to happen.

In today's New York Times , reporters Barry Meier and Duff Wilson provide an update on one of the two fraudulent physicians discussed in my last post, Dr. Timothy R. Kuklo.  Dr. Kuklo, who happens to also be a lawyer, is the orthopedic surgeon who created a fraudulent study touting the benefits of one of Medtronic's bone-growth products based on his treatment of severely injured U.S. soldiers at the Army's Walter Reed Hospital.  Dr. Kuklo was a paid “consultant” for Medtronic at the time.  Once it was discovered that the had forged the signatures of four physicians on the study, and that the study included non-existent soldier-patients, the gig was up for Dr. Kuklo.

Today's article reveals that Iowa's Senator Charles E. Grassley, who is the ranking Republican on the Senate Finance Committee, has opened an inquiry into Dr. Kuklo's conduct.  This will not be good public relations for Medtronic, according to Meier and Wilson, who report that “since late last year, Senator Grassley and, separately, the Justice Department have been investigating whether the company [Medtronic] illegally promoted uses of Infuse [the bone-growth product] that were not approved by the Food and Drug Administration–by paying doctors, among other alleged measures.”

So, let's review.  Medtronic is the type of company that now enjoys the huge benefits of federal preemption.  Medtronic pays physicians to come up with the results Medtronic wants, so that Medtronic can sell more of its products.  The studies are not only biased, but out and out fraudulent.  The patients on the receiving end of this profit-not- patient- driven medicine are returning soldiers with life-changing orthopedic injuries, who may or may not benefit from Medtronic's product because a fraud like Dr. Kuklo cannot be relied upon to have used it properly while his eyes were on his consultancy fees only.  And certainly, the results of the fraudulent study funded by Medtronic will not benefit the medical/surgical community.

And, this case is one of the known cases.  Chances are, this kind of fraud has happened, is happening, and will continue to happen.  But wounded veterans who find themselves injured by such tainted products will not be able to sue, due to the Feres Doctrine .  And civilian recipients of such products that got through the FDA's approval process who are injured or killed by them are equally without recourse.

Come on, folks in Washington, DC.  It's past time to right the wrong of federal preemption, and the sooner, the better.  What's going on now is just un-American, and an outright disgrace.

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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