DePuy Hip Lawsuit Calls Designer to the Carpet
...or at least before the bench, where he and other high-ups at DePuy Orthopaedics will have to answer some hard questions during a DePuy hip lawsuit.
You may not have heard of Dr. Thomas Schmalzreid, but if you had one of DePuy's ASR hip plants, you had the dubious honor of using a product he designed – and for which he was handsomely compensated. In 2007, DePuy paid Dr. Schmalzreid somewhere in the neighborhood of $1.3 million dollars. At that time, DePuy and other medical device manufacturers were facing criminal charges (fancy that!) for violating federal “anti-kickback” laws and using “consulting agreements” with surgeons in order to create incentives for them to use their devices – particularly in patients covered under Medicare, Medicaid and other taxpayer-funded health care programs.
The USDOJ started investigating in 2005, finding hundreds of such “consulting agreements” had been signed over the previous three years, for which the physicians performed no real services for the companies. All they had to do was agree to “exclusively use the company's products.”
Of course, hospitals and patients knew nothing about these agreements. On the other hand, Medicare payments for implant surgeries did go up substantially.
DePuy and the others were able to wriggle out of their legal trouble by agreeing to “new corporate compliance procedure” and “federal monitoring.”
Well...that wasn't the end of it. Over the next several years, Dr. Schmalzreid continued to receive huge sums of money for “consulting services” - over $3 million in 2009 and 2010 alone (this was “royalty income for intellectual property and/or product development” according to Bloomberg). An investigations editor for the British Medical Journal also recently reported that Schmalzreid published an article entitled “Setting the Record Straight on Metal Hypersensitivity,” which was used by DePuy to allay concerns over its product's safety. According to Deborah Cohen of the BMJ, the article was distributed to members of DePuy's sales team. However, actual publication itself does not appear to have been published in any professional journals – and is not listed in Schmalzried's curriculum vitae among the over 120 publications has has either authored or to which he contributed (a great many of which are on the topic of metal-on-metal implants).
Nor does Schmalzried's C.V. mention the designing and consulting work he has done for DePuy.
One would think that being a consultant and designer for a major medical device manufacturer would be quite a feather in one's cap...
Well...the good doctor, along with several of DePuy's corporate officers, will have a chance to explain it all to the Honorable Judge David Katz in a U.S. District Court in Ohio this spring. Among other pieces of information, the court will be asking for documents pertaining to “consulting agreements,” identity and contact information for sales representatives who were “present at the surgical facility” when the surgery or consultation was performed, and financial records on how much DePuy paid Schmalzried and other healthcare providers – including perks such as “gifts” and “travel.”
It should make for some interesting days in court...
Cohen, Deborah. “How Safe Are Metal-on-Metal Hip Implants?” British Medical Journal, 28 February 2012.
U.S. District Court For The Northern District of Ohio. In re: DePUY ORTHOPAEDICS, INC.,
ASR™ HIP IMPLANT PRODUCTS LIABILITY LITIGATION,MDL Docket No. 1:10-md-2197. Available : http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197/amended-cmo-no.-10.pdf
Pringle, Evelyn. “Feds Crack Down on Medical Device Implant For Profit Industry – Part 1.” Laweys and Settlements (http://www.lawyersandsettlements.com/articles/drugs-medical/device-maker-kickbacks-01570.html), 12 November 2007. Retrieved 13 March 2012.
Learn more about DePuy Hip Replacement