Thursday, December 30, 2010

Claims by presenters re Depuy behavior at the HarrisMartin Litigation conference materials I found of interest:

  • Depuy OrthoPedics was charged with conspiring to violate antitrust kickback statute in 2007.
In September of 2007, Depuy Orthopedics was charged with conspiring to violate antikickback statute by using financial incentives to encourage surgeons to use their specific devices.  DePuy avoided prosecution by agreeing to new corporate compliance procedures and federal monitoring..[This is indicative of inappropriate behavior evidenced by Depuy but is not directly related to the ASR system per say.]

  • The ASR system (the recalled item) was approved by the FDA for THR (total hip replacement) although it appeared that this system was NOT designed for THR (total hip replacement.)
ASR was purportedly meant for hip resurfacing not total hip replacement. Instead of being completely replaced with a new head and cup, the femoral head is reshaped and a cap is placed over it.  There is NO stem involved.  The femoral neck is resurfaced only and glides against a cup implanted in the socket.

In order to use the ASR system for resurfacing surgery, DePuy would have had to conduct clinical trials to prove the safety and efficacy of this device.  The FDA never approved this device for resurfacing in the US but as discussed in other posts on this blog, the FDA approved the use for a THR based on the 501k process whereby Depuy claimed it was "substantially equivalent" to other devices that were previously on the market.

The ASR XL Acetabular Head System was advertized as a high performance hip replacement and also as an alternative to THR AND Resurfacing.  The XL System was marketed next to hip resurfacing while highlighting the advantages of ASR THR over Resurfacing.  The latter again, was not approved in the US for sale by the FDA.

In the packet describing the ASR System, the following claims are made:
   -preserving bone
   -reducing wear
   -affixes itself to the thigh bone (all of which-as it turns out, are reasons why the implant is    being removed in patients.)
    -product has a strong clinical history

·         On August 19th, 2010, the FDA warned Depuy that it was illegally marketing two products for uses that were NOT approved by FDA, neither related to the recalled hip replacement system. [This is indicative again of inappropriate behavior by Depuy but is not directly related to the Depuy ASR system per say.]

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