In what was a major ruling,
Judge Katz of the U.S. District Court for the Northern District of Ohio, the
presiding Judge of the DePuy ASR MDL, ruled that evidence of the recall of the
DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial
over the device.
The first bellwether trial, Ann McCracken v. DePuy Orthopaedics, is
slated for trial beginning September 9th.
Katz ruled last month on a
number of pre-trial motions from both plaintiffs and defendants, granting
DePuy's bid to keep evidence about the recall out of the trial. McCracken had argued
that the recall should not count as a "subsequent remedial measure"
following the 2009 implantation of a DePuy ASR LX model.
Katz disagreed, and ruled for DePuy.
McCracken had a revision surgery performed in January 2011. Judge Katz noted in
his order that evidence relating to the voluntary recall by DePuy of the ASR
hip implant was inadmissible in this case because the Plaintiff’s original hip
replacement surgery took place prior to when the recall was issued. Judge Katz
determined the recall to be a “subsequent remedial measure,” which would have
prevented harm if it had occurred prior to the plaintiff’s initial surgery.
Judge Katz also denied a motion by McCracken
to exclude evidence of the FDA’s 510(k) clearance process of the device.
Although stated in her motion that the
evidence was “irrelevant and prejudicial,” Judge Katz noted that the 510(k)
process was the way in which this particular device arrived on the market. He
ruled the defendants should be allowed to present the 510(k) process as
evidence, as all parties involved would understand this is a clearance process
based on an equivalency standard and not just a rubber stamp by the FDA.
We are not sure what this means for the
first bellwether trial but I do not think it is a good sign of things to come.
We are still confident that the bellwether jury will see the facts in a
reasonable light and weigh the evidence accordingly.
