UPDATED August 12, 2013, with information on a 3rd DePuy ASR trial.
Evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial over the device, a federal judge ruled last month.
Many of the suits filed in federal courts have been consolidated into multi-district litigation overseen by Judge David Katz of the U.S. District Court for Northern Ohio. The 1st bellwether trial in that litigation, Ann McCracken v. DePuy Orthopaedics, is slated for trial in September, according to court documents.
Katz ruled last month on a number of pre-trial motions from both sides, granting DePuy’s bid to keep evidence about the recall out of the trial. McCracken had argued that the recall shouldn’t count as a "subsequent remedial measure" following the 2009 implantation of a DePuy ASR LX model.
Katz disagreed, on the grounds that McCracken is likely to assert her claim as having begun at the time of her hip replacement surgery in 2009 (a revision surgery was performed in January 2011, according to the documents).
"Her injury began with the initial implantation and, but for that event, she would not have suffered injury, including the revision surgery," Katz wrote. "Assuming the plaintiff will claim her harm commenced before the recall, in this instance, the recall is a subsequent remedial measure which, if it had occurred prior to the implantation, would have prevented the harm. As such, the recall is inadmissible."
DePuy can present evidence of the FDA granting 510(k) clearance for the DePuy ASR hip implant, Katz ruled.
"The court is persuaded that Defendants are entitled to present evidence of the 510(k) clearance as it represents the process by which the device came to be on the market and is, therefore, relevant," he wrote. "Despite plaintiff’s protestations, the probative value outweighs the danger of unfair prejudice or jury confusion and this evidence will also be subject to a special jury instruction. Therefore, plaintiff’s motion to exclude evidence of 510(k) clearance is denied."
The judge also granted DePuy’s motion to use split-screen video depositions, writing that "the presentation of a split-screen method is no different from what the jury would see in the live courtroom, therefore, no prejudice results to either side."
DePuy can also exclude evidence of compensation paid to expert witnesses in prior trials (but must divulge if asked evidence of payments to experts in this trial). Evidence of payments from Broadspire Services, a 3rd-party administrator that handled DePuy ASR claims, can be included in the trial, the judge ruled.
In a separate ruling, Katz granted McCracken’s bid to exclude any reference to lawyer advertising and any suggestion that the high revision rates on the ASR devices "are driven by lawyers," according to the documents. DePuy withdrew a motion to exclude "evidence and argument that DePuy misled the FDA, violated federal law, or should have conducted clinical testing," but can re-file the motion later, the judge ruled.
The 1st trial over the DePuy ASR implant settled in August 2012 before it could go to trial. In March, a jury awarded another plaintiff, Loren Kransky, $8.3 million after deciding that the device was defectively designed (California Judge J. Stephen Czuleger rejected DePuy’s request for a new trial in May). In April, an Illinois state jury found for DePuy in Carol Strum vs. DePuy Orthopaedics & Premier Orthopaedic Sales.
And plaintiffs in 7 lawsuits filed over the device can add claims over the DePuy Pinnacle implant, a state judge in California ruled last month.
The August 2010 recall of the DePuy ASR devices was "due to the number of patients who required a second hip replacement procedure," according to a company report. An internal review in 2011 found that 37% of DePuy’s ASR hip implants would require revision or replacement in less than 4.6 years.