DePuy Hip Recall Evidence Barred From Bellwether Trial

Judge David Katz recently ruled on several motions regarding a lawsuit in the DePuy multidistrict litigation (MDL), which is proceeding in the U.S. District Court for the Northern District of Ohio. The MDL consolidates federal DePuy ASR hip lawsuits filed by plaintiffs who allege problems with the now recalled hip replacement system. The order, which was issued on July 8, 2013, specifically concerns motions filed in the bellwether case of plaintiff Ann McCracken, who is scheduled to have her day in court on September 9, 2013.

Judge Katz rules DePuy hip recall evidence inadmissable

Judge Katz granted a motion filed by the defendants, DePuy Orthopaedics, regarding the exclusion of certain evidence. All evidence concerning the voluntary ASR hip implant recall, which was issued in August of 2010, has been found inadmissible, pursuant to the Federal Rules of Civil Procedure.

Ann McCracken had noted in her complaint that she experienced significant mobility impairment and pain and suffering subsequent to the implantation of her device. Since the plaintiff claims her injuries began before the defendants issued the recall, the Judge ruled evidence regarding the recall inadmissible. According to the order, “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 under Rule 407.”

The Judge also denied the plaintiff’s motion to exclude evidence regarding payments made to her. According to the order, the plaintiff allegedly received payments as compensation for her injuries from a third-party vendor contracted by the defendants. According to the order, “The Court also notes that this ruling is subject to modification depending upon how the evidence unfolds at trial.”
Other motions ruled on included the presentation of evidence regarding the 510(k) clearance procedure from the FDA. The Judge ruled the defendants were allowed to present evidence of this process.

Bellwether cases underway

Ann McCracken’s DePuy hip recall lawsuit is the first in the MDL to go before a jury. Her case is known as a bellwether trial, which allows both parties to analyze jury reactions. Other bellwether cases have yet to be assigned a trial date.

Currently, the MDL includes more than 7,800 DePuy ASR hip lawsuits. The plaintiffs share similar allegations, including premature failure of the device. Although hip implants generally last 15 to 20 years, many plaintiffs have alleged the need for revision surgery and removal of the failed devices in just a few years. Some estimates suggest the rate of failure of the metal-on-metal hip implant is about 12 to 13 percent, while other studies indicate failure rates significantly higher than this.

When a hip implant fails, the patient typically experiences significant pain and the loss of mobility. Patients may need to undergo additional surgery to replace the defective device. Furthermore, with a metal-on-metal implant device, they are at risk of metallosis, or metal contamination in the bloodstream and surrounding tissues.

Recall acknowledged device failure

In August 2010, DePuy Orthopaedics acknowledged the high level of hip implant failures and issued a voluntary DePuy hip recall. The recall involved the DePuy ASR XL model, which plaintiff Ann McCracken had received. Although the recall was not issued until August, a field safety notice indicates that the company acknowledged the problems with the device as early as March 2010. The notice, which discussed the potential complications, was sent to healthcare professionals. Prior to the recall of the DePuy hip replacement, more than 90,000 patients in various countries had already received the implants.