Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics must work together with plaintiffs who are suing the company over allegedly faulty hip implants, ordered U.S. District Judge Ed Kinkeade.
Judge Kinkeade, who is presiding over a multidistrict lawsuit combining more than 1,100 hip replacement cases against DePuy’s Pinnacle metal-on-metal hip implants, instructed plaintiffs and defendants to come to terms on a notice that will be sent to hospitals and physicians participating in the FDA-mandated Pinnacle explant studies.
The parties already once failed to come to an agreement on the wording of the letter, but Judge Kinkeade insisted they try again, according to a Rottenstein Law Group press release.
DePuy’s Pinnacle implants have not been the subject of a recall, but became the focus of heightened scrutiny amid the high-profile recall of the company’s metal-on-metal ASR implants, a move which spurred class action and multi-district lawsuits, public outcry and FDA scrutiny.
The Pinnacle device, which pre-dates DePuy’s ASR implant by a few years, is like its older cousin in that it’s been found to shed minute particles of metal as the hip’s ball joint wears on the metal cup. The lawsuits allege that increases the risk of problems and make the implants prone to early failure.
In May 2011 the FDA asked a clutch of device makers, including Biomet Inc., Stryker (NYSE:SYK) and Zimmer (NYSE:ZMH), to run post-market studies of their metal hip replacements in order to look for metal ions in patients’ blood.
It took Johnson & Johnson more than a year to submit its research protocol to the FDA and gain agency approval to proceed, but some researchers are skeptical that the studies will yield much in the way of worthwhile results, Drug Watch reported.
Researchers warned that the metal-on-metal hip studies aren’t well-organized, in that each manufacturer will come up with their own protocol, making the data difficult to pool and draw larger conclusions from. In addition, the studies must span only 3 years, about ⅓ of the devices’ expected lifespan.
