Wednesday, August 29, 2012

DePuy Pinnacle Hip Lawsuits Update: Judge Issues Order Regarding FDA Study

DePuy Pinnacle hip lawsuits included in the federal consolidated action, In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), are subject to a new court order stemming from a mandate issued by the U.S. Food and Drug Administration (“FDA”), Bernstein Liebhard LLP reports.* As described in the court’s order, the FDA mandated that DePuy conduct an explant study protocol pursuant to a Section 522 Order as part of the post-market surveillance study of the metal-on-metal Pinnacle hip replacements, which are the subject of this ongoing litigation. Issued by the FDA, a Section 522 Order mandates a medical device manufacturer to conduct post-market studies of a device that has the potential to cause injury when implanted into patients. On August 27, 2012, the Honorable James E. Kinkeade, who is overseeing the federal DePuy Pinnacle hip lawsuits pending in the U.S. District Court for the Northern District of Texas, issued an order requiring counsel for plaintiffs and defendants to confer in an attempt to reach an agreement on the correspondence to be sent to hospitals and surgeons who perform revision surgeries on patients with the metal-on-metal Pinnacle hip replacements regarding the explant study protocol

In May 2011, the FDA ordered manufacturers of metal-on-metal hip implants to conduct post-market surveillance studies on their products.** According to the New England Journal of Medicine (“NJEM”), as of June 18, 2012, the FDA and manufacturers had reached agreements on study protocols for less than one quarter of the devices. According to the August 27, 2012 order issued by Judge Kinkeade, the FDA recently approved DePuy’s study protocol. Notwithstanding the FDA’s approval of DePuy’s study protocol, the NJEM identified several limitations that may constrain the amount of useful information that emerges once studies proceed. For example, each manufacturer is permitted to conduct its own independent study on its products, making it difficult to pool the data and make cross-product comparisons. Further, manufacturers may measure chromium and cobalt levels differently, which can lead to uncertainty when pooling results. According to the NJEM, “this lack of harmonization limits the public health benefit of the studies.”

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