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

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DePuy Pinnacle hip lawsuits subject to new order regarding FDA post-market surveillance studies on metal-on-metal Pinnacle hip replacements, Bernstein Liebhard LLP reports.

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.

Bernstein Liebhard LLP is actively representing clients and filing lawsuits on behalf of individuals claiming injuries stemming from the metal-on-metal Pinnacle hip replacements. Firm partner Jeffrey S. Grand serves on the Plaintiffs’ Steering Committee in the federal DePuy Pinnacle litigation.

Metal-On-Metal Hip Replacement Manufacturers Scrutinized By FDA

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.”

Hip Replacement Litigation Against DePuy Continues

In addition to actively filing DePuy Pinnacle hip lawsuits, the DePuy hip replacement lawyers at Bernstein Liebhard LLP are also filing lawsuits on behalf of individuals who have been implanted with metal-on-metal ASR hip replacement systems, also manufactured by DePuy, in In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio. The hip replacement lawsuits allege that the ASR hip replacement systems and the metal-on-metal Pinnacle hip replacement systems were defectively designed.

Those who received a DePuy Pinnacle metal-on-metal hip replacement and have experienced hip replacement pain or had to undergo revision surgery may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Learn more about the DePuy Pinnacle hip replacement litigation by visiting our website, For more information, contact a DePuy hip lawyer at Bernstein Liebhard LLP today at (877) 779-1414.


About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.

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Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP

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