Recently in Orthopedic Device Category

On-Going Concerns with Hip Replacement Devices

August 30, 2012

The litigation concerning revision surgeries and metal poisoning following certain hip replacement devices continues to grow. Other manufacturers' products are being called into question and the presiding judge of the federal MDL (No. 2197) has scheduled the first bellwether trials in the DePuy case for May and July of 2013.

These trials will be an important step in moving these cases toward resolution.

Bellwether trials are used by both sides in mass tort litigation to gauge the success of future trials. Obviously, the party that prevails more often in the bellwether cases will have a stronger negotiating position at the settlement table. For example, the Vioxx litigation provides some guidance into these cases. In the Vioxx litigation, the parties conducted six federal trials and 13 in state courts around the country. The plaintiff was successful in only 1 of the 6 federal trials. The state court verdicts were more evenly split between the parties. However, the verdicts for the plaintiffs tended to be large. As a result, after these cases were concluded, the parties were able to reach a global settlement of $4.85 billion for qualifying cases. While the Vioxx litigation is just one example, it illustrates the importance of these cases.

The hip replacement device litigation continues to evolve. You can follow its progression on our website's new page concerning these medical devices.

Mike Sudekum is personal injury attorney in St. Louis, Missouri. You may contact him here.


More Trouble for Hip Replacement Manufacturers, More Pain for Hip Replacement Patients

June 7, 2011

In addition to the 93,000 ASR hip replacement systems that DePuy voluntarily recalled in August 26, 2010, the manufacturer of medical devices is now facing at least 57 additional lawsuits for damages related to its Pinnacle hip replacement system.

Both hip replacement systems are metal on metal medical devices that were advertised as providing a greater range of motion and longevity as compared to other systems. Interestingly, the ASR system was approved in 2005 without clinical testing because of its similarities to the previously fast-tracked Pinnacle system because of its similarily to previously approved devices.

Consumer groups and lawyers representing patients with these devices find the approval process alarming. In response to these concerns and others, the FDA, on May 6, 2011, mandated that DePuy, through its parent company, Johnson & Johnson, and other manufacturers conduct a post-market study on the safety of these products, including whether metal on metal hip devices release shreds of metal into the blood stream resulting in metallosis. Metallosis which may be diagnosed by excessive levels of cobalt in the blood has been linked to rashes, damage to surrounding tissue, neuropathy or nerve pain and pseudo tumors.

This FDA action comes less than a month after the United States Senate Special Committee on Aging heard testimony on the role of the FDA and the approval of the DePuy ASR hip system.

The lawsuits against DePuy for the Pinncale hip have been consolidated into a MDL in the U.S. District Court for the Northern District of Texas, Honorable James E. Kinkeade, presiding. Like other metal on metal hip replacement systems, the Pinnacle system may increase the risk of metal ions in the blood stream and surrounding tissue of patients.

The ASR lawsuits have been consolidated into a MDL in the U.S. District Court of the Northern District of Ohio, the Honorable David A. Katz, presiding. The recall on August 26, 2010, and subsequent filing of a number of lawsuits related to these devices followed a report by a British joint registry that showed a failure rate of 12-13% which is two to three times the average rate of similar devices.

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