Judge David A. Katz of the United States District Court for the Northern District of Ohio once again delayed the first bellwether trial in the multi-district litigation against Johnson & Johnson’s DePuy Orthopaedics subsidiary. The lawsuits allege that the company’s ASR metal-on-metal hip implants caused serious and painful injuries to patients.
Issues remain with regard to scheduling of additional depositions and pretrial discovery.
The trial was originally scheduled to commence on September 9, 2012. Judge Katz had previously delayed the start date for two weeks so that the parties could engage in additional discovery.
On September 20, 2013, Judge Katz issued an order stating that the trial would commence sometime within 90 days. The order states that “issues remain with regard to scheduling of additional depositions and pretrial discovery which are necessary for the thorough preparation and presentation of this bellwether case.”
To date, over 10,000 lawsuits have been filed against Johnson & Johnson and its DePuy subsidiary alleging that the ASR metal-on-metal hip implants have caused serious injuries and required patients to undergo corrective surgeries. The ASR metal-on-metal hip devices have been implanted in approximately 30,000 patients in the United States.
On August 24, 2010, DePuy issued a voluntary recall of its ASR hip devices. The hip replacements reportedly have a failure rate as high as 49%. Studies have shown that metal-on-metal hip implants can wear quickly. Furthermore, the friction caused by the metal-on-metal components sheds metal particles, which can lead to bone loss, tissue damage, and other painful medical complications.
The New York Times has called the device “one of the most troubled orthopedic implants of the past decade.”
The metal-on-metal hip implants received approval from the Food and Drug Administration under its 510(K) approval process. Under this program, a new medical device that is “substantially similar” to another product that has received FDA approval can be used in patients without first undergoing clinical trials to demonstrate that the medical device is safe.
According to a study published in the New England Journal of Medicine, the ASR XL Acetabular Cup System was, in fact, not substantially similar to other hip implants. The study concluded that none of the previously approved hip implants that DePuy relied on in its 510(k) application had the same combination of characteristics as the ASR XL Acetabular.
The New England Journal of Medicine study states that the approval of the ASR hip implant “reveals serious flaws in the 510(k) procedure for metal-on-metal hips, which resulted in clearance of a new device that was never shown to be safe and effective.”
Stay tuned for further updates on the DePuy ASR hip litigation.