MDL Defective DePuy ASR Lawsuit Slated in U.S. District Court for Northern Ohio

Lawsuits filed by a number of recipients of recalled DePuy ASR hip implant manufactured by DePuy Orthopedics, a Johnson & Johnson subsidiary, are being consolidated under a federal district court judge in Ohio.

Under Judge David Katz, the multi-district litigation on DePuy ASR lawsuit is scheduled to be held in the U.S. District Court for Northern Ohio.

Putting several cases into one litigation makes it possible for lawyers of different plaintiffs work together and share discovery issues and evidences. It is the same process that was instituted in the litigation involving BP Oil.

“Based on Judge Katz’s experience with other MDLs, we expect that he will do a good job of pushing these cases along, whether it be by settlement or trial. Any existing cases filed in various federal courts around the country will likely soon be transferred to his court in order to begin litigation in his court,” One of the lawyers said in a prepared remarks.

In August, DePuy Orthopedics based in Indiana recalled its ASR XL Acetabular and ASR Hip Resurfacing systems following mounting reports of a higher-than-normal number of patients requiring surgeries to correct or remove defective implants.  Affecting 93,000 people, the recall was prompted by fresh data from the National Joint Registry of England and Wales.  According to a DePuy press release announcing the recall, the report showed “a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System,”

In June, a Florida woman accused the company of knowing about the device’s problems but failed to warn doctors. Thus, the first DePuy ASR lawsuit was born over the allegedly defective ASR devices. Three more lawsuits by California residents – who all had to have revision surgery after the implant partially detached from their hip sockets – followed the lawsuit days later.

By March, DePuy discontinued manufacturing the cup and had it phased out.  The company also sent letters to doctors that same month.  The letter warns that information from the Australian Medical Device Registry reflect a “higher-than-expected” failure rate in traditional hip replacements.  The data is especially true in smaller patients or those with weak bones.

According to the New York Times, these developments came after two years of reports gathered, showing that the implant was prone to early failure. The director of the Australian database, Dr. Stephen Graves, told the newspaper that the DePuy was quite sluggish in pulling the device off the market. The Times also reported that the Food & Drug Administration was in receipt of approximately 300 complaints about the ASR cup since 2008. Most complainants are currently undergoing revision surgeries to correct the device. Furthermore, the device’s co-developer, Dr. Thomas Schmalzried, said he and DePuy officials have come to realize that the ASR cup might be more of a challenge to implant properly than competing cups.

In 2005, DePuy introduced the ASR in the U.S. after obtaining a 510(k) clearance from the Food & Drug Administration for the device.

DePuy ASR Hip Implant Recall Lawsuits Triggered By Multiple Debilitating Side Effects

DePuy Orthopaedics issued in August 2010 a global recall of its ASR Hip Resurfacing System and ASR Acetabular System.  The action resulted from the data provided by the National Joint Registry of England and Wales.  It showed that 1 in every 8 individuals (about 12%-13%) whowere implanted with the devices needed revision surgery only after five years of receiving it. Prior to the issuance of the recall, there were about 93,000 defective ASR Hip Implants sold and implanted in individuals in the U.S. and abroad.

The DePuy ASR Hip Implants were sold between 2005 and 2009. An individual who received the metal-on-metal hip implant within this period, and is suffering serious complications due to the implant’s failure requiring corrective surgery, may have been a victim of DePuy ASR Hip Implant. Symptoms usually occur as follows:

    Swelling or pain in the effected hip or surrounding areas

    Difficulty walking or pain in the hip when doing so

    Grinding or popping noises originating in the hip area

    Inflammation or infection in the affected hip area

    Implant loosening

    Dislocation of the implant components

    Bone fractures at the hip

Metal poisoning, akametallosis, resulting from metal debris shed by device components rubbing each other

Awareness of this recall by those who are not even yet affected by these problems is necessary. The absence of these symptoms is not an indication that the implant has not failed or is not affecting the health of the user. Thus, it is imperative that every individual who have received a DePuy ASR Hip Implant contact their physician for reevaluation, despite feeling no problems with the device.

Though recall was issued in 2010, there is apparent reason for DePuy Orthopaedics to know that its ASR Hip Implant devices pose dangers to patients years before its recall. In fact, in March 2006, DePuy already wrote to doctors to alert them of the ASR devices’ higher-than-expected failure rate with the clarification that this only affects certain patients: women, patients of short stature, and those with weak bones. Then, come December 2009, units of ASR were withdrawn from the Australian market and released plans to do so worldwide in 2010. In DePuy ASR hiplawsuit pre-trials, the company insists that the recall the ASR Hip Implant in Australian was due to poor sales.

The DePuy ASR hip implant was approved by the U.S. Food & Drug Administration (FDA) through its 510(k) approval process. This process of streamlined clearance allowed medical devices such DePuy’s to gain approval without human clinical trials by showing that the device is “substantially equivalent” to existing products being distributed in the market. Nonetheless, a report by the New England Journal of Medicine (NEJM) says that the DePuy ASR’s approval by the FDA was based on the similarities to existing implants, though the device has significant changes in material as it used a metal alloy cup from a different hip device that retrofits to a standard hip implant. This metal-on-metal design change was thought of as a major innovation despite lack of test, the NEJM reported.

What are the dangers of a metal-on-metal hip implant?

The DePuy ASR Hip Replacement devices subjected to the recall of August 2010 are metal-on-metal hip implants.  It is a class of devices that recently have been suspected of serious complications and injuries. Individuals with metal-on-metal hip implants, these include the DePuy ASR devices, suffered loss of bone, the demise of surrounding tissue, the development of pseudo-tumors in the same area, and early failure that requirescorrective surgery. There is the belief that these complications are resulted from minutemetal shards being shed by the rubbing metals into the blood stream.  This leads to metallosis and cobalt poisoning. Come 2011, the rising number of complications reported by people with metal-on-metal hip implants prompted the FDA to direct DePuy Orthopaedics and 20 more manufacturers of hip replacement to conduct post-market studies of their devices to see if the metal shedding result to dangerous amounts of metallic debris among its users.  The foregoing medical findings, combined with the FDA’s directives and consequent recall, scores of individuals are now geared towards filing Depuy ASR hip lawsuits.