Metal-on-metal hip problems are associated with J&J’s DePuy division with its infamous and ongoing ASR tribulations. Stryker isn’t without its own problems however. Following the $8.3M award in the first DePuy case to come to court, an implantee has filed a $100 million defective medical product liability lawsuit in the U.S. District Court for the Northern District of Illinois against Stryker Orthopaedics. The news has been reported by the Fort Worth Examiner, here.
The Stryker ABG II system is a metal-on-metal hip implant composed of interchangeable chrome cobalt neck and titanium stem components. The FDA cleared the marketing and distribution of the hip replacement system in 2009 under the 510(k) substantial equivalence route.
The plaintiff alleges that it was defective and directly caused him to sustain permanent injuries. As has been claimed in DePuy suits too, the plaintiff in this case claimed that Howmedica Osteonics, doing business as Stryker Orthopaedics was negligent and failed to warn patients about the risks associated with the hip replacement system.
The difficulty with all of this is that once again the manufacturer was clearly aiming at offering an improved implant design. Stryker’s ABG II system featured interchangeable components and could be custom-fitted for patients, providing greater flexibility. It was supposedly more resistant to corrosion, which should in theory have improved the device’s performance and longevity.
Sadly, post-market data challenged these claims and suffered the same pitfalls as the DePuy device, including loosening corrosion and release of metal particles into the bloodstream and soft tissues.
These problems associated with the hip device led to early failure rates and allegedly harmed the patients’ health.
In April last year Stryker issued an Urgent Field Safety Notice to inform medical professionals that the hip device posed a potential safety risk to patients due to corrosion and metal contamination. This was followed by an FDA adverse event report which stated that medical complications included inflammation, metallosis, tissue damage, bone loss, chronic pain, and “pseudotumour” formation. Some patients needed to undergo revision surgery so that the defective hip implant could be replaced.
Bringing things up to date then, the Stryker hip lawsuit alleges that the defendants designed, manufactured, and distributed a defective medical device. The plaintiff’s attorney claims the hip implant is unreasonably dangerous and unfit for its intended purpose.
Sounding awfully familiar for anyone who’s followed the DePuy cases, the company is accused of failing to adequately test the safety of the product prior to distributing it and furthermore not warning patients of the safety risks associated with using the product.
The U.S. Judicial Panel for Multidistrict Litigation is considering consolidating the lawsuits. On May 30, 2013, attorneys presented oral arguments to the Judicial Panel regarding the possible federal consolidation of the Stryker hip implant cases.
We’ll be looking out for news of the proceedings.