Stryker Begins Settling Lawsuits Over its Recalled Rejuvenate Hip ImplantsDec 19, 2013
Hip device maker, Stryker Corp., just settled four lawsuits it is facing over its Rejuvenate hip implants.
Stryker was unable to reach a deal on two other Rejuvenate injury cases that are under mediation, according to court records, MassDevice.com reports. The first phase of this mediation, under Judge Brian Martinotti of the New Jersey Superior Court for Bergen County, involves 10 cases. In all, six cases have been completed. Four of the cases were settled for undisclosed terms, three are scheduled for mediation next month, and one case was withdrawn from mediation, "because of plaintiff's ongoing medical treatment," MassDevice.com reported, citing court records. These represent just some of the many other cases brought against the device maker.
In July 2012, Stryker announced its recalls of the Rejuvenate and ABG II devices indicating, at that time, that the devices may be subject to "fretting and/or corrosion at or about the modular-neck junction." This, explained Stryker, may cause pain, swelling, and adverse reactions in area tissue, according to MassDevice.com. The next—second—phase of the multi-county litigation in New Jersey is scheduled to include 10 more cases, according to court records.
Although the Rejuvenate is not an all-metal device, it is constructed with metal components and has shown similar failure rates and adverse reactions.
In addition to the Stryker devices, a number of metal-on-metal hip devices have been recalled globally. One of the most notorious examples is DePuy Orthopaedics’ ASRs, which were globally recalled in August 2010 following exceptionally high and premature device failure rates, which led to high revision rates. Revision surgeries are typically more complicated, costlier, and painful than the original implant surgery and usually involve surgeons working with less bone and tissue mass due to the damage believed to be caused by the allegedly faulty devices. Recuperation and rehabilitation times tend to be longer and more complex and there is no guarantee that patients will be restored to a prior condition.
Thousands of lawsuits have been brought against the makers of these devices and litigation continues to mount, including hundreds filed over the recalled Stryker hips. Lawsuits allege an array of adverse reactions including, dislocation; fracture; pain and inflammation; bone and tissue damage; the development of pseudotumors; difficulty ambulating, rising, and standing; and increased blood ion levels and metallosis (metal poisoning). It seems that the devices fail with normal activities, such as walking, The devices’ metal components wear against each other, shedding tiny metal shards into patients’ bodies.
Earlier this year, the U.S. Food and Drug Administration (FDA) issued a Safety Communication concerning the health risks associated with all-metal hip devices, including guidelines for patients implanted with these devices. The agency advised patients experiencing symptoms consistent with device failure to undergo physical exams including, blood metal testing and diagnostic imaging.
Meanwhile, the metal devices have drawn significant criticism for the way in which they were cleared for market release. Under the 510(k) process, a medical device may receive agency clearance if the device manufacturer is able to prove that the device is similar to a previously approved device.