Stryker Rejuvenate Recall Litigation in State and Federal Courts
Stryker Orthopaedics has ceased to recruit subjects for its longitudinal study on one of its two recently recalled hip implant models, but it has continued to try to resolve lawsuits filed by the ailing patients of both hip replacement stems.
Meanwhile, a major orthopedic medical journal has published a study that confirmed the corrosive potential of such devices.
The New Jersey-based medical technology corporation Stryker, voluntarily recalled its Stryker Rejuvenate and ABG II modular-neck hip stems and announced July 6, 2012, that it had “terminated global distribution of these products” based on data derived from “continued post-market surveillance.
These were not all-metal devices. Nevertheless, the necks, for instance, were made of a “cobalt chrome alloy,” according to Stryker’s answer to lawsuits filed in state court in New Jersey. The metal parts posed certain adverse-reaction risks including metal poisoning.
Ultimately, as New Jersey’s multi-county litigation center quoted the manufacturer, “These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling. … Possible adverse outcomes allegedly include metallosis, necrosis and osteolysis.”
Study Published on Complications of Affected Stryker Hip Recipients
The May 2013 edition of The Journal of Bone & Joint Surgery published research in accordance with the reported damage that plaintiffs in Stryker class action lawsuits have suffered.
“Corrosion at the modular neck-body junction in dual-tapered stems with a modular cobalt-chromium-alloy femoral neck can lead to release of metal ions and debris resulting in local soft-tissue destruction,” concluded researchers from Northwestern University and Indiana University medical schools and from Rush University Medical Center.
They evaluated the case studies on 12 new hips at multiple medical centers. “Adverse local tissue reaction should be considered as a potential cause for new-onset pain in patients with these components, and early revision should be considered given the potentially destructive nature of these reactions.
“A workup including serologic studies (erythrocyte sedimentation rate and C-reactive protein), serum metal levels, and MARS MRI can be helpful in establishing this diagnosis.”
Some of the adverse-event reports were serious enough that Stryker stated in its patient follow-up guidance, “Stryker is suggesting that surgeons consider performing a clinical examination, such as blood work and cross sectional imaging, on all patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether a patient is experiencing pain and/or swelling.”
Continuing to observe the performance of the Rejuvenate model, Stryker has been sponsoring a clinical trial since November 2010, for which data was scheduled to be collected through November 2022. Trial researchers reported April 12 that the study had ceased recruiting subjects. The Stryker Rejuvenate patients “will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery,” according to a summary of the study made available by the U.S. National Institute of Health.
Many patients, especially those who have been injured by the Stryker Rejuvenate Recall, have turned to their surgeons for help, an option Stryker has been recommending.
Some have taken the additional step of exercising their right to seek compensation after experiencing side effects related to the Stryker Rejuvenate Recall.
Stryker Orthopaedics on the Defense
Stryker has been defending itself from hip replacement failure litigation filed at the state and federal levels. The door is still open for injured patients to follow suit. Stryker has been financially equipping for the formidable challenge following the Stryker Rejuvenate Recall.
Referring to the cost of dealing with product liability lawsuits on one hand and reimbursements for patient testing, treatment and revision surgeries on the other, Stryker estimated that “the probable loss to resolve this matter [would] be in the range of approximately $190 million to $390 million, before third-party insurance recoveries,” according to Stryker’s recently released annual report for 2012.
Claimants’ causes of action include negligence, defects in design and in manufacture, and the failure to warn of increased risks of serious complications. Some lawsuits have sought compensation for impairment of marital relations that hip replacement injury and surgical revision have caused.
Multi-county state-court litigation has been centralized in New Jersey, the home state of Stryker Orthopaedics, before Judge Brian R. Martinotti in Bergen County. The next status conference has been scheduled for June 18.
Meanwhile, federal multidistrict litigation was designated for oral arguments at a May 30th hearing in Louisville, Kentucky, where two plaintiffs motioned for the consolidation of certain actions to federal district court in Minnesota and to federal district court for the Northern District of Illinois.
We Can Help with Your Stryker Lawsuit
Anyone who has suffered tissue damage and related injuries that may be traced to the Stryker Rejuvenate Recall or ABG II may be entitled to compensation for their suffering.
One way to determine your legal options, without charge, is to seek a free consultation from the experienced trial litigation attorneys we work with here at Consumer Claims Center of America.
Complete our Free Case Review Form located in the right side bar or call 1-800-272-0491 to speak with a claims representative today.
Do not become a victim of the Stryker Rejuvenate Recall, exercise your legal rights now!