Judge Allows Stryker Gamma 3 Nail Case to Go Forward

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Public Health Watchdog Breaking News

A federal judge, ruling on Pennsylvania law, allowed a strict liability manufacturing defect claim to proceed against Howmedica Osteonics Corp. and Stryker Corporation for the failure of their hip and leg prosthetic device.

The plaintiff in the case had a Stryker Gamma 3 Nail System implanted in his hip in March 2015. In September 2015, X-ray images showed that the Stryker nail had broken and in April 2016, the man underwent a total hip replacement. He contracted an infection, causing further medical consequences.

Gamma Nail Procedure

A gamma nail procedure is performed when the neck of the femur (thigh bone) has been fractured and where there is a good chance that the fracture will heal if held in place by internal fixation, according to the British National Health Service. The gamma nail consists of a large screw placed in the head of the femur and a nail that goes down the center of the shaft of the femur. These metal pieces remain in place permanently, even after the fracture has healed.

The gamma nail procedure has certain advantages. The surgery is less invasive than total hip replacement; there is blood loss, and less postoperative illness. But, according to Johns Hopkins Medicine, this treatment carries a higher risk of the patient needing more surgery in the future. Hip replacement, in contrast, has a higher risk of postoperative complications, but a lower risk of the need for reoperation for nonunion, hardware failure, and bone death.

The personal injury attorneys at Parker Waichman LLP stay aware of new information about medical devices. The firm offers free legal consultations to individuals with questions about filing a medical device lawsuit.

Strict Liability

The injured man filed strict liability, negligence, and breach of implied warranty claims under Pennsylvania law in the U.S. District Court for the Eastern District of Pennsylvania. “In the absence of a controlling decision by the Pennsylvania Supreme Court, a federal court applying that state’s substantive law must predict how Pennsylvania’s highest court would decide this case,” Judge Wendy Beetlestone wrote. The judge predicted “the Pennsylvania Supreme Court would not bar strict liability claims asserting a manufacturing defect against medical device manufacturers.”

A strict liability claim generally requires proof “(1) that the product was defective, (2) that the defect existed when it left the hands of the defendant, and (3) that the defect caused the harm.” The judge said the allegation of a manufacturing defect strict liability claim was satisfied by the allegation that the Stryker Gamma 3 Nail System broke down after “it was subjected to normal and anticipated use, and that there were no reasonable secondary causes.” The failure of the Stryker Gamma 3 Nail System necessitated a subsequent surgery to remove it, and then total hip replacement. The hips replacement “gave rise to a secondary infection.” The judge therefore denied the motion to dismiss the strict liability claim.

Stryker is also a defendant in 1,806 claims in Minnesota federal court before Sr. District Judge Donovan W. Frank, involving the Stryker Rejuvenate and ABG II Hip Implant devices. In addition, the company faces eight claims in Massachusetts federal court involving the LFIT V40 Femoral Head device.

Many of these hip replacement devices are the subject of litigation because they have shown higher than expected early failure rates and patients have experienced serious injuries and complications, including pain, inflammation, loosening or instability of the joint, hip dislocation, bone and tissue death, and the need for revision surgery to remove and replace the failed device.

Metal-on-metal hip devices like the trouble-plagued Striker devices have both a metal ball and metal cup. Manufacturers brought these devices to market with the promise of greater durability compared to earlier hip device designs. Stryker LFIT metal hip implant were marketed with the promise of greater durability and shorter recovery time compared to older hip implant devices made from materials like ceramic or plastic. Device manufacturers believed all-metal devices would last longer than previous devices did. Unfortunately, metal-on-metal hip implants have not met these expectations.

Legal Help for Those Injured by a Stryker Hip Device

If you have experienced injuries or complications after a Gamma 3 Nail procedure or a hip replacement in which a Stryker hip device was used, or if you have needed additional surgery to replace a failed Stryker device, please contact the attorneys at Parker Waichman LLP for a free, no obligation evaluation of your legal options. To reach the firm, fill out the online contact form to arrange an online chat or a phone call at a time convenient for you. Or you can call 1-800-YOURLAWYER (1-800-968-7529).