A case stemming from a hip implant lawsuit against Wright Medical has caught the attention of several professional associations, including AdvaMed, as the outcome could have broad implications for the medical device industry.
The lawsuit makes a strict liability design defect claim against Wright Medical, the manufacturer of the device implanted in both of plaintiff Dale Burningham’s hips. The company argued the hip implants are « unavoidably unsafe » products and are therefore categorically barred from strict liability design defect claims under the exception to strict products liability set forth in Comment k to Section 402A of the Restatement (Second) of Torts.
It will now be up to the Utah Supreme Court to decide if, under state law, the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts apply to implanted medical devices. If so, the court will decide if the exception applies categorically to all implanted medical devices, or only to some devices on a case-by-case basis. If the court decides the exception applies on a case-by-case basis, then it will have to decide the proper analysis for determining whether the exception applies. Another important question for the quart, if it decides that the exception applies to implanted medical devices, is whether or not that requires a showing that such devices were brought to market via FDA’s more stringent premarket approval process or the 510(k) clearance pathway.
AdvaMed filed an amicus curiae brief with the Utah Supreme Court in the case in which the association asks the court to apply longstanding tort law principles « fairly and evenly to the medical devices that help save and improve patients’ lives. »…