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."
"Some products, given their advanced technological design, can only be sold subject to proper instructions and related precautions, and under the direction of a physician," said Matthew Wetzel, vice president and assistant general counsel at AdvaMed.
Therefore, he said, the so-called Comment k tort principle indicates that manufacturers of such products (including devices cleared through the 510(k) process) cannot be held to strict liability for their use.
AdvaMed is not alone in this quest. The organization is joined by a coalition composed of the American Tort Reform Association, the National Association of Manufacturers, the U.S. Chamber of Commerce, PhRMA, and BioUtah.
"We hope that our brief will encourage the Utah Supreme Court to give medical device manufacturers a fair shake in defending themselves under Utah law,” Wetzel said.
The Washington Legal Foundation (WLF) also weighed in on the case by filing a 34-page brief of its own.
"WLF supports a balanced approach to products-liability rules that takes into account both the interests of consumers in adequate compensation for injuries caused by defective products and society’s interest in the continued availability of products that provide significant health benefits yet are unavoidably unsafe," the WLF's brief states.
The organization raised concern that if the court decides not to apply Comment k to implanted medical devices, or to do so only on a case-by-case basis, would allow juries to question FDA's judgment about safety and effectiveness.
The WLF brief points out that the Utah Supreme Court has previously adopted Comment k's policy as the law to be applied categorically to prescription drugs. Regarding prescription drugs, the court decided back in 1991 that prescription drugs potentially affect each patient differently so it is impossible to design a drug in a manner that will render it safe for all individuals. As a result, prescription drug manufacturers are not strictly liable for injuries caused by their drugs.
"Much the same way, implanted medical devices are unavoidably unsafe, as each device has the potential to injure certain patients based on the particular characteristics of a given individual," the WLF brief states.
The organization adds that Comment k will not eliminate all avenues of recovery for injured consumers, it only exempts device manufacturers from strict products liability suits for design defects."
Plaintiffs may still bring negligence claims or sue for manufacturing defects or failure-to-warn, leaving open the ability to recover for injuries while providing some protection and clarity to manufacturers, the WLF noted.
In 2016 Wright Medical agreed to pay $240 million to settle 1,292 lawsuit claims related to its Conserve, Dynasty, and Lineage metal-on-metal hips.