Medical Device Lawsuit Pitted One Manufacturer Against Another

Washington, DCIt is somewhat ironic that a company itself having faced allegations of defective medical devices, has litigated against a rival citing an allegedly defective product. Given the spike in complaints over hip & knee replacement implant failure, such an allegation is nothing new, save for the twist that saw the complaint stem from a competitor.

According to Medical Industry Week (8/31/12), the lawsuit was between Stryker and Corin, a UK based company that manufactures the Cormet hip resurfacing system. Cormet was approved by the US Food and Drug Administration (FDA) in 2007 and was distributed in the US and Canada by Stryker.

Corin had signed on with Stryker as its US partner a year earlier. However, according to reports the relationship soon soured and the partnership terminated before Stryker launched a lawsuit against Corin citing the Cormet hip resurfacing system was defective, requiring replacement surgery.

A New York State court subsequently ruled in favor of Corin, noting the Medical Device Amendments Act effectively preempts the claim due to the FDA's review process, and the requirement to publish and list appropriate warnings before a device goes to market.

Pundits, however, will note that the FDA's own guidelines—and specifically those, which allow similar devices to be fast-tracked to market—serve as a contradiction to such a position.

Many a hip replacement lawyer will make the point that the FDA grants a pass from extensive testing to manufacturers introducing new products that have a similarity to existing devices. The prevailing wisdom is that existing products have already been extensively tested. Thus, if an emerging product is similar, there is little need for extensive testing beyond a cursory review. The goal is to bring promising products to market more quickly, to benefit the greatest number of patients.

The result, according to many a hip replacement lawsuit, are implant failures stemming from design updates and replacement of materials that served as a detriment, rather than an improvement. Metal-on-metal hip implants, for example, have proven to fail much faster than more traditional designs, leaving patients in pain or physically incapacitated—and in need of revision surgery. Metal toxicity is another concern.

The Cormet hip resurfacing device was approved for skeletally mature patients with non-inflammatory degenerative arthritis or inflammatory arthritis. The New York Court that found in favor of Corin in the Stryker lawsuit cited Charles R. Riegel, et ux. v. Medtronic, Inc., Supreme Court of the United States Case # 06-179 (2008) that applied pre-emption to similar medical devices.

Such a finding, however, does little to help a patient who expects a hip or knee implant to last upwards of 15 years or more with normal use, rather than having to face device failure in as little as a few months after implantation, often resulting in a knee replacement lawsuit.

For active patients—many of them still working and relatively young—facing surgery for a knee or hip implant is sacrifice enough, to heal and undergo therapy to bring the artificial device to full use. The prospect of revision surgery so soon after the initial procedure following a hip and knee replacement implant failure, can dramatically affect an individual's livelihood for which compensation with the help of a hip replacement lawyer is a welcome and necessary option.