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Home > News > August, 2011

Court: Stryker Still on the Hook for Pain Pump Liability

Denies manufacturer's request to dismiss injured patient's lawsuit.

Published: August 25, 2011
Categories: Legal/Regulatory, Orthopedics, Pain Management, News

A federal court in Oregon has denied Stryker Corporation's request to dismiss a product liability lawsuit from a patient who suffered joint damage due to post-op use of a local anesthetic infusion pump.

The patient, Eric Shoenborn, is seeking financial compensation for the glenohumeral chondrolysis he suffered following a 2004 arthroscopic surgery on his shoulder. The surgeon who performed the procedure placed the pain pump's catheter directly into his shoulder joint, resulting in pain and destruction of the joint's cartilage. He filed suit in 2008, accusing the company of marketing pain pumps despite knowing the risk of delivering anesthetics into the joint space, and failing to warn physicians that the U.S. Food and Drug Administration had not cleared the devices for such use.

The Kalamazoo, Mich.-based medical device manufacturer countered that the lawsuit fails to show that. at the time of Mr. Shoenborn's surgery, the scientific and medical community had any reason to know of these joint space risks. It maintained that under Oregon law its duty to alert physicians was limited to the dangers it was aware of.

Mr. Schoenborn's attorneys, however, presented the court with a 1985 clinical study on anesthetic risks in the joint space; internal communications from Stryker which discuss the lack of FDA approval of pain pump use in the joint space and the potential for anesthetic toxicity; and a deposition from the surgeon, who stated she would not have used the pump as she did had she known the FDA hadn't cleared it for joint space use.

In its July 11 ruling, the court wrote, "Though not overwhelming, plaintiffs present some evidence that Stryker knew or should have known of toxicity concerns associated with the administration of local anesthetics directly into the joint area."

It acknowledged that "several courts have held otherwise and found that any danger from intra-articular pain pump use was 'not knowable' prior to 2005 or 2006," but "disagree[d] with those decisions and instead find this question appropriate for the trier of fact."

Robert Murphy

© Copyright Herrin Publishing Partners LP 2011. REPRODUCTION OF THIS COPYRIGHTED CONTENT IS STRICTLY PROHIBITED. We encourage LINKING to this content; view our linking policy here.


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CMS Updates Emergency Equipment Requirement

© Copyright Herrin Publishing Partners LP 2011. REPRODUCTION OF THIS COPYRIGHTED CONTENT IS STRICTLY PROHIBITED. We encourage LINKING to this content; view our linking policy here.

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