Virginia Lawyers Weekly

A woman who claims that a surgical device malfunctioned during an operation, resulting in severe damage to both her uterus and her colon, may be prevented from suing the manufacturer of the device.

A February decision by the U.S. Supreme Court bars product liability claims against the makers of most medical devices. In that decision, the court reasoned that federal regulations preempted state law, including tort claims.
Following that high court decision, Senior U.S. District Judge Jackson L. Kiser this month dismissed the major claims in the lawsuit filed by Lois Lorraine Adkins.

The case is Adkins v. Cytyc Corp. (VLW 008-3-244).

The Pennsylvania woman sued Cytyc Corporation, alleging that she was injured permanently in a procedure using its “NovaSure” device, designed to correct heavy menstrual bleeding. As explained on Cytyc’s Web site, the NovaSure device uses radio frequency energy to permanently remove the lining of the uterus, reducing or eliminating future bleeding.

Prior to that procedure, according to Adkins’ suit, the device is designed to perform a test to ensure that the uterus is strong enough to tolerate the procedure. The suit alleged that, in a pre-surgical test, the device improperly gave a green light for surgery — it failed to show conditions that should have precluded the procedure.

Adkins’ doctor went ahead with the surgery, resulting in a thermal burn to her colon, according to the suit. Several additional surgeries allegedly were required, including a hysterectomy and a colon resection with a colostomy.

Adkins’ lawsuit alleged both that the device was faulty and that a manufacturer’s representative, who was present during the procedure, failed to ensure that the device was operating correctly and that the gynecologist was following appropriate procedures.

Cytyc’s lawyers responded by citing the recent Supreme Court decision, Riegel v. Medtronic Inc., 128 S.Ct. 999 (2008), and argued that Adkins’ product defect claims were preempted by federal regulation. Kiser agreed. He threw out those portions of the lawsuit relating to the design, manufacturing, and labeling of the device.

As the judge remarked in a footnote, the “main focus” of the suit was on a standard products liability negligence theory, and that theory was “effectively destroyed by the intervening Riegel decision.”

Nevertheless, Kiser ruled that Adkins could go ahead with her claims involving the manufacturer’s representative. Because those allegations were not as thoroughly described as the product liability claim, Kiser allowed Adkins’ lawyers to file an amended complaint to flesh out the case against the representative.

Kiser warned, however, that Adkins may shoulder a heavy burden in building a case solely on the actions of the manufacturer’s representative. Adkins’ lawyers will have to show that negligent instruction by the representative, rather than any faults in the device, was the more likely cause of the injuries.

One of Adkins’ lawyers, W. Wirt Brock of Roanoke, said that he was working on an amended complaint and hoping to prevail. “We plan to make it stick,” he said.

Brock acknowledged that the new legal landscape for medical product claims makes it tough for injured patients. He said the Adkins legal team will be closely watching another preemption case now pending before the U.S. Supreme Court. That case, Wyeth v. Levine, involves a claim against a pharmaceutical maker.

The Adkins case is scheduled for a jury trial in Danville beginning Dec. 8.

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