ATLANTA — Med-tech companies shouldn’t expect a long lasting victory from last month’s Supreme Court Case ruling in the case of Riegel v. Medtronic (Minneapolis) according to a panel speaking on critical issues with product liability at the Southeastern Medical Device Association’s (SEMDA; Norcross, Georgia) conference at the Ritz Carlton here in Atlanta last week.

The ruling in the case sets a precedent that gives protection against thousands of lawsuits filed against companies who receive premarket application (PMA) approvals from the FDA, saying patients generally can’t sue in state courts for defects in products that have received that agency approval (Medical Device Daily Feb. 21, 2008).

A key question in the case was when the “pre-emption” provision in the 1976 Medical Device Amendments kicks in to bar state lawsuits that claim a product is defective or that a manufacturer failed to warn of risks.

The federal law says pre-emption applies when the U.S. government imposes a “requirement,’’ but not specifying if this term applies to FDA approval.

“There was not an answer to the question as to whether PMA had a pre-emption defense until this case,” Caryn Silverman an attorney with Partner, Sedgwick, Detert, Moran & Arnold, and panelist said during the conference. “Now we have a window here where manufacturerers are rushing to court to get their cases dismissed. But I don’t know how long we [in the med-tech community] remain optimistic.”

Silverman pointed out that hours after the decision was brought down some members of Congress were already working to get a draft of a bill that would hold med-tech companies accountable for PMA defects.

In a statement sent to media outlets Sen. Ted Kennedy (D-Massachusetts) sharply disagreed with the court’s ruling and touted that Congress needed to correct the decision (MDD, Feb. 25, 2008). The panel said that a draft was already on the table.

“In essence this draft would allow for patients to sue [med-tech companies] in the case of PMA devices with defects,” she said.

By now the background for the case is well known throughout the med-tech community.

In 1996, Charles Riegel underwent a balloon angioplasty with a stent placement, with Medtronic’s Evergreen serving as the balloon catheter. The Evergreen’s label indicated a maximum inflation rate of eight atmospheres and the device was contraindicated for patients with calcification in the affected arteries. However, the surgeon inflated the Evergreen used on Riegel to 10 atmospheres causing the device to rupture, and Riegel’s arteries were demonstrably “heavily calcified,” according to lower court documents.

The plaintiff lost the initial trial and subsequent appeal. Riegel died three years ago, and the case was being pursued by his widow.

“Once the results of this case were published our phones rang off the hook,” said panelist Patty Nichols, a Medical Technology Underwriting Leader, with Travelers Insurance. “Companies wanted to know what this was going to mean for them.”

She said the Insurance agency is taking a wait and see approach and an increase or decrease in premiums was really going to rely on the bill drafted in response to the Supreme Court’s decision.

“But even still a small percentage of our clients are working with PMAs,” Nichols said. “We have to remember there is no protection for 510Ks. This case is going to have a very limited and short term affect ... .”

The panel switched gears and discussed company liability in clinical trials a topic that incurred some discussion from the audience. To illustrate the issue, the panel discussed the Guckin V. Nagle case in which the patient filed suit because the surgeon, who also functioned as a clinical investigator in a trial, recommended an experimental intervention as “the best therapeutic alternative for a patient’s occasional fecal incontinence.

The patient’s anal sphincter was permanently damaged when the radio frequency device overheated and failed to shut off automatically. The consent form did not indicate that the procedure was part of a clinical trial, nor did it mention alternative treatments.

The patient successfully argued that she was a victim of “therapeutic misconception,” that is, she believed that the intervention would directly benefit her based on the information provided by the surgeon and consent form.

Nichols said the companies must incorporate language into the consent form that can be understood by someone who has an 8th grade reading level to insure full protection.

“Are all of the risks put on the patient consent form explained in a way so those who sign it know what they’re getting into and can understand it,” Nichols said. “It has to be clear to the patient.”