FDA Asked to Order Warnings to Heart Valve Users

A consumer group on Wednesday asked the Food and Drug Administration to order an Orange County company to warn users of its mechanical heart valves that the devices might be defective.

Public Citizen, a Washington-based organization affiliated with Ralph Nader, estimated that warning notices should go to about 56,000 people with heart valves manufactured by Shiley Inc. of Irvine, a subsidiary of the Pfizer Inc. pharmaceuticals firm.

The group filed a civil lawsuit against Shiley in Los Angeles seeking a court order requiring the notification. The suit was dismissed in May after a judge found that the FDA had sole authority to issue such an order.

Shiley voluntarily stopped making the controversial valves in 1986, after defective welds were blamed for deaths around the world. The FDA attributed 246 deaths to defective Shiley valves, but other estimates are far higher.

Nearly 82,000 valves were implanted before the devices were withdrawn from the market. The consumer group said that at least 56,000 people who still have Shiley valves should be warned so they can consider having surgery to replace them.

The group said the warning notices also should describe the signs of imminent valve failure and the emergency steps that should be taken to minimize the risk of a malfunction causing death or serious injury. The notices also should identify hospitals where open-heart surgery can be performed to replace a defective valve in an emergency, the group said.

“All available evidence indicates that lives will be saved if more patients are notified directly with truthful and accurate information,” said Dr. Sidney M. Wolfe, director of Public Citizen’s health research group.

FDA guidelines call for sensitive medical information to be conveyed to patients through their doctors. A spokesman for Shiley said the company has followed that policy in connection with the heart valves and will continue to do so unless instructed otherwise by the FDA.

Susan Cruzan of the FDA said the agency was reviewing its notification policy for patients with heart valves. She said that the Public Citizen petition would be considered as a part of that process.