Lawsuit Against Valve-Maker Dismissed : Litigation: Irvine-based Shiley Inc. will not have to notify recipients of its heart valves about potential defects. The consumer group seeking to force the firm to do so will appeal the court decision.


Pfizer Inc., the parent company of Irvine-based Shiley Inc., said Thursday that a Los Angeles Superior Court has dismissed a consumer group's lawsuit seeking to force the company to notify recipients of Shiley heart valves about potential defects.

Judge Ronald M. Sohigian on Wednesday accepted the company's argument that Congress has given the U.S. Food and Drug Administration authority that supersedes the state's in the area of medical devices.

"Judge Sohigian's decision thus upholds the supremacy of federal regulatory law relating to medical devices and leaves intact the longstanding policy of both FDA and Pfizer and Shiley of communicating with patients through their physicians," Pfizer said.

Jim Capretz, attorney for the Public Citizen Health Research Group, a Washington-based organization founded by Ralph Nader, said the group will appeal the decision in the state courts. Capretz contends that a state court can make a decision about how Shiley heart valve recipients should be notified because the FDA has not taken any action in this area.

"The FDA has never used its power (since it received the authority from Congress in 1976) to force any manufacturer to notify patients or physicians about any problems or defects in any medical device," he said.

Capretz also said the Public Citizen Health Research Group will petition the FDA to require warnings to be sent directly to more than 85,000 people who received implants of certain Convexo-Concave heart valves made by Shiley. The valves have not been used since 1986.

"The real human issue is that notice, in our opinion, will save lives," he said.

Since the first of two Shiley valves that are the center of controversy went on the market in 1979, the company has reported 389 failures resulting in 272 deaths.

In addition to demanding patient notification, the consumer group's lawsuit had sought payment for medical examinations and psychological counseling for heart valve recipients. The FDA's current policy calls for the valve manufacturer or the hospital at which a heart valve is implanted to notify physicians about defective devices. The physicians, in turn, decide how to advise their patients.

Shiley has periodically sent warning letters to cardiologists and other physicians since 1980 after the first valve fractures were reported and the valves began to be pulled off the market. Earlier this year, the company sent more than 270,000 letters to physicians and emergency room practitioners nationwide to update them about the risks and to describe symptoms to look for in patients whose implanted valves may have fractured.

The FDA currently is conducting a series of public hearings to determine whether to revise its public notification procedure.

The court action seemed to boost investors' confidence in the company on Wall Street. Pfizer's stock closed at $65.87 a share, up $2.25, in heavy trading Thursday on the New York Stock Exchange.

Analysts said Pfizer's court victory was welcomed by investors, who have had serious concerns about the company's mounting financial liability from an onslaught of lawsuits filed by valve recipients or their survivors.

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