Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: THURSDAY, March 22, 1990 TAG: 9003221927
SECTION: BUSINESS PAGE: B7 EDITION: STATE
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
Public Citizen asked the court to order Shiley Inc. and its parent company, Pfizer Inc., to notify all those who have had the valve implanted about alleged defects and possible life-threatening consequences if it fails.
The suit also asked that the companies pay for psychological counseling and medical consultation to advise these people of the risks and benefits of having the valve removed, the symptoms of valve failure and emergency steps to be taken if those symptoms occur.
The group, founded by consumer activist Ralph Nader, filed the lawsuit in Los Angeles County Superior Court.
Shiley's principal offices are in California.
Pfizer, based in New York, said the suit is "completely without merit" and will "frighten cardiac patients unnecessarily and ultimately do much more harm than good."
Pfizer said the valves "have saved the lives of tens of thousands of patients. All but a small fraction of 1 percent of these valves continue to function properly."
The device is called the Bjork-Shiley Concavo-Convex heart valve, also known as the Shiley valve. It was implanted in more than 80,000 people, including about 40,000 in the United States.
The Food and Drug Administration approved the valve in April 1979, but after reports of malfunctions, Shiley removed it from the market in November 1986.
The company has reported to the FDA nearly 400 failures of the valve, 248 of which resulted in death.
The valve consists of a disc inside a metal ring covered by a Teflon sewing ring that is sutured to the heart to hold the valve in place. The disc, pivoting on two thin metal struts, opens to allow blood to flow through, and then closes.
The malfunctions have involved fractures of the struts. When a fracture occurs, the disc escapes from the ring, allowing an uncontrollable blood flow through the heart.
The lawsuit alleged that Pfizer and Shiley were aware of problems with the valve but engaged "in a course of conduct . . . designed to prevent the true facts regarding the risks created by the implantation of the defective valves from being known and to shield themselves from legal liability through deliberate concealment of material facts."
Pfizer said it notified all physicians who have implanted the valves "of the very small fracture risk" and advised them to educate and monitor their patients.
"We believe this is the proper and most effective way to communicate with patients about such a sensitive medical issue," the company said.
It added that the FDA has endorsed this method of communication.
But Public Citizen said that surgeons who implant the valves "do not ordinarily follow their patients for more than a few weeks after surgery."
The lawsuit also alleged that Pfizer's letters "failed to contain accurate and complete information" about the risks posed by the valves.
by CNB