Nader Group Sues Heart Valve Firm : Lawsuit: The nonprofit Public Citizen is demanding that 80,000 people receive a prompt medical consultation and a warning of the dangers posed by the device.
A Washington watchdog group filed a sweeping lawsuit Wednesday against an Orange County company that made faulty artificial heart valves, demanding that all 80,000 people whose lives depend on the mechanical devices receive a prompt medical consultation and a warning of the dangers posed by the device.
The consumer-protection lawsuit, filed in Los Angeles Superior Court by Public Citizen, a nonprofit group founded by Ralph Nader, is the biggest lawsuit yet filed against Irvine-based Shiley Inc. over potentially fatal defects in its Bjork-Shiley artificial heart valves.
The lawsuit represents all of the approximately 80,000 people who have received the valves worldwide; about half are believed to be in the United States. Breakage of the valves has killed at least 248 people worldwide, according to company statistics.
“We are asking the question for each person who has an implanted (Shiley) valve: Are they entitled to know the risk, the danger signs and what to do?” attorney Kenneth S. Kasdan said. Shiley and its New York-based parent firm, Pfizer Inc., have been named in scores of lawsuits filed by the families of people who died or suffered serious injury when their artificial heart valves broke and by others who live with the daily fear of a malfunction.
Wednesday’s lawsuit differs from others against Shiley in several ways. It demands no monetary damages, but seeks a court order forcing Shiley to notify every valve recipient that the device carries a high risk of failure, tell patients what they can do to minimize their risk of trouble and inform them of the signs that a malfunction is occurring. Shiley would also have to finance a medical examination for each implantee and psychological counseling for those who want it.
Pfizer issued a statement attacking the lawsuit as “totally without merit” and asserting that the benefits of the Bjork-Shiley valves outweigh the risks. “Bjork-Shiley heart valves have saved the lives of tens of thousands of patients,” said Pfizer spokesman Rick Honey. “All but a small fraction of 1% of these valves continue to function properly. Suits like (Wednesday’s) frighten cardiac patients unnecessarily and ultimately do much more harm than good.”
Of the 87,500 valves produced, about 389 have fractured, Honey said. He added that Pfizer has met its obligations by repeatedly urging the surgeons who implanted the devices to “educate and monitor” their patients.
Dr. Sidney M. Wolfe, director of Public Citizen’s Health Research Group, said informing surgeons about the valve’s risk of failure is not adequate because many patients received the devices years ago and are now seeing other doctors.
“There is a massive number, tens of thousands of patients, who are completely unaware of this problem,” Wolfe said. “It’s worse than having a ticking time bomb in your chest.”
Valve recipients are caught in a difficult position, Wolfe said, because surgery to replace the faulty devices is more risky than leaving them in place. If the valve does fail, however, patients who have been educated to recognize the symptoms and act quickly can “dramatically improve their chances of survival,” Wolfe said.
Shiley, which pioneered the manufacture of artificial heart valves after its founding in 1966, has been criticized for two models it manufactured and sold between 1979 and 1986. Shiley was acquired by Pfizer in 1979.
The devices were designed to replace diseased or deformed tissue that regulates the flow of blood through the organ. One model--the “60-degree convexo-concave” valve, so-called because it opens 60 degrees--was withdrawn by the company in 1986 after the U.S. Food and Drug Administration began moving to suspend its sale because of reports of cracking.
Another, the “70-degree” model, was sold only overseas from 1980-1983. One study concluded that model had a rate of fracture that was seven times greater than the 60-degree version.
Soon after the 60-degree model began being sold in 1979-80, reports of valve fractures began cropping up. In two-thirds of those cases, the patients died. In testimony before a House subcommittee last month, acting FDA Commissioner James S. Benson admitted that the agency had waited too long before beginning action to pull the Shiley valves off the market.
Shiley’s “convexo-concave” valve consists of a flexible disk installed in a half-dollar-sized metal ring, which is in turn surrounded by another ring that is sewn into the heart. The disk, which replaces the damaged heart valve, opens to let blood flow through as the heart beats, and then closes, making a tiny but audible clicking sound. It is held in place by two wire holders called struts. The problems have occurred in struts that break or fracture, allowing uncontrolled blood flow through the heart.
Shiley and federal investigators have said the risk of death for a patient whose struts break is greater than 50%. Plaintiffs’ lawyers have put the risk as high as 66%.
Honey said Pfizer has settled about 200 lawsuits and claims filed by people whose valves have fractured, or by their relatives. Still others are pending, but the exact number is not known. Dozens more lawsuits were filed by implantees who fear that their valves might fail, but Pfizer has settled only one of those so-called “anxiety suits” and does not intend to settle any more, Honey said.
“People whose lives are being sustained by the valves have no reason to sue us,” Honey said.
Shiley is selling a new “Monostrut” heart valve overseas and is seeking FDA approval to market it in the United States.
