A class-action lawsuit has been filed against Pfizer Inc. and its Shiley Inc. subsidiary in federal court here alleging that they conspired to hide potential defects in the manufacturing of heart valves whose fractures have resulted in about 250 deaths.
The Miami-based product liability law firm of Robles & Gonzales filed the 30-page complaint late Monday on behalf of about 55,000 recipients around the world now implanted with the Bjork-Shiley Convexo-Concave Heart Valve.
Numerous lawsuits have been filed against Shiley nationwide wide relating to the heart values. But this is the first seeking class-action status. Attorneys for the plaintiffs did not specify damages but said they would be substantial.
“We believe that the damages based on our research will be in excess of $75,000 to $100,000 per plaintiff,” said Ervin Gonzales, one of attorneys filing the suit. “That turns out to be billions of dollars.”
The suit claims Shiley was aware of the potential defects as early as 1978 but sold tens of thousands of the valves nonetheless between 1979 and 1986. Shiley voluntarily stopped selling the Bjork valve in 1986 after some implanted devices malfunctioned.
The complaint charges the company with faulty workmanship, including failing to use quality wire in the manufacture of the valve.
“They didn’t take any precautions to assure the safety of the patients who were having the heart valves implanted,” Gonzalez said. “What they were most concerned about was making a profit. They continued to market the product knowing it was defective. This is a case of corporate greed. There was a massive cover-up.”
Shiley spokesman Robert Fauteux denied the accusations.
“Pfizer is going to defend itself against this purported class action and although we haven’t seen the complaint and don’t have any details about it, we oppose claims on behalf of patients with properly functioning valves,” he said.
The suit was filed on behalf of five individuals. Three of the plaintiffs claim they have sustained physical injuries from the valve and two, who are still in good health, say they suffered all kinds of psychological problems including “severe mental anguish and suffering, shock and injury to their nervous system, emotional distress and fright” knowing the valve could fracture at any time.
Tom Shields is one of the five plaintiffs, a 30-year old Jacksonville, Fla., area man who had a Bjork-Shiley valve installed after one of his own collapsed close to Thanksgiving in 1985.
Shields said he was in “pure shock” when he read a newspaper article about the valve’s failures.
“It’s a time bomb and I’m sitting there not knowing when it is going to go off,” he said Monday. “They recall 35-cent parts on cars but they don’t do the same thing when it’s something life-threatening.”
The U.S. Food and Drug Administration has said some patients can survive a Bjork-Shiley fracture if they recognize early signs of the problem and get immediate medical attention. Shiley officials have said replacing the valves would be more risky than just leaving them implanted because the death rate from such surgery is about 5%.
Last month, the FDA approved Shiley’s plan to warn about 23,000 North Americans that artificial heart valves implanted in their chests are potentially defective. Shiley decided to notify all patients with the Bjork-Shiley heart valves in response to concerns raised by the FDA and the group Public Citizen Health Research.
The suit claims a fracture of the valve occurred at least once during clinical trials in April, 1979, but that “no changes were made to the subject valve in either design or manufacturing, as a result.”
Fauteux said the FDA was aware of that first fracture. “That’s a widely known fact that has been public information since before the valve was even approved by the FDA,” he said.
“The FDA approved the valves nonetheless because of its benefits and lifesaving capacities. No artificial heart valve or any other medical device or procedure is risk free.”
But the lawsuit claims Shiley was disguising problems. “Defendants knowingly withheld vital information from, and misled, the FDA regarding the subject valve in order to obtain approval for marketing of the valve,” the complaint said.
What’s more, it contends the company told its lead investigator in 1980--Dr. Viking Bjork--to not “release information relative to fractures to the public.”
Fauteux said Bjork was asked to wait until more complete studies could be completed.
“They had enough information before they marketed the product to know it wasn’t safe,” Gonzalez said.
Once a Shiley-Bjork valve fractures, it releases an uncontrollable flow of blood. What’s more, a mechanical disk is released into the patient’s bloodstream which can actually cut off the blood supply in other parts of the body.
“They have at times found different pieces of the valve in different parts of the body--in the lung, in an extremity, in the stomach,” Gonzalez said. “It can blow up any minute and there is nothing you can really do about it.”
Fauteux said the malfunction of Shiley valves is being greatly exaggerated, claiming the failure rate is comparable to that of other manufacturers and that in the majority of cases these valves have saved someone’s life.
“Shiley’s business is saving lives. We’ve been in that business for 25 years now and all of our products are designed to help people who are critically ill,” he said. “Our products are sold here in the United States and abroad and are highly esteemed by physicians who have saved the lives of tens of thousands of patients.”