New Plaintiffs in Heart Valve Suits Allege Fear of Death
Until recently, most of the lawsuits filed against medical device manufacturer Shiley Inc. in Irvine involved fractures in a type of heart valve associated with at least 134 deaths.
In a new twist, however, patients whose Bjork-Shiley convexo-concave heart valves are still intact are now suing, alleging they live in “fear of sudden death” should the valves break.
Last week, 84 Bjork-Shiley valve recipients who live in Sweden sued Shiley in Orange County Superior Court for an unspecified amount of damages.
The number of suits filed on behalf of patients whose heart valves remain intact is relatively small, perhaps no more than 100 out of an estimated 84,000 recipients. None of the cases involving functioning valves has yet gone to trial or been settled by Shiley.
Suits May Increase
But it seems likely that the number of such cases will grow, plaintiffs’ lawyers said Tuesday.
“The word is starting to get out to people who have the valves,” said Bruce Finzen, a Minneapolis lawyer who filed the Swedish suits.
“I suspect we’ll see a lot more.”
Finzen’s firm, Robins Kaplan Miller & Ceresi, also handled many of the lawsuits in a much bigger liability case, A.H. Robins’ Dalkon Shield, a contraceptive device associated with sterility and other medical problems among thousands of women users.
That is one reason the Swedish valve recipients brought their case to the firm. Also, U.S. product liability law generally favors plaintiffs more than the laws in European countries.
The Bjork-Shiley valves received an enthusiastic reception in Sweden. A Swedish surgeon helped develop the device, clinical trials were held in Sweden and the device got a lot of publicity in that country.
The problems with the valve are getting a lot of publicity these days, Finzen said, leading his clients to file suit.
Finzen said his firm has filed most of the lawsuits pending against Shiley, a subsidiary of the giant pharmaceutical company Pfizer of New York.
While Shiley has settled some previous cases involving deaths attributable to heart valve failures, it has indicated it will fight lawsuits where no fracture of the valve is involved, Finzen said.
The company declined to comment on the lawsuits Tuesday.
Shiley stopped making the Bjork-Shiley heart valve in October, 1986, shortly before the Food and Drug Administration was to consider rescinding approval of the device.
The tiny circular valve also underwent three different recalls in the 1980s.
The problems involve a metal strut fastened to a disk that opens and closes inside a metal ring, regulating the flow of blood through the valve. The strut has fractured in a small percentage of the valves, causing the disk to float away.
Patients whose valves fracture require immediate open heart surgery. Two-thirds of patients whose valves malfunctioned have died, according to plaintiffs’ lawyers.
The valve makes a tiny--but audible--clicking noise when it is working, a constant reminder to a person with an implant.
Having the valve replaced isn’t a good alternative: The risk of dying from open-heart surgery is greater than the risk of dying from a fracture, according to the company.
Shiley faces as many as 200 pending suits involving failures of Bjork-Shiley valves, according to Public Citizen Health Research Group, a Washington organization founded by Ralph Nader.
The FDA has attributed at least 134 deaths to fractured valves. The number of patients who have survived valve failures is unknown.
Shiley has has settled about 30 suits involving deaths, some for as much as $1 million each, the organization said.
The Nader group is critical of both Shiley and the FDA for keeping the device on the market until late 1986.
“The people filing these suits are very upset, and understandably so,” said Dr. Sidney Wolfe, the organization’s executive director.
“They know that if something goes wrong, they stand a one-in-three chance of living, though their odds are better if they camp out across the street from an open-heart surgery center.”
But winning lawsuits where a fracture is not involved will be difficult, even under California’s lenient liability laws, said one plaintiff’s lawyer, because the suits involve a largely unexplored area of product liability.
A plaintiff might have to prove that Shiley showed gross negligence or recklessness to recover any damages from mental anguish over the possibility that the valve might fail.
“The normal procedure with a faulty product is to repair or replace it,” said Mark Edwards, a Tustin lawyer who has settled some cases with Shiley involving fractured valves. “Obviously you can’t do that here. So some of these people are ticking time bombs.
“This is a very unique area of the law, and I have no idea what the courts will do.”
Even should plaintiffs start to win such suits, it is unlikely to have much effect on giant Pfizer, which reported $690 million in profits last year.
“They should be able to weather this rather easily, regardless of what the outcome is,” said Neil B. Sweig, a stock analyst at Prudential-Bache Securities. “We’re talking about a company with $5 billion in worldwide sales.”
Pfizer, which is said by analysts to be extraordinarily sensitive about the valve cases, is the only drug company to make heart valves. Its chief competitors are medical-device companies, one of which--Baxter International of Deerfield, Ill.--is having the same problems.
Baxter suspended sales of its Edwards-Duromedics Bileaflet valve in May after 12 of 20,000 implants malfunctioned, resulting in six deaths.
A subsidiary, Baxter-Edwards, also based in Irvine, was recently hit with a suit filed by a person who alleges mental anguish from worrying about a possible fracture.
While most heart devices such as pacemakers have proven profitable, the valve business “has caused nothing but grief,” Sweig said.
“Other drug companies have stayed away and with good reason.”
Even Shiley has been shying away from the business. According to the company, valves accounted for only 18% of its $200 million in revenue last year, down from 46% in 1982.
