A support group for recipients of Shiley heart valves urged the U.S. Food and Drug Administration Monday to require the manufacturer to pay all medical and related costs of patients who choose to have the potentially defective valves removed.
The letter, written by the leader of the Pittsburgh-based VALV, calls for Shiley Inc. in Irvine and its parent company, Pfizer Inc. of New York, to "bear all reasonable costs" of the surgery. It was written partly in response to the FDA's announcement earlier this month that the likelihood of the valves breaking is greater than previously thought.
Shiley officials say that there is greater risk in replacing the valve during open heart surgery than in leaving it in place.
In December, Pfizer offered to spend up to $205 million to settle hundreds of lawsuits from recipients and some of the survivors of those who have died when the valve cracked. The FDA has received reports of 350 fractures among 82,000 valves implanted worldwide. Attorneys for some of the 55,000 who have received the implants in the United States said the settlement would work out to about $2,000 to $4,000 per recipient.
But Shiley officials say the attorneys' figures fail to include $75 million to develop a technique that will determine the condition of a heart valve. An independent panel would then weigh the risks and recommend whether a recipient should have the valve replaced, said Shiley spokesman Robert Fauteux. The company would then pay the cost of replacement, he said.
"What the (letter) seeks is already provided for," he said.
Elaine Levenson, a heart-valve recipient and leader of the support group, said in the letter that one recipient and his family spent nearly $70,000 out of their own pockets on the surgery. She added that most insurance companies won't cover the cost of the valve replacement.
"I have a lot of confidence that (the FDA) is starting to show concern for the valve implantees," Levenson said.
The support group was founded last year and has about 200 members.