More than 400 Americans who say they were paralyzed in 1976 after taking swine flu shots will be compensated by the federal government without having to prove negligence on anyone's part, Health, Education and Welfare Secretary Joseph A. Califano Jr. said yesterday.
The decision to pay all "valid" claims could cost the government millions of dollars. So far 439 men, women and children - including the heirs of 23 persons who died, have claimed $365 million in damages, an average of $831,435 each.
Califano said he expected the government would end up paying only a fraction - perhaps 10 percent - of the value of the claims. A lawyer representing 14 victims said 10 percent "wouldn't be enough, and we'd sue to get more." In that case, the claims would have to be settled in court.
The government decision not to require claimants to prove negligence was, in effect, an admission of guilt for an unexpected tragedy. It could affect future federal immunization campaigns, including a probable one to protect older and other susceptible persons against an expected outbreak of Russian influenza next fall.
Several vaccine experts now think that Guillain-Barre disease or "French polio" - the king of paralysis that hit some of the 40 million or more persons who got swine flu shots - may occur during any mass immunization, not just swine flu injections.
Dr. Ivan Bennett of New York University told an HEW conference last winter that the risk of Guillain-Barre after any flu shot is about one case per 100,000 vaccinations, with one such case in 20 fatal.
Dr. June Osborn of the University of Wisconsin said that for susceptible persons this is "a very small fraction of the risk" of pneumonia or death from influenza.
But an HEW official who declined to be identified said yesterday that in considering any future immunizations "we are going to have to" do a more precise job of balancing good effects against harmful ones, assess the dollar cost of any harm - whether a cost to the government or to others - and "give everyone" a clear, written warning of possible effects.
Congress in 1976 passed a law giving vaccine makers immunity ogainst lawsuits to get them to cooperate in the government's $135 million program to try to inject all Americans after an Army recruit at Fort Dix, N.J., died of swine flu.
The disease, so named because the apparently guilty virus is harbored in pigs, spread to other soldiers, which made many scientists fear a worldwide epidemic like the 1918-19 flu, possibly swine flu, that claimed 20 million lives.
There was no such epidemic. And yesterday, 2 1/2 years later, Califano said that, with the Justice Department, "we have decided" to pay any Guillian-Barre claims proved valid. "We are not legally bound" to do so, he said, but the government did launch the "unprecedented" vaccination effort, and "the informed-consent forms given those who took the shots did not warn of a Guillain-Barre risk because "there was no evidence" of one at the time.
Califano drew on his own law experience - he was a partner in the Washington firm of Williams, Connolly and Califano before he became secretary - to estimate that negligence awards or settlements generally run around 10 percent. "Unless," he added with a laugh, "we were representing the client, in which case we generally got more."
John Estes, an Oklahoma City lawyer who said he represents 14 Guillain-Barre victims and plans to file claims for "15 or 20 more," said he, too, expects to collect more. His largest claim, he said, is for $6.5 million for a woman in her mid-30s who was totally paralyzed and hospitalized for six months and will be unable to work again.
Califano made no promises or comments on the validity of $410.7 million more in claims by 1,044 people who say they were injured by the flu shots in ways other than Guillain-Barre disease.
They range from individuals who suffered dizzy spells to those who say they are blind or deaf, or fainted after a shot and suffered severe skull or even brain damage.