23. VACCINE LIBEL SUITS CREATE MONOPOLY: AFFECT QUALITY AND
      SUPPLY

The risk that this year's kindergarten class will ever contract diphtheria or whooping cough is extremely small thanks to the infant immunization program. But their younger brothers and sisters might not be so lucky according to the American Academy of Pediatrics (AAP).

The problem is vaccine liability: who, if anyone, should compensate the relatively few children who suffer serious, permanent injury after vaccination?

The risk is relatively small: the AAP estimates that one out of every 310,000 pertussis (whooping cough) vaccine doses results in permanent brain damage; for every four million people who take live polio vaccine, one may contract the disease itself.

But the potential libel risk is large: Paul Stessel, of Lederle Laboratories, said that the total dollars demanded in suits now pending against the company relating to alleged injury from pertussis vaccine are "200 times the total sales of the vaccine we produced in 1983. You don't need many $10 million lawsuits to wipe out the business."

And that's one reason many companies have left the vaccine business. Live polio vaccine was once offered by three companies, now it's offered by only one. Two companies once produced whooping cough vaccine, but one of them, Wyeth, dropped out in June, 1984, and, in July, the remaining company, Lederle, doubled its prices. Both cited legal costs as the reason for their actions.

Now there are 19 vaccines offered by a single American producer. And the price of whooping cough vaccine is now 20 times higher than it was just two years ago.

The Department of Health and Human Services is beginning to stockpile vaccines against the possibility that one or another of these manufacturers might discontinue production.

Legislation that would establish a no-fault, federal compensation program for vaccine-associated injury cases --- as an optional alternative to court awards -- has been batted about both houses of Congress for more than a year, with still no final resolution.

Meanwhile, Martin H. Smith, of the AAP, said the issue, with several vaccines, is rapidly reaching a crisis point -- "we are sitting on an explosive situation, and it could have a short fuse."

SOURCES:

SCIENCE NEWS, 9/15/84, "Litigation a Threat to Vaccine Supply?," by D. Franklin; WASHINGTON POST (editorial), 9/12/84, "Immunization Risk;" NEW YORK TIMES (editorial), 10/15/84, "The Cost of Ignoring Vaccine Victims."