Lawsuits could threaten to create shortages at the cost of many lives

The Supreme Court last week heard oral arguments in Bruesewitz v. Wyeth, a case concerning a Mt. Lebanon infant who tragically exhibited seizures and mental disabilities shortly after receiving a whooping-cough vaccine manufactured by Wyeth Pharmaceuticals (now part of Pfizer). The case has huge implications both for the future of the vaccine industry and public health.

Vaccines have saved more lives than any other drug or device in the history of modern science. But in rare cases, vaccinating infants can still cause serious or even life-threatening adverse effects. It’s vital that we encourage parents to continue vaccinating children, and it’s just and proper to compensate families who suffer in these cases.

But America’s liability system has already proved itself ill-equipped to deal with such events. After a 1974 British study suggested dangers stemming from the whooping-cough vaccine, U.S. personal-injury lawyers filed a wave of lawsuits against vaccine manufacturers. In 1985, such lawsuits sought over $3 billion in damages. Vaccine manufacturers understandably started pulling out of the market, and the price for the whooping-cough vaccine shot up 10,000 percent.

In 1986, Congress reacted to this crisis by passing legislation that pre-empted state courts from handling vaccine lawsuits. Congress established an alternative compensation system -- the Vaccine Injury Compensation Program -- which puts all childhood vaccine injury claims before a specialized judicial panel.

Now 25 years old, the VICP has been a stunning policy success. The families of children genuinely injured by vaccines have been compensated well. Under elaborate federal testing regimes, vaccines have grown safer since the VICP was established.

But the VICP has taken a bite out of trial lawyers’ business, and they have been working aggressively to get around the program. The VICP court determined that in the Bruesewitz case there was no scientific basis to conclude that the vaccine had caused young Miss Bruesewitz’s medical hardships.

The Bruesewitz’s lawyers are attempting an end-run by claiming that the infant’s alleged side effects were “avoidable” -- they say Wyeth could have used an alternative vaccine design developed in the 1960s by Eli Lilly, even though Lilly’s design was never accepted as safer by the Food and Drug Administration.

“Design-defect” cases like the Bruesewitz’s are precisely what Congress was trying to pre-empt with the VICP. The medical community realizes that if the Bruesewitz’s prevail, vaccine availability could be seriously threatened.

Original Source: http://www.post-gazette.com/pg/10294/1096725-109.stm