- The Washington Times - Tuesday, October 12, 2010

The Supreme Court heard arguments in a case Tuesday that could pave the way for numerous lawsuits against vaccine manufacturers, a particularly high-stakes issue in light of the thousands of claims, so far unproven scientifically, linking vaccines to autism.

In the case before the high court, the parents of an 18-year-old woman who suffers from severe developmental disabilities want to sue a vaccine manufacturer and argue broad legal immunity for such companies shouldn’t apply in this case.

They challenged a 1986 federal law that says vaccine manufacturers can’t be sued “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Much of Tuesday’s arguments focused on the meaning of the word “unavoidable” in the context of the law.

Attorneys for the parents of Hannah Bruesewitz said the adverse effects she suffered could have been avoided because the company, Pfizer Inc.’s Wyeth, had a safer vaccine available when she was immunized in 1991.

Attorneys for Wyeth dispute that a safer alternative existed.

Several justices said the Bruesewitzes’ argument that the side effects were avoidable because a safer vaccine could have been used was problematic.

Justice Antonin Scalia said that allowing people to sue vaccine manufacturers on the basis that another company makes a safer vaccine could lead to manufacturers removing potentially harmful ingredients, which would make vaccines safer, but far less effective.

“As has been said, the government interprets ‘unavoidable’ to mean unavoidable with respect to the vaccine that has been approved,” Justice Scalia said. “If it doesn’t mean that, if it simply means unavoidable with some other vaccine, you could always avoid them if you have a vaccine that is significantly less effective.”

But other justices, such as Justice Sonia Sotomayor, expressed concerns that the immunity vaccine manufacturers have provides no motivation for them to improve vaccines and make them safer. She also didn’t seem to buy the arguments that allowing certain cases to go to court would cripple the vaccine-manufacturing industry.

“I do understand the cost of litigation. It can be very, very onerous,” she said. “So I’m not trying to minimize it, but I do think that there’s a whole lot of hurdles in place before a plaintiff wins on one of these claims.”

Congress passed the 1986 federal law, known as the Vaccine Act, in response to a rising tide of lawsuits against vaccine manufacturers that lawmakers feared would cause manufacturers to stop making crucial vaccines. The act created a so-called “vaccine court” in which the federal government pays people who suffer side effects after taking vaccines. According to court documents, the court has paid out $18 billion since it opened and generally pays about 50 to 100 claimants each year, roughly half the number of people who file claims.

The “vaccine courts” have two methods to determine whether to award compensation: People must either prove the vaccine caused the side effects or show they suffer from a specific illnesses that the government has already listed among those for which compensation is automatic.

Ms. Bruesewitz’s parents went to the “vaccine court” in 1995, claiming she suffered residual seizure disorder, but the federal government had removed that affliction from the list of illnesses for which it will pay compensation a month earlier. Lawyers for Wyeth say that’s because there is no evidence the vaccine causes residual seizure disorder.

The “vaccine court” ultimately determined the Bruesewitzes did not prove the diphtheria-tetanus-pertussis vaccine she received as a 6-month-old caused her afflictions. Ms. Bruesewitz was healthy before receiving the vaccine, and her symptoms, including major seizures, began hours after her immunization.

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