The U.S. Supreme Court will begin hearing arguments later on Tuesday in a case that could shake up protections aimed at keeping vaccine makers in business.
The high court has agreed to hear a Pennsylvania case involving a lawsuit by the parents of Hannah Bruesewitz, now 18, who suffered seizures after her third dose of a diphtheria-tetanus-pertussis (DTP) vaccine, one of the regular childhood vaccines.
Normally, such cases are referred to a special no-fault program that compensates people genuinely harmed by vaccines. In this case, the parents, Russell and Robalee Bruesewitz, sued the vaccine manufacturer, Wyeth, now owned by Pfizer Inc.
They say the vaccine has an outmoded and flawed design and contained toxins that caused the seizures. They say Hannah has suffered developmental problems since then.
At issue is the National Childhood Vaccine Injury Act of 1986.
Congress passed the law to prevent repeated lawsuits against vaccine makers and says no manufacturer is liable for injuries from “side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”
The question before the court is whether suits over the design of a vaccine may bypass the vaccine compensation system.
State courts have issued conflicting rulings on the question.
The Georgia Supreme Court found that federal law allows some design defect claims against vaccine manufacturers while a U.S. appeals court in Philadelphia ruled Congress expressly prohibited such lawsuits in an effort to shield manufacturers from liability.
President Barack Obama’s administration agrees federal law prevents such design defect lawsuits in state courts. The Department of Justice filed a friend of the court brief asking the Supreme Court to rule against the Bruesewitz family.
Public health experts argue vaccines are vital to the health of the nation as a whole and say no drug company will make them if they must fear repeated lawsuits.
“Withdrawal of a vaccine is particularly damaging because vaccines are administered not only to immunize individuals, but also ‘to reduce transmission of infection and thereby to prevent disease even in non-vaccinated individuals, thus to protect communities,'” the Justice Department argues.
The vaccine injury program has a pot of money, provided by a tax on vaccines, to pay people genuinely injured by vaccines.
Pfizer has said it was “hopeful that the Supreme Court will affirm” the Philadelphia appeals court ruling in Wyeth’s favor.
(Reporting by Jim Vicini and Maggie Fox; Editing by Jerry Norton)
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