October 4, 2010
by Ed Silverman
Next week, (10/12) the US Supreme Court will hear a case that is being closely watched because of the enormous health and legal implications for drugmakers and parents, among many, many others – whether the family of an 18-year-old Pennsylvania woman should be allowed to proceed with a lawsuit against Wyeth for defects with its diphtheria, pertussis and tetanus, or DTP vaccine. She was vaccinated when she was six months old and now suffers from residual seizure disorder.
At issue is the underlying notion of preemption – in this case, whether a federal law known as the National Childhood Vaccine Injury Act of 1986 prevents the family of Hannah Bruesewitz to press their lawsuit, which was rejected by (the federal vaccine court) that is empowered to provide compensation. The Bruesewitz family then filed a lawsuit in state court before it was moved to federal court and, later, dismissed (see this).
The law says that a vaccine maker should not be held liable in a civil acdtion if an injury was caused by unavoidable side effects, “even if the vaccine was properly prepared and was accompanied by proper directions and warnings.” In other words, the provision bars lawsuits in state courts but with an exception – claims except those alleging a manufacturing defect or a failure to warn. And that is what the family is citing as it proceeds to the US Supreme Court.
In their brief, the family argues that allowing design-defect claims for “preventable harms” would provide incentive for vaccine makers to conduct adequate research, design their vaccines as safely as possible, and incorporate scientific advances into vaccine design to protect the public from unnecessary harm.” They also maintain that lawsuits can promote FDA because they help to disclose side effect info the agency does not require as part of the regulatory approval process.” And they add that, if the Supreme Court lets the previous decision stand, “injured children would be denied redress even for injuries caused by recklessly designed vaccines or vaccines that a manufacturer knew would cause unnecessary harm. No sound policy justifies such a result.”