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October 12, 2010

The Justices of the Supreme Court heard arguments today in a case regarding whether a person who develops injuries from a childhood vaccination can file a lawsuit against the vaccine maker if that drug company could have offered a safer vaccine.

In 1986, the U.S. government enacted the National Childhood Vaccine Injury Compensation Act in an effort to encourage pharmaceutical companies to continue the manufacture of vaccines and ensure an adequate supply of them by reducing the financial liability of the drug companies from vaccine injury claims. Congress felt that substantial awards in vaccine injury lawsuits could deter pharmaceutical companies from developing and manufacturing vaccines.

Under this law, those injured or killed by certain vaccines, or their guardian, must first file injury claims through the National Vaccine Injury Compensation Program (VICP), called vaccine court, instead of suing the vaccine maker.

Health and Human Services and the Department of Justice review VICP vaccine injury claims and file a combined report with the U.S. Court of Federal Claims. A special master, a lawyer appointed by the judges of the Court, then decides if the claim will be paid and the amount. The injured party may accept or reject the award from the special master and can the appeal the decision to a judge of the Court by the petitioner or HHS, then to the U.S. Court of Appeals for the Federal Circuit, and finally, to the U.S. Supreme Court.

Compensation the injured person may receive from the VICP program is restricted to a reasonable amount for medical care, lost earnings, reasonable attorneys’ fees and legal costs, and up to $250,000 for pain and suffering compensation. Wrongful death claims are restricted to reasonable attorneys’ fees and legal costs plus $250,000.

Awards are paid from a compensation trust fund funded by a .75-cent excise tax on every vaccine purchase.

There are currently more than 5,000 vaccine injury claims before the VICP vaccine court.

According to the Washington Post, the parents of Hannah Bruesewitz and their attorney David C. Frederick filed the case Bruesewitz v. Wyeth (09-152), because their infant daughter developed seizures and will require life-long care after receiving the Tri-Immunol diphtheria-pertussis-tetanus vaccine made by Wyeth Inc., which is now part of Pfizer Inc.. They allege their daughter’s injury was avoidable because Wyeth owned another vaccine for the same diseases that had fewer side effects but the company and U.S. Food and Drug Administration failed to encourage approval of this potentially safer vaccine.

The Bruesesitzes had first filed a claim with the VICP that the special master denied. They then filed a personal injury tort lawsuit in the court of Pennsylvania. However, the court would not allow the lawsuit to proceed because federal law prohibits lawsuits for defective vaccines.

The Justices of the Supreme Court must now interpret just what Congress meant when it passed this law as it does not specifically exempt vaccine makers from all injury lawsuits. The court must decide whether those injured by vaccines have the legal right to sue the manufacturers if a safer vaccine was available.

"The language that they used is certainly, to say the least, confusing," said Justice Ruth Bader Ginsburg.

"What is the motivation for the manufacturer to either continue the testing of their product and voluntarily stopping it if a better design has been found by someone else, or even an inducement for them to find a better design if a competitor comes around?" Justice Sonia Sotomayor asked during today’s argument. "Because I don’t see why they should stop until they have caused as many injuries as they need to before the FDA says stop."

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