Does federal law shield the makers of vaccines from product-liability lawsuits? Last week, the US Supreme Court began considering this question, which is the heart of a lawsuit against Wyeth, now a part of Pfizer (New York).
After receiving a diphtheria–pertussis–tetanus (DPT) vaccine, Hannah Bruesewitz began having seizures and later experienced developmental problems. Blaming the vaccine, the girl’s parents turned to the “vaccine court” established by Congress. The court denied them compensation because the alleged injuries had been removed from a list of those that qualified. The Bruesewitzs subsequently filed a product-liability suit against Wyeth, which had acquired the vaccine’s manufacturer. Lower courts ruled that the Vaccine Act of 1986, which established the vaccine court, barred such claims.
Justice Ruth Bader Ginsburg finds the law’s language confusing, according to a report by UPI. It says that “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after Oct. 1, 1988, 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.” Congress “could have said simply that no vaccine manufacturer may be held civilly liable if the vaccine is properly prepared and accompanied by proper directions and adequate warnings,” Ginsburg said last week. Despite being asked to amend its statement, Congress did not. The Court could conceivably interpret the wording about unavoidable side effects as leaving the door open to product-liability suits.
Drugmakers might fear that such an interpretation would lead to a flood of lawsuits that could drive vaccine manufacturers out of business. The Vaccine Act was passed to prevent such an occurrence and maintain the country’s vaccine supply. In the 1980s, before the Act, many patients filed claims against makers of the DPT vaccine. Courts required some manufacturers to pay claimants large awards, and many companies ceased production. Through the Vaccine Act, Congress established the vaccine court, which pays compensation from a fund generated by an excise tax on vaccines.
If we do not maintain our supply of vaccines at an adequate level, public health naturally will suffer. Yet I am sympathetic to the idea that consumers should have recourse, and that drugmakers should bear responsibility, if a vaccine can be shown to cause avoidable and harmful side effects. Funding claims with an excise tax on vaccines protects drugmakers from potentially ruinous settlements, but the tax’s practical effect is that patients pay for damages when drugmakers are responsible.
The Supreme Court’s verdict could affect our health, as well as drugmakers’ costs. Patients and industry alike should follow this case closely.