Vaccine productionSupreme Court ruling renders vaccine manufacturers immune to lawsuits

Published 15 March 2011

The Supreme Court ruled in favor of vaccine manufacturers declaring that they could not be sued in state court for damages as a result of design-defects in their products; the court found six to two that the National Childhood Vaccine Injury Act protects vaccine manufacturers from design-defect claims; the law was passed in response to a massive increase in litigation against vaccine manufacturers that led to a shortage of vaccines; Justice Sotomayor and Ginsberg dissented; the two argued that the decision leaves a regulatory void and insufficient oversight over vaccine manufacturers; proponents say that this helps stabilize the vaccine market and protects children

Supreme Court upholds shield for vaccine makers // Source: antalvali.com

The U.S. Supreme Court recently ruled in favor of vaccine manufacturers declaring that they could not be sued in state court for damages as a result of design-defects in their products.

The court found six to two that the National Childhood Vaccine Injury Act protects vaccine manufacturers from design-defect claims.

The case was brought to the attention of the Supreme Court after Wyeth, a vaccine producer now owned by Pfizer, was sued by the parents of Hannah Bruesewitz. Her parents claim that a dose of Wyeth’s diphtheria-tetanus-pertussis vaccine induced seizures and caused developmental delays in their daughter. Wyeth insisted that the company did no wrong.

The Supreme Court ruling is based on the 1986 National Childhood Vaccine Injury Act, which was passed by Congress in response to a massive increase in litigation against vaccine manufacturers that led to a shortage of vaccines.

From 1978 to the mid-1980s, dramatic rises in product liability lawsuits drove two of the largest domestic manufacturers out of business.

To combat the growing shortage of vaccines, Congress created a law to shield vaccine manufactures from tort litigation and help stabilize the vaccine market. Under the National Childhood Vaccine Injury Act, individuals can file for compensation against a vaccine manufacturer in the U.S. Court of Federal Claims.

In the majority opinion, the Supreme Court found that the law, “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the [Food and Drug Administration] and the National Vaccine Program, rather than juries.”

In her dissent, Supreme Court Justice Sonia Sotomayor, wrote that the court’s ruling “misconstrues the Act’s legislative history, and disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market.”

She added, “Its decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”

Ruth Bader Ginsberg joined Sotomayor in dissenting.

Critics echoed these sentiments claiming that the ruling effectively denies parents effective recourse when vaccines are defective or cause irreparable damage.

 

Louise Kuo Habakus, a vaccine safety advocate said, “The Court is telling parents that they’re on their own.  Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program. The Supreme Court has slammed the courthouse doors shut.”

A Los Angeles Times editorialdefends the decision, arguing that while it may seem unfair to consumers to give vaccine manufacturers immunity from lawsuits in state courts, the Supreme Court’s ruling was ultimately correct.

 

The editorial reasons, “Consumer groups long have argued that preemption of state claims against pharmaceutical companies and manufacturers of medical devices unfairly tilt the law against consumers. That may be true as a general proposition. But preemption in the case of vaccines serves the interests of children because the uncertainty caused by state actions in vaccines cases can deter the manufacture of new vaccines.”