The 1986 National Childhood Vaccine Injury Act, passed by Congress, holds that vaccine manufacturers cannot be held liable for injuries due to vaccine side effects except in cases of manufacturing defects and improper warning claims (marketing defects). That much is agreed by the plaintiff and the drug manufacturer in the case of Bruesewitz v. Wyeth before the Supreme Court. The Obama Administration, siding with the pharmaceutical industry in this lawsuit, was represented in the Supreme Court by Mr. Horvich, Assistant to the Solicitor General, Department of Justice.
What is in question is whether or not ‘design defect claims’ are submissible in State courts, outside of the Vaccine Court system set up by the federal government. Design defects are those inherent in the design of a product unlike manufacturing defects which are accidental production errors. At question is whether or not a pharmaceutical company is liable if they are aware of a better designed vaccination (one with fewer side effects) yet continue to use the less safe vaccination. The less safe vaccination is thereby defective by design.
The National Childhood Vaccine Injury Act expressly protects manufacturers from being sued in an effort to incentivize manufacturers to produce vaccines without fear of lawsuits. Congress has also created the federal Vaccine Court system to provide compensation for vaccine injured persons from the money generated by a tax on vaccine manufacturers.
The parents of Hannah Bruesewtiz were denied compensation in the Vaccine Court system and now seek compensation through State court. Six month old Hannah received a DPT (diphtheria, pertussis, tetanus) vaccination and immediately suffered a series of 125 seizures over a period of 16 days. Now 18 years of age, Hannah cannot speak or care for herself as a result of her injuries. The vaccine used on Hannah has since been discontinued in favor of safer alternatives.
Before the Supreme Court, attorneys for the Bruesewitz family argue that safer alternatives were available at the time Hannah received her vaccine and that the manufacturer had the responsibility of providing the safer alternative and at the very least had the responsibility of providing labeling noting that a safer alternative is available. Mr. Frederick, attorney for the plaintiff argues, “for many vaccines there is no safer alternative, and there could be no design defect claim. But for those instances in which there is a safer alternative, the burden under State law is for the manufacturer to act reasonably in pursuing the safer design, if that is available.” Mr. Frederick added that there will not be excessive lawsuits as a result of a verdict in favor of the Bruesewitz family since the Vaccine Court system already handles all cases except rare exceptions such as this.
Justice Ginsburg showed deep concern when questioning Mr. Horvich of the Obama Administration, “there were an unusual number of adverse reactions to the particular lot that this child's third vaccine came from, and that those adverse reactions were not disclosed to the doctors. And the doctors -- the child's doctor said if I had known about the unusual number of adverse reactions, I never would have used this vaccine.”
Chief Justice Roberts Agrees with Justice Sotomayor
The Supreme Court Justices seemed concerned that design defects were disallowed as a reason to sue in the court system as a result of prior rulings in this case. Justice Sotomayor asked pointedly of Ms. Sullivan, attorney for the pharmaceutical company Pfizer, Inc. (now owner of Wyeth), “Point me to the FDA regulations or law where the FDA, in giving a license to or permitting a new vaccine, actually looks at whether that vaccine is the most efficacious way with the least serious harm to the population. Is there a regulation that requires that judgment by them before they issue permission to market?” Ms. Sullivan replied, “There is not, Justice Sotomayor.” Justice Sotomayor responds, “All right. What is the motivation? If there is no -- there's no approval mechanism for the FDA to look at that issue, what is the motivation for manufacturers to voluntarily remove a drug that is causing harm to the public before the FDA acts? If they are completely immune under your reading of this preemption statute, what motivates them to act more quickly?” The drug company lawyer did not respond with an answer. Justice Sotomayor continued, “Could you please just answer that question? 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? 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.” Once again, Ms. Sullivan did not answer the question only to be probed by Chief Justice Roberts, “Before you get to that, I think your answer to Justice Sotomayor's question is: Nothing; the manufacturers have no reason to take the vaccine off the market until the FDA tells them to.”
The Court is Stunned
In the following argument, Justice Kennedy is concerned that the pharmaceutical company attorney asserts that the drug company need never inform the government of safer vaccines and that the consumer may not sue on the basis of the drug company intentionally withholding drug safety information. Justice Kennedy asked, “But if the manufacturer is slow or remiss or negligent or willful in not giving the information to the Government, there is nothing the injured person can do. There is still complete preemption, under your view?” The drug company attorney replied, “Of design defect claims, Justice Kennedy, but not of warning claims.” Justice Kennedy replied, “The warning doesn't have to say, 'Warning: We could make something better if we wanted to'." The court then erupted in laughter.
Avoidable Harm vs. Unavoidable Harm Protection
Justice Breyer then noted that the1986 National Childhood Vaccine Injury Act legally protects drug companies from lawsuits due to unavoidable harm (such as side effects from vaccinations) but that the drug company lawyers are now suggesting that they are also protected from avoidable harm lawsuits. Avoidable harm includes withholding information from the government and the public concerning safer vaccines and also not informing doctors and nurses of high incidences of reactions to particular batches of vaccines. The attorney for the drug company replied that if manufacturers were to be sued for avoidable harm they would be “driven from the market” and she reiterated her position that pharmaceutical manufacturers should only be held liable for manufacturing defects and warning claim issues.