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The Ninth Circuit Court of Appeals ruled on Tuesday that a couple who lost a child due to vaccine-related complications cannot sue drug manufacturers in state court, reports the San Francisco Chronicle. Instead, the parents are limited to accepting no-fault damages through a Court of Federal Claims “Vaccine Court” under the National Childhood Vaccine Injury Act of 1986.
The decision is not surprising, considering that the Supreme Court held in 2011 that the Act bars parents from suing pharmaceutical companies for their children’s vaccine-related injuries. In that case, the Court ruled that the Act’s lawsuit limitations reflected “a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”
The Vaccine Act directs a party alleging a vaccine-related injury to file a petition for compensation in the Vaccine Court, which must resolve the case by a specified deadline. Then, the claimant can either accept the court's judgment, or reject it and seek tort relief from the vaccine manufacturer.
Awards from the Vaccine Court are paid out of a fund created by an excise tax on each vaccine dose. As a quid pro quo, manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine's unavoidable, adverse side effects.
The appellants in the Ninth Circuit case, Erin and Shawn Holmes, lost their one-year-old son, Jacob, following complications with Merck's M-M-R II vaccine. Jacob's pediatrician properly administered the vaccine, but within nine days Jacob began experiencing seizures and developed encephalopathies. Jacob died approximately six months later.
Acting on behalf of Jacob's estate, the couple petitioned for compensation from a Vaccine Act fund, and received $250,000. While not an insignificant amount, it was still far less than the standard wrongful death award, so the couple filed a wrongful death lawsuit against Merck in Nevada. Their complaint alleged negligence, strict product liability, negligent design, failure to warn, misrepresentation, express warranty, implied warranty of merchantability, implied warranty of fitness for a particular purpose, and punitive damages.
Merck removed the case to federal court, and filed a motion for summary judgment, arguing that the Vaccine Act foreclosed the lawsuit. Both the district court and the Ninth Circuit Court of Appeals agreed with Merck.
The parents argued that because Section 11 of the Act barred a parent from filing his own claim for compensation in Vaccine Court, no other part of the Act -- particularly not Section 22's tort-liability limitations -- should apply to their claims in state court.
The Ninth Circuit disagreed, noting, "Regardless of whether a plaintiff is the vaccine-recipient or the parent of one, Section 22 expressly preempts design-defect claims seeking compensation for injury or death caused by a vaccine's unavoidable side effects. Section 22 expressly preempts tort suits based 'solely' on the manufacturer's failure to provide direct warnings to the injured party."