Ninth Circuit affirms ruling in lawsuit against vaccine maker

Jessica M. Karmasek Sep. 27, 2012, 1:27pm


SAN FRANCISCO (Legal Newsline) - A federal appeals court on Tuesday upheld a district court's grant of summary judgment in favor of pharmaceutical company Merck and Company in a wrongful death lawsuit.

The U.S. Court of Appeals for the Ninth Circuit ruled that the U.S. District Court for the District of Nevada did not err in applying the standards of the National Childhood Vaccine Injury Act.

Plaintiffs Erin and Shawn Holmes, the parents of Jacob Holmes, had appealed to the Ninth Circuit, arguing that the Vaccine Act should not limit their state law claims.

When Jacob was a year old, his pediatrician administered a measles, mumps and rubella vaccine. The vaccine was manufactured and distributed by Merck.

Within nine days, Jacob began experiencing seizures and developed encephalopathies, or diseases of the brain. He died about six months later.

Acting on behalf of their son Jacob's estate, Erin and Shawn Holmes petitioned for compensation from a government fund created by the Vaccine Act. They received $250,000 through the program.

Subsequently, acting in their individual capacity, the parents initiated a wrongful death lawsuit in Clark County, Nevada.

Their complaint set forth allegations of 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 the district court.

After three years of discovery, the company filed a motion for summary judgment, arguing that the Vaccine Act foreclosed the parents' lawsuit.

The district court only partially agreed, holding that the act limited the plaintiffs' strict liability and negligence claims to the extent that the claims relied on allegations of design defect and failure to warn.

However, the court disagreed with Merck's assertion that the Vaccine Act limited the parents' other state law claims.

The district court therefore granted in part and denied in part Merck's summary judgment motion and requested supplemental briefing on the plaintiffs' claims of misrepresentation, breach of warranty and punitive damages.

After the supplemental briefing on the remaining state law claims, the district court granted Merck summary judgment.

Plaintiffs appealed to the Ninth Circuit, challenging only the district court's application of Section 22 of the Vaccine Act to their design defect and failure to warn claims.

Following oral arguments, the Ninth Circuit deferred submission of the case to wait on the U.S. Supreme Court's decision in Bruesewitz v. Wyeth.

The nation's high court, in its 6-2 ruling last year, protected vaccine makers from lawsuits by parents whose children have allegedly suffered side effects from the medications.

Judge Sidney R. Thomas, who authored the Ninth Circuit's opinion, said the question in this case was whether the Vaccine Act preempts all, or part, of the plaintiffs' claims.

The plaintiffs argued that because Section 11 of the act renders them ineligible for compensation through the 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.

"The exhaustion requirement in Section 11 is only a subsection of Congress' larger statutory scheme to ensure that vaccine manufacturers have an affordable and predictable way of handling injured parties' compensation claims. Though parents are not bound by Section 11's exhaustion requirement, they are not free from the Act's tort liability limitations," Thomas wrote.

"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."

The parents also argued that the express preemption discussed in Bruesewitz does not apply to their case because Bruesewitz involved a claim brought on behalf of an injured minor child.

The Ninth Circuit again disagreed, calling the plaintiffs' interpretation of the Vaccine Act "cramped."

"If we were to conclude that the parents of those suffering a vaccine-related injury could bring design defect and failure to warn claims outside of Section 22's limitations, we would be acting contrary to the statute's central purpose of managing vaccine manufacturers' liability because our construction would do little to protect the vaccine manufacturers from suit," Thomas wrote.

The Ninth Circuit said it recognizes that a parent's loss of a child is an injury "distinct" from the harm the child him or herself suffered.

"But despite Plaintiffs' protests to the contrary, applying Section 22 to their claims does not leave them without a remedy for their injuries," Thomas wrote.

The court pointed out that the plaintiffs' alleged eight claims, plus a claim for punitive damages, in their state wrongful death action.

Application of Section 22 affects only two of these claims -- the strict products liability and negligence claims to the extent that they were based upon allegations of design defect and failure to warn, the Ninth Circuit noted.

"Therefore six of Plaintiffs' claims remain unaffected by the Act and each of these provide a possible remedy to the injuries that they suffered as a result of Jacob's illness and death," Thomas wrote.

"Accordingly, our conclusion is in keeping with the strong presumption that Congress does not, 'without comment, remove all means of judicial recourse for those injured by illegal conduct.'"

From Legal Newsline: Reach Jessica Karmasek by email at

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