Vaccine Design Defect, Warning Claims By Parents Are Preempted, 9th Circuit Says

SAN FRANCISCO - (Mealey's) The Ninth Circuit U.S. Court of Appeals on Sept. 25 said design defect and failure-to-warn claims filed by the parents of a child who died after getting vaccinated are preempted by the federal vaccine law, but noted that parents may pursue some state law claims on their own and outside of the national vaccine injury compensation program (Erin Holmes, et al. v. Merck & Co., Inc., No. 08-16557, 9th Cir.). 

(Opinion available. Document #28-121004-005Z.) 

Jacob Holmes, age 1, received a measles-mumps-rubella (M-M-R II) vaccine and then experienced seizures, developed encephalopathies and died six months later.  His parents, Erin and Shawn Holmes, filed a petition for benefits under the federal National Childhood Vaccine Injury Act (Vaccine Act) and were given a death benefit of $250,000. 

Later, the Holmeses, acting on their own behalf, filed a wrongful death lawsuit against vaccine manufacturer Merck & Co. Inc. in a Nevada state court alleging negligence, strict product liability, negligent design, failure to warn, misrepresentation, breach of express warrant, breach of implied warranty of fitness for a particular purpose and punitive damages.  Merck removed the case to the U.S. District Court for the District of Nevada. 

The District Court eventually granted Merck's motions for summary judgment, finding that all claims are foreclosed by the Vaccine Act.  The Holmeses appealed, arguing that the District Court misapplied Section 22 of the Vaccine Act to their claims of design defect and failure to warn. 

Express Preemption Of 2 Claims 

The Ninth Circuit deferred submission of the case pending the U.S. Supreme Court's resolution of another vaccine case, Bruesewitz v. Wyeth (562 U.S. __, 131 S. Ct. 1068 [2011]). 

The Ninth Circuit panel found that although parents of vaccine-injured children are not bound by the requirement of Section 11 that they exhaust their Vaccine Act remedies before filing a civil suit, Section 22 expressly preempts design defect claims seeking compensation for injury or death caused by a vaccine's unavoidable side effects.   

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

"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," the panel said.  "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,'" the panel said, citing Supreme Court case law. 

But Plaintiffs Are Limited 

Having concluded that Section 22 generally applies to limited tort liability in a parent's claim for individual injuries, the court said it must consider if a civil damage action for vaccine-related injury or death is limited by the Vaccine Act.  "We conclude that the Plaintiffs' suit is so limited," the panel said. 

"For these reasons, there is no cause to disturb the district court's application of Section 22 to Plaintiffs' state law products liability claims of design defect and failure to warn," the panel held.  "Nor was the district court's grant of summary judgment in favor of Merck error." 

"During the proceedings below, Merck produced evidence that it had complied with all regulatory requirements related to M-M-R II," the panel continued.  "But Plaintiffs failed to submit evidence sufficient to show that the vaccine had not been properly prepared or that it had not been accompanied by proper directions and warnings." 

The panel noted that the Holmeses do not appeal the District Court's rulings on their state law claims that were not preempted by the Vaccine Act. 

Panel, Counsel 

Circuit Judge Sidney R. Thomas wrote the opinion.  Circuit Judges Betty B. Fletcher and N. Randy Smith concurred. 

Eckly M. Keach of Eckly M. Keach Chartered and Robert E. Murdock of Murdock & Associates, both in Las Vegas, represent the Holmeses.  The government is represented by Denice Barton of Morris Peterson in Las Vegas and Donald F. Zimmer of King & Spalding in San Francisco.

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