697 F.3d 1080
9th Cir.2012Background
- Erin and Shawn Holmes sued Merck in Nevada state court for wrongful death of their son Jacob after vaccination with Merck's M-M-R II.
- Jacob died about six months after seizures and encephalopathy began within nine days of vaccination.
- Holmeses had previously received $250,000 from the Vaccine Act fund for Jacob's injury/death.
- District court granted partial summary judgment recognizing some Vaccine Act effects but allowed other state-law claims to proceed, then granted summary judgment on remaining claims.
- Issue at center: whether the Vaccine Act preempts portions of the Holmeses' state-law claims, especially design defect and failure-to-warn theories.
- Court ultimately affirmed, holding that Section 22 preempts certain state-law claims while six other claims remain viable for the Holmeses.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does Section 22 of the Vaccine Act preempt design-defect and failure-to-warn claims? | Holmeses contend Section 22 does not bar their state-law claims since they could not have filed in Vaccine Court as parents/estate representatives for individual damages. | Merck argues Section 22 preempts design-defect and failure-to-warn claims regardless of Exhaustion under Section 11, applying to all civil actions arising from vaccine injuries. | Section 22 preempts design-defect and failure-to-warn claims arising from a vaccine injury. |
| Is Section 11’s exhaustion requirement limited only to vaccine-recipients, not parents, such that Section 22 could still apply to parental claims? | Parent claims are not barred from filing in state court and should not be governed by Section 22 because Section 11 targets only vaccine-recipients’ petitions. | Exhaustion is part of a broad framework; Section 22 applies to all civil actions for vaccine-related injuries, including parental claims. | Exhaustion does not immunize parental claims from Section 22; Section 22 applies to parents' claims as to design defects and failure to warn. |
| Should the court apply Section 22 to limit the Holmeses' state-law claims in this case as a whole, given the Vaccine Act framework? | Section 22 should not limit parental damages not within the narrow scope of Section 22’s provisions. | Section 22 broadly preempts state-law actions arising from vaccine injuries, including parental claims when based on design or warnings. | Yes, Section 22 applies to limit the narrowed state-law claims in this case. |
| Are the Holmeses' remaining non-preempted claims viable under Nevada wrongful-death law after preemption of certain design/warn claims? | Non-preempted state-law claims should proceed to damages for parental losses and related injuries. | Preemption does not bar all state-law claims; several claims survive and may be pursued. | Six non-preempted claims remain viable; the district court’s partial grant of summary judgment was affirmed. |
Key Cases Cited
- Bruesewitz v. Wyeth Inc., 131 S. Ct. 1068 (2011) (express preemption of design and warning claims under § 22)
- American Home Products Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008) (parent claims treated under § 22; preemption analysis discussed)
- Moss v. Merck & Co., 381 F.3d 501 (5th Cir. 2004) (exhaustion of Section 11 not applicable to parents' individual claims)
- Schafer v. American Cyanamid Co., 20 F.3d 1 (1st Cir. 1994) (exhaustion and scope of Vaccine Act claims for non-recipients)
- Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984) (presumption against preemption; respect for congressional intent)
- Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001) (preemption framework and express vs. implied preemption)
- Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007) (application of § 22 to failure-to-warn claims)