The Supreme Court granted cert in Bruesewitz v. Wyeth, a case with massive repercussions for vaccine manufacturers. (Chief Justice John Roberts Jr. recused himself, as he owns shares in Pfizer, which acquired Wyeth in 2009.) The National Childhood Vaccine Injury Act (NCVIA), aimed at maintaining a stable vaccine market supply, has shielded pharmaceutical companies from most vaccine injury claims since 1986. It established the National Vaccine Injury Compensation Program as a “vaccine court” to hear such claims.

The Supreme Court in Bruesewitz could alter that landscape to allow some vaccine claims to go before a jury. A district court dismissed the case on grounds of express pre-emption, and the 3rd Circuit affirmed. At issue is a split created by a 2008 Georgia Supreme Court ruling that the NCVIA “does not [pre-empt] all design defect claims, but instead provides that a vaccine manufacturer cannot be held liable for defective design if it is determined on a case-by-case basis that the injurious side effects of the particular vaccine were unavoidable.” It was a major reinterpretation for the statute and the split has opened the door for high court review.

Bruesewitz involves a since-discontinued type of DPT (diphtheria-pertussis-tetanus) vaccine that parents claim caused a seizure disorder and developmental delay in their daughter. In the Georgia case, American Home Products Corp. v. Ferrari, parents claim thimerosal, a preservative once widely used in childhood vaccines, caused their son to suffer permanent neurological damage including autism.

For more on the Supreme Court's action, read the Drug and Device Law Blog roundup on Bruesewitz.