Bruesewitz vs. Wyeth Case Resolved

Bruesewitz vs. Wyeth Case Resolved

February 22, 2011 Anonymous

Pertussis bacteria, Copyright Dennis Kunkel Microscopy, Inc.After having heard arguments in the fall, the U.S. Supreme Court ruled on February 22 on Bruesewitz vs. Wyeth, upholding a federal law that established protection for vaccine makers from lawsuits and that provides compensation for certain vaccine injuries.

The National Vaccine Injury Compensation Program (NVICP) was established in 1988 after a series of lawsuits resulted in large payments to individuals claiming vaccine injuries. The number of vaccine manufacturers had declined sharply, and the federal government stepped in to establish an alternate pathway to compensate vaccine injuries. Under the NVICP, certain medical events are regarded as potential side effects of vaccination and are automatically reimbursed according to a formula. NVICP is funded by a tax on vaccines (paid by the manufacturers) and has awarded $1.8 billion in claims since 1989.

The Bruesewitz suit claimed that a vaccine Hannah Bruesewitz received in 1992 (her third dose of the diphtheria-whole cell pertussis-tetanus vaccine) was defective in its design and thus resulted in the girl’s seizures and developmental delays. The Bruesewitz family earlier had been denied compensation from the NVICP. (The pertussis component of the vaccine has since been replaced by a less reactogenic acellular preparation.)

Antonin Scalia wrote the majority opinion, stating that "Vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries; in exchange they avoid costly tort litigation and the occasional disproportionate jury verdict."  He asserted that the intention of the National Childhood Vaccine Injury Act of 1986 (which established NVICP) to exclude drug design defects from liability claims is evident in its “lack of guidance for design defects combined with the expansive guidance for the grounds of liability specifically mentioned.” Therefore, as Scalia said, "Taxing vaccine manufacturers' product to fund the compensation program, while leaving their liability for design defects virtually unaltered, would be an odd way to make vaccine manufacture more effective.” Justices Sotomayor and Ginsburg dissented, writing that Congress would not have intended to protect manufacturers that produced a defective vaccine.

Pfizer (formerly Wyeth) had encouraged the Supreme Court to hear the Bruesewitz case, in spite of a lower court’s earlier ruling against the Bruesewitz claim, to address the potential similar claims in the future. Directly facing the issue now, they successfully argued, would address unresolved legal issues affecting the vaccine market.

We’d like to recommend Paul A. Offit’s book Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, for his discussion of how the DTP vaccine came under the scrutiny of parent activists, lawmakers, and the media. He also describes large-scale studies that failed to find a relationship between pertussis vaccination and encephalopathies, as well as recent work documenting genetic mutations affecting a sodium channel protein in certain individuals claiming vaccine injury.

Sources and Information

CNN: Justices Rule for Drug Makers in Vaccine Dispute: http://www.cnn.com/2011/CRIME/02/22/us.scotus.vaccines/

LA Times: Supreme Court Shields Vaccine Makers from Lawsuits: http://www.latimes.com/health/sc-dc-0223-court-vaccines-20110223,0,2497178.story

Vaccine Injury Table: http://www.hrsa.gov/vaccinecompensation/table.htm

MPR: Does Pertussis Vaccine Cause Brain Damage? http://www.empr.com/does-pertussis-vaccine-cause-brain-damage/article/177151/

Comments

Posted by Marcia Stone (not verified)

Excellent article. For those who might not know, there's a meeting "Vaccines Under the Gun: Politics,Science, Media and the Law" on Monday March 28th I'll be covering it for the American Society for Microbiology and welcome information and comments from the vaccine community.

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