CALawMama's Blog


Experiences at the interface of life, law, and motherhood in Cali

Supreme Court Justice Sotomayor’s Dissent in Bruesewitz v. Wyeth, 562 U.S. __ (2011)

“Justice Sotomayor, with whom Justice Ginsburg Joins, dissenting:

Vaccine manufacturers have long been subject to a legal duty, rooted in basic principles of products liability law, to improve the design of their vaccines in light of advances of science and technology. Until today, that duty was enforceable through a traditional state-law tort action for defective design. In holding that §22(b)(1) of the National Childhood Vaccine Injury Act of 1986)[] 42 U.S.C. §300aa-22(b)(1), pre-empts all design defect claims for injuries stemming from vaccines covered under the Act, the Court imposes its own bare policy preference over the considered judgment of Congress.

[/]In doing so, the Court excises 13 words from the statutory text, misconstrues the Act’s legislative history, and disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market.

[/]Its decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers take account of scientific and technological advancements when designing or distributing their products.

[/]Because nothing in the text, structure, or legislative history of the Vaccine Act remotely intended such a result, I respectfully dissent.”

And later:

“Rather, the function of ensuring that vaccines are optimally designed in light of existing science and technology has traditionally been left to the States through the imposition of damages for design defect. citing to Wyeth v. Levine, 555 U.S. ____, ____ 2009)(slip op., at 22-23)(noting that the FDA has “traditionally regarded state law as a complementary form of drug regulation” as “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”)


“Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the design of vaccines that are already generating significant profit margins. nothing in the text, structure, or legislative history remotely suggests that Congress intended that result.

I respectfully dissent.”

I wholeheartedly concur.



Facts of the Case (from Oyez, love them!)

“Two hours after Hannah Bruesewitz received her six-month diphtheria, tetanus and pertussis vaccine in 1992, she started developing seizures and was hospitalized for weeks. Hannah has continued to suffer from residual seizure disorder that requires her to receive constant care, according to her parents. When their daughter was three-years-old, Russell and Robalee Bruesewitz filed a petition seeking compensation for her injuries. One month prior to the petition, new regulations eliminated Hannah’s seizure disorder from the list of compensable injuries. The family’s petition was denied. Three years later, in 1998, the drug company Wyeth withdrew the type of vaccine used in Hannah’s inoculation from the market.

The Bruesewitzes filed a lawsuit against Wyeth in state court in Pennsylvania. They claimed the drug company failed to develop a safer vaccine and should be held accountable for preventable injuries caused by the vaccine’s defective design. A federal judge dismissed the lawsuit, ruling that the National Childhood Vaccine Injury Act protected Wyeth from lawsuits over vaccine injury claims. The U.S. Court of Appeals for the 3rd Circuit affirmed.”

Full opinion

Wiki version (ordinarily I wouldn’t rely on a Wikipedia entry for discussion of a Supreme Court decision, but a beloved Constitutional Law I professor, and former Supreme Court Justice law clerk, adjudged it reliable enough to accomplish the same, on more than one occasion, and for ease of understanding for the non-lawyer, I readily agree with his judgement)


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