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New FDLI's Food and Drug Policy Forum Focuses on Liability Issues in Vaccine Design Defect Claims

Tue, 02/08/2011 - 9:37am
Bio-Medicine.Org

WASHINGTON, Feb. 8, 2011 /PRNewswire-USNewswire/ -- The ability of families to sue vaccine producers for faulty design could lead to a rise in litigation and force manufacturers to abandon the market, which, in turn, could cause disastrous public health consequences in the United States, assert Daniel J. Gage, Assistant Director and Alison R. Perencevich, Legislative Assistant, at the American Academy of Pediatrics' Department of Federal Affairs.

Writing in the February 8, 2011 issue of FDLI's Food and Drug Policy Forum (Volume 1, Number 3), the authors take a close look at this emerging health care liability question: "Should the National Childhood Vaccine Injury Act of 1986 Allow Families of Children Injured by Vaccines to Sue Manufacturers Directly for Design Defect Claims?"

Gage and Perencevich argue that the Supreme Court should uphold the ruling in Bruesewitz v. Wyeth, Inc. which held that the National Childhood Vaccine Injury Act of 1986 preempts design defect claims. They also recommend that policymakers review the entire statute, which, they maintain, can both protect manufacturers from uncontrolled litigation and compensate families fairly for any injuries caused by defective vaccine. In their article, the authors stress the importance of primary care providers in vaccine administration and suggest that they receive adequate reimbursement for their services.

FDLI's Food and Drug Policy Forum is a twice-a-month, peer-reviewed, digital publication on current food and drug policy topics. Posed in the form of a question, each issue provides subscribers and purchasers with pertinent background information, relevant research, discussion of central issues, relevant resources and policy recommendations. The views, opinions and statements expressed in the Policy Forum are those of the authors. The Food and Drug Law Institute neither contributes to nor endorses Policy Forum articles. As a nonprofit 501 (c) (

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