New FDLI's Food and Drug Policy Forum focuses on liability issues in vaccine design defect claims

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 USA, assert Daniel Gage, assistant director, and Alison Perencevich, legislative assistant, at the American Academy of Pediatrics' Department of Federal Affairs.

Writing in the February 8 issue of the USA-based Food and Drug Law Institute (FDLI) 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?"

Mr Gage and Ms Perencevich argue that the Supreme Court should uphold the ruling in Bruesewitz versus Wyeth (now part of Pfizer), 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.