The Supreme Court ruled on February 22, 2011 that the National Childhood Vaccine Injury Act of 1986 (NCVIA) bars state-law design-defect claims against vaccine manufacturers. The Act had eliminated a manufacturer’s liability for a vaccine’s unavoidable, adverse side effects but was silent on the manufacturer’s liability for a vaccine’s design-defects. The Court stated that the language of the relevant provisions of the act suggested that “the design of the vaccine is a given, not subject to question in the tort action.” In essence, when the FDA licenses the product, and provided that the manufacturer meets regulatory requirements, including GMP manufacture and proper warnings, any design-defects would be insulated from liability.
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October 28, 2009
Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.