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US federal law protects vaccine makers from lawsuits.


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US federal law protects vaccine makers from product-liability lawsuits.

The United States Supreme Court reached a decision recently, concluding that federal law protects vaccine makers from product-liability lawsuits that are filed in state courts and seek damages for injuries or death attributed to a vaccine.

In the 57-page opinion written by Justice Antonin Scalia, the Supreme Court explained that the National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects.

The Court’s 6-2 decision reasoned that “a vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the [NCVIA] thus suggests the design is not subject to question in a tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design.

This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, inadequate directions or warnings, and defective design—the Act mentions only manufacture and warnings. It thus seems that the Act’s failure to mention design-defect liability is “by deliberate choice, not inadvertence.”

The opinion further explained that “design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process.” As a result, the Court concluded that this “lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability.”

Read the full article at www.policymed.com. Date: May 5, 2018

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