Its Flu Season – Remember the National Childhood Vaccine Injury Act

It is getting to be flu season – with the annual barrage of public-service announcements about the importance of getting this year’s flu vaccine.  Vaccines were also in the news recently on reports of a polio outbreak in Syria.

Vaccines also end up the subject of lawsuits, including the recent decision from the United States Court of Appeals for the Federal Circuit in Tembenis v. Sec’y Health & Human Servs., (October 28, 2013), available here, which ruled that future lost earnings cannot be awarded to the estate of a deceased child under the National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. § 300aa, et seq. 

But what is the Vaccine Act?  As vaccine manufacturers – and their counsel – know, the Vaccine Act is the statutory no-fault compensation program established by Congress in 1986 both to stabilize a vaccine market that was being adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation for claimants who found legitimate vaccine-related claims to be too costly or difficult to pursue.

Under the Vaccine Act, a party that alleges a vaccine-related injury may file a claim for compensation in the Court of Federal Claims against the Secretary of the Department of Health and Human Services.   A special master reviews the claim and makes an informal decision, and the Court of Federal Claims then considers any objections to the special master’s determination and makes a final ruling.  To aid in the special master’s, and the court’s, review, a Vaccine Injury Table maintained under the Vaccine Act lists the different vaccines covered by the Vaccine Act, the different adverse side effects of those vaccines, and how soon after vaccine administration each side effect should manifest itself.  Assuming a claimant can show a listed injury that manifested itself within the applicable time period, the claimant is relieved of proving causation, and the Secretary shoulders the burden of disproving causation.

Once the court rules on the claim, the claimant has the option of accepting the court’s judgment, or rejecting it and seeking relief in tort from the vaccine’s manufacturer.

However, should the claimant elect the latter option, the Vaccine Act contains an important protection for vaccine manufacturers: 

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

Although this statutory language only speaks in terms of two of the three potential grounds for liability in a product liability suit – namely a manufacturing defect and a failure to warn – the United States Supreme Court held in Brusewitz v. Wyeth, 562 U.S. ___ (2011), available here, that the Vaccine Act also preempts all design-defect claims against vaccine manufacturers.

Thus, just as we are all mindful to protect ourselves against the flu each Fall, those who counsel and defend pharmaceutical companies that are involved in manufacturing vaccines – as well as those who counsel and defend potential claimants for vaccine-related injuries – should  be mindful of the important protections for both manufacturers and claimants under the Vaccine Act.

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