US Supreme Court upholds Childhood Vaccine Injury Act

As reported earlier, the US Supreme Court has been hearing a case in which the parents of Hannah Bruesewitz were trying to sue the vaccine maker, Wyeth, for Hannah’s alleged vaccine related injury.  Back then, I took exception to the way the media was reporting on the case, implying that the Supreme Court was hearing a case about the side effects, when in reality what the Supreme Court was trying to decide was the right of individuals to sue a vaccine manufacturer outside of vaccine court.

The US Supreme Court has reached a decision and it has decided to uphold the 1986 National Childhood Vaccine Injury Act, thus upholding the original purpose of that law to ensure that children that suffer from vaccine injuries are compensated,  while at the same time eliminating frivolous suits against vaccine manufacturers, thus preserving our vaccine supply.

The full text of the ruling on the case can be read here. Below are some excerpts of importance.

We consider whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)1 bars state-law design-defect claims against vaccine manufacturers.

The above quote goes to prove my initial assertion that what was at stake in this suit was the parent’s right to sue the vaccine manufacturers directly, and specifically for “design-defect claims”. My understanding is that “design-defect claims” means defects, a.k.a. side effects, that are inherent to the design, and does not mean improper production of the vaccine.

For the last 66 years, vaccines have been subject to the same federal premarket approval process as prescription drugs, and compensation for vaccine-related injuries has been left largely to the States. Under that regime, the elimination of communicable diseases through vaccination became “one of the greatest achievements” of public health in the 20th century. But in the 1970’s and 1980’s vaccines became, one might say, victims of their own success. They had been so  effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases, and much more concerned with the risk of injury from the vaccines themselves.

I just think this passage is cool; the US Supreme Court understands the issue perfectly. Next the decision explains how the DTP vaccine scare of the 1980s affected the manufacturers and the supply of vaccines:

This led to a massive increase in vaccine-related tort litigation.  Whereas  between 1978 and 1981 only nine product-liability suits were filed against DTP manufacturers, by the mid-1980’s the suits numbered more than 200 each year.  This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer, Lederle Laboratories, estimated that its potential tort liability exceeded its annual sales by a factor of 200.  Vaccine shortages arose when Lederle had production problems in 1984.

Next a summary of the NCVIA is given.

To stabilize the vaccine market and facilitate compensation, Congress enacted the NCVIA in 1986.  The Act establishes a no-fault compensation program “designed to work faster and with  greater ease than the civil  tort system.”

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A person injured by a vaccine, or his legal guardian, may file a petition for compensation in the  United States Court of Federal Claims

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A special master then makes an informal adjudication of the petition within (except for two limited exceptions) 240 days.

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At that point, a claimant has two options: to accept the court’s judgment and forgo a traditional tort suit for damages, or to reject the judgment and seek tort relief from the vaccine manufacturer. Fast, informal adjudication is made possible by the Act’s Vaccine Injury Table, which lists the vaccines covered under the Act; describes each vaccine’s  compensable,adverse side effects; and indicates how soon after vaccination those side effects should first manifest themselves.

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No showing of causation is necessary; the Secretary bears the burden of disproving causation. A claimant may also recover for unlisted side effects, and for listed side  effects that occur at times other than those specified  in  the Table, but for those the claimant must prove causation. Unlike in tort  suits, claimants under the Act are not required to show that the administered vaccine was defectively manufactured, labeled, or designed.

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Attorney’s fees are provided, not only for successful cases, but even for unsuccessful claims that are not
frivolous.These awards are paid out of a fund created by an excise tax on each vaccine dose.

The immunity that vaccine manufacturers enjoy is also explained:

They are immunized from liability for punitive damages absent failure to comply with regulatory requirements, “fraud,” “intentional and wrongful withholding of information,” or other “criminal or illegal activity.

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“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.”

The rest of the ruling is, as is expected, heavy in legaleze and goes into detail into the various arguments over usage of word such as “if” and “even though” which we need not worry about here. The important point to take home is that the 1986 National Childhood Vaccine Injury Act has been upheld; that individuals do not have the right to sue vaccine manufacturers directly for “design defects”, although they have the right to reject the special vaccine court ruling and try to go after the manufacturer; and that individuals do have the right to hold manufacturers accountable for defective manufacture, and inadequate directions or warnings.