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Should Manufacturers of Vaccines Have Special Protections for Defects?


Twelve years ago, the medical and scientific community was rocked when Lancet, the leading medical journal in the United Kingdom, published the results of a study led by Andrew Wakefield which had concluded that there was a direct link between autism and the childhood vaccine for mumps, measles and rubella (MMR).  The conclusions of the study were later renounced by ten of the 13 authors of the paper and retracted by Lancet, but the suggestion that there was a link between autism and a routinely-given childhood vaccine caused uproar throughout the world.

Worldwide, many parents were convinced that the MMR vaccine, given to almost every child in every civilized nation of the world for decades, was directly responsible for the rise in autism diagnoses and many parents refused to allow their children to be vaccinated.  Those parents whose child had already been diagnosed with autism were faced with evaluating whether they had “given” autism to their children by agreeing to have their child vaccinated.   Not only did the study wreak havoc in the scientific and medical communities, the refusal by many parents to allow their children to receive the MMR vaccination led to measles outbreaks in the United States and Europe and the number of children with measles in England was deemed to be at epidemic levels in 2008.

Despite the retraction of the article by Lancet; despite the multiple studies which have been done in an attempt to duplicate Dr. Wakefield’s findings (none of which did); despite Dr. Wakefield being stripped of his right to practice medicine in the England; and despite the general consensus in the medical and scientific communities that the conclusions of the Wakefield study were erroneous, there are still many individuals who continue to believe his findings and Dr. Wakefield remains resolute that his findings were significant and accurately concluded that the link exists.

Brian Deer, a British journalist, published an article in the British Medical Journal detailing the misrepresentation by Dr. Wakefield in his study.  The Deer article concluded that not only was there no causal connection between the MMR vaccine and autism, the claims made by Dr. Wakefield were completely unfounded. Deer also claimed that Dr. Wakefield falsified medical documentation regarding all of the children in the study in one way or another. In fact, the BMJ article maintained that none of the children had underlying medical issues and   the editors of the BMJ deemed the results claimed by Dr. Wakefield “an elaborate fraud.”

This article is related closely to a case in which the United States Supreme Court heard argument last fall.   In the case of Bruesewitz v. Wyeth, the parents of a young girl brought a lawsuit claiming that their daughter suffered significant neurological damage as a result of receiving a vaccine, which was defectively designed.

The National Childhood Vaccine Injury Act, passed in 1986, was enacted to shield vaccine manufacturers from being sued (repeatedly) by recipients of vaccines for damages they allege.  The Act established a “no-fault” system and a separate court to hear cases involving damages which are alleged to have been caused by vaccines.  The rationale behind passage of the Act was the fear that pharmaceutical companies would stop manufacturing vaccines if they were exposed to litigation for defective vaccines. This would leave children worldwide vulnerable to a myriad of diseases which could otherwise be easily prevented.  The unfortunate and practical result of the Act is a situation in which there is little protection for the defective manufacture of the vaccines and a reduced motivation to conduct expensive research into the continued efficacy of them. If a child has been severely injured by a vaccine, under the Act, the manufacturers of that vaccine are essentially immune from being legal recourse.

The Bruesewitz family claimed that it was not the intent of Congress to create this immunity and that Wyeth should have used an alternative design for the vaccine their daughter received. Beyond this, though, the lot from which Hannah Bruesewitz received her vaccine was the subject of over 65 complaints of adverse reactions in patients to whom it was administered.

This is the situation in which the Act creates a problem. If a manufacturer produces a bad batch of vaccine and ignores complaints, should they be immune from suit? If a manufacturer could redesign a vaccine in keeping with developments in science, but they do not and injury is caused by the failure to maintain the best efficacy of the vaccine, should the manufacturer be able to avoid liability simply because of the Act?

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