October 9, 2008
Geogia Supreme Court Finds Vaccine Suit in Autism Case Not Preempted
The Georgia Supreme Court, in a ruling that conflicts with two federal district courts and state courts in New York and Pennsylvania, has concluded that a suit brought by parents of an autistic child against a vaccine manufacturer is not preempted by the federal National Childhood Vaccine Injury Compensation Act. The case was brought on behalf of Stefan Ferrari against two pharmaceutical firms, Wyeth and GlaxoSmithKline, that manufactured vaccines for children. Ferrari stopped speaking at the age of 18 months, after he was vaccinated. The suit claims that thimerosal, a preservative containing mercury that until 2001 was commonly used in the production of childhood vaccines, caused the child's autism.
The defendants argued that the federal act preempts claims against companies which produce vaccines approved by the U.S. Food and Drug Administration if an injury or death resulting from a vaccine's side effects are considered "unavoidable," and that any vaccine-related side effect should be deemed to be "unavoidable" if the vaccine was properly prepared and accompanied by the proper FDA-mandated warnings. But the Georgia court rejected such a "far-reaching interpretation" of the federal statute and suggested that the U.S. Supreme Court may be asked to consider the question.
October 9, 2008 | Permalink
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Over the past few years I have gone back and forth over whether preemption is good for the public.
It is reasonable to argue that the FDA has more expertise to determine what is in the best interest of the American public than twelve random jurors. However, when I see the FDA approving things such as the Ortho Evra birth control patch I believe that it would be a mistake to allow preemption to become an absolute defense that provides a shield for companies to hide behind.
The Johnson & Johnson Ortho Evra birth control patch is a great example what is wrong with the preemption argument.
When a jury is asked to determine whether a product has a Design Defect they use commonly what is known as risk/utility analysis. One of the criteria of risk/utility analysis is the availability of a substitute product or products at the time of manufacture, sale or distribution, which would meet the same needs of perform the same functions as the product without containing the alleged defect.
Studies on the Ortho Evra birth control patch show this product has double the risk of the pill that is currently on the market. So far, 20 deaths have been linked to Ortho Evra and listed symptoms are deep vein thrombosis, blood clots in legs and lungs, pulmonary embolisms and stroke.
As long as the FDA continues to approve products such as Ortho Evra, when safer alternatives exist, it would be wrong to allow designers of such products to hide behind preemption.
Posted by: Paul Owens | Jan 7, 2009 10:45:34 AM