Wednesday, March 4, 2009

Product Liability

The Supreme Court ruled today on a product liability case that was before it.   The case was Wyeth v. Levine and the court ruled in favor of Levine and against Wyeth.  The issue before the court was whether federal law preempts relevant state law, specifically whether a Vermont state failure-to-warn law was preempted by the FDA approving the label for a drug.  In this case the label for the drug failed to link a method of delivery of the drug to a potentially serious side effect.  The Supreme Court ruled that the FDA approving the label did not shield the company from liability from a state law. 

I am oversimplifying the case.  There is a good write up of the decision on ScotusBlog here and here.

What I found interesting here was some of the comments by Justice Stevens in his opinion (via ScotusBlog) :
Justice Stevens had fervent praise for the function that patients’ lawsuits — based on state, not federal, law — may serve. “State tort suits,” he wrote, “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”
When those lawsuits are based on claims (as in the Wyeth case) of manufacturers’ failure to warn about risks, Stevens added, they “lend force to the promise [of federal law] that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.”
So apparently Justice Stevens feels that lawsuits are a valid mechanism to keep companies honest and that the manufacturers, not an agency of the government, should be responsibility for the safety and warnings attached to their products.

Let's compare and contrast against the the legal rights of someone who feels that they have been injured by a vaccine.  In these instances the case has to be brought before what is commonly called Vaccine Court where different rules and procedures apply.  

In this court it is not the manufacturer that bears the responsibility to defend their product, it is the federal government.  In this court it is not the manufacturer that bears responsibility for damages caused by their products, rather it is the consumers who use the product that pay the damages (by means of a surcharge on the product).

The system may have been needed when it was created but it is possible that it has outlived its purpose now.  Especially considering the fact that the vaccines are increasingly becoming big business for the companies that make them - a recent Wall Street Journal article puts the size at 21.5 billion dollars 

Anyone see a problem and potential for abuse here?  

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