Supreme Court to Bar Defective Product Lawsuits against Drug Makers?
By Richard Seward
Published on February 28, 2008
The proceedings come less than a week after the Supreme Court ruled that medical device manufacturers were conditionally shielded from liability for personal injuries provided that the Food and Drug Administration approved their products before they were marketed.
Arguments on Monday in the first of two cases concerning injuries caused by defective drugs dealt specifically with a Michigan statute that places restrictions on filing lawsuits against pharmaceutical companies. The law states that a person cannot file an injury claim against a drug maker unless he or she can demonstrate that the company deliberately mislead the Food and Drug Administration by withholding information that would have potentially caused the agency to prevent the drug from being sold.
In October, the court will hear arguments in a pharmaceutical case that asks if FDA approval precludes personal injury lawsuits. This is the same basic issue upon which the court ruled with regard to medical devices.
In the past, the FDA’s position has been that litigation provided consumers with another level of protection. Now the agency has reversed its position, claiming that lawsuits undermine its effectiveness.
Though receiving apparent support from Supreme Court justices, the FDA is still under fire from the Institute of Medicine, the Government Accountability Office, and the FDA’s own internal science board. Officials from all of these groups have issued reports suggesting ineffective management and scientific deficiencies continue to handicap the agency, leaving it incapable of adequately protecting consumers against dangerous pharmaceuticals, medical devices, and food products.
The Supreme Court will likely delay any official ruling until next year.
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