On February 20, 2008 the United States Supreme Court in a decision written by Justice Scalia, Estate of Rigel v. Medtronic, Inc., http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf, held that that "the MDA's pre-emption clause bars common law claims challenging the safety and effectiveness of medical devices marketed in a form that received premarket approval from the FDA." The ruling is limited to Class III medical devices, which make up approximately 10% of all devices, and does not apply to prescription drugs.
While the Court's decision does effect many claims that are now in litigation, notably cardiac defibrilliators, it should not be read as a bar to all state court injury claims for damages resulting from defective medical devices. Justice Scalia writes in his conclusion that this "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations". The door is still open for claims even involving Class III devices as long as violations of FDA regulations are alleged and proven.
Though there are still two prescription drug cases pending before the Court on pre-emption issues, we believe that based the upon the language of this decision there will be know extension of pre-emption to prescription drug cases. The FDA regulations governing prescription drugs do not contain the express pre-emption language that is present in the MDA. This Court has made it clear that it will apply the plain language of the statute in applying pre-emption. No deference will be given to the current FDA position given the express language of the statute.
Lawsuits of Interest
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