The United States Supreme Court agreed on Tuesday September 25, 2007 to make a decision on whether or not federal law preempts the product liability claims filed by diabetes patients in Michigan state court against Warner-Lambert & Co, a pharmaceutical company.
According to the claim of the plaintiffs, Rezulin a diabetes drug introduced in 1997 and pulled off the market in 2000 by Warner-Lambert caused serious and sometimes deadly liver problems.
Warner-Lambert was acquired by Pfizer Inc. after the drug was introduced.
The cases filed by the plaintiffs were consolidated and moved to New York to a special multi district federal court, where a federal judge ruled that liability under Michigan law was preempted by federal law.
A Michigan law passed in 1995 shields pharmaceutical companies from product liability claims unless plaintiffs can show that the U.S. Food and Drug Administration was misled by the defendant about the safety of its medication.
The plaintiffs claim that they were misled and that the Michigan exception applied, thus allowing her case to move forward.
However, the case was tossed out by a Federal District Court judge who ruled that a U.S. Supreme Court decision from 2001 holds that “fraud-on-the-FDA” claims are “impliedly” preempted by federal law.
But that ruling was overturned in January by a 2nd U.S. Circuit Court of Appeals panel. It was ruled by the federal appellate court that, among other things, the Michigan case was not an effort “to police fraud against the FDA.” Instead it is an attempt to recover damages under the existing Michigan product liability laws before 1995 when the state enacted its pharmaceutical liability shield.
The drug company appealed and the case will now be decided by the Supreme Court of The United States.