U.S. Supreme Court may place limits on patient lawsuits concerning drug companies

The U.S. Supreme Court will consider Pfizer's appeal in a case involving the now-withdrawn Rezulin diabetes treatment. The procedural details of this case are a bit byzantine:
Pfizer, the world's biggest drugmaker, is seeking to overturn a lower court ruling that said a group of Michigan residents could press ahead with lawsuits claiming they were harmed by Rezulin, which has been linked to liver damage.

The dispute gives the drug and medical-device industries a chance to extend a victory they won in 2001, when the Supreme Court said patients can't sue companies for defrauding the U.S. Food and Drug Administration during the approval process. A ruling favoring the industries would help Merck & Co., which is fighting more than 27,000 lawsuits over its Vioxx painkiller.

In its appeal, Pfizer contends the 2nd U.S. Circuit Court of Appeals in New York created a loophole that would let patients in some states press the types of suits barred by the high court in 2001. Pfizer said the lower court ``adopted an unduly narrow reading'' of the 2001 decision.

The 2nd Circuit said the Michigan lawsuits could go forward because they focus primarily on traditional product-liability allegations, claiming Rezulin was defectively designed and manufactured. The suits depend ``only incidentally on such fraud'' against the FDA, the 2nd Circuit ruled.
That does seem like a bit of legal dodging, albeit perhaps to achieve a more just result. At the same time, if there is a valid products liability claim, then the 'FDA fraud' portion would be incidental, unless it is needed to trigger the possibility of a punitive damages award. It turns out that:
Michigan law generally shields drugmakers from product- liability suits over approved products, making an exception for companies that withhold information or deceive the FDA. Texas has a similar law, and six other states have a ``fraud on the FDA'' exception to their ban on punitive damages for approved drugs.
The case will be heard in July, in Warner-Lambert v. Kent, 06-1498.
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