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Posted in Products Liability Blog, General Blog, Pharmaceuticals Blog

High Court’s 4-4 tie makes the latest preemption battle a draw

March 6th, 2008 by Dawn Mefford

A handful of my posts have addressed the issue of federal preemption.  You can read past blog posts from March 4, 2008, December 17, 2007, August 7, 2007.  In general, preemption is a legal concept which dictates that state laws are inferior to federal law.  Within the last decade, there has been a legal battle raging over whether federal regulations of certain industries “preempt” lawsuits against corporations who are being regulated.  One of the most litigated areas in the preemption conflict has come from the health care industry.  Generally, the courts have had to decide whether injured medical patients can sue medical device makers and drug manufacturers for injuries caused by their products, or whether the Food and Drug Administration’s (FDA) regulatory system protects those corporations from such lawsuits. 

Earlier this year, the United States Supreme Court handed down a decision that medical device manufacturers cannot be sued when their products are defective.  My blog posting regarding that decision can be read here.  Two weeks ago, the Court heard arguments on another preemption case called Warner-Lambert Co. v. Kent.  The plaintiffs in Kent were attempting to sue the maker of a diabetes drug called Resulin for allegedly withholding relevant information from the FDA during the drugs approval process.  The FDA approved the drug for sale in 1997, and then withdrew that approval three years later when it was shown that Resulin caused patients to suffer from liver damage. 

Warner-Lambert argued that because the FDA approved their drug, they could not be sued for the damaged caused by it.  The plaintiffs’ argued that the drug maker wasn’t honest with regulators, and that their selective information paved the way for the approval of a dangerous drug that should never have been put on the market. 

The nine-member Court voted 4-4 on the question of whether the suit was preempted by the federal regulations.  Chief Justice John Roberts, who owns stock in Warner-Lambert’s parent company, Pfizer, recused himself from the deliberations. 

Because the Court tied, the ruling of the lower Court of Appeals will be allowed to stand, and thus, the plaintiffs’ suit will be allowed to proceed to trial.  

A larger battle looms on the horizon.  During next year’s term, the Court will hear the case of Wyeth v. Levine.  Lawyers and preemption experts expect that case to be vital in determining whether patients who are injured by dangerous drugs will be able to use the courts to seek justice. 

To read the New York Time’s take on the decision, click here.

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