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"Learned Intermediary" Emerges as Key Defense in Drug Suits

Now more than ever it's crucial to have a strong backup defense. That's what pharmaceutical companies are learning after a Supreme Court decision that shot down pre-emption as a defense in many cases where plaintiffs claim prescription-drug warnings are inadequate.

While the court's March ruling in Wyeth v. Levine stripped the defendants' arsenal of a primary weapon, it did not render drug manufacturers defenseless. Recent 5th Circuit decisions in Ebel v. Eli Lilly & Co. and Allgood v. GlaxoSmithKline, echoing similar rulings in other jurisdictions, have reinforced an old standby--the learned intermediary doctrine--as a prime litigation spoiler.

Label Disputes

In Ebel, Beatriz Ebel claimed that Lilly's drug Zyprexa contributed to her husband's suicide in 2002. Philip Ebel, who suffered from chronic, severe headaches, had been taking Zyprexa for nearly four months when he fatally shot himself. The suit alleged Zyprexa's label did not warn that the drug might cause a patient to commit suicide. The district court dismissed the plaintiff's claim, concluding that Zyprexa's warning was adequate and that the plaintiff failed to prove that the drug was the producing cause of her husband's death. The 5th Circuit agreed with the district court ruling that granted summary judgment to Lilly on the grounds that Ebel's doctor--the learned intermediary--informed him of Zyprexa's risks.

Dave Wieczorek

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