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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.

Under the doctrine, prescription-drug manufacturers are required to inform doctors--the "learned intermediaries"--of the risks associated with taking prescription drugs, but are not required to give consumers a direct warning of the potential risks or side effects of their products. Thus a patient taking a drug prescribed by a doctor can't claim warnings were insufficient. While a handful of states, including West Virginia (Johnson & Johnson v. Karl, 2007), reject the doctrine outright, others make exceptions when it comes to drugs advertised directly to consumers (see "Advertising Angle").

"Right now learned intermediary is a really potent defense," says Steven Weisburd, a partner in Dechert's Austin office. "It's the next fallback argument in any individual case for a pharmaceutical company. But I do expect plaintiffs lawyers to spend a lot of energy trying to limit and narrow application of the doctrine."

Although most states recognize learned intermediary defenses, interpretations vary between jurisdictions, meaning the doctrine's existence does not guarantee drug manufacturers immunity from warning-label suits.

"Anytime the 5th Circuit reiterates that learned intermediary is a good doctrine, that's important, because plaintiffs lawyers have been mounting a serious attack to undermine learned intermediary drug cases as being unfair to consumers," says Gene Williams, managing partner at Shook, Hardy & Bacon. Williams represented the defendant in Ebel v. Eli Lilly.

A leader in the attack is Andy Vickery, a Vickery Waldner & Mallia partner. He represented plaintiffs in both recent 5th Circuit cases. "It's a travesty of justice when we cede the case to prescribing physicians who inevitably have an agenda of their own," Vickery said in a March statement after the Ebel and Allgood rulings.

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.

In Allgood, the plaintiffs appealed the district court's grant of summary judgment in favor of GlaxoSmithKline, manufacturer of the antidepressant Paxil. New Orleans longshoreman Jake Palermo was diagnosed with prostate cancer in 2000 and with terminal lung cancer in 2002. He also suffered from depression. In 2003 his doctor prescribed Paxil for depression and to stimulate his appetite. Three days later Palermo committed suicide. In their suit, Palermo's daughters alleged that their father's use of Paxil contributed to his suicide and that the drug label contained an inadequate warning. The 5th Circuit confirmed the district ruling, noting that Louisiana applies learned intermediary to product liability claims involving prescription drugs.


Doctor's Decision

The prescriber's decision is the critical element in prescription-drug litigations, which experts say usually boil down to failure-to-warn cases.

"You've got to show causation," says Andy Bayman of King & Spalding, who represented GlaxoSmithKline. "[Plaintiffs] have to show that some hypothetical different warning would have somehow made a difference in the decision [to prescribe the drug]." In the majority of these cases, he adds, most doctors testify that, given what they knew about the drug and their patients' needs, they would not have changed their prescribing decision.

With pre-emption no longer the "stopper" in many warning-label disputes, that makes a physician's testimony and the legitimacy of the learned intermediary doctrine vital to drug manufacturers' defense in prescription-drug litigations.

"The defense that was being raised in the pre-emption cases is one that would have required courts to rely on the FDA to get [labeling] right, and the Supreme Court said it's not going to do that," says Douglas Schneebeck, a shareholder at Modrall Sperling.

Schneebeck says that learned intermediary becomes more significant because it is a doctrine that doesn't apply merely to whether the warning complies with FDA requirements. "It also relies on what the physician knows."

Experts warn that just a few plaintiff victories could weaken the doctrine.

In light of the Supreme Court's ruling in Wyeth, the last thing pharmaceutical companies want to see is a weakening of learned intermediary--their current frontline defense.

"We want doctors making the choice about prescription drugs, not consumers," Schneebeck says. "Learned intermediary represents important public policy. Most states that look at it will agree."

Dave Wieczorek

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