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A Note on Ackermann v. Wyeth, Learned Intermediaries, and the Heeding Presumption

By James M. Beck and Mark Herrmann

Since Herrmann argued this case, and Bexis contributed an amicus brief, we're going to be quite guarded in what we write here. But please remember the existence of Ackermann v. Wyeth, 526 F.3d 203 (5th Cir. 2008), the next time you're briefing whether a so-called "heeding presumption" applies in cases involving the learned intermediary doctrine.

On that issue, Ackermann hits the trifecta for the defense. Ackermann holds, first, that "the read-and-heed presumption does not apply to Texas cases involving learned intermediaries." That's strong precedent for cases pending in the Lone Star State, and one could plainly suggest that other states should follow Texas's lead.

Ackermann holds, second, that, even if a read-and-heed presumption did apply, in the context of learned intermediaries, that presumption would mean "'only that the physician would have incorporated the additional risk into his decisional calculus,'" not that the physician would automatically have decided not to prescribe the drug.

And Ackermann holds, third, that, "even if the [heeding] presumption applied, it would not change the result" in Ackermann itself, given the testimony of the treating physician.

That makes the Fifth Circuit decision in Ackermann an exceptionally strong precedent when plaintiffs assert that a court should presume that a physician would not have prescribed a drug if the package insert had contained some altered warning.

(Oh, yes: If you've ever arguing about whether a drug company should have included a "black box warning" in its package insert, Ackermann's footnote 13 is helpful on that score, correctly suggesting that manufacturers cannot unilaterally add black box warnings, but rather can give those warnings only when the FDA requires them.)

Full post as published by Drug and Device Law on September 30, 2008 (boomark / email).