[Drug and Device Law] Learned Intermediary Doctrine Gets an Assist in Preempting a Failure to Update Claim

Posted by Law



Last week, the Eighth Circuit put the final seal on Pliva’s victory in Brinkley v. Pfizer, Inc., 2014 U.S. App. LEXIS 22742 (8th Cir. Dec. 2., 2014), upholding the district court’s dismissal with prejudice under Mensing and Bartlett.  The case involved a doctor who prescribed Reglan and a pharmacist who, when filling the prescription, switched it out for Pliva’s generic metoclopramide.  Id. at *2.  While the Reglan label had been changed in 2004 to add a warning on long-term use, Pliva, plaintiff claimed, failed to make the corresponding update to its label.  So she pursued a failure to update claim.

In some sense, that’s a good starting point.  By styling her failure to warn claim as a “failure to update,” Plaintiff was conceding that she could not bring a standard failure to warn claim.”  Generic manufacturers can only change their label to match a corresponding change in the branded label, and plaintiff hoped that her “failure to update” claim would avoid Mensing preemption.

But this claim had problems too, and they centered on the learned intermediary doctrine.  Pliva’s duty to warn, if any, ran to plaintiff’s prescribing doctor.  But, as plaintiff alleged, her doctor prescribed Reglan, not Pliva’s generic metoclopramide.  Consistent with that, the doctor consulted the Reglan label, not the Pliva label.  Id. at 2-3.  In short, the doctor never read Pliva’s label.  So no matter what Pliva put there, it could not have affected the doctor’s decision to prescribe the drug to plaintiff.  We lawyers call that a failure of proximate causation.  

Plaintiff tried to patch this over.  But she only moved, as the court put it, from “the frying pan, into the fire.”  Id. at *8.  She went on to allege that her prescribing doctor didn’t read the 2004 Reglan label change and therefor wasn’t aware of the new warning on long-term use.  So, she argued, Pliva’s failure to change the warning in its label could have caused plaintiff’s injuries.  

It takes only a second to realize how this allegation can’t work.  The fact (alleged by plaintiff) still remains that the prescriber did not read Pliva’s label.  The proximate cause problem remains.  No matter what Pliva said in its labeling materials, it wouldn’t have matter:

[W]hether from Pliva or the brand-name manufacturer, the adequacy of the instructions . . . made no difference in the outcome of Brinkley's injury because Brinkley alleges her prescribing physician did not read those materials.

Id. at *10-11.  Accordingly, the court upheld the dismissal with prejudice of plaintiff’s failure to update claim.  Id. at *11.

Now, we would have felt a little better about this decision if the Eighth Circuit had simply held, as other courts have, that plaintiff’s failure to update claim was preempted regardless of the facts alleged.  It seeks to enforce the federal labeling requirements of the FDCA, yet there is no private right of action under the FDCA.  Nonetheless, we’re satisfied.  And who knows?  In time, with the right facts and arguments, the Eighth Circuit may accept this reasoning and reject failure to update claims in their entirety.  As it is, the court did well.  Not only did it uphold the dismissal with prejudice of plaintiff’s failure to update claim, it also upheld the dismissal with prejudice of plaintiff’s defect and warranty claims as preempted under Bartlett.  Id. at *13-17.  With that, plaintiff’s case has ended.

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Posted By John J. Sullivan to Drug and Device Law at 12/08/2014 10:27:00 AM

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Posted by Law at 7:27 AM

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