Friday, June 14, 2013

Breaking News - Innovators Ring The Bell In a Generic Case (And The Generics Do OK, Too)

This post, being about metoclopramide/Reglan, is from the ReedSmith side of the blog only.

The Eighth Circuit decided branded and generic liability issues today in Bell v. Pfizer, Inc., No 12-1647, slip op. (8th Cir. June 14, 2013).  The innovator drug drug defendants rang the bell, their dismissal as a matter of law affirmed.  The generics did almost as well, but some issues were sent back.

Bell is a metoclopramide/Reglan case where, as usual, the plaintiff only took the generic (that is, metoclopramide).  The district court gave the plaintiff the old one-two - granting sumary judgment to the generic defendant on the basis of preemption under Mensing, and to the innovator defendants because the plaintiff never used their product.

The Eighth Circuit affirmed as to the innovator defendants, since the plaintiff admitted never taking their drug.  That court had already decided the identical issue in favor of the same defendants under Minnesota law in the original Mensing opinion, which we discussed here when it came down.  The Bell court reached the same conclusion under Arkansas law:


Arkansas law compels the same result. . . .  [T]o prove her product liability claims under Arkansas law, [plaintiff] must show that a product manufactured or distributed by the brand defendants caused her injuries.  Because [plaintiff] never used [the product] the brand defendants manufactured, [plaintiff] cannot hold them liable under Arkansas law.

Bell, slip op. at 6 (citations and footnote omitted).  The court refused to recognize any causation distinction between product liability claims and other claims such as "negligence, misrepresentation, suppression of evidence and fraud" that would affect the product identification requirement.  Id. at 7.  Furthermore, even if there had been some sort of duty (which the court rejected), the plaintiff's claims would still fail under the learned intermediary rule, which Arkansas follows.  Id. at 7-8.  That rule does not support "extending such a duty of care to the customer of a competitor using a competing product."  Id. at 8.
 
The generic defendants in Bell did not do quite as well as the innovators, but only because they hadn't addressed the plaintiff's non-warning claims specifically in the district court.  All of the warning-related claims were either preempted or failed on causation grounds.  As to preemption:


While we agree with the district court that the vast majority of [plaintiff’s] allegations . . . set forth preempted failure to warn claims, we are unable to conclude, at this point, that [plaintiff’s] design defect and breach of implied warranty claims, other than those based on an inadequate warning or labeling, are “in essence, failure-to-warn claims that are barred by Mensing.”

Bell, slip op. at 11-12 (quoting district court).  Mensing didn't control, because the plaintiff there "did not contest" that those claims involved warnings, whereas this plaintiff did.  Id. at 12.  The defendant pointed out that the "vast majority" of courts had found those other claims to be preempted, id., and the Eighth Circuit did not disagree.  However, the district court had not done the analysis.  Although, since preemption is a legal issue the Court of Appeals could have easily analyzed the issue itself, it chose not to address the "alternative ground not considered by the trial court" itself, and remanded for further proceedings.  Id. at 13.

We can't, of course, read judicial minds.  But we suspect that Bell took this tack because of Bartlett pending in the Supreme Court.  This way the court could decide the case without having to guess which way Bartlett would come down.

Bell did dispose of the label-related claim that has caused metoclopramide manufacturers the most trouble lately  - claims specific to this particular drug that the defendants failed to update their labels when the FDA required such a change.  The court avoided the preemption issues and decided this issue on causation grounds under the aforementioned Arkansas learned intermediary rule.  The plaintiff was hoist on her own petard - the prescriber reliance evidence she had developed in her unsuccessful attempt to hold the innovator defendants liable precluded a finding of causation, due to prescriber non-reliance on the generic label:


[The prescriber] relied on information published in the brand defendants’ “package inserts and/or the Physicians’ Desk Reference . . . or otherwise disseminated by” the brand defendants. “Thus, the causal link between [plaintiff’s] injury” and [the generic manufacturer’s] admitted failure to incorporate the [FDA-approved] label change, if any, was broken. . . .  [T]here is nothing to indicate [the] failure to update [the generic] warning affected [plaintiff’s] physician’s prescribing decision or [plaintiff’s] injury in any way.  Because there is no causal link . . . the district court’s dismissal of that claim was not error, regardless of whether Mensing preempted that claim.

Bell, slip op. at 15 (quoting plaintiff's prior admissions).

In sum, in Bell, the innovator defendants won complete affirmance of their dismissal.  The generic defendants won affirmance of every point the court was willing to rule on.  The plaintiff won nothing substantive - only the chance to wait for Bartlett to be decided.

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