Law

This post is from the Reed Smith side of the blog only – the Dechert lawyers were not involved. 

The Iowa Court of Appeals has affirmed summary judgment entered in favor of both branded and generic manufacturers of metoclopramide, looking at Mensing's effect on both in the process.  In Huck v. Trimark Physicians Group, 2013 Iowa App. LEXIS 435 (April 24, 2013), the Plaintiff sued manufacturers of brand-name and generic metoclopramide after she developed tardive dyskinesia while taking the drug.  While her doctor relied upon the branded product's labeling as published in the Physician's Desk Reference – which warned about the risk of tardive dyskinesia - the Plaintiff took only the generic form of the drug.  Id. at *2.  Plaintiff relied on the fact that after she had taken the drug for about five months, the FDA approved a label change for the branded product to include a warning that the drug should not be used for more than 12 weeks; the branded product's label was updated accordingly, but the generic's was not.  Id. at *3-4.

The lower court granted summary judgment in favor of the brand-name manufacturers on straightforward product identification principles:  Plaintiff hadn't taken their drug, and therefore, under Iowa law, they could not be liable to her.  Id. at *4-5.  Plaintiff apparently agreed, as she didn't oppose the branded manufacturers' summary judgment motion.  Id. at *5.  After the Supreme Court issued its opinion in Mensing, the generic manufacturer in Huck moved for summary judgment, arguing that each of Plaintiff's claims were preempted.  Id. at *5.  The lower court agreed, and Plaintiff appealed.  Id. 

Noting that the Plaintiff had gone to "great lengths in her brief to distinguish Mensing," the Huck appellate court, like the lower court before it, found the facts "indistinguishable."  Id. at *7.  The appellate court first reiterated the conundrum recognized in Mensing:  that if the generic manufacturer had independently changed its label in an effort to comply with a purported state law duty, it would have violated federal law, which requires that the generic's label be the same as the branded product's label.  Id. at *7-8.  The Huck court also "appreciate[d]" what it called a "harsh result" for Plaintiff Huck – because she took only the generic form of metoclopramide, and her claims were preempted against that manufacturer were preempted, she was left with no means of recovery.  Id. at *8-9.  (We don't mean to be, well, harsh, but isn't this just the correct result, based on the law?  Would the court have expressed a similar sentiment if things in the lower court had gone differently, and Plaintiff had ultimately been permitted to recover against the generic manufacturer because she had suffered a harm that was warned about in the label?  But we digress . . . .)

The appellate court also rejected Plaintiff's other attempts to get around Mensing preemption.  First, it noted that even if the generic's label didn't comply with the requirement that it must be the same as the branded drug, this didn't help Plaintiff, given the fact that there's no private right of action for such a claim under the FDCA.  Id. at *9.  The court also rejected Plaintiff's argument that the generic manufacturer should have disseminated warnings via other means – presumably, things like Dear Doctor letters.  Id. at *10.  Plaintiff conceded that these additional warnings would have to be consistent with what was in the approved labeling.  Id.  The court not only rejected this argument on Mensing grounds, it noted that at the heart of Plaintiff's claims was the argument that the approved labeling was inadequate, and that "Iowa law does not provide a cause of action for failing to disseminate allegedly inadequate warnings."  Id. 

That wasn't the end of the opinion, though.  While Plaintiff had not appealed the grant of summary judgment in favor of the brand-name manufacturer (or even opposed their summary judgment motion, remember), after Mensing was decided, she eventually got around to asking the lower court to revisit the ruling in favor of the brand-name manufacturer under its "inherent power to correct interlocutory errors."  Id. at *12.  To support that request, she claimed that Mensing had overturned prior precedent that the lower court had relied upon, which held that "generic manufacturers had the ability to change their labels."  Id. at *12.  The reason for Plaintiff's procedural maneuvering to get the claims against the brand-name manufacturer in front of the appellate court seems pretty clear:  under Mensing, this was her only shot at a non-preempted claim. The appellate court didn't take the bait, though. 

On appeal, Plaintiff argued that the brand-name manufacturer had "designed" metoclopramide, and that as such, her negligence, misrepresentation and fraud claims didn't require product identification.  Id. at *13.  However, the appeals court observed that the only issue explicitly decided by the lower court was that of the branded manufacturer's duty to this Plaintiff, and that her "design" claims had not been preserved for appellate review.  Id.  There seems to be a question as to whether these claims were even made in the lower court in the first place – the brand-name manufacturer seemed to think they weren't, and the appellate court rather tepidly referred to them as only "minimally presented."  Id.  The court held that the only claims that were properly before it were whether Mensing changed Iowa's law with regard to claims against branded manufacturers (no), and whether Iowa's law on product identification would allow the Plaintiff's claims against the branded manufacturer to go forward (again, no).  

We'll be sure to add this case to our preemption scorecard(s).