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If we have said it once, we have said it a hundred times:  medical product manufacturers are not insurers of their products.  Almost as frequently uttered would be that strict liability is not the same thing as absolute liability.  In the show position might be that the temporal relationship between a new medical condition and the use of a drug or medical device does not, without more, prove causation.  When you put together the trifecta, it means a plaintiff should need much more than an injury after exposure to the defendant’s medical product to get past a motion to dismiss.  When a court understands preemption, the bar gets higher.

The preemption primarily at issue in Brashear v. Pacira Pharms., Inc., No. 1:21-cv-700, 2023 WL 3075403 (S.D. Ohio Apr. 25, 2023), is one we have been talking about for a long time.  As detailed here, the decision in Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281 (6th Cir. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs.  The Supreme Court had found preemption of the design defect claims for generic drugs in Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), but that hinged largely on the duty of sameness—that is, the generic manufacturer cannot change the formulation of its drug to be different from the branded drug on which its ANDA approval depended.  We are pleased to see how, at least in the Sixth Circuit, Yates is leading to easy analyses and dismissing claims with prejudice at the pleading stage.  When you add in the narrowing of the CBE loophole in the years since Levine opened it up, the preemption cocktail offered up in Brashear reflects positive changes in the law in this space over the last decade or so.

The facts in Brashear—at least those set out in the decision and discussed here—are pretty straightforward.  Plaintiff had a shoulder replacement surgery and received defendant’s branded prescription non-opioid analgesic via a nerve block infiltration.  She claimed the drug partially paralyzed her diaphragm, which resulted in a cascade of other issues.  Although she brought the obvious claims under the Ohio Product Liability Act, along with its quirky supplier liability claim that we are not discussing, she did not have any specific criticisms of the manufacturer, the drug, or the drug’s labeling other than that its warning of “paralysis . . . which may have slow, incomplete, or no recovery” did not mention diaphragms by name.  2023 WL 3075403, *3.  Defendant moved to dismiss on preemption and TwIqbal.

First up was plaintiff’s vague claim for design defect.  Rather than decide whether Ohio law required the plaintiff to specify a defect in the product and how it caused plaintiff’s injury, the court addressed preemption with icy efficiency.  (The allegations were clearly insufficient under TwIqbal, but plaintiff probably would have been allowed to amend her boilerplate complaint to try to fix that issue.)  Yates made that an easy analysis.  FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own.  Id.  Yates also dispensed with the argument that the drug should have been different before an NDA was filed, which does not work because you cannot just assume FDA would have approved a hypothetical different drug based on the hypothetical results of its hypothetical preclinical and clinical testing.  Id. (See here for more.) So, the design defect claim was dismissed with prejudice.  It seems that plaintiff did not get multiple shots at amending because preemption was going to be the end result anyway.

Next up was the plaintiff’s somewhat incongruous warnings claim, which the court generously construed as complaining about the specificity of the paralysis warnings.  Id.  The court correctly understood from Albrecht and Fulgenzi that the label for an FDA-approved drug can be changed through a supplement requiring FDA approval (which cannot be assumed) or a CBE, which allows a temporary change under limited circumstances.  Here, because there was already pertinent risk information in the “Warnings and Precautions” section of the Full Prescribing Information portion of the label, FDA regulations required that any proposed change be done through a prior approval supplement because the “Highlights” section would also need to change. *4.  Because the defendant could not change the label independently, the claim was preempted.

For some reason, however, the court also went ahead and analyzed a claim contingent on utilizing a CBE.  This was unnecessary:  the requirement of prior approval supplement means that a CBE could not be used for the labeling change at issue.  End of story.  Nonetheless, plaintiff did not identify newly acquired safety information after approval or any basis that FDA would have changed the label to refer specifically to diaphragmatic paralysis.  Id. at *4-5.  Rather than muddle things, this provided an alternate ground for the holding.  We would also be stunned if plaintiff alleged facts to support that plaintiff’s prescribing physician would have altered her behavior based on such a change.  The sprig of mint of top of the analysis, if you will, is that Levine was not mentioned, something almost inconceivable for a drug warnings preemption analysis in the years after it came out.

Relatedly, the claim for “false marketing”—the court’s term, whereas the OPLA calls it “Product conforming to representation made by manufacturer” and it would usually be called “misrepresentation”—was really a re-packaged warnings claim.  The only thing approaching a misrepresentation that plaintiff identified in her complaint was a general criticism of the label.  This was insufficient under TwIqbal, but it also meant that the preemption analysis for the warnings claim applied equally.  Id. at *5.  Rather than cutting off plaintiff on this claim, she was given another shot at pleading a non-preempted claim based on a misrepresentation outside of the label.

An argument that is often a long-shot at the pleading stage also came through.  Ohio is one of several states, with New Jersey being the most notable, with statutes precluding punitive damages in product liability cases based on FDA approval or compliance.  The intersection between these statutes, or the more complete “FDA defense” provisions in Michigan and Texas, and Buckman’s prohibition on fraud-on-the-FDA claims has been the subject of variable treatment from courts.  This was seen most starkly in the non-precedential affirmance of a bad decision on the Michigan statute’s exception in Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965-66 (6th Cir. 2004).  The Ohio statute has an exception in its provision providing the punitive damages bar where the plaintiff proves the manufacturer “fraudulently and in violation of applicable regulations of the food and drug administration withheld from the food and drug administration information known to be material and relevant to the harm that the claimant allegedly suffered or misrepresented to the food and drug administration information of that type,” which runs right into Buckman.  Drawing on the Sixth Circuit’s decision in In re Aredia & Zometa Prods. Liab. Litig., 352 Fed. App’x 994, 995 (6th Cir. 2009), which looked at the Michigan statute and followed Garcia, the Brashear court concluded the only way to avoid the bar on punitive damages was “if FDA (or some other federal agency) has already discovered that [the manufacturer] made some sort of fraudulent representation about [the drug].”  2023 WL 3075403, *7.  We can quibble that the proof needs to be even more specific than that (e.g., final determination, about the risk of diaphragmatic paralysis, material), but plaintiff did not offer any facts supporting the more general formulation.  That meant plaintiff’s claim for punitive damages was preempted and dismissed with prejudice.  Usually, one-off product liability cases are worth taking across the finish line only if there is a legitimate chance for an award of punitive damages.  We will not lay odds on whether this observation has anything to do with how often punitive damages stays on track as other claims fall away through motions to dismiss and motions for summary judgment.

In case we were too subtle, enjoy your mint juleps on Derby Day.  (Were you expecting a Star Wars theme for a post on May the Fourth?  Do that already we did.)