United States: Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

Last Updated: April 6 2017
Article by Eric Alexander

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal.  Part of why the defendant drug or device manufacturer may prefer federal court over state court is that the belief that the chances of winning on preemption are better in federal court.  On the other hand, we have described many instances where federal courts mess up their preemption analysis by presuming that state law imposes the duty that plaintiff claims does not conflict with FDA obligations or by extending state law in new directions to provide a basis for a parallel claim, Erie restraint notwithstanding.  It may be that state court judges are less likely to impose duties not recognized explicitly in higher court decisions.

Tibbe v. Ranbaxy, Inc., No. C-16o472, 2017 Ohio App. LEXIS 1139 (Ohio App. Mar. 29, 2017), is a case that stayed in state court despite the explicit claims that the defendants—the generic drug manufacturer and the non-diverse pharmacy defendant—violated the FDCA in various ways.  On its basic facts and history, the case had the hallmarks of a case pursued in disregard of controlling law.  A typical warnings claim that information in the generic drug label about the risk that allegedly befell plaintiff was insufficient should not fly post-Mensing.  A claim predicated on defrauding the FDA should not fly post-Buckman.  Claims against the pharmacy that it should be liable for nothing more than filling a prescription with the generic form of the particular antibiotic (presumably as required by plaintiff's insurance) should not fly under Ohio law.  It should not have been enough to defeat a motion to dismiss for plaintiff to claim that discovery might help them determine if the generic drug's label was different than the reference drug's label.  After the Sixth Circuit's decision in Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013), discussed here, this is something that can and should be determined before suing.  Even though Fulgenzi held that there is exception to Mensing's preemption of warnings claims for generic drugs where there has been a failure to update, the plaintiff there lost because the prescriber did not review the label.  So, you would think some pre-suit investigation into the labels of the reference drug and the generic drug and the prescriber's practices should be done in determining if there is a good faith basis to plead a non-preempted claim.  Maybe that is just our silly defense-sided way of thinking.

Regardless, in Tibbe, the plaintiff got her discovery and the preemption issues were presented again on motion for summary judgment.  Despite plaintiff's earlier protestations, the labels were actually the same during the relevant time periods, including the language as to the risk of the condition that plaintiff claimed to have developed from the medication, so Mensing applied and Fulgenzi did not.  2017 Ohio App. LEXIS 1139, *10.  The intermediate appellate court reviewed the grant of summary judgment de novo.  Even though the Sixth Circuit had carved out an exception for non-preempted generic drug warnings claims in Fulgenzi, later the same year it recognized in Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 391 (6th Cir. 2013), discussed here, that Mensing had broad application to "claims that the generic manufacturers failed to provide additional warnings beyond that which was required by federal law of the brand-name manufacturer," no matter how the claims were couched. Id. at *18.  Faced with this law and the factual record on sameness, plaintiff came up with an argument that we do not recall seeing before.  She claimed that there was a "duty to warn consumers of the generic version of the drug that they cannot bring a state-law failure-to-warn claim when their prescriptions are filled with Ranbaxy's generic minocycline and the labeling is that of the RLD." Id. at *19.  In other words, the plaintiff claimed the manufacturer had to give legal advice—not just legal advice, but legal advice about Mensing that was contrary to the position plaintiff advocated.

This is where being in state court maybe helped the defendants.  The court did not have to engage in much of an analysis to see whether there was already a duty to do what the plaintiff wanted and did not even consider making up a new duty.  The duty to warn under the Ohio Product Liability Act related to "the risks associated with the product." Id. at *20.  "There is no corresponding duty to warn a consumer of her legal rights or the prospective outcome of litigation should she decide to sue a drug manufacturer at a future point in time.  Thus, a claim based on that theory would not be available under Ohio law." Id. at **20-21.  Any warnings claim based on actual Ohio law conflicted with federal law and was preempted.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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