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Here’s another guest post by Reed Smith’s Dean Balaes.  This one looks into a major (but not too recent) post-Albrecht drug preemption case.  Can’t have too many of those!  As always, our guest posters deserve all the credit (and any blame) for their writings.


There is no hiding the fact that federal preemption is a sword that cuts deeply into the other side of the “v.”’s mass tort business prospects.  In the context of state-law failure-to-warn claims, such actions are sometimes held preempted under the Supremacy Clause of the U.S. Constitution, especially when the FDA acts on a manufacturer’s label and requires manufacturers to comply with the FDA’s language.  See Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019).  In other words, by virtue of the FDA approving a manufacturer’s label through its rigorous control process, state-law failure-to-warn claims are preempted by the federal agency’s judgment call as to what is and is not included.  Bad news for the coffers of the other side of the “v.” and great news for the interests of fairness.  One recent case cited in the Blog’s newly acquired information post illustrating the aforementioned tension is Mahnke v. Bayer Corp., ___ F. Supp.3d ___, 2020 WL 2048622, at *3 (C.D. Cal. March 10, 2020).  The Blog mentioned Mahnke briefly in a previous post.  It has since been designated to be published in F. Supp., so it is worth a closer look.

As many of the Blog’s readers know, one of the takeaways from Albrecht is that to bring an unpreempted state-law failure-to-warn claim about a branded drug, one must plead a labeling deficiency that the manufacturer could have corrected using the “changes being effected” (“CBE”) regulation.  To avoid conflict with federal requirements, the plaintiff would need to show that a manufacturer could have unilaterally changed its label because “newly acquired information” arose about evidence of a causal association between a drug in question and a clinically significant adverse reaction.  See Klein v. Bayer Healthcare Pharm. Inc., No. 218CV01424APGEJY, 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019).  The newly acquired information, however, must have been available to a manufacturer after the FDA approved of the label in question, but before a plaintiff last used the drug.  See Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019).  Only after such facts are sufficiently pleaded will the Court turn its attention to the manufacturer and ask whether the manufacturer satisfied its burden to show by “clear evidence” that the FDA would not have approved of the labeling changeSee Wyeth v. Levine, 555 U.S. 555 (2009).

In Mahnke, the defendant defeated (once again) a state-law failure-to-warn claim related to an FDA-approved gadolinium-based contrast agent (“GBCA”) administered intravenously to enhance the quality of magnetic resonance imaging (“MRI”).  For those readers pondering the question:  what exactly is gadolinium good for?  Look no further.  Gadolinium is a rare earth material used in conjunction with an MRI exam because it is inherently opaque to magnetic resonances.  But elemental gadolinium can be toxic.  It cannot be introduced into the body without being bound to a chelator, which prevents gadolinium from having adverse interactions with tissue while preserving gadolinium’s contrast enhancing property.  The chelator also permits the kidneys to eliminate GBCAs from the body after the MRI exam.

Plaintiffs in these cases claim that GBCAs spontaneously undergo de-chelation, allowing elemental gadolinium to escape.  Think salt.  It’s essential to life, but only when the sodium and chlorine are bound to one another.  Bodily contact with either sodium or chlorine in their elemental forms is not recommended.  De-chelation allegedly increases the risk of Nephrogenic Systemic Fibrosis (“NSF”), a rare scleroderma-like cutaneous disorder.  The FDA has found no evidence of any of these problems in people with healthy kidneys – therein lies the preemptive rub.

In Mahnke, Plaintiff never alleged that gadolinium caused NSF and did not claim to have NSF – or even weakened kidneys.  Instead, it was alleged that by taking a GBCA drug to assist in MRI imaging, the Plaintiff with normal kidney function suffered gadolinium “toxicity,” a nebulous term that means whatever plaintiffs want it to mean.  Allegedly, the manufacturer should have warned of a nebulous “risk of gadolinium retention toxicity” to “individuals with healthy kidneys.”  2020 WL 2048622 at *2.

Mahnke questioned the other side’s failure-to-warn theory, observing that:  (1) the FDA tied the manufacturer’s hands from changing its label to incorporate gadolinium retention toxicity, even if the manufacturer so desired;  (2) even if the FDA permitted a manufacturer unilaterally to change its label under federal law, the FDA would not have approved this change;  and (3) any newly acquired information “must have been available to the manufacturer after the FDA approved the relevant label on August 19th, 2010, but before the plaintiff last used [the drug] on May 1st, 2015.”  Id. at *2-3.  The rationale for this nearly five-year window is simple causation:  plaintiff could not have been injured by lack of “newly acquired information” when plaintiff was injured before the information ever existed.

The other side pleaded that the “newly acquired information” was merely gadolinium being retained in the body following injection of a GBCA.  Id. at *1.  Big whoop.  That only stated the obvious.  That is, gadolinium is retained in the body before a healthy renal system removes it.  Mahnke held that the other side “did not connect the dots between gadolinium retention in [a healthy] body and a clinically significant adverse reaction,” i.e., gadolinium toxicity.  Id. at *3;  see also McGrath v. Bayer HealthCare Pharm. Inc., 393 F. Supp.3d 161, 169 (E.D.N.Y. 2019) (“[r]reports and studies that discuss the fact of gadolinium retention but do not reach any conclusions regarding the adverse effects or risks associated with gadolinium retention in patients with normal renal function do not plausibly allege the existence of newly acquired information that could have justified Defendants’ revising the drug label through the CBE regulation”;  internal quotations marks omitted).

Plaintiff pointed to two pieces of supposed newly acquired information that could have triggered use of the CBE regulation:  two review papers published in 2016 and 2018 collecting research regarding GBCAs.  Id. at *3.  But the 2016 and 2018 research papers were “published outside of the relevant time frame” (i.e., August 2010 through May 2015).  Id.  Any newly acquired information alleged by Plaintiff “must have been available to [defendant] after the FDA approved the relevant label on August 19, 2010, but before Plaintiff last used [the product] on May 1, 2015.”  Id.;  see also Goodell, WL 4771136, at *4.  Moreover, both articles failed “to establish the requisite connection in the body and a clinically significant reaction in patients with normal kidney function,” discussing only the effects of GBCAs in patients with advanced kidney disease—not normal renal function.  Id. at *4  (meaning these articles will not be enough in a case without Mahnke’s timing problems).  Thus, the Court concluded that the articles do “not constitute newly acquired information warranting invocation of the CBE regulation.”  Id.  To otherwise rule against the manufacturer would impose the unreasonable requirement that one should have “pieced together” vague research standing for a different proposition to “conclude[] that gadolinium is toxic when de-chelated in patients with normal renal function,” so accordingly the other side failed to meet their burden to plead a labeling deficiency that the manufacturer could have corrected.  Id.

Beyond their failure to warn claim, the other side also (unsuccessfully) alleged a design defect.  Application of Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), outside of the generic context was conclusive.  Thus, the Court agreed with the defendant that plaintiffs failed to articulate a theory of liability that avoids preemption.  The bottom line is that the defendant successfully fended off inappropriate claims from the other side of the “v.” trying to gin up “newly acquired information” where none actually existed.

The only claim that survived is whatever vague piece of a warranty claim that might exist outside of the Defendant’s warnings.  But on the plus side, that fragment of a claim makes Mahnke non-appealable.