Photo of Bexis

One of 2022’s top-ten cases, In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022), opened with a 4-page critique of the shortcomings of the product testing conducted by a purportedly “independent” laboratory that touched off that massively meritless MDL litigation.  Id. at *1-4.

More bogus product “testing” formed the basis for Sapienza v. Albertsons Companies, Inc., et al., 2022 WL 17404919 (D. Mass. Dec. 2, 2022), which was likewise dismissed four days earlier, only on preemption rather than Rule 702 grounds.  Sapienza was a putative nationwide class action based on allegations that “independent testing” showed the defendant’s over-the-counter (“OTC”) “rapid release” acetaminophen product “dissolve[d] more slowly than” similar products that were not labeled “rapid release.”  Id. at *1.  The rest of the complaint consisted of the usual boilerplate economic loss/“premium” pricing claims.  Id.

Because Sapienza asserted economic loss, rather than personal injury claims, the “product liability” exception to OTC express preemption in 21 U.S.C. §379r(a) was applicable, and as a result Sapienza was duly dispatched on a motion to dismiss, rather than lingering until summary judgment, as in Zantac – or escaping preemption altogether as in the dreadful In re Acetaminophen − ASD-ADHD Products Liability Litigation, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022), that we blogged about here.  This preemption provision bars any state-law claim “that is different from or in addition to, or that is otherwise not identical with, a [FDA] requirement” applicable to this OTC drug.  Id. at *2 (quoting §379r(a)).

For plaintiff Sapienza, the now-“final administrative order” governing acetaminophen (and a number of other) products included “dissolution standards” – incorporating standards “promulgated in the United States Pharmacopeia (USP).”  Id.  Specifically:

The USP standards identify acetaminophen tablets as “immediate release” when a product dissolves by at least 80% after 30 minutes.  Further FDA guidance identifies acetaminophen tablets dissolving 85% or more within 30 minutes as “rapidly dissolving” and those that dissolve within 15 minutes as “very rapidly dissolving.”

Id. (citations omitted).  Plaintiff’s case had a serious problem, “[t]he testing on which [plaintiff] rests her claims confirms that the [product] meet the USP and Immediate Release Guidance dissolution standards.”  Id. at *3.

The Sapienza opinion thus observed that, as a result, all of the “claims are preempted insofar that they attempt to augment the existing approved labeling requirement.”  Id.  Plaintiff first argued that preemption didn’t apply because the USP standards were phrased in terms of “immediate release” rather than “rapid release, the term that appeared on the product.  Id.  That argument vanished, almost immediately.

FDA preemption regulates dissolution standards generally − the subject matter of Sapienza’s state-law claims − even if the wordings slightly differ. . . .  [W]hile the FDA may not have considered the exact language addressed it had clearly addressed the substance of the claims at issue.

Id. (citations and quotation marks omitted).  Plaintiff relied on a food decision “to argue that “rapid release” would need to appear verbatim in the FDA and USP regulations to have preemptive effect.”  Id. (citation omitted).  But unlike the food case, the monograph here became final by congressional fiat.  Id.

Further, since the product in fact met the applicable dissolution standards for “rapid release,” that other products not so labeled “may dissolve just as (or even more) rapidly is no more relevant as a comparison than is a bag of ice labeled ‘frozen’ as opposed to one simply branded as ‘ice.’”  Id.

Finally, the plaintiff’s position made no sense as a practical matter:

To find otherwise would require the FDA to list phrases in every possible permutation of similar words to have preemptive effect.  Yet limiting the FDCA’s preemptive power in such a way would undermine the latitude Congress gives agencies to have authority over matters in which they have subject matter expertise – here the FDA’s responsibility to evaluate and regulate drugs.

Id. at *4.  To limit preemption, and therefore the scope of FDA regulation, to verbatim identical phrases would not only depart from the plain language of §379r(a), but would place a premium on bizarre claims:

This argument proves too much. By this logic, a manufacturer could make any claim − wild, untruthful, or otherwise − about a product whose contents are not addressed by a specific regulation.”

Id. (citation and quotation marks omitted).

While “sapienza” means “wisdom” in Italian, plaintiff’s arguments certainly were not.  Poof.  Sapienza quite rapidly dissolved, thanks to OTC preemption.