The plaintiffs’ allegations in In re MDL 2700 Genentech Herceptin (Trastuzumab) Marketing & Sales Practice Litigation, ___ F.3d ___, 2020 WL 2781287 (10th Cir. May 29, 2020), weren’t safety related.  Rather, they sought damages for purely economic loss because the way the vials of Herceptin (a prescription biologic) were filled allegedly resulted in most of them having slightly less of the active ingredient than the labeled amount.  The district court, in an excellent opinion (discussed here), held the claims impliedly preempted for a number of reasons – chief among (from our product liability perspective) them being that to do what the plaintiffs demanded would have required a manufacturing change significant enough to require prior FDA approval, resulting in preemption under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).

Well, recently the Tenth Circuit reversed.  It did so for two reasons.  First, it disagreed with the district court’s conclusion that the product in question was a “solid.”  It might have started out that way, but by the time the plaintiffs used it, it was a “liquid.”

[The product] could, at least arguably, qualify as either a “solid drug” or a “liquid drug,” depending upon the point in time that we consider its state.  More specifically, [it] is shipped to healthcare providers as a freeze-dried block or potential “solid drug.”  But, before it can be administered to patients, [it] must be reconstituted by a healthcare provider, using . . . water that is provided by [defendant].  Thus, at the time [the drug] is actually administered to a patient, it is clearly a “liquid drug.”

Herceptin, 2020 WL 2781287, at *18.  The court opted for “liquid” over “solid” because the regulatory definition for “liquid” included the descriptive “intended for injection” whereas the definition of “solid” did not.  Id. (citing 21 C.F.R. §201.51(g)).  That’s not really something that we, as product liability lawyers, frankly care very much about.  Calling it one rather than the other changed how the dose of the product was calculated – “solid” allowed a range of amount of active ingredient, whereas “liquids” had to “express the minimum quantity” of product.  Id.

That the FDA hadn’t seen it that way didn’t matter much.  “[W]e need not . . . under Kisor, defer to the FDA’s interpretation of §201.51(g) as applied to Herceptin.”  Id.  “Kisor” refers to Kisor v. Wilkie, 139 S. Ct. 2400 (2019), which we discussed here.  So to the question we posed in that earlier post, “Will Agency Deference Ruling Affect Preemption?” – the answer in this particular case was yes.  Thus, the defendant can be sued for doing what the FDA said, because according to the Tenth Circuit, the FDA got it wrong.  That duty becomes “the same” only because private plaintiffs managed to convince the appellate court that the FDA misread its own regulation.  We don’t like that, but it is what it is.  At least it doesn’t happen much in product liability litigation.

The second key point in Herceptin has to do with our bread and butter – implied conflict preemption.  The court held that what the plaintiffs were demanding didn’t affect the safety or effectiveness of the product, and thus was not a “major” change requiring FDA pre-approval:

[W]e conclude that [defendant] has failed to conclusively establish either that employing a target range . . . of [active ingredient] per vial, or targeting a drug substance concentration per batch . . ., would have resulted in a “major” change under 21 C.F.R. §601.12(b) that required FDA preapproval.  In other words, we conclude . . . that [defendant] has failed to establish that it could not have independently implemented these changes in order to comply with the state law duties alleged by plaintiffs.

2020 WL 2781287, at *23 (product-specific statistics omitted).

While that holding is unfortunate for this defendant and its preemption arguments in this case, the rationale underlying it is actually helpful to defendants in product liability litigation.  The Tenth Circuit in Herceptin also recognized the converse:

A supplement . . . “shall be submitted for any change . . . that has a substantial potential to have an adverse effect on . . . the safety or effectiveness of the product.”  Such changes are deemed to be “major” for purposes of the regulatory scheme. . . .  The parties essentially agree, as do we, that . . . “major” changes under § 601.12(b) generally give rise to impossibility pre-emption.

2020 WL 2781287, at *20 (quoting 21 C.F.R. §601.12(b)) (emphasis added).  Thus, in Herceptin, the Tenth Circuit, while not finding preemption in that case, became the latest court of appeal to hold that a “major change” – which is the only kind relevant in product liability litigation litigation, with product “safety” as the key issue – supports impossibility preemption in prescription medical product cases.

For us, that’s a rather bright silver lining on what is otherwise a defense loss.