Here’s a guest post prepared by Dick Dean and Corena Larimer, both of Tucker Ellis, on something we’ve been interested in as well – the transubstantivity of the implied preemption “impossibility” analysis of the Supreme Court’s Mensing opinion, with particular emphasis on generic drugs.  They give a new twist to the argument, tying it to statements made during the Bartlett oral argument (albeit by justices who dissented in Mensing).  Fingers crossed, okay?

As always we’re just the piano player on guest posts.  The authors get all the credit and all the blame.  Here goes:

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As we wait patiently (okay, maybe a little impatiently) for the Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett, we’ve been looking back through the arguments and wondering what the Court has in store for the generic pharmaceutical industry. But what is striking, and very clearly articulated by several justices during the Bartlett oral argument, is what the Court already may have given to all drug and medical device defendants facing design defect claims—two years ago, in Mensing.

Yes, Mensing was a generic drug case. And, yes, it focused on a federal duty that is unique to generic drugs. And it was about failure-to-warn claims, not design defect claims. But hear us out.

Recall that Mensing was an impossibility preemption decision, in which the Court held failure-to-warn claims against generic drug manufacturers preempted because federal law requires a generic drug’s warnings to match those of its brand-name equivalent. That aspect of Mensing is specific to generics.

But the Mensing Court went further, framing the general test for impossibility preemption in broad terms: “The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Mensing, 131 S. Ct. at 2579. And again:

To decide these cases, it is enough to hold that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

Id. at 2580-81.

In essence, the Court held that preemption applies unless a defendant can independently—that is, without FDA permission or assistance—comply with the state-law duty at issue. That’s a pretty broad test, and one that can apply to any type of defendant—brand or generic, drug or device manufacturer.

Now, fast-forward two years. Failure-to-warn claims against generics are should be a thing of the past. Now the Court is considering Bartlett, which asks whether a manufacturer can be held liable for its generic drug’s design—which, like its warning, must match the brand-name equivalent. (And this blog has covered the case extensively.) The Supreme Court may not overtly decide that issue, if it instead finds that the case really presents a warning claim (because the warning has considered by the jury in judging the drug’s design) that is clearly barred by Mensing.

But some of the questions from the Court during oral argument illustrate that a straightforward application of Mensing’s impossibility test would preempt a true design defect claim (i.e. one that doesn’t factor in warnings) against either generic or brand manufacturers. Justice Kagan was first out of the box, asking Mutual’s counsel whether there is any way to distinguish between the two.

Justice Kagan:

It seems to me that in this case we are not really dealing only with generics, we are also dealing with brand-name drugs. . . .  [T]he thought there would be . . . as to design, as compared to warnings, . . . they’re really all in the same boat. In other words . . . they have a design; that it is only that design that’s approved. If they change their design there’s no authority to continue marketing it. They have to go back to square one. And that’s just as true of brand names as it is of generics. So am I right about that? . . . If we’re just looking at a pure design defect claim, putting the warning card aside, where you are in a different position from the brand-name drugs, but as to design, don’t the brand-name and the generics go hand in hand? (Trans. 3:24 – 4:16 (emphases added).)

After continuing to press Mutual’s counsel on the issue (“am I right that generics and brand-name manufacturers are in the same position with respect to [design defect] claims?”), Justice Kagan explained “I just can’t figure out what distinction there would be.” (Trans. 5:3–9, 21–22.)

Justice Sotomayor (who authored the dissent in Mensing) then weighed in, referencing Mensing’s test for impossibility. When Mutual’s counsel suggested that the plaintiff could have brought a design defect claim against the brand-name manufacturer if she had taken the brand-name drug instead of the generic, Justice Sotomayor asked: “How? The FDA approved the design. . . . And they couldn’t change it without FDA approval.” (Trans. 10:5–10.) Later in the argument, responding to a question from Justice Kagan, counsel for Ms. Bartlett agreed that brand and generic defendants stood in the same shoes as to design changes, agreeing that “if there was to be a tweak to the design, they’d need to go to the FDA to get approval for that.” (Trans. 51:10–14.) So both Justice Kagan and Justice Sotomayor seem to believe that a straightforward reading of Mensing leads to preemption of design defect claims.

And the federal government agreed. The Solicitor General’s office, arguing as amicus curiae, confirmed that it is impossible for any drug manufacturer—brand or generic—to change its drug’s design without FDA approval:

[T]he FDCA also has within it the judgment that safety is best effectuated not only by having the FDA set the standard, but by forbidding any manufacturer from deviating from that once it’s been approved by the FDA. When we’re talking about a drug’s formulation, the manufacturer cannot change it. And that’s what brings this within the ambit of PLIVA v. Mensing.

(Trans. 24:1–9 (emphasis added).) (For more on the government’s amicus brief, check out this post.)

The Bartlett oral arguments certainly highlight that the Mensing test for impossibility is not limited to generics or to failure-to-warn claims. Read literally, it requires that design defect claims that would force a manufacturer—any manufacturer—to make a design change that the FDA must approve, clear, or otherwise act on prior to marketing are preempted.

We often do not think of drugs as “designed” when they are composed of a single molecule, but there are many drugs that nonetheless have a design aspect to them (like transdermal patches that deliver a drug through the skin, or combinations of drugs). And the FDA’s regulations describe “major” changes requiring prior FDA approval. See 21 C.F.R. § 314.70(b). “Major” changes include “any change in the drug substance [or] drug product . . . that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.” 21 C.F.R. § 314.70(b)(1) (emphasis added). That covers many changes in the “qualitative or quantitative formulation of the drug product, including inactive ingredients.” 21 C.F.R. § 314.70(b)(2)(i). The “moderate” or “minor” changes that may be made without prior approval (through a Changes Being Effected supplement or in an annual report) are listed in the same regulation, 21 C.F.R. § 314.70(c), (d), and would not have the same impossibility preemption defense.

Medical devices are governed by a different set of statutes and regulations, but the same general principles apply. If the manufacturer could not have independently changed the device’s design to correct an alleged design flaw—but instead would have required the FDA’s permission to make that change—the design defect claim is preempted.

In short, Mensing’s impossibility preemption framework can be a powerful tool for all drug and device defendants facing a design defect claim. We just have to get lower courts to accept what Justice Kagan, Justice Sotomayor, and the Solicitor General all said: as long as a design change requires the FDA’s permission, it doesn’t matter if the defendant is a brand or generic drug manufacturer—or, we think, a drug or device manufacturer.  Those claims are preempted.