Bartlett

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This is more of a think piece, we won’t be citing many cases (by our standards) today.

There are two preemption principles at work in the Supreme Court’s recent Bartlett decision.  The first of these, which we’ll call “independence,” was articulated first in PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  “[W]hen 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 2581.  That was reiterated in Bartlett in the design defect context, holding that “redesign was not possible” in part because that would require intervening FDA action.  Any redesign “would be a new drug that would require its own NDA to be marketed.”  Mutual Pharmaceutical Co. v. Bartlett, 2013 WL 3155230, at *8 (U.S. June 24, 2013).  And, as in Mensing, to the extent that the “design” claim in Bartlett devolved into a warning claim (because redesign was impossible), FDA regulations “prevented [defendant] from independently changing” its label.  Id. at *10 (quoting Mensing).

The Supreme Court has now enunciated and applied this “independence” principle twice.  Nor has it limited that principle to the FDCA.  See Id. at *10 n.3 (invoking Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963) (a non-FDA case involving agricultural pricing)).  Moreover, since Bartlett (and Mensing) involved solely implied preemption, their principles apply regardless of the statutory scheme.  E.g., Bartlett, 2013 WL 3155230, at *6 (impossibility preemption applies “in the absence of an express preemption provision”).
Continue Reading Ruminations on Independence and Inaction: Further Implications of Bartlett

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Well, the First Circuit just had its bluff called.  In Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012), it essentially dared the Supreme Court to take the case and close off what Bartlett viewed as the plaintiff’s last option – a “pure” design defect claim, with no alternative design offered, explicitly
amounting to a claim that – under state law − an FDA-approved product should have been pulled from the market.

The Supreme Court has obliged.  Most fundamentally, from our perspective, it has definitively killed off (for all federally-regulated products everywhere, we believe) the facile “stop-selling” argument that conflict-based preemption can be avoided because a defendant can simply remove its product from the market.  That’s a red herring we remember from all the way back to airbag preemption days:

The Court of Appeals’ solution − that [defendant] should simply have pulled [the drug] from the market in order to comply with both state and federal law − is no solution.  Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.

Mutual Pharmaceutical Co. v. Bartlett, No. 12–142, slip op. at 2 (U.S. June 24, 2013).

Good riddance. We’re happy to announce that one of our earlier #1 worst annual decisions list toppers, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), is no longer good law for the proposition that earned it that ranking.  The Supreme Court wasn’t buying “stop-selling.”Continue Reading Bartlett – A Big Win For Preemption

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The Supreme Court just decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, slip op. (U.S. June 24, 2013).  That, of course, is the generic drug case out of the First Circuit where that court had permitted the plaintiffs to recover on a “design defect” claim alleging that the drug should never have been sold…

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No, we didn’t attend the Bartlett oral argument, but the Supreme Court has become wonderfully efficient at providing argument transcripts.  So we’ve read through the argument.  Our strongest impression is, boy, is Bartlett a change from the “traditional” tort claims that the Supreme Court has previously considered in connection with FDCA preemption.  See Wyeth …

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Bartlett – that is to say Mutual Pharmacy Co. v. Bartlett, No. 12-142 – is being argued in the United States Supreme Court today.  All of the briefs, and lots of other useful information on Bartlett, can be found on the invaluable SCOTUSblog.  In the early days of our blog (back during…

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It’s written somewhat strangely – weak at the beginning, strong at the end – but the Department of Justice’s amicus curiae brief , filed yesterday in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S. pending), eventually gets to the right place.  That is, even the generally anti-preemption political leadership of this FDA and DoJ took the only institutionally logical position that they could take and told the Supreme Court that, yes, state tort claims asserting that an
FDA-approved product should have been removed from the market altogether were impliedly preempted.

Because we like good news (and still can use some after Stengel and Weeks), we flip right to the back of the DoJ’s Bartlett brief.  The last substantive paragraph states:

Federal law would preempt a pure defective-drug-design claim that required a jury to second-guess FDA’s safety determination, without any further need to find the existence of new and scientifically significant evidence that rendered the product misbranded under federal law.

DoJ Bartlett br. at 34.

Let’s look at this. First of all, what’s this “pure” design defect business?  As we said above, the DoJ brief starts out weakly, trying to turn Bartlett into something it wasn’t in order to avoid what it was.  Instead of what really went on at trial (the trial court allowing plaintiffs’ counsel to ask the jury to flip a bird at the FDA), the DoJ first portrayed the verdict as based primarily on an “unreasonably dangerous even with warnings” theory under Restatement (Second) of Torts §402A, comment k (1965).  DoJ br. at 14-18.  The primary purpose of that argument was to reduce Bartlett to a “nothing to see here” misapplication of Mensing.Continue Reading Bartlett – DOJ Says Remove-From-The-Market Claims Preempted

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As we had hoped, the United States Supreme Court agreed today to review the First Circuit’s remarkable ruling in Mutual Pharmaceutical Co. v. Bartlett, that a state court plaintiff can argue that an FDA approved drug should be removed from the market altogether.  The Supreme Court’s order granting certiorari is here.

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