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

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

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

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

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

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.

Thanks to a

In our two prior posts concerning Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012), we first hoped that the defendant would “take it up” to the Supreme Court, and ended our second with our belief that Bartlett was worthy of summary reversal.  Well, that happened earlier this week, and in the