Indulge us for a moment as we recount another airline adventure. Recently, we traveled thousands of miles to an important argument. Our first flight boarded right on time, left the gate right on time, and taxied down the runway . . . partway. Then stopped. Enter the inevitable announcement: “Ladies and gentlemen, we’re very sorry,

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess.  But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or the distinction between taking under false pretenses vs. larceny by trick – Chicago sports teams  got better.  Much better.  The perpetually mediocre White Sox, who shared the South Side with U of C (no matter what former U of C law professor POTUS says about his glee that the Cubs are in the World Series, don’t believe him; he roots for the White Sox and any self-respecting fan of that team is miserable over the Cubbies’ success) (and if either presidential candidate dons a Cubs cap even though we know full well they root for New York’s arrogant American League franchise, we will barf like a DePaul student who shot-gunned too many cans of Old Style; we don’t care if it’s complicated), started “winning ugly” and made it to the playoffs.  So did the Cubs, though when Tim Flannery’s weak little ground ball dribbled “right between [Leon Durham’s] legs!”, we knew that the Billy Goat curse was still strong and that the Padres would ultimately knock out the home town team.  And so they did.  Tragedy still tainted triumphs.  But triumph was unalloyed in 1985, when Da Bears assembled the most fearsome defense of all time and captured the team’s only Super Bowl title.  (Please do not refer to the Bears as the Monsters of the Midway.  That title properly belongs to the University of Chicago Maroons, a college football team that, in the early part of the last century, brought home many wins and the very first Heisman Trophy.)  Oh, we almost forgot – in 1984 the Bulls drafted a guard out of North Carolina who looked like he might be a pretty good basketball player.

Sports weren’t the only thing that improved on our law school watch.   The Seventh Circuit started raiding the U of C faculty.  Posner became a judge.  Then Easterbrook.  Then Wood.  If there is an appellate court anywhere that approaches the Seventh Circuit in terms of pure intellectual wattage, we’d be frightened to hear about it.   Seventh Circuit opinions come with doctrinal heft, sharp insights, brave creativity, and the occasional ounce of craziness.  (Remember Posner’s drawing of an ostrich with its head in the ground?)  Today’s case is more interesting than it has any right to be.  The plaintiff in Wagner v. Teva Pharmaceuticals USA, Inc., — F.3d —, 2016 U.S. App. LEXIS (7th Cir. Oct. 18, 2016), was pro se, though she was also a lawyer.  She had taken both brand name and generic versions of hormone therapy drugs and claimed they caused her to develop breast cancer.  The complaint included causes of action under Wisconsin law for defective product and failure to warn.  The generic manufacturers argued that the claims were preempted by federal law, relying primarily on the SCOTUS opinions in Mensing and Bartlett. The district judge agreed with the defendants and granted their motion for judgment on the pleadings.  The plaintiff appealed to the Seventh Circuit, arguing that the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) meant that her claims were not preempted.  The plaintiff also argued that her claims are not preempted to the extent they are based upon the failure to update the generic drug labels to match the updated labels on the brand name drug. 


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This guest post is from Richard Dean at Tucker Ellis. We’re both greatly interested in extending impossibility preemption beyond generic drugs, particularly in the context of design defect claims, so when Dick saw this case, he both sent it to us (he’s very good about that) and was willing to write it up. As always with guest posts, the author deserves all the credit and gets assigned any blame for the contents of what follows.

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Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of the FDA. And if FDA approval or permission is required, PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), requires implied preemption.

Last Friday’s post regarding Batoh v. McNeil-PPC., Inc., No. 3:14-cv-01462 (MPS), 2016 WL 922779 (D. Conn. Mar. 10, 2016), is followed only a few days later by this report on Barcal v. EMD Serono, Inc., No. 5:14-cv-01709-MHH, 2016 WL 1086028 (Mar. 21, N.D. Ala. 2016). Barcal involved alleged heart birth defects from a fertility drug – Serophene. The drug’s labeling included a statement about congenital heart defects being observed in children of mothers whose pregnancies had been induced by the drug, but the plaintiff claimed the risk was higher than indicated. Before discovery commenced, the defendant filed a motion to dismiss. The plaintiff filed a Rule 56(d) request saying she needed to have discovery to respond to the motion. As to some parts of the motion – the failure to warn claim – the court denied the motion and agreed that the plaintiff was entitled to discovery, but the court disagreed as to the design defect claims and entered judgment on behalf of the defendants. The court held that the design claims were both preempted under the Supremacy Clause—the focus of today’s post—and barred by Alabama’s Extended Manufacturer’s Liability Doctrine (AEMLD) under the principles of comment k.

This case is significant procedurally, as well as substantively, because the preemption motion was granted at the preliminary pleading stage – not at the end of years of litigation as in Yates v. Ortho-McNeil Pharm., Inc., 808 F.3d 281 (6th Cir 2015). Yates was this blog’s leading defense decision of 2015.

Barcal is notable for its succinctness and clarity on the preemption issue. It dispenses with preemption in three short paragraphs. The first paragraph repeats the core holding of Mensing: that the question for impossibility “is whether the private party could independently do under federal law what state law requires of it.” 131 S.Ct. at 2579. The reference to a “private party” is key; the court did not refer to a “generic pharmaceutical company.” This is the building block of the design preemption argument. In Barcal, there is not even a discussion of whether Mensing applies beyond generics. It is assumed given the broad language of Mensing.


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We’ve been advocating preemption of all product liability design defect claims against prescription drug manufacturers – “whether generic or brand name” – since we read that phrase in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2471 (2013), two years ago.  We’ve written on just about every case since Bartlett that has done so.  One of them was Yates v. Ortho-McNeil Pharmaceuticals, Inc., 76 F. Supp.3d 680 (N.D. Ohio 2015).

Today, Yates was affirmed by the Sixth Circuit, creating the first appellate authority recognizing impossibility preemption of design defect claims under the Bartlett rationale in a case not involving a generic drug.  Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 15-3104, slip op. (6th Cir. Dec. 11, 2015).  The court held both “post-approval” and “pre-approval” design claims were preempted.  A “post-approval design defect claim is clearly preempted” because both “major” and “moderate” changes required FDA preapproval.  Slip op. at 18.  While “minor” changes do not, a dosage change that would affect the product’s safety could not be considered “minor.”

We think it clear that changing the dosage level of the active ingredient of [the patch] constitutes a “major change,” such that prior FDA approval is necessary.  Therefore, to the extent [plaintiff] argues that defendants should have altered the formulation of [the patch] after the FDA had approved the patch, we find this claim clearly preempted.  Quite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.

Id. at 18-19.


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Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post was preemption of design defect claims involving §510(k) medical devices.  We were aware of four such rulings, all in the last year or so:  Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680, 686-88 (N.D. Ohio 2015); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *5 (N.D. Ill. May 26, 2015); Booker v. Johnson & Johnson, 54 F. Supp.3d 868, 874-75 (N.D. Ohio 2014); Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 168-69 (W.D.N.Y. 2014).

We think the argument that Bartlett intended for implied impossibility preemption extend to all drugs – generic and innovator – is painfully obvious.  The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’”  133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added).  After all, why else would the Court have specifically mentioned “brand name” drugs if not to indicate that the same preemptive logic included them?


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The recent decision in In re Fosamax Products Liability Litigation, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013), put it squarely in the red in explaining why no type of design defect claims survive preemption in generic drug cases after Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).

In Bartlett the Supreme Court held that, because drugs – all drugs − cannot be redesigned without prior FDA approval, state-law claims alleging design defects were preempted:

Once a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.

133 S. Ct. at 2471 (regulatory citation and quotation marks omitted) (emphasis added).  Generic drugmakers (as opposed to innovator manufacturers) also cannot change their warnings without prior FDA approval.  Id. (“[g]eneric manufacturers are also prohibited from making any unilateral changes to a drug’s label”).  The Court also rejected taking a drug off the market as an exception to preemption.  Id. at 2477 (“[w]e reject this ‘stop-selling’ rationale as incompatible with our pre-emption jurisprudence”).


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We would like to invite all blog readers to a call-in Roundtable forum being hosted by the Mass Tort Committee of ABA’s Litigation Section (Bexis is the editor of the committee’s newsletter).  The subject is preemption – specifically the the United States Supreme Court’s recent ruling in Mutual Pharmaceutical Company, Inc. v. Bartlett and where the law may be headed after Bartlett.  We’ve already posted here, here, and here, about Bartlett, and during the forum, you’ll hear more of Bexis’ views on the subject – along with those of some folks who actually know what they’re talking about.

The Roundtable − Mutual Pharmaceutical Company, Inc. v. Bartlett and Preemption in Pharmaceutical Litigation − is scheduled for August 7, 2013, from 3:00-4:00 p.m. EDT.  There is no charge for the Roundtable, nor, however, is there CLE credit available.

Now some details.

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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”).
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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.”


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