United States: Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

Last Updated: October 26 2016
Article by Stephen J. McConnell

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. 

The Seventh Circuit rightly read Mensing and Bartlett to stand for the proposition that federal law preempts state tort laws "when the generic drug manufacturer could not have abided by this duty without: (1) changing the drug's formula; (2) changing the drug's label; or (3) withdrawing the generic drug from the market altogether."  The plaintiff contended that Mensing and Bartlett are outdated in light of the FDAAA.  SCOTUS did not consider that argument, but other courts have, and have rejected it.  The Wagner court has now created the first published appellate precedent by joining those courts that have rejected the notion that the FDAAA somehow alters the preemption analysis:  "The FDAAA imposed certain obligations on generic drug manufacturers when they propose labeling changes.  But the FDAAA did not remove the prohibition against doing so unilaterally."  Therefore, Mensing and Bartlett remain in full force, and the tort claims are preempted.   

That is not quite the end of the case.  The plaintiff made the same argument in the alternative that we see every day in cases against generics: she wanted to proceed on her claims to the extent they are based upon an alleged failure to update the generic drug label to match the updated label on the brand name drug.  At this point, the Seventh Circuit does something that it usually does very well.  It identified a procedural problem.  The plaintiff had failed to raise this update theory in her complaint.  So what was really going on in this appeal was that the plaintiff was making "an untimely request of this Court for leave to file a Second Amended Complaint."  She had never  sought leave to amend her complaint in the proceedings below.  There are no second chances in the Second City, at least not on appeal.   

Moreover, any amendment would have  been legally and factually futile.  At various times in the proceedings, the plaintiff had "made conflicting assertions undermining any causation of her failure-to-update claim.  Even in her reply brief to this Court, Wagner characterizes both the brand-name and generic labels as deficient."  If the brand labels are still deficient, then there is no substance to a claim that the generic label should have been updated to be the same as the brand label.  One cannot have it both ways.  The Seventh Circuit also mused skepticism about whether the plaintiff, who began taking the brand-name drug in 1993 and the generic drug in 2000, "could establish causation based upon a failure to update in 2007."  In any event, the plaintiff never alleged such a claim in her complaint.  As a result, she waived the right to press the claim on appeal.

That is a nice defense preemption win in the Windy City.   

This article is presented for informational purposes only and is not intended to constitute legal advice.

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