Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive
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Guest Post – Generically Speaking – “Sameness” Creates Sanctuary From State Law Liability
Today’s guest post is by Reed Smith associate Devin Griffin. It’s about preemption in a generic drug case, something that has become so routine that, other than add cases to our generic preemption scorecard, we rarely feel the need to discuss them. But Devin’s case is better than most, and thus worthy of individual…
Another PMA Preemption Victory
This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to…
Non-News: Warnings Claims For A Generic Drug Preempted (Still)
We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check. …
Innovator Liability Fails Again
As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws that branded drug manufacturers could not be liable for injuries suffered by plaintiffs who never used their…
Post-BMS Personal Jurisdiction Cheat Sheet
In the wake of the defense wins during the last Supreme Court term in Bristol-Myers Squibb Co. v. Superior Court, 137 S.Ct. 1773 (2017) (“BMS”), and BNSF Railway Co. v. Tyrell, 137 S.Ct. 1549 (2017), we’re retiring the personal jurisdiction cheat sheet we had been maintaining for the last three-plus years…
Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption
Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal court over state court is that the belief that the chances of winning on preemption are better…
The Peaks – The Ten Best Prescription Drug/Medical Device Decisions of 2016
Today we’re going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year’s drug/medical device product liability jurisprudence. Last week, we visited the abyss, naming our 2016 Bottom Ten. This week we go in the opposite direction, to the mountaintops. …
The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016
The “pits of hell,” “black as a pit,” a “bad feeling in the pit of my stomach” – that’s how we feel about 2016’s bottom ten decisions of the year arising from prescription medical product liability litigation. This year’s collection of coal in our collective stockings is as justifiable a cause for seasonal affective disorder as almost anything we can think of, since we do not discuss politics on the blog.
So here we go. Don’t shoot us, we’re only digital piano players. If any of these cases is yours, we sympathize. We’ve been there (see 2013 -2), and we know how it feels. We can’t wait for next week we get to toast in the New Years with the best, instead of drowning our sorrows with the worst.Continue Reading The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016
Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption
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. Continue Reading Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption