No. It can’t be. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that. Just look at our generic preemption scorecard – the proof is there. The warnings on generic drugs must be the “same” as those on branded drugs. Generic drug manufacturers cannot unilaterally alter, amend, or change any warning and
You’ll find plenty of decisions from the amiodarone litigation discussed on the blog. Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing. But there are cases involving exposure to the branded product as well. And earlier this…
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…
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…
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.
When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and “fuzzy” being applied more often to our own characterization of what we think we recall. (We can only imagine how different things will be should be advance to the current age of McConnell, Bexis, or Weil.) Buried somewhere between esoteric and important would be the question of whether we have seen a certain issue before in cases that have been the subject of past posts. With a caveat about our memory, supplemented by a less than exhaustive search of prior posts, we thought we could present a decision addressing an issue we have never talked about before—and we have talked about a boatload of issues through the years. (No, “boatload” was not our first choice, but we try to keep it clean here.)
The silly Conte case popularized the idea that a company that developed and brought a drug to the market could be liable for injuries allegedly caused by a generic version of the drug sold by a competitor. Conte was itself a reaction to the realization, even before Mensing and Bartlett, that most traditional product liability theories against the makers of generic drugs would be preempted. When plaintiffs have tried to sue both the manufacturers of the generic drug they took and the company that “innovated” the drug and a single decision rejected the claims against both sets of defendants, we have called that a one-two punch. Because plaintiff lawyers are stubborn in their pursuit of ways to pin liability on defendants with money—or get far enough along in the case to take some of that money to go away—we have described a number of varieties of these one-two punch cases. Just skimming our scoresheets on these issues should give some idea of that variety.
While off-label promotion allegations feature prominently in a range of cases involving prescription drugs, we have not seen them much in innovator liability or generic drug cases. That might be because NDA holders tend not to do much promotion at all on their drug once generic drugs have entered the market and ANDA holders tend not to promote their generic drugs much at all, especially when there are multiple generics available. This is not a matter of on-label or off-label promotion as much as it is of economics. So, when we saw that Perdue v. Wyeth Pharms., Inc., No. 4:15-CV-208-FL, slip op. (E.D.N.C. July 20, 2016), delivered a one-two punch in a case where both the branded manufacturer and three generic manufacturers were alleged to have promoted off-label, we thought we might have a chance to talk about something novel. We were wrong. We wrote about another case last year. Twice. Involving the same drug as in Perdue. One post even talked about elephants, known not just for their girth but for their memories. Oh, the irony. But that will not stop us from talking about the good result in Perdue.
We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins. And the cat. (We mostly resisted the all-day live feed of the breed judging.) Since the Best in Show lineup didn’t include a Standard Poodle, our “breed of the heart” (a cute Bulldog named Annabelle beat Ricky, the stunning black Standard Poodle, in the Nonsporting Group), and being nothing if not bandwagon jumpers, we were rooting for “Rumor” a gorgeous German Shepherd who was the top winning show dog of 2015 by many, many points. And she showed beautifully. But she was defeated by “C.J.,” a German Shorthaired Pointer. While we don’t count ourselves as sporting breed fanciers, C.J. is a cool dog. And, most interestingly (maybe not, but it gives us a hook to transition to our case in a minute), C. J.’s grandmother, Carlee, was Best in Show in 2005. Carlee was known for her flawless “free stack” – instead of needing her handler to place her feet in the right positions and stretch out her neck – “stack” her – for the judge’s examination, she did it all by herself in the most striking of fashions. Westminster trivia: like the Adamses and the Bushes, Westminster can count one example of a father siring his eventual successor: Robert, the English Springer Spaniel, was Best in Show in 1993. His daughter, Samantha, “took the Garden” seven years later. The ostensible point of dog shows is to reward the best specimens of each breed so they will pass their genes to future generations, so it is neat when a judge’s good decision is affirmed.
And so it was recently in the Third Circuit. In In re Avandia Marketing, Sales Practices and Products Liability Litigation (Linda and John Schatz, appellants), — Fed. Appx, –, 2016 WL 574074 (3d Cir. Feb. 12, 2016) (applying Pennsylvania law), the panel considered Judge Cynthia Rufe’s grant of summary judgment to the defendant manufacturer in a case in the Avandia MDL. The plaintiff, who had taken Avandia, sustained bone fractures in two accidents and alleged that the manufacturer had failed to adequately warn of the risk of such fractures. The manufacturer had informed doctors of this risk and, shortly thereafter, updated its warnings to include this information. While it was not clear whether the plaintiff had already stopped taking the drug at this time, it was undisputed that she resumed taking it for a short time after the “bone fractures” warning was added to the label.