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 held, we called it a one-two punch. We cannot say that we coined the term as used here, but we repeated it more than a few times. It has since become fairly standard for most claims against generic manufacturers to be held preempted by the frightful duo of Mensing and Bartlett. Save abominations like the T.H. case, the concept of innovator liability has largely been put to bed like a kid crashing after a sugar high. Still, plaintiffs sometimes try to impose liability on both the generic manufacturer whose drug they took and the branded manufacturer whose drug they did not.

When they do and a court rules, we pull the one-two punch from the back of our metaphor closet and see how it lands. In Preston v. Janssen Pharms., Inc., No. 158570/17, 2018 WL 5017045 (N.Y. Sup. Ct. Oct. 12, 2018), the plaintiff claimed vision loss from her off-label use of the generic version of Topiramate, a well-established anti-convulsive. For more than a decade before she began her three year course, the label for the branded version contained warnings and precautions about ocular conditions that could result in permanent vision loss if untreated. After waiting more than two years to sue, she sued both the branded and generic manufacturers, claiming the records were unclear as to which drug she took for three years.

The branded manufacturer moved to dismiss, contending the complaint only asserted claims based on the generic drug that it did not make. It is not clear that the plaintiff tried to assert innovator liability in addition to claiming that the branded dug might have been used, but the court looked at the evidence and ruled on the merits. Because the evidence was clear that only the generic drug had been used, the next step to first punch was whether New York recognizes innovator liability. Citing the same cases we have before, the Preston court held that “named-brand drug manufacturers . . . cannot be held liable to the user of the generic form of that drug, since the manufacturer of the brand named drug owes no duty to the user of the drug’s generic form.” Id. at *3.

That takes us to the motion to dismiss of the generic manufacturer, the potential second punch. Plaintiff conceded, and the court accepted, that design claims are preempted because the generic manufacturer cannot change the drug’s design. Id. at *6. The plaintiff disputed that the warnings claim was preempted based on an alleged failure to update the generic label to match the branded drug’s label. For about eight months after the plaintiff started the generic drug, its label allegedly did not match. When the plaintiff alleged suffered her injuries, it did. A few years later, it allegedly did not match again. Plaintiff claimed that the later mismatch knocked out preemption for any warnings claim, but the court parried that argument. Following Mensing, the court held preempted claims based on any period when the warning of the generic drug matched, but allowed at the pleadings stage any claim based on the pre-injury period when there was an alleged failure to update. Id. at *5. So, the second punch did not quite land flush. It may be difficult for the plaintiff to sustain a claim about the warning when the plaintiff was first prescribed the drug when she kept receiving it when the warning was updated and her injuries allegedly developed during this later period. We suppose the warning claim might get kicked at the summary judgment stage. Preston also addressed the adequacy of pleading of various other claims that tend to be thrown into a product liability complaint, but she will have a chance to try to correct what was inadequately pled. Nothing too decisive or interesting about that, at least to us and at this stage.

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 in federal court.  On the other hand, we have described many instances where federal courts mess up their preemption analysis by presuming that state law imposes the duty that plaintiff claims does not conflict with FDA obligations or by extending state law in new directions to provide a basis for a parallel claim, Erie restraint notwithstanding.  It may be that state court judges are less likely to impose duties not recognized explicitly in higher court decisions.

Tibbe v. Ranbaxy, Inc., No. C-16o472, 2017 Ohio App. LEXIS 1139 (Ohio App. Mar. 29, 2017), is a case that stayed in state court despite the explicit claims that the defendants—the generic drug manufacturer and the non-diverse pharmacy defendant—violated the FDCA in various ways.  On its basic facts and history, the case had the hallmarks of a case pursued in disregard of controlling law.  A typical warnings claim that information in the generic drug label about the risk that allegedly befell plaintiff was insufficient should not fly post-Mensing.  A claim predicated on defrauding the FDA should not fly post-Buckman.  Claims against the pharmacy that it should be liable for nothing more than filling a prescription with the generic form of the particular antibiotic (presumably as required by plaintiff’s insurance) should not fly under Ohio law.  It should not have been enough to defeat a motion to dismiss for plaintiff to claim that discovery might help them determine if the generic drug’s label was different than the reference drug’s label.  After the Sixth Circuit’s decision in Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013), discussed here, this is something that can and should be determined before suing.  Even though Fulgenzi held that there is exception to Mensing’s preemption of warnings claims for generic drugs where there has been a failure to update, the plaintiff there lost because the prescriber did not review the label.  So, you would think some pre-suit investigation into the labels of the reference drug and the generic drug and the prescriber’s practices should be done in determining if there is a good faith basis to plead a non-preempted claim.  Maybe that is just our silly defense-sided way of thinking.

Regardless, in Tibbe, the plaintiff got her discovery and the preemption issues were presented again on motion for summary judgment.  Despite plaintiff’s earlier protestations, the labels were actually the same during the relevant time periods, including the language as to the risk of the condition that plaintiff claimed to have developed from the medication, so Mensing applied and Fulgenzi did not.  2017 Ohio App. LEXIS 1139, *10.  The intermediate appellate court reviewed the grant of summary judgment de novo.  Even though the Sixth Circuit had carved out an exception for non-preempted generic drug warnings claims in Fulgenzi, later the same year it recognized in Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 391 (6th Cir. 2013), discussed here, that Mensing had broad application to “claims that the generic manufacturers failed to provide additional warnings beyond that which was required by federal law of the brand-name manufacturer,” no matter how the claims were couched. Id. at *18.  Faced with this law and the factual record on sameness, plaintiff came up with an argument that we do not recall seeing before.  She claimed that there was a “duty to warn consumers of the generic version of the drug that they cannot bring a state-law failure-to-warn claim when their prescriptions are filled with Ranbaxy’s generic minocycline and the labeling is that of the RLD.” Id. at *19.  In other words, the plaintiff claimed the manufacturer had to give legal advice—not just legal advice, but legal advice about Mensing that was contrary to the position plaintiff advocated.

This is where being in state court maybe helped the defendants.  The court did not have to engage in much of an analysis to see whether there was already a duty to do what the plaintiff wanted and did not even consider making up a new duty.  The duty to warn under the Ohio Product Liability Act related to “the risks associated with the product.” Id. at *20.  “There is no corresponding duty to warn a consumer of her legal rights or the prospective outcome of litigation should she decide to sue a drug manufacturer at a future point in time.  Thus, a claim based on that theory would not be available under Ohio law.” Id. at **20-21.  Any warnings claim based on actual Ohio law conflicted with federal law and was preempted.

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

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.

Continue Reading A One-Two Punch Case With An Off-Label Twist

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.

Continue Reading Solid Affirmances: Avandia Summary Judgment, and Westminster