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.

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 discussion.  However, in the end, the plaintiff is out of court, as is usually the case.  Everything preempted save “failure to update,” which was TwIqballed for lacking any factual basis.  As always, our guest posters are 100% responsible for their posts, deserving of all the credit and any blame.  Take it away Devin.

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When writing a blog post, there is an inevitable (and often tedious) brainstorming process that one must go through before coming to a final conclusion about how to present the relevant information.  For this post, I found myself tasked with writing about a highly favorable generic drug case that hails out of the Southern District of Florida.  Sounds easy enough, right?  Well, not entirely.  Five minutes into my brainstorming process, and a few Google searches later, I found myself in a veritable research rabbit hole.  My initial search of “Puns about Florida” led me to a few chuckle-worthy jokes, but none that the DDL Blog would share with its readers in this age of political correctness.

After my preliminary brainstorming, I paused to think “how can I tie any of this into my post?” Should I take the “Florida: God’s Waiting Room” angle and make a pun about how the DDL Blog would like to breathe new life into this Southern District of Florida generic drug decision from December of 2017—a decision that is particularly blog-worthy for its clear-cut analysis of products liability causes of action as applied to generic drug manufacturers?  No … much too crass.  Or I can take the angle of “There are many bad things to come out of Florida” (i.e., the trend of bath-salt induced cannibalism) “but this case is certainly not one of them.”  No … much too morbid.  Or I can make a pun about how the Blog’s readers are likely reading this post, about a delightfully refreshing Southern District of Florida decision, while enjoying some of Florida’s finest OJ?  No.

Instead, I decided to present this case to you with no angles, no fun-facts, no themes to tie in throughout. I followed the lead of the Southern District of Florida, which took a direct approach when it found in favor of the generic pharmaceutical manufacturer on the basis of federal preemption.

In Allbright v. Teva Pharms. USA, Inc., 290 F. Supp. 3d 1321 (S.D. Fla. 2017), the Southern District of Florida decided a Motion to Dismiss filed by a generic drug manufacturer.  Plaintiff asserted the usual causes of action—strict liability design defect, strict liability failure to warn, and negligence. Id. at *1.  Ultimately, the Southern District of Florida dismissed them all, providing a useful roadmap of generic preemption.

After providing us with a law school refresher on the various types of preemption, id. at *3, Allbright then applied the two implied preemption presumptions that blog readers have come to know and detest since Wyeth v. Levine, 555 U.S. 555 (2009):  (1) that the police powers of the States were not to be superseded by federal preemption unless that was the clear and manifest purpose of Congress, and (2) that “the purpose of Congress is the ultimate touchstone in every case … such that any preemption provision and [the] surrounding statutory framework[] … provide [the] primary guide for discerning Congressional intent” regarding the scope of preemption. Id. (internal citations omitted).

Then, Allbright turned to the attributes of generic drugs that support preemption.  Generic drug manufacturers can forego the New Drug Approval process “by demonstrating equivalence to a drug that has already undergone clinical trials and been approved by the FDA.” Id. at *4 (citing 21 U.S.C. § 355(j)(2)(A)).  Once a generic drug has been approved through an ANDA, the generic manufacturer has a “duty of sameness” requiring that a generic manufacturer simply bear the verbatim identical label of its brand-name bioequivalent. Id.  To maintain this identity, a generic manufacturer does not have the authority to unilaterally change its generic drug’s label, design, or formulation—to do so would be in violation of its federal duty of sameness. Id.

This “sameness” mostly removes generic manufacturers from the realm of product liability law.  First, claims against generic manufacturers for failure to warn or design defect are preempted.  Id. at *5-6.  When a plaintiff brings a failure to warn claim against a generic manufacturer, the plaintiff is demanding that the generic manufacturer should have changed or enhanced the approved warning label in some way to deviate from what appears on the brand-name counterpart drug label.  To meet both that state law duty and the federal duty of sameness would be impossible, thus the generic manufacturer’s federal law duty of “sameness” trumps. Id.  Ditto for why state law design defect claims are preempted as to generic manufacturers. Id.

There remains one particular instance where federal and state law requirements for generic manufacturers would not conflict.  Id. at *6-7.  Where a generic manufacturer fails to update its label, meaning the label is no longer the same as its brand-name counterpart, the manufacturer can be subject to state law liability if that failure to update is also a failure to warn under state law.  Id.  A failure to update claim does not claim that warnings stronger than the brand-name drug were required . Id.  Instead, failure to update claims allege that the generic manufacturer failed to maintain sameness.  Id.  In this situation, the generic manufacturer’s federal and state law duties are congruent, not conflicting.  Id.

Ultimately, (as is often the case) the duty to update claim failed anyway.  While the claim was cognizable, in the abstract, Plaintiff’s evidentiary support for this claim was “sparse at best.” Id.  Plaintiff failed to present sufficient evidence to substantiate her allegation that the generic manufacturer failed to update its drug label consistent with the brand name label, and thus Plaintiff could not withstand the generic manufacturer’s Motion to Dismiss.  Id.

One more win for generic manufacturers in the preemption wars. One more case for the Blog’s generic preemption scorecard.

Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s there. What do you find? Old empty checkbooks. Gift card to a restaurant that closed two years ago. Any variety of expired items from coupons to salad dressing to cough medicine. And of course that half-eaten bag of cookies that are so stale you can use them as coasters. But, sometimes you also find a hidden gem. Like the cord to charge your radio that you haven’t been able to use for the last 6 months. Or the great family photo from Aunt Susie’s 80th birthday. Or your favorite pair of socks. How did they get there?

Well cases, just like socks and salad dressing, can get pushed to the back of the shelf – where they too get stale. And if courts still used paper dockets, the file in Beswick v. Sun Pharmaceutical Industries, Ltd., 2018 U.S. Dist. LEXIS 15012 (W.D.N.Y. Jan. 30, 2018) would be covered in an inch of dust with discolored pages stuck together from sitting at the bottom of a pile in a basement storeroom. The decision rendered just last week is on a motion that was filed in June 2012 on the basis of the Supreme Court’s ruling in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). A 5 ½ year old motion based on a 6 ½ year old ruling. Fortunately, the decision is to dismiss the case, but it’s a decision that could have been entered a long time ago. We imagine the delay has not been without some financial consequences to the defendant. Indeed, plaintiff’s counsel withdrew back in 2015, likely recognizing the folly of pursuing what is essentially a failure to warn case against a generic drug manufacturer. But still the case sat.

The complaint, alleging plaintiff suffered from Stevens Johnson Syndrome as a result of using defendant’s generic anticonvulsant drug to treat his epilepsy, was filed in 2010. Id. at *1, *4-5. In early 2011, the court granted defendant’s motion to dismiss all claims except those alleging breach of express and implied warranty. Id. at *2. The case was then stayed pending the Supreme Court’s decision in Mensing. Id. A year after Mensing, defendant file a motion for judgement on the pleadings on the two remaining claims and the motion was fully briefed by August 2012. Defendant then filed supplemental declarations in support of its motion in November 2012 and again in August 2013. In 2015, defendant formally requested that the stay be lifted and filed yet another supplemental declaration in support of its motion. Id. at *3-4. The supplements we assume necessitated by the development of the law over the years the motion was pending. And finally, three years later the motion was ruled on.

It should come as little surprise that the warranty claims, premised on a failure to warn, were found to be preempted.  Plaintiff alleged that defendant breached its express warranty that the drug was safe and effective by failing to disclose known risks of side effects including SJS. Id. at *6-7. Plaintiff similarly alleged that defendant breached the implied warranties of merchantability and fitness for the drug’s intended use by failing to warn about the drug’s side effects and risks. Id. at *7-8.

The court then analyzed both claims in light of Mensing and Bartlett (5 years old itself) which we know held that because generic drug manufacturers are prohibited from making any unilateral change to the drug’s label, federal law “preempts any duty the generic drug manufacturer otherwise would have under state law to provide additional warnings.” Id. at *18. Therefore, because plaintiff’s warranty claims are essentially “state law tort claims attacking a drug label warning as insufficient” they are preempted. Regardless of the theory, if the claim is premised on a failure to warn, it is preempted. See id. at *22.

Plaintiff attempted to advance two arguments to avoid preemption. First, plaintiff argued that defendant didn’t have to change its label but rather could have sent out Dear Doctor letters containing additional warnings. The Supreme Court deferred to the FDA that such letters would be misleading because they would imply a “therapeutic difference” between the brand and generic drugs. Id. Second, plaintiff argued that defendant should have pulled the drug off the market. This too has been rejected by the Supreme Court. When faced with a conflict between federal and state law, the manufacturer is not obligated to stop selling. If that were the case, “impossibility preemption would be all but meaningless.” Id. at *23 (citing Mensing).

There is nothing new or novel about the court’s decision other than the amount of time it took to be entered. The case simply hung around for way too long and could have been disposed of five years ago. Like the receipt for the gloves you bought your mom for Christmas 2014.

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.  Stories on a social media stream come with a presumption of newness, but the date of the release of the story—once you find it—may make you stop reading because it is not news any more.  You may even have read the old news when it was new and just got suckered back by the misimpression of novelty.  A story about a new species of dinosaur, or even beetle, being discovered?  We are clicking.  Einstein’s prediction of gravitational waves verified?  Click—wait, we saw that way back in early 2016, and a Nobel Prize was awarded for that last month.

Generic drug preemption may not be as clickworthy as a “new” ankylosaur, but these decisions do still catch our attention.  After Mensing, Bartlett and scores of published decisions preempting the vast majority of conceivable claims—or holding that state law does not recognize the claim the plaintiff would need to sidestep preemption—you might think that plaintiffs would stop pursuing these claims.  Well, the nonsense that is innovator liability has not provided a viable alternative—although the plaintiffs keep trying (like here and here)—and courts have not yet resorted to Rule 11 for pursuing obviously preempted claims, so the plaintiffs keep trying.  When Kious v. Teva Pharmaceuticals USA, Inc., No. 16-990-R, 2016 WL 9559038 (W.D. Okla. Dec. 8, 2016), popped up in our searches, we thought it might be new and newsworthy.  It really was old news made to seem new because it had taken eleven months to get on Westlaw.  The generic manufacturer defendant secured dismissal of the claims against it on preemption, but was there anything new, different or interesting about it?  We think it is pretty much old hat, but that may be the point.

Kious involves a plaintiff who claims to have developed Stevens-Johnson Syndrome as the result of the use of a generic antibiotic, the label for which apparently matched that of the reference drug.  The plaintiff sued the generic manufacturer, asserting standard state law claims, and a motion to dismiss the amended complaint followed.  (He also sued the branded manufacturer, but that is not discussed in the opinion.)  The court walked through each asserted claim, starting with design defect.  Preemption of such claims is not really a question post-Bartlett, but the Tenth Circuit’s decision in Schrock, discussed here, left no doubt that strict liability and negligence design claims fail.  Id. at *2.  Next up was the claim for manufacturing defect, which was really just a re-packaged claim for design defect.  Plaintiff claimed “that every dose of azithromycin was defective because of its design and/or lack of adequate warnings,” so he did not plead a manufacturing defect claim under Oklahoma law (and the design claim under a different label was still preempted). Id.

Next up were the warnings claims.  Plaintiff did not allege a failure to update the generic label to mirror the reference drug’s label, so Mensing’s application should have been straightforward.  Not so, claimed the plaintiff, because Mensing involved prescriptions written before the Food and Drug Administration Amendments Act of 2007, which established a procedure under which FDA could ask for a new label from a generic manufacturer if the reference drug was no marketed and there is new safety information.  Even this argument, however, was not new, as courts like the Seventh Circuit had already rejected it.  The Wagner decision (a lofty fifth place on last’s year’s best list) made clear that the FDAAA did not remove the prohibition against a generic drug manufacturer changing its label unilaterally.  2016 WL 9559038, *4. Kious went a step further—and we think this was actually novel—and noted that the FDA’s proposed rule from 2013 to allow generic manufacturers to change their labels unilaterally in some situations supports preemption.  “The proposed rule would be unnecessary if, as Plaintiff urges, the 2007 Amendments permitted unilateral labeling changes by generic manufacturer.” Id. No news is good news, at least here, so warnings claims are still preempted.

The remaining claims were also dismissed.  Express warranty claims are really preempted warnings claims and implied warranty claims were really preempted design claims or preempted warnings claims, depending on how construed.  Again, the Schrock decision, also under Oklahoma law, determined the result. Id. at *5.  For the claims of fraud, negligent misrepresentation, and negligent concealment, the court looked to the Eleventh Circuit’s decision in Guarino for clear authority that these were simply another version of preempted warnings claims. Id. at **5-6.  That was it for every claim plaintiff offered and, plaintiff did not get to amend again.  Judgment for the defendant after only two strikes.  Could it be that sanctions for asserting frivolous claims are next in such suits?  That would be news, no matter when it happens.

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents.  Still, that’s no reason not to praise good results.  Recently, the manufacturers of generic amiodarone scored two big wins on the same day.  Moore v. Zydus Pharmaceuticals (USA), Inc., ___ F. Supp.3d ___, 2017 WL 4365162 (E.D. Ky. Sept. 29, 2017); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330 (D.S.C. Sept. 29, 2017).  Moore, which is headed for F. Supp. publication, is the more comprehensive case, so we’ll start with it.

The plaintiffs’ pitch, such as it is, in these cases is that the generic defendants either piggybacked on the branded manufacturer’s earlier off-label promotion or else engaged in such promotion themselves.  Secondarily, they claim that they didn’t receive the medication guide that the FDA requires manufacturers of this product to provide to prescribing physicians.  Somehow, the failure of the prescriber to pass along this pamphlet is the manufacturer’s fault.

Didn’t work (mostly) in Moore.  As for the off-label promotion allegations, they were barred – as other information-related claims involving generic products are barred – because “the generic drug manufacturer could not change its labeling without violating FDA regulations.”  Moore, 2017 WL 4365162, at *3 (citing Mensing).  Further, the entire concept of “off-label” is derived from the FDA-approved label, and thus from the Food, Drug & Cosmetic Act (“FDCA”).  Id. at*7.  Plaintiff’s attempt to gin up a state-law negligence claim based on this alleged conduct ran straight into a quirk of Kentucky law that we’ve blogged about before:  Kentucky, by statute, prohibits negligence per se claims based on violations of federal law.

The Kentucky Supreme Court’s holding in T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky. 2006) offers binding and unequivocal precedent concerning the scope of KRS 446.070 and demonstrates that [plaintiff] does not have a state based right to sue for negligence in this matter.

*          *          *          *

Under Kentucky law and the Kentucky Supreme Court’s analysis of KRS 446.070, which codifies the doctrine of negligence per se, . . . the statute “did not intend for KRS 446.070 to … confer a private civil remedy for” violations of federal law.

Moore, 2017 WL 4365162, at *7-8.  Aside from the off-label aspect, all warning claims were preempted under Mensing.  Id. at *8-9.  Plaintiff did not allege design- or manufacturing-related claims.  Id. at *8.

As for the purported failure to supply the FDA-mandated medication guide, that was something that the plaintiff simply made up.  Kentucky, like every other state, follows the learned intermediary rule.  Id. at *6.  The manufacturer thus has no obligation, “non-delegable” or otherwise, to communicate warnings directly to a patient who has been prescribed a drug.  Id.  Because there is no such state-law duty, any obligation to supply medication guides was imposed solely by the FDCA.  The FDCA, however, “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.”  Id. at *5 (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001)).

Since [plaintiff’s] claim concerning receipt of the medication guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of action is merely based upon alleged violation of the FDCA and it is the FDA, not [plaintiff], that “has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.”

Id. (again quoting Buckman, 531 U.S. at 349).

Implied warranty claims were preempted for the same reasons as negligence and strict liability claims.  Id. at *9.  Express warranty claims failed because there was nothing the “explicitly warranted” the drug’s safety for the off-label use in question.  Id. at *10.  Without any express language, the warranty claim was simply a doomed repackaging of plaintiff’s preempted warning claim.  Id. at *11.

The only claim that could conceivably survive preemption in Moore was a fraud claim based on false off-label promotion.  As we’ve seen numerous times in PMA preemption, while every other aspect of off-label promotion was protected by preemption, an allegation that was both false and an FDCA violation could survive – if a plaintiff ever properly pleaded it.  The plaintiff in Moore didn’t come close:

The majority of the complaint fails to specify actions undertaken by [defendant] and instead conflates accusations of wrongdoing against the two originally named “Defendants.”  Instead of providing specific details concerning when the wrongful conduct took place, the Complaint alleges that the “Defendants’ scheme in the past involved and continues to involve a calculated and deceitful sales campaign. . . .”

Id. at 12.  The complaint was such a mess that “it is unclear whether providing [plaintiff] with an opportunity to amend her complaint would be futile.”  Id.  The court decided to give her one more shot.  Id.

The second preemption win, Bean, 2017 WL 4348330, was mostly along the same lines, except that, being from South Carolina, the Kentucky quirk on negligence per se wasn’t at issue.  The plaintiff made same the allegations about off-label promotion and medication guides.  Id. at *1-4.  The court was even firmer about preemption, not allowing any loophole for “fraudulent” off-label promotion:

Plaintiff’s “off-label” promotion claims are due to be dismissed as preempted under Mensing and Bartlett. . . .   The basis for Plaintiff’s “off-label” marketing claim is that Defendants, by virtue of their marketing of [the drug off-label], rendered the manufacturer’s warning inadequate.  Defendants are prohibited by the FDCA and FDA regulations from adding or strengthening any warnings for [the drug] to address any risks associated with off-label use.  If successful, Plaintiff’s “off-label” promotion claims would necessarily require Defendants to either: 1) change the warning label or disseminate additional warnings to reflect the alleged additional dangers associated with the “off-label” use of amiodarone for atrial fibrillation; 2) accept state tort liability; or 3) exit the market place. . . .  [S]uch a result requires preemption under Mensing and Bartlett.  Plaintiff’s “off-label” promotion claims, whether sounding in fraud or negligence, are preempted by the FDCA.

Id. at *5.

Also, as in Moore, the medication guide allegations were preempted as private FDCA enforcement under Buckman.  2017 WL 4348330, at *6-7.  Plaintiff didn’t even respond to Buckman, which the court found particularly “telling. Id.; see id. at *7 (“the requirement to provide a Medication Guide to distributors is based solely in the requirements of the FDCA and related regulations”).  The learned intermediary rule, which South Carolina follows, precluded any state-law liability for failing to provide warnings directly to a patient . Id. at *8.  Buckman also did in the off-label promotion claims, because the court found no state-law obligation to avoid off-label promotion.  “[T]he duties Plaintiff alleges Defendants breached regarding ‘off-label’ promotion exist solely under the FDCA.”  Id. at *7.

The court in Bean was particularly unhappy with both plaintiffs’ allegations and with her counsel.  The allegations were inherently inconsistent, because by alleging that the medication guide contained “adequate and sufficient” warnings, the plaintiff necessarily defeated her own allegations.  “Plaintiff does not allege that the prescribing physician did not receive the Medication Guide, was unaware of its contents, or the risk [the guide discussed].”  Id. at *8.  These allegations weren’t “plausible on [their] face” under TwIqbal, because the prescriber received “adequate” warnings.  Id.  As for counsel:

Plaintiff’s failure to respond to the learned intermediary argument is striking because Plaintiff’s counsel has been involved in several other amiodarone cases that were dismissed in part pursuant to the learned intermediary doctrine.

Id. at *7 n.4 (string citation omitted).  Thus, the plaintiff in Bean, unlike the plaintiff in Moore, didn’t deserve – and didn’t get – any chance  to replead.  Id. at *8.

One thing that Moore and Bean exemplify to us is how preemption principles cut across product lines.  As we’ve chronicled, much of the favorable law as to off-label promotion was developed in the context of PMA preemption.  Buckman, of course, was an implied preemption case involving a 510(k) medical device.  Both Moore and Bean employed this precedent to dismiss claims involving generic drugs.  In view of this cross-pollination of defense arguments in preemption cases, we offer one final opportunity for improvement.  As we blogged about at length here, there is an additional Mensing/Bartlett preemption argument whenever off-label warning claims are asserted.  Only the FDA can require warnings about off-label uses.

A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

21 C.F.R. §201.57(c)(6)(i) (emphasis added).  See also 21 C.F.R. §201.80(e).   Thus, regardless of anything else, a manufacturer cannot add or alter warnings related to off-label uses without first getting the go ahead from the FDA.  In and of itself, that requires preemption of off-label warning claims under Mensing/Bartlett.  For more details, see the other post.

A defense win anywhere helps defendants everywhere.  Keep winning.

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.

This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).

Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims

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

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election.  We believe that, for all practical purposes, this means that the proposed rule is dead.  Here’s why we think that.

As we have maintained from the beginning, the statute, which requires generic labeling to be the “same” as innovator labeling, simply does not support the FDA proposal to allow CBE labeling changes that would result in generic labeling that is not the “same.”  The FDA can do a lot of things, but it can’t do that – the opposite of what its organic statute specifically requires.  The generic drug industry knows this, too, and from day one has vowed an administrative challenge to any rule that violates statutorily-mandated sameness.

As we have also maintained almost from the beginning, the FDA’s proposed rule has been driven by the desire of the political FDA leadership (who broke the rules regarding impartial communication with outside groups) to overturn the generic preemption decisions, PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  They are doing this as affirmative political payback to satisfy the plaintiffs’ trial bar, for whom they broke the aforesaid rules.  The plaintiffs’ trial bar have, of course, been major political supporters of the current administration, and as long as they tell the FDA’s political leadership to jump, during this administration the response will be “how high.”

Continue Reading Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.

Continue Reading Yet Another Failure-To-Update Claim Bites the Dust