It is quite unusual for a state trial court to depart from that state’s highest court precedent.  But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.”  If the United States Supreme Court comes out with a case that renders your state supreme court’s opinion null, void, or wrong, you go with SCOTUS.  That is what happened in Russell v. Johnson & Johnson, Inc., 2017 WL 2261136 (Ky. Circuit Court May 8, 2017).  To see intervening SCOTUS authority dislodge a vexing state ruling is remarkable enough.  When that SCOTUS authority compels application of preemption – well, you just know we’re going to blog about it.

The plaintiff in Russell alleged injuries from a cardiac ablation procedure in which doctors used an “SF catheter.”  The plaintiff’s claims included strict liability, design defect, negligence (including failure to test), failure to warn, breach of warranties, fraud, unjust enrichment, and violation of Kentucky’s consumer protection statute.  The defendant filed a motion for judgment on the pleadings, arguing that the SF catheter was a Class III medical device that had gone through the pre-market application (PMA) process, thereby earning the protection of conflict preemption.  That is, no state jury could, via its verdict, impose obligations on a defendant that were in any way different from the FDA’s federal scheme.

If a product went through the PMA process, product liability litigation involving that product is usually a laydown.  No matter what theories are invoked by the plaintiff, preemption applies.   Sure, there is that annoying “parallel violation” exception, which we have written about endlessly, but let’s for the moment put that aside and pretend that the Supreme Court in Riegel had never penned that unfortunate dicta, and that appellate courts around the country had not wrestled with that same dicta in ways various and often incoherent.  This doctrinal confusion really is an instance of “what the SCOTUS giveth, the SCOTUS taketh away,” for it was the Riegel decision that established medical device preemption, and it was the Riegel case that permitted the Russell court to dispense with a bothersome Kentucky precedent.

The complication in the Russell case is that the SF catheter at issue had gone through several modifications since the initial PMA approval.  The SF catheter used in the procedure was part of an FDA-approved clinical trial under the auspices of an FDA investigational device exemption (IDE).  The legal question front and center in Russell was whether the IDE regulations involve the same sort of rigorous, device-specific safety requirements as the PMA process, such that full-blown preemption should apply.  The Russell court held that they did, and that preemption therefore foreclosed all of the plaintiff’s claims.

The plaintiff resisted preemption by contending that the SF catheter at issue did not receive PMA approval until 14 months after the procedure.  On the date of the procedure, all the SF catheter had going for it was an IDE, and a Kentucky Supreme Court decision back in 1997, Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997), had held that certain state law claims were not preempted in a case involving an intraocular lens used during a clinical trial under an IDE.  That non-preemption ruling would seem to be squarely relevant and binding precedent — save for Riegel, which SCOTUS decided 11 years after Niehoff.

The facts in Niehoff were distinguishable from Russell in two significant ways: (1) the product in Niehoff never received PMA approval, whereas the SF Catheter in Russell had, and (2) unlike the plaintiff in Niehoff, the plaintiff in Russell had signed a lengthy, FDA approved consent form acknowledging that the medical procedure in question was investigational. Even aside from those factual distinctions, the Russell court concluded that Riegel and its progeny made clear that the IDE procedure involved the same rigorous safety review process as pertains to a PMA, and that preemption applied. We do not know of a single IDE case after Riegel that has failed to apply extensive PMA preemption. Put another way, an IDE was much more like the PMA process covered by Riegel preemption than like the 510(k) substantial equivalence process that the earlier Lohr decision held did not merit preemption.  Plus there is the additional fact that the device in Riegel had gone through the PMA supplemental process, making it very like the SF catheter in terms of FDA posture.  (It really pays to read the details of a case, not just the headnotes.)

Once the Russell court decided that Riegel preemption applied to the SF catheter, the rest was easy.  Would the causes of action impose requirements different from or additional to the federal requirements?  The answer for every claim in the complaint was Yes.  And now inevitably, we come to the issue of whether there was a parallel violation alleged.  The Russell court reasoned that such a parallel violation must include: (1) a violation of a specific federal regulation (that “specific” is important and right away makes the Russell decision better than most), (2) a violation of an identical state law duty, and (3) a showing that violation of the federal rule caused the injuries. The plaintiff’s claims failed this test.  For one, the plaintiff alleged no deviation from the IDE requirements. Beyond that, the plaintiff’s claims essentially demanded that the defendant do more (secure a more detailed informed consent) or say more (additional warnings) than required by the federal scheme.  That is the stuff of preemption, not any parallel violation, and the court dismissed all of the plaintiff’s claims with prejudice.

Put a New Yorker and a Californian in a room together and the debate will begin almost immediately. Hollywood v. Broadway. Atlantic v. Pacific. Dodgers v. Yankees or Giants v. Forty-Niners. Shake Shack v. In-N-Out (or is Five Guys overtaking both?). And more generally speaking that east coast/west coast divide extends beyond those two urban hubs. Laid back v. fast-paced lifestyle. Deserts v. low country. Golden Gate v. Sunshine Skyway. Disneyland v. Disney World. And let’s not forget – the west coast may be synonymous with California sunshine, but the east coast gives you actual seasons.

While failure to report adverse event claims are not limited to the west coast, we think of them as Stengel claims. In case you need reminding, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA. Since Stengel is a Ninth Circuit case and the Ninth Circuit includes the entire west coast – we’re going to saddle the west coast with that one. And we’re going to praise an east coast court for saying, thanks but no thanks.

We’ve talked about Burrell v. Bayer Corporation before when earlier this year the court ruled that allegations of parallel claims in plaintiff’s complaint conferred federal question jurisdiction. After winning on removal, the defendants next moved to dismiss the entire case on preemption. Round 2 goes to defendants as well.

The product at issue is the Essure birth control medical device. It is a pre-market approved device so preemption shouldn’t be a big surprise. Burrell v. Bayer Corp., 2017 WL 1955333, *1 (W.D.N.C. May 10, 2017). As is true of the vast majority of drug and medical device products cases, failure to warn is at the heart of the case. But as we already know, traditional failure to warn claims are preempted in PMA device cases. So, plaintiffs pushed for a Stengel-claim. Plaintiff’s argument is failure to warn premised on failure to provide adverse event reports to the FDA is a non-preempted parallel claim. Unpersuaded by the reasoning of that west coast court, Burrell found that the requirement to report adverse events exists under the FDCA rather than state law and therefore, plaintiff’s failure to warn claim is “being brought because the [] defendants allegedly failed to meet these reporting requirements.” Burrell, at *5 (emphasis added). And where a claim is being brought solely based on a violation of the FDCA – that’s Buckman implied preemption. Traditional failure to warn is expressly preempted, failure to report to the FDA is impliedly preempted. Score one for the east coast for getting this.

But the court didn’t stop there. Analyzing the claim under state law, it still didn’t hold up because plaintiff’s allegations didn’t support a finding of causation. This is where most Stengel claims. By the time the device was implanted in plaintiff, the FDA had received and analyzed the adverse event reports and the subsequent warning did not contain any new information. Id. at *5 (although a black box warning was required, that was a new “type” of warning, the substance of the warning was unchanged). So there was no causal nexus between the alleged failure to report and plaintiff’s injury.

None of plaintiff’s remaining claims fared any better. On failure to train, the claim only survives preemption if premised on allegations that defendant failed to train in accordance with federal requirements. Plaintiff made no such allegations. Id. at *6. Moreover, plaintiff again failed to allege any facts to support a causal connection between the failure to train and her injury. Id. Plaintiff’s negligent manufacturing claim suffered the same fate – no alleged violation of federal requirements and no facts to support causation. Id. Plaintiff’s design defect claim was dismissed as expressly preempted. As a PMA device, the “FDA made its determination of this products safety and effectiveness for its given use. As the plaintiff cannot allege that [defendant] departed from its FDA-approved design of this product, these design defect claims are preempted.” Id. at *7. Even if not preempted, North Carolina does not recognize strict liability claims for products liability. Id.

            Moving on to warranty claims, plaintiff alleged that defendant expressly warranted the product was safe. To find that defendant breached that warranty, a jury would have to conclude that the product was unsafe – which is contrary to the FDA’s conclusion in its pre-market approval that the device was in fact safe and effective. So, express warranty is expressly preempted. Id. Since plaintiff’s implied warranty claim also turned on whether the product was reasonably safe, it too was expressly preempted. “The FDA, under the FDCA and the MDA, has the express authority to make such determinations as to the safety and effectiveness of Class III medical devices.” Id.

Plaintiff’s final claims against the manufacturer were for fraud and unfair trade practices. The court first noted that most of the allegations on these claims were just a re-packaging of the allegations pleaded with plaintiff’s other claims. Since the allege misrepresentations were largely “indistinguishable from FDA-approved labeling statements” – they too were preempted. Id. at *8.

Nice job North Carolina. In the east coast v. west coast debate, we’ll side with an anti-Stengel jurisdiction every time.

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug (Eliquis) were preempted under the impossibility preemption reasoning in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  However, as we noted in that post, dismissal of the non-design aspects of complaint was with “leave to amend.” See also Utts, 2016 WL 7429449, at *1.

Of course, plaintiffs amended.

Now, they probably wish they hadn’t.

In a second opinion, issued earlier this month, the Utts litigation was dismissed a second time, this time with prejudice. Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2017 WL 1906875 (S.D.N.Y. May 8, 2017) (“Utts II”).  Preemption was once again front and center, but this time an excellent preemption result was accompanied by a variety of equally pleasing common-law – California law – rulings.

Impossibility Preemption

First, preemption. Design defect claims had already been preempted under Mensing/Bartlett, as plaintiffs were reminded whenever they crossed the line into design-type claims. Id. at *1, 9, 10 n.10, 13 n.15, 16, 19.  But the major preemption issue this time around involved warnings – and whether any of the information that plaintiffs claimed required some kind of “better” warnings involved “newly acquired information” of the sort that a defendant could unilaterally add given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device regulation here).

For a more detailed discussion of the “newly acquired information” aspect of preemption, see our post here about In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), which was the first appellate decision finding preemption where plaintiffs failed to come forward with any “new” information to support their warning claims. Utts II explained that, in the preemption context, “if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.”  2017 WL 1906875, at *9.

Plaintiffs threw a lot of mud at the drug and its manufacturer, but nothing they heaved against the wall stuck – everything plaintiffs cited all old information that did not go beyond what the FDA had before it when it approved the drug in the first place.

Why is that?

Basically, Eliquis is a next-generation anticoagulant, very effective at what it does, and not requiring the kind of dietary restrictions and constant blood testing that older blood thinners such as warfarin – originally sold as rat poison – do.  Utts II, 2017 WL 1906875, at *2 & n.4.  Unfortunately, the plaintiffs’ bar has decided that anybody needing anticoagulation therapy should be should only have such older drugs available, and has launched an ongoing litigation assault at practically every next generation anticoagulant (others include Xarelto and Pradaxa) – because of risks of serious and sometimes fatal bleeding inherent in what these drugs are supposed to do.

The FDA was well aware of the risks that Eliquis, like any other anticoagulant, could cause uncontrollable bleeding when it approved it. Indeed, the “label warns about the risk of serious bleeding no less than five times.” Id. at *3.  It “specifically warns about the risk of bleeding” during concomitant therapy “in conjunction with antiplatelet agents, such as aspirin.”  Id. at *4.  The labeling also “twice warns about the fact that there is no specific antidote” should serious bleeding occur.  Id.

That’s why plaintiffs lost in Utts II.

Basically, the well-known fact that anticoagulants carry with them serious bleeding risks is why none of the information that the plaintiffs in Utts II brought forward qualified as “new.”  “New” is defined in the FDA’s CBE regulation as “studies, events, or analyses [that] reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.  21 C.F.R. §314.3(b) (quoted at 2017 WL 1906875, at *8).  In the preemption context, “

  • “The table and the description from the ISMP report do not suggest − nor do the plaintiffs allege − that the real-world signal data for [the drug] shows a greater severity or frequency of bleeding events or deaths than previously disclosed in [defendant’s] submissions to the FDA. Accordingly, the information contained in this table does not constitute newly acquired information. Utts II, 2017 WL 1906875, at *13.
  • Plaintiffs argue “that the guidance regarding concomitant use of antiplatelet agents is inadequate because the label does not advise how or when to use combination therapy . . . or how commonly bleeding events will occur. This omission . . . was evident to the FDA when it approved the label and the plaintiffs have not identified any newly acquired information.” Id. (quotation marks and footnote omitted).
  • This observation does not constitute newly acquired information, as it simply speculates whether [drug] safety could be further improved. Id. at *14 (as to “improved dosage guidance”).
  • [E]mbolic-thrombotic events are . . . not bleeding events. Nor do the plaintiffs argue that any of this data comparing the incidence of embolic-thrombotic events . . . constitutes newly acquired information. Id. (footnote omitted).
  • [T]he findings directed towards the risk of ischemic stroke for [the drug] users do not constitute newly acquired information. Id. at *15.
  • [P]laintiffs do not allege, however, that this expert guidance contains, or is founded upon, any newly acquired information regarding reversal agents or the treatment of excessive bleeding.” Id.
  • “[P]laintiffs do not allege that this statement contains newly acquired information about what constitutes a safe residual drug level.” Id. at *16.
  • “[T]his article does not refer to any new information that would have permitted the defendants to amend the [drug’s] label. And, in their opposition to this motion, the plaintiffs do not argue that it does.” Id.
  • “[P]laintiffs do not contend that any of the five remaining documents . . . contains newly acquired information regarding an undisclosed risk of bleeding. Several of these articles merely express a desire for further investigation. Id.

Thus, although plaintiffs loaded up their amended complaint with no fewer than “34 warnings that the defendants allegedly failed to provide,” 2017 WL 1906875, at *11, there was no safety in numbers. None of their supposedly missing warnings was based on “newly acquired information” as defined and required by the FDA’s CBE regulation.

Because, plaintiffs could not point to any “newly acquired information” to support their warning-related allegations, those allegations fell outside the scope of the Levine CBE exception and were preempted, because under Mensing/Bartlett such warnings could not be added without prior FDA approval.  2017 WL 1906875, at *9.

Next, in accordance with practically all law, Utts II held that preemption could be decided on a motion to dismiss.  A “determination regarding preemption is a conclusion of law.” Id. at *19 (pointing out that Mensing had been decided on a motion to dismiss).  To the extent that the Third Circuit’s aberrant Fosamax decision was pertinent, it was distinguishable.  Fosamax was limited to “clear evidence” determinations, and in Utts II, because plaintiffs offered no “new” information, clear evidence was never at issue.  Id. at *19-20.  Finally, plaintiffs were “not entitled to discovery on preempted claims.”  Id. at *20 (discussing TwIqbal).

In a way, the new evidence requirement discussed in Utts II resembles the so called “public disclosure” requirement that is a defense to False Claims Act claims (see here for more discussion), except that the “newness” of the information in preemption of state-law warning claims is measured against the evidence presented to the FDA, as opposed to the public.

Buckman Preemption

Utts II also found fraud-on-the-FDA preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Plaintiffs ran from their blatant fraud-on-the-FDA allegations, asking that they “be read merely as evidentiary background.”  2017 WL 1906875, at *26.  The court read them as they were written (and no doubt intended), and found preemption:

Each of the statements on which the fraud claim is premised depends on statements made to and approved by the FDA. There is no newly acquired information that required or suggested that the allegedly fraudulent statements should be altered to remain truthful and non-fraudulent.  Accordingly, the fraud claims are preempted.

Id.

Other FDCA-Related Issues

On other FDCA-related issues, Utts II ends up on our Adverse Drug/Device Event cheat sheet because of its discussion of how voluntarily reported adverse events aren’t legitimate proof of causation:

Federal regulations advise that a report submitted by a manufacturer “does not necessarily reflect a conclusion by the [manufacturer] or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect.” 21 C.F.R. § 314.80(l).  As the FDA Website explains:

FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

The Supreme Court has similarly warned that “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011). I n sum, “the mere existence of reports of adverse events . . . says nothing in and of itself about whether the drug is causing the adverse events.” Id.

Utts II, 2017 WL 1906875, at *12.

In addition, Utts II contains an excellent discussion of the harmful effects of overwarning.  The need to prevent overwarning is the reason that the CBE regulation does not apply to all information, new or old, that could in some way “strengthen” existing warnings:

The FDA has recognized that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Indeed, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” For this reason, the CBE regulation requires that there be sufficient evidence of a causal association between the drug and the information sought to be added.

Utts II, 2017 WL 1906875, at *8 (all quotes from “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices,” 73 Fed. Reg. 2848 (FDA Jan. 16, 2008).

Another notable FDA-related aspect of Utts II has to do with so-called “comparative claims” – claims that one medication is better than another in some respect.  Plaintiffs often claim (as they did in Utts II) that there is some sort of duty to warn that ones product is less safe than its competition.  However, Utts II points out that the FDA does not permit such claims except when supported by specific types and amounts of scientific evidence.  “[A]ny claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”  2017 WL 1906875, at *7 (citing 21 C.F.R. §201.57(c)(7)(iii)).  Further, “federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80).

State-Law Warning Issues

Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mostly about California law.  The decision contains an excellent discussion of the state of the art defense.  2017 WL 1906875, at *10.  It also points out that, the California Supreme Court’s holding – quite apart from preemption – that as a matter of federal/state comity, warning liability does not exist as a matter of state law where the purported duty flies in the face of FDA regulation:

Even where a risk is “known” or “knowable” at the time of distribution, under California law, a manufacturer “may not be held liable for failing to give a warning it has been expressly precluded by the FDA from giving.” Thus, if the manufacturer disclosed to the FDA “state-of-the-art scientific data concerning the alleged risk” and the FDA determined, after its review, “that the pharmaceutical manufacturer was not permitted to warn − e.g., because the data was inconclusive or the risk was too speculative to justify a warning,” then the manufacturer could not be held strictly liable for failure to warn. “[T]he FDA’s conclusion that there was, in effect, no ‘known risk’ is controlling.”

2017 WL 1906875, at *11 (all quotations from Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996)).  Thus, the same grounds that support preemption as a matter of federal law – where, as here, the FDA says “no” – also preclude liability as a matter of state law.

In tandem with preemption, Utts II also holds that the defendant’s drug labeling was adequate as a matter of California law on the bleeding issues raised by plaintiffs – just as our prior post thought it should.  In general, the label “clearly discloses that there is a risk of excessive bleeding and that there is no known antidote if that occurs.”  2017 WL 1906875, at *21.  Nor could plaintiffs prevail with any of the usual nitpicking that goes on in this type of litigation.

  • Monitoring – “The label provides, in unambiguous terms, all of the scientifically reliable information that physicians may need to determine how to monitor their patients.” Id.
  • Bleeding Reversal – A “recommendation is to discontinue [the drug] and apply ‘standard supportive treatment and other local measures’ . . . does not supply a basis for a plausible claim that the label needed to add further guidance.” Id. at *22 (quoting medical article).
  • Dosage – Plaintiffs do “not identify any research or data that undermines or contradicts the dosing guidance” and “speculation about information that the defendants may possess is insufficient to plausibly plead a claim.” Id. (citing TwIqbal).

Similarlly, plaintiffs other warning-based claims failed due to the adequacy of the warning.  Id. at *24 (implied warranty), *26-27 (fraud); *29 (consumer fraud)

Finally, here are some other California warning-related nuggets we can use:  (1) Under the learned intermediary rule, “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient.”  2017 WL 1906875, at *11. (2) “[P]harmaceutical manufacturer[s] may not be required to provide warning of a risk known to the medical community.” Id. (quoting Carlin).  (3) “[W]arnings relevant to any breach of warranty claim are those directed to the physician rather than the patient.” Id. at *22 (quoting Carlin) (emphasis original).  (4) The opinion notes that the learned intermediary rule applies to California consumer fraud claims.  Id. at *28 n.32.

Looking Forward

Utts II contains by far the most detailed discussion to date of the interplay between preemption and the “newly acquired evidence” requirement of the FDA’s CBE regulation.  It would be notable for that reason alone.  However, it also finds the labeling adequate as a matter of law, which is second highly significant ruling in any prescription medical product litigation.  What’s more, since the entire Utts amended complaint is now dismissed with prejudice, not only Utts II, but also the original Utts design defect preemption ruling, is now appealable.

Any appeal would be interesting.  Every ruling in Utts II is double-breasted, in that preemption is bolstered by independent state law grounds.  That is not the case with design defect preemption in the original Utts decision, where preemption is the sole basis for dismissal.  Utts, 2016 WL 7429449, at *12.  So, if plaintiffs were to appeal, their only clean shot at preemption would involve their design claim.  In any event, the preemption rulings in both Utts (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)), and Utts II (Celexa, 779 F.3d 34) are supported by court of appeals decisions, as our preemption cheat sheet demonstrates.  At best, in a hypothetical appeal, we would get an affirmance and reinforcing appellate precedent supporting preemption in innovator drug cases.  At worst, there would be a circuit split, which would offer the further (double-hypothetical) possibility of additional Supreme Court review of what Utts II called the Levine “trilogy.”  2017 WL 1906875, at *9.  While we always prefer to win, whenever, however, and as quickly and as thoroughly as possible, we certainly would find another shot at innovator drug preemption in the Supreme Court an interesting proposition.

We like bright lines in the law.  They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability.  Rear-end a car and you’re liable, even if the other guy stopped short.  Leave a sponge behind in a patient’s abdomen, and you and your operative team are on the hook.  The thing speaks for itself, and the thing it speaks is very bad for your defense case.  Utter a negative statement about someone in a courtroom, and you’re immune from libel liability.  Say the same thing on the courthouse steps, and you might be in trouble.  Sell a pharmaceutical product with a federally approved label, and when someone sues you for failure to warn you’re … uh oh. Thanks to the Supreme Court’s opinion in Wyeth v. Levine, you’re still in the soup if you could have added warnings via the Changes Being Effected (CBE) provision.  You might not like that rule, but at least it’s clear, right?  Wrong.  Recent opinions have come out on opposite sides as to what would constitute “clear evidence” that the FDA would have rejected an additional warning, or even who gets to decide that ‘fact.’

 
But at least we know that the CBE provision is available only in certain circumstances, right?  Thanks to the recent case of Blackburn v. Shire US, Inc., 2017 WL 1833524 (N.D. Alabama May 8, 2017), even that inquiry is muddy.  The plaintiff in Blackburn alleged that he contracted kidney diseases from a drug known as LIALDA.  Please forgive us for thinking that the failure to warn claim is a straight loser, since the LIALDA warned of precisely the injuries suffered by the plaintiff.  That would be a nice example of a bright line rule.  The defendant filed a motion to dismiss the entire First Amended Complaint.  That motion to dismiss was strongly supported by the Wyeth v. Levine “clear evidence” standard.  Or at least it should have been.  The motion to dismiss was also strongly supported by the Pliva/Bartlett independence/impossibility principle.  Or at least it should have been.  The Blackburn court granted the motion to dismiss only in part, and it is hard to characterize the court’s reasoning as anything but disappointing.
 
The plaintiff argued that the label was defective because it merely recommended “periodic” evaluations for possible kidney damage.  The plaintiff argued that “periodic” was too vague.  According to the plaintiff, “periodic” might mean semi-monthly or annual.  According to the plaintiff, the LIALDA label should have suggested evaluations every month for the first three months after therapy, then on a quarterly basis for at least one year.  The court bought the plaintiff’s argument, which amounts to a duty to tell doctors how to practice medicine.  Technicality and a belief in the vicissitudes of juror deliberations triumph over common sense. This ruling is further proof that no matter what a warning label says, a clever plaintiff lawyer and a cautious court can always conjure up an ‘improvement’ to a product label and thereby keep a weak case on the docket.
 
Even assuming that “every month for a while, then quarterly” would be an improvement, or even a distinction with a difference vs. “periodic,” the defendant had a pretty good argument in support of preemption. The CBE supplementation process applies only when “newly acquired information” becomes available and would support the label change that the plaintiff wants.  Prior to the LIALDA label, there was already information regarding the sort of testing protocol argued for by the plaintiff.  That’s not just how we defense hacks parse the record.  The plaintiff admitted “that evidence of the renal toxicity of LIALDA and his proposed testing regimen existed prior to LIALDA’s FDA approval.”  Blackburn, 2017 WL 1833524 at *4. That pre-existing information environment should support preemption.  Shouldn’t it?  No, said the court, because there was additional evidence about testing after the label went into effect.  Such incremental evidence could have had a cumulative effect, and that effect could constitute “newly acquired information.”  Ugh.  How much more is enough to make a difference?  Is mere repetition enough?  Who knows?  So we have a label that warned of the injury suffered, advised periodic testing, and even if it didn’t specify the period as much as the plaintiff would like, there was already pre-label information about such testing.  Maybe the only bright line the court favors is one against preemption.
 
The plaintiff’s proposed change faced another preemption barrier.  The change would seem to apply both to the “Full Prescribing Information” section in the label and the “Highlights” section.  The regulations (21 C.F.R. §314.70(b)(2)(v)(C), to be specific) do not permit a drug manufacturer to change the Highlights section without FDA approval.  That would be a “major change.”  The plaintiff argued that the FDA might have approved a change in the Highlights section, but that sort of speculation is foreclosed by the Pliva/Bartlett independence/impossibility principle.  If a manufacturer cannot take unilateral action, a lawsuit insisting on such action is preempted, and even this cautious court agreed that any change to the Highlights section would be preempted.  The “periodic” language criticized by the plaintiff appeared in both the Highlights section as well as the body of the label.  Is it possible to demand change in one without demanding the same for the other?  The Blackburn court was not sure, but gave the plaintiff the benefit of the doubt.  The plaintiff might be going forward on “shaky ground” (2017 WL 1833524 at *7), but the court permitted the plaintiff to proceed under the highly fictional notion that the term “periodic” in the Highlight section is okay so long as the body of the label supplies a “mere clarification” of what “periodic” means.  So the elaboration of “periodic” to mean a particular testing regimen manages to be both crucial and perfunctory at the same time.  
 
Even aside from preemption, the learned intermediary doctrine should have barred the plaintiff’s failure to warn claim.  There was no allegation that the treating doctor would have prescribed a different treatment.  It is not even clear that there was a specific, plausible allegation that the doctor would have done anything different.  If preemption is Scylla and the learned intermediary doctrine is Charybdis, how did the plaintiff evade both?  The court thought it sufficient that the plaintiff alleged that the treating doctor was a gastroenterologist, and that he probably missed the nephrology literature that expounded on the preferred testing regimen.  Thus, the First Amended Complaint offered sheer speculation that the treating doctor would have implemented a different testing regimen if only the label had informed him of as much.  But, did the treater read beyond the Highlights?  That treating doctor’s deposition will turn out to be quite important, though the court’s roadmap promises a bumpy trip, filled with blind alleys and detours.
 
Not everything the Blackburn court did was dismal.  The court dismissed the express warranty claim because the LIALDA label cannot be construed as “an express warranty of safeness.”  Id. at *9.  What the label did say was that LIALDA was safe to treat the illness at issue, and that the medicine presented a risk of precisely the injury suffered.   How can there be a breach of warranty?  At this point, we are nodding our head in agreement, quickly followed by shaking it in puzzlement over how this rationale does not equally apply to the failure to warn claim.  The court also dismissed the fraud claims because there was no misstatement of a material fact.  Rather, the plaintiff alleged only deficiencies with the label’s recommendation for testing.  We certainly agree that the alleged deficiency is not material, but then wonder how that same immateriality permitted the plaintiff to circumvent both preemption and the learned intermediary doctrine.   

Today, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017).  You can read our discussion of the district court opinion in Cerveny here.

While any decision with a description of “affirmed in part, reversed in part, and remanded” is necessarily something of a mixed bag, we’re pleased to report that the defense side won the two most important preemption issues presented in Cerveny (preemptive effect of FDA citizen’s petition denials and of FDA “no evidence” determinations, the court dodged the third (the judge/jury issue from Fosamax), and did its reversing and remanding on issues that could still eventually be preempted, but that it thought the district court had paid insufficient attention.

Cerveny was a birth defect case, and the plaintiff’s major claim was that she took the drug before becoming pregnant.  Slip op. at 2, 13 (all “parties agree that [plaintiff mother] took [the drug] before she became pregnant, but not afterward”).  Plaintiff made a secondary claim – about warnings of risks that the plaintiff did not actually encounter – that if a warning the FDA had actually proposed, concerning the possibility of birth defects during pregnancy, had been included, she wouldn’t ever have taken the drug, even though she never actually took it during pregnancy.  Id. at 3-4.  As we recently discussed in our Smoke Screens & Side Shows post, the law overwhelmingly rejects warning claims based on risks that the plaintiff never actually encountered.

The first theory was the important one, and the Tenth Circuit affirmed preemption:

The ruling was correct on [plaintiffs’] first theory, for the undisputed evidence shows that the FDA would not have approved a warning about taking [the drug] before pregnancy.

Slip op. at 4. As for the second, stay tuned, we’ll discuss it in the order the opinion addressed the claims.

The “clear evidence” required by Wyeth v. Levine, 555 U.S. 555 (2009), existed as to plaintiffs’ before-pregnancy theory because that issue was directly presented to the FDA prior to the injuries claimed in Cerveny by a citizen’s petition that the FDA rejected for lack of evidence.  Thus Cerveny presented the same “changes being effected” exception to FDA pre-approval of warning changes situation as had Levine.  However, “even when this exception applies, the FDA will ultimately approve the label change only if it is based on reasonable evidence of an association.”  Cerveny, slip op. at 7-8 (regulatory citation omitted).

Plaintiffs first tried to argue that there could never be preemption in branded drug warning cases, claiming that Levine’s “discussion of the “clear evidence” standard [w]as dicta.”  Id. at 11.  That Hail Mary pass went nowhere:

[O]ur court has relied on Levine in holding that a state tort claim is preempted if a pharmaceutical company presents clear evidence that the FDA would have rejected an effort to strengthen the label’s warnings.  Thus, we must apply the “clear evidence” test.

Id. at 11-12 (citing Dobbs v. Wyeth Pharmaceuticals, 606 F.3d 1269 (10th Cir. 2010)).

Next, as this blog has discussed, while Cerveny was pending, the Third Circuit decided In re Fosamax Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), including its precedent-shattering holding that the “what the FDA might have done” question posed by Levine “clear evidence” preemption wasn’t a question of law after all.  Id. at 286-89.  Plaintiffs in Cerveny had not argued that proposition, but once Fosamax was decided, they belatedly tried to raise it.  The Tenth Circuit was not inclined to go there.

[Plaintiffs] insist that we should adopt the Third Circuit’s approach and deny summary judgment if “no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected” the proposed label.  We are reticent to take this approach, for the parties’ appeal briefs do not address this issue.

Cerveny, slip op. at 11-12.  Ultimately, though, Fosamax didn’t matter because even assuming that its standard applied, preemption barred plaintiffs’ before-pregnancy warning claim.

The court first looked at the direct regulatory history of the drug, and FDA consideration of teratologically-related warnings.  Not enough, the court held:

[The drug’s] regulatory history is similar to Phenergan’s [the drug in Levine].  Like Phenergan, [this drug] had appeared on the market for decades before [plaintiff mother] took [it].  And [defendant] has intermittently corresponded with the FDA about [the drug’s] labels. . . .  Likewise, the FDA’s approval of [the drug’s] labels suggests only that the FDA knew about potential issues involving pre-pregnancy use . . . not that the FDA would have rejected a stronger warning if one had been proposed.

Cerveny, slip op. at 17.  So, if that was all the regulatory history, the defendant would have lost. – but it wasn’t.

Enter the citizen’s petition.

A plaintiff’s lawyer brought a citizen’s petition seeking to force the FDA to add a pre-pregnancy birth defect warning to the drug after the use at issue in Cerveny.  Id. at 14 & n.8, 18-19.  That petition was denied in 2009 (the use in Cerveny occurred in 1992).  Id. at 19.  Critically, the FDA denied that petition for lack of scientific basis – using the same regulatory standard of proof applicable if the manufacturer had sought the same change.

The FDA concluded that . . . “the scientific literature [did] not justify ordering changes to the labeling that warn of such risks beyond those presently included in labeling”. . . .  [Petitioner] sought reconsideration, which he twice supplemented with more information.  The FDA declined to reconsider, explaining that the original denial had “appropriately applied the standards in the [FDCA].

Cerveny, slip op. at 19.

The petition denial satisfied Levine’s “clear evidence” standard.  Plaintiffs’ “failure-to-warn claims are based on the same theories and scientific evidence presented in [the] citizen petition.”  Id.

Cerveny rejected plaintiffs’ argument that citizen’s petitions shouldn’t count.  First, label changes are serious business.  “[T]he FDA views overwarnings as problematic because they can render the warnings useless and discourage use of beneficial medications.” Id. at 20.  Second, “the FDA standard for revising a warning label does not discriminate between proposals submitted by manufacturers and proposals submitted by citizens.” Id. at 21 (regulatory citation omitted).  Arguments that the FDA nonetheless differentiated between manufacturers and independent petitioners didn’t hold water:

[Plaintiffs] suggest that the FDA disobeys its own regulations to apply different standards depending on the source of the proposed change. But we do not presume that the FDA deviates from regulatory requirements.

*          *          *          *

[plaintiffs] hypothesize that the FDA would be more receptive to a manufacturer’s request to strengthen a warning than to a citizen’s effort to compel a stronger warning.  But a factual dispute cannot be based on speculation that the FDA would jettison its legal requirements and rubber-stamp [defendant’s] hypothetical proposal notwithstanding the risk of overwarning.

Under the same standard for manufacturer-initiated changes, the FDA rejected a citizen petition containing arguments virtually identical to [plaintiffs’].  We will not assume that the FDA would have scuttled its own regulatory standard if [defendant] had requested the new warning.  Thus, we reject [plaintiff’s] challenge to [defendant’s] reliance on [the] citizen petition.

Id. at 21, 23 (citations and alternative explanations for FDA conduct omitted).  Third, even under a Fosamax standard, the FDA’s rejection of the citizen’s petition was a “smoking gun” that “foreclose[d] any reasonable juror from finding that the FDA would have approved” the label change advocated by plaintiffs.  Id. at 23 n.11.

Thus a no-evidence rejection of a comparable warning change was preemptive.  There was no “bright-line rule” that such a rejection was insufficient to constitute “clear evidence” satisfying Levine.  Thus, Cerveny rejected contrary cases, including one that we have criticized – slip op. at 25-27 (rejecting Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015), Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F. Supp.2d 1125, 1133 (D. Minn. 2011), and Forst v. Smithkline Beecham Corp., 639 F. Supp.2d 948, 954 (E.D. Wis. 2009)) − and distinguished others.  Slip op. at 24-25, 27 (distinguishing Mason v. SmithKline Beecham Corp., 596 F.3d 387, 396 (7th Cir. 2010), Koho v. Forest Laboratories, Inc., 17 F. Supp.3d 1109, 1117 (W.D. Wash. 2014), Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1158-59 (C.D. Cal. 2010), and Hunt v. McNeil Consumer Healthcare, 6 F. Supp.3d 694, 700-01 (E.D. La. 2014)).  Critically, Cerveny distinguished Mason because there, the petition “had been rejected before the plaintiff’s injury.”  Cerveny, slip op. at 24 (emphasis original).  The “bright line” were interested in – that an FDA insufficient-evidence rejection after a plaintiff’s injury is necessarily preemptive, since even less evidence would have existed at any earlier time – remains intact in Cerveny.

Finally, some clarity for the “clear evidence” standard.

However, the court reversed dismissal of the plaintiffs’ weaker claim, that if they had received a stronger warning about a birth-defect risk existing only during pregnancy, they wouldn’t have taken the drug at all (even before pregnancy) and thus the injury wouldn’t have occurred.  As to that risk, they could point to a label change proposed (but not required) by the FDA.  Slip op. at 28-29.  That proposal “d[id] not suggest that the FDA would have approved a warning about taking [the drug] prior to pregnancy,” id. at 29, and thus did not affect preemption of plaintiff’s pre-pregnancy claims.  Id.

Plaintiffs’ pre-pregnancy claim is exactly the sort of attenuated allegation that we addressed at length in our Smoke Screens & Side Shows post – that the plaintiff mother “would not have taken [the drug], even pre-pregnancy, if [defendant] had used the FDA’s proposed wording” about post-pregnancy risks.  Id. at 32.  The problem on appeal in Cerveny was that dismissal had been sought from, and granted by, the trial court solely on preemption grounds, whereas (as our post demonstrates) the best defense was that remote causation claims did not exist under state law.  Id. at 34.

The Tenth Circuit cut plaintiffs a break. Even though the district court had pointed out that it “would be a nonsensical result if a plaintiff could avoid a preemption defense by arguing that a drug label could have been strengthened in any form, regardless of its relevance to the plaintiff’s case,” id. at 34 (quoting Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203, 1220 (D. Utah 2016)), the appellate court decided that wasn’t enough to affirm dismissal on non-preemption grounds.

In sum, the district court did not consider whether it could rest on Utah law when deciding a summary judgment motion that had relied solely on federal preemption.  Because the district court did not consider this question and it has not been fully briefed on appeal, we leave this question for the district court to address on remand.

Cerveny, slip op. at 36.  So much for affirming on any ground.  Strange things happen in tort preemption cases.  At least the blog’s already done some of the defendant’s research (although we didn’t find any Utah cases, unfortunately).

The last bit was the disposition of plaintiffs’ fraud, misrepresentation, and implied warranty claims. The district court had dismissed them as just preempted warning claims under different names.  Id. at 37.  Again the court cut the plaintiffs a break, holding that any preemption dismissal needed to address those claims separately:

[W]e reverse and remand the award of summary judgment on the claims of fraud, negligent misrepresentation, and breach of an implied warranty.  We do not foreclose the possibility that these claims might be preempted.  But on remand, the district court should explain the effect of preemption on th[os]e claims.

Id. at 38.  Finally, the Tenth Circuit held that plaintiffs were not entitled to additional discovery before preemption was decided.  Id. at 38-41.  At least, on remand, the defendant won’t be forced to incur additional discovery costs before teeing up preemption again.

Although not every claim was held preempted on appeal, in our books Cerveny is a significant defense win.  It finds “clear evidence” as a matter of law to preempt the plaintiffs’ main claim.  It holds that citizen’s petition denials are as preemptive as any other form of FDA decisionmaking.  It affirms the importance of overwarning, and thus that an inadequate-information FDA label change preempts all prior claims where there can be no claim of additional information being discovered in the interim.

We wonder whether plaintiffs will appeal.  There is now a direct conflict between Cerveny (a court of appeals) and Reckis (a state high court) on FDA citizen’s petition denials being “clear evidence” under Levine.  We’ve thought from day one that Levine was appallingly reasoned and should be reconsidered, and maybe this is the vehicle.  We also think that Justice Gorsuch, a textualist, won’t put much stock in the Reckis (and plaintiffs’ in Cerveny) rationale that the identical FDA standard doesn’t mean the same thing depending on who is submitting a proposed label change.

Do plaintiffs roll the dice?

 

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district court allowed a claim alleging that the defendants failed to provide medication guides for distribution with amiodarone prescriptions. The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Marvin v. Zydus Pharmaceuticals (USA) Inc., 203 F. Supp. 3d 985, 986 (W.D. Wis. 2016) (citing 21 C.F.R. §§ 208.1, 208.24(b)).

A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the district court in Wisconsin concluded that this very federal-sounding claim was actually based on an “independent” state duty to warn.  Go figure.

That cheesy conclusion spilled over last week into an amiodarone case in Illinois, which again alleged that the defendants failed to provide medication guides. And again the district court concluded that federal law did not impliedly preempt the plaintiffs’ state law tort claims based on a failure to warn.  The case is Hernandez v. Wyeth-Ayerst Laboratories, Inc., No. 15 C 11176, 2017 U.S. Dist. LEXIS 58743 (N.D. Ill. Apr. 18, 2017), and if anything, these plaintiffs were even more forward about co-opting federal regulations that the plaintiffs were in Marvin.

The Hernandez plaintiffs alleged two violations of the FDCA:  First, that the defendants violated the FDCA by promoting amiodarone off label as a first-line anti-arrhythmic medication; and second, that the defendants failed to provide medications guides. Id. at *3.  The generic drug manufacturer defendants justifiable argued that these claims were preempted under PLIVA v. Mensing and Buckman v. Plaintiffs’ Legal Committee, but the district court rejected both arguments.

The district court’s discussion of Mensing is a bit confused.  Applying the often-misunderstood “parallel claim” exception to express preemption, the court held that because the plaintiffs were alleging a violation of federal regulations, their claim was “parallel” to federal law and thus was not preempted. Id. at **8-10.  The problem with this is that Mensing did not apply express preemption.  It was an implied preemption case, and the district court had no business applying “parallel claim” analysis to implied preemption, where a “parallel claim” exception does not exist.  The district court even concluded that the plaintiffs’ claim was “not expressly preempted.” Id. at *9.  That is fine as far as it goes.  But we would be surprised if the generic defendants argued express preemption.  And even if they did, disposing of express preemption does not dispose of implied preemption.  They are different things.

What cases did the district court cite? One was the Seventh Circuit’s opinion in Bausch v. Stryker Corp., for which we have expressed our vigorous disagreement multiple times (including here and here), and another was a district court case called Garross v. Medtronic.  Both addressed express preemption as applied to pre-market approved medical devices.  Apples versus oranges.  Or if staying with our cheese theme, cheddar versus Limburger.

The district court’s treatment of Buckman fares no better.  According to the court, the “plaintiff alleges that [the generic manufacturer defendant] violated its duty to warn under Illinois law because it violated the FDCA’s requirement to provide distributors with medication guides.” Hernandez, at *9 (emphasis in original).  Did you catch that?  The plaintiff was suing because the defendant alleged violated the FDCA.  The court even put “because” in italics.  This is a recipe for implied preemption under Buckman, and it runs directly into section 337(a) of the FDCA, which gives the government exclusive power to enforce the Act.  We have often observed that plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging that are suing for a violation of the FDCA, but not because the defendant violated the FDCA.

These plaintiffs were not even close. The district court acknowledged they were suing because the defendants violated the FDCA, but it somehow found that Buckman did not apply.  Recall that Buckman held that claims were preempted where “federal enactments [were] a critical element” in the plaintiffs’ case. Buckman, 531 U.S. 341, 352 (2001).  That seems to describe the Hernandez plaintiffs’ case to a tee.  The district court also did not discuss, or even acknowledge, section 337(a), which prohibits private causes of action to enforce the FDCA.  The district court again cited Bausch, and it observed that the generic defendant did not cite an express preemption provision.  It did not otherwise explain how these plaintiffs could so overtly purport to enforce the FDCA through a state law failure-to-warn lawsuit.

The defendants also argued statute of limitations and that the plaintiffs did not sufficiently plead their claims, but the former argument failed, and latter resulted only in leave to amend. For our part, summer is approaching, and we still have not tried Wisconsin cheese curd.  Maybe we will soon have the good fortune of attending a Midwestern county fair, where we are told cheese curd runs in abundance.  Or maybe we’ll just go to Chicago and have a hot dog.

Just yesterday we made the following observation: a design defect claim is often a make-weight claim. How should the design have been improved? Not selling the product at all is hardly a design improvement. An entirely different product is not a safer alternative under the law of any enlightened state. Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).

And miss the point the court did in In re: Xarelto Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 56629 (E.D. La. Apr. 12, 2017). Plaintiffs in the Xarelto MDL allege that the anti-coagulant drug caused serious bleeding events and that the drug was unreasonably dangerous due to its defective design. Id. at *3. As we noted yesterday, true design claims, as opposed to failure to warn claims, aren’t the crux of most pharmaceutical drug cases. But the Xarelto plaintiffs went that route and so defendants raised preemption as a defense. Unfortunately, to no avail.

Xarelto is an anti-coagulant drug that is taken once a day and all patients are given the same dosage without the need for routine monitoring. Id. Plaintiffs argue that patients’ reactions to the drug vary causing some to experience bleeding complications. Id. at *3-4. It is undisputed that both the dosing and monitoring specifications were approved by the FDA. Id. at *4. So, if the FDA approved the design, what do plaintiffs say the manufacturer could have done differently? Essentially, plaintiffs’ position boils down to the manufacturer should not have sold Xarelto but should have developed and sought FDA approval of a different product. Wait. We’ve been down this road before and the Supreme Court found such claims preempted. Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

Before we get to Bartlett, let’s look at the specific design defects plaintiffs alleged in this case. First, the manufacturer should have designed an assay to allow doctors to monitor the effects of the drug on each patient. Second, the manufacturer should also have designed and marketed an antidote to counteract a major bleeding event. Third, in the absence of the first two, the manufacturer should have warned about the availability of other tests to measure anticoagulation. Id. Putting aside failure to warn, a claim that the manufacturer should have submitted a different version of the drug to the FDA for approval is the functional equivalent of the “stop-selling” claim that the Court found preempted in Bartlett.

Now that we are back to Bartlett, we should point out that the Xarelto court wrongly discounts defendants’ reliance on it, saying that it relates to generic drug manufacturers, not name brand manufacturers. Id. at *7-8. While it is true that that drug at issue in Bartlett was a generic, the rulings are in Bartlett are not so limited, and certainly not on the very issue germane to this case. The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’” 133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added). Instead the Xarelto court, in its discussion of design defect, relies more on Wyeth v. Levine, using that decision on failure to warn claims to suggest that preemption is not as clear for brand manufacturers. But the distinction between Bartlett and Wyeth isn’t that one involved a generic and one involved a brand. It’s that Bartlett dealt with design defect and the court’s failure to follow the preemptive logic of Bartlett in this context is an error – at least in our books.

The way the court appears to get around Bartlett is by drawing an artificial distinction between “pre-approval” and “post-approval” design defect claims. Id. at *10. But, as noted above a pre-approval design defect claim is the same thing as saying the manufacturer should stop selling the current product – that it never should have been brought to market. But it was. And only after the FDA reviewed and approved it, including its dosage and monitoring specifications. A design defect claim is about whether the product at issue – the one that was sold and marketed and used by plaintiffs – was defectively designed and whether there is a feasible alternative design. By focusing on the “pre-approval” time period, the court is basically inviting the jury to second guess the FDA’s approval of the drug — a question clearly not meant for a jury. If the court had focused on the “post-approval” product, the actual product at issue, the design defect claims would fall squarely into Bartlett preemption.

But the court didn’t and so we add this to the list of cases that simply miss the point.

We’ve addressed sunscreen class actions here from time to time. The FDA regulates sunscreen as an OTC drug, and so these class actions can generate decisions of interest in areas of preemption and primary jurisdiction. For instance, we told you about, Gisvold v. Merck & Co., 62 F. Supp. 3d 1198 (S.D. Cal. 2014), in which a court found preempted a putative class action plaintiff’s claim that the Coppertone SPORT SPF 100+ she bought at Walmart should have disclaimed that it was no more effective than sunscreen with an SPF of 50.  The court based its preemption determination on the plaintiff seeking labeling that was different from that required by the FDA.  In addition, the court invoked primary jurisdiction, deferring to the FDA on how to address SPF values greater than 50, as the FDA was already in the process of evaluating that issue.

But, as in medical device cases, preemption in sunscreen litigation can seem muddled. Just recently in another sunscreen class action, Dayan v. Swiss-American Prods., Inc. (E.D.N.Y. Mar. 30, 207), a federal court in New York rejected a preemption-based motion to dismiss a claim that the labeling of a sunscreen product as SPF 45 was misleading because the product actually performed at a lower SPF level.  As support for his claim, plaintiff pled data from tests conducted under the FDA’s SPF testing protocols. The court adopted a magistrate’s report and recommendation, which reasoned that the plaintiff’s “state law claims [sat] next to federal regulations and are not premised on Defendant’s alleged failure to comply with FDCA requirements.” Id. at *4. Sort of a parallel violation claim for sunscreen.

As the court conceded, though, its distinction between what is preempted and what is not is, at best, “tricky.” Id. at *10. There seems to be little to no air on which plaintiff’s claim can survive between express and implied preemption. If, as his case develops, plaintiff is left to argue that the defendant followed FDA-mandated protocols in testing the sunscreen and disclosing the results, his claim that the label should nonetheless be different would seem to trigger preemption because it would require something different from what the FDA requires. On the other hand, if plaintiff’s claim, as fleshed out through discovery, appears to be that the defendant failed to follow FDA protocols, it would start to read like an improper attempt to privately enforce FDA regulations.

In other words, sunscreen preemption seems every bit as messy as medical device preemption. Maybe, in this case, it can be cleared up at the summary judgment stage—that is, if this case gets passed class certification—where defendant may have another chance, based on a full record of what plaintiff is trying to do, to ask for judgment based on 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 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.

 

We talk a lot on this blog about Buckman preemption. That isn’t just out of pride regarding Bexis’s role in the bone screw litigation that led up to the Buckman decision. The principle in Buckman is important. What happened in Buckman? Here is a nice summary: “In Buckman, the plaintiffs brought state law claims against a consultant for injuries caused by orthopedic bone screws alleging that the defendant made fraudulent representations to the Food and Drug Administration (‘FDA’) in the course of obtaining approval to market the screws. 531 U.S. at 343. The Supreme Court found that federal law preempted state-law tort claims for fraud on the FDA.” Meijer, Inc. v. Ranbaxy, Inc., 2017 U.S. Dist. LEXIS 45527 (D. Mass. March 28, 2017).

 

The Buckman principle is crucial for our drug and device clients because most lawsuits against them challenge products and/or communications that were approved or cleared by the FDA. If promises were made, they were made in both directions. FDA action or inaction gave rise to settled expectations. Are the plaintiffs saying that the FDA’s review and acquiescence meant nothing, or that the FDA erred? Usually not. More often, plaintiffs are prone to suggesting that the defendants somehow bamboozled the FDA. In the feverish dreams of a mass tort plaintiff lawyer, it is a two-fer: the defendant not only lied to the public, it lied to the FDA. Go ahead and read any mass tort complaint and count how many times that story is told.

 

Still, plaintiffs and their lawyers and their experts are also not shy about asserting that the FDA is not up to the job.  According to the plaintiffs’ parable, the FDA is overworked, lazy, and dumb.  By contrast, it is the regulated companies that hold up FDA personnel as being competent and well-intentioned.  But let’s stick to the fraud claim for a moment. How often do you really think that major drug and device companies intentionally withhold from the FDA material evidence about risks and benefits?  How often do these companies make affirmative misstatements to the FDA, hoping to pull the wool over the government’s eyes?  No individual product approval would be worth such a risk.  Companies try to do the right thing because it is the right thing, and also because it is good business.  A claim of fraud on the FDA is invariably itself fraudulent.

 
In Buckman, SCOTUS rightly decided that juries have no business determining whether the FDA was fooled. Rather, that is for the FDA to address. If FDA findings or conclusions could be undermined by juries, we would see inconsistent verdicts all around the country, and FDA processes would become virtually meaningless. So now, in the wake of Buckman, we are treated to plaintiff claims and arguments that tip-toe right up to the edge of asserting fraud on the FDA. The plaintiff lawyers want the benefit of nasty implications without blowing up their case with preemption dynamite. Oh, let’s not kid ourselves; edge-schmedge. Plaintiff lawyers cannot help vaulting over the edge and shouting fraud on the FDA. Buckman has given rise to kabuki theater on preemption. It calls to mind that curious phrase about something being “honored in the breach.”

 
The Meijer case is interesting, not in spite of the fact that it is not a tort claim, but because of it. Meijer is an action brought by a direct purchaser class. The class alleged claims under both the Sherman Antitrust Act and RICO. Surely, dear reader, you know that both statutes are federal. The Meijer opinion does not make it clear exactly why this is so, but everyone in the case agrees that “all of the plaintiffs’ claims are predicated on fraud on the FDA.” The issue, then, is whether the Buckman holding halts these claims in their tracks. It is not a matter of preemption, for all of the claims in Meijer are federal. The supremacy clause is not implicated. Rather, we are now talking about one statute precluding resort to another. The effect of preclusion would be the same as preemption – dismissal of claims.

 
The district court in Meijer held that the antitrust and RICO claims can proceed, but did so uneasily. The court agreed with the plaintiffs’ reading of the SCOTUS holding in POM Wonderful LLC v. Coca Cola, 134 S.Ct. 1228 (2012), which harmonized Lanham Act claims with the Food, Drug, and Cosmetic Act. But – and the district court acknowledged as much – SCOTUS did not really confront a defense of flat-out preclusion in POM Wonderful. (The phrase “primary jurisdiction” does not crop up in Meijer, but it is not hard to see its relevance here.)

 
Hence, even though the defendants lost their Buckman argument in Meijer, they convinced the court that the issue was a controlling question of law, that its disposition would materially advance the termination of the litigation (that is, application of Buckman would end the case completely), and there was substantial ground for a difference of opinion. The district court said that “this is the first time a party has brought antitrust claims predicated on fraud on the FDA.” Some of us here at the DDL blog are not so sure that is right.  Be that as it may, it is an open question whether Buckman preemption/preclusion affects claims based on other federal statutes. The POM case focused on statutory interpretation, and followed the maxim of finding consistency wherever possible. There was no reference to Buckman or its underlying principles. The issue was simply not on the High Court’s radar screen. Consequently, the Meijer defendant’s reliance on Buckman is “sufficiently novel,” is purely legal, and therefore warrants interlocutory review by the First Circuit. The very interesting issue of the scope of Buckman has been kicked upstairs.

 
It will be fascinating to see what the First Circuit does. Courts are loath to permit the mere form of an action to circumvent fundamental principles of jurisprudence. Buckman is fundamental in terms of protecting the integrity and reliability of administrative actions. Consistency and predictability for a vital part of our economy and healthcare are at stake. Dressing up a case in the garb of antitrust or RICO claims should not change things one bit.