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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.

Not so now.

Given what Dr. Gottlieb has said – and is saying – we doubt that the FDA’s absolutist ban on truthful industry speech about off-label uses (pejoratively called “promotion”) will continue much longer in its current form.  For instance, on the FDA’s website, Dr. Gottlieb is quoted here as giving a speech saying:

The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just because the wheels of my government institution and its meticulous work may take longer to turn than the wheels of clinical science?  Some people believe that patients should be treated only according to the clinical evidence included in a drug’s approved indications.  Yet this evidence may be two or maybe three years old, especially in a fast-changing field like cancer, where off label use of medicines provide important opportunities for patients to get access to the latest clinical practice and for doctors to tailor their patients’ treatment plans based on medical need and personal preferences.

*          *          *          *

Efforts to limit prescription and scientific exchange to indications only specified on a label could retard the most important advances in 21st century medicine.  The development and deployment of drugs is becoming more and more closely linked to understanding of mechanism of action, which means that physicians can use drugs in more sophisticated ways that cannot all be anticipated on a label, or easily or quickly studied in prospective studies. . . .  More important, medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis. Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency.  In the future, personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients.  Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information.

(Emphasis added).  Defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA Commissioner’s positions – particularly to rebut contrary views offered by former FDA officials.

Dr. Gottlieb’s non-FDA writings show similar solicitude for scientific speech – whether or not that speech originates with FDA-regulated manufacturers.  In an article for the American Enterprise Institute, Dr. Gottlieb criticized FDA policies that “prohibited” a manufacturer with a drug undergoing supplemental FDA approval for a new use from “distributing the findings or educating doctors on the new use through sponsored medical education.”  “[A] more measured approach to the regulation of promotion” would allow “sharing of useful information that falls within the bounds of appropriate clinical care.”

Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. . . .  [E]stablishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.

In another AEI article a few years later – shortly after the government lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) − Dr. Gottlieb’s criticism of the FDA’s prohibition of truthful speech about off-label uses was even more pointed.

When this [off-label] speech is truthful, nonmisleading, and promulgated in an educational context, it is quite possible that the speech would be deemed constitutionally protected by the courts under doctrines that recognize commercial speech as being subject to First Amendment considerations.

(Footnote omitted).  Basically, Dr. Gottlieb took issue with whether scientific speech concerning off-label uses could ever be considered illegal “promotion”:

A core principle of America’s constitutional speech protections is that the government should not establish what is orthodox, especially when it comes to politics, the arts, religion, and science.  The founders recognized that these matters are by their nature iterative, and that it would be dangerous in a democratic society for the government to use its resources to pick a side in these debates.  Matters that are subject to their own evolution − a core feature of how new science unfolds − are better addressed by adding voices to the debate, not suppressing them.

Dr. Gottlieb even urged FDA regulated manufacturers to stand up and challenge the constitutionality of off-label informational restrictions promulgated by the FDA – the agency he now leads:

[T]he drug industry needs to be willing to take the prerogative to challenge the facts in some of these cases and have that day in court. When investigations turn on the sharing of truthful, nonmisleading information about widely accepted uses of drugs, in fast moving fields like cancer, there is a legitimate question about whether public health is being served by suppressing this sort of information.  However, until these cases are challenged in court, there will remain ambiguity around where the appropriate lines rest, what speech is constitutionally protected commercial speech or clearly violative, and how public health is best served.

(Emphasis added).  Not long after that, a company took up Dr. Gottlieb’s challenge, and the result was Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

To some extent, where one stands depends upon where one sits, but Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that the FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways.

With that in mind, we examine the newest First Amendment precedent rejecting governmental prohibition of a manufacturer’s truthful speech about its product, Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017).  Ocheesee is a food (skim milk) case, but doesn’t involve the FDA – it doesn’t even involve the federal government.  Instead, Ocheesee is a demonstration that, when given the chance, state regulators are still equally capable of behaving just as badly towards the First Amendment as the feds, albeit on a smaller scale.

It may be that Ocheesee doesn’t involve interstate commerce, see 851 F.3d at 1231 n.1, or it may be that there is something peculiar about milk regulation that we don’t know, but the State of Florida (not the FDA or any other federal entity) came down on the plaintiff, described as “a small dairy creamery located on its owners’ farm” that “sells all-natural dairy items,” like a ton of bricks.  Id.  Apparently, the process of “skimming” the cream from whole milk “depletes almost all the vitamin A naturally present in whole milk because vitamin A is fat-soluble and is thus removed with the cream.”  Id.  Thus Florida agricultural regulations require vitamin A to be added to skim milk before it can be sold as “skim milk.” Id.

That was a problem for the plaintiff because, as a matter of philosophy, this business “prides itself on selling only all-natural, additive-free products.”  Id.  It therefore “refuse[d] to replace the lost vitamin A in its skim milk” with a vitamin A additive as Florida law required.  Id.  The State of Florida thus prevented the plaintiff from calling its product “skim milk,” even though that “product contains no ingredients other than skim milk.”  Id.  Instead (and ironically) the state sought to require the plaintiff to call its product “imitation milk.”  Id. at 1232.  Not surprisingly, the plaintiff refused and sued instead.

Readers attuned to the First Amendment no doubt see the problem already.  Calling such a product “skim milk” is truthful.  The State of Florida – like the FDA with truthful off-label speech – sought to suppress the plaintiff’s truthful speech in a commercial context, using the public health (vitamin A is not just good for you, but essential to health) as its reason for doing so.  Who wins – the First Amendment right to engage in truthful commercial speech, or the state’s public-health-based rationale for suppressing such speech?

In Ocheesee, freedom of speech prevailed.  851 F.3d at 1233 (“The sole issue on appeal is whether the State’s actions prohibiting . . . truthful use of the term ‘skim milk’ violate the First Amendment.  We hold that they do.”).

First, the lay of the constitutional land.  Ocheesee applied the now-venerable “Central Hudson” intermediate scrutiny test for constitutionality of governmental restrictions of commercial speech.  851 F.3d at 1233 (citing Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557, 563-64 (1980)).  Thus, Ocheesee did not apply the more speech protective tests enunciated in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (“heightened scrutiny”) (see our discussions here, here, here, and here); and Reed v. Town of Gilbert, 135 S.Ct. 2218 (2015) (“strict scrutiny”) (see our discussion here).  That doesn’t mean that the Eleventh Circuit was unaware of these cases – quite the contrary:

There is some question as to whether under the Supreme Court’s decisions in Sorrell and Reed an analysis to determine if the restriction is content based or speaker focused must precede any evaluation of the regulation based on traditional commercial speech jurisprudence, and if so, whether this would alter the Central Hudson framework.  In Sorrell, the Supreme Court found the restriction at issue to be content based but nevertheless cited, articulated, and applied the Central Hudson test.  And in Reed, the Court arguably broadened the test for determining whether a law is content based. . . .  We need not wade into these troubled waters, however, because the State cannot survive Central Hudson scrutiny, and in any event the [plaintiff] does not argue the State’s restriction was content based or speaker focused.

851 F.3d at 1235 n.7.  Thus, the favorable First Amendment decision in Ocheesee sets a floor for the protection of truthful commercial speech in the Eleventh Circuit that parties arguing Sorrell and Reed may exceed.

Under the Central Hudson criteria, as a “threshold question,” the government (which always has the burden of proof) had to establish that the suppressed speech either concerned “unlawful” conduct or was “false or inherently misleading.”  851 F.3d at 1235-36.  It failed because selling the plaintiff’s product was not unlawful – the state would have allowed its sale under the “imitation” description.  Id. at 1237.  Note the parallel to off-label speech – doctors are free to engage in off-label use, and products so used may be lawfully sold.  “[T]he only difference between the two courses of conduct is the speech.”  Id.

Nor could the speech be considered false or misleading.  The state could not simply “define” a product in whatever way it chose, and declare anything not meeting that definition “misleading.”  The court rejected such “self-evidently circular” reasoning:

Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.  All a state would need to do in order to regulate speech would be to redefine the pertinent language in accordance with its regulatory goals.

Id. at 1238.  Again, any resemblence to the FDA’s salami slicing of “intended uses” is entirely intentional.  Consumer “unfamiliarity is not synonymous with misinformation.”  Id. at 1239 (citation and quotation marks omitted).

Next up in Ocheesee was the three-pronged “intermediate scrutiny” Central Hudson test:  (1) was the asserted governmental interest substantial? (2) did the regulation directly advance the that substantial governmental interest? And (3) was the restriction on speech more extensive than is necessary to serve that interest?  851 F.3d at 1235-36.

As in off-label promotion cases, the “substantiality” of the government’s “interest in combating deception and in establishing nutritional” – that is to say product safety and effectiveness – “standards” was concededly “substantial.”  Id. at 1240.  Ocheesee jumped over the second prong and went right to the third, “because the measure is clearly more extensive than necessary to achieve its goals.”  Id.

In all commercial speech cases, “the preferred remedy is more disclosure, rather than less.”  Id. (Supreme Court citation omitted).  Florida’s flat ban on use of the term “skim milk” failed because a disclaimer would serve the same purpose in a “less restrictive” and “more precise” way.  Id.  “[A]llowing skim milk to be called what it is and merely requiring a disclosure that it lacks vitamin A” was sufficient “to serve [the state] interest in preventing deception and ensuring adequate nutritional standards.”  Id.

The First Amendment thus prevailed where the speech is truthful – without the court going even having to go to the trouble of relying on heightened (Sorrell) or strict (Reed) scrutiny, both of which would be argued in truthful off-label speech cases.  Visions of shattered backboards come to mind.  We don’t think Dr. Gottlieb wants the FDA to end up like Bill Robinzine, so we’re looking for a more reasonable off-label speech policy to emerge from the FDA, before a court has to do so for the agency.

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.

One of the issues that the federal Civil Rules Committee’s discovery subcommittee considered, but that eventually fell by the wayside, on the way to the 2015 discovery rules amendments, were proposals to convert to a “requestor pays” discovery system.  That would be a very significant change, and one of the criticisms that the other side leveled at such a system was that only rich people (or at least only rich plaintiff lawyers) could afford to bring suit, given the prospect of having to pay for expensive discovery that current system now gives plaintiffs for free.

Well, not for free.  Nothing is free.  The current “producer pays” discovery system gives plaintiffs a windfall by allowing them to demand production of millions of dollars’ worth of documents – and as importantly, electronically stored information (“ESI”) − and to impose those costs almost entirely on defendants.  As any economist will tell you, any system that provides access to something for free or at greatly below-market cost, be it health care, “dumped” imports, or discovery, creates greater demand for whatever the below-cost item is than would exist otherwise.

It’s worse in the legal system, because the other side’s heightened demand for “free” discovery has the concomitant effect of increasing the nuisance (that is to say, settlement) value of all litigation in which such demands are made – since one’s opponent is stuck with the bill.

All our side got out of the 2015 rules amendments cycle on requestor pays is a provision more clearly recognizing the authority of courts to shift discovery requests.  See Fed. R. Civ. P. 26(c)(1)(B).  As we’ve mentioned, a couple of courts have done this during prescription drug/device MDL litigation.  See In re Bard IVC Filters Products Liability Litigation, 317 F.R.D. 562 (D. Ariz. 2016); In re Benicar (Olmesartan) Products Liability Litigation, 2016 WL 5817262 (D.N.J. Oct. 4, 2016).  Both of those cases involved what the courts viewed as excessive and unnecessary MDL discovery targeted at the defendants’ overseas activities.

Now we’ve found a third case – it took a little longer because it didn’t involve prescription medical products – that also invoked the new cost-shifting provisions in a very familiar (and frustrating) situation.  McClurg v. Mallinckrodt, Inc., 2016 WL 7178745 (E.D. Mo. Dec. 9, 2016), wasn’t an MDL, but it could have been, except for a limited geographic scope.  Many hundreds of plaintiffs were all seeking recovery for alleged radiation-induced injuries from the same two defendants.

A situation depressingly familiar to any defense counsel in mass tort litigation developed.  Although plaintiffs are nominally responsible under the rules for collecting (and paying for the collection of) their own medical and related records in response to discovery requests, they botched the job so badly that the defendants – in whose interests it was to have these records – had to step in and do it themselves on their own dime.  Plaintiffs did produce “a list of known health care providers and a signed authorization for the release of medical records.”  Id. at *1.  “Because Plaintiffs did not timely and fully produce all of their records, Defendants contracted with a third-party vendor . . . to collect records directly from Plaintiffs’ health care providers and employers.”  Id.  Also, “the parties in this matter could not agree to a reasonable scope of record collection and allocation of costs.”  Id. at *4.

So things stood until bellwether plaintiffs were selected (interestingly, by random selection, id. at *2).  All of a sudden the plaintiffs became very interested in the additional records that the defendants had been collecting at their own expense.  So they served discovery requests seeking those records – only for the bellwether plaintiffs – for free.  Id. (“Plaintiffs served document requests seeking ‘all documents and records’ that Defendants had collected regarding each of the 16 Bellwether Plaintiffs”).  Somewhat ironically, they also claimed that the defendants had engaged in excessive records gathering, and therefore also demanded access to the defendant’s records database (also set up at defendants’ sole cost) so they could select which records they wanted.  Id. (“Plaintiffs assert that they, too, wish to access [defendants’] secure portal free of charge, in order to decide which records they want”).

The two McClurg defendants’ response was “hell, no; not without you sharing the cost equally – that is shouldering one-third of the expense along with the defendants each sharing a third.  Id. (subject to a credit for whatever records plaintiffs had actually collected and turned over).

The McClurg court shifted costs, not 33% but 18%, to plaintiffs under Rule 26(c)(1)(B).  2016 WL 7178745, at *3.  Cost-shifting was necessary so that the plaintiffs did not become free riders:

The Court finds . . . that good cause exists to order some amount of cost-sharing before Plaintiffs may obtain the records collected by Defendants here.  Plaintiffs would ordinarily have been, and pursuant to the Court’s order were, responsible for gathering and producing their own records.  But while Plaintiffs appear to have produced some records as new complaints were filed, they did not do so in a complete and timely manner.  Indeed, Plaintiffs apparently produced records for a few of the Bellwether Plaintiffs just one or two days before their scheduled depositions.

Id.  That “Plaintiffs [were] seek[ing] access to the portal establish and maintained at Defendants’ expense” further justified a cost allocation order.  Id.

Although it was “unfortunate” that the parties never sought court intervention after failing to reach a records production protocol, id. at *4, giving plaintiffs free access to records collected and maintained at the defendants’ expense was unfair.  Id. (“it would be unfair to allow Plaintiffs to gain the benefit of Defendants’ early record collection and creation of the portal, which helped move the case forward, without contributing a fair share of the overall costs of such collection”).  Crediting plaintiffs’ complaints about excessive collection, McClurg reduced the percentage to 18%.  Id. (eliminating records collected concerning plaintiffs that the defendants knew could not be in the bellwether pool).  Plaintiffs also received a credit for the comparatively small amount of timely produced records they had collected.  Id.

Since the same failure by plaintiffs to collect their own records competently is endemic to prescription medical product MDLs, the cost-shifting in McClurg is of significant interest to us.

In fact, the results in all three of these cases – Bard IVC, Benicar, and McClurg – are also of interest to us because they provide pointers to where the requestor pays debate might reasonably go.  We certainly don’t agree with the other side’s largely bogus argument that across-the-board requestor pays discovery might shut the courthouse doors on the “poor” plaintiffs in the litigation-funded, advertising-driven mass tort industry.  In such litigation, there “does not appear to be a significant financial disparity in the parties’ ability to finance these putative litigations.  Thus, what this Court and other courts similarly situated are faced with is ‘Goliath versus Goliath.’”  Arch v. American Tobacco Co., 175 F.R.D. 469, 496 (E.D. Pa. 1997).

However, since the federal rules are supposed to be transubstantive, we will accept for the sake of argument that some deserving plaintiffs in some types of litigation might be excluded by a blanket requestor pays regime.  As an alternative, we think that the rules should include a presumption that the requestor pays for certain types of unduly burdensome, or otherwise unfair, discovery.  While such discovery might nonetheless be “proportionate,” were it to uncover something significant, these types of discovery are expensive and not particularly likely to produce evidence usable at trial.

Here are some examples of discovery that we have encountered that we think deserve to be presumptively discoverable only at the requestor’s expense – there are undoubtedly more:

  • Discovery into a defendant’s overseas activities, particularly if the documents are not in English (Bard IVC and Benicar both involved this kind of discovery);
  • Discovery into information independently gathered by the defendant for purposes of the litigation, excepting witness statements, and other items specified by the rules as peculiarly relevant (that’s McClurg);
  • Discovery into products manufactured by defendants other than those used by plaintiffs;
  • Discovery into product risks other than those suffered by plaintiffs;
  • Discovery into information in the possession of third parties, including government agencies;
  • Discovery into time periods where recovery is barred by relevant statutes of limitations;
  • Discovery into post-litigation information, after the alleged conduct has ceased;
  • Subjects of Rule 30(b)(6) depositions where the entity faced with deposition has no available percipient witnesses, and any witness would only have reviewed the same documents available to the deposing party;
  • ESI discovery into information located on inactive legacy/obsolete computer systems; and
  • Other similarly burdensome discovery, not of a type likely to produce significant evidentiary benefit, as determined by research commissioned by the Federal Judicial Center.

None of this kind of information is ordinarily essential to the hypothetical impecunious plaintiffs who would otherwise be shut out of court by having to pay for what are almost always expensive wild goose chases.

And if one of these categories turns out to be of particular importance in a given lawsuit, the requestor pays directive is only presumptive.  The party requesting the discovery would be able to go to the judge – either before or after the discovery takes place − and explain why a category of discovery, presumptively disfavored under the new regime, should be exempted from the requestor pays rule on the facts of the case in question.  Likewise, if the requestor is able to overcome the presumption beforehand, and the supposedly important discovery turns out to be a wild goose chase anyway, then the producer should be entitled to file a motion to shift those costs back to the requestor.

Implementing across-the-board requestor pays is a long shot right now, and such a dramatic change in the system could well have unintended and unforeseeable litigation consequences.  We think our proposal is not only a way to discourage types of discovery that are peculiarly prone to abuse, but might also be a way of trying out requestor pays on a smaller scale to see whether it is indeed a desirable change to the system generally.

If anybody out there is interested in this idea, have at it. Unlike discovery, our blogging is free to all readers.

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims.  Recent cases finding preemption of design defect claims due to the need for FDA pre-approval of “major” or “moderate” design changes (basically, anything that could be causal in a product liability lawsuit) include:  Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir. 2015); Young v. Bristol-Myers Squibb Co., 2017 WL 706320, at *5 (N.D. Miss. Feb. 22, 2017); Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449, at *12 (S.D.N.Y. Dec. 23, 2016); Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1364 (N.D. Ga. 2016); Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826, 832-34 (W.D. Tenn. 2016); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 320-22 (D. Conn. 2016) (OTC drug); Barcal v. EMD Serono, Inc., 2016 WL 1086028, at *4 (N.D. Ala. March 21, 2016); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035, 1040-41 (S.D. Ohio 2015); Trahan v. Sandoz, Inc., No. 3:13-CV-350-J-34MCR, 2015 WL 2365502, at *6 (M.D. Fla. March 26, 2015).

We don’t expect the other side just to sit idly by and watch their design defect claims get washed away by a preemptive deluge, and they haven’t. To counter preemptive FDA-pre approval design requirements, they’ve conjured up the idea of a “pre-approval” design defect.

What the heck is that, you ask?  Well, since preemption depends on the regulatory requirement to get FDA approval for any design change that could affect product safety, these cockamamie claims try to change the time-line – targeting the design as it stood before the drug was submitted to the FDA in the first place.  Since way back when, the prospective NDA holder could have chosen to submit some different molecule to the FDA, plaintiffs claim that the failure to do that was a “design defect.”  That is, they contend the drug was defectively designed before it could ever legally be produced commercially.

Got it?

Thankfully, this “pre-approval” defect concept hasn’t done all that well, even as a matter of preemption. In Yates the Sixth Circuit, the first appellate court to pass on such a claim, accurately rejected it as another variant of a preempted claim that the defendant should never have sold its product.

In contending that defendants’ pre-approval duty would have resulted in a [product] with a different formulation, [plaintiff] essentially argues that defendants should never have sold the FDA-approved formulation of [their drug] in the first place.  We reject this never-start selling rationale for the same reasons the Supreme Court in Bartlett rejected the stop-selling rationale of the First Circuit.

808 F.3d at 800; accord Utts, 2016 WL 7429449, at *11; Brazil, 196 F. Supp.3d at 1364 (subjecting pre-approval design defect claims for preemption for similar reasons.

However, a few recent cases from Fifth Circuit turf have let pre-approval design defect claims escape preemption.  See In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1395312, at *3 (E.D. La. Apr. 13, 2017) (“Louisiana law imposes a duty on all manufacturers to consider feasible, alternative designs. . . .  Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval.”) (following Guidry v. Janssen Pharmaceuticals, Inc., 206 F. Supp.3d 1187, 1206-97 (E.D. La. 2016)); see also Young v. Bristol-Myers Squibb Co., 2017 WL 706320, at *8 (N.D. Miss. Feb. 22, 2017) (“there is no conflict between [plaintiff’s] pre-approval theory and the defendants’ federal law duties”) (also following Guidry).

We, of course, think Yates nailed it on preemption – any common-law claim, the result of which would be a jury finding that an FDA-approved product design should never have been sold, is a stop-selling claim barred by Mensing/Bartlett.  The FDA determines what products may be marketed, not individual juries misled by reptile-minded plaintiffs’ lawyers.

But this post isn’t about that – it is not another defense of preemption.  Another thing Yates had to say about pre-approval design defect claims was:

[Plaintiff’s] argument regarding defendants’ pre-approval duty is too attenuated.  To imagine such a pre-approval duty exists, we would have to speculate that had defendants designed [the drug] differently, the FDA would have approved the alternate design.  Next, we would have to assume that [plaintiff] would have selected this [hypothetical product].  Further yet, we would have to suppose that this alternate design would not have caused [plaintiff’s injuries].  This is several steps too far.  Even if New York law requires defendants to produce and market a different design, the ultimate availability to [plaintiff] is contingent upon whether the FDA would approve the alternate design in the first place.

808 F.3d at 299.  Thus, the Sixth Circuit was “unable to conceive of any coherent pre-approval duty that defendants would have owed to [plaintiff] when it was developing” the product.  Id. at 300.  See also Young, 2017 WL 706320, at *8 (“the parties have not argued whether Mississippi law recognizes a pre-approval claim, and the Court does not reach the issue”).

The reason that Yates (and, apparently, Young) was “unable to conceive of” a state law pre-approval duty is because such duties do not exist.  Design defects under Restatement (Second) of Torts §402A (1965), do not suffer from the “attenuation”/”speculation” problem identified in Yates because §402A is limited to products that are defective at sale.  “The rule stated in this Section applies only where the product is, at the time it leaves the seller’s hands, in a condition . . . which will be unreasonably dangerous” to the ultimate consumer.  Restatement (Second) of Torts § 402A, comment g (1965).

In the Third Restatement, this time in the black letter, rather than the comments, all “categories of product defect” are likewise determined “at the time of sale or distribution.”  Restatement (Third) of Torts, Products Liability §2 (1998).  The comments reinforce this view.  “[F]or the liability system to be fair and efficient, the balancing of risks and benefits in judging product design and marketing must be done in light of the knowledge of risks and risk-avoidance techniques reasonably attainable at the time of distribution.”  Id., comment a.  “[T]he plaintiff must prove that such a reasonable alternative was, or reasonably could have been, available at time of sale or distribution.” Id. comment c.  Similarly the black letter of Restatement Third §6(b), specifically applicable to prescription medical products, expressly measured defectiveness – including design defect, to the extent allowed at all − “at the time of sale or other distribution.”

Statutory product liability schemes are generally similar to the common law stated in the Restatements with respect to when defectiveness is measured.  Since both Xarelto and Guidry (on which it almost exclusively relied) are from Louisiana, we looked up the equivalent provision of the Louisiana Product Liability Act, which for design defects provides:

A product is unreasonably dangerous in design if, at the time the product left its manufacturer’s control:  (1) There existed an alternative design for the product that was capable of preventing the claimant’s damage. . . .

La. Stat. Ann. §9:2800.56 (emphasis added).  Thus, under Louisiana law, an available alternative design must exist “at the time the product left its manufacturer’s control.”  E.g., Reynolds v. Bordelon, 172 So. 3d 607, 614 (La. 2015) (“the plaintiff was first required to show an alternative design for the [product] existed at the time it left [defendant’s] control”); Roman v. Western Manufacturing, Inc., 691 F.3d 686, 700–01 (5th Cir. 2012) (“the statute required [plaintiff] to prove (i) that an alternative design existed at the time [defendant] manufactured the [product]”)  (applying Louisiana law).

Thus, quite apart from preemption, there is no common-law claim for a product that became defective at some time – years, perhaps decades, before the product itself was sold – when the design was first submitted to a government regulator like the FDA.  This essentially universal common-law requirement exists, as the Restatement Third discussed, to ensure that defendants are judged by the state of the art existing at the time of manufacture, not some other time way later, or presumably way earlier (although we suspect that the Restatements’ drafters were, like the court in Yates, “unable to conceive of” something as bizarre as a purported duty to redesign a product years before it had ever been sold to anyone).

In order to avoid this result, Guidry was forced to ignore the express terms of the Louisiana statute – “at the time the product left its manufacturer’s control.”  Contrary to what the Louisiana legislature had mandated, Guidry replaced “product” with “design” – specifically “chemical composition”:

Defective design claims are supposedly preempted because the drug manufacturer loses control to alter the chemical composition of the drug once the FDA approves it.  Application of the defendants’ preemption theory necessarily entails that the drug “leaves the manufacturer’s control” when the FDA approves it, not when it is sold to consumers.  Consequently, the “unreasonably dangerous” analysis in the defective design context necessarily occurs pre-FDA approval (the only period in which the drug manufacturer has control over the drug’s design).

206 F. Supp.3d at 1208.  As a regulatory matter, that proposition is simply false.  A manufacturer still has “control” of product design.  It can file what’s called a “supplement” to its NDA at any time to change a design.  However, the FDA gets to evaluate the supplement first, before it can go into effect – and that triggers preemption.

But for present purposes, note how Guidry put the rabbit in the hat.  It truncated its quotation of the statute – starting just after the legislature’s operative term “the product.”  The LPLA even defines “product”:

(3) “Product” means a corporeal movable that is manufactured for placement into trade or commerce, including a product that forms a component part of or that is subsequently incorporated into another product or an immovable.

La. Stat. Ann. §9:2800.53(3).  A “product” is thus “corporeal” – it is not merely its “design,” nor is it just its “chemical composition.”  Guidry never acknowledges this statutory definition.  “Corporeal” nowhere appears in that extremely long opinion.

Thus Guidry conveniently omitted what the legislature in fact enacted.  Only by substituting “design”/“chemical composition” for “product” as defined by the LPLA could Guidry advance to its next remarkable proposition:  that in the case of all FDA-approved products, Louisiana’s (or presumably some other state’s) “’unreasonably dangerous’ analysis in the defective design context necessarily occurs pre-FDA approval.”  206 F. Supp.3d at 1208 (emphasis added).

“Necessarily”?  Come on, now.

What does Guidry cite for this remarkable proposition that juries must determine the defectiveness of an FDA-approved design at a point before it was ever approved by the FDA – that is, many years before it was ever used by any plaintiff?

Nothing at all.  Zilch.  Not a single statute.  Not a single case.  Guidry made it up.

As we have stated many times before, for a federal court to invent new state law, expanding liability where the state’s courts and lawmakers have not gone, is a serious violation of federalism under Erie v. Tompkins.  “As always, in conducting [an Erie] inquiry our task is ‘to predict state law, not to create or modify it’ − that is, we are ‘to apply existing Louisiana law, not to adopt innovative theories for the state.’”  Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002) (quoting United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986)).  As the en banc Fifth Circuit explained thirty years ago:

As a federal court, it is not for us to adopt innovative theories of state law, but simply to apply that law as it currently exists. . . .  We are emphatically not permitted to do merely what we think best; we must do that which we think the [state’s] Supreme Court would deem best.  Finally, under Erie we cannot skirt the clear import of state decisional law solely because the result is harsh.

Jackson v. Johns-Manville Sales Corp., 781 F.2d 394, 397 (5th Cir. 1986) (en banc) (citations and quotation marks omitted), overruled in part on other grounds, Salve Regina College v. Russell, 499 U.S. 225 (1991) (rejecting appellate deference to in-state district court Erie predictions).

As Jackson “emphatically” held, “under Erie we cannot skirt the clear import of state decisional law solely because the result is harsh.”  That’s exactly where Guidry erred.  Before mangling Louisiana’s statutory defect-at-sale requirement, Guidry complained about a harsh result:

The Court first notes that, if it finds the plaintiff’s defective design claim is preempted, even under a pre-FDA approval theory, the result is that a Louisiana plaintiff can never bring a defective design claim against a drug manufacturer. . . .   And no federal remedy exists either. . . .  As a result, if the defendants’ preemption argument prevails, Louisiana plaintiffs will have no remedy against a drug manufacturer for a defect in a drug’s design.

206 F. Supp. at 1206-07 (Levine quotation omitted) (emphasis original).  Thus, the Erie error in Guidry is no accident.  The decision deliberately flouted the law to avoid a result it didn’t like.  For the hundredth time we’ll say, strange things happen in tort preemption cases.  In Guidry, that strangeness was the invention out of whole cloth of a novel “pre-approval” design defect that is flatly inconsistent with Louisiana’s defect-at-sale requrement for design defects.

Not only that, but the contortions that this novel idea of “pre-approval” design defects require of the well-established defect-at-sale requirement (both statutory and common-law) will have unintended consequences.  The LPLA, similarly to the common-law as stated in the Second and Third Restatements, imposes the exact same “at the time the product left its manufacturer’s control” limit on warning defects.  La. Stat. Ann. §9:280.57(A).  Warnings are FDA approved, too, so if defect analysis “necessarily occurs,” Guidry, 206 F. Supp.3d at 1208, prior to FDA approval, consider whether a plaintiff should be able to “claim[] that the defendants intentionally concealed or downplayed the seriousness and likelihood of these adverse side effects” during post-approval promotional activities.  Id. at 1199.  Guidry found nothing amiss with the warning claims, id., but unless we are dealing with a “heads plaintiffs win; tails defendants lose” situation, the defect at sale requirement – whether statutory or common-law – has to run from the same date for both warning and design claims.  And on warning claims, that absurdly early date favors defendants.

In sum – forgetting about preemption − the notion of a “pre-approval” design defect is a non-starter under state law, and rightly so. The legal requirement that a product be defective at the time of distribution is a bedrock product liability principle in all states, and as just discussed, that requirement is utterly incompatible with plaintiffs’ new defect theory that pushes the defect analysis earlier by years if not decades.  This novel theory is being asserted solely to avoid the FDA-pre-approval trigger for preemption first recognized in Wyeth v. Levine, 555 U.S. 555 (2009).  But federal courts under Erie are not supposed to make up new state law just because Levine’s preemption analysis happens to require broad preemption in design defect cases.

This guest post by Andrew C. Bernasconi, of Counsel at Reed Smith, is about a hopeful development in a False Claims Act case we’ve already blogged about once.  The previous post queried, what happens when a FCA relator, blinded by the dollar signs in his/her eyes, resorts to questionable means to gin up “facts” that substitute for the personal knowledge that the statute assumes the relator has, but in this case did not?

This time, the chickens came home to roost.  Read and enjoy.

As always, our guest bloggers are 100% responsible for their insights – entitled to all the credit (and any blame – maybe for the asides about the greatest Super Bowl ever played).

*********

“I’m sure you all share my view when I say, ‘Go, Patriots.’”

These words from Boston-based U.S. Judge Dennis Saylor IV of the District of Massachusetts, when closing out a motion to dismiss hearing just a few weeks prior to Super Bowl 51, undoubtedly intended to reference the mighty New England Patriots and their impending appearance in what would become a historic win over the outmatched Atlanta Falcons.

Judge Saylor’s recent decision dismissing a qui tam False Claims Act (FCA) case, based on what he determined were deceit and ethical violations by plaintiff’s counsel, calls to mind the words of a different kind of patriot, Chief Justice John Marshall:

“Let the end be legitimate, let it be within the scope of the constitution, and all means which are appropriate, which are plainly adapted to that end, which are not prohibited, but consist with the letter and spirit of the constitution, are constitutional.”

McCulloch v. Maryland 17 U.S. 316, 421 (1819) (interpreting the Necessary and Proper Clause).  While the context of Judge Saylor’s recent decision differs dramatically from the issues considered by Justice Marshall in 1819, the focus of both on just ends and means provides a common theme.

We first blogged back in November about the case of U.S. ex rel Leysock v. Forest Laboratories LLC, where we explained that the defendant filed a motion to dismiss the qui tam relator’s False Claims Act allegations that were premised on false claims tied to alleged off-label marketing of a drug indicated to treat Alzheimer’s Disease.  Although the court denied a prior motion to dismiss relator’s complaint, finding that it contained sufficient particularity to satisfy Rule 9(b)’s heightened pleading standard, the defendant took the unusual step of filing a subsequent motion to dismiss while discovery was ongoing.  In the subsequent motion to dismiss, the defendant relied on discovery showing that relator’s counsel had hired a physician as an “investigator” to persuade other unwitting physicians, under the guise of conducting a “research study,” to provide confidential patient medical records for what (unknown to these other physicians) turned out to be for litigation purposes.  Relator’s counsel, of course, vigorously opposed the motion and contended that they had not engaged in any wrongdoing.

On April 28, 2017, Judge Saylor issued his opinion (copy here), in which he granted the defendant’s motion and dismissed the relator’s complaint. Leysock, No. 12-11354-FDS, slip op, (D. Mass. Apr. 28, 2017).  In a well-reasoned decision, Judge Saylor found there was “no dispute” that relator’s counsel had engaged in a scheme that involved “an elaborate series of falsehoods, misrepresentation, and deceptive conduct,” including:  (1) designing an investigation to obtain confidential information from physicians under the guise of a medical research study and (2) employing a physician as their agent to tell other physicians that records supplied by physicians to facilitate the “study” would remain confidential.  Slip op. at 14.

According to the court, this conduct violated ethical rules prohibiting knowing false statements of material fact made to third persons (Mass. R. Prof. Conduct 4.1(a)), and engaging in conduct involving dishonesty, fraud, deceit, or misrepresentation (Mass. R. Prof. Conduct 8.4(c)).  Slip op. at 15.  While acknowledging limited exceptions to these rules, where counsel may employ deception in investigations (e.g., using “discrimination testers” or investigators to uncover evidence of racial discrimination), the court concluded that the extreme conduct authorized by relator’s counsel – obtaining the confidential health information of innocent and unsuspecting patients under false pretenses from innocent physicians, and then breaching the disclosing-physicians’ trust by publishing confidential patient information in a lawsuit – easily distinguished this case from those where counsel’s deception was permissible.  Id. at 15-21.  [Editor’s note:  As a fan of the Patriots, Judge Saylor was well-positioned to evaluate whether sleazy schemes involved permissible deception or something worse.  Take that how you want, good reader.]

The court also rejected the argument by relator’s counsel that the ends justified the means.  Slip. op. at 21-23.  Relator’s counsel essentially argued that if relators are not permitted to use the type of deception at issue here, then it would be “difficult, if not impossible” for qui tam relators to satisfy the Rule 9(b) particularity requirement applicable to FCA cases.  Id. at 22.

This is where the concerns we mentioned in our earlier blog post, about opportunistic plaintiffs’ attorneys who manufacture cases lacking legitimate factual bases in hopes of obtaining financial windfalls, come to mind.  As Judge Saylor recognized, the FCA is designed to encourage claims by relators with actual, personal knowledge of fraudulent conduct, slip. op. at 22-23 – not by those who must resort to such deceptive tactics, like now-adjudicated unethical intrusions into the sanctity of the physician-patient relationship, as their only basis to prepare a complaint with sufficient information to survive a Rule 9(b) motion to dismiss.  A proper whistleblower has knowledge.  Different labels apply to those who mislead people for their own gain.

Employing the court’s inherent powers, Judge Saylor removed from relator’s complaint all information derived from the unethical investigation, and evaluated whether the remaining allegations could satisfy Rule 9(b).  They could not.  In other words, relator’s complaint had survived the defendant’s initial motion to dismiss only because of the information obtained from the unethical investigation.  Slip. op. at 23-27.  As a sanction, the court dismissed the relator’s complaint with prejudice to the relator (and without prejudice as to the United States, the real party in interest in qui tam cases).  Id. at 27.  But for a benevolent fan of patriots and Patriots (is there any other kind?), who determined that individual sanctions against relator’s attorneys were “not appropriate in this proceeding,” slip. op. at 24, there could have been more severe monetary or other sanctions for the use of deceptive or fraudulent means to advance that case.

As Judge Saylor held, the ends did not justify the unethical means employed by relator’s counsel.  Thus, for the defendant, justice finally (albeit belatedly) prevailed in this case.  If only relator’s counsel had been fans of patriots like Chief Justice Marshall, and employed only “means which are appropriate” to reach legitimate ends, this entire situation could have been avoided.

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 week, the United States Supreme Court also heard argument in the “other” litigation tourist personal jurisdiction case pending before it – BNSF Railway Co. v. Tyrell, No. 16-405 (U.S. argued April 25, 2017) (“BNSF”) (link to transcript).  While BNSF mostly concerned statutory issues under the Federal Employees Liability Act (“FELA”), it does involve a personal jurisdiction question related to litigation tourism.  The Court considered it sufficiently related to BMS that it scheduled oral argument back-to-back with BMS (see here for last week’s post on the BMS oral argument).  Because we’re interested in personal jurisdiction as a constitutional check on the litigation tourism phenomenon, we’ve also taken a look at what went down during the BNSF argument.

Once again the United States government appeared as amicus supporting the defense.  Tr. at 1, 12-18.  It appears to us that the plaintiff in BNSF had an even tougher time before the Court than the plaintiffs in BMS – and that’s saying something.  Another perhaps notable aspect of the oral argument was that the Justices, particularly as to the defense and defense-supporting United States arguments, were a lot less engaged than in BMS.  These counsel actually argued for entire pages of transcript without being interrupted by questions.  Indeed, the defendant’s rebuttal argument in BNSF drew no questions at all, and thus the defense used only a fraction of its reserved time.  Id. at 43-44.  The entire BNSF transcript was 44 pages – 20 pages (almost 1/3) shorter than BMS.

Justice Sotomayor, the sole dissenter from the personal jurisdiction rationale in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), seemed most animated when discussing an issue that was not even before the Court in BNSF – nonconsensual “consent” to general jurisdiction by virtue of mere registration to do business in a state.  Tr. at 4-6.  We’ve written on this Bauman dodge before, and were somewhat perplexed to see it arise in a United States Supreme Court argument – until we heard from Chief Justice Roberts:  “[T]he issue . . . was not addressed below and is not before us.”  Id. at 6.  Whew!   We thought we’d missed something significant.

The heart of the plaintiff’s argument was that FELA, in provisions that spoke only to venue (it’s a peculiar statute in that it allows plaintiffs to choose to bring federal claims in state court), somehow also authorized an expanded form of personal jurisdiction that permitted litigation tourism.  We gathered from the argument that the plaintiff was a North Dakota resident claiming workplace injuries in Washington State, id. at 40 – so of course, he sued the defendant in Montana, which was neither the defendant’s principal place of business nor its state of incorporation.

Since BNSF was a statutory case, the Court was interested in whether Congress could authorize litigation tourism by statute.  The defense response was that Congress could authorize nationwide service of process allowing expanded federal court jurisdiction, should it choose to create a federal cause of action, but that Due Process would render problematic any attempt to expand state-court personal jurisdiction to accommodate litigation tourists.  Tr. at 8.  The fundamental problem with the plaintiff’s statutory argument was put most succinctly by the Assistant Solicitor General arguing for the government:

[T]here’s a strong Federal interest in not having words that don’t say anything about service of process being interpreted to in fact say something about service of process[.  W]e have a first sentence that refers to venue only in Federal courts, and then a second sentence referring to State courts.  But all it does is to clarify that there’s concurrent jurisdiction in the State courts.  And we just don’t see how you can get to conferral of personal jurisdiction in the State courts.

Tr. at 13.

Nobody, not even Justice Sotomayor, the justice most sympathetic to litigation tourism, seemed comfortable with that argument. The statutory argument was criticized by:

Chief Justice Roberts:  Tr. at 23-24, 29-30.

Justice Ginsburg:  Id. at 19-20, 31, 40.

Justice Alito:  Id. at 25-26.

Justice Sotomayor never appeared inclined to support plaintiff’s statutory argument in BNSF.  Rather, she suggested that “we could just say it [FELA §56] doesn’t apply to State courts,” id. at 37 – which was precisely where the plaintiff had sued.

So, aside from the seemingly doomed argument that FELA should be interpreted to say what it didn’t say – and apparently what no federal statute has ever provided – about personal jurisdiction/service of process, what did the argument have to say about Bauman and Due Process?

The government argued that “[i]f the Court’s decisions in Goodyear and Daimler mean anything,” it “just can’t be correct” that “a company like BNSF is subject to general personal jurisdiction in 28 or more States.”  Tr. at 14.  Justice Breyer did not “really see the difference” between Bauman and BNSF.  Id. at 38-39.  Justice Kagan tried to limit the plaintiff’s non-statutory personal jurisdiction argument to railroads being “so unique that they should be subject to general jurisdiction everywhere.”  Id. at 32.  After some hemming and hawing plaintiff agreed, id. at 34, but plaintiff seemed even more interested in a fact-specific, Montana-only exercise of Bauman personal jurisdiction.  Id. at 33, 36 (arguing that the defendant was “at home” because it had Montana “lobbyists”).  Unlike the plaintiffs in BMS, the plaintiff in BNSF was never so bold as to call for overruling Bauman.

Finally, when pushed by Justice Gorsuch, plaintiff abandoned altogether the argument that Bauman be limited to “foreign corporations.”  Id. at 41-42.

We’ve been burned making Supreme Court predictions before, but we frankly can’t see a path to affirmance for the plaintiff in BNSF.  It could well be a unanimous reversal of the Montana Supreme Court, albeit with at least one concurrence offering a different rationale (similar to Bauman).

As our loyal readers know, the Reed Smith side of the blog has been very interested in 3D printing, and particularly in its product liability implications. We recently shared with you the most comprehensive law review article to date on this subject (here) – authored by Bexis and Reed Smith associate (and sometimes guest blogger) Matt Jacobson – and we have posted about 3D printing here, here, here and here.

If you’ve found yourself equally fascinated by this new technology – and its potential impact on life sciences product liability – we’re pleased to announce that Bexis and Matt will be presenting a free 60-minute webinar on “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8 at 12 p.m. ET.

This webinar is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy.

The program is free and open to anyone interested in tuning in, but you do have to sign up, which you can do here.

 

 

The other day, the United States Supreme Court heard argument in Bristol-Myers Squibb Co. v. Superior Court, No. 16-466 (U.S. argued April 25, 2017) (“BMS”) (link to transcript).  We’ve blogged many times about the issues in Bristol-Myers-Squibb.  In BMS, the United States government, as amicus curiae, appeared in support of the defense position that personal jurisdiction did not be extend to suits in state courts brought by non-resident plaintiffs against non-resident defendants.

Here’s a description of what went down.

Justice Sotomayor, who had been the sole dissenter from the personal jurisdiction rationale in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), was seemingly hostile to the defense position.  Her initial questioning suggested that not allowing an in-state resident’s successful assertion of personal jurisdiction to supply jurisdiction for out-of-state residents who simply took the same product in their home states somehow destroyed pendent jurisdiction.  Tr. at 5-6.  As we’ve discussed before, pendent jurisdiction typically applies to consolidated claims, not consolidated lawsuits.

Justice Ginsburg (author of Bauman) rode to the rescue, pointing out that general jurisdiction, and perhaps specific jurisdiction where there was a more substantial link than just using a product, would allow plaintiffs from across the country to sue in one place.  Id. at 7.

The defense position (articulated in response to a question from Justice Kagan) was that federalism, predictability, and fairness all weighed against allowing anybody and everybody who took a product to sue in a single state with no connection to the litigation beyond the presence of other, resident plaintiffs. Fairness involved extending state-specific principles – the defense mentioned choice of law, procedural standards, such as for summary judgment, expert admissibility (Daubert), and evidentiary issues – to plaintiffs from other states who had no reason to benefit from California’s peculiarly pro-plaintiff rules.  There was also whether it was fair to have 600+ separate trials in California involving non-residents.  Id. at 10-12.  Fairness, in the Due Process context, does not allow every plaintiff in the country to go forum shopping for the “least common denominator.”  Id. at 14.

There was also the issue of predictability, as discussed in Bauman.  A company incorporating in a particular state, or having a principal place of business in a particular state, such as BMS in New Jersey, expects to be sued there by anyone with a claim.  That is not the case in every other state in the country.  Id. at 15-16.

Justice Breyer asked whether Due Process principles in personal jurisdiction could affect MDL practice and class actions. The response was that federal jurisdictional issues are different, and where federal issues are involved, the minimum contacts analysis at the federal level controls, rather than rivalry between the states, with one state potentially offering more to out-of-state litigants than those litigants’ home states.  Id. at 17-19.  Justice Ginsburg wondered if Congress could expand MDL practice to include trials, and heard that MDL practice could be reserved until that change happened, and the plaintiffs’ anybody-in-any-state could nonetheless fail Due Process, as it should.  Id. at 19-20.

That concluded the defendant’s principal argument, with only Justices Ginsburg, Kennedy, Breyer, Kagan, and Sotomayor being heard from.

Then the United States argued.

The government’s position is familiar to us – because it’s always been our position – that a state cannot recreate the same “exorbitant” and “grasping” scope of jurisdiction under the “specific” rubric that Bauman rejected under the “general” rubric as incompatible with Due Process.  Neither other in-state plaintiffs nor other in-state defendants matter, as jurisdiction is personal to each party.  Tr. at 20.  Justice Ginsburg wanted to know about a California co-defendant.  Unless they were conspiring, jurisdiction is personal to each defendant.  Id. at 21. Justice Kennedy wondered if California plaintiffs could skirt due process by trying to join an out-of-state defendant to an earlier-filed suit against a California defendant by claiming “necessary party” status.  Essentially the same answer.  Id. at 22-23.

In response to Justice Sotomayor, the government stated that, given the realities of the federal system, with jurisdiction over state-law claims determined for states individually, mass torts asserting state-law claims may well not be amenable to a single aggregated forum with all plaintiffs able to sue all defendants. Not so for federal criminal prosecutions.  Id. at 23-25.

The mention of federalism brought Justice Gorsuch forward.  He wanted to know about the implications of the California rationale on other states administering their own procedures for resident tort plaintiffs.  The obvious answer was that all states have equal interest in adjudicating conduct occurring within their borders (such as drug sales and marketing).  Id. at 25-26. Justice Kagan wanted to know whether the residence of the plaintiff or the residence of the defendant was the concern.  The government’s counsel responded that either of those states had a strong interest sufficient to support jurisdiction, with the implication that other states do not.  Id. at 26.

Justice Kagan then made an important point – that the interest of the plaintiff’s home state becomes “attenuated” where the plaintiff has abandoned his/her own state and gone elsewhere – it was “weak to say that the State has a very strong interest in protecting its own citizen that doesn’t want to be there.”  Id.  Justice Kennedy added the flip side of federalism, “State A has a very strong interest in confining State B to State B’s territorial….”  The flow was interrupted by the government’s quick agreement.  According to the Justice, states are limited territorially, whereas the federal government is not.  Id. at 27.

Justice Breyer then had a tall order − asking for the government’s “solution to mass torts.” Id. at 28.  The government’s position was that state-law mass torts can be brought according to the limits of general jurisdiction, as can MDLs.  If a “particular” mass tort is not being adequately handled by state law, Congress could step in.  Id.  Justice Ginsburg asked if the government was arguing that Congress could “create a nationwide claim.” Id. at 29.  The government agreed that Congress had that prerogative in the mass tort field.

Justice Alito asked the final question of the government, asking how it would “phrase the rule” being sought.  The government’s response:

[T]he Court could simply say in this case that for purposes of specific jurisdiction, when we’re talking about conduct that arises out of . . . activity within the forum, there has to be something that’s connected to the claim, some causal connection between the individual claim . . . and the forum, the parties in the forum.

Tr. at 30.

Then it was time for the plaintiffs to argue.

Plaintiffs asserted four bases for personal jurisdiction: (1) the defendant exploited the California market; (2) litigation in California did not create significant additional burdens on the defendant, which would be defending litigation there in any event; (3) a governmental interest in aggregating mass torts.  Counsel didn’t get to four.  Id. at 30-31.

The idea of a governmental interest in aggregating mass torts in a single state stuck in a lot of craws. Justice Kennedy wanted to know which state had that interest.  Justice Ginsburg opined that single-forum aggregation was “impossible” as long as plaintiffs get to choose where to sue.  Id. at 31-32.

Actually, plaintiffs did get to four, only several pages later. The fourth being the presence of a California defendant as an alleged nationwide distributor.  Id. at 32-33.

However, as Justice Kagan pointed out, the California distributor was not common to all plaintiffs. Plaintiffs had to admit that it was “impossible” to trace the distribution of any given individual’s pills.  Id. at 33.  That meant that the involvement of a California distributor was not a case-specific fact, but only of general significance.

Plaintiffs tried to respond to Justice Ginsburg, arguing for an interest in “allowing the litigation to be centralized,” which they asserted was preferable to litigation in multiple states.  Justice Kennedy found that statement to be “a very patronizing view of federalism” that ranked some states (such as California) over others.  “[T]hat’s not the idea of the Federal system.  The Federal system says that States are limited.” Id. at 34.  Chief Justice Roberts, and Justices Kennedy and Ginsburg agreed that plaintiffs’ reliance on the Keeton libel case was not well taken because that case involved in-state injury, and even then was “peculiar to” or “sui generis” in libel cases.” Id. at 34-36.

Interrupting plaintiffs’ explanation of why a libel rule was pertinent, Justice Kagan looked to the other side of the “v.”

Well, how about the interest of the State that Bristol-Myers resides in? In other words, they might have an interest in not having their citizens hailed [sic] into court against their will in another part of the country.

Tr. at 37. Plaintiffs disagreed and attacked the defendant’s suggestion that plaintiffs not wanting to sue in their own states could bring suit in New Jersey.

That answer led Justice Breyer to expound on the differences between general and specific jurisdiction, whereby defendants could be sued in states where they actually caused the plaintiff’s harm, but not in states where they did not. Jurisdiction thus depended on which states had a “special federalism interest” – a defendant’s “home” state having such an interest.  Id. at 37-38.

Plaintiffs responded that New Jersey as a forum meant that plaintiffs there were not suing in their home states, which overlooked the fact that they always could sue in their home states.  Plaintiffs were more interested, however, in highlighting their joinder of a California defendant.  Justice Gorsuch wasn’t impressed, finding that to be too “fact-specific” when the question before the Court was “whether we have some sort of causation requirement or permit this sliding scale business that California engages in.” Id. at 38.  He thought plaintiffs were attempting to “collapse” the prongs of “purposeful availment” and “fairness,” removing all the “bite” from the former – which “suggest[ed] some problem doctrinally” with the plaintiffs’ position. Id. at 39.

Plaintiffs rejected any causation requirement, asserting that they only needed to show “continuous and systematic exploitation” of the market and that each claim be “on the same operative facts.” Id. Justice Kagan was skeptical:

[T]hat’s like saying . . . that the claim relates to another claim that relates to contacts with the forum. . . .  I’m missing what the relationship is between an Ohio plaintiff’s claim and the defendant’s contacts with the forum that doesn’t go through another claim.

Tr. at 39. Justice Kagan thought that specific personal jurisdiction involved claims that arose from the defendant’s contacts with the state in that particular case, not on some general basis.

Plaintiff’s response that “the relevant contact is the nationwide activity” of marketing the drug.  Id. at 40.  Because the activity was national, any state in the country, such as California, could equally adjudicate the “same conduct.”  Id. at 41.  That, and don’t forget the California defendant that plaintiffs decided to sue.  If plaintiffs can find an in-state defendant to sue in whatever jurisdiction they choose, that state can assume jurisdiction over any plaintiff’s similar claim, wherever in the country that plaintiff may be located.  Id. at 41-42.

Justice Ginsburg returned to the issue of class actions – could this be a class action, and if so where could it be brought. Plaintiffs’ answer was California, because of the California defendant.  Id. at 42-43.

Plaintiffs then tried to make some hay about there being a “special master” for cases across the country.  Id. at 43-44.  However, they appear to concede that this “master” was “best regarded as Federal,” so that didn’t help much with their state-law arguments.  Id. at 44.  That concession led Justice Breyer to suggest that the “answer” to this “terrible problem for mass torts” is to “[b]ring your case in Federal court.”  Id. at 44-45.  “[T]he solution to this great mass tort problem is that’s what Federal courts are for.”  Id. at 45.  However, as Justice Ginsburg pointed out “there’s no complete diversity” since plaintiffs saw fit to join a California defendant.  Id. at 46.  However, plaintiffs “could redesign the case” to fix that problem.  Id.

Plaintiffs, of course don’t want to be in federal court, and did what they did in BMS specifically to avoid that.  So they effectively abandoned their efficiency arguments when federal court was the alternative and argued that just because there was a more efficient way didn’t mean their way violated Due Process.  “[Y]es, there are other ways to do it, but that doesn’t make the way we are doing it unconstitutional.  What the Court has talked about here is minimum due process.”  Id. at 47.

Chief Justice Roberts then changed the subject, looking for a “simple” jurisdictional rule.  Id.  A sliding scale, suggested in Plaintiffs’ papers, where some percentage of out-of-state plaintiffs passed muster, whereas a smaller (unstated) percentage would not, would be hard to administer.  Plaintiffs’ response was that everything should be decided “case-by-case” and Due  Process imposed no “categorical rule.”  Id. at 48.  The Chief rejoindered, “but you’re articulating a rule that requires businesses trying to figure out where to do business and plaintiffs where to sue,” so what was the line? Id. Plaintiffs were unable – or unwilling − to give one.  Justice Kagan then took Plaintiffs’ reluctance to its logical conclusion:

[O]n your theory, it could be zero California plaintiffs, because . . . [y]ou told me . . . that an Ohio citizen’s claim arises out of the contacts in California is because the contacts in California are really nationwide contacts. And if that’s so, it’s met regardless of whether there are any California plaintiffs are not.

Tr. at 50. “Right,” Plaintiffs agreed.  Id.

Perhaps sensing that he had gone too far, Plaintiffs’ counsel started to backtrack, but Justice Sotomayor wouldn’t let him.  She asked for Plaintiffs’ definition of “relating to.”  Id. at 52.  Getting the expected definition, which involved only the “same conduct,” without any causation requirement, that led Justice Sotomayor to comment, “[s]o is that a yes to Justice Kagan’s question about it wouldn’t matter if there were no California plaintiffs?”  Id.  Plaintiffs’ response was that the first prong of Due Process (fairness, we think) would be satisfied, but not the reasonableness prong.  Justice Gorsuch followed up:

[If you don’t need a single plaintiff to satisfy the first prong of the due process inquiry, again, what function does that first prong have left to do?  Why doesn’t it all just run into the second fundamental fairness test?

Tr. at 53.  After some word salad, Plaintiffs got to their basic point – they were seeking a redefinition of Due Process – apparently a return to Pennoyer v. Neff, 95 U.S. 714 (1877), so that California could adjudicate claims against any defendant, to the extent that the defendant had property in the state.  Thus, they asked that both Bauman and Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011), be overruled.  Tr. at 53–54.

Notwithstanding these arguments, Plaintiffs denied that they were trying to accomplish through specific jurisdiction what Bauman had – in the middle of the case – eliminated under the rubric of general jurisdiction.  All well and good, Justice Breyer thought, but what is the one-sentence basis for personal jurisdiction in this case?  The answer, “You’re already here on this claim, and there is nothing unfair about having you . . . with respect to another plaintiff, because that plaintiff could quite clearly get you estopped.”  Id. at 56.  Justice Breyer summed it up, “[s]o once I’m here, I can now sue him.”  Id.  Plaintiffs then discussed “nonmutual offensive collateral estoppel.”  Id. at 57.

Chief Justice Roberts did not seem convinced.  “[T]he same thing’s going to happen in every other State.  I don’t see that it increases the efficiency at all.”  Id.  Plaintiffs responded by returning to bootstrap argument – that because we chose to join a California defendant, that gave California a leg up over any other state.  Id. at 58.  After further discussion of MDLs, Plaintiffs finished their argument by asserting their maximalist position − restoring Pennoyer, at least as an alternative basis of jurisdiction:

It doesn’t seem unfair to me to say his clients did almost a billion dollars’ worth of business in the State of California. They have enormous assets that they have placed in the State.  That they could be held liable up to the extent of those assets is not a violation of due process.

Tr. at 60.

In rebuttal, defendant pointed out that joinder of the California defendant was a red herring, since Plaintiffs admitted they could not prove that defendant distributed any particular plaintiff’s medication.  It is “plainly unconstitutional to exert [sic] jurisdiction over one defendant based on the activities of another.”  Id. at 62.  An out-of-state defendant could be liable to actual California residents for any injuries they suffered – for the entire $918 million in sales (Plaintiffs’ “almost one billion”), but those in-state injuries don’t confer jurisdiction in other, distinct cases with different, non-resident plaintiffs.  In response to Justice Sotomayor’s question, the defense clarified that it didn’t matter who distributed any particular pill in California, the defendant’s manufacture of then was what established specific jurisdiction as to in-state residents.

The defense pointed out that, under CAFA, federal jurisdiction was already available.  The reason these claims were in state court was that Plaintiffs deliberately structured them to avoid CAFA, by “filing less than a hundred claims in each action.”  Id. at 63.  So Plaintiffs themselves brought about the inefficiency of which they complain.  Finally, the defendant ended with a plea for “business predictability.”  Id. at 64.

What do we think?  Predictions are always dangerous, particularly if they involve the future.  However, we sensed no groundswell on the Court to overturn decades of personal jurisdiction precedent and return to Pennoyer.  In fact, we don’t think that the lineup will be much different from Bauman – which was an 8-1 decision from 2014.  Eight-1 decisions just aren’t overruled that soon after being decided.  The Plaintiffs’ efficiency arguments are undercut by their original forum-shopping.  Their fairness arguments are undercut by the fact that every plaintiff could sue in his or her home state, or if aggregation were important, where the defendant is “at home.”  The California court’s mid-course correction from general to specific jurisdiction after Bauman was decided does look like a “backdoor” move to avoid that precedent – which Plaintiffs alternatively seek to overrule.  Our gut tells us that the votes are there to reverse, perhaps with a statement like that in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), that Congress can act to federalize mass torts (like it did interstate tort class actions under CAFA) if it so chooses.

In any event, we’ll know if we’re on target – or just all wet – in a couple of months at the most.

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time.  It’s another example of plaintiffs throwing mud against the wall to see if it will stick; anything to divert attention from a weak merits case concerning the injuries actually being claimed.

Sometimes plaintiffs argue that, even though they never encountered a particular risk, it was so severe and downright scary that if they had only been warned about that risk, they wouldn’t have used the product.  Trouble is, while that argument could be causal in a “but for” sense (assuming plaintiffs aren’t lying), it’s not causal in the legal, or proximate, sense.  One of the major tort treatises explains the difference:

More centrally, the injury suffered must be within the class of injury that the warning requirement was meant to avoid.  For example, the plaintiff, if properly warned that asbestos might cause cancer, might have ceased to work around asbestos.  A failure to give such a warning could result in liability if the plaintiff did develop cancer as a result of asbestos exposure.  But the failure to provide such a warning would not result in liability if the plaintiff, not being warned, kept her job and lost a hand in a job-related machine accident.  In that example, failure to warn would be a cause in fact – the plaintiff would have been elsewhere, not working at the machine, if a proper warning had been given – but it is not a proximate legal cause.  It is not, in other words, within the risk that a warning was designed to avoid.

Dan B. Dobbs, The Law of Torts, at 1018 (2001).

Federal appellate decisions similarly reject this sort of “causation” over and over, initially in cases involving non-prescription products.  Most commonly, asbestos plaintiffs have been precluded from introducing evidence of cancer when they had no such injury, or even a significant risk.  See O’Banion v. Owens Corning Fiberglass Corp., 968 F.2d 1011, 1013 (10th Cir. 1992) (“evidence of cancer is so prejudicial that in the absence of expert medical testimony that ‘a reasonable degree of medical certainty’ exists that the plaintiff will develop cancer, such evidence should be excluded”) (applying Oklahoma law); Smith v. A.C. & S, Inc., 843 F.2d 854, 859 (5th Cir. 1988) (cancer evidence in non-cancer case “is highly inflammatory and understandably incites the passions and fears of most reasonable individuals”) (applying Louisiana law); Jackson v. Johns-Manville Sales Corp., 750 F.2d 1314, 1321 (5th Cir. 1985) (same) (applying Mississippi law); In re Related Asbestos Cases, 543 F. Supp. 1152, 1160 (N.D. Cal. 1982) (excluding reference to cancer “in any cases in which the plaintiff has not contracted cancer”).

The same result has occurred in automotive product liability.  For example, in Kane v. Ford Motor Co., 450 F.2d 315 (3d Cir. 1971), the plaintiff started out claiming one type of brake defect in a car, but then shifted to a different defect claim at trial.  The Third Circuit affirmed exclusion of such evidence, because it was “irrelevant to appellant’s theory of the case.”  Id. at 316.  See Fields v. Volkswagen of America, Inc., 555 P.2d 48, 58 (Okla. 1976) (excluding recall where “the defect mentioned in the recall letter is not the defect claimed to have cause the [plaintiff’s injury]”); Johnson v. Ford Motor Co., 988 F.2d 573, 578-80 (5th Cir. 1993) (affirming exclusion of five other incidents that different car models and different claims of mechanical defect); Olson v. Ford Motor Co., 410 F. Supp. 2d 869, 873-75 (D.N.D. 2006) (excluding automotive recalls where the reason for recall differed from plaintiff’s alleged product defect); Jordan v. General Motors Corp., 624 F. Supp. 72, 77 (E.D. La. 1985) (same).

But we’re more interested in prescription medical product liability litigation.

In our sandbox, the New York Court of Appeals rejected failure to warn of risks the plaintiff had not suffered in Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993), where the plaintiff claimed that a drug should have been contraindicated in patients with a history of depression – but personally had no history of depression.  “Since it is undisputed that [plaintiff] had no history of mental depression, we are not concerned with the adequacy of the Contraindications section of the insert.  Id. at 1313. See McFadden v. Haritatos, 448 N.Y.S.2d 79, 81 (N.Y.A.D. 1982) (“Since there was no showing” that plaintiff “had a history of that condition,” the allegedly inadequate warnings “are not applicable”).

Other state appellate courts agree.  A Texas appellate court in Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513 (Tex. App. 2007), entered judgment n.o.v. on a warning claim, where the prescriber knew of the risk that the plaintiff encountered − rejecting allegations of inadequate warnings about diabetes (“[n]othing in the record suggests that [plaintiff] was diabetic”), and several general surgical risks (“[a]ssuming that the general . . . risk factors . . . could form the basis of an appropriate warning, there is no evidence that the lack of such a warning caused [plaintiff’s] injury”).  Id. at 519.

In King v. Danek Medical, Inc., 37 S.W.3d 429 (Tenn. App. 2000), one of Bexis’ Bone Screw cases, the plaintiffs’ expert attempted to opine about a condition that the plaintiffs did not have.  Same result:

[Plaintiffs’ expert] did not attempt to testify that either [plaintiff] developed [that condition] as the result of their implants. . . .  The theoretical possibility that some [products] of other manufacturers can cause various bone problems, without proof that it occurred to these plaintiffs because of the products of these defendants, cannot defeat summary judgment.

Id. at 446-47.

Likewise, in Peterson v. Parke Davis & Co., 705 P.2d 1001 (Colo. App. 1985), the court affirmed rejection of a proposed jury instruction that would have required the defendant to warn about every possible drug risk:

[T]he request for an instruction that [defendant] had a duty to warn of all known dangers was properly denied.  In a failure to warn case, the plaintiff has the burden of proving that the manufacturer gave inadequate warning of the danger which caused the injury.

Id. at 1004.

Here in Pennsylvania, plaintiffs tried warning claims about the risk of injuries they never suffered in both the breast implant and fen-phen mass torts – failing both times.  In fen-phen litigation, plaintiffs alleging primary pulmonary hypertension (“PPH”) were precluded from arguing that better warnings about valvular heart disease (“VHD”) (and vice versa) would have made a difference, even when a prescriber would not have been deterred by better warnings about the injury (PPH) the plaintiff actually had:

In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation.  Therefore, as a matter of law, there is no proximate, causal connection between [defendant’s] failure to disclose the risk of VHD and [plaintiff’s] specific injury.

Cochran v. Wyeth, Inc., 3 A.3d 673, 681 (Pa. Super. 2010); accord Owens v. Wyeth, 2009 WL 3244890, at ??? (C.P. Phila. Co. Aug. 17, 2009) (“the only warnings properly at issue in a failure to warn case are those relating to the condition to which the plaintiff alleges to have suffered”), aff’d mem., 6 A.3d 572 (table), 2010 WL 2965014, at *5-6 (Pa. Super. 2010) (adopting trial court’s reasoning).

Likewise, in breast implant litigation, the Pennsylvania mass tort court held that liability for inadequate warnings about risks not encountered was too broad to be permitted:

If I accept plaintiffs’ argument, the law will be permitting recovery for a risk that the plaintiff assumed because the plaintiff might have made a different decision as a result of knowing of other risks for which the plaintiff did not experience any harm.

In re Silicone Breast Implant Litigation, 64 D. & C. 4th 21, 25-26 (C.P. Allegheny Co. 2003).  Recovery for warnings about risks that never happened “would have a reach that extends far beyond the purposes for the [duty to warn] doctrine.”  Id. at 26.

The same has proven true with mass torts in other state courts.  In re NuvaRing Litigation, 2013 WL 1874321, at *23 (N.J. Super. Law Div. April 18, 2013) (“any failure to notify the FDA of increased [other] risks would not affect the adequacy of the warning with respect to the . . . cause of [plaintiff’s] death”); Hedrick v. Genentech Inc., 2011 WL 5902794, at ??? (Cal. Super. Oct. 20, 2011) (“liability should be limited when a plaintiff does not suffer the unwarned-of injury”) (applying Massachusetts law).

In federal court, the plaintiffs in Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315, 321 (5th Cir. 2002) (applying Texas law), “never assert[ed] that they were part of a risk group that should have been warned.”  Id. at 321.  Their warning claims were therefore “absurd”:

To find causation, we would have to infer the absurd − for example, that an extra warning, though inapplicable to [the lead plaintiff], might have scared her and her doctor from [the drug].  Such reasoning is too speculative to establish Article III standing.

Id.

In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), the plaintiff alleged that his prescriber “would have read and heeded a warning” about not to prescribe two drugs together.  Turns out that didn’t happen.  The other drug was prescribed later by somebody else.  The warning to the first prescriber had nothing to do with plaintiff’s eventual injury.  Therefore, no causation as a matter of law:

[I]t is undisputed that [plaintiff] did not ingest the [two drugs] concomitantly . . . until . . . his prescribing physician was [somebody else]. . . .  That [the first prescriber] might have heeded a warning. . .about possible adverse effects were he to prescribe [the two drugs together] is of no significance given the facts before us.

Id. at 1020.

In Mills v. United States, 764 F.2d 373 (5th Cir. 1985) (applying Louisiana law), the adverse reaction that the plaintiff suffered was the subject of thorough warnings – so plaintiff claimed that warnings about other conditions were inadequate.  The court held that, since, plaintiff didn’t have those injuries the alleged lack of warnings about them were irrelevant.

The question of the adequacy of the warnings must be confined to consideration of whether the warnings were sufficient to inform the plaintiff of the risk of the particular condition or disease which allegedly caused his injury or death. . . .  [A] determination that warnings were inadequate with respect to some other condition does not bear on our conclusion that [plaintiff] was adequately informed of the risk of severe allergic reaction to the swine flu vaccine.

Id. at 379.

Likewise, in Novak v. United States, 865 F.2d 718 (6th Cir. 1989) (applying Ohio law), the plaintiff lacked any scientific evidence that the product could cause her condition, and therefore claimed inadequate warnings about a different risk she never suffered.  Amazingly, the district court allowed the switch.  The court of appeals did not, and reversed:

There was, therefore, no reason for the defendant to make the references deemed important or vital by the district court, and there was no duty on the part of the defendant to warn about any of these conditions.  Particularly, the district court erred in finding the warning inadequate, negligent, and insufficient because it did not specifically caution those who may have experienced [the other condition].  It was not proven that [plaintiff] had actually suffered from [that condition]. . . .

Id. at 726.  See In re Avandia Marketing, Sales Practices & Products Liability Litigation, 639 Fed. Appx. 874, 879 n.8 (3d Cir. 2016) (expert opinion had “no impact” on causation when based on a study that “dealt with a population of which [plaintiff] was not a part”) (applying Pennsylvania law); Coursen v. A.H. Robins Co., 764 F.2d 1329, 1336 (9th Cir. 1985) (“collateral misconduct unrelated to the specific injury suffered by the plaintiffs” properly excluded) (applying Oregon law).

Numerous other cases have reached the same conclusion. In Stahl v. Novartis Pharmaceuticals Corp., 2000 WL 33915848 (E.D. La. Nov. 29, 2000), aff’d, 283 F.3d. 254 (5th Cir. 2002), the plaintiff’s prescriber knew all about the drug’s alleged risks that he suffered.  Id. at *4.  Thus, plaintiff alleged inadequate warnings about other more serious conditions that he didn’t have.  Summary judgment granted:

[T]his Court is unpersuaded by [plaintiff’s] complaints that the warnings did not warn of death, liver failure, and the need for transplant.  [Plaintiff] has not suffered any of those injuries and is, therefore, precluded from imposing a duty to warn regarding those injuries not suffered. . . .  [A] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained.

Id. (citation and quotation marks omitted).  See also Vakil v. Merck & Co., 2016 WL 7175638, at *6 (D.N.J. Dec. 7, 2016) (“Defendants cannot be held accountable for failing to warn Plaintiff of a symptom he never experienced”); Guidry v. Janssen Pharmaceuticals, Inc., 2016 WL 633673, at *4 (E.D. La. Feb. 17, 2016) (“The only specific . . . that supports the plaintiff’s failure-to-warn claim is that the FDA issued a safety announcement warning [about] ketoacidosis. But the plaintiff does not allege (at least coherently) that she ever suffered from ketoacidosis”; warning claim dismissed); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *3 (N.D. Ala. Oct. 31, 2013) (“warnings for a wide range of conditions from which decedent did not allegedly suffer . . . would not have had any effect on him”; motion to dismiss granted); Austin v. Bayer Pharmaceuticals Corp., 2013 WL 5406589, at *7 (S.D. Miss. Sept. 25, 2013) (“Plaintiff failed to state a claim for the failure to warn of side effects which Plaintiff did not suffer”); Harris v. Eli Lilly & Co., 2012 WL 6732725, at *3 (N.D. Ohio Dec. 28, 2012) (“For a plaintiff to succeed on an inadequate warning claim, the risk about which the manufacturer allegedly failed to warn must be the same risk which harmed the plaintiff.”) (following Ohio Rev. Code §2307.76(A)(1)); Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538, at *4 (N.D. Ohio July 30, 2012) (same); Mason v. Smithkline Beecham Corp., 2010 WL 2697173, at *5 n.3 (C.D. Ill. July 7, 2010) (“a warning is only inadequate if it fails to list risks or side effects that do occur”); Harrington v. Biomet, Inc., 2008 WL 2329132, at *6 (W.D. Okla. June 3, 2008) (“no evidence” that two allegedly inadequate warnings caused plaintiff’s alleged injuries; summary judgment granted); Hernandez v. Ciba-Geigy Corp. USA, 200 F.R.D. 285, 295 (S.D. Tex. 2001) (dismissing plaintiffs who “do not plead that the[ir] children suffered any injuries or side effects of which [defendant] allegedly failed to warn”) (applying Texas law).

We’ve observed many times that multi-district litigation all too often becomes a breeding ground for bogus claims, and warning claims asserting injuries that plaintiffs don’t actually have is no exception.  Plaintiffs in Pelvic Mesh litigation have repeatedly advanced similar bogus warning claims based on risks they had not encountered, and lost each time.  The MDL judge granted an in limine motion against such evidence in Tyree v. Boston Scientific Corp., 2014 WL 5445769 (S.D.W. Va. Oct. 22, 2014):

I agree that evidence of complications that no plaintiff experienced is irrelevant and lacking in probative value. For the claims that require evidence of injury (strict liability for failure to warn, strict liability for design defect, and negligence), only the injuries experienced by the complainant are relevant.  Strict liability . . . requires the plaintiff to show . . . that the defect was the probable cause of her injuries. . . .  [E]vidence that the [the product] causes injuries not experienced by the plaintiffs has little probative value.  Moreover, elaborating on injuries that the plaintiffs did not incur risks needless presentation of cumulative evidence.

Id. at *6 (citations and quotation marks omitted) (emphasis original).  Accord Hall v. Boston Scientific Corp., 2015 WL 856786, at *5 (S.D.W. Va. Feb. 27, 2015) (“Evidence of complications that the plaintiff has not experienced is irrelevant and lacking in probative value.  For the claims that require evidence of injury, only the injuries experienced by the complainant are relevant.”) (applying Wisconsin law); Eghnayem v. Boston Scientific Corp., 2014 WL 5465741, at *7 (W.D. Va. Oct. 28, 2014) (same) (applying Florida law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 505234, at *10 (S.D.W. Va. Feb. 5, 2014) (excluding purported cancer risk where plaintiff “does not have cancer or allege any injuries related to an increased risk of cancer”) (applying Texas law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 457544, at *2 (S.D.W. Va. Feb. 3, 2014) (“secondary infections were not ‘a fact in issue’ because [plaintiff] did not experience a secondary infection”) (applying Texas law).

Other MDL cases reaching the same result include:

In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1352860, at *4, 7 (E.D. La. April 13, 2017) (excluding expert testimony about cancer where “cancer was not an issue for either Plaintiff”) (defense testimony); Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556, 564 (D.N.J. 2013) (“Plaintiff, however, did not suffer from transient ischemic stroke.  Thus, this study is irrelevant to Plaintiff’s claim”) (applying Texas law); Carr-Davis v. Bristol Myers-Squibb Co., 2013 WL 322616, at *5 (D.N.J. Jan. 28, 2013) (“because the studies are not relevant to Decedent’s condition, then the failure to inform the physicians of such findings cannot establish causation”) (applying Missouri law); Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291, at *6 n.11 (D.N.J. Jan. 7, 2013) (plaintiff “does not link those potential warnings to his personal circumstances”) (applying Alabama law); Thrope v. Davol, Inc., 2011 WL 470613, at *32 (D.R.I. Feb. 4, 2011) (“[n]othing in [the surgeon’s] account indicates that he handled the [product] in a manner that [defendant] failed to warn against”; judgment as a matter of law granted) (applying North Carolina law); In re Fosamax Products Liability Litigation, 2010 WL 1257299, at *5 (S.D.N.Y. March 26, 2010) (“Plaintiff cannot establish proximate cause without evidence [of a] failure to warn of the specific risk that allegedly materialized”) (applying Florida law); In re Rezulin Products Liability Litigation, 331 F. Supp.2d 196, 200-01 (S.D.N.Y. 2004) (alleged inadequate warning about risk plaintiff did not suffer held “quite beside the point”; “95 percent of the patients who took [the drug] suffered no liver injury” so “there is no evidence from which a trier of fact reasonably could conclude that these plaintiffs’ treating physicians would not have prescribed Rezulin even if plaintiffs are right as to the warning concerning liver toxicity”); In re Rezulin Products Liability Litigation, 2004 WL 1802960, at *3 (S.D.N.Y. Aug. 13, 2004) (“these plaintiffs do not claim to have suffered any liver injury” so “that there may have been a breach of the duty to warn of liver toxicity for which patients suffering from liver dysfunction may recover does not avail these plaintiffs”) (footnotes omitted), vacated in part on other grounds, 2004 WL 2009445 (S.D.N.Y. Sept. 8, 2004) (applying Mississippi and Texas law); Greiner v. Medical Engineering Corp., 99 F. Supp.2d 759 (W.D. La. 2000) (breast implants; “[a] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained”), aff’d, 243 F.3d 200 (5th Cir. 2001); In re Norplant Contraceptive Products Liability Litigation, 1997 WL 81094, at *1 (E.D. Tex. Feb. 21, 1997) (“whether the [product] warnings were not adequate with respect to an injury not alleged is not relevant to whether physicians were adequately warned of Plaintiffs’ alleged injuries”).

Punitive Damages

Finally, one other argument that plaintiffs sometime advance about alleged failures to warn of risks that they didn’t actually encounter is that such non-causal failures to warn are relevant to “punitive damages.”

We don’t think so, and this time the argument is constitutionally based. Evidence of inadequate warnings about risks not encountered by plaintiffs is solely relevant to injuries suffered (if at all) by persons other than the plaintiff who is before the court.  That’s a punitive damages no-no.

In considering punitive damages, the United States Supreme Court first held:

A defendant’s dissimilar acts, independent from the acts upon which liability was premised, may not serve as the basis for punitive damages. . . .  Due process does not permit courts, in the calculation of punitive damages, to adjudicate the merits of other parties’ hypothetical claims against a defendant under the guise of the reprehensibility analysis.”

State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408, 422-23 (2003).

A few years later, the Court decided that, “[t]o permit punishment for injuring a nonparty victim would add a near standardless dimension to the punitive damages equation.”  Philip Morris USA v. Williams, 549 U.S. 346, 354 (2007).  Williams therefore flatly declared it unconstitutional to base punitive damages on allegations of harm to absent third parties (such as other people suffering different injuries):

We did not previously hold explicitly that a jury may not punish for the harm caused others. But we do so hold now. . . .  [W]e believe the Due Process Clause prohibits a State’s inflicting punishment for harm caused strangers to the litigation.

Id. at 357.  Thus, “it is particularly important that States avoid procedure that unnecessarily deprives juries of proper legal guidance.  Id. at 355.  It is “constitutionally important” to insure that “the jury will ask the right question, not the wrong one.”  Id.

[W]here the risk of. . .misunderstanding is a significant one – because, for instance, of the sort of evidence that was introduced at trial or the kinds of argument the plaintiff made to the jury – a court, upon request, must protect against that risk.  Although the States have some flexibility. . ., federal constitutional law obligates them to provide some form of protection in appropriate cases.

Id. at 357 (emphasis added).

Admission of warning/risk evidence beyond that involving the plaintiff in question constitutes a state-law “procedure” doing the exact opposite of what the Supreme Court required in Williams.  With respect to punitive damages, such evidence is inherently suspect because by definition it places before the jury “injury . . . inflict[ed] upon those who are, essentially, strangers to the litigation.”  Id. at 353.

In Skibniewski v. American Home Products Corp., 2004 WL 5628157 (W.D. Mo. April 1, 2004), after State Farm, but before Williams, the court excluded evidence of “any alleged side effect or risk of the products at tissue other than the side effect or risks that allegedly harmed plaintiff” both generally, and in response to a punitive damages argument.  Id. at *12-13.

[F]ailure to warn of a medical condition plaintiff does not have cannot serve as the basis of a failure to warn claim and . . . evidence regarding injuries plaintiff does not have is irrelevant.  Because plaintiff does not have [certain conditions], evidence of these should be excluded.

Id. at *7. See Ray v. Allergan, Inc., 863 F. Supp.2d 552, 565 (E.D. Va. 2012) (punitive damages argument based on all persons taking a drug for a condition, regardless of injury, required new trial under Williams); Schilf v. Eli Lilly & Co., 2010 WL 3909909, at *6 (D.S.D. Sept. 30, 2010) (evidence about a different drug “are irrelevant to Plaintiffs’ claim for punitive damages” under Williams); In re Fosamax Products Liability Litigation, 647 F. Supp.2d 265, 284-85 (S.D.N.Y. 2009) (conduct occurring after a plaintiff’s injury cannot be used to support punitive damages under Williams); In re Prempro Products Liability Litigation, 2007 WL 4189510, at *3 (Mag. E.D. Ark. Nov. 15, 2007), adopted, 2007 WL 4189497 (E.D. Ark. Nov. 21, 2007) (under Williams evidence “will not be permitted to testify regarding [defendant’s] general badness or badness in the specific areas which are not connected to [plaintiff’s] injury”). See also Branham v. Ford Motor Co., 701 S.E.2d 5, 24 (S.C. 2010) (punitive damages theory that “invited the jury to punish [defendant] for all [product-related] deaths and injuries, rather than the “harm to [plaintiff],” was improper under Williams); Pedroza v. Lomas Auto Mall, Inc., 2009 WL 1300944, at *4-5 (D.N.M. April 2, 2009) (conduct occurring after a plaintiff’s injury cannot be used to support punitive damages under Williams) (non-product liability case); Berardi v. Village of Sauget, 2008 WL 2782925, at *5-6 (S.D. Ill. July 17, 2008) (other allegedly similar incidents could not be admitted to prove punitive damages) (non-product liability case).

So there you have it.  Evidence of alleged product defects, that did not give rise to the harm that the plaintiff actually encountered, should be irrelevant and inadmissible in product liability litigation, no matter what the rationale offered for their admissions.  Such evidence is a smoke screen and a side show offered when a plaintiff is trying to distract attention from a lousy liability case.