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Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.  How this suit could not be a blatant First Amendment violation is beyond us.

But that’s not really the point of this post.

The alleged “facts” are downright bizarre:  The plaintiffs were sore losers in previous litigation against the same defendant.  They had managed, through the use of now-discredited legal gamesmanship – a nationwide class action involving the extraterritorial application of the Illinois consumer protection statute – to obtain a verdict of over a billion dollars on claims involving State Farm and allegedly inferior replacement parts used in car repairs.  Thankfully, plaintiffs couldn’t hold it.  In Avery v. State Farm Mutual Automobile Insurance Co., 835 N.E.2d 801 (Ill. 2005), the court rejected extraterritoriality and nationwide consumer fraud class actions. Id. at 855 (“we conclude that the circuit court erred in certifying a nationwide class that included class members whose claims proceedings took place outside Illinois”).  The nominal vote was 4-2, with one justice not participating, but even the dissent agreed on this issue.   Id. at 864 (“I agree with the ultimate result reached by my colleagues − I, too, would find that the circuit court erred in certifying the nationwide class”) (concurring and dissenting opinion).  There were a slew of other issues in this contentious case, but with rejection of the nationwide extraterritorial class, any basis for the boxcar, billion-dollar verdict disappeared.

But plaintiffs (or their lawyers) didn’t give up.  Instead they filed a RICO action alleging that State Farm was “racketeering” when it gave large amounts of campaign contributions – Hale contains nothing to suggest that any state-law campaign finance violations were involved − to support the election of a particular “pro-business” candidate to the Illinois Supreme Court, while the Avery appeal was pending:

In essence, plaintiffs allege that defendants secretly recruited [the candidate] to run for an open seat on the Illinois Supreme Court, where the Avery . . . appeal was pending; that defendants organized and managed his campaign behind the scenes; that defendants covertly funneled millions of dollars to support his campaign through intermediary organizations over which [defendants] exerted considerable influence.

Hale, 2018 WL 3241971, at *1.  You get the drift.  Next came the predictable allegations that everything was covered up so no recusal occurred.  Id.  The new justice supposedly “broke” a “deadlock” – yeah, right, in a case where the main result was unanimous − and “voted to overturn the judgment.”  Id.  All this purportedly nefarious politicking supposedly “deprived [plaintiff plaintiffs] of their constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics.”  Id.

It’s not the point of this post to debate the intricacies of RICO causation, damages, or enterprises.  We don’t think Hale should ever have gone that far.  We’ve previously advocated the First Amendment protection of purely scientific speech, because we don’t believe that one side to a scientific debate should be allowed to sue the other into submission.  That was our primary interest when Citizens United v. Federal Election Com’n, 558 U.S. 310 (2010), was handed down.  We frankly didn’t dream that core political speech of the sort at issue in Hale could give rise to private prosecutions under RICO.

But be that as it may. If it’s open season on the opposition’s campaign contributions, can the defense side play, too?  After all, in most judicial elections, contributions from the defense are dwarfed by what our politically minded adversaries are able to raise and spend.  It’s no secret.  Here, for example, is the “Campaign Finance Online Reporting” of the Pennsylvania Secretary of State.  You can type in the name of your most (or least) favorite judge and relevant election year and see everybody from whom s/he reported receiving contributions.  Or you can click on “contributions made” and track the donations by your favorite plaintiffs’ lawyer or firm.  Our clients have just as much of a “constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics” as do plaintiffs.  Are there RICO violations here?

But maybe that’s not enough.  Perhaps it’s too diffuse to assert a RICO violation just because the other side’s contributions made up 90%+ of the total contributions to a particular judge sitting on a particular case.  Maybe there needs to be a “pending” matter to focus things more precisely.  Still, our side might be able to play.  Consider all of those “civil enforcement” actions nominally brought by cities, counties, and states against our clients – where the real vigorish goes to the contingent fee, private counsel brought in to prosecute the action for the government.  We’ve complained about those actions, as well, without much success.  If it turns out that contingent fee counsel (or those acting in concert with counsel) made large political contributions to the particular politicians who later authorized the filing of one of those suits against a client, does the client have a RICO counterclaim under the same rationale as Hale?

Our bottom line is that suits like Hale are abuses of the judicial system and attempts to sue over the other side’s First Amendment protected political activity.  We’re, frankly, shocked that Hale survived summary judgment.  But if plaintiffs insist on opening up that Pandora’s Box, our side should consider whether it wants to play, too.

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When we sit around the table this Thanksgiving, we’ll have another thing to be grateful for this year: ACI’s 23rd Annual Drug and Med Device Conference will be just days away on November 28-30, 2018 in New York City. We’re looking forward to the usual interesting and informative content, networking opportunities with clients and colleagues – and maybe even the chance to catch up with some of our loyal readers.

Bexis expects to be in his usual front and center seat if you want to chat (somebody’s got to ask questions). And you can also catch him presenting on November 29 on “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health and 3D Printing.”

Other sessions we have earmarked on our agendas include: “MDLs: Their Intended Purpose, What Attempts Have Been Made at Improving the MDL System, and Effective Ways for Wrapping Them Up,” and “Engaging the Courts in the Right Way: What Does It Mean to Be an Innovative Thinker as an Outside Counsel?” and breakout sessions on personal jurisdiction and innovator liability.

If you want to register, you can do so here. We look forward to seeing you in New York!

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Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery.   (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood. In any event, the premise of the event is that actors are scattered among the paying audience “guests.” At some point during the cocktail hour, one of the actors will “die.” During the ensuing dinner hour, clues are revealed and everyone tries to solve the “murder” in time for dessert. We think this sounds like fun, and we like the idea of not knowing what to expect and not being able to predict the result.

But sometimes a predictable result (to the extent that preemption jurisprudence is ever predictable) is just fine. In In re Bard IVC Filters Prods Liab. Litig. (Hyde v. C. R. Bard, Inc.), 2018 WL 4356638 (D. Ariz. Sept. 12, 2018), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter. Three years later, the plaintiff learned that the filter had perforated the IVC wall and had fractured. The filter was removed shortly thereafter. The plaintiff filed suit, asserting the usual panoply of product liability claims. After the court granted summary judgment for the defendant on several claims, the plaintiff’s claims for strict liability design defect and negligent design remained pending, along with a claim for negligence per se.

Under Wisconsin law, which governed the plaintiff’s substantive claims, a claim for negligence per se arises from violation of a statute, where the plaintiff can show that “(1) the harm inflicted was the type the statute was designed to prevent; (2) the person injured was within the class of persons sought to be protected; and (3) there is some expression of legislative intent that the statute become a basis for imposition of civil liability.” Hyde, 2018 WL 4356638 at *2. In her negligence per se claim, the plaintiff asserted that the defendants violated provisions of the Federal Food, Drug, and Cosmetic Act. As the court commented, “Far from containing an expression that FDA regulations are intended to form the basis of civil liability, . . . [t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Id. (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001)) (internal punctuation and additional citations omitted).   “Thus,” the court continued, a private litigant cannot bring a state-law claim [that] is in substance . . . a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist,” because, under Buckman, such claims are impliedly preempted by the FDCA.  Id. (citations omitted). All correct, even if it conflates Buckman preemption with the plaintiff’s simple failure to state a negligence per se claim under the requirements of Wisconsin state law.

The court held that, as in Buckman, the plaintiff’s negligence per se claim was more accurately characterized as a “negligence claim based solely on violations of FDA regulations,” id., and was therefore impliedly preempted. As the court emphasized, “. . .where the plaintiff was not suing under state law for conduct that happen[ed] to violate the FDCA, but instead [was] suing solely because the conduct violate[d] the FDCA,” the claim was preempted by federal law. Id. (emphasis in original, internal punctuation and citation omitted). The court contrasted such claims to traditional tort claims like plaintiff’s negligent design claim, which arose from a duty owed under state law and which was not subject to Buckman preemption.

We like this correct, methodical, predictable decision.   We’ll let you know how the mystery thing goes.

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It’s been a long road.  Well after product liability litigation over Accutane and inflammatory bowel disease (“IBD”) had been thoroughly debunked everywhere else in the nation, such litigation lived on in New Jersey – for year after interminable year.  First, a number of trials occurred, but literally every verdict for the plaintiffs was reversed on appeal.  Here are some of our posts on that phase of the litigation.  Then, once the trial court had had enough and began dismissing large numbers of cases, the intermediate appellate court reversed those decisions, too.  Here are some of our posts on that phase of the litigation.

Ultimately, it was up to the New Jersey Supreme Court to step in and figure everything out.  We blogged recently about it reversing the Appellate Division and entering a landmark decision on the admissibility of expert testimony in New Jersey.  See In re Accutane Litigation, ___ A.3d ___, 2018 WL 3636867 (N.J. Aug. 1, 2018).  Well, the defendant went back to the well on the adequacy of the drug’s warnings, and yesterday it rang the bell again.  In In re Accutane Litigation, ___ A.3d ___, 2018 WL 4761403, slip op. (N.J. Oct. 3, 2018), the court unanimously reversed the Appellate Division and affirmed the grant of summary judgment against another 532 cases brought mostly by litigation tourists.  “Of the 532 plaintiffs, 18 are New Jersey residents and 514 are residents of 44 other jurisdictions.”  Id. at *5.

The trial court had told the tourist plaintiffs that they were stuck with the consequences of choosing to descend on New Jersey like a plague of locusts – New Jersey law applied, including the presumption of adequacy that the state’s Product Liability Act (“PLA”) gives to FDA-approved warnings.  The warnings were adequate as a matter of law because “plaintiffs failed to overcome the presumption of adequacy.”  2018 WL 4761403 at *5.  The Appellate Division held that the law of each of the plaintiffs’ home states, 45 states altogether, governed, and reversed summary judgment under the laws of most of those states (all but eight).  Id.

Choice of Law

The New Jersey Supreme Court first said “you’ve got to be kidding” to the Appellate Division’s multifarious choice of law result.  The plaintiffs made their bed and thus had to sleep in it:

[W]e hold that New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL [multi-county litigation] purposes. . . .  The aggregation of hundreds of cases under MCL allows the resolution of common issues of law.   A trial judge cannot be expected to gain a mastery of the law of forty-five different jurisdictions.  Construing New Jersey’s PLA is challenging enough.  New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact.

Accutane, 2018 WL 4761403 at *6 (summarizing ruling).  See Id. at *15-20 (lengthy discussion of rationale for applying New Jersey law to all cases).

The court “proceed[ed] under the assumption” that true conflicts existed – that “application of New Jersey’s PLA may lead to an outcome different from the application of the laws of those other jurisdictions.”  Id. at *17 (citation and quotation marks omitted).  Even so, the most “significant relationship” for choice of law purposes in all cases was New Jersey.  First, as to alleged failures to warn, the corporation’s principal place of business “is where the alleged conduct causing the injury occurred − the manufacturing and labeling of [the product].”  Id. at *18 (citation and quotation marks omitted).

Second, in mass torts, “ordinary choice-of-law practices should yield in suits consolidating large numbers of claims and that courts should apply a single law in such cases.”  Id. at *17 (citation and quotation marks omitted).

The two most significant Restatement factors in this MCL matter are . . . “certainty, predictability and uniformity of result” and . . . “ease in the determination and application of the law to be applied”.  Applying a single standard to govern the adequacy of the label warnings in the 532 individual cases will ensure predictable and uniform results − rather than disparate outcomes among similarly situated plaintiffs.

Id. at *20 (discussing factors under Restatement (Second) of Conflict of Laws §6 (1971)).  Litigants cannot expect “[a] single judge . . . to gain a mastery of the laws of forty-five jurisdictions.”  Id.  If mass tort plaintiffs don’t want New Jersey law to apply they should “bring suit in the state where they reside.”  Id.  Under this new, mass-tort-specific application of choice of law, the plaintiffs in Accutane were stuck with New Jersey substantive law, which “is not as beneficial to their cause as the laws of other jurisdictions.”  Id.

We recommend that defense counsel study the court’s choice of law rationale.  It is no accident that, in its discussion of choice of law, the court cited Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Accutane, 2018 WL 4761403 at *20.  Save for Delaware, more major pharmaceutical manufacturers are probably “at home” in New Jersey than anywhere else.  Thus, if the other side in the future chooses to congregate in New Jersey, they’ll have to put up with New Jersey substantive law, at least if the defendant makes motions in the aggregate.  Query, however, if the practicality rationale still applies in a single “bellwether” case where the alternative is application of one other state’s law, rather than the multi-state muddle the court faced in Accutane.  We think defendants have another opportunity to exercise some strategic discretion here.

Presumption of Adequacy

On the merits, the Supreme Court agreed with the trial court, that the defendant’s warnings were adequate as a matter of law under the PLA’s presumption of adequacy of FDA-approved labeling.  Initially, we get another shout out for the learned intermediary rule from the court:

[T]he PLA codifies what is commonly referred to as the learned intermediary doctrine – . . . that the physician acts as the intermediary between the manufacturer and the patient.  The prescribing physician − as a learned intermediary − generally is in the best position to advise the patient of the benefits and risks of taking a particular drug to treat a medical condition.  Under the learned intermediary doctrine, a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities.

Accutane, 2018 WL 4761403 at *21 (citations and quotation marks omitted).  We’re always on the lookout for high court reaffirmations of the learned intermediary rule.

As to the statutory presumption of the adequacy of FDA warnings, the court reached the right result, but not before a lengthy detour based on a questionable source (a law review article written by plaintiff-side professional expert David Kessler) and the infamous decision in Wyeth v. Levine, 555 U.S. 555 (2009).  2018 WL 4761403 at *21-24.  The upshot is a ruling on how the PLA’s “rebuttable” presumption of adequacy can be rebutted:

[T]he rebuttable presumption of adequacy attaching to an FDA-approved drug label is overcome when a plaintiff presents clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal association between the use of the drug and “a clinically significant hazard” and that the manufacturer failed to update the label accordingly.

Id. at 26.  Notably, the substantive aspects of this rebuttal standard are based on federal regulations, including the notorious Levine “CBE regulation,” 21 C.F.R. §314.70.  This result leaves little daylight between the PLA presumption and implied preemption under Levine, except for the burden of proof.  Preemption is also based on “newly acquired information” – specifically the lack of it.  So any claim that would be preempted in other jurisdictions because plaintiffs can’t point to anything new that the FDA hadn’t already considered is independently barred in New Jersey by the PLA presumption.  However, while defendants bear the burden of proving preemption, in New Jersey the PLA presumption means that plaintiffs bear the burden of proving the presence of the necessary “new” information, and must do with clear and convincing evidence, which Accutane defined as “evidence so clear, direct, weighty in terms of quality, and convincing as to cause one to come to a clear conviction of the truth of the precise facts in issue.”  Id. at *26 (citation and quotation marks omitted).

The Accutane court added “one caveat” – regardless of anything else:

A manufacturer that acts in a reasonable and timely way to update its label warnings with the FDA, in accordance with its federal regulatory responsibilities, will receive the protection of the rebuttable presumption.

Id.

The Accutane court acknowledged that this “is a standard protective of responsible drug manufacturers.”  Id.

The PLA’s rebuttable presumption of adequacy that attaches to label warnings gives pharmaceutical companies the protection necessary to research and develop the drugs that will improve and extend the lives of people around the world.  The presumption of adequacy protects manufacturers from unmeritorious lawsuits.

Id.

Plaintiffs’ Failure of Proof

Finally, Accutane applied the law to the facts, and found that none of the 532 plaintiffs came close to overcoming the statutory presumption of adequate warnings.  “[M]ultiple warning tools,” the package insert, the patient package insert, the medication guide and “blister packaging,” all warned about the possibility of IBD.  Id. at *27.  “Association” was the proper description of the drug’s relationship to the plaintiffs’ injuries; “cause” would have been too strong.  Defendant “had reports that some patients, after taking [the drug], developed symptoms of IBD.  That one followed the other does not prove cause and effect.”  Id. (citing Accutane, 2018 WL 3636867, at *8-10).  Plaintiffs offered only “isolated examples” that had been “culled from the voluminous discovery.”  Id. at *27-28.  “To be sure,” that evidence “is not clear and convincing evidence that [defendant] knew or should have known that the use of the word ‘associated’ was inadequate.”  Id. at *28.

Nor is there any evidence that [defendant] avoided necessary label changes for economic reasons.  [Defendant’s] marketing personnel certainly expressed an interest in Accutane’s financial success; it would have been surprising if it were otherwise.  However, there is no evidence that [defendant’s] financial interest in Accutane’s success led it to withhold necessary IBD-related warnings.

Id.

*          *          *          *

This latest Accutane decision is a great result and should finally drive a stake through this vampire of a litigation.  Still, a couple aspects of this ruling give us pause.  As for choice of law, the application of multiple states’ laws was one means of defending against class actions, since doing so defeated both proportionality and manageability.  Many other reasons for rejecting class actions in personal injury litigation remain, but like practically everything else about choice of law, this could be a two-edged sword.  Second, the continued willingness of New Jersey courts to craft extra-statutory “exceptions” to the New Jersey legislature’s presumption of adequacy of FDA warnings bothers us doctrinally.  The statute says what it says, and we think that – as with all other statutory provisions (including preemption clauses) – courts should enforce statutes as written, and not use subsequent developments to change what the legislature did.  Short of a constitutional issue, courts should not encroach on the legislature’s prerogative to draft legislation.

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Gather round brothers and sisters, and hear the word of the Texas Court of Appeals. Today’s sermon addresses the intersection of religion and regulation.  Take out your hymnal, and turn to Hawkins v. State, 2018 Tex. App. LEXIS 7863 (Texas Ct. App., 14th Dist. Sept. 27, 2018).  Consider the case of Mr. Hawkins, hereinafter referred to as “the defendant,” but who self-identified as a bishop of the Genesis II Church of Health and Healing.  A primary teaching of said church was the amazing curative power of “MMS,” which variously stands for Miracle Mineral Solution, Master Mineral Solution, or  Miracle Mineral Supplement. (We think of MMS as an abbreviation either for the more prosaic Multimedia Messaging Service or the sillier Make Me Smile.  But who are we to depart from church doctrine?).  MMS is a sodium chloride product typically used as a disinfectant.  It is an industrial bleaching agent.  The defendant held monthly seminars and taught his flock how to mix and consumer MMS.  And what bounty shall this marvelous MMS elixir deliver?  Why, nothing less than a cure for cancer, HIV, heart disease, autism, and Ebola.  So sayeth the defendant.

 

The state of Texas heard this preaching and, lo, announced that it was Bad.  The state filed an action under the Deceptive Trade Practices Act (DTPA). The main prayer for relief was to enjoin the defendant and his followers to refrain from promoting MMS.  Justice in Texas was swift.  The state’s prayer was answered.  The MMS folly was put asunder.  The injunction was issued.  Thusly were poor innocents spared the fate of dousing their innards with bleach and tumbling into the fiery pit of disease and despair.

 

But the defendant gnashed his teeth against this ruling, and filed an appeal.  Alas, his teeth must still be gnashing, because the Court of Appeals decreed that the trial court’s ruling was Right and Good.

 

As a preliminary matter, the trial court quickly disposed of a raft of frivolous arguments, such as that the court had no jurisdiction over a sovereign church, that the government lawyers were unauthorized to practice law, that a church cannot be a dba, and that there was no contract between church and state.  For anyone who clerked and had to attend to tax objector appeals, this litany of beefs will seem familiar.  Sometimes the hardest part for a court or opponent is first to figure out exactly what the argument is, then restate it cogently, then bash it with solid precedent (which is much preferable to the jawbone of an ass, though we have occasionally encountered or even employed that weapon, too, in our almost two score of legal practice).

 

The actual substantive argument by the defendant is the most interesting: that “no one has the right to prevent a church or its believers from teaching its belief and offering its sacraments if the sacraments do not consist of controlled or illegal substances.”  Ah, at last we arrive at the type of lofty issue we might have encountered in Con Law class.  But the religious freedom claim here is framed exceedingly weakly.  The state brought the DTPA action on the grounds that the defendant had engaged in false, misleading, and deceptive ads and practices by promising benefits of MMS that it in fact lacks, by failing to disclose the utter lack of scientific research supporting such claims, and, worst, by failing to disclose the health risks of MMS.  Religious freedom is not a freedom to poison fellow citizens.  That much is clear.   We’d also say that religious freedom is not a freedom to lie to one’s fellow citizens, but even with the passing of Christopher Hitchens we’d expect some debate on that proposition.  But more to the point, religious freedom does not call off neutral application of the state’s police powers.

 

Whereupon the Hawkins court consulted a Higher Authority – the federal Food and Drug Administration.  In 2010, the FDA issued a safety alert about MMS, warning that it was an industrial bleach used for stripping textiles, and that consumption of MMS could lead to nausea, vomiting, diarrhea, and severe hydration.  At least one person suffered a life-threatening reaction after drinking MMS.  That’s the FDA warning against physical harm, not taking sides in some religious schism.

 

What’s the church’s position? According to at least some MMS labels, reactions such as nausea and vomiting were “evidence that MMS is working.”  Indeed, MMS seems to work in mysterious ways.  Some of the most damning evidence resides on the defendant’s website.  Those who adhered to the ways of MMS would know how to fix 95% of mankind’s maladies.  The church claimed to be “superior to health insurance.”  (Okay, our mind might be open about that one.). Learn about MMS, and you can call yourself a Reverend.  Dispense MMS to 50 unlucky people, and you can call yourself Doctor.

 

But the defendant probably should not call himself Lawyer.  For all of his arguments fell on deaf ears.  Hawkins was not a case of religious discrimination.  The police power of the state had not been exercised arbitrarily or capriciously.  Render unto Caesar, etc.  Little wonder that the appellate court wasted little ink in affirming the trial court’s ruling and offering an easy Amen.

 

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We have written a lot about personal jurisdiction. We certainly haven’t lacked for defense favorable decisions since Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017). Its impact has been felt in many contexts – class actions, innovator liability, litigation tourism. And, as we discussed in our post here, “stream of commerce” jurisdiction has also taken a significant hit post-BMS. Today we add another case to the growing precedent that “purposeful availment” rather than the “fortuitous” conduct of third persons is (i) a difficult standard to meet and (ii) is required to establish jurisdiction.

In Morgan v. Trokamed GmbH, 2018 WL 4388457, at *1 (W.D. Wis. Sep. 14, 2018), plaintiff, a citizen of Wisconsin, sued the German manufacturer and the North American distributor of a Class II medical device used in laparoscopic surgery. The manufacturer moved to dismiss for lack of personal jurisdiction and both the plaintiff and the distributor opposed. It was undisputed that the manufacturer had no offices or employees in Wisconsin, no representative of the manufacturer had ever visited Wisconsin, and the manufacturer doesn’t ship products to Wisconsin. Id. at *2. So, for plaintiff to make a prima facie showing of specific jurisdiction, she had to show that the German company had “purposefully availed” itself of conducting business in Wisconsin. The court analyzed each of plaintiff’s allegations of contact.

Exclusive distribution agreement: Plaintiff’s first argument was a straight-forward stream of commerce theory. The manufacturer gave the distributor exclusive rights to sell the manufacturer’s medical devices in the U.S., Canada, and Mexico. Based on that, the manufacturer should have reasonably expected its products to be sold in all 50 states. Id. But, as the court points out, that’s the same argument made by Justice Ginsburg in her dissent in J. McIntyre Mach., Ltd. v. Nicastro, 564 U.S. 873 (2011). But, the plurality (Kennedy, J.) and concurring (Breyer, J.) opinions found nationwide transmission insufficient to confer jurisdiction tethered only to a prediction that a defendant should have known its product would reach a specific state. Id. at *3.

Plaintiff tried to distinguish Nicastro by arguing that the manufacturer here exhibited more control over the distributor, but the court found nothing in the distribution agreement that showed targeting of Wisconsin particularly. The agreement covered the U.S. as a whole and did not direct the distributor to sell the devices in Wisconsin which is “the type of control that matters under a personal jurisdiction analysis.” Id. at *4.

Sales Volume: Plaintiff next tried to distance herself from Nicastro by pointing out that the plurality and the concurrence relied on the small number of sales of the product to New Jersey in deciding personal jurisdiction was lacking. Id. But, plaintiff here could only identify 2 sales of the manufacturer’s medical device in Wisconsin. Id. So, she focused on disposable components (blades and valves) of the device that she claims the distributor “regularly” sent to Wisconsin. This argument failed for several reasons, including that plaintiff neglected to produce any evidence that the components were manufactured by the German defendant. Id. at *5. Plaintiff also doesn’t allege that her injury had anything to do with the component parts, “so those sales would have a more tenuous connection with her claims.” Id. Finally, plaintiff still had no evidence that the manufacturer was aware it had customers in Wisconsin at the relevant time. Plaintiff alleged that the manufacturer became aware of its Wisconsin customers in 2015, but plaintiff “does not explain how knowledge that [the manufacturer] had in 2015 could serve as the basis for an exercise of jurisdiction for a claim arising out of 2014 injury ad a [device] sale made years earlier.” Id.

             Instructions for Use: Relying on Justice Breyer’s concurrence in Nicastro that offering “special state-related . . . advice” might be enough to confer jurisdiction, plaintiff alleged that the manufacturer “established channels of advice” via its warranty and Instructions for Use. Id. at *6. What plaintiff missed, however, is that the instructions “direct the customer to send the device to [the distributor] for repairs,” the instructions have the distributors contact information and logo, and state that the device is a product of the distributor. “No one reading the [instructions] would know that he or she should contact [the manufacturer] for any reason.” Id. at *7.

FDA Approval: Perhaps the most significant part of the opinion is the court’s conclusion that “the process for FDA approval does not provide a basis for exercising jurisdiction in a particular state.” Id. We’ve talked about this in the context of innovator liability, where the innovator may be the NDA holder, but they didn’t sell or distribute the product used by plaintiff. If the brand defendant didn’t sell the product at issue, but rather a different product to different people, and FDA-approval isn’t enough – what’s left on which to base specific jurisdiction?

Plaintiff also tried to use post-approval FDA communications to establish purposeful contacts. In response to a request from the FDA, the manufacturer had its distributor update all the instructions and send them to all customers. During this process, the manufacturer received a list of all of the U.S. customers for its devices. Id. at *8. Not only did this process take place after plaintiff’s alleged injury (after the relevant time period), it still relates only to the manufacturer’s contacts with the U.S. as a whole, not with Wisconsin. Id.

The bottom line: The facts alleged by [plaintiff], may reveal an intent to serve the U.S. market, but they do not show that [the manufacturer] purposefully availed itself of the [Wisconsin] market. Id. at *9 (quoting Nicastro).

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We had occasion not long ago to reread closely Lexecon v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), the Supreme Court decision that clipped the wings of transferee judges in multi-district (“MDL”) litigation by reminding them that the MDL statute, 28 U.S.C. §1407, conferred no authority to try cases.  Except for one justice on one section, Lexecon was unanimous.  While the result came as something of a shock to the MDL insider community, to the Supreme Court, Lexecon was not a hard case.

While the facts of Lexecon (more accurately, the procedural history, since the issue was wholly procedural) involved a MDL judge’s so-called “self-transfer” of a case originally filed in another state, it’s important to examine what the Lexecon court actually held.

First, the MDL statute “authorizes the Judicial Panel on Multidistrict Litigation to transfer civil actions with common issues of fact ‘to any district for coordinated or consolidated pretrial proceedings,’ but imposes a duty on the Panel to remand any such action to the original district ‘at or before the conclusion of such pretrial proceedings.’”  523 U.S. at 28.

Second, at the time the JPMDL had a rule that, despite the explicit language of the MDL statute of coordination being for “pretrial purposes,” allowed self-transfer for trial.  Id. at 32-33.  While appellee (which had won at trial – Lexecon is also a poster child for why the MDL system needs interlocutory appeals as of right, see id. at 31) tried to argue that rule as a basis for authority to self-transfer, the Supreme Court held that the JPMDL lacked authority to authorize by rule an action that was ultra vires under its organic statute.  The import of such arguments “is simply to ignore the necessary consequence of self-assignment by a transferee court: it conclusively thwarts the Panel’s capacity to obey the unconditional command of §1407(a).  Id. at 36 (emphasis added).  “[T]he statute places an obligation on the Panel to remand no later than the conclusion of pretrial proceedings in the transferee court, and no exercise in rulemaking can read that obligation out of the statute.”  Id. at 36-37.

Thus, once §1407 is used to transfer a case, not even a formal JPMDL rule can oust the statutory requirement to remand back to the original court at the end of coordinated pre-trial proceedings.  The Court was clearly in no mood to tolerate gamesmanship in derogation of express statutory language – not even by the JPMDL.

Third, appellees also argued that nothing in the MDL statute precluded the MDL judge from subsequently re-transferring an action to himself under the general transfer statute, 21 U.S.C. §1404.  523 U.S. at 34.  The Court relied on the restrictive, and mandatory, language of §1407 to deep-six that argument:

§1407 not only authorizes the Panel to transfer for coordinated or consolidated pretrial proceedings, but obligates the Panel to remand any pending case to its originating court when, at the latest, those pretrial proceedings have run their course.

“Each action so transferred shall be remanded by the panel at or before the conclusion of such pretrial proceedings to the district from which it was transferred unless it shall have been previously terminated.”  §1407(a) (proviso without application here omitted).

The Panel’s instruction comes in terms of the mandatory “shall,” which normally creates an obligation impervious to judicial discretion.

Id. at 34-35 (citation omitted) (emphasis added).  In short, there is only one place a case can go after being initially transferred pursuant to the MDL statute – back to the “originating court.”

Fourth, appellees argued that, once a self-transfer for trial occurred, the §1407 obligation to re-transfer the case to its original court magically vanished, “because the self-assignment ‘terminates’ the case insofar as its venue depends on §1407.”  Id. at 37. The Court was having none of that too-cute-by-a-half argument either:

The trouble with this creative argument, though, is that the statute manifests no such subtlety.  Section 1407(a) speaks not in terms of imbuing transferred actions with some new and distinctive venue character, but simply in terms of “civil actions” or “actions.”  It says that such an action, not its acquired personality, must be terminated before the Panel is excused from ordering remand.  The language is straightforward, and with a straightforward application ready to hand, statutory interpretation has no business getting metaphysical.

523 U.S. at 37 (emphasis added).

Last and least, appellees argued that because §1407 allowed one type of action (Clayton Act antitrust cases) to be transferred for trial as well as pretrial purposes, power was implicitly conferred to do the same for all MDL cases.  No dice.  That special exception actually cut the other way, because it “demonstrate[d] that Congress knew how to distinguish between trial assignments and pretrial proceedings in cases subject to §1407,” id. at 38 – and did not allow transfers for trial purposes to any other type of case.

Lexecon also examined the legislative history of §1407 (which is why Justice Scalia, the scourge of legislative history, did not join that section).  That history reinforced that §1404 general-purpose transfers were not available as long as the case involved was part of an MDL proceeding:

But the question is not whether a change of venue may be ordered in a case consolidated under §1407(a); on any view of §1407(a), if an order may be made under §1404(a), it may be made after remand of the case to the originating district court.  The relevant question for our purposes is whether a transferee court, and not a transferor court, may grant such a motion.

523 U.S. at 39 (footnote omitted) (emphasis added).  And even such a post-remand §1404 transfer would have to comply with general venue requirements.  Id. at 39 n.2. Among other things, as we pointed out here, that would require personal jurisdiction in the district where the MDL judge sat, which depending on where the MDL was situated, might not be the case.

Beyond that, §1407’s “legislative history tends to confirm that self-assignment is beyond the scope of the transferee court’s authority.”  Id. at 39.  “The bill does not, therefore, include the trial of cases in the consolidated proceedings.” Id. at 40 (quoting House Report at 3-4).

The Court concluded in Lexecon that the statute meant what it said, and that if trials in MDL actions were “desirable,” Congress would have to amend the MDL statute to allow them:

In sum, none of the arguments raised can unsettle the straightforward language imposing the Panel’s responsibility to remand, which bars recognizing any self-assignment power in a transferee court and consequently entails the invalidity of the Panel’s Rule. . . .  [Appellee] may or may not be correct that permitting transferee courts to make self-assignments would be more desirable than preserving a plaintiff’s choice of venue . . ., but the proper venue for resolving that issue remains the floor of Congress.

Id. at 40 (emphasis added).

We have engaged in this detailed exegesis on Lexecon as much to demonstrate what the Court didn’t say, as what it did.  What is absent from Lexecon’s absolutist reading of §1407 is any mention of state boundaries.  Rather the Lexecon court focused entirely on what was allowable in any MDL case initially transferred under §1407, whether that case was first filed in another state or not.

We think that’s critically important.  In their zeal to use the threat of trials to bludgeon defendants into settling, some MDL judges have relied upon territorial distinctions that are wholly absent from Lexecon itself.  They have sought to create a pool of “bellwether” trial cases from actions originally filed in the same state, or the same judicial district, as the MDL itself.

We think that this questionable practice could be the next Lexecon.  Frankly, we don’t think Lexecon allows that.

The basis for the Court’s unanimous holding in Lexecon is what the MDL statute “straightforward[ly]” requires – cases that come to the MDL through to §1407 remain subject to the statute’s absolute remand requirement.  There is no exception in Lexecon for trial (as opposed to remand) of cases transferred under §1407 from other district courts in the same state, or even from other judges in the same judicial district.  Unless the MDL judge happens to have received such a case through ordinary random assignment, s/he can’t try it – unless it’s first transferred out of the MDL and then retransferred back, if that is possible, under §1404.

No gimmicks allowed; the Court came down hard on gimmickry in derogation of §1407’s express limits in Lexecon.

And even if an MDL judge were able to cajole, or pressure, another judge to retransfer a case back to it for a “bellwether” trial, that case would no longer be part of the MDL.  MDL case management orders, MDL scheduling orders, MDL lead counsel (on both sides) would no longer be applicable – otherwise the transfer starts to look like another gimmick to get around the express limitations on allowable MDL activity that Congress wrote into the statute.  In particular, we don’t think that the plaintiff’s counsel in such a bellwether-after-retransfer trial can be compensated from MDL common benefit funds.  The MDL statute straightforwardly limits MDL proceedings to “pre-trial.”

Along these lines, the Lawyers for Civil Justice has a proposal to condition the conduct of “bellwether” trials in MDLs upon the voluntary – and confidential – consent of all parties.  That’s what prompted us to reread Lexecon in the first place.  Since a voluntary consent/waiver appears to be the only way to conduct MDL trials (whether called “bellwether” or anything else) consistently with what Lexecon actually held, we recommend that proposal as a possible way to avoid the next Lexecon.

Otherwise we wouldn’t be surprised to see the Supreme Court, when presented with the opportunity, to make MDL “bellwether” trials go the way of the dinosaurs.

Photo of John Sullivan

So you’re sitting next to one of your client’s senior executives. You’re at a large table in a larger conference room. There’s a lawyer for every seat at the table. There’s a court reporter in the room. A videographer too. The lawyer across the table from you slides a document to your client and gives you a copy. And then she starts asking questions. You look at the document. It dawns on you. This is a privileged document. It’s an email attaching a power point that was used in a presentation by your client’s legal department to its employees. The videotape is rolling. The court reporter is typing. Uh-oh. Bad thing.

What to do? Well, whatever you do, don’t panic. It’s not over. You probably have a chance to fix this, to claw it back. And, if you do it right—which in part involves speaking up—and you’ve done the preparation, the court will likely back you.

This precise predicament happened to the defendant in In re Abilify (Aripiprazole) Prods. Liab. Litig., 2018 WL 44440707 (N.D. Fla. Sept. 17, 2018). Bristol Myers Squibb’s lawyer objected to a plaintiffs’ attorney’s use of a document at a deposition, asserting that it was privileged and had been inadvertently produced. The BMS lawyer sent a follow-up email that night further asserting the privilege. Three business days later, the lawyer sent another written notification, this time accompanied by a privilege log. As it turned out, taken together, these actions weren’t perfect. But they were enough.

The plaintiffs filed a motion asking the court to confirm that the documents should remain produced material. They argued that (1) the defendant did not follow the claw-back procedure set out in a protective order addressing inadvertent disclosures and (2) regardless, the document was not privileged. Neither argument won.

For their procedural argument, the plaintiffs pointed to the protective order’s requirement that the defendant provide the plaintiffs with written notification of the claw-back and an accompanying privilege log within two business days of the deposition, not three. The court agreed that the protective order required this. But the court found it more important that the BMS lawyer gave a detailed verbal notice of the privilege assertion at the deposition and followed-up that evening with a detailed email confirming it. In other words, speaking up quickly and clearly helped. Preparation helped to—that is, already having a protective order on inadvertent disclosures in place. The court held that the defendant’s clarity in immediately clawing the document back and stating the reasons won out over missing the two-day deadline by one day. Substance over form:

Although BMS might not have followed the precise terms of the Protective Order, in the Court’s view the one-day delay in sending the privilege log can charitably be described as a situation where the expression “no harm, no foul” applies. Plaintiffs cannot point to any prejudice they suffered or could have suffered as a result of the receipt of a privilege log one day late, which simply confirmed the privilege timely raised by BMS at the deposition and then confirmed in writing the same day. Consequently, Plaintiffs’ argument that BMS waived its ability to claw back the email and PowerPoint is due to be denied.

Id. at *2.

Plaintiffs argued that the power point wasn’t privileged because a non-lawyer assisted in preparing it and, regardless, it conveyed publicly known facts about a corporate integrity agreement (“CIA”). This argument lost too.

It did not matter that a non-lawyer assisted in preparing the power point. What mattered was that the power point’s content came from an attorney using it to advise a client:

While the final preparation of the PowerPoint slide deck may have been created by a paralegal or non-attorney, the information does not lose its privileged nature simply because the attorney did not perform the ministerial function of actually preparing the PowerPoint deck. Thus, the fact that the meta data reflects the deck was prepared by a non-attorney has little relevance to whether the PowerPoint is protected by the attorney-client privilege.

Id.

And the fact that the power point addressed a publicly available CIA didn’t destroy its privileged nature either. It contained counsel’s interpretation of the CIA and the obligations that it placed on defendants, and it was used in counsel’s presentation to senior management on those issues:

BMS not only asserts that the redacted portions of the PowerPoint dealing with the CIA were prepared by in-house counsel but importantly that the PowerPoint was part of a presentation by Regina Cavaliere, a Senior BMS counsel, made to BMS management employees. According to BMS, Ms. Cavaliere’s presentation was not simply a historical account of the CIA but instead was Ms. Cavaliere’s interpretation of the scope of BMS’ obligation under the CIA. The redacted portions of the PowerPoint specifically related to the presentation, which provided BMS employees with both factual background to the CIA and BMS counsel’s interpretation of BMS’ obligations under the CIA. The information in the slides in the PowerPoint therefore must be viewed in the context for which the slides were prepared and how the slides were used by BMS’ in-house counsel in her presentation.

Id. at *3. The court ordered that the email and attached power point were privileged and had been inadvertently disclosed.

Phew. Bad thing averted. So, if you’re at a deposition and your opposition hands a privileged document to your witness, ignore that shiver going down your spine. Just go to work, speak up and follow up.

Photo of Steven Boranian

Multidistrict litigation is not special. By making this pithy observation, we do not mean to denigrate what has become the mother of all procedural mechanisms.  What we mean is that multidistrict litigation is, at its core, nothing more than a bunch of venue transfers, bringing multiple cases involving common issues before a single district judge for coordinated pretrial proceedings.  The MDL statute does not grant an MDL judge any extraordinary or special powers.  In fact, the statute purports to augment a district judge’s prerogative in only one way:  An MDL judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions.”  28 U.S.C. § 1407(a).

Not very Earth-shattering stuff, but the point is that whatever exceptional gravitas you might attribute to an MDL comes not from an act of Congress.  It comes from the fact that one judge has all the parties and their attorneys in front of him or her with the power to preside over all their cases at the same time.  That includes deciding which cases will proceed, and which will wait, and how proceedings will be conducted for those chosen to go ahead, maybe a few at a time, or maybe in entire “waves.”

It also includes naming the plaintiffs’ Lead and Liaison Counsel, a function that is uniquely important for the plaintiffs’ side because there are usually many more plaintiffs’ lawyers involved and they are generally being paid based on the results. That requires a leadership structure with defined responsibilities and a common-benefit compensation structure to go along.

But where do Lead and Liaison Counsel’s responsibilities begin and where do they end? According to the Yaz MDL judge, who as far as we can tell is the first judge anywhere to address this particular issue, they begin and end with the court’s order creating those roles and defining those responsibilities.  That was the ruling in Casey v. Denton, No. 3:17-cv-00521, 2018 WL 4205153 (S.D. Ill. Sept. 4, 2018), where the district judge presiding over the Yaz hormonal contraceptive MDL held that the plaintiffs’ Lead and Liaison Counsel owed no general fiduciary duty to plaintiffs in the MDL, other than their own clients.  After the bulk of the cases in the MDL resolved, the MDL judge entered an order placing the unresolved cases on separate litigation tracks, with all the deadlines that you would expect:  Fact sheets, case-specific expert reports etc. Id. at **2-3.

Here is where is got ugly. Many of the non-settling plaintiffs blew the deadlines, resulting in motions to dismiss.  The plaintiffs blew the deadlines to oppose those motions, too.  Presented with violations of court orders and utter indifference from the plaintiffs (and their individual attorneys) toward their own cases, the MDL judge justifiably dismissed their cases. Id. No one appealed or sought reconsideration. Id.

So, what is a plaintiff to do, after rejecting settlement and opting to litigate, only then to blow off the resulting litigation deadlines? Of course, you sue your lawyer.  But not your own lawyer.  You sue the Lead and Liaison Counsel who created this whole mess, right?  That is exactly what these plaintiffs did, claiming that the Lead and Liaison Counsel “breached purported fiduciary duties by failing to address (or failing to delegate) the directives laid out” in the court’s orders. Id. at *2.  The plaintiffs analogized to duties owed by attorneys representing classes of plaintiffs, i.e., that Lead the Liaison Counsel’s duties arose from and were created by the court’s order creating those positions and “bestowing” certain duties. Id. at *3.

That proposition was a nonstarter for this judge. First, the court found no fiduciary duty:

It is well established that a “fiduciary” is a person, having a duty, created by his undertaking, to act primarily for another’s benefit in matters connected with such an undertaking. The Court finds the ending of that statement to be the pinnacle instruction on this entire dispute: One can only act in a fiduciary capacity, and thus have a fiduciary duty, to the extent his actions comport within the boundaries set by the agreement initially creating the relationship.

Id. at *4 (emphasis added).  In this case, the document creating the relationship was Case Management Order No. 2, which created the roles of Lead and Liaison Counsel and “very clearly set[ ] out what responsibilities the Lead and Liaison Counsel . . . owed to plaintiffs.”  Moreover, “it is clear from the text that Order No. 2 only imposed tasks geared towards facilitating general work product that could be used for the common good of all plaintiffs,” such as coordination of document depositories, preparing agendas, and conducting common discovery. Id. As the MDL judge concluded, “It was never the intention or spirit of Order No. 2 to supersede the authority or importance of each plaintiff’s individually-retained counsel when it came to specific matters unique to each case.” Id. at 5.

That is not to say that Lead and Liaison counsel own no duty to MDL plaintiffs.  The court analogized to a trustee, who owes a duty to pursue the “good of all.” Id. at *6.  As Judge Cardozo reminded us all in law school, “A trustee is held to something stricter than the morals of the market place. Not honesty alone, but the punctilio of an honor the most sensitive, is then the standard of behavior . . . .” Meinhard v. Salmon, 164 N.E. 545 (N.Y. 1928) (emphasis added).  Whatever the “punctilio of an honor” encompasses, it does not extend to representing an individual plaintiff when her or her own lawyer fails to do so.

Second, the court decided it would be a bad idea to create the fiduciary duty that the plaintiffs wanted.  After all, who would want to be Lead and/or Liaison Counsel if those roles came saddled with the duty to respond to every deadline and otherwise represent individuals with whom they have no engagement?  We have no qualm with the idea that the plaintiffs’ leadership in an MDL should earn their pay, and we know from our view from the other side of the aisle that they work very hard.  But even we have to admit that the plaintiffs in this case were asking too much.

The lesson here is that Lead and Liaison Counsel’s duties are defined by court order, and not so much by common law principles governing fiduciaries. So be careful in drafting and presenting those proposed orders for the judge’s signature.  They may be used against you.  A little gratuitous advice to plaintiffs’ attorneys, who are very unlikely to read our blog.

Photo of Stephen McConnell

The toughest thing about defending product liability cases is the occasional immersion in human misery.  Securities and antitrust cases pose intellectual challenges but they are, in the end, pretty much about money.  By contrast, the plaintiffs in our cases are claiming injuries to their bodies, not just their wallets.  Sometimes those alleged injuries are phony or trivial.  Mostly, though, they are real.  You wouldn’t wish them on your worst enemy.  Every once in a while, the alleged injury is unspeakably sad.  That sadness hits us extra hard when the injury involves a child.  For instance, several of the plaintiffs in SJS-TEN cases were children.  Try to imagine what it would be like to be on the other side of the courtroom in such cases.  And then there are cases brought after a child or adolescent committed suicide.  No parents want to outlive their children.  And the ending of a life so prematurely must be devastating.  It must also be infuriating.  It would be natural to blame the catastrophe on a drug.  It might even be right to do so.  Or it might not.

 

In Patton v. Forest Labs, Inc., 2018 U.S. Dist. LEXIS 160368 (C.D. Cal. Sept. 19, 2018), the plaintiffs alleged that their daughter committed suicide after taking the antidepressant Lexapro.  After some dismissals and amendments, the Second Amended Complaint (SAC) was teed up for another motion to dismiss. There were claims for relief based on negligence, violation of California’s Unfair Competition Law (UCL), and wrongful death.  The claims were based on allegations that the anti-depressant was marketed in such a way as to mislead the FDA, doctors, pharmacists, and the public about suicide-related risks. In considering the motion to dismiss the SAC, the court “again extends its condolences.”  But the court still dismissed the SAC without leave to amend.

 

The central obstacle for the Patton SAC was that the suicide warning was quite clear.  The Highlights section of the Lexapro label contained a boxed warning about the “[i]ncreased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.”  The plaintiffs argue that the warning should have been stronger.  One can always conceive of ways to enhance a warning, but the possibility of such enhancements does not mean that the original warning was not adequate.  The label warned in plain and explicit terms of the specific risk that caused the alleged injury.  The plaintiffs’ pleading as to why the failure to say more in the warning constituted negligence was, to say the least, confusing and amorphous.  The plaintiffs pointed to nondisclosure or understatement of risks, and also inserted allegations of other misconduct, including purported violations of a Corporate Integrity Agreement.  None of it mattered, because the Patton court held that the warning at the relevant time was adequate as a matter of law.

 

The Patton court also held, after reciting the holdings in Levine, Mensing, and Bartlett,  that the warning claims were preempted because the plaintiffs could not point to any newly acquired evidence to support a label change. (This same issue was central to the case we discussed yesterday.)  Moreover, there was another reason why the usual resort to the Changes Being Effected provision would not work: the change to the suicide warning would need to appear in the Highlights section, and changes to the Highlights section cannot be done without prior FDA approval.  (The inability to make unilateral changes to the Highlights section might ride in to the rescue of many defendants.)  The Patton plaintiffs argued that preemption did not reach claims for breach of warranty and fraud, but there was no claim for breach of warranty, and the fraud claim (part of the UCL) did not come close to satisfying the heightened pleading requirements for fraud claims, because it involved statements allegedly made to “unspecified audiences at unspecified times.”

 

The Patton plaintiffs’ fundamental contention was that the defendants were required change the drug label based on new information (even if we do not know exactly what the new information was).  The Patton court’s rejection of this argument is worth quoting:  “While it is obvious that the FDA, in approving the relevant Lexapro initial labeling and not yet requiring Defendants to change their label, disagreed with Plaintiffs, even if the FDA were wrong, only the government (i.e., not Plaintiffs) may bring a lawsuit to enforce the FDCA and the FDA’s regulations requiring Defendants to change their label.”  The Patton court then cited Buckman, completing the quartet of essential drug and device preemption SCOTUS cases.

 

Because this was the Second Amended Complaint, and because futility had been demonstrated to a fare thee well, the Patton court dismissed the SAC with prejudice.  Thus was a sad tale brought to its conclusion.

 

 

 

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