One of the intriguing things about cases decided by a jurisdiction’s highest court is that pronouncements by such courts can often have far-reaching implications.  Sometimes they pan out, as the application of the First Amendment to the FDA’s ban on off-label promotion seems to be doing following Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011).  With some, the results are conflicting, as with the “independence principle” in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  And sometimes they don’t pan out.  Anyway, thinking outside of the box is always fun.  So that’s what we’re doing today.

In our first case, the United States Supreme Court recently held that the Federal Trade Commission couldn’t seek the “monetary relief” of “restitution and engorgement” based on language in the Federal Trade Commission Act, 15 U.S.C. §53(b) (§13b of the FTCA), allowing the FTC to “grant mandatory injunctions and such other and further equitable relief as they deem appropriate in the enforcement of such final orders of the Commission.”  See AMG Capital Management, LLC v. FTC, 141 S.Ct. 1341 (U.S. 2021) (answering “no” to the question “Did Congress, by enacting §13(b)’s words, ‘permanent injunction,’ grant the [FTC] authority to obtain monetary relief directly from courts, thereby effectively bypassing the process set forth in [other parts of the FTCA]?”).

As one would expect, a lot of the AMG decision turned on the specific context of the FTCA.  141 S.Ct. 1348-50 (explaining how “[t]he language and structure of §13(b), taken as a whole, indicate that the words “permanent injunction” have a limited purpose − a purpose that does not extend to the grant of monetary relief”).  These include:

  • The “permanent injunction” phrase appears in a separate “provision that focuses upon purely injunctive, not monetary, relief.”   Id. at 1348.
  • “[T]he structure of the Act” – that other sections of the FTCA “gave district courts the authority to impose limited monetary penalties and to award monetary relief.”  Id. at 1349.
  • The provision of the FTCA that explicitly governs when “monetary relief” may be sought “comes with certain important limitations that are absent in §13(b).”  Id.

All together AMG concluded that “to read §13(b) to mean what it says, as authorizing injunctive but not monetary relief, produces a coherent enforcement scheme.”  Id.

So that takes us back to the first “consideration” the Court addressed in AMG – what the statutory language actually provided − and, more specifically the disconnect between the FTC’s demands for “monetary relief” with the language of the FTCA limited to “injunctive” relief:

For one thing, the language refers only to injunctions.  It says, “in proper cases the Commission may seek, and after proper proof, the court may issue, a permanent injunction.”  An “injunction” is not the same as an award of equitable monetary relief.

141 S.Ct. 1347 (citations omitted) (emphasis added).

That got us thinking about Fed. R. Civ. P. 23, and in particular comparing AMG to Rule 23(b)(2), which permits class actions for “final injunctive relief.”  By analogy, can the discussion of injunctive versus monetary relief in AMG be used to prevent the courts from claiming “authority” (the word used in AMG) to order the payment of money (such as funding “medical monitoring”) in a Rule 23(b)(2) class?  After all “what it says,” AMG, 141 S.Ct. 1349, is limited to “injunctive . . . or declaratory relief”:

the party opposing the class has acted or refused to act on grounds that apply generally to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole; or

Fed. R. Civ. P. 23(b)(2).

Taking the AMG analogy further, Rule 23:  (1) addresses solely “injunctive” relief in 23(b)(2); (2) is structured so that a separate provision, Rule 23(b)(3), governs monetary relief; and (3) class actions for money “come[] with certain important limitations that are absent in” Rule 23(b)(2) – such as predominance, superiority, and manageability.

Thus, we invite our defense-minded audience to consider whether it is now appropriate to argue, based on the Supreme Court’s reasoning in AMG, that as to monetary relief, Rule 23(b)(2) did not “g[i]ve that remedy in the first place.”  141 S.Ct. 1351.  Are we off the wall?

Our second case comes not from the United States Supreme Court, but rather from the New Jersey Supreme Court − Hager v. M&K Construction, ___ A.3d ___, 2021 WL 1380984 (N.J. April 13, 2021).  Hager held that New Jersey employers are obligated to reimburse now-legal medical marijuana prescriptions on the same basis that they pay for any other employee benefit required under that state’s Workers’ Compensation statute.  We don’t deal with medical marijuana much on this blog, but it is a prescription drug of sorts, so when we find something useful in this area, we’ve discussed it.

The interesting thing to us about Hager is its treatment of federal preemption – the employer in Hager argued that, regardless of what New Jersey law might require, it could not be forced to pay for something that remained illegal under supreme federal law.  2021 WL 1380984, at *16.  The New Jersey Supreme Court found no preemptive conflict, given how both Congress and the Executive Branch had treated the illegality of cannabis in recent years.  Congress has passed a number of legislative “riders” that “deprioritized prosecution for possession of medical marijuana.”  Id. at *15-16.  The Department of Justice, under both Democratic and Republican administrations, has similarly “deprioritized − but not prohibited − federal prosecution of marijuana activities that are legal under state law.”  Id. at *15.  Hager went into great detail about these actions, so we won’t.

Based on these executive and legislative actions, Hager added the imprimatur of the judicial branch, finding that there was no longer any conflict between federal law (marijuana being illegal under the Controlled Substances Act) and New Jersey state law under which medical marijuana (and as of 2021, recreational as well) is legal.  Hager determined that, based on congressional and DoJ actions, the illegal status of marijuana has been repealed “by implication.”  Id. at *17.

Congress has, for seven consecutive fiscal years, prohibited the DOJ from using funds to interfere with state medical marijuana laws through appropriations riders. The present rider and its predecessors have changed federal law. . . .  The rider language leaves “no doubt” as to its effect by “forbidding the use of funds to interfere with state medical marijuana schemes. . . .  Congress is empowered to amend the CSA [Controlled Substances Act] via an appropriations action provided it does so clearly, and the most recent appropriations rider, in our view, clearly is intended as a substitute” to the CSA . . . .  Therefore, we find that Congress has spoken through the most recent appropriations rider and give it the final say.

We thus conclude that the CSA . . . is effectively suspended . . . and that it would be inappropriate for this Court to give any legal effect whatsoever to the earlier statutory enactment.  The earlier statute cannot coexist with the enacted appropriation and, consequently, must be deemed to be suspended by adoption of the later appropriation act.  We repeat that the case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to tolerate whatever tension there is between them . . . .

[W]e find here that this clear, volitional act in the form of appropriations law takes precedence over the earlier legislation.  Because DOJ enforcement of the CSA may not, by congressional action, interfere with activities compliant with [New Jersey state law], we find that there is no positive conflict and that the CSA and the Act may coexist.

Id. at *19-20 (lots of citations and quotation marks omitted) (emphasis added).

So according to the unanimous New Jersey Supreme Court, the illegality of marijuana under the federal Controlled Substances Act has been impliedly repealed and suspended by the appropriations riders passed by Congress that forbid federal enforcement against marijuana-related activity that is legal under state law.  The Hager court recognizes that its holding “departs from the holdings of other state supreme courts.”  Id. at *20 (citations omitted).  However, in New Jersey, anyway, Hager is the law unless and until it is overturned by the United States Supreme Court.

Treating recent congressional and DoJ actions as “implied suspension as opposed to implied repeal,” 2021 WL 1380984, at *18, of the illegality of marijuana under federal law – at least in New Jersey – opens up a number of possibilities.  The one that intrigues us the most has to do with an area we don’t know much about – banking.  Perhaps the most significant way that federal illegality continues to hassle the cannabis industry is by forbidding banks to enter into normal depository relationships with this industry due to the purported federal illegality of marijuana − the very thing that Hager now rejects.

Thus, as with AMG, we invite any cannabis-oriented readers of ours to consider whether it can now be considered legal – at least in New Jersey – for New Jersey state-chartered banks to treat cannabis-related businesses in the same fashion that they would treat any other sellers of legal products.  Off the wall?  Time will tell.

We hope, when our time on earth is up, we are remembered as someone who possessed skills and made contributions.  We are certain that gardening will not be among them.  In that vein, we recently hired professionals to plant a lovely new bed at the end of our driveway.  We were admonished that we must water for at least a month until the bed became self-sustaining.  And water we did.  Too late, we regretfully report, we learned that it is possible to have too much of a good thing, at least where water and new plantings are concerned.

Not so for good decisions on issues that are important in our own practice.  In that vein, we are pleased that the last week or so brought a bumper crop of great results for the Taxotere defense team, all under the In re: Taxotere (Docetaxel) Prods. Liab. Litig. caption – two Fifth Circuit appellate affirmances and several victories from the MDL court.  We share the former today and will save the others for our next post.

First Case:  Claims Are Time-Barred

As blog readers know, Taxotere is a chemotherapy drug, used to treat certain cancers, including breast cancer.   The MDL plaintiffs are women who claim to have suffered permanent hair loss after their breast cancer was treated with Taxotere.  Today’s first case, — F.3d —, 2021 WL 1560724 (5th Cir. Apr. 21, 2021), is a decision on three plaintiffs’ appeals of the MDL court’s grant of summary judgment for the defendant on statute of limitations grounds.

Some background:  Louisiana applies a one-year “prescriptive period,” or statute of limitations, for personal injury claims, including product liability claims.  In their MDL master complaint, the plaintiffs defined “permanent hair loss” as hair loss that persists six months after the completion of chemotherapy.  All three plaintiffs suffered “permanent hair loss,” as the complaint defined it, after their chemotherapy treatment.  All three filed their Complaints years (six to seven years) later.  The MDL granted summary judgment for the defendant on all three suits, holding that the claims were “facially prescribed” (time-barred on their face – more about this in a moment) and that the doctrine of contra non valentum (a discovery rule-esque doctrine – more below) did not save the claims.  All three plaintiffs appealed.

The Fifth Circuit explained that Louisiana’s one-year “liberative prescription period” (limitations period) “commences to run from the day injury or damage is sustained.”  2021 WL 1560724 at *2 (citation to statute omitted).  The burden of proof “is normally on the party pleading prescription” (a defendant arguing that the case is time-barred);  “however, if on the face of the petition it appears that prescription has run, the burden shifts to the plaintiff to prove a suspension or interruption of the prescription period . . . .”  Id.  (internal punctuation and citations omitted).

In this case, the appellants argued that the one-year prescription period did not begin to run until they “learned of their injury and its cause,” and that they did not acquire this knowledge until years after their treatment.  The appellees countered that, under the plaintiffs’ own definition, as pled in the master complaint, the injuries were sustained, and prescription began to run, six months after the last chemotherapy treatment, when all three appellants’ hair loss persisted.  The Fifth Circuit agreed, affirming the MDL court’s holding that the appellants’ claims were “facially prescribed.”

It then turned to the issue of whether the prescription period was tolled for these appellants.  Unlike some Louisiana prescription statutes, the statute that applies to products liability cases does not include tolling language.  Instead, the equitable doctrine of contra non valentum agere non currit prescriptio (“no prescription runs against a person unable to bring an action,” contra non valentum for short) tolls the prescription period in certain “exceptional circumstances.”  There are four such “exceptional circumstances,” but the only one that possibly applies to this case is the fourth:  the period is tolled “where the cause of action is not known or reasonably knowable by the plaintiff, even though this ignorance is not induced by the defendant.”  Id. at *4 (citations omitted).  As the court explained, this doctrine is “often named the ‘discovery rule’” and it “applies only when such ignorance is not willful and does not result from negligence.”  Id. (citations omitted).  Actual knowledge is not required, under this doctrine – constructive notice suffices:

Whatever is notice enough to excite attention and put the plaintiff on [her] guard and call for inquiry is tantamount to knowledge or notice of everything to which inquiry may lead, and such information or knowledge as ought to reasonably put the plaintiff on inquiry is sufficient to start the running of the prescription.  That means prescription runs from the time there is notice enough to call for inquiry about a claim, not from the time when the inquiry reveals facts or evidence sufficient to prove the claim.

Id. (emphasis in original, internal punctuation and citations omitted).  In other words, a Louisiana plaintiff must “seek out those whom [she] believes may be responsible for a specific injury.”  Id. at *5 (citations omitted).  Plaintiffs “are not entitled to wait to sue until they are certain of what and/or who caused their injury.”  Id. 

Here, the appellants testified in deposition that they attributed their initial hair loss to their chemotherapy treatments, and the court held that “the standard of ‘knew or should have known’ [meant that] they needed to investigate Taxotere as a potential cause” of their persistent hair loss.  Id. at *6.  A “reasonable inquiry,” according to the court, “would likely [have included] consultation with doctors . . . .”  Id.  None of the appellants asked her doctor what might be causing her persistent hair loss.  In addition, “a plaintiff with persistent hair loss might instead search for the cause herself.”  Id.  If she had, she would have learned that, by 2006, a group of women “with an online presence” argued that the defendant’s product caused them to suffer permanent hair loss.  By 2010, articles had been published about this possible relationship.  (Plaintiffs pled much of this material in their own complaints.)  But the appellants did not file suit until 2016.

The Court concluded, “[W]e find that Taxotere as a possible cause of the persistent hair loss was not an obscure possibility . . . , [and], insofar as we are concerned with evaluating each Appellant’s effort to seek the cause of her injury, diligence required that Taxotere be explored as a possible explanation, . . . [and a] reasonable inquiry would have uncovered at least some information that linked Taxotere to persistent alopecia.”  While the appellants did not link the appellee to their injuries “until they saw [lawyer] advertisements in 2016,” that is “not the question.”  The appellants “did not act reasonably in light of their injuries, and their causes of action were reasonably knowable in excess of one year” before they filed suit.  Id.  (internal punctuation and citations omitted).  Summary judgment affirmed, in a testament to solid reasoning (and a “be careful how you plead the definition of your injury” cautionary tale).

Second Case:  No Warnings Causation

The second decision brings us particular joy, as it relates to our favorite (oft-misapplied) doctrine.   In this case, — F.3d —, 2021 WL 1526429 (5th Cir. April 19, 2021), the appellant was treated with Taxotere for an aggressive form of breast cancer that had spread throughout her body.  She had serious pre-existing cardiac conditions that affected her doctor’s treatment choices.  He recommended a Taxotere-based chemotherapy regimen as her best option for reducing the risk that her cancer would recur.

At the time (2013), Taxotere’s warnings did not include a warning of the risk of permanent hair loss, though, the doctor was aware – and warned the appellant – of the risk of temporary alopecia and of the risk that the hair might grow back with a different color, texture, or thickness.  The appellant did not ask about alternatives that would avoid this risk, and she consented to the recommended treatment.  Her lawsuit asserted the usual litany of claims, including failure to warn.  The appellee moved for summary judgment only on the warnings claim, and the MDL court granted the motion.  After conferral, all of the plaintiff’s remaining claims were dismissed, the district court entered final judgment, and the plaintiff appealed.

On appeal, the Fifth Circuit explained that, in Louisiana (like most everywhere else), a plaintiff asserting a failure-to-warn claim must prove both that the warning was inadequate and that the inadequate warning was both a cause-in-fact and proximate cause of the alleged injuries.  Because it was undisputed that the prescribing information did not warn of the risk of permanent hair loss, the inquiry, on summary judgment and on appeal, focused on the second prong, so-called “warnings causation.”  To defeat summary judgment on this prong under Louisiana’s learned intermediary doctrine, a plaintiff must adduce evidence that “a proper warning would have changed the decision of the prescribing physician, i.e. that but for the inadequate warning the prescribing physician would not have used or prescribed the product.”  2021 WL 1526429 at *3 (internal punctuation and citations omitted).  The appellant, like so many plaintiffs we have encountered, tried to muddy this standard, arguing that “the focus of [the court’s] inquiry should be how patient choice would have steered the conversation and the ultimate prescribing decision” if the warning had been provided.  And, while the court conceded that, “under Louisiana law, the decision to use a drug in a particular circumstance rests with both the doctor and the patient, . . . [the] causation analysis  in a failure-to-warn claim asserted against a drug’s manufacturer . . . is focused on the prescribing physician’s decision to prescribe the drug.”  Id. (internal punctuation and citations omitted).  The court concluded,

So, to the extent that patient choice is relevant, that relevance is cabined to helping us decide whether [the appellant’s] evidence – including that of other available treatments and the importance she places on her appearance – is sufficient to introduce a genuine dispute of material fact as to whether [the doctor’s] prescribing decision would have been different had he known that [the] risk of alopecia was potentially permanent rather than temporary.  It is not.

Id.  In reaching this conclusion,  the court expressly rejected the MDL court’s conclusion, made repeatedly in Taxotere decisions, that “the chemotherapy decision-making process is unique,” which the MDL court used to shift the focus of warnings causation towards the plaintiff’s actions, rather than the prescriber’s.   2021 WL 1526429, at *3 n.4  (“Under Louisiana state law, we find no support for this proposition and no occasion to deviate from binding caselaw to apply this standard.”)

First, the doctor testified that the inclusion of the permanent alopecia warning had not materially altered his risk benefit analysis for Taxotere, and that alopecia is a widely-known side effect of chemotherapy drugs.  The court emphasized, “The specific type of alopecia appears . . . to have had no effect on [the doctor’s] prescribing decision, and this support the conclusion that [the defendant’s] failure to warn could not have been the cause of [the appellant’s] injury.”  Id. at *4 (internal punctuation and citation omitted).  Second, the doctor “repeatedly testified that a . . . label warning of potentially permanent hair loss . . . would not have changed his” prescribing decision.  In fact, he testified that, if someone with appellant’s cancer and medical history came to him today, he would make the same recommendation.  Id. at *4.   Finally, there was no indication that the appellant had sought alternatives that might carry less risk of hair loss, notwithstanding her claim that her appearance was important to her.  In other words, “there [was] little evidence that [the appellant] might have steered the conversation in such a way that [the doctor] would have changed his prescribing decision had he known” of the risk of permanent hair loss.  At most, the court concluded, there was a “scintilla of evidence” in support of the appellant’s position, which was “insufficient to create a genuine dispute of material fact” as to whether a “permanent hair loss” warning would have changed the doctor’s prescribing decision.”  Id.  Again, summary judgement affirmed, in another great decision resting on a correct analysis of the applicable standard and burden of proof.

We will report on the second group of Taxotere victories in an upcoming post.  In the meantime, if you are driving around, our yard is the one with the swamp.  Stay safe out there.

We are careful when discussing discovery sanctions, particularly spoliation, for a simple reason.  The companies we represent that make medical products tend to have allegations about failing to produce discoverable information in the course of the litigation against them.  Indeed, there is a style of litigating against drug and device companies, and other corporate defendants, that focuses on burdensome discovery, discovery-on-discovery, and motions on discovery and discovery-on-discovery in the hopes that the defendants will settle before plaintiffs get to their holy grail, default judgment entered in their favor.  The willingness of some state courts to head down this road has been a major driver in fights over litigation tourism, including personal jurisdiction and the enactment of CAFA.  Even in federal court, some MDLs—like Actos and Pradaxa—have seemed to feature allegations of spoliation by the defendants more than anything like the merits of plaintiffs’ claims.  In other litigations, it looks like the plaintiffs have pushed a similar spoliation angle, but the courts have not bought it.  Overall, when you represent a company in a bunch of cases, you know there will be lots of documents to produce and continuing claims that you did not produce enough.  If the issues in the litigation implicate events in the distant past and/or a number of entities in different places, then the chances increase that spoliation allegations will accompany the complaints about non-production.

On the other side of the “v,” it often seems like a different story.  We have tracked decisions imposing requirements on plaintiffs suing drug or device manufacturers to maintain documents, access electronic sources, produce documents, etc., and we can say that significant sanctions against a plaintiff for failing to produce documents are rare and a spoliation instruction against a plaintiff is rarer.  Purcell v. Gilead Sciences, Inc., No. 17-3523, 2021 U.S. Dist. LEXIS 77379 (E.D. Pa. Apr. 22, 2021), takes a deep dive into these issues in a False Claims Act case brought by two former sales representatives over the marketing of two of defendant’s drugs.  We will jump to the end and state that the plaintiff was assessed relatively small financial sanctions and a spoliation instruction was denied without prejudice while a last-ditch effort was going to be pursued to find some of the missing materials.  As we recount a boiled-down version of history and the court’s analysis, we invite the reader to ask the question “how would things be different if the defendant manufacturer and its counsel did what the plaintiff and his counsel did here?”  Ask it a few times if you want.

The nature of the Relators’ allegations are not clear, but they clearly implicated the preservation and discovery of text messages they sent while working for the defendant.  In fact, one of the relators (we will call her “Relator 1”) produced thousands of text messages, including hundreds to/from the other relator (we will call him “Relator 2”), and attempted to withhold hundreds more.  Relator 2 produced five text messages and attempted withhold nine more, all to/from Relator 1.  This was a tip off for the defendant.  Although the suit was filed in 2017, concerned events starting before then, and he kept working for defendant until 2018, the few texts Relator 2 produced started in July 2019.  This was another tip off.  Despite an order requiring the parties to preserve documents and making text messages discoverable, multiple representations of relators’ counsel about compliance, letter writing, motions practice, hiring an independent third-party vendor, a deposition of Relator 2, and two hearings—the latter of which included experts for both sides—Relator 2 still had not produced an additional text message one year later.  Yet, the record was quite clear that otherwise discoverable messages existed when the suit was filed—by which time the relators certainly had to retain relevant evidence—and were created while the case was pending but before discovery began after the case was unsealed.  That is the short version.  While spoliation inferences and instructions under Fed. R. Civ. 37(e) require the court to find that “the party acted with intent to deprive another party of the information’s use in the litigation,” the reality is that a party—particularly a large corporate defendant—will have to come forward with a convincing explanation about the lack of bad intent.  Here, the court found that Relator 2 and his counsel had offered no such explanation.  Even though the court found that they had failed to comply with its orders and misrepresented compliance to the defendant, it determined the record was insufficient to find that Relator 2 had acted with such bad intent.

The longer version (even our abridged version of it) sounds way worse.  Relator 2 had five electronic devices and cloud storage as potential sources of electronic information.  The main focus was the smartphone he used from 2013 through March 2019, when he replaced it with a new model and put the old phone in a drawer in his house.  He never produced a text message from the first phone, which he had used in connection with his employment for defendants over five years, including almost a year after bringing suit.  The old phone did not go to his counsel until after opposing counsel had complained about the adequacy of production and been assured that all reasonable steps had been taken to preserve documents and produce them, including Relator 2’s texts.  In the interim, it had been wiped.  The independent vendor found forty-two unproduced texts in the backup for his new phone, but efforts to get texts from the old phone from any of the obvious sources had failed.  The mysterious wiping may have been—again, Relator 2 and his counsel offered no benign explanation, just ignorance and non-compliance—from one of Relator 2’s daughter taking phone from the drawer, changing the passcode through the cloud service, and trying to use it as her own phone, which resulted in a number of failed attempts to access the phone before providing it to a vendor.  Of course, the old phone and the various back-up sources were known to be sources of evidence in a pending federal lawsuit, but the relators’ counsel did not obtain them until late in the game.  Even when the court held the first hearing and ordered relators to facilitate the third-party forensic review, relators’ counsel somehow failed to turn over the new phone or information to allow cloud access for the old phone.  We could go on, especially if we wanted to highlight how a corporate defendant could never get away with such apparent shenanigans.

Instead, we will go to the rulings on the two types of sanctions sought, basically costs under 37(b) and spoliation under 37(e).  On the former, the court found lots of non-compliance by Relator 2 and his counsel.  For instance, they “did not comply with their obligations to preserve any possible evidence,” counsel “did not ensure compliance with [the ESI order] by undertaking reasonable steps to ensure all of his electronically stored information including his text messages shall not be permanently deleted or altered,” and they “offer no explanation for this failure to preserve since August 2017 and disregard of our [ESI order] despite their statement of compliance on March 18, 2020.”  Id.at **22-24.  Such non-compliance (and misrepresentations) caused the defendants to incur significant costs and fees, for which relators’ counsel was ordered to pay up to about $20,000 plus the full cost (instead of half) of the third-party vendor’s work.  In addition to that not being much given the conduct at issue, it was also payable by counsel not Relator 2.  As the court found, “[w]e have no basis to impute the Relators’ counsel’s strategy on disclosing partial information to Mr. Purcell and thus do not impose a monetary sanction on him nor may his lawyers seek or obtain repayment from their clients.”  Id. at *25.  This may change, though, as further sanctions were possible once the third-party vendor finished its work.  That work could change the court’s finding—with our italics—that there was “no basis today to find Mr. Purcell” was personally responsible for wiping the old phone or preventing access to its backup.  Id. at *22.

That could also change the denial without prejudice on the second type of sanctions sought.  While the court found that it could not meet the 37(e) requirement of Relator 2’s “intent to deprive” the defendant of the text messages from his old phone—the one he used during the relevant time period, including for a year and a half after he brought suit—it did find Relator 2 and his counsel “acted in conscious disregard (either through oversight or negligence) in their preservation of electronically stored information.”  Id. at *28.  It also noted they had no benign explanation for how or when the old phone got wiped.  If further evidence shows that Relator 2 or his lawyers “intentionally deleted these texts as opposed to his family using and changing the activation code and [] backup” in a way that led to accidentally deleting everything from the old phone, then an order for an adverse instruction would probably be issued.  Id. at *33.  As we suggested at the start, we prefer litigation to be decided on the merits rather than on motions about discovery.  That preference applies across the board, but we do look forward to evening out the playing field when it comes to the rules for discovery and potential sanctions on both sides of the “v.”

 

Covid has altered how and where we practice law. Along the way, it has also improved our exercise regimen. Every couple of days, we receive bankers boxes of binders and documents and then tote them upstairs to what passes for our home office.

For some reason, that makes us think of hernia mesh litigation.

Cosh v. Atrium Med. Corp., 2021 U.S. Dist. LEXIS 59649 (SDNY April 2, 2021), is round two of a battle between mesh plaintiffs and the manufacturer. The plaintiff alleged that she experienced stomach injuries from implantation of hernia mesh. The complaint included the usual litany of causes of action – design defect, manufacturing defect, and failure to warn, among others. The defendant moved to dismiss the complaint and won. The plaintiff filed another complaint, the defendant again moved to dismiss the complaint, and again won.

Under New York law, a claim for design defect must be supported by a showing of a safer, feasible alternative product. The plaintiff made no such showing. The plaintiff alleged that the defendant “could have used heavyweight small-pore mesh instead of midweight mesh or non-woven mesh instead of a knitted or woven mesh,” but did “not allege facts showing this would be technically and economically feasible and result in a safer design.” Moreover, when the plaintiff suggested the use of entirely different materials, the court reasoned that “alleging that the product should not be used at all is insufficient to satisfy the feasible alternative design element.” Hmmmm. What if that reasoning applied to pelvic mesh litigation? In any event, the safer alternative requirement has doomed several other hernia mesh cases, and you can read about them here and here and in other posts on this blog site.

The manufacturing defect claim was originally tossed because the plaintiff had not identified anything specifically wrong with the manufacturing process. In the amended complaint, the plaintiff pointed to an FDA complaint and warning letter involving the factory where the hernia mesh was made. But other medical devices were made in the same factory. The FDA complaint and warning letter were not aimed at the specific unit making the hernia mesh, and there was no allegation as to what precisely the violations were and how they could conceivably have played a role with respect to the plaintiff’s injuries.

The failure to warn claim did not address any communications to the plaintiff or her doctor concerning safety or efficacy. Rather, it “merely reframed Plaintiffs’ design and manufacturing defect allegations.” The plaintiff added an allegation that the defendant had failed to follow up on some adverse events, but there was no suggestion that the plaintiff or her doctor had relied on that or anything else the defendant said or failed to say.

This time when the court dismissed the Cosh complaint, it did so for good, ordering that the case be closed. It was not a heavy lift.

A little over a year ago, the Southern District of New York dismissed a multi-plaintiff amiodarone suit primarily on the grounds of preemption.  We discussed the decision in our post on lessons learned from the Amiodarone Litigation.  Now we can add to those lessons the Second Circuit’s affirmance of the dismissal.  Notably, the appellate court concluded that it did not need to reach the preemption issues because all of plaintiffs’ claims were implausibly pled under either Federal Rule of Civil Procedure 8 or 9.  Frei v. Taro Pharmaceutical USA, Inc., — Fed. Appx. –, 2021 WL 1541141 (2nd Cir. Apr. 20, 2021).

Plaintiffs’ complaint contained causes of action for failure to warn, negligent marketing, negligence per se, and fraud.  Id. at *1.  Regardless of the cause of the action, the appellate court found the case boiled down to three theories:  (1) defendant failed to make Medication Guides available to patients; (2) defendant failed to ensure the accuracy of reference materials relied on by physicians such as the physician Desk Reference (“ PDR”); and (3) defendant concealed information about adverse events.  Id. at *2.    What was missing from plaintiffs’ complaint however, were any allegations of the defendant’s wrongdoing.

We’ve discussed plaintiffs’ medication guide theory in the context of other cases (see post noted above).  It just doesn’t fly.  It is based solely on an FDA regulation that only requires manufacturers to provide guides “in sufficient number” or the “means to produce” them to “distributors, packers, or authorized dispensers” – not end users.  21 C.F.R. §208.24(b)(1-2).  Plaintiffs did not allege that defendant violated the requirements of the regulation. Rather, they created a “hypothetical enhanced duty” to provide medication guides directly to end users but failed to allege how defendant violated that duty either.  Id.

As far as providing misleading information in physician reference materials, plaintiffs’ complaint contains no allegations concerning what the misleading information was and only general allegations that defendant’s intent was to deceive physicians.  Id.  Moreover, the reference materials are considered labeling and therefore, defendant, as a generic manufacturer, could not change the information from that provided by the brand manufacturer.  Plaintiffs failed to explain what defendant’s “contribution to or authority to correct the reference materials was.”  Id.  Since plaintiffs could not demonstrate what role defendant had in creating the reference materials (none), this theory of liability was also not viable.

Finally, for plaintiffs’ allegation that defendant failed to report adverse events they were relying on a general statistical analysis that given the sheer number of amiodarone prescriptions and the number of people diagnosed with pulmonary toxicity, there must be “tens of thousands” of adverse events that were not reported.  Even if plaintiffs had support for this assertion, it is aimed at the entire amiodarone market, not defendant.  But an allegation that all manufacturers collectively failed to report says nothing about whether this defendant concealed information.  Id. at *3.

The opinion is short and sweet and while not preemption focused, it gets the job done.

This post is from the non-Reed Smith side of the blog.

This blog has repeatedly lamented the tendency of MDL courts to flout federal pleading standards when assessing the sufficiency of master complaints. All too often MDL courts disregard Rule 8(a), which—as authoritatively interpreted by the Supreme Court in Twombly and Iqbal—requires plaintiffs to plead facts plausibly suggesting an entitlement to relief, and Rule 9(b), which requires that fraud be alleged with particularity. Today we report on another example of this unfortunate tendency, In re: Allergan Biocell Textured Breast Implant Product Liability Litigation, 2021 WL 1050910 (D.N.J. Mar. 19, 2021). Although the court got a number of things right and dismissed a few claims from the master complaint, it allowed all too many of the claims to proceed on frustratingly familiar grounds that effectively insulate MDL master complaints from many motions to dismiss.

As its full name indicates, In re: Allergan involves the manufacturer’s Class III textured breast implants and Class II textured tissue expanders, which were voluntarily recalled after evidence suggested that they cause a certain form of cancer at a higher rate than other textured breast implants. The plaintiffs allege that the process by which the implants were manufactured resulted in “overly aggressive and inconsistent texturing” that in turn allegedly increased the implants’ surface area and led particles to form on their surface. The plaintiffs claim that these purported conditions caused them to suffer cancer or be at a higher risk of suffering cancer. Based on those allegations, the plaintiffs assert failure-to-warn, manufacturing-defect, negligence-per-se, breach-of-warranty, misrepresentation, and consumer-fraud claims under the state laws of various states.

The manufacturer moved to dismiss the plaintiffs’ master complaint, moving to dismiss all claims on state-law grounds and moving to dismiss the claims implicating Class III devices on preemption grounds as well. The motion to dismiss on preemption grounds targeted claims involving devices that had received premarket approval (PMA) from the FDA and devices that that had been cleared by the agency under the Investigational Device Exemption. Applying unduly lenient pleading standards, the court granted the motion in small part and denied it in large part. The court justified its application of a lax pleading standard on two grounds.

First, the court refused to consider whether the master complaint adequately pleaded certain elements of the plaintiffs’ claims, precisely because those claims were asserted in an MDL master complaint. For example, the court declared that it “need not review the factual sufficiency of Plaintiffs’ negligent misrepresentation allegations,” explaining that assessing their “factual sufficiency under the potentially varying state laws of negligent misrepresentation would be both cumbersome and unrealistic at this stage, especially when individual Plaintiffs may allege separately in their Short Form Complaints [the] misrepresentations to which they each [supposedly] have been exposed.” 2021 WL 1050910, at *32. Indeed, time and again the court “decline[d] to scrutinize … at this stage” of the proceedings whether the master complaint alleged facts sufficient to establish elements of the plaintiffs’ claims. Id. at *42. This is true with respect to claims subject to Rule 8(a) as well as claims subject to Rule 9(b). Simply put, the court would not apply the otherwise applicable pleading requirements because the complaint at issue was a master complaint in an MDL. When one compares the result in the In re: Allergan MDL to the opposite result in D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), a one-off case raising similar allegations against another manufacturer’s textured breast implants, the MDL effect is cast in sharp relief.

The court’s second justification for ignoring basic federal pleading standards is in some sense even more disturbing because it would by its logic apply to all cases, not just MDLs. According to the court, “fairness compels that some leniency be afforded plaintiff[s] from the stringent Twombly/Iqbal pleading standards to allow [their manufacturing-defect] claim to proceed” because the plaintiffs “do[] not have access to” the relevant PMAs, which are confidential, and are thus supposedly unable to plead a specific federal violation, as is necessary to avoid express preemption under 21 U.S.C. § 360k(a). 2021 WL 1050910, at *13 (internal quotation marks omitted). That of course echoes the Seventh Circuit’s abominable decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), which we have pilloried many times, including here and here. And, as in Bausch, the court’s analysis fails to appreciate that both Twombly and Iqbal involved situations in which the plaintiffs did not have access to information within the defendant’s control. In Twombly, the plaintiffs asserted an antitrust claim that required them to prove, and thus to allege, a conspiracy among the defendants. Despite the defendants controlling the information that would be necessary to establish a conspiracy, the Supreme Court held that the plaintiffs were required to plead facts sufficient to plausibly suggest an entitlement to relief. Iqbal confirmed that requirement, holding that a plaintiff who brought a Bivens action had to plead facts sufficient to plausibly suggest that the defendant acted with “discriminatory intent,” even though the defendant’s mental state was known only to the defendant. In short, Twombly and Iqbal hold that a plaintiff must plead facts sufficient to state a claim even where the plaintiff is at an informational disadvantage. Like Bausch before it, In re: Allergan cannot be reconciled with this Supreme Court precedent.

You know that things are not going to go well from a defense perspective when a court ignores Twombly and Iqbal. And, sure enough, there is much to dislike in In re: Allergan.

That said, the court did get some things right.

Rejecting the plaintiffs’ contrary contention, the court held that claims implicating devices used pursuant to the Investigational Device Exemption (IDE) are subject to express preemption under 21 U.S.C. § 360k(a). 2021 WL 1050910, at *8.

Another bright spot in an otherwise dreary decision is the court’s recognition that the Changes Being Effected (CBE) regulation, which allows device manufacturers to change a device label under certain circumstances without receiving prior FDA approval, “is permissive, not mandatory”—and that a state-law failure-to-warn claim that would require a manufacturer to have used the CBE process to change its label is therefore preempted under § 360k(a) because it would impose “a state-law duty that differs from or adds to the federal requirements.” 2021 WL 1050910, at *9–10 (internal quotation marks omitted). On this basis, the court dismissed the plaintiffs’ failure-to-warn claims insofar as they rested on the allegation that the manufacturer failed to revise its labeling to warn of the purportedly enhanced risk of cancer.

Satisfying too is the court’s recognition that § 360k(a) preempts claims implicating a device that had originally been classified as a Class II device but was subsequently reclassified as a Class III device and given premarket approval. As the court put it, “claims against … reclassified devices, which had the PMA approval when used by Plaintiffs, are treated no differently from the claims against the” devices that were PMA-approved from the outset. 2021 WL 1050910, at *14.

Finally, the court correctly concluded that the plaintiffs’ failure-to-warn claims were expressly preempted insofar as they rested on the manufacturer’s alleged failure “to conduct post-PMA clinical studies,” because “there is no state law duty that requires [a manufacturer] to undertake [such] studies.” 2021 WL 1050910, at *15.

Apart from that and the dismissal of a various claims under the laws of various states, the decision isn’t great, but it does provide ample fodder for this blogpost.

Different models of breast implants are at issue in the In re: Allergan MDL. They were distributed through different legal pathways. The great majority received PMA; a few others were IDE devices; yet others (empty implants used as “tissue expanders”) were cleared through the 510(k) process. As noted above, the court recognized that claims implicating IDE devices, like those implicating PMA devices, are subject to preemption under § 360k(a). Although the manufacturer did not seek dismissal of claims implicating the tissue expanders on preemption grounds, the court nevertheless addressed preemption in the context of 510(k) devices. Without any analysis beyond an indirect citation to the ill-conceived and outdated decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the court said in dicta that claims implicating 510(k) devices are not subject to preemption.  As the blog has noted before, that conclusion is dubious not only because the 510(k) today is significantly different from the process by which the Lohr device was cleared, but also given PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), which suggest that some claims implicating 510(k) devices are at least impliedly preempted even if not expressly preempted.

While the court recognized that claims implicating PMA and IDE devices are in principle subject to preemption under § 360k(a), it took an exceedingly narrow view of when claims are preempted.

Citing a series of unpublished Ninth Circuit decisions that mechanically follow that court’s misguided decision in Stengel v. Medtronic, Inc., 704 F.3d 1224 (2013), while at the same time ignoring Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), and other precedential appellate decisions that have rejected such claims, the court held that failure-to-warn claims predicated on a manufacturer’s alleged failure to file adverse-event reports with FDA are neither expressly nor impliedly preempted

In so concluding, the court disregarded the nature of adverse-event reports, misconstrued Restatement (Second) of Torts § 388 cmt. n, and adopted an unduly restrictive view of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). The court failed to recognize that, as explained in Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994, 1005 (S.D. Ohio 2016), adverse-event reports are not warnings. The court compounded that error by misreading the Restatement as imposing a state-law duty to submit adverse-event reports to the FDA. Comment n to § 388 says that a manufacturer can satisfy its duty to warn a product’s end-user by warning a third-party “through whom the [product] is supplied” when the manufacturer can reasonably rely on the third-party to convey the warning to the end-user, such as when the third-party has a duty to do so. In treating the FDA as a third-party intermediary for purposes of § 388, the court ignored the obvious fact that medical products such as breast implants are not supplied by the FDA, the fact that the FDA is not obligated to make adverse-event reports public, and the fact that adverse-event reports are not actively distributed to doctors even when made public. Finally, declaring itself “bound by the Third Circuit’s interpretation of the holdings in Buckman,” the court—citing no Third Circuit decision, when the only Third Circuit precedent, Sikkelee v. Precision Airmotive Corp., 907 F.3d 701, 716–17 (3d Cir. 2018), supports preemption—suggests that failure-to-warn claims predicated on a manufacturer’s alleged failure to file adverse-event reports with FDA are not preempted under Buckman because Buckman’s holding is, supposedly, limited to fraud-on-the-FDA claims. 2021 WL 1050910, at *11. That suggestion ignores the various cases that have characterized such failure-to-warn claims as fraud-on-the agency claims and cannot be reconciled with the Supreme Court’s own understanding of Buckman, which, the Court has explained, held that the FDCA preempts any “state tort-law claim based on failure to properly communicate with the FDA.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 619 (2011).

The In re: Allergan court also missed the mark when analyzing whether plaintiffs’ manufacturing-defect claims are preempted. As noted at the outset, the court—ignoring Twombly and Iqbal in the name of “fairness”—excused the plaintiffs’ failure to identify a specific PMA requirement that the manufacturer allegedly violated. Moreover, it held that the plaintiffs could base their manufacturing-defect claims on the manufacturer’s alleged violation of an FDA Current Good Manufacturing Practice (CGMP). 2021 WL 1050910, at *13. There is conflicting law on that point, and the court’s conclusion is arguably contrary to Irizarry v. Abbott Laboratories, 833 F. App’x 947, 949–50 (3d Cir. 2020), in which the Third Circuit affirmed the dismissal of a manufacturing-defect claim, finding that a complaint that “d[id] not set forth the premarket approval requirements” that were allegedly violated “d[id] not plausibly allege” a parallel claim that survived preemption.” This blog has repeatedly argued that because the CGMPs are intentionally vague and designed to give manufacturers complete discretion in how they are to be implemented, a state-law claim based on an alleged CGMP violation necessarily imposes a state-law duty that is “different from, or in addition to” the federal requirements and is thus expressly preempted under 21 U.S.C. § 360k(a).

But even if a CGMP violation could in theory support a manufacturing-defect claim, it is hard to see how 21 C.F.R. § 820.30(g), the CGMP cited by the In re: Allergan court, could sustain a non-preempted claim. To start, § 820.30(g) addresses “design validation,” not manufacturing processes. Furthermore, its requirement that a manufacture conduct “testing of production units under actual or simulated use conditions” is—to the knowledge of this blogger—not found in the law of any state. If it is not, and the court cited no state’s laws to suggest otherwise, then a claim based on an alleged violation of § 820.30(g) would be both expressly preempted, because the state and federal requirements would not be “identical” (Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)), and impliedly preempted, because the “existence of the[] federal enactment is a critical element in [the plaintiffs’] case.” Buckman, 531 U.S. at 353.

As if these problems weren’t enough, the court’s conclusion that the plaintiffs’ manufacturing-defect claims avoid preemption disregards the essence of their master complaint. To state a manufacturing-defect claim, one must allege and ultimately prove that the particular unit received by the plaintiff differed from its intended design or from other ostensibly identical units. The In re: Allergan plaintiffs, however, do not allege that their textured breast implants differed from their intended design or from other ostensibly identical units. On the contrary, the plaintiffs contend that every Biocell breast implant was defective because the manufacturing process supposedly resulted in the formation of particles and excessive surface areas—and even assert a class action on behalf of all recipients. Thus, plaintiffs’ real complaint is with the manufacturing process as designed and as approved by the FDA. That is to say, the plaintiffs’ manufacturing defect claims “are a frontal assault on the FDA’s decision to approve” the device’s PMA “after weighing the product’s benefits against its inherent risks.” In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1207 (8th Cir. 2010).

By this point it should not surprise the reader that the In re: Allergan court denied the manufacturer’s motion to dismiss the plaintiffs’ negligence-per-se claims on preemption grounds. What is particularly depressing about the court’s ruling in this regard is that it relied on In re Orthopedic Bone Screw Product Liability Litigation, 193 F.3d 781 (3d Cir. 1999), to support its conclusion. But that decision is part of the same litigation that ended in Buckman, which squarely held that 21 U.S.C. § 337(a) impliedly preempts any state-law claim for which the existence of the FDCA “is a critical element.” 531 U.S. at 353. Given that the plaintiffs’ negligence-per-se claims rest on the defendants’ alleged violation of the FDCA and its implementing regulations, Buckman plainly precludes such claims (as many but not all courts have held). The In re: Allergan court went astray when it concluded that the plaintiffs’ negligence-per-se claims were not preempted under Buckman because they “invoke the statutory violations to prove defendants’ liability for a separate underlying tort, instead of contending the violations themselves form a cause of action.” 2021 WL 1050910, at *14 (quotation marks omitted). But the mere fact that states recognize negligence actions does not save negligence-per-se claims from preemption. Rather, to avoid preemption under Buckman, “the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law—and that would give rise to liability under state law even if the FDCA had never been enacted.” Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009). A negligence-per-se claim predicated on a violation of the FDCA and its implementing regulations does not satisfy that test.

Despite getting most of the preemption analysis wrong, the In re: Allergan court did ultimately dismiss some of the plaintiffs’ failure-to-warn, negligence-per-se, negligent-misrepresentation, warranty, and medical-monitoring claims on state-law grounds, concluding (after providing useful multi-state surveys) that some states do not recognize the plaintiffs’ theories of liability. That is a good reminder that dismissal on state-law grounds is possible even when a court gets the preemption analysis wrong and that counsel should not rely exclusively on preemption when seeking dismissal of arguably preempted claims.

But the In re: Allergan court let most of the claims (and class allegations) through after declaring once again that it would review the sufficiency of plaintiffs’ allegations “with leniency.” 2021 WL 1050910, at *18. That’s an MDL for you.

We have long endorsed the use of Lone Pine orders as a partial antidote to wasteful mass litigation.  The issue is the numbers, large numbers of meritless claims that are parked in a mass proceeding, such as an MDL, where they both strain judicial resources and detract from litigation of claims that have arguable merit.  They also apply undue pressure on defendants to settle, which of course is why plaintiffs’ attorneys file the cases in the first place.

So-called Lone Pine orders come in various shapes and sizes, but they essentially require plaintiffs to produce threshold prima facie support for their claims, such as proof of a relevant injury and expert reports.  If you want to come to the dance, you have to show you belong.  Our only consistent criticism of Lone Pine orders is that courts should enact them much sooner than they typically do.  Why wait?

The district court in Hamer v. Livanova Deutschland GMBH, No. 20-1656, 2021 WL 1324028 (3d Cir. Apr. 9, 2021), had the right idea, and it executed well, but the Third Circuit let the plaintiff off the hook.  In Hamer, the district judge presiding over an MDL involving surgical heater-cooler systems (which we last blogged about here) entered a Lone Pine order requiring that each plaintiff produce (1) a positive culture for the particulate type of infection at the center of the MDL and (2) expert reports showing general and specific causation.  Id. at *1.  The timing is key.  The district court entered the Lone Pine order after the defendant implemented a mass settlement, leaving only non-settling plaintiffs to comply.  Id.  The apparent intent, at that stage, was to give plaintiffs further incentive to join the settlement, rather than to cull meritless claims (which would require a much earlier order).  But nonetheless Lone Pine orders have that effect, whenever entered.  And so it was here.

The plaintiff had plenty of time, yet he still failed to comply.  Id. at *2.  The district court therefore entered an order to show cause, then dismissed the case with prejudice, after the plaintiff acknowledged that he had no proof of the particular kind of infection at issue.  Id. at *2.  The Third Circuit reversed in an opinion that endorses and even commends Lone Pine orders, but held in the end that the sanction (involuntary dismissal) did not fit the crime, since while the plaintiff’s action did not belong in the MDL, it might not be meritless.

According to the Third Circuit, Lone Pine orders serve an important purpose:

[A]n MDL court “needs to have broad discretion to . . . keep[ ] the parts in line” by entering Lone Pine orders that “drive[ ] disposition on the merits.”  Such orders may impose preliminary discovery requirements, like the production of relevant expert reports, or may require plaintiffs to furnish specific evidence like proof of a medical diagnosis, with the goal of winnowing non-compliant cases from the MDL.

Id. at *3 (quoting In re Asbestos Prods. Liab. Litit. (No. VI), 718 F. 3d 236 (3d Cir. 2013)).  The district court was right on the money in entering its order, and the Third Circuit did not find or even suggest otherwise.  Instead, the Third Circuit gave the plaintiff a second chance because, even if he could not prove the “signature” infection, maybe he had a different infection, or maybe his infection had passed before a culture could be taken.  Id. at *3-*4.  The Third Circuit’s solution was not to dismiss the case, but to remand the case from the MDL to the transferor district for separate case-specific proceedings.  Id. at *4-*5.

This opinion is at the intersection of two prevalent trends.  On the one hand, we see mass inventories of cases with large numbers of plaintiffs whose claims are questionable and will never be genuinely questioned.  That is the issue that Lone Pine orders are tailored to address.  On the other hand, once a mass settlement has been reached—motivated in many cases by the desire to resolve large inventories—the non-settling plaintiffs are often not ready to go because they never thought they would have to prove anything.  That is what happened here.  The plaintiff in Hamer passed on settlement, then struggled when he had actually to prove that he had a bona fide claim.  He found a narrow loophole, but query how long his claim will last if he cannot prove the diagnosis needed for the injury that drove his claim in the first place.

So Lone Pine orders are alive and well, and the narrow result here should not deter courts from entering them.  We can only hope that courts start entering them sooner, which would both “winnow non-compliant” cases and also deter others from filing claims when they have no proof.

Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent:  Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998).  This article came to be cited twice by the United States Supreme Court in BuckmanBuckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350, 351 n.5 (2001), and by a raft of other cases, and helped give “off-label use” its name (as opposed to the more pejorative references preferred by the FDA and the other side of the “v.”).

Anyway, a lot has happened on the off-label use front over the past 23 years, and Bexis has often been in the thick of those developments.  A couple of aspects of off-label use – pertaining to preemption and to First Amendment protection – did not even exist back in 1998 in any meaningful sense.  After much urging, Bexis has written a second, more comprehensive article about off-label use issues that has just been published in the UIC John Marshall Law Review.  See James M. Beck, “Off-Label Use in the Twenty-First Century:  Most Myths and Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021), available here online.

The article took over a year to write, and reflecting Bexis’ obsession with thorough research, is a lengthy read.  To decide if you’re interested, here is the table of contents for the article:

Page 2:            I. INTRODUCTION

Page 4:            II. OFF-LABEL USE – THE MEDICAL AND LEGAL FRAMEWORK

Page 14:          III. OFF-LABEL USE IS A RECOGNIZED AND ACCEPTED ASPECT OF MEDICAL PRACTICE

Page 14           A. The General Status of Off-Label Use

Page 35:          B. Distinctions Between “Experimental,” “Investigational,” and “Off-Label” Use

Page 42:          C. The Conundrum of Off-Label Promotion

Page 49:          IV. FIRST AMENDMENT CONSTRAINTS ON FDA PROHIBITION OFTRUTHFUL OFF-LABEL SPEECH/PROMOTION

Page 50:          A. First Amendment Protection of Off-Label Speech in Commercial Contexts

Page 57:          B. First Amendment Protection of Off-Label Speech as Scientific Speech

Page 58:          C. First Amendment Protection of Off-Label Against Tort Claims

Page 60:          V. EFFECT OF OFF-LABEL USE AND PROMOTION ON PREEMPTION

Page 63:          A. Express Preemption and Off-Label Use

Page 66:          B. “Parallel” Violation Claims Involving Off-Label Use

Page 75:          C. Implied Preemption and Off-Label Use

Page 84:          VI. OFF-LABEL USE ISSUES INVOLVING INFORMED CONSENT

Page 84:          A. Informed Consent and Off-Label Use

Page 86:          B. Informed Consent and Medical Experimentation

Page 88:          C. FDA Regulated Intended Uses and the Medical Standard of Care

Page 91:          D. Independent Physician Investigation of Off-Label Uses

Page 92:          E. Off-Label Informed Consent Claims Against Manufacturers or Their Sales Representatives

Page 94:          VII. OFF-LABEL USE AND PRODUCT LIABILITY LITIGATION

Page 95:          A. The Learned Intermediary Doctrine and Off-Label Use

Page 98:          B. Product Manufacturers and Their Representatives Have No Duty to Intervene to Prevent Physician Off-Label Use

Page 104:        C. Duty To Warn Of Risks Of Off-Label Use

Page 104:        1. Decisions Predicated On A Greater Duty To Warn

Page 107:        2. Decisions Predicated On A Standard Duty To Warn

Page 111:        3. Decisions Predicated On A Lesser Duty To Warn

Page 104:        4. Decisions Finding No Duty To Warn Of An Off Label Use

Page 113:        5. Causation Issues in Warning-Based Off-Label Use Cases

Page 119:        D. Off-Label Use and Express Warranty Claims

Page 120:        E. Duty-To-Test Claims Involving Off-Label Uses

Page 122:        VIII. CONCLUSION

Happy San Jacinto Day. On April 21, 1836, Texans won the battle of San Jacinto, the last battle of the Texas revolution, in which Texas secured its independence from Mexico. In the past 185 years, Texans have never ceased showing an independent streak.

That is true for Texas product liability law. It is uncommonly sensible. Put another way, drug and device defendants often get a fair shake under Texas law. There is a reason why all those Texas plaintiff lawyers spend so much time in Philadelphia. It’s not because they love Cheesesteaks or the Eagles.

Moncibaiz v. Pfizer Inc., 2021 U.S. Dist. LEXIS 62213 (S.D. Dist. March 31, 2021), is an example. The plaintiff alleged that a hormone drug gave her breast cancer. The label warned of that precise risk, but the plaintiff said the warning was not as complete as it should have been. She filed her complaint, which was premised on failure to warn theories, in state court.

The defendant removed to federal court, and moved to dismiss because a Texas statute sets up a rebuttable presumption that FDA approved labels furnish adequate warnings. (Just last week we blogged about a Delaware court’s application of this Texas statutory presumption of adequacy). The plaintiff then amended her complaint to allege claims for design defect, negligence, and breach of the implied warranty of merchantability.

The defendant again moved to dismiss, arguing that the recharacterization of the claims did not change the fact they were really about a failure to warn, and they were still precluded by the Texas presumption. The plaintiff did not even try to fit within any of the five possible rebuttals specifically outlined by the statute. Thus, the entire issue was whether the plaintiff’s amended complaint hinged on some sort of warning defect.

It did. The Moncibaiz court held that the claims formally pleaded as design defect, negligence, and breach of warranty were “really just dressed up failure to warn claims”.

The design defect claim mimicked the proper structure of such a claim, but the actual defect alleged was the failure to inform the physician of risks and safer alternatives. The court treats us to a sane explication of learned intermediary and comment k, concluding that “the presumption against liability applies to the design defect analysis under comment k, which recognizes that some products (like prescription drugs) simply can’t be produced to eliminate all risk of serious harm… And under comment k, Defendants’ only duty in this regard is to manufacture [the drug] under the approved process and to supply it with the approved directions and warnings”. Adios, design defect claim.

The negligence claim also ran into these same doctrinal problems. The plaintiff did not allege that the product was improperly prepared. And so their only avenue to prove unreasonable danger is to prove inadequate warnings”. Again, the learned intermediary rule applies. So does the Texas presumption of adequate warning. The negligence claim has no chance – kind of like the Dallas Cowboys.

The easiest claim for the Moncibaiz court to dismiss was the implied warranty of merchantability. The plaintiff could not support the warranty claim of the drug was not unreasonably dangerous, and she could not prove the drug was unreasonably dangerous “without arguing that it’s warnings are inadequate”. Therefore, [i]t follows that the reach of warranty claim is in substance a failure to warn claim.” It is all hat and no cattle. The presumption of warning adequacy and the learned intermediary again ride in to rescue the defendant. Like the design defect and negligence claims, the warranty claim was chewed up, spit out, and stepped on. Don’t mess with Texas courts.

Thank you, Texas. You are a unique, beautiful state. And we’d say that even if the bluebonnets weren’t currently blooming.

Last week we brought you both the federal and state court decisions in the Incretin Litigation granting summary judgment on the grounds of preemption.  But that was not the only obstacle in plaintiffs’ way.  Even if the claims were not preempted, plaintiffs’ experts fell woefully short of the mark.  Today we bring you part two of the state court decision – exclusion of plaintiffs’ experts.  As a reminder, these cases were dismissed back in 2015 and revived in 2018.  So, five years had passed since plaintiffs’ experts had authored their original opinions.  Five years of new science to be considered.  Five years to complete analyses.  Five years to be thorough and complete.  It’s telling that the court’s first words about these experts is: “The unwillingness or inability of these experts . . . to grapple with all the available epidemiological evidence is troubling.”  In re Byetta Cases, slip op. at 2 (Cal. Super. Ct. Apr. 6, 2021).  Troubling is just the beginning.

Maybe plaintiffs’ experts experienced a “blip”?  For those not versed in the Marvel Cinematic Universe (“MCU”), Thanos, a super villain, wanted to “save” the world by halving its population.  Despite heroic efforts by an extended group of Avengers, Thanos succeeded in collecting all six infinity stones.  With those and a snap of his fingers, half the people on the planet turned to dust and faded into oblivion.  They remained gone for five years, until the remaining Avengers figured out time travel and undid the blip.  Just as they had vanished, so did billions return, with no memory of the intervening five years.  For those who were gone, it was like those five years did not exist.  So too apparently for some of plaintiffs’ experts, or at least they chose to be ignorant of it.  Plaintiffs’ experts failed to consider “all the available epidemiological evidence and not just the state of research as it existed in 2015,” leaving the court to conclude “that a medical causation opinion which not only lacks, but ignores, this essential logical support is of highly doubtful provenance.”  Id. at 3.

Meanwhile, plaintiffs’ counsel appear to have been among those who survived the blip.  They experienced the last five years and so at oral argument they presented lots of more recent scientific references, including analyses the lawyers conducted themselves.  Putting aside the lack of a sound scientific method to support an attorney-prepared risk analysis, none of the “science” counsel touted was considered or relied upon by their experts.  Id. 3-4.  “[P]laintiffs’ counsels’ vigorous arguments about the science do not and cannot fill the methodologic and foundational gaps that exist in their experts’ analyses.”  Id. at 5.

Let’s start with one of those gaps.  Plaintiffs’ biostatistician conducted an analysis in 2015 that found no statistically significant association between incretin-based therapies and pancreatic cancer.  Id. at 5-6.  In 2019, that same expert conducted a separate analysis but only as to one of the incretin drugs, meaning he excluded the others and only considered a limited set of clinical trial data.  At his deposition, the expert admitted he could have re-done his analysis as to all of the drugs, but “that was not what he was asked to do” by plaintiff’s counsel.  Id. at 6.  That was certainly not a sound scientific basis for changing his methodology in 2019.  Nor was it supported by any of the peer-reviewed literature which found no basis for treating any of the drugs separately.  Id. at 7.  Moreover, even with the studies plaintiffs’ expert did consider, he chose to exclude certain events with no reasonable or scientific basis for doing so.  He thereby deflated cancer events in placebo groups and inflated them in incretin groups.  Id. at 7-8. That same expert also failed to consider one of the largest observational studies done; performed in 2019 it found no association between the drug and pancreatic cancer.  Id. at 9.  Plaintiff’s other experts took a similar litigation-driven approach to their opinions, reflecting “unsound, ramshackle methodology” and “an undisciplined analysis suggestive of an authorial interest on achieving certain results rather than examining the data objectively.”  Id. at 11.

Moving from epidemiology to medical causation – because a statistical association is not the same as causation.  Plaintiffs offered only one medical causation expert.  He claimed he performed a “weight of the evidence” analysis.  Putting aside whether that is a scientifically sound methodology, the problem was that the expert did not apply the methodology in a reliable fashion.  At a minimum, the expert was required to “review the totality of available evidence” and “supply his method for weighing the studies he has chosen to include.”  Id. at 12.  He did neither.  To start, the expert admitted that he considered no epidemiological data published since 2015.  Id. at 13.  There’s that blip again.  To the extent he relied on the epidemiological experts discussed above, we already know they did not come close to considering the “totality” of the evidence.  What evidence the expert did consider, he failed to weigh.  He could not explain what weight he gave to the studies or why.  “As a result, [the expert’s] causation analysis is a black box that cannot be examined, replicated, or reproduced by other scientists or physicians.”  Id. at 13.

As if his own flaws were not enough, the sins of the epidemiology experts were laid at the feet of the medical causation expert.  Plaintiffs’ medical causation expert’s opinion was largely predicated on the analyses of the other excluded experts.  As a medical doctor, the expert could have evaluated whether certain events were properly included or excluded by the statistician and epidemiologist.  Instead, he blindly relied on their conclusions, which having been excluded were not the type on which an expert could reasonably rely.  Id. at 15.

Finally, the medical causation expert seemed to have the most to gain from a blip.  He certainly would have blipped away his 2016 peer-reviewed article in which he stated that “[s]ome data suggest insulin therapies may further increase pancreatic risk, although some drugs may decrease risk, and others “have no discernible effect,” while still others “are controversial, requiring further study.”  Id. at 15.  So, in 2016 in a peer-reviewed journal, plaintiffs’ expert could not or would not repeat his 2015 litigation-based opinion that incretin-based therapies cause or contribute to the development of pancreatic cancer.  A conclusion he quickly reverted to in 2019 in the context of the lawsuit.  Id. The only explanation offered for the “flip-flop” was that he relied on confidential materials produced in the litigation for his expert opinion.  But plaintiffs could not point to what those confidential discovery materials were.  Given his change of heart when expressing his opinion to the medical community at large, the court could only conclude that in authoring his expert opinion he did not use “the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”  Id. at 16.

Plaintiffs’ last principal expert sought to testify as to how incretin stimulated cell growth which he opined led to an increased risk of pancreatic cancer.  Id.  But at deposition, he admitted his opinion was an “unproven hypothesis” and “it was a mere hypothetical possibility that incretin-based therapies could cause pancreatic cancer.”  Id. at 17.  Since his opinion was nothing more than “inadmissible speculation,” it too was excluded.  Id.

The court also addressed three additional plaintiff experts.  The first two were clearly victims of the blip.  The first testified in 2015 that he ran out of time to finish his analysis, but still had not fixed that problem five years later.  Id.  The second testified in 2015 that there was additional research he would like to have done, but still had not done it by 2020.  Id. at 18.  Neither seemingly offered an explanation more plausible than they had turned to dust for five years.  Because their analyses necessarily were missing several key studies and having not considered the totality of the evidence, their “conclusion[s are] not worthy of consideration by a jury.”  Id.

The final expert studied images of lesion in baboons, but with no standard for assessing those lesions “he simply did an ad hoc analysis applying human specimen standards.”  Id. at 19.  With no literature or other analytical support for his use of animals to draw conclusions about humans, his testimony was likewise excluded.  Id.

Having excluded all of plaintiffs’ experts, the court granted summary judgment based on a lack of evidence of general causation.  Id.  Plaintiffs tried to argue biological plausibility, but that is not causation and without causation, plaintiffs cannot meet their burden of proof on an essential element of their claims.  Id. at 20.  Finally, plaintiffs tried to argue they could establish general causation through a differential diagnosis.  They relied on a case involving a rare type of cancer that occurred only a few hundred times in medical history.  With such a rare injury, there was a lack of epidemiological data and so plaintiffs’ experts were allowed to opine on specific causation without demonstrating general causation.  Pancreatic cancer, on the other hand and unfortunately, is not rare and there is a wealth of epidemiological data.  Data plaintiffs’ experts failed to consider.  Plaintiffs cannot simply “skip the general causation question.”  Id. at 21.  Nor can they “blip” away the years and the evidence developed in that time that contradicted their litigation-driven opinions.  And no simple “snap” can undo those years of failing to employ scientific rigor.