A recent order in the Xarelto MDL caught our attention because it is an example of something we see more and more:  A plaintiff in multidistrict litigation who neither accepts a settlement program worked out in the MDL nor is prepared to proceed with his or her claims once the chance to settle has passed.  So which will it be?  Take the defendants’ money or take your chances going it alone?

The plaintiff in In re Xarelto Rivaroxaban Products Liability Litigation, No. 17-5372, 2021 U.S. Dist. LEXIS 176170 (E.D. La. Sept. 15, 2021), chose his litigation strategy poorly.  The plaintiff’s decedent in that case used the defendant’s anticoagulation medicine under the direction of his cardiologist to reduce the risk of stroke and embolism.  Id. at *1.  He later stopped taking the drug seven days before a surgical procedure, again under his doctor’s orders, but sadly suffered uncontrollable bleeding during surgery and died.  Id.

At its peak, the Xarelto MDL included more than 30,000 individual cases, and more than 99 percent of them were resolved by an opt-in settlement program.  Id. at *4.  We have no information on the terms of the settlement program or how generous they were.  But, with a take rate exceeding 99 percent, we can commend both sides for coming to terms acceptable to the defendants and all but less than one percent of the plaintiffs.

The flip side, however, is that the less-than-one-percent had to prove their cases.  This plaintiff and her lawyers couldn’t do it.  They had no expert on causation.  They served one expert report, but did not provide all the materials required by the applicable case management order, and ultimately withdrew that expert.  Id. at *21.  Then, in opposing summary judgment, they submitted (late) an affidavit from the decedent’s surgeon stating that the excessive bleeding was caused by the use of the product and that if the product’s label had warned him of the risk of bleeding “he would have changed his decision on [the decedent’s] surgery.”  Id. at *6.

The affidavit, however, was a sham.  The surgeon later testified that the plaintiffs’ attorneys drafted the declaration (although he did sign it) and that he never read the product label until his deposition.  Id. at *7.  He also testified that he was unwilling to opine on whether the product could have caused the decedent’s death and that he did not know if there was any Xarelto in the decedent’s system during surgery.  Id. at *7-*8.

In other words, his sworn deposition testimony repudiated his affidavit, so the district court disregarded it:

Having reviewed [the surgeon’s] affidavit and deposition transcript, the Court finds that the affidavit is not competent summary judgment evidence.  The sham affidavit doctrine “prevents a party who has been deposed from introducing an affidavit that contradicts that person’s deposition testimony without explanation.”  Inconsistencies abound between [the surgeon’s] affidavit and his deposition testimony just three months later. . . .  In view of these unexplained inconsistencies, the Court need not consider the affidavit for summary judgment purposes.”

Id. at *19-*20 (citations omitted).  We call this the sham affidavit rule applied in reverse.  We have long understood that a party cannot raise a triable issue of fact by filing an affidavit contradicting his or her prior deposition admissions.  (See some of our prior commentary on sham affidavits here and here.)  In that event, the later affidavit is disregarded as a sham.  Here, we have the opposite.  The affidavit came first, and it was astute defense counsel and an honest live witness who completely obliterated it.  A sham flowing the other way.

That left the plaintiff again without a causation expert, so she requested leave to disclose yet a third expert.  But that expert’s report did not meet the requirements of Rule 26, and it did not proffer opinions sufficient to defeat summary judgment in any event.  The district court denied leave.  Id. at *21-*23.  And, the decedent’s other treaters could not fill the gap, as they confirmed that Xarelto would not have been in the decedent’s system a week after discontinuing use.  Id. at *17-*18.  The district court granted summary judgment on medical causation.

This ruling demonstrates the value of deposing affiants like the decedent’s surgeon here, and if that were the only takeaway from this order we would be satisfied.  However, in addition to medical causation, the district court ruled that the plaintiff’s warnings claims failed, too.  Applying Louisiana’s learned intermediary rule, the district court ruled that a drug manufacturer’s duty to warn runs to the prescribing physician and stated that “the plaintiff must show that ‘a proper warning would have changed the decision of the treating physician; but for the inadequate warning, the treating physician would not have used or prescribed the product.’”  Id. at *12-*13 (citations omitted).

The decedent’s prescribing physician “unequivocally testified” that the Xarelto label adequately warned him of the risk of bleeding and that it provided him with the information necessary to make an informed prescribing decision.  Id. at *13-*14.  He also said that Xarelto was the preferred medicine for the decedent and “I would still feel that way.”  Id. at *14.  The defendants therefore met their duty to warn.  Id. at *15.  Notably, the plaintiff’s third proposed expert purported to opine that the defendants failed adequately to warn the decedent of an increased risk, but that made no difference either because the duty to warn runs to the treating physician—the learned intermediary—not directly to the patient.  Id. at *22-*23.

The plaintiff’s design and manufacturing claims failed for lack of evidence too, but the main takeaway here is twofold.  First, if this plaintiff turned down an inventory settlement despite having failed to marshal evidence to support her case, imagine how many plaintiffs received settlement money despite being in similarly unsupported positions.  Such thoughts make us double down on our reservations about multidistrict litigation and its potential for harboring claims with no arguable merit.  Second, look out for affidavits that are too bad to be true.  They may not be.

Today we discuss a putative class action in which the named plaintiffs are a registered nurse who refuses to take a basic precaution to protect her vulnerable patients and a mother who is more interested in displaying her livestock than protecting her neighbors. Brought on behalf of all New Mexico residents who are equally selfish, the plaintiffs sought an injunction barring the state from enforcing a public health order that requires (with limited exceptions) all hospital, nursing-home, assisted-living-facility, adult-day-care, rehabilitation-facility, and prison workers, all employees of the governor’s office, and all who would enter the New Mexico State Fair grounds to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. The plaintiffs asserted various constitutional and statutory claims. In a thorough and trenchant decision, Valdez v. Grisham, — F. Supp. 3d —-, 2021 WL 4145746 (D.N.M. 2021), a federal district court rejected them all. That is consistent with long-standing precedent and other recent decisions—as we discussed here, here, and here.

The plaintiffs’ first claim was that requiring them to be vaccinated with “experimental” vaccines violated the FDCA. The claim was predicated on the fact that, at the time suit was filed, the three SARS-CoV-2 vaccines available in the United States—the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines—had not received full FDA approval and were instead being distributed and administered under Emergency Use Authorizations (EUAs). The plaintiffs claimed that requiring them to be vaccinated violated the terms of the vaccines’ EUAs, which require that those receiving each vaccine be informed of its “benefits and risks” and “of the option to accept or refuse” its administration. 2021 WL 4145746, at *4.

The court rejected the plaintiffs’ FDCA claim.

Implicitly responding to the plaintiffs’ assertion that the vaccines were “experimental,” the court recited at the outset both the extensive testing that each had undergone before the EUAs were granted, including “at least one well-designed Phase 3 clinical trial that demonstrate[d] the vaccine’s safety and efficacy in a clear and compelling manner,” and the fact that “[c]omprehensive data collected since the three vaccines received EUA status demonstrates that they are safe and highly effective in preventing infection and severe illness, and that serious adverse side effects from the vaccines are exceedingly rare.” 2021 WL 4145746, at *1. The court further observed that, “despite Plaintiffs’ protestation to the contrary, the FDA has now given its full approval—not just emergency use authorization—to the Pfizer vaccine” for administration to those 16 and older. Id. at *4. That did not moot the plaintiffs’ statutory claim, however, because the livestock-display-over-human-health plaintiff asserted the claim on behalf of not only herself but also her 11- and 12-year-old children, who were also keen to “show[] their animals” at the state fair. Id. at *2.

Addressing the merits of the plaintiffs’ FDCA claim, the court found that there were none. It explained that although the EUAs issued pursuant to the FDCA require “medical providers” administering the vaccines to inform would-be recipients of the risks associated with each vaccine and their right to refuse it, the EUAs do not prohibit the state from requiring individuals, duly informed by their medical providers, to be vaccinated. Id. at *4. In so holding, the court cited both Bridges v. Houston Methodist Hosp., 2021 WL 2399994, at *2 (S.D. Tex. 2021), which rejected a nearly-identical anti-vaxxer claim on the ground that the FDCA “neither expands nor restricts the responsibilities of private employers” and “does not confer a private opportunity to sue the government,” and a recent Department of Justice Office of Legal Counsel memorandum opinion concluding that the FDCA’s informed-consent provision “specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements.”

Having dispensed with their statutory claim, the court proceeded to dispense with the plaintiffs’ constitutional claims—brought under the Due Process, Equal Protection, and Contract Clauses.

Asserting a violation of their right to substantive due process, the plaintiffs alleged that they “‘have [constitutionally] protected liberty interests’ ‘in their right to live without governmental interference,’ their right ‘to bodily integrity,’ their right ‘to raise their children as they see fit,’ and their right ‘to engage in their chosen professions,’ and that because the state’s public health order is ‘not narrowly tailored,’ it violates these substantive due process rights.” 2021 WL 4145746, at *5.

Relying on well-established constitutional precedent, the court explained that a two-part analytic framework applies when a legislative enactment or executive action is challenged on substantive due-process grounds. The first step is to identify the “fundamental liberty interest” purportedly at issue. The second step is to determine whether that interest “is ‘deeply rooted in this Nation’s history and tradition’ and ‘implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if they were sacrificed.’” 2021 WL 4145746, at *5 (indirectly quoting Washington v. Glucksberg, 521 U.S. 702, 720–21 (1997)). If the asserted liberty interest meets that standard, then the government may not infringe it “‘unless the infringement is narrowly tailored to serve a compelling state interest.’” Id. (quoting Glucksberg, 521 U.S. at 721). If, by contrast, the legislative enactment or executive action “does not implicate a fundamental right,” the action is permissible if it “bear[s] a rational relationship to a legitimate government interest.” Id. (quotation marks omitted).

The court found that the plaintiffs did “not explain how the rights allegedly violated by the [public health order] are fundamental.” 2021 WL 4145746, at *5. “[I]ndeed nowhere,” said the court, did the plaintiffs “address how the right to work in a hospital or attend the State Fair, unvaccinated and during a pandemic, is ‘deeply rooted in this Nation’s history and tradition.’” Id.

In their request for preliminary relief, the plaintiffs relied on “the right to ‘engage in their chosen profession.’” 2021 WL 4145746, at *5. That, however, was no help to them, the court held, because “the Tenth Circuit”—the circuit within which the court sits—”has unequivocally held that the ‘right to practice in [one’s] chosen profession … does not invoke heightened scrutiny.’” Id. (quoting Guttman v. Khalsa, 669 F.3d 1101, 1118 (10th Cir. 2012)). Thus, said the court, “while Plaintiffs may ‘have a right to engage in their chosen professions,’ governmental infringement on this right will be “‘presumed to be valid’” so long as it is “‘rationally related to a legitimate state interest.”’” Id. (quoting Klaassen v. Trustees of Indiana Univ., 2021 WL 3073926, at *17 (N.D. Ind. 2021), in turn quoting City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 440 (1985)).

Moreover, said the court, “federal courts have consistently held that vaccine mandates do not implicate a fundamental right and that rational basis review therefore applies in determining the constitutionality of such mandates.” 2021 WL 4145746, at *5. Applying that standard, the court rejected the plaintiffs’ substantive due-process claim, concluding that “[t]he vaccination requirements set forth in the [New Mexico public health order], … grounded in medicine and science, are rationally related to [the state’s] legitimate purpose of protecting our community ‘against an epidemic of disease [that] threatens the safety of its members.’” Id. at *8 (quoting Jacobson v. Massachusetts, 197 U.S. 11, 27 (1905)).

As Bexis did last month, the Valdez court explained that “[w]ith its decision in Jacobson”—which upheld “a Cambridge, Massachusetts regulation that required all adult inhabitants of that city, without exception, to be vaccinated against smallpox”—“the Supreme Court ‘settled that it is within the police power of a state to provide for compulsory vaccination.’” 2021 WL 4145746, at *6–7 (quoting Zucht v. King, 260 U.S. 174, 176 (1922)).

All that is necessary for state action to survive the “rational basis test” is that it bear “a rational relationship to a legitimate government interest.” Glucksberg, 521 U.S. at 721. The Valdez court found that New Mexico’s vaccination requirements did more than that, concluding that “[t]he governmental purpose of stemming the spread of COVID-19, especially in the wake of the Delta variant, is not only legitimate, but is unquestionably a compelling interest.” 2021 WL 4145746, at *7 (quotation marks omitted).

Having rejected plaintiffs’ substantive-due-process claim on the ground that that the New Mexico public health order requiring certain people to be vaccinated against SARS-CoV-2 “meets the rational basis test” (2021 WL 4145746, at *8), the Valdez court quickly disposed of the plaintiffs’ remaining constitutional claims. It concluded that the plaintiffs’ equal-protection, procedural-due-process, and impairment-of-contract claims were also subject to rational-basis review and that they therefore failed for the same reasons as the plaintiffs’ substantive-due-process claim. Id. at *9–11.

Finding that plaintiffs were unlikely to prevail on the merits of their claims, and that the remaining equitable factors likewise cut squarely against them, the court denied the preliminary injunction that the plaintiffs requested.

Onward to full vaccination.

Get a group of experienced lawyers together and it won’t be long before there is a one-upsmanship game of Crazy-Things-Judges-Have-Done. A learned and revered colleague tells the story of how he went to argue before a law and motion judge many years ago and low comedy ensued. Being a diligent sort of fellow, said learned colleague arrived at the courtroom early. His motion was far down the docket so he sat and watched other arguments. He figured he might learn something about this judge’s methods. He did learn something. Maybe he learned the ultimate something. It was not something expected.

He perked up upon hearing that the motion immediately before his involved the same legal issue and very similar facts. What good luck! Even better, the judge ruled exactly the way our friend wanted for his case. As you can imagine, our friend confidently planted himself in front of the lectern when it was his turn and said, “Your Honor, my motion will be very easy for you to decide, because it is precisely the same fact pattern you confronted a mere two minutes ago, it implicates precisely the same statute, and it warrants precisely the same outcome.” He grinned when he said this. That grin soon disappeared.

The judge proceeded to ask impertinent questions, voiced bizarre policy concerns, induced the opposing side to make arguments nowhere in the briefs, and then announced he was going to rule against our befuddled friend. Before packing up his brief bag in disgust, our friend could not help himself and voiced frustration to His Honor: “Judge, I simply cannot understand how I came in here and saw you rule my way in a case on all fours with mine, and yet you went against me. What ever happened to precedent?” The judge showed no annoyance. Rather, he beamed with beneficence, wearing a smile that seemed to acknowledge the difficulties in finding fairness in a world full of indignities, shook his head, and said, “Ah ah ah: fifty-fifty.”

Rough justice, indeed. It is one thing to face a judge who reliably rules pro-defense or pro-plaintiff. You get what you expect, be it a jolly or awful moment. It is quite another to face a judge who is visibly aiming for fairness, but whose idea of fairness is little more than splitting the difference, spinning a roulette wheel, or, as in our friend’s experience, alternating rulings — “fifty-fifty.” One almost prefers the punch in the nose from a hostile judge to being tripped up by a clumsy one. Note that we said “almost.”

While looking through Daubert decisions, we tripped over a case that is now over a half a year old. The case is In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litigation, 2021 WL 781682 (D. Md. March 1, 2021). The defendant moved to exclude various opinions offered by plaintiff expert opinions. The main issues were expert qualifications and … preemption. Right away, that seems a bit weird. Usually, the Daubert issues are qualification, reliability, and fit. But we‘ll never turn down a dinner date when preemption is on the menu. So let’s dig in, shall we?

Then again, maybe this case won’t be so appetizing. It begins with the court fretting over “the difficulty of drawing precise lines that anticipate every iteration of an opinion that may be offered in support of a specific claim that itself is yet to to be precisely defined in the context of an individual case.” That is the sound of reluctance, not decisiveness. That is something we often hear from judges who deny Daubert challenges or motions in limine without prejudice. They’d rather rule in real time at trial. You know – after the plaintiff’s witness has already waved the bloody stump or tossed the skunk into the jury box. (That “yet to be precisely defined” bit also sounds like a case that maybe does not pass muster under the pleading requirements of Twombly and Iqbal.)

Then the court tells us that Rule 702 “was intended to liberalize the introduction of relevant expert evidence.” Ouch. (Our prescription for deadening the pain of this malady is a dose of Bexis’s write-up on the proposed revisions to Rule 702. Find it here.) To be fair, the court was quoting from a Fourth Circuit case, but that quotation seems to wish away Daubert, reliability, and judicial gate-keeping. Then we get a list of Daubert factors, but also an admonition that the list is not a checklist. Get ready for loosey-goosey.

There is something in the Smith & Nephew opinion for everyone. That is true for preemption. The court held that several of the plaintiffs’ claims were preempted: strict liability, duty to change the label, duty to warn patients and doctors, liability for claiming the product was safe, and liability for representations the FDA required. But the court held that other claims, “to the extent they parallel federal obligations, are not necessarily preempted.” The plaintiffs focused on conditions imposed as part of the FDA’s approval of the hip implant system, including implementation of a surgeon training program and submissions of analyses of adverse events and complaints.

The latter seems in obvious tension with Buckman preemption of fraud-on-the-FDA claims. How did the Smith & Nephew court resolve this tension? The court excluded anything related to the PMA approval process, but did not exclude any expert opinions that the defendant failed to make adequate disclosures in its required annual reports after receiving premarket approval. To our defense hack eyes, all that stuff is subject to preemption, be it express (statutory) preemption, implied preemption, or Buckman preemption.

Similarly, the court held that a “claim which challenges a representation the FDA blessed in the approval process is preempted, while a claim challenging a warranty above and beyond any guarantee that was explicitly or implicitly approved by the FDA is not preempted.” The court also excluded testimony relating to Dear Doctor letters and other communications to the medical community or patients, but reasoned that testimony opining that the defendant “had a duty under the PMA or another federal requirement to disclose certain information to the FDA directly could still be relevant to a parallel state law failure to warn claim … so long as that claim can be proved based on a violation of a condition imposed by the FDA.” That all feels a bit fifty-fifty-ish, but the court clamped down on the plaintiffs’ claim that the company had a duty to modify its training program. The court also excluded any expert opinions that the defendant had a duty to withdraw its products. Only the FDA has authority to withdraw approval from a device.

The plaintiffs offered opinions from their experts regarding the duties of a reasonable manufacturer and whether the product was unreasonably dangerous. The court held that to the extent “any expert testimony seeks to rely exclusively on state law duties that are not pinned to federal requirements, they are irrelevant to the remaining claims in this case.” But one expert asserted that there were violations of a federal regulation or condition of approval, and the court refused to exclude that opinion. Expect plaintiff experts to drive a big-rig, tractor trailer through that hole, whether or not they have a commercial driver’s license or any similar driving expertise.

That brings us to the court’s discussion of expert qualifications. It is a dismal discussion. Most gaps or shortcomings in expertise went to weight, not admissibility, were fodder for cross-examination, etc. One expert was permitted to opine whether a surgeon training program was adequate from a clinical perspective, but could not opine as to whether it satisfied FDA regulatory requirements.

The court imposed some limitations on speculative testimony, historical-factual narratives, and legal conclusions (“except in a case involving a specialized industry where such a conclusion may be helpful to the trier of fact” – excuse us while we groan at another Mack truck-sized hole).

What do we think of the Smith & Nephew court’s rulings on the proffered expert testimony? Fittingly, perhaps, we are fifty-fifty.

We looked back over the blog and it’s been over one year since we posted on snap removal.  Last spring and summer, we reported on new pre-service removals almost monthly.  So, we decided to poke around a bit and see if there was anything going on outside the drug and device law space.  We found Choi v. GM LLC, 2021 U.S. Dist. LEXIS 172291 (C.D. Cal. Sept. 9, 2021) and thought the court’s reasoning was worth bringing to our audience.

Plaintiffs filed suit in Los Angeles County Superior Court against GM and three local dealerships.  Three days later, before any defendant was served, GM removed the case to federal court.  It was undisputed that complete diversity existed between plaintiffs and defendants.  Id. at *4n1.  It was also undisputed that the local dealerships were forum defendants which means that the “local-defendant” limitation on removals applies – if a case is otherwise removable on the grounds of diversity, it “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.”  28 U.S.C. §1441(b)(2).

There are two schools of thought on the forum-defendant rule.  There is the view that one should read into the statute a requirement that at least one defendant be served or that plaintiff be given a reasonable opportunity to serve at least one defendant before a case can be successfully removed.  We’ll call that the plaintiff-school.  Or simply, wrong.

The alternative view is that the statute should be afforded its plain meaning.  Only if a local defendant is “properly joined and served” may an action not be removed.  We’ll call that the defendant-school.  Or simply, correct.

The court first looked to the Ninth Circuit.  It has not addressed the issue.  Plaintiffs, therefore argued that since the majority of courts in the Central District of California have opted to follow the plaintiff-school, so too should this court.  But defendants had Central District cases on their side as well.  The court determined it need not decide “on which side of the line this District comes down with mathematical precision.”  Id. at *7.  Instead, the court looked to the reasoning of the only three federal appellate courts to have decided the issue.  And all three applied the plain meaning of the statute.

We’ve posted about all three appellate decisions – the Third Circuit’s Encompass Ins. Co. v. Stone Mansion Restaurant Inc., 902 F.3d 147 (3d Cir. 2018); the Second Circuit’s Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019); and the Fifth Circuit’s Tex. Brine Co., LLC v. Am. Arbitration Ass’n. Inc., 955 F.3d 482 (5th Cir. 2020).   Plaintiff tried to argue that there are in fact four appellate decisions on snap removal citing the Eleventh Circuit’s opinion in Goodwin v. Reynolds, 757 F.3d 1216 (11th Cir. 2014).  But the issue decided by that case was whether the district court erred in allowing the plaintiff to voluntarily dismiss her suit without prejudice.  Id. at *9.  While the district court had also denied plaintiff’s motion to remand, that ruling was not appealed and was not before the court – a point the 11th Circuit repeatedly points out in the opinion.  While there is some language in the decision to suggest that the court found the pre-service removal to be a “technicality” or “gamesmanship,”

the appellate court did not effectively re-write Section 1441(b)(2) by ignoring the “properly joined and served” language (as Plaintiffs essentially as the Court to do here).

Id. at *10.

The Choi court’s view is that if Section 1441(b)(2) is going to be re-written, it needs to be by Congress.  Id. at *11.  Indeed, the plaintiffs’ bar took the issue to Congress in 2019.  And as we discussed in our post at that time, the real issue should have been litigation tourism.  If Congress is going to do anything, it should get rid of the archaic forum-defendant rule not pre-service removal.

Putting Congress aside, the court explained why not adhering to the plain language of the statue is problematic.  To the extent plaintiffs wanted the court to read into the statute a requirement that they be given a “reasonable” opportunity to serve the complaint before service, the court recognized that would cause more problems than it would solve.  What is a “reasonable” time to effectuate service?  What is to stop one court from deciding 24 hours is sufficient and another from finding a week is reasonable?  Plaintiffs encouraged the court to follow the district majority on this issue to promote predictability and consistency.  But introducing an undefined “reasonableness” standard into the rule would only lead to less, not more certainty.  Id.*13-14.  And, as for that district majority in the plaintiff-school, none of the Central District cases on which plaintiffs relied were decided after Encompass, Gibbons, or Tex. Brine.  Following the overwhelming appellate level support for pre-service removal, the Central District cases started joining the defendant-school; they just don’t outnumber the earlier cases yet.  Id. at *13n.6.

In sum, “[c]ertainty follows from application of the plain language of a statute, an approach that is in-line with the only federal courts of appeal to have directly-considered the question.”  And not through “inexact standards based upon words and/or principles that do not actually appear in the statute.” Id. at *14.

Today, we chronicle two more decisions from the Zantac MDL.  Once again, kudos to this MDL transferee judge for outstanding willingness to tackle legal issues, and decide them, at an early stage of the litigation.  Because we’ve gone through these issues before, here and here, we discuss these latest rulings in one post.

Chronicle VII

In In re: Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2021 WL 2682602 (S.D. Fla. June 30, 2021), most innovator liability claims are once again dismissed.  In the interim, since the first Zantac innovator liability decision, the United States Supreme Court decided the somewhat expansive specific personal jurisdiction decision in Ford Motor Co. v. Montana Eighth Judicial District Court, ___ U.S. ___, 141 S.Ct. 1017 (2021), so to that extent the Zantac plaintiffs at least had something to argue about.

Ford Motor didn’t do them any good.

First, the plaintiffs did not bother to reallege innovator liability under any of the 35 states that the earlier Zantac decision predicted would not adopt such liability.  2021 WL 2682602, at *3-4.  Instead, they made their last stand under the laws of California and Massachusetts, the only two states in the nation that currently allow innovator liability.  Id.

Plaintiffs’ main argument was that Ford Motor somehow (it was never really quite clear) allowed residents of California and Massachusetts to assert “related to” specific jurisdiction over defendants whose products they never ingested, based on regulatory facts that had no nexus to these two states.  Plaintiffs, in an argument redolent of the losing side in Bristol-Myers Squibb Co. v. Superior Court, ___ U.S. ___, 137 S.Ct. 1773 (2017), asserted that “Defendants ‘targeted the California and Massachusetts markets’” through certain general activities.  2021 WL 2682602, at *5 (referencing physician education, market research, social media, medical education and studies, advertising, contracts with in-state intermediate sellers).  Glaringly, that list of activities did not include any defendant selling any product that any California or Massachusetts plaintiff ever allegedly ingested.  Those allegations formed the basis for negligent misrepresentation (California) and reckless misrepresentation (Massachusetts) causes of action.  Id.

None of these amended allegations sufficed to establish personal jurisdiction, notwithstanding the new Ford Motor decision.  Critically, all of the in-forum activity that the Supreme Court found supportive of specific personal jurisdiction in Ford involved that defendant’s own products, and its own products injured the plaintiffs.  Innovator liability was just the opposite – it solely involved liability for different manufacturers’ products, because those manufacturers were required by federal law to use identical warnings.  Id. at *9-11.  Thus “Plaintiffs have not met their burden to show that their claims arise out of or relate to Defendants’ activities in California or Massachusetts.”  Id. at *12.

The innovator-liability theory adds a layer of uniqueness and complexity to the traditional specific personal jurisdiction analysis because it seeks to hold brand-name product manufacturers liable for injuries caused by products that they did not manufacture, distribute, or sell.  Under this theory, the nexus between the brand-name product manufacturer’s conduct and the generic product consumer’s claims is more tenuous than had the claims been based on consumption of the brand-name manufactures’ products.

Id. (citation omitted).

The defendants’ alleged in-state activities, while satisfying the first jurisdictional prong of purposeful availment, id., went no further.  They were like the generalized allegations of in-state conduct found insufficient in BMS.  Id.  Activities related to the development and marketing of the innovators’ own products – as opposed to the generic products the plaintiff alleged they had actually used − do not “relate to” the conduct allegedly creating innovator liability:

Plaintiffs have not sufficiently alleged that Defendants’ contacts “relate to” Plaintiffs’ claims. . . .  [T]he specific allegations about Defendants’ sales and marketing activities in California and Massachusetts do not relate to the core conduct that constitutes the rationale for holding brand-name manufacturers liable for claims brought by consumers of generic bioequivalent products based on the theory of innovator-liability, . . . a brand-name manufacturer’s labeling decisions regarding its own product.

Id.  Those labeling decisions were not made within the states in question.  For purposes of the only claim plaintiffs were asserting – innovator liability – the “only conduct that gives rise to Plaintiffs’ claims is Defendants’ alleged failure to update the warning label for brand-name ranitidine products, not the alleged misrepresentations . . . made in the course [defendant’s]of sales and marketing activities.”  Id. at *14.  None of plaintiffs’ conduct allegations was “jurisdictionally relevant.”  Id.

Thus, by divorcing liability from the defendants’ sale of their own products, innovator liability necessarily divorced the defendants’ alleged liability-producing conduct from their own products as well – and all of plaintiffs’ allegations of in-state conduct involved defendants’ activities relating to their own products.  Otherwise “related to” jurisdiction would not have “real limits,” contrary to Ford Motor.

The nature of an innovator-liability claim, therefore, compels the Court to establish those “real limits,” for purposes of specific personal jurisdiction, as only those activities that relate to the brand-name manufacturers’ labeling decisions regarding their own product.  It follows that Defendants’ other activities do not relate to the claim and as such, allegations relating to those activities do not support specific personal jurisdiction of the brand-name manufacturers in California and Massachusetts.

Id.  Fatally, plaintiffs “conceded . . . that they do not allege that Defendants made labeling decisions related to brand-name ranitidine products in California or Massachusetts.”  Id.

Plaintiffs also invoked something called “legislative jurisdiction” in an attempt to override normal choice-of-law rules (while also ignoring plaintiffs’ own prior arguments about the laws of multiple states), and apply California and Massachusetts law extraterritorially to plaintiffs having nothing to do with those states.  Since that would require a state-by-state choice-of-law analysis, Zantac postponed it until later.  Id. at *15.  Technically, plaintiffs won that round – but only in the sense that they didn’t lose outright.  More about that, later.

Finally, one relatively minor defendant had the misfortune to be subject to general jurisdiction in Massachusetts.  Based on plaintiffs’ allegations about the role of that defendant, innovator liability claims against it survived dismissal.  Id. at *16.

Chronicle VIII

In re Zantac (Ranitidine) Products Liability Litigation, 2021 WL 2685605 (S.D. Fla. June 30, 2021), TwIqballed all of the personal injury claims against the “retailer and pharmacy defendants” with prejudice.  Id. at *1.  Thus, the decision did not reach these defendants’ constitutional preemption motion (which we also thought was rock solid).

Following the first dismissal of their retailer/pharmacy claims, plaintiffs filed an amended complaint with only one claim:  “negligent storage and transportation outside the labeled range” (which is 68º-77º F).  Id. at *5.  To avoid preemption, plaintiffs now alleged only failure to conform to the storage temperatures stated in the drug labeling – that it had been stored at excessively “hot” temperatures.  Id.  Since storage and transportation is inherently variable, plaintiffs sought to generalize these claims by attacking these defendants’ allegedly negligent “usage of common carriers (such as the postal service).”  Id.

What should they have used?  Carrier penguins?

The Zantac plaintiffs were once again making things up as they went along.  All but one paragraph of purported factual support pleaded in their complaint was “on information and belief.”  Id. at *6.  However, like most courts, the Eleventh Circuit holds that unless the information is peculiarly in an opponent’s possession, “information and belief” allegations are to be disregarded in evaluating motions to dismiss.  Mann v. Palmer, 713 F.3d 1306, 1315 (11th Cir. 2013).  See also Zamfirova v. AMAG Pharmaceuticals, Inc., 2021 WL 2103287, at *8 (D.N.J. May 25, 2021); Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218, 225-26, 231-32 (W.D.N.Y. 2016); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *10 (E.D. Va. Aug. 23, 2012); Gelber v. Stryker Corp., 788 F. Supp.2d 145, 161 (S.D.N.Y. 2011); Funk v. Stryker Corp., 673 F. Supp.2d 522, 525 (S.D. Tex. 2009), aff’d, 631 F.3d 777 (5th Cir. 2011).

Even as to the common-carrier allegations, plaintiffs were simply making things up.  Unfortunately for them federal regulations exist that govern drug transportation and storage, and they allowed “excursions” during storage and shipping of up to 86º F and “transient spikes” of up to 104º F.  Zantac, 2021 WL 2685605, at *8 (quoting United States Pharmacopoeia (“USP”)).  The existence of these regulations rendered plaintiff’s broad, vague indictment of common-carrier transportation and storage implausible:

The Court fails to see how this general allegation plausibly suggests a Defendant violated a duty of care because, pursuant to the FDCA through the USP, it is lawful for a room-temperature drug to be subjected to elevated temperatures, within certain limitations.  Through their silence on the topic, the Plaintiffs have made no argument that the Defendants could somehow be found to have breached a state duty of care if they fully complied with the federal transportation requirements contained in the USP.

Id.  Plaintiffs were thus no better off than before their amendments, alleging only “that from time to time, in certain locations, in certain weather, there may have been a rogue truck, a rogue warehouse, or a rogue store” where the product received excessive heat exposure.  Id.

Moreover, when exposed to actual facts, the wheels once again fell off plaintiffs’ allegations.  Their own complaint stated that the drug required five “continuous” days of exposure to temperatures of 158º F or more to exceed the FDA’s “unacceptable daily level” of exposure to the allegedly carcinogenic breakdown product (N-nitrosodimethylamine).  Id. at *9.  That made plaintiffs’ entire theory simply implausible:

[T]he Court finds it implausible to conclude, without any supporting factual allegations, that common carriers would expose the products in their care to 158-degree heat for a continuous period of 5 days before the ranitidine reached its ultimate destination.

Id.

Plaintiffs’ claims suffered from as second form of inherent implausibility.  It’s simply not negligent to ship drugs by common carrier, such as the post office.  Id.  “The practice of providing pharmaceuticals by mail or other courier has existed for at least a century and was particularly prevalent in rural areas where distances between pharmacists often made in-person dispensing of medications impractical.”  Id. (citation and quotation marks omitted).  Indeed, the laws of “nearly four-fifths of the states . . . expressly permit such shipments.”  Id. at *10 (citation and quotation marks omitted).  Since “the shipment of drugs through a common carrier in the United States is such a routine, ubiquitous practice, [plaintiffs allegations] would mean that each day thousands of companies commit ordinary negligence.”  Id.

That’s what happens when plaintiffs make things up as they go along and never stop to think about what they’re actually alleging.  This implausible negligence allegation – “one allegation in one paragraph in a complaint spanning 3,268 paragraphs” – required dismissal of all plaintiffs’ negligence claim under TwIqbal.  Id. at *10.

And, finally, the MDL court had enough of plaintiffs’ willingness to plead anything, no matter how fantastical, to avoid dismissal.  It dismissed all claims against the pharmacy/retailer defendants with prejudice, rather than let plaintiffs make up something else:

The Defendants, over the course of the past sixteen months, have no doubt incurred substantial costs in the form of motion practice and discovery. . . .  Notwithstanding the significant costs that the Defendants have incurred, at no time have the Plaintiffs stated a claim against the Defendants.  The Court provided the Plaintiffs a fair and just opportunity to state a claim against the Defendants. . . .  Were the Plaintiffs to file a third master pleading, any sustainable theory in that pleading against the Defendants would be a new, previously untested theory.  The introduction of new legal theories at a later stage of proceedings amounts to undue prejudice.

Id. at *11 (citations omitted).  Given “Plaintiffs’ desire . . . to hold all Defendants liable in a master pleading for all sales of ranitidine,” any further amendment would be futile.  Id. (emphasis original).

Epilogue

Given the Zantac plaintiffs’ prolix and over-exuberant pleadings, suing everyone for everything, there are procedural difficulties regarding appeals from these orders.  Enough legalistic flotsam and jetsam remains that there are questions about appealability – the finality of the orders as to all claims and all parties (such as the leftover claims, described above, after innovator liability was dismissed), and whether final judgment should be entered for some of the defendants.  Plaintiffs moved for entry of a particular form of final judgment, but failed to get what they wanted.  See In re Zantac (Ranitidine) Products Liability Litigation, 2021 WL 3473759 (S.D. Fla. Aug. 6, 2021).  The Court stated that its orders as to the retailers and distributors were not final, and that while the Master Complaint allegations against them were dismissed, “[u]pon remand, the individual Plaintiffs should have the option to seek through amendment a negligence claim on case-specific facts, provided an individual Plaintiff has a factual basis to do so.”  Id. at *3.

As to the generic defendants, the Court’s dismissal orders were final, but plaintiffs asked for entry of final judgment as to those parties without identifying which MDL member cases involved only generic manufacturer defendants.  “Due to this lack of specificity from the Plaintiffs, the Court declines at this juncture to enter a final order of dismissal as to the Generic Defendants.”  Id.

And as to innovator liability orders involving the brand manufacturer defendants, those were not final because:  (1) plaintiffs were allowed to replead, if they could, that the branded defendants “made labeling decisions” in California or Massachusetts; (2) every plaintiff’s complaint joined the one, unfortunate defendant arguably subject to general jurisdiction in Massachusetts; and (3) plaintiffs “legislative jurisdiction” theory was left unresolved.  Id. at *4.  Although Plaintiffs had sought to manufacture finality by abandoning the claims the Court had allowed them to replead, or keep for now, they were hoist on their own pleading petard.  Id. at *4.  Here, as well, plaintiffs offered no authority that, “simply because they have now chosen not to pursue the[se] claim[s],” they can “convert the Court’s dismissal without prejudice of the innovator-liability claims brought in California and Massachusetts courts to a dismissal with prejudice.”  Id.

They pleaded it; they own it.

So plaintiffs’ request for orders allowing immediate appeal was denied.  Id. at *5.

But prolix is prolix:  We also understand that plaintiffs were undeterred and already have filed more than 50 notices of appeal.

We are back from a weeklong vacation in Greece, with time split between Athens and a lovely, tiny, lightly-touristed island called Symi.  We offer these observations:

  • It is challenging, but not impossible, to enjoy the copious culinary offerings on international flights without removing one’s N-95 and face shield.
  • The fifteen-hour overnight ferry trip from Athens to Symi is its own vacation – a mini-cruise on a surprisingly large and lovely vessel.
  • If your parents really walked five miles back and forth to school, uphill in both directions, they probably lived in Greece.
  • If we were forced to subsist on nothing but Greek-made feta and baklava, we’d do just fine.

It was a great adventure and a welcome taste of near-normalcy, but we are glad to be home, COVID-negative, and reporting today’s correctly-reasoned decision, Normandy v. American Medical Systems, Inc., — A.3d —, 2021 WL 3482928 (Conn. Aug. 9 2021).  Normandy is the Connecticut Supreme Court’s decision on the appeal of a decision on which we reported just over two years ago.  In that decision, the trial court granted summary judgment for the defendant hospital, holding that: 1) the hospital was not a “product seller” for purposes of the plaintiff’s strict liability claims under Connecticut’s product liability statute; and 2) the plaintiff’s common-law claims and her claims under Connecticut’s unfair trade practices statute (“CUTPA”) were time-barred.   (The plaintiff had already withdrawn her complaint against the named defendant, the manufacturer of her pelvic mesh device.)

“Product Seller”

On appeal, the plaintiff argued that the hospital “was engaged in the business of selling mesh slings and that the primary, if not sole, purpose of [the hospital’s] relationship with [the plaintiff] was providing the sling to be implanted by [the implanting physician’s medical practice].”  Normandy, 2021 WL 3482928 at *3 (internal punctuation and citation omitted).  She asserted that “evidence of [the hospital] regularly stocking pelvic mesh products, marketing the . . . sling on its website, and selling the device at a markup” created issues of fact that should have defeated summary judgment.  Id.  The hospital countered that the trial court had correctly concluded that the hospital was not a “product seller” because it was not “engaged in the business” of selling the mesh sling and because “the nature of the relationship between [it] and the plaintiff was that of medical service provider and patient.”  Id. (internal punctuation and citation omitted).

The Court agreed.  It explained that, under prevailing Connecticut law, a party is a “product seller” when “a sale of a product is a principal part of the transaction” and “the essence of the relationship between the buyer and the seller is not the furnishing of professional skill or services.”  Id. (emphasis in original, internal punctuation and citations omitted).   The Court also cited the Restatement (Third) of Torts, Product Liability §20, reporters’ note to comment d, for the proposition that “most jurisdictions hold that hospitals and doctors provide a service – medical treatment – and immunize them from strict liability for defective products used in medical treatment, whether the product is implanted in the patient, loaned to the patient, or merely used as a tool.”  Id.

The Court emphasized that the record did not support the plaintiff’s argument that the hospital advertised and marketed the sling on its website.  Instead, the hospital’s website provided information on different types of treatments for the condition from which the plaintiff suffered, but the content was “purely educational or informational in nature” – nowhere did the website mention the specific sling the plaintiff received.   While the website for the implanting surgeon’s medical practice group did mention the sling, there was “no evidence that the [hospital had] any control over the medical practice group’s webpage.”  Id. at *5.  The Court concluded, “Thus, if the defendant’s website constitutes advertising at all, it is advertising the hospital as a service provider.”  Id.

The plaintiff also argued that “the essence” of her relationship with the hospital was for procurement of the sling because “the defendant obtained and stocked the mesh sling, any services provided were dependent on its sale, and the defendant billed” the plaintiff’s insurance company for significantly more than it had paid for the sling.  Again, the Court disagreed, stating, “The mere fact that the defendant billed for the . . . sling does not conclusively establish that its sale was the main purpose of the plaintiff’s relationship with the defendant,” even if it profited from the sale.  Finally, the Court considered “other indicia that the essence of the transaction” was for services, not for the sale of the product:  the largest portion of the bill the hospital submitted to the plaintiff’s insurance carrier was not for the sling but was for other supplies and recovery and operating room services.”  While “not dispositive, the fact that the majority of the bill was for services, rather than products, strongly indicate[d] that the essence of the transaction was for the provision of services.”  Id. at *7 (citations omitted).  In sum, the Court concluded, because the hospital did not advertise the sling for sale to patients and because the transaction between the plaintiff and the hospital was primarily for services, not for the sale of the product, “the trial court correctly determined that the defendant was not a product seller as a matter of law” and correctly granted summary judgement on the plaintiff’s product liability claims.

Statute of Limitations/Statute of Repose

The plaintiff argued that the trial court incorrectly held that the CUTPA and common-law claims were time-barred, finding that the statutes of limitations and repose for those claims were not tolled under either the doctrine of “continuing course of conduct” or the doctrine of fraudulent concealment.

First, the plaintiff argued that the statutes were tolled under the “continuing course of conduct doctrine” because the hospital “continued to market and promote mesh slings after the plaintiff’s surgery, while concealing the risk” of the procedure until at least a year after the plaintiff filed her complaint.  Id. at *8.  The court reiterated that the hospital’s web site did not mention the sling, and, while the implanting surgeon’s medical practice’s web site did mention the sling, there was no evidence that the hospital had any control over this web site.  Moreover, there was no evidence that the plaintiff ever saw the hospital’s web site or received any marketing materials from the hospital.  The Court concluded, “Because there is no evidence that the defendant committed the initial wrong of marketing the product in a way that contributed to the plaintiff’s injury, the continuing course of conduct doctrine does not toll the statute of limitations applicable to the plaintiffs’ CUTPA claim.”  Id. at *8 (emphasis in original).  The Court continued, “We further conclude that the [hospital] did not have an independent duty to inform the plaintiff of the risks associated with a mesh sling implant procedure, even after the procedure ha[s] been completed . . . .”  As such, there was no genuine issue of material fact as to whether the continuing course of conduct doctrine tolled the statute of limitations applicable to the plaintiff’s common-law claims.  Id. at *9.

Finally, the plaintiff argued that the applicable statutes of limitations and repose were tolled under the doctrine of fraudulent concealment because the defendant “had actual knowledge of the dangers associated” with the implant procedure and “intentionally concealed that information from the plaintiff.”  Id.   In response, the Court noted that the hospital’s web site listed risks associated with the sling implant procedure and referred to FDA comments about the procedure, and that there was no evidence that any alleged concealment by the hospital was for the specific purpose of delaying the filing of the complaint.  Hence, the doctrine of fraudulent concealment, like the doctrine of continuing conduct, did not apply, the statutes of limitations were not tolled, and the claims were time-barred.

And, just that neatly, the Court affirmed the trial court’s grant of summary judgment, nailing shut the coffin on the plaintiff’s claims.  We love the no-nonsense approach and solid reasoning of this decision, and we agree with its holding.  (As do many courts – you can see our post cataloguing such decisions here.)  We are happy to be back “stateside” to report this to you, and we will keep our eye out for similar decisions.  In the meantime, stay safe out there.

After eschewing our blogging duties during a very long trial—followed by short deliberations and a verdict for the good guys—we are back at it.  Normally, a significant criterion in how we select a case for a post is the length of the decision—the shorter, the better for our normally busy work lives.  After trial, there is an inevitable bit of a lull and we were willing to take on a longer decision, in part because of a scintilla of guilt at having not blogged for so long, but also because we had deposed two of the three experts at issue a few times many years ago.  Back then (and for a while before and after), we were involved in a number of Daubert decisions on alleged serotonin-mediated effects of prescription drugs.  We have also been involved in and blogged about a range of litigation over claimed impacts on offspring from drug use during pregnancy.  Thus, the decision in Daniels-Feasel v. Forest Pharms., Inc., No. 17 CV 4188-LTS-JLC, 2021 U.S. Dist. LEXIS 168292 (S.D.N.Y. Sept. 3, 2021), covered some familiar ground.  It also covered it well, as the general causation opinions of the three plaintiff experts were excluded as unreliable.

The issue in Daniels-Feasel was whether plaintiff’s experts had offered admissible general causation opinions about the relationship between the pregnant mother’s use of defendants’ prescription SSRI for depression and the development of autism spectrum disorder (“ASD”) in an offspring.  The familiar experts, Dr. Moye (epidemiologist) and Dr. Plunkett (pharmacologist), were paired with Dr. Whitaker-Azmitia, a neuropharmacologist and something of an advocate for such a relationship.  Even though these opinions were not solely generated for-litigation, as is usually the case, and the defendants conceded the qualifications of each of the plaintiff’s experts were sufficient, the court could not get past the cherry picking of evidence and general result-driven shoddiness of their methodologies.  In short, the trial judge—the current chief judge of “the Southern District”—assiduously carried out her role as gatekeeper and the sort of “junk science” that Daubert addressed will not get to a jury.  (This is our assumption at least, as a plaintiff without admissible evidence on general causation should lose summary judgment.)  Even though we note that the decision cited some pre-Daubert cases and many pre-2000 amendment of Rule 702 cases, it is a good example of why a rigorous application of Rule 702 makes sense and why the pending revisions to Rule 702 would be a good thing to adopt.

In terms of the causation theory that plaintiff’s experts espoused—and with a healthy disclaimer on our knowledge of the science here—we do note that it seemed pretty out there.  The causes of and risk factors for ASD have been studied extensively.  SSRI use is prevalent and has been the subject of lots of research and litigation.  If there really were a relationship between maternal use of SSRIs and ASD in offspring, then one would think it would have garnered significant attention.  By contrast, when the court cited Dr. Moye’s report for the proposition that “[a]lthough ‘changes in neural growth during prenatal and postnatal periods’ and genetics may play a role in causing ASD, there is no ‘gene for autism’ and the precise cause of the disorder is unknown,” we knew plaintiff’s experts were reaching.  If Rule 702 and Daubert have any teeth, then how can an opinion that a drug causes a condition be admissible when science does not yet know any causes for the condition?  The court did not cite it, but the old Rosen saw of “law lags science; it does lead it” comes to mind.  That said, we were surprised that plaintiff’s experts did have some studies reporting an increased risk of ASD with SSRI use.  That meant the court would dig into the details of epidemiology, which is something we like to see and something we think courts do not do enough (especially those courts that excuse the absence of proof of increased risk from epidemiologic or clinical studies in an effort to let mere theories be presented to juries).

We were not surprised, however, that Dr. Moye purported to apply the Bradford Hill criteria as the key part of forming his causation opinion.  He was doing that when he first appeared in litigation more than twenty years ago and the criteria are still widely accepted in epidemiology, although often misapplied in litigation.  In addition, we were pleased that the court’s recounting of the applicable law emphasized what hurdles the expert and proponent of the evidence had to clear rather than the notion that a jury could hear untested and unsupported theories as long as the opponent of the evidence had a chance to cross-examine the expert.  The court also accurately presented the Bradford Hill criteria as applying only when there is an association between an exposure and condition, rather than a framework that be used in the absence of supporting epidemiologic evidence.  2021 U.S. Dist. LEXIS 168292, **18-20.  In doing so, the court relied heavily on the decisions from the Mirena MDL—also in the S.D.N.Y.—and Zoloft MDL, both of which were affirmed on appeal.  We posted a bunch on these decisions, which garnered cherished spots in our Top Ten lists over the last six years, and think they represent the state-of-the-art when it comes to Daubert and general causation.  See here, here, here, and here for Mirena and here, here, here, and here for Zoloft.  With this background, and knowing that Dr. Moye’s causation opinion in Mirena was also excluded, the court walked though Dr. Moye’s opinion, considering not just what he said studies found but what the study authors said they actually found.

The court concluded that Dr. Moye’s causation opinion was unreliable, as “he fails to adequately support his conclusions using the selectively favorable data he relies upon, unjustifiably disregards inconsistent data, and admittedly ignore categories of relevant evidence.”  Id. at *21.  We could spend some time wading into the specific conclusions about how Dr. Moye’s application of the Bradford Hill criteria fared—it is a good yet weedy read—but we will instead focus on something we noticed here that seems pretty new and potentially useful.  The court held that “Dr. Moye’s opinion is not generally accepted, as no regulatory agency, professional organization, peer-reviewed study, or medical treatise concludes that Lexapro causes ASD, and the FDA has approved its prescription to pregnant women.”  Id. at *22.  That is a double-dip on looking to what regulatory agencies say and do.  Later, the court dinged Dr. Moye for failing to address a 2016 report by the European Medicines Agency (“EMA”) that concluded the then-available data “on prenatal exposure to SSRI/SNRI and ASD do not support a causal relation.”  Id. at **39-40.  While we do not know if the plaintiff here tried the usual dismissal of FDA and EMA as under-staffed, incompetent, pawns of industry, etc., it seems noteworthy that the court evaluated a novel causation theory with some credit to what regulatory agencies do.  At a minimum, the expert should have to answer “why did everybody else looking at the same science come to the opposite conclusion?”

Next up was Dr. Plunkett (addressed here and here), who limited her opinion to whether a relationship between prenatal exposure to SSRIs and ASD was biologically plausible.  “Biological plausibility” is one of the Bradford Hill criteria, but Dr. Plunkett did not try to offer a general causation opinion and the other experts did not rely on her for theirs.  This probably made her opinions excludable as to causation simply based on relevance.  Nonetheless, the court analyzed the reliability of her opinions.  After noting that she failed all the Daubert factors of testing, peer review, error rate, and general acceptance, the court walked through her methodology.  As an initial matter, the court was skeptical about Dr. Plunkett’s reliance on animal studies data without reliable evidence of correlation to humans.  Id. at **45-48.  Her treatment of human studies and data was “inscrutable as a scientific method of weighting that is used and explained, and therefore falls should or meeting the rigorous examination standards of Daubert and Rule 702 under the weight of the evidence methodology.”  Id. at *48 (internal citation and quotation omitted).  For us, the obvious analytical gap here was whether Dr. Plunkett could identify animal behaviors or findings that correlated to ASD, not just to alterations in serotonergic pathways.  Similar to what we said above, if the causes of and risk factors for ASD are not known, then evidence on biological plausibility will need to be really specific and convincing.  This was recognized later, when the court noted Dr. Plunkett’s concession that “animals cannot even be diagnosed with autism in the same way humans can, because ‘human brains are different than rodent brains’ and animals ‘are not communicative in the way . . . humans are.’”  Id. at *56.  Without correlation, discussion of animal studies was, at best, an interesting exercise disconnected from any causation issue.

Along the way, the court found numerous methodological failings from Dr. Plunkett, generally categorized as cherry-picking data and failing to address contrary data.  Id. at *50.  As with Dr. Moye, one bit of contrary data was the EMA report, which she disingenuously said was outside the scope of her review (as a purported regulatory expert who reviewed other regulatory materials).  Id. at *59.  This all added up to her opinions being excluded as unreliable.

Last was Dr. Whitaker-Azmitia, who did not fail every one of the Daubert factors like Drs. Moye and Plunkett did.  She had done rat studies to test her hypothesis that hyperserotonemia, high serotonin levels in developing brains, causes ASD and had published at least some of her work describing her hypothesis.  Id. at *65.  This is where form meets substance, however, as it is not enough for a hypothesis to have been presented or even published.  This particular hypothesis based on animal studies had been widely rejected in the medical literature and by the EMA and not supported in the “wealth of epidemiological data on the associative and causal relationship between maternal SSRI use and ASD.”  Id. at **66-67.  Dr. Whitaker-Azmitia’s attempt to support her opinion with epidemiological data, based on a “face validity” methodology, was rejected as unreliable for failings similar to what plagued the other experts.  Most notably, she focused her analysis on studies that might support her hypothesis and not those that might undercut it.  Id. at *69.  While that would have no doubt made for effective cross-examination at trial, when the trial court fulfills its gatekeeping role, the jury should never hear opinions based on a results-driven and unscientific analysis.  If that is all that the plaintiff can offer on causation, then summary judgment should be granted and a huge waste of judicial resources, not to mention the cost of trial and the burden on jurors, can be avoided.

“There is naked Nature, inhumanly sincere, wasting no thought on man, nibbling at the cliffy shore where gulls wheel amid the spray.”

We are presently on vacation, in the place that inspired Thoreau’s words above. The meeting of land and water, deceptive solidity sitting hard by the greatest force of caprice on the planet, has put us in a philosophical mood. Or is that the vodka and cranberry juice?

A millennial recently (an unnecessary adverb; to our gray ears, everything we hear from millennials is recent) assured us that the phrase “Nothing is true; everything is permitted” came from the Assassin’s Creed video game. Like most things uttered by juveniles (“Try this IPA,” “I just can’t even,” “Okay Boomer”) it is risible nonsense. We distinctly remember how that dark, nihilistic formulation brought us up short while reading Nietzsche in our college course on the Greatest Hits of Western Philosophy. Back then, in 1979, the ascendant video game was Pac-Man. Talk about a cold-hearted – and hungry – assassin.

Now we think of that aphorism (and others by Nietzsche – e.g., “When you look into the abyss, the abyss looks into you”) in the context of Multidistrict Litigations, in which plaintiff lawyers pile up inventories of spurious cases and courts permit scandalously sloppy lawyering (no product identification, no testing of claims, no specific expert opinions) as claims roll down an assembly line toward settlement. We are reminded of an in-house friend who lived close to the Hatfield meat processing plant. She told us how trucks carried pigs up the road to the plant, and trucks came back down the road filled with packages of hot dogs and scrapple. This was the circle of life, though the folks at Disney have not yet written a song about it.

Even when an MDL judge requires plaintiff lawyers to invest a little work in their cases and do the things required by the rules of civil procedure, what we usually get is thin gruel, just enough sustenance to keep the cases on life support as the gurney wheels them into the settlement grid. But what if the meat-grinder jams, the hogs run wild through the streets, and cases get remanded for actual trial work-ups? At that point, the occupants of the other side of the v. emit an audible “oops” as they set about trying to fix their cases. With eyes afresh, these enterprising lawyers reacquaint themselves with their clients and start stuffing the file with goodies.

Here is one way we have seen this comedy of errors play out: plaintiffs’ standard modus operandi seems to be to file “supplemental” expert reports that cover topics that should have been, but weren’t, covered in the expert reports filed in the MDL. Do plaintiff lawyers get away with that maneuver, even well past deadlines for expert reports? Sometimes yes, and sometimes no. We prefer the latter.

An example of the latter is Robinson v. Ethicon Inc., 2021 U.S. Dist. LEXIS 167615 (S.D. Texas Sept. 3, 2021). This decision didn’t let the plaintiff get away with the late filing of brand new expert opinions. The court struck the “supplements” as improper under the MDL orders. The expert reports contained material that could have been filed in the MDL if the plaintiff lawyers had devoted a moment to considering what state law would apply (Texas).

Robinson was part of the pelvic mesh litigation. Over 100,000 complaints had been filed against this particular defendant The MDL judge organized the MDL into “waves,” each with its own set of deadlines. As we write this we hear the rhythmic crash of waves, reminding us of their relentless and chaotic power. But the analogy breaks down. You can’t surf your way out of an MDL.

The Robinson case had been filed in 2013. Then the case sat for six years. Plaintiff expert reports were due in May 2019, defense reports were due in June 2019, and plaintiff rebuttal reports were due in July 2019. The Robinson case was remanded to the Southern District of Texas in October 2020. The MDL judge’s transfer order urged the receiving courts not to reopen discovery.

The S.D. Texas remand court geared the case up for trial. As part of that gearing up, the court set deadlines for supplemental expert reports pursuant to Fed. R. Civ. P. 26(e).

The plaintiff seized this opportunity to file two “supplemental” expert reports that addressed safer alternative products. The plaintiff did so after realizing, upon reading the defendant’s summary judgment motion, that Texas law did not consider safer alternative procedures to satisfy that state’s statutory requirement of a safer alternative design.

Understandably, the defendant was irked by the plaintiff’s backfilling effort, and moved to strike the supplemental expert reports because they were not truly supplemental; rather, they offered wholly new opinions based on information that was available to the experts at the time of their original reports. The plaintiff responded that (a) the MDL expert reports were merely generic and she ought to be able to supplement to address the specific requirements of Texas law, (b) one of the experts referenced a new article unavailable at the time of the original report, and (c) in any event, the supplement was “substantially justified and harmless.”

The remand court did not buy what the plaintiff lawyers were selling. The plain text of Rule 26(e) is the key. Rule 26(e) requires parties to supplement disclosures “in a timely manner if the party learns that in some material respect the disclosure or response is incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing.”

Supplemental disclosures are not an extension of the expert deadline. The defendant correctly argued that the supplemental reports in Robinson were not the types of supplements contemplated by Rule 26(e) and “instead are an attempt to avert summary judgment by filing new and improved reports”. Here, the plaintiff should have expected Texas law, with its strict alternative design requirements, would apply. Further, the plaintiff failed to establish that any information in the “new” study was actually not available at the original MDL expert deadline, since it was merely string-cited. That “new” study came out in 2019. As the Robinson court reasoned, if the 2019 study “indeed provided new scientific information that had an impact” on the experts’ opinions, “then waiting two years to provide this information to the opposing party is more akin to gamesmanship than timely supplementation.”

Nor was there anything “new” about the Texas statute addressing design defect and alternative design. Nor was the delay justified or harmless. Rather, the supplement was used in an attempt to defeat a pending summary judgment motion – a “roadmap” to the weaknesses of plaintiff’s case. The Robinson court emphasized that “[t]he purpose of the MDL is to increase efficiency in these cases, and [the plaintiff’s] strategy of holding these opinions until discovery was complete and the case was remanded to this court is contrary to that purpose.”

So it turns out that some things are true. Not everything is permitted. For a millisecond, the Robinson court managed to restore our reverence for rules and – dare we say it? – prompt a hope that MDLs really can serve efficiency and fairness.

But perhaps these are mere idle thoughts. Like lobster bibs and lighthouse souvenir key rings, they are fit only for vacation.

Sometimes our weekly searches for what is going on in the drug and device world lead as outside the traditional products liability context that is our bread and butter.  Occasionally that can be refreshing – a break from preemption and causation and TwIqbal.  It’s also interesting to see how things like off-label use come up in different situations.  For instance, when a group of doctors sues the FDA alleging they were injured because they could not prescribe a drug the way they wanted.  Association of American Physicians & Surgeons v. United States Food and Drug Administration, — F4th –, 2021 WL 4097325 (6th Cir. Sept. 9, 2021).  As it turns out, the association did not have standing.

You may recall early on in the COVID pandemic, there was some belief that the drug hydroxychloroquine might help treat the disease.  The medical community has since determined that is not so, but this case pre-dates that change in thinking.  Hydroxychloroquine has been FDA approved for the treatment of malaria, lupus, and arthritis since 1995.  Id. at *1.  For COVID treatment, the FDA issued an Emergency Use Authorization permitting the federal government’s stockpile of the drug to be used to treat COVID patients who were hospitalized and for whom a clinical trial was not available or feasible.  Id.  The Association of American Physicians and Surgeons (AAPS) did not think the authorization was broad enough believing that the best use of hydroxychloroquine was as a prophylaxis before diagnosis or immediately after diagnosis.  Id. at *2.

The AAPS brought suit and the FDA challenged its standing to do so.  The AAPS alleged it had associational standing – a doctrine that allows an association that has not suffered an injury to sue on behalf of its members who have.  Id. at *1.  So, the bulk of the opinion is about associational standing, including questioning the doctrine as a whole.  Id. at *3-7.  But that’s not really what is of interest to us, so we’ll leave it to you to read if you are so inclined.

Our focus is on the injury alleged by the AAPS as the basis for their associational standing.  The AAPS claimed that its members were injured because they could not prescribe hydroxychloroquine the way they wanted because of the restrictions of the emergency use authorization.  Id. at *9.  But the AAPS misinterpreted the FDA’s authorization:

It nowhere barred physicians from prescribing hydroxychloroquine to non-hospitalized patients. Indeed, it did not regulate doctor prescribing habits at all. Rather, it governed distribution of the hydroxychloroquine specifically in the federal stockpile, not of hydroxychloroquine generally.

Id.  The reason the court was willing to read the authorization this way was due in large part to the fact that the FDA “regulates drug distribution; it does not bar doctors from prescribing an approved drug . . . for an off-label use.”  Id.  The Sixth Circuit even cited Buckman v. Plaintiffs’ Legal Comm, 531 U.S. 341, 350-51 (2001) to support the fact that the FDA does not regulate a doctor’s practice of medicine, a function that is left to the states.  Id. at *1.

Because hydroxychloroquine was FDA approved and therefore lawfully on the market, physicians could, at their discretion, prescribe it for other purposes, such as prophylaxis or early onset COVID-19 treatment.  At most, the FDA’s authorization did not facilitate such off-label use by allowing the government’s own stockpiled supply to be used in that manner.  Nothing, however, stopped physicians from prescribing the drug and their patients filling their prescriptions through non-governmental channels.  Id. at *9.

The AAPS also tried to argue that they had standing because unidentified state medical boards (the proper regulators of off-label use) might bring some unspecified disciplinary action at some future date based on the FDA’s authorization.  But, to confer standing a “yet-to-happen” injury needs to be more than just speculative.  Nowhere did the AAPS identify what state law or regulation some physician would be running afoul of by prescribing hydroxychloroquine for COVID outside the hospital context.  Id. at *10.  Moreover, the AAPS was suing the FDA, not the state medical boards.  The FDA could not control or be responsible for the actions of independent actors.  Id.

Just another case re-affirming that off-label use falls within the practice of medicine – not the domain of the FDA.

 

Have you ever had a plaintiff dead to rights with a dispositive motion, and instead of opposing the motion, the plaintiff moves for voluntary dismissal?  We have, and it can be annoying as hell, especially if the judge is one of those who would rather not decide anything – and grants the plaintiff’s motion.

What if you had a better judge, though?  Did you know that a judge has discretion to respond to such a motion by dismissing the case with prejudice?  See Graham v. Mentor Worldwide LLC, 998 F.3d 800 (8th Cir. 2021).

In Graham, the plaintiff did everything she could to stay out of federal court.  The plaintiff sued the manufacturer of breast implants – a Class III PMA medical device – because her implants ruptured after the plaintiff was in a car accident.  Id. at 802.  But that’s not all.  In the same action she also sued the nondiverse driver of the other car in the accident, as well as the hospital in which the implantation surgery had occurred for strict liability as the intermediate seller of the implants.  Id.  And she brought suit in St. Louis County, Missouri, one of the most notoriously pro-plaintiff jurisdictions in the country.

The defendant removed, claiming both fraudulent joinder (as to the hospital) and fraudulent misjoinder (as to the negligence claim over the auto accident).  Id.  The defendant also followed up with, what else, a preemption motion.  Id. at 803.  Plaintiff moved to remand, but lost on both grounds.  Id.  First, there was no possible basis for hospital strict liability in Missouri, so the hospital was fraudulently joined.  Id.  The Graham decision doesn’t discuss this much (because plaintiff did not appeal the ruling), but our 50-state survey on this topic indicates that the decision was correct.  Second, the auto accident claim had nothing to do with the product liability allegations, so the court found fraudulent misjoinder, and severed and remanded that claim against the only other non-diverse defendant.  Id.  Plaintiff eventually attempted to appeal that issue.  Id.

So the plaintiff in Graham couldn’t run back to state court.

On preemption, though, the plaintiff caught a break.  The court denied dismissal based on plaintiff’s allegation that she had been implanted “as part of a clinical trial approved by the FDA.”  Id.

The defendant had records disproving plaintiff’s false IDE allegation, and almost immediately threatened Rule 11 sanctions and to move imminently for summary judgment.  So the plaintiff couldn’t hide, either.  Rather than wait for that motion, plaintiff again tried to run, moving to dismiss her own action voluntarily without prejudice under Fed. R. Civ. P. 41(a).  Id.  Setting up the issue we described at the outset, the district court dismissed plaintiff’s complaint “with prejudice because [plaintiff’s] failure to give a reason for wanting to dismiss without prejudice reflected an inappropriate purpose of finding a more favorable forum or to escape an undesirable outcome.”  Id. (citation and quotation marks omitted).

On appeal, the Eighth Circuit first dodged the knotty fraudulent misjoinder issue.  Whether or not misjoinder existed ultimately didn’t matter because in the interim that jurisdictional defect had been cured by the severance and remand.

A district court’s error in failing to remand a case improperly removed is not fatal to the ensuing adjudication if federal jurisdictional requirements are met at the time judgment is entered. . . .  What matters is that the district court dismissed the jurisdictional spoiler prior to judgment.  As the district court had diversity jurisdiction when it entered final judgment, there is nothing to remand.

Graham, 998 F.3d at 804 (citation and quotation marks omitted).  That’s an interesting procedural point to remember, but alone would not have caused us to discuss the Graham case.

What’s much more significant to us is affirmance of a dismissal with prejudice entered in response to a plaintiff’s motion for voluntary dismissal without prejudice.  The plaintiff offered no justification for invoking Rule 41(a) in the face of the defendant’s imminent summary judgment preemption motion.  That supported the court’s discretionary dismissal:

When deciding whether to allow voluntary dismissal, the court should consider whether the party has presented a proper explanation for its desire to dismiss; whether a dismissal would result in a waste of judicial time and effort; and whether a dismissal will prejudice the defendant.  Likewise, a party is not permitted to dismiss merely to escape an adverse decision nor to seek a more favorable forum.

Id. at 804-05 (citations and quotation marks omitted).  Given the plaintiff’s failure to assert any proper basis for dismissal without prejudice, it did not matter that the case was recently filed or that no discovery had occurred.  Id. at 805.  Even on appeal, plaintiff “still fail[ed] to provide a justification for her motion.”  Id.  Graham emphasized “the importance of inquiring into whether a party has a proper explanation for its desire to dismiss and whether a party’s motive in requesting a voluntary dismissal is merely to seek a more favorable forum.”  Id.

The court cited several cases, and we reviewed them.  Significantly, none of those cases had actually affirmed what was done here:  a with-prejudice dismissal in response to a plaintiff’s motion for voluntary dismissal without prejudice.  We also reviewed the defendant’s brief in Graham as appellee, and found no cases from any circuit court affirming a dismissal with prejudice.

Rule 41(a) “implicitly permits the district court to dismiss an action with prejudice in response to a plaintiff’s motion for dismissal without prejudice.”  Id. at 805 (quoting Jaramillo v. Burkhart, 59 F.3d 78, 79 (8th Cir. 1995)).  But Jaramillo had reversed for lack of notice.  Id.  Critically, the defendant in Graham did not make the same mistake – having argued in response to the plaintiff’s motion that “the action should be dismissed with prejudice.”  Id. at 803.  That was sufficient notice.  Given plaintiff’s repeated machinations to avoid federal court, and lack of any other explanation, the with-prejudice dismissal was well within the district court’s discretion:

[Defendant’s] motion response gave [plaintiff] notice that dismissal with prejudice was at issue, and [plaintiff] had multiple opportunities to respond but did not do so – in her reply to the district court; by filing a motion to reconsider after the district court dismissed with prejudice; and in her briefs on appeal. . . .  The only relief [plaintiff] seeks on appeal (other than remand) is the grant of voluntary dismissal without prejudice, reinforcing the inference that her motive is to avoid an adverse judgment in an unfavorable forum.

Id.

As far as we can tell, the Graham decision affirming dismissal with prejudice as a response to an inadequately explained Rule 41(a) voluntary dismissal motion is a result of first impression in the federal courts of appeals.  Now, if a plaintiff tries the same shenanigans in one of our cases, we have on-point appellate precedent to support a response seeking dismissal with prejudice.