In In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL 2809, 2022 WL 43244 (E.D. Ken. Jan. 5, 2022), the MDL judge bifurcated discovery into two phases with general causation proceeding first.  At the close of expert discovery, plaintiffs move to exclude three defense experts and defendants moved to dismiss one plaintiff expert.  Plaintiffs went down swinging and defendants caught it right in the sweet spot.

The drugs at issue are in class that is generally used as a second-line treatment for diabetes.  Plaintiffs allege that the drug causes heart failure and related cardiac conditions.  At the request of the FDA, manufacturers conducted a cardiovascular outcomes study, a randomized controlled trial with multiple cardiac endpoints.  The result of the trial was that there was no statistically significant difference between the drug and placebo for any primary endpoint (cardiac death, non-fatal heart attack, non-fatal stroke) or secondary endpoint except for hospitalization due to heart failure.  Id. at *4.  Following the cardiac trial, the authors of the study explained that when you test for multiple endpoints, the more endpoints tested, the greater the likelihood of at least one false positive where the statistical significance is due to chance.  The authors cautioned that the outcome regarding hospitalization for heart failure warranted further investigation.  Id. at *5.  Further study was done in the form of observational studies and meta-analyses, none of which found an association between the drug and heart failure.  Id.   Trials of other drugs in the class also failed to show an association.

It is against that background that the court had to conduct its Daubert analysis.  The court’s primary focus was on the Bradford Hill causation analysis.  The Bradford Hill framework consists of nine factors used by epidemiologists to assess “whether an observed association may be causal.”  Id. at *1.  The court sets out and describes all nine factors.  Id. at *2.  We’ll focus on the analysis of each expert.

Defendants’ first expert was an endocrinologist – the type of doctor who treats diabetes.  Plaintiffs argued that he was not qualified to opine on whether the drug causes heart failure because he is not a cardiologist.  Id. at *7.  But he does prescribe medications to diabetics, including diabetics with heart disease, and must understand the risks and benefits of those medications.  Therefore, he was aware of the risks and benefits of and the scientific literature on the drug before becoming an expert in the litigation.  “Thus, [the expert’s] testimony in this case is about a matter growing naturally and directly out of research [he has] conducted independent of the litigation.”  Id. (citation omitted).

Defendants’ second expert was a cardiologist.  Plaintiffs’ primary challenge to this expert was an unsupported claim that he did not write his expert report.  They claimed it was “virtually identical” to another defense expert’s report.  However, both experts testified to never seeing each other’s reports or spoke to one another.  But they both are cardiologists who were asked to opine on the same issue – whether the drug can cause heart failure.  So, there was nothing untoward about them both citing the same sources.  Nor was it surprising that both reports used the same language when most of the phrases that plaintiffs point to are exact quotes from the relevant literature.  The experts did not copy from each other, they quoted the relevant scientific literature, of which there is not a lot.  Id. at *8.

Plaintiffs’ second attack on this expert is that he was not qualified to opine on how to correct multiple-endpoint studies to account for false positives.  But the doctor had extensive research experience including with clinical trials and as the head of a research laboratory.  Further, the expert explained his opinion on how the correction should be applied, a position supported by other scientists in the field.  Id. at *9.  If the jury were to accept his corrections, then the cardiac trial did not show any association and there is no need to conduct a Bradford Hill analysis.  If, however, the jury discounted the corrections, defendants’ expert’s opinion contained a thorough analysis of why the association does not rise to the level of causation.  Id. at *10.  Nor could plaintiffs support an argument that defendants’ expert failed to consider any study that he should have in reaching his conclusions.  Id. at *11.

The third defense expert challenged by plaintiffs was a pharmacoepidemiologist and based on his regular work and experience he was qualified to review the medical literature and opine on whether it established a causal connection between the drug and heart failure.  Using the reverse of their first argument, plaintiffs took issue with this expert not being a cardiologist.  But the court found he was not determining whether the patients in the studies had heart failure, rather the relationship between the heart failure diagnosed by others and the drug.  Id. at *12.  Next plaintiffs attacked the expert’s failure to undertake his own analysis of the raw data underlying the studies.  That is not a requirement for a reliable Bradford Hill analysis.  Nor was it an issue that defense counsel provided the expert with most of the literature where he also conducted his own searches to satisfy himself he had all relevant studies.  Id.  In fact, defendant’s expert reviewed plaintiffs’ experts’ reports and testified that he considered all the materials they had.  Id. at *13.

The court then turned to plaintiffs’ expert – a cardiologist who testified that using the Bradford Hill methodology, it was his opinion that the drug more likely than not is capable of causing heart failure.  Id. at *15.  However, neither the expert nor plaintiffs’ counsel “have been able to identify any other expert who has reached this opinion.”  Id.  Having used the same methodology as defense experts but being the only scientist – inside or outside the litigation – to reach that conclusion, the court was “wary that the method ha[d] not been faithfully applied.”  Plaintiffs’ expert had never published an article using the Bradford Hill analysis, nor written on it at all until this litigation.  Id.  Defendants argued that his analysis was flawed because he only considered the cardiac outcome trial and certain animal studies – no other human data.  Indeed, plaintiff’s expert testified that the one finding of a statistically significant increase “should be interpreted as cause and effect unless there is compelling evidence to prove otherwise.”  Id.  That flies directly in the face of the Bradford Hill criteria that there should be consistency of association – “has the observed association been repeatedly observed by different persons, in different places, circumstances, and times.”  Id. at *2.  The answer here is no.

Moreover, the authors of the cardiac outcomes study themselves did not come to the same conclusion as plaintiff’s expert.  They concluded the finding merited further investigation, not that it established causation.  Also, relying on and drawing conclusions from limited data lacks “scientific rigor.”  Id. at *16.  While plaintiffs’ expert chose to ignore the observational studies, he could not identify any defects in those studies to warrant their exclusion from consideration.  And certainly nothing to justify relying on pre-clinical animal studies over human data.  Id. at *17.   Finally, in an attempt to draw an analogy (the Bradford Hill criteria that asks whether exposure to analogous drugs causes the same outcome), plaintiff’s expert compared the drug at issue not to other drugs in the same class, but a different class of diabetes drugs known to worsen heart failure.  “In other words, [plaintiff’s expert] cherry picked [the analogous drug] as a comparison only because they have been shown to cause the outcome at issue.”  Id. at *18.  Results-driven analysis is not permitted.

This is a jam-packed opinion with critical analyses of four experts – three who considered the totality of the evidence and correctly applied the Bradford Hill criteria and one who went out on a limb and found himself very much alone – and excluded.

There are two main questions that surround the issue of all-vaccinated juries in the COVID-19 era.  The first is can you seek to exclude non-vaccinated persons from the venire for cause.  The second is do you want to.  At just about every CLE program we attend these days, whether in person or electronically, where judges or jury consultants are speaking about COVID-19 issues, we raise these questions.  The responses vary but in general, the answers to the first question have been that a significant number of courts are informally excusing unvaccinated persons from jury venires, typically through use of a questionnaire.

As to the second question, the answers we’ve received are all over the lot.  Unfortunately, things are changing rapidly, with widespread availability of vaccines now rendering obsolete jury research conducted even as recently as the end of 2020.  Our gut reaction – based entirely on stereotypical reasoning − is that vaccinated would-be jurors tend to be both more educated and better disposed to those who manufacture that type of product.  On the other hand, they’re more likely to be suspicious of corporations generally.  Unvaccinated potential jurors skew “conservative” – whatever that means these days – aren’t particularly respectful of either science or expertise, and thus are not likely to care much about things like FDA approval.

We bloggers can’t do much to elucidate the second question, but we can research the first.

Joffe v. King & Spalding LLP, ___ F. Supp.3d ___, 2021 WL 5864427 (S.D.N.Y. Dec. 10, 2021), is the most significant case on the question of vaccine-qualified juries.  It’s both a civil case (albeit having nothing to do with drugs, devices, or even product liability) and contains the most thorough discussion of the pros and cons of striking unvaccinated people as jurors for cause.  The Joffe decision, overruling the plaintiff’s objection to an all-vax jury, was driven by the practical consideration that very few courtrooms are physically large enough to accommodate the forms of social distancing that COVID-19 requires:

In an effort . . . to accommodate more trials, [this] trial was slated to be held in a regular courtroom, unmodified other than to provide jurors and other participants with at least three feet of social distance.  If an unvaccinated juror were to be selected, that juror’s social distance would have been expanded to six feet; the Undersigned’s courtroom could not have accommodated more than two unvaccinated jurors.

Id. at *1 (footnote omitted).  Barring unvaccinated jurors, in short, was the only way to get this judge’s – and probably most judges’ – courtroom back into the business of conducting jury trials.  “[E]xcluding unvaccinated persons as jurors would increase the likelihood that all trial participants (including the jury) would be safe and would minimize the probability that the trial would be interrupted by a juror testing positive for COVID-19 during the trial.”  Id. at *3.

As the legal basis for excluding unvaccinated persons from the jury venire, Joffe relied on 28 U.S.C. §1866(c), which provides that prospective jurors may be “excluded by the court on the ground that . . . [their] service as a juror would be likely to disrupt the proceedings.”  Joffe cited several reasons for considering unvaccinated jurors to be inherently “disruptive” during the pandemic:

  • “An unvaccinated juror would be considerably more likely to contract COVID-19 and to spread it to other jurors.”
  • “Many jurors may . . . feel unsafe or uncomfortable serving on a jury with unvaccinated individuals.”
  • “[A]nxiety may impair a juror’s ability to perform his or her duty by being a distraction from the proceedings, both during trial and during deliberations.”
  • “[I]f a juror were to be infected with COVID-19, not only would the juror jeopardize the safety of everyone around them, the juror and other jurors with whom the infected juror came into contact might have been required to quarantine, which could have disrupted the trial or otherwise caused scheduling and other logistical issues.”

2021 WL 5864427, at *5.

Joffe also ruled that barring unvaccinated persons from serving on juries did not violate the Jury Selection and Service Act (“JSSA”).  That act entitles federal litigants to juries drawn “from a fair cross section of the community.”  28 U.S.C. §1861.  To violate the statute’s “fair cross section” requirement requires those being excluded from service to be a “distinctive group,” due to their “systematic exclusion,” resulting in the venire “not [being] fair and reasonable” compared to the “community” at large.  2021 WL 5864427, at *6.  Relying on a criminal case, United States v. Moses, ___ F. Supp.3d ___, 2021 WL 4739789 (W.D.N.Y. Oct. 12, 2021), Joffe concluded that the unvaccinated population was sufficiently diverse and changing that it did not qualify as a “distinctive group.”

Because there are a multitude of reasons why an individual might be unvaccinated, the group lacks a basic similarity in attitudes or ideas or experience that defines and limits the group.  Moreover, membership in the unvaccinated group changes on a daily basis.  The claim that vaccination status is a “proxy” for individuals who hold a particular point of view is speculative at best. . . .  There is nothing to suggest that the viewpoints held by the unvaccinated will not be adequately represented by the vaccinated.

Id. at *6 (citations and quotation marks omitted).

In what seems to us something of a stretch, Joffe also determined that prohibiting unvaccinated jurors was not “systematic exclusion” under the statute because COVID-19 was an “external force,” not “due to the system of jury selection itself.”  Id. (citing United States v. Charles, 2021 WL 2457139, at *4 (S.D.N.Y. June 16, 2021), and United States v. Tagliaferro, 2021 WL 1172502, at *5 (S.D.N.Y. March 29, 2021), neither of which involved juror vaccination).

Joffe was interesting enough we decided to see what else was out there.  The only other civil cases we found are C.B. v. D.B., ___ N.Y.S.3d ___, 2021 WL 4696606 (N.Y. Sup. Oct 7, 2021), and Benaron v. Simic, 2021 WL 4464176 (D. Or. Sept. 29, 2021).  Neither has any analysis.  Benaron simply states, in a footnote at the end of an order dealing with other issues, that “[t]he Court intends to require that everyone who appears in the courtroom for trial (including . . . jurors) are fully vaccinated against COVID-19 at the time of trial.”  Id. at *10 n.13.  C.B., a child custody case, included in a list of COVID-19 restrictions that “[u]nvaccinated individuals can even be precluded from serving on juries before the U.S. Federal Court.”  2021 WL 4696606, at *2.  Cf. Hodor v. Home Depot U.S.A., 2021 U.S. Dist. Lexis 221231, at *6 (D. Md. Oct. 4, 2021) (mentioning that “[t]he parties unanimously agreed on the record to a jury pool that is vaccinated against COVID-19”); Carey-Powe v. Washington Metropolitan Area Transit Authority, 2021 WL 5504298, at *3 (D. Md. Oct. 1, 2021) (seeking the parties’ “agree[ment] to a jury pool that has been fully vaccinated against COVID-19”).

The rulings in the aforementioned Moses criminal case were similar to those in JoffeMoses decided “to excuse from the pool of prospective jurors summoned in this matter all individuals who are not vaccinated against COVID-19” over the prosecution’s objection.  2021 WL 4739789, at *1.  The analysis in Moses centered on the JSSA, with a finding “there is no basis to conclude that individuals who are unvaccinated against COVID-19 satisfy the standard for distinctive.”  Id. at *3.  It was “highly speculative” that the unvaccinated population shared a similar “attitude” that could create a “danger of . . . partiality or bias,” since “the group for example likely includes individuals who would like to be vaccinated but cannot be for medical reasons.”  Id. at *3.  Further, “[w]hether or not to be vaccinated is not an immutable characteristic, but an active choice made by a particular person for his or her own individual reasons.”  Id. at *4.  Nor was failure to vaccinate a “proxy” for any “distinctive group” – either racial or “point of view.”  Id.  “[I]ncomplete” statistics failed to establish the former, and “no data whatsoever” supported the latter.  Id.  As in Joffe, due to the heightened possibility of infection, unvaccinated jurors were “likely” to disrupt the expected “lengthy” trial:

[I]f an unvaccinated juror were to be exposed to a COVID-19-positive person at any point during the lengthy trial in this case, that juror would be lawfully required to quarantine for ten days.  No such quarantine requirement exists for vaccinated individuals.  As a result of the COVID-19 pandemic, this District . . . has a staggering backlog of jury trials that are ready to proceed.  It would cause massive disruption not just to the instant trial but to other trials . . . if the Court was required to manage multiple mandated quarantines.

Id. at *5.

That’s pretty much it, as far as significant analysis goes.  There are a number of other criminal cases in which the issue of juror vaccination is touched upon, but nothing comparable to the analysis in Moses – let alone in JoffeSee United States v. Muhammad, 2021 WL 4471594, at *4 (E.D. Va. Sept. 29, 2021) (observing “that the parties agreed to strike unvaccinated prospective jurors for cause”); United States v. Liberto, 2021 WL 4459219, at *8 (D. Md. Sept. 29, 2021) (mentioning the court’s policy of “seating only jurors who are vaccinated against the COVID-19 virus” in connection with denying a criminal defendant’s objection to “asking the jury venire’s vaccination status”); United States v. Donoho, 2020 WL 5350429, at *2-3 (W.D. Wis. Sept. 4, 2020) (mentioning “the promise of a vaccinated pool of jurors from which to draw” in criminal cases); United States v. Elder, 2021 WL 4137533, at *1 (E.D.N.Y. Sept. 3, 2021) (denying, in a two-sentence minute order, a criminal defendant’s objection “to the Court’s decision to exclude individuals who are not vaccinated against COVID-19 from the impaneled jury”); United States v. Bryant, 2021 U.S. Dist. Lexis 175499, at *1 (E.D.N.Y. Sept. 2, 2021) (same); United States v. Thompson, ___ F. Supp.3d ___, 2021 WL 2402203, at *4 (D.N.M. June 11, 2021) (dictum in confrontation clause case that “[t]he Court will not be inquiring about the vaccination status of potential jurors and witnesses”).

We begin by introducing a new Drug and Device Little Rescue Dog.  We lost the oldest of our rescued angels – a perfect soul we will miss as long as we are breathing – in the fall.  Our other dog was sad and lonely, so we set out to adopt a companion for him.  Our checklist was simple:  15 pounds max (to be a size match for our remaining dog), young-ish, and anything but a terrier.  We report that “JoJo” is a 20-pound terrier mix.   And he is eight years old.  With a scruffy face and a head that tilts back and forth when you talk to him.  And huge ears.   And we are smitten.  As we always say, a new dog can’t fill the hole left by a treasured companion of so many years.  But he digs his own space and fills that up.  And everyone starts smiling again.

“Smitten” would overstate our reaction to today’s case.  But we like a lot of it.  In Mikula v. C.R. Bard, 2021 U.S. Dist. LEXIS 241659 (W.D. Pa. Dec. 17, 2021), the plaintiff alleged that he was injured by the defendant’s inferior vena cava (“IVC”) filter.  He asserted the usual litany of product liability claims for negligence, strict liability, breach of warranty, and negligent misrepresentation.  The defendant moved to dismiss all of the claims.

We will get to other rulings in a second, but we jump first to one of our pet issues:  whether or not comment k to Section 402A of the Restatement (Second) of Torts bars strict liability claims against medical device manufacturers.  Regular readers of this blog will recall that Pennsylvania’s federal district courts have split on this issue.  Some have followed decades of Pennsylvania state court decisions (and dozens of federal district court decisions) that have predicted that the Pennsylvania Supreme Court will adopt the reasoning of the Pennsylvania Superior Court’s Creazzo decision and will hold that comment k’s bar to strict liability claims against prescription drug manufacturers applies equally to manufacturers of prescription medical devices.  Others have conjured wholly illogical distinctions to hold to the contrary.  (You can see some of our posts here and here and here and here and here).  Back in August, after the Third Circuit certified the question to the Pennsylvania Supreme Court, the Court granted review of the issue.   For a while, we anxiously awaited that decision, but as we noted recently in our end-of-the-year review, it settled.

The Mikula court has weighed in on the correct side of the scale.  The defendant argued that comment k barred the plaintiff’s strict liability claims.  The court began its analysis by explaining the Third Circuit’s mandate that “where, as here, jurisdiction in federal court is based on diversity of citizenship, we must give serious consideration to the decisions of the intermediate appellate courts in ascertaining and applying state law.”  In that vein, the court cited Creazzo for the (incontrovertible) proposition that there is “no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.”  Mikula, 2021 U.S. Dist. LEXIS 2419659 at *12-13 (internal punctuation and citation omitted).   Citing the string of recent correct decisions by Pennsylvania’s federal courts (and ignoring the cases going the other way), the court concluded

Here, the Court is persuaded that the current state of strict liability law, based upon Pennsylvania Superior Court precedent and decisions by other federal courts in Pennsylvania, compels a prediction that the Pennsylvania Supreme Court would preclude strict liability claims against medical device manufacturers.

Id. at *14-15.  And it dismissed the strict liability claims with prejudice, and the implied warranty claim along with them.  The court explained that “Pennsylvania law has recognized an interconnectedness between strict liability and implied warranty claims” in the contexts of prescription drugs and medical devices, id at *14 (citation omitted):  because the products are “unavoidably unsafe,” there can be no implied warranty.

Needless to say, we love this portion of the decision.  As we have said on previous occasions, there is no straight-faced basis for a distinction between prescription drugs and prescription medical devices for comment k purposes.  If the former are “unavoidably unsafe,” in the words of the comment, so are the latter, and decisions finding otherwise represent poor reasoning and misapplication of Pennsylvania law.

The rest of the Mikula court’s holdings are a mixed bag.  With respect to the negligent design claim, the court held that the plaintiff’s allegations “failed to address either the design of [the defendant’s] product of the availability of safer, feasible alternatives in any level of meaningful detail.”  The negligent market claim failed because, “without any factual allegation as to the nature of what went wrong during the manufacturing process, there is no plausible road to recovery for negligent marketing.”  Id. at *9 (internal punctuation and citation omitted).  The court dismissed both claims without prejudice.  But the court found that the plaintiff had stated a claim for negligent failure to warn by alleging that the defendant “did not warn [the plaintiff’s] physician about the dangers and risks associated with the [IVC filter],” id. at *12, and by setting forth the specific warnings the defendant allegedly should have provided.

Finally, the court addressed the negligent misrepresentation claim.   The defendant argued that the plaintiff had not pled the claim with the specificity required by Fed. R. Civ. P. 9(b), that the claim was a failure-to-warn claim in the guise of fraud, and that Pennsylvania’s learned intermediary doctrine negated the reliance element of the claim.

With respect to the second argument, the court acknowledged that courts routinely dismiss fraud claims in medical product cases, holding that they are disguised failure-to-warn claims.  But the court emphasized the distinction between negligent misrepresentation claims and fraud claims – the latter includes an element of intent – and held that precedent (including Hahn) did not mandate the dismissal of the negligent misrepresentation claim.  The court also rejected the third, learned intermediary, argument, holding that “a defendant may still be held liable under a theory of negligent misrepresentation if Plaintiff can prove that Defendants breached their duty to Plaintiff’s prescribing physician.”  Id. at 23 (citation omitted).  The court agreed, however, with the first, pleading-related, argument.  The complaint, including only conclusory allegations “without the requisite specificity as to the reported representations, their falsity, or [the plaintiff’s or his physician’s] alleged reliance,” did not satisfy Rule 9(b), which applied to claims labeled “negligent misrepresentation” as well as “fraud.”  Id. at *18.  The court dismissed the claim without prejudice and granted the plaintiff leave to amend the claim (along with the negligent design and manufacturing claims).

On balance, we are pleased.  Mikula got the comment k issue right, which matters more now that no appellate resolution of that question is imminent.  And Rule 9(b) applies to negligent misrepresentation, which is useful.  And as always, as we wade through Omicron, stay safe out there.  And get your booster.

Discovery can be very expensive.  Defendants really like to win on motions to dismiss in part because they get to avoid the costs of discovery.  We can pile on these shockingly obvious statements with two more.  From a defense perspective, a narrow scope of discovery tends to be a good thing.  If narrow discovery leads to summary judgment, then that is a really good thing.  Why are we dispensing such platitudinous nuggets?  It could be that we are just impressed with the straightforward reasoning of the decision we will discuss.  Or that we could not think of some clever introduction.

Just the other day, we told you about a federal court’s rejection of innovator liability under Wisconsin law.  Well, that plaintiff also took the branded defendant’s prescription drug, so the case continued after partial summary judgment.  A continuing case meant discovery and, in this case, discovery would focus on preemption.  The basic facts of the case screamed preemption under Albrecht and maybe even under Levine.  A prescription drug for asthma was approved in 2008 and prescribed to the minor plaintiff in 2010.  He took the branded drug for under two years and then switched to a generic version for another two and a half years.  About halfway through his time on the generic, he allegedly begin exhibiting a range of “severe neuropsychological side effects,” which later resulted in hospitalization at a psychiatric facility and a number of diagnoses of major psychiatric issues.  In 2020, after reviewing adverse event data, FDA required the addition of a black box warning for “the risk of mental health side effects.”  The same year, plaintiff (through his mother) brought a suit that alleged, among other things, that the branded manufacturer had provided inadequate warnings.  Plaintiff served a bunch of broad discovery on the branded manufacturer and motions practice followed its response.  That brings us to R.S.B. v. Merck & Co., Inc., No. 20-C-1402, 2021 WL 6128191 (E.D. Wisc. Dec. 28, 2021).

We have written a bunch over time on preemption of warnings claims against prescription drug manufacturers and we will not attempt to recap the subject or even provide a bunch of links.  Instead, we will note a few basics before we get into the discovery dispute.  First, Albrecht set out a standard for how judges are supposed to decide preemption as a question of law.  Second, that standard focuses on newly acquired evidence received after approval of a label that allegedly should have triggered an independent label change through a CBE.  Third, there is not too long of a time between this drug’s approval in 2008 and plaintiff’s initial prescription in 2010 or even his last use of the branded drug in 2012; there is even less time between a May 2010 approval of a label change and the August 2010 initial prescription.  Fourth, it is hard to read backwards from a black box warning being added in 2020—something that FDA controls and cannot be added through a CBE—to suggest new risk information that should have triggered a change in the warnings was received in the early years after approval.  That is part of why we say the case screams preemption.

To try to defeat preemption, the plaintiff will have an opportunity to get discovery on whether there was such newly acquired evidence of risk received at the relevant time.  The discovery is basically one-way because the manufacturer presumably knows the regulatory record and what evidence of risk it had when.  We have noted previously how the plaintiff bar has touted a strategy of invasive discovery as a way to avoid summary judgment post-Albrecht.  (See here and here.)  We have also noted at least one case where the defendant won on preemption a second time after a reversal and remand for discovery based on Albrecht.  But R.S.B. is the first case we have seen that spells out the contours of discovery, at least written discovery, post-Albrecht.

In response to plaintiffs’ requests for production and interrogatories, the defendant produced 455,000 pages of documents, including three NDAs, relevant adverse events, and some non-NDA correspondence with FDA.  2021 WL 6128191, **1-2.  Plaintiff wanted much more.  The first issue in dispute was that plaintiff wanted all correspondence with FDA whenever it occurred and the defendant applied a time restriction.  “The Court agrees with Merck that the relevant period is the time between when Singulair’s label was last approved by the FDA and the date R.S.B. last used Singulair [the branded drug].”  Id. at *3.  Not only would this be a narrow time period for this case, but it would be much narrower than plaintiffs would generally seek.  Specifically, in terms of pre-approval correspondence, “Plaintiffs fail to demonstrate how communications between Merck and the FDA prior to 1998 could impact Merck’s ability to unilaterally change their label for Singulair through the CBE regulation.”  Id.

The next dispute related to plaintiff fishing for safety information.  Apparently following the old version of Rule 26, plaintiff claimed that his broad requests for communications with third-parties “may lead to the discovery of evidence” that he wanted.  However, the current Rule 26 has a proportionality standard and this request did not meet it:

But requiring Merck to examine two decades of communications on the speculative basis that the communications may contain unfavorable study data is not a sufficient reason to require Merck to undertake the production of what is likely to be tens, if not hundreds, of thousands of pages.

Id.  The proportionality analysis is case-by-case, so this ruling is not as broad.  However, the ruling that the defendant did not have to produce “all clinical and preclinical trial [sic] data” beyond what was in the NDAs it produced could apply broadly.  The court reasoned that NDAs should contain descriptions and analyses of the clinical studies and other data relevant to evaluating the safety and efficacy of the drug, so production of the 46 clinical studies and 80 preclinical studies in the three NDAs was plenty.  Id.

Knowing how drug litigation can go, the next ruling may be the most important.  Plaintiff sought raw data so he could have his retained experts reanalyze it to gin up some sort of safety signal or perhaps misrepresentation to FDA.  Although this sounded close to the relevant standard, the court saw the important difference.

But “new analyses of previously submitted data” does not mean an analysis conducted by an expert in preparation for litigation with the benefit of hindsight.  Instead, it refers to the scenario in which “the sponsor [of a drug] submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to the FDA.” [Levine], 555 U.S. at 569 (quoting 73 Fed. Reg. 49607).

Id. at *4.  “In other words, Plaintiffs are not entitled to create their own ‘newly acquired information’ through the use of experts; rather, they must point to the existence of newly acquired information that Merck possessed during the relevant time period.”  Id.  This is an important distinction not just for discovery but for the substantive preemption analysis down the road.

The disputes over the interrogatories followed a similar path.  Presumably as a predicate to requesting a bunch of depositions, plaintiff sought the identity of every regulatory affairs employee at the company since 1996.  Defendant countered with names of the regulatory liaisons “who had responsibility for Singulair over its entire lifecycle.”  Id. at *5.  Plaintiff again argued that he needed more names because he wanted to prove that the defendant downplayed or “buried” data in what it submitted to FDA.  With the NDAs in hand, the names of the liaisons were enough.  “Absent something more than a mere hunch that Merck had some form of ‘newly acquired evidence’ in their possession, the Court will not require Merck to provide more information that they already have.”  Id.  We think many plaintiffs in this posture will not have more than a hunch about there being important safety information that was newly acquired between the last approval of the label and the plaintiff’s last use of the drug.  We also suspect that the next fights in this case will arise in the context of depositions of the company witnesses.  While those are often a battleground for a range of larger discovery disputes, when it comes to discovery on the narrow preemption inquiry under Albrecht, holding the line on scope makes sense.

Multidistrict litigations are big piles of wrong. Wrong incentives invite the wrong cases, the wrong rulings, and the wrong results. Plaintiff lawyers park weak cases in MDLs, counting on ultimately collecting money for cases into which they invested virtually no work. Courts encourage that dysfunctional conduct by doing everything possible to force settlements, even if that means making bad rulings or no rulings at all.

The federal judiciary probably considers the end of the pelvic mesh MDLs a huge success, because, well, they ended. Sort of. There were, in fact, large-scale settlements. But such ‘success’ came as a result of risible rulings (admitting irrelevant/prejudicial material safety data sheets, excluding evidence of FDA 510(k) clearance, etc.). To be sure, those rulings were mostly affirmed, not reversed, by appellate courts. Why? We cynically attribute those affirmances to sheer gratitude that the MDL was being ‘handled’. What the great Alexander Bickel called the “least dangerous branch” of government can sometimes be plenty dangerous.

And yet some remand courts have struggled to mitigate the mischief wrought by those rulings. To the extent pelvic mesh cases did not settle because of greedy, truculent plaintiffs and their counsel, many not-ready-for-trial-or-prime-time cases landed in the laps of remand courts. Judicial gratitude turned into frustration. Put simply, many remand pelvic mesh cases were a mess. Some remand courts have taken steps to clean up that mess.

Donalds v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 246609 (D. Md. Dec. 28, 2021), was one of those messy pelvic mesh remand cases. It was another pelvic mesh case unprepared for life after remand, and the court cleaned it up in the best possible way: dismissal via summary judgment. We’ll focus on two of the claims – design defect and failure to warn – and only briefly mention the rest.

The plaintiff proffered one expert who purported to connect the mesh’s alleged design defect with the plaintiffs alleged injury. That expert submitted a two page expert report bereft of any explanation supporting the specific causation opinion. Here is the report’s conclusion:

It is my opinion to a reasonable degree of medical probability that the complications Ms. Donalds endured following implantation of the TVT ABBREVO mesh product, as described above, were proximately caused by the erosion of the mesh product. These complications include pain (during intercourse and otherwise), vaginal bleeding, bladder spasms, headaches, and urinary leakage. The medical procedures Ms. Donalds underwent to treat the mesh erosion and continued stress incontinence, and the related costs, were reasonable and necessary.

The problem is that the plaintiff’s expert did “not explain how he reached that conclusion. Instead, he provides only a brief recitation of the documents he reviewed and offers a short summary of Donalds’ surgical history…. He does not explain how the alleged erosion caused her complications or why he reached that outcome.“ (Emphasis in original.)

If you have ever had the displeasure of reading a plaintiff pelvic mesh specific medical causation expert report, you know that 90% of such a report will be a mind-numbing summary of the plaintiff’s medical records. The Donalds case makes clear that such summary is not enough. Tacking on an ipse dixit conclusion at the end is not enough. Post hoc arguments by plaintiff counsel are not enough.

The main post hoc argument by the plaintiff was that the defendant had the opportunity to depose the expert “to further elucidate the completeness of his opinions and the basis for them.” But the court held that a defendant is not obligated to depose an opposing expert and give the other side a chance to overcome an inadequate report. The plaintiff “cannot point the finger at [the defendant] for failure to draw out the grounds for her expert’s opinion in a deposition.” The burden is on the party proffering the expert. This is why when we depose an expert we never ask them what their opinions are or what they will say at trial. We simply take the expert’s report as a given and inquire as to its bases and things considered or not considered.

The plaintiff in Donalds went the post hoc route whole hog by appending a supplemental expert affidavit “offering a previously undisclosed explanation of his methodology.” Too late. In fact, too late by more than three years. The court refused to consider the belated affidavit. The plaintiff offered no justification for the last minute affidavit. Because the only specific causation design defect expert’s opinions were unreliable and inadmissible, the Donalds court dismissed the design defect claims.

The failure to warn claims fared no better. Here, as is often the case in pelvic mesh cases, the existence of the learned intermediary rule and the non-existence of warning causation doomed the failure to warn claims. Even a bad (Maryland) statutory heeding presumption could not save the plaintiff’s warning claims where the implanter testified that she did not place great reliance on the device’s Instructions for Use, that she stood by her decision to implant the particular mesh device in question, and that she would not change anything even after viewing a current risk chart.

Sometimes during depositions of plaintiffs the parties play a game of chicken. No one wants to ask the question that clobbers oneself. But the plaintiff’s failure in Donalds to question the implanter about anything that might have established warning causation, read against the rest of the evidence in the case, overcame the heeding presumption and sank warning causation.

Because there were other claims, we will talk about them, but we needn’t say much. The Donalds court wasted little ink in dismissing the warranty claims. The utter lack of evidence of specific medical causation evidence undermined those claims. Beyond that, the plaintiff’s opposition brief provided “the vague promise that she will offer evidence at trial to support her claims. Such assurances are insufficient to survive a motion for summary judgment.” Indeed.

Finally, we get to the flotsam and jetsam fraud claims. Both the common law and consumer fraud statutory claims failed for want of proximate causation.

The Donalds case ended for reasons that all seem perfectly obvious. It is obvious that it should have ended a lot sooner. It is also sadly obvious why it did not.

In the Mid-Atlantic this week, unless your roots run deep – they are frozen.  After a balmy sixty degrees on New Year’s Day, we got hit with our first snowstorm of the winter.  As did so many, this blogger’s family had to cancel nearly all our holiday plans.  So, on what should have been the teenagers’ first day back to school, the last thing we needed was an excuse to deepen the roots we grew over winter break.  We binge-watched, we binge-ate, we binged Parcheesi, Liverpool rummy, and the Blockbuster Movie game.  Fortunately, the nice temps did lend themselves to walks, but it was a whole lot of togetherness.  Enough so, that we were all looking forward to some re-potting in new terrain.  And that is just when nature decided we needed one more day.

While the roots that kept us glued to the sofa over the past week are ones we are eager to shed, some roots – common law roots – are meant to be tended, nourished, and enriched.  Because those are the roots that protect us from things like innovator liability.   At least so said the court in R.S.B. v. Merck & Co., Inc., 2021 WL 6113765 (E.D. Wis. Dec. 27, 2021).  Plaintiff is a minor who used the asthma drug Singulair from 2010 to 2012, at which time he was switched to the generic version.  Id. at *1.  Plaintiff alleges that the drug caused him to experience various psychiatric disorders that required hospitalization.  Id.  Plaintiff’s complaint alleged causes of action for strict liability design defect, strict liability failure to warn, and negligence against the manufacturer of the brand name drug.  The brand manufacturer moved for summary judgment for any injury allegedly caused by the generic drug.  This was an important issue in the case because there is a dispute regarding whether plaintiff experienced any symptoms while on the brand name drug.  Id.

Plaintiff conceded that it could not maintain claims for strict liability design defect or failure to warn against the brand manufacturer for injuries caused by the generic drug.  But he argued his negligent misrepresentation claim was viable on the grounds that the brand manufacturer was responsible for the misrepresentations in the generic labeling.  Id. at *2-3.  The court started its analysis with the Wisconsin products liability statute which was enacted “to return tort law to its ‘historical, common law roots.’”  Id. at *3 (citing Wis. Stat. §895.046(1g)).  Under that statute, plaintiffs have two avenues for relief – one for when plaintiff can identify the specific product that caused the alleged harm and another for when he cannot.  When the specific product is known, plaintiff must prove that “the manufacturer, distributor, seller, or promoter of a product manufactured, distributed, sold, or promoted the specific product alleged to have caused the claimant’s injury or harm.”  Id. (citing Wis. Stat. §895.046(3)).  If plaintiff cannot identify the specific product, the statute allows for a risk-contribution theory.  Id. But, this avenue is only available when “the product was distributed or sold without labeling or any distinctive characteristic that identified the manufacturer, distributor, seller, or promoter.”  Id. at *3.  The generic drug had labeling that identified its manufacturer.

Plaintiff’s initial argument was that the statute should not apply at all to his negligent misrepresentation claim because it was not a products liability claim.  A fairly standard argument in innovator liability cases.  But the Wisconsin statute applies to all claims that allege a product caused personal injury – including claims based on promotion, instructions, and warnings and “all related or independent claims.”  Id. at *4.  So, even if plaintiff’s negligent misrepresentation claim was not directly covered by the statute, it is related to plaintiff’s claims for design defect and failure to warn and therefore encompassed by the statute.  Id. at *4.

Having decided the statute applies, the court also found this was a case of a known, specific product.  Plaintiff can only proceed under the first avenue and therefore can only bring a claim against the “the manufacturer, distributor, seller, or promoter” of the product that allegedly caused the harm.  Here that is the generic product which defendant did not manufacture, distribute, sell or promote.  Although plaintiff tried to argue defendant fell into that last category.  That by promoting the brand name drug, defendant also promoted the competing generic version.  The court recognized the illogicality of the argument:

A company, no matter what precarious position it may be in, does not intend to promote a competitor’s product to the detriment of its own sales. The same is true of here. [Defendant] is not promoting generic [drug] or the chemical composition of the drug when it promotes [the brand]; it is promoting . . .. the brand-name version of the drug produced by [defendant]. To assert that [defendant] is promoting generic [drug] is to assert that [defendant] is promoting the products of its direct competitors to the detriment of its own product. This line of logic belies basic business principles and would render [the statute] meaningless.

Id. at *5.

Therefore, plaintiff’s negligent misrepresentation claim against the brand manufacturer for injuries allegedly caused by the generic drug were dismissed – causing innovator liability to wither before it had a chance to take root.

In law as in real estate, “location, location, location.” Where a case is filed is often outcome-determinative. Jury pools and jurisprudence vary from one jurisdiction to the next. In some states, any complaint written on paper is sufficient; in others, a plaintiff must actually plead facts to avoid dismissal. Similarly, juries in some places routinely award plaintiffs massive judgments while juries elsewhere do not. Because being sued in a favorable jurisdiction increases the odds of winning a quick dismissal while being sued in an unfavorable jurisdiction increases the odds of having to pay a large verdict, the value of a case depends on where it is filed, even though the same substantive law would be applied to the same underlying facts regardless of jurisdiction.

Plaintiffs know this and so do we. That is why questions of personal jurisdiction are so important.

And that is why we were pleased to receive the recent decision in Mallory v. Norfolk Southern Ry., ___ A.3d ____, 2021 WL 6067172 (Pa. 2021), which held that—as a matter of constitutional law—corporations are not subject to suit in Pennsylvania merely because they are registered to do business there.

For a corporation to be subject to suit in a particular state, that state’s courts must have personal jurisdiction over it. The U.S. Supreme Court recognizes two types of personal jurisdiction: general jurisdiction and specific jurisdiction. If a corporation is subject to specific jurisdiction in a state, then it may be sued in that state only on claims that arise from or relate to the corporation’s in-state activities. If, by contrast, a corporation is subject to general jurisdiction in a state, then it may be sued there on all claims, even those that do not arise from or relate to activity in that state.

The more states in which a corporation is subject to general jurisdiction, the greater plaintiffs’ ability to sue the corporation in a plaintiff-friendly jurisdiction. If a corporation were subject to general jurisdiction in every state, it could be sued anywhere on any claim. Plaintiffs would file suit in only the most plaintiff-friendly jurisdictions and settlement values would reflect that.

Luckily, however, the Due Process Clause limits where corporations are subject to general jurisdiction. Specifically, the U.S. Supreme Court held in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011), and Daimler AG v. Bauman, 571 U.S. 117 (2014), that a corporation is subject to general jurisdiction only in states where it is “essentially at home,” and that (absent exceptional circumstances) a corporation is at home only in the states where it is incorporated or has its principal place of business. Thus, corporations are usually subject to general jurisdiction in only one or, at most, two states.

Hoping to file every suit in a plaintiff-friendly forum, plaintiffs bristle at the limits on general jurisdiction and have tried to erode them.

One theory that plaintiffs have advanced since Daimler is jurisdiction-by-consent. Recognizing that a defendant may voluntarily submit to personal jurisdiction because Due Process is an individual and thus waivable right, plaintiffs have argued that a corporation consents to general jurisdiction in a state if it registers to do business in the state. Given that most nationally active corporations, including drug and device manufacturers, are registered to do business in every state, they would be subject to general jurisdiction in every state on plaintiffs’ theory.

Most states have rejected the jurisdiction-by-registration theory. Thanks to the Mallory decision, Pennsylvania is the latest state to conclude that registering to do business in a state is not by itself subject a corporation to general jurisdiction in that state. Mallory is especially noteworthy because the Pennsylvania business-registration statute, unlike similar statutes in other states, expressly states that registering to do business in Pennsylvania constitutes consent to general jurisdiction there. See 42 Pa. C.S. § 5301(a)(2)(i).

Mallory found the consent-through-registration provision unconstitutional, holding that “a foreign corporation’s registration to do business in the Commonwealth does not constitute voluntary consent to general jurisdiction but, rather, compelled submission to general jurisdiction by legislative command.” 2021 WL 6067172, at *20. That is so, said the court, because it put every “foreign corporation desiring to do business in Pennsylvania” to the “Hobson’s choice” of “lawfully register[ing] to do business and submit[ting] to the general jurisdiction of Pennsylvania courts or not do[ing] business in Pennsylvania at all.” Id. Under those circumstances, “a foreign corporation’s consent to general jurisdiction in Pennsylvania can hardly be characterized as voluntary, and instead is coerced.” Id. (quotation marks omitted).

The Mallory court was aware of the issue’s significance:

It cannot be ignored that if Pennsylvania’s legislative mandate of consent by registration satisfied due process by constituting voluntary consent to general jurisdiction, all states could enact it, rendering every national corporation subject to the general jurisdiction of every state. This reality flies in the face of Goodyear and Daimler and cannot be condoned.

Id.

Indeed not.

We have long thought that “direct filing” procedures in multidistrict litigation were a solution in search of a problem.  We also think direct filing procedures in MDLs pose significant waiver risks without a corresponding upside.  Alas, our inclinations were confirmed recently when the Seventh Circuit ruled that a mass tort defendant’s acquiescence to complaints filed directly in an MDL constituted a waiver of the usual choice-of-law rules.  That waiver resulting in summary judgment being denied where it otherwise would have been granted.  See Looper v. Cook Inc., No. 20-3103, 2021 WL 5964709 (7th Cir. Dec. 16, 2021).

What happened?  In the world envisioned by the drafters of the MDL statute (28 U.S.C. § 1407), an MDL is a procedural device only—one of a few ways under the U.S. Code to transfer venue.  “When civil actions involving one or more common questions of fact are pending in different districts,” the Judicial Panel on Multidistrict Litigation can transfer the cases to a single district court for coordinated pretrial proceedings.  The process is pretty straightforward, owing largely to the very professional and helpful clerks who work for the JPML.

The choice-of-law rules are pretty straightforward, too.  When a case is transferred from one district court to another, the substantive law goes with it—including the rules governing choice of law.  See Van Dusen v. Barrack, 376 U.S. 612, 639 (1964).  So if a plaintiff files in the Northern District of California and the JPML then transfers the case to an MDL in the District of New Jersey, the MDL judge in New Jersey will apply California’s choice-of-law rules.  Those rules might predict the application of California law, or they might not.  Either way, one thing is clear—California’s choice-of-law rules apply.  Easy.

Somewhere along the way, the exponential growth of MDLs led to procedures allowing plaintiffs to file their complaints directly in the MDL district—so-called “direct filing.”  We admit that we have gone along with direct filing procedures in a number of MDLs, and we probably will again sometime in the future.  But we have always wondered whether direct MDL filing is really the best way to go.  The plaintiffs get an express lane to building large inventories of cases (the primary objective in modern MDL practice), and in return the defendants get . . . ?  Well, not very much.

We have read the commentary about the convenience of direct filing and how direct filing avoids the trouble of filing in a proper venue and going through the transfer process.  But we have never found the process of transferring cases to an MDL to be all that inconvenient.  Indeed, as every mass tort defense lawyer knows, the time-consuming work at the front end is in cases where the plaintiffs resist MDL transfer, usually because they want to be remanded to state court.  Direct MDL filing does nothing to alleviate that burden because those plaintiffs have already chosen to file in another place.

What about the risks of direct filing procedures?  There are three that we can think of—jurisdiction, venue, and choice of law.  As Bexis has noted, there is no jurisdictional basis for direct filing.  That is to say, a judge who otherwise lacks personal jurisdiction over claims and defendants cannot assume jurisdiction merely because he or she presides over an MDL.  Thus, a defendant who agrees that plaintiffs from everywhere can file their complaints directly in an MDL risks acquiescing to the MDL court’s jurisdiction and thus waiving defenses based on personal jurisdiction.  That may not be a big deal when the MDL is in the defendant’s home state, but it is a very big deal when the MDL is located somewhere else.

A defendant might place its Lexecon venue rights at risk, too.  As the Supreme Court held in Lexecon Inc. v. Milberg Weiss, 523 U.S. 26 (1998), because an MDL transfer is for pretrial purposes only, an MDL judge cannot preside over the trial without the parties’ consent.  Instead, he or she has to remand the case for trial in the original transferor district.  The Lexecon right to re-transfer can be waived, and that is partly what happened in Looper v. Cook, the case that started this blogpost.  The parties in an IVC filter MDL “agreed in practice” that new plaintiffs could initiate their cases by filing short-form complaints directly in the MDL rather than in their “home districts.”  The court, however, never entered an order formally adopting that procedure.  Looper, 2021 WL 5964709, at *1.  When the plaintiffs later objected to trials in the MDL, the MDL judge ruled that they had not preserved their Lexecon rights in direct-filed cases.  Id. at *8 n.3.  But for the “agreement in practice” to allow direct filing, the direct-filed cases may have been filed somewhere else, in which case the parties would have had the right to object to the MDL as a trial venue.  According to the district court, direct filing wiped that right away.

Finally, there is choice of law—the marquee issue in Looper v. Cook.  Again, direct filing muddied the water, and again the defendant came out holding the short end of the stick (please forgive the mixed metaphor).  Under the normal rules, this would have been easy:  Because the cases were filed directly in the MDL court, the choice-of-law rules for the state in which the court sat (Indiana) should have applied.  That would have resulted in application of a shorter statute of limitations and summary judgment, which is what the defendant argued.  Id. at *1.

The MDL judge agreed and granted summary judgment, but the Seventh Circuit reversed.  Following its own opinion in Dobbs v. DePuy Orthopedics, Inc., 842 F.3d 1045 (7th Cir. 2016), the Seventh Circuit held that all the issues affected by direct filing—jurisdiction, venue, and choice of law—are waivable.  Looper, 2021 WL 5964709, at *3.  It held further that the defendant in Looper had implicitly consented to the choice-of-law rules of the “originating jurisdictions,” i.e., the jurisdictions in which the plaintiffs would have filed had they not filed directly in the MDL.  The choice-of-law rules made a difference because the rules of the originating jurisdictions (South Carolina and Mississippi) pointed to longer statutes of limitations.  Looper, at *1.

According to the Seventh Circuit, applying the choice-of-law rules of jurisdictions where the cases had never been was a pragmatic accommodation to the bureaucratic state know as multidistrict litigation.  As the court stated, “In the alternative, ‘every district court receiving a direct-filed MDL suit would be bound to apply the choice of law principles of the MDL forum.  In effect, the accident of bureaucratic convenience would elevate the law of the MDL forum.’”  Id. at *4.

The problem with this statement is that there was no accident.  The direct-filed plaintiffs chose to file directly in the MDL.  It was not mandatory.  A plaintiff enjoys the advantage of deciding where to file his or her lawsuit in the first instance, and if one byproduct of that decision is the application of that forum’s choice-of-law rules, then so be it.  Moreover, we are talking here about choice-of-law rules, which very well could predict application of another state’s substantive law.  There is no wholesale “elevation” of any particular state’s laws.

Another problem with the Seventh Circuit’s analysis is that the court imposed another jurisdiction’s choice-of-law rules over the defendant’s objection and against Supreme Court authority.  Even if venue is waivable, the Seventh Circuit had to resort to the defendant’s “implicit consent,” without acknowledging any standard for consent, let alone a standard recognizing that consent must be knowing and voluntary.  Instead, the Seventh Circuit repeatedly criticized the defendant for applying the law of the “originating jurisdiction” in multiple prior filings.  Id. at *6-*7.  But that was before the MDL judge held that the defendant had waived its Lexecon rights (observed only in a footnote), which was a game changer.

In the end, the defendant got the worst of two worlds.  When it came to Lexecon rights, the district court treated the cases as though they had been filed directly in the MDL district, per the usual rules.  But on choice of law, the Seventh Circuit reversed course and treated the cases as though they were filed somewhere else.  The usual, clear-cut rules did not apply.  Summary judgment denied.  Go figure.

Note:  This blogpost was revised on January 13, 2022, to correct the discussion of Lexecon to reflect that the plaintiffs objected to trials in the MDL, not the defendants.  

2021 is almost over.  Before 2021 – indeed, before the last half of 2021 – practically nobody other than stargazers had ever heard of “omicron,” unless someone was part of some fraternity or sorority.  Now everybody has.  The omicron viral variant demonstrates, once again in real time (as had the delta variant before it) that, yes, evolution is a fact, not a theory.  The law also evolves, and we hope that, like history, the arc of that evolution ultimately bends towards justice.  Chronicling cases that helped that hoped-for trend along, we once again take time for the Drug & Device Law Blog’s top ten decisions of the year.  Some cases directly extinguish harmful legal mutations, others provide overriding immunity, and still others limit the scope of infection.  All influence the course of future legal events, we think, for the good.

We temper our metaphysical tendencies with the relatively limited scope of our analysis.  To make our top (or bottom) ten lists, a case must involve some form of prescription medical product liability litigation.  Lots of other decisions occur each year that significantly impact what we do, even though not involving prescription medical products.  So, we’ll salute Mallory v. Norfolk Southern Railway Co., ___ A.3d ___, 2021 WL 6067172 (Pa. Dec. 22, 2021) (good on general jurisdiction by consent, here); Normandy v. American Medical Systems, Inc., ___ A.3d ___, 2021 WL 3482928 (Conn. Aug. 9 2021) (good on hospital liability, here); Sardis v. Overhead Door Corp., 10 F.4th 268 (4th Cir. 2021) (good on Fed. R. Evid. 702, here); United States v. Supervalu, Inc., 9 F.4th 455 (7th Cir. 2021) (good on FCA objective reasonableness, here); Judge Rotenberg Educational Center, Inc. v. United States FDA, 3 F.4th 390 (D.C. Cir. 2021) (good on not banning off-label uses, here); Webb v. Trader Joe’s Co., 999 F.3d 1196 (9th Cir. 2021) (good on food preemption, here), Texas Health Huguley, Inc. v. Jones, ___ S.W.3d ____, 2021 WL 5405794 (Tex. App. Nov. 18, 2021) (good on ivermectin litigation, here); and Sullivan v. Holy Redeemer Hospital & Medical Center, ___ A.3d ___, 2021 WL 4344068 (Pa. Super. Sept. 24, 2021) (good on vaccinator liability, here).  All should come in handy in the future.

Enough with the introductions.  Now, let’s proceed

  1. State ex rel. Hunter v. Johnson & Johnson, ___ P.3d ____, 2021 WL 5191372 (Okla. Nov. 9, 2021).  We can’t discuss this case, but others have.  The Product Liability Advisory Council (“PLAC”), told its members:  “This is an extremely significant decision which, if followed by other States, could rein in the efforts of Plaintiffs to get around traditional principles of product liability through a sweeping application of nuisance law.  The Court’s finding that nuisance law does not apply to the lawful manufacturing, marketing and selling of products is a broad and unequivocal one that should apply with equal force to all products, not just prescription medications.  The Court also offers a sound and detailed analysis of the numerous reasons that nuisance law should not apply to the sale of products, which will make it more persuasive authority as similar issues are litigated in other courts throughout the United States.”  For other commentary, seehere, here, here and here.
  2. Brooks v. Mentor Worldwide LLC, 985 F.3d 1272 (10th Cir. 2021).  Our best preemption decision of the year.  Brooks is an example of breast implant litigation done right.  The FDA’s reclassification of breast implants as Class III in response to the original spate of – now scientifically discredited – breast implant litigation brought with it PMA preemption.  Brooks affirmed dismissal of all claims on preemption grounds, either express or implied.  Between §360k(a) and §337(a), the “narrow gap” could not be threaded.  Brooks recognized something we’ve been arguing all along, that FDCA-based negligence per se is necessarily preempted because the FDCA has to be a critical element of any such claim, and there’s no private FDCA enforcement allowed.  Warnings also fell.  First, there’s no mandatory duty to update FDA-approved labels.  Second, as we’ve put a lot of effort into arguing, there is no state-law equivalent to support a “parallel claim” for purported failure to make adverse event reports to the FDA.  Nor can there be an unpreempted “manufacturing defect” absent any facts that the particular implant the plaintiff received “differed” both from what the defendant’s design intended and from an FDA-approved product specification.  Alleging only general Good Manufacturing Practice violations did not cut it.  We burnished Brooks here.
  3. Albert v. Sheeley’s Drug Store, Inc., ___ A.3d ___, 2021 WL 6062555 (Pa. Dec. 22, 2021). The “in pari delicto” or “wrongful acts” doctrine prevents criminals from becoming plaintiffs.  One primary fact pattern is squarely in our sandbox – preventing illegal drug users from suing drug manufacturers or suppliers over injuries caused by their own criminal acts committed in order to obtain possession of controlled substances.  We’ve opposed recent efforts in the ALI that have sought to abolish in pari delicto, which precludes liability as a matter of law, and to replace it with a jury question of comparative fault.  Thus, Albert’s reaffirmation of the doctrine could not have been better timed.  In Albert the Pennsylvania Supreme Court agreed with us (literally, Bexis filed an amicus brief) that, because in pari delicto involved criminal activity, it was not merely another aspect of comparative fault.  Albert is powerful evidence refuting those who would green-light criminal plaintiffs by replacing in pari delicto’s bright line rule with a mushy jury issue.  Albert thus adds Pennsylvania to the majority view that overdose cases brought by illegal drug users are squarely within the scope of the in pari delicto  The doctrine exists “principally because holding otherwise would force courts to condone and perhaps even encourage criminal conduct.”  Albert warned litigants that “the judiciary is not tolerant of fraud and illegality,” and that criminal “culpability” can preclude perpetrators from later “seeking common-law redress.”  We adulated Albert here.
  4. In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2021 WL 2209871 (D. Mass. June 1, 2021).  Zofran is our highest ranked district court decision of 2021, not only because of its preemption ruling disposing of an entire MDL, but also because of its procedural approach to establishing preemption post-Albrecht (2019+1,-6).  The best way, after Albrecht, to establish “clear evidence” preemption in prescription drug cases is to show that the FDA did reject a label change along the lines of that the plaintiffs were proposing while considering whatever junk science the plaintiffs rely on.  Since the FDCA now requires the FDA to respond to “new information” however received, 21 U.S.C. §355(o)(4)(A), the defendant filed its own citizen’s petition during the litigation that did precisely that.  Such petitions require a formal response from the FDA.  So, when the FDA declined to order a label change the label in response to all that the MDL plaintiffs had to offer, that was “clear evidence” barring the plaintiffs’ claims.  For companies confident that the science supports their warning-related positions (comprising most of our clients), Zofran provides the playbook for bringing the FDA’s expertise to bear in mass tort litigation.  The substantive preemption rulings in Zofran were excellent as well.  Zofran pointed out that, unlike other products, the FDA’s approach to labeling includes prevention of overwarning.  Nor could the court ignore the FDA by “assuming” that the FDA had not done what the statute required.  Nor was preemption in any way limited to FDA consideration of what a particular manufacturing defendant (that had sold the NDA in the interim) had done.  Science is science, whoever presents it, so the preemptive significance of the FDA’s action was the same no matter who prompted it.  Finally, the FDA’s decision finding insufficient scientific basis for a label change was necessarily dispositive of that same question for all prior dates, because earlier scientific knowledge could not have been declined in the interim.  We offered huzzahs for the dazzling Zofran decision here.
  5. Salinero v. Johnson & Johnson, 995 F.3d 959 (11th Cir. 2021).  Our best learned intermediary rule case of the year.  As longtime advocates of the learned intermediary rule, we oppose the other side’s unending attempts to poke holes in the doctrine.  One of the worst of supposed learned intermediary “exceptions,” due to the inherently prejudicial nature of its basis, is based upon supposed “financial bias” created by financial ties between the prescribing physician and the defendant.  Plaintiffs argue that such ties undermine the rule by compromising physician independence.  We explained before why such assumptions are ill founded and that the supposed exception has been almost universally rejected.  Still, the other side keeps trying.  In Salinero the court flatly rejected arguments that such an exception could exist under Florida law.  Basically, Salinero refused to allow a plaintiff, who was dead to rights under the prescriber’s unrebutted testimony, to instead attack the prescriber’s credibility.  Enhancing the opinion’s value was its reliance on another of our favorite doctrines – Erie conservatism.  “For us to create a wholly new doctrine, virtually out of whole cloth, would work a profound change in Florida’s law.  Sitting in diversity, we are Erie bound to follow Florida’s courts,” which have never even hinted at such an exception.  We saluted Salinero here.
  6. Ignacuinos v. Boehringer Ingelheim Pharmaceuticals, Inc., 8 F.4th 98 (2d Cir. 2021).  The logic of the Mensing (2011+1) independence principle is ineluctable.  “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  564 U.S. at 623-24.  Given that decision, any state-law demand for the alteration of a drug (or a device) that the FDA regards as a “major” change is necessarily preempted, because all “major” changes require FDA pre-approval.  That’s precisely what Ignacuinos held, and that’s why it makes our top-ten list for this year.  This proposition is powerful.  It powered the Gustavsen (2018+2) decision to a lofty perch a few years ago.  Ignacuinos agreed with Gustavsen.  Any common-law demand for what the FDA lists a “major” change, as defined in 21 C.F.R. §314.70(b)(2), is preempted.  In so holding, Ignacuinos adopted an argument that we had articulated on the Blog back in 2013.  Given the preemptive power of this rationale – implied preemption could just as easily apply to medical devices as to drugs – Ignacuinos makes our list this year.  We agreed with Ignacuinos here.
  7. In re Taxotere (Docetaxel) Products Liability Litigation, 995 F.3d 384 (5th Cir. 2021), and In re Taxotere (Docetaxel) Products Liability Litigation, 994 F.3d 704 (5th Cir. 2021).  The Fifth Circuit decided these two related appeals two days apart.  The underlying litigation is founded on a presumption that we simply find incredible – that cancer victims would jeopardize their lives by refusing to use the most effective available chemotherapy treatment because they might permanently lose their hair.  The first case involved a statute of limitations decision based on plaintiffs defining their “injury” as hair loss persisting for more than six months.  That created an objective date for the statute of limitations running, six months plus the applicable statutory period.  Given that widespread attorney solicitation in MDL situations dredges up any number of stale cases (these plaintiffs filed their cases more than six years after the passing of pleaded six months of hair loss), a bright line is a wonderful thing, particularly when provided by the plaintiffs themselves.  The second case rejected the lenient “MDL treatment” that learned intermediary causation had received in Taxotere.  There was nothing “unique” about the physician-patient relationship in chemotherapy cases that would shift the focus from a prescriber’s decision-making to a patient’s.  The prescribing oncologist’s testimony that the label change about permanent hair loss wouldn’t have made any difference in his decision regarding what to do to keep cancer from killing this plaintiff was dispositive.  We expect that such prescriber testimony will be widespread in this MDL.  We trumpeted the Taxotere decisions here.
  8. Hrymoc v. Ethicon, Inc., 249 A.3d 191 (N.J. Super. App. Div. 2021), appeal granted, 261 A.3d 349, 350 (N.J. 2021).  In the Pelvic Mesh MDL, the court disregarded the previous majority rule that FDA regulatory decisions were generally admissible.  By misapplying the antiquated Lohr decision to an evidentiary issue to which it did not apply, Pelvic Mesh created a contra-factual world in mesh cases where juries never learned about the FDA’s role in clearing those products.  This led to some very (2020-1) bad (2018-1) decisions (2017-2).  In device litigation, those decisions converted the FDA’s oversight role into an all-or-nothing proposition – either it’s preemptive or it’s not even admissible.  Through this evidentiary sleight of hand, courts essentially repealed state compliance presumption statutes in medical device litigation in numerous states, one of them being New Jersey.  But in New Jersey, anyway, thanks to Hrymoc, that’s not the case, at least for now.  A unanimous panel recognized that exclusion of FDA device clearance was unduly prejudicial to defendants, reversing two multi-million dollar jury awards.  Thus, what the Pelvic Mesh MDL required is reversible error in New Jersey.  Hrymoc recognized that, since Lohr, the FDCA had been amended so that the §510(k) process could no longer be fairly characterized as having nothing to do with device safety.  Just because it is “less rigorous” than PMA approval does not make §510(k) clearance irrelevant under state evidentiary rules.  Further, jurors are not ignorant.  They know what the FDA is and expect to hear about in prescription medical product cases.  Plaintiffs may not mislead the jury by arguing that state law required pre-clearance actions that the FDA did not without the defendant being able to explain to the jury that the FDA did not require those steps.  We hailed Hrymoc here.
  9. Incretin-Based Therapies Products Liability Litigation, 524 F. Supp.3d 1007 (S.D. Cal. 2021).  In another preemption ruling taking down an entire MDL, Incretin dismissed the plaintiffs’ claims that the drugs in question caused pancreatic cancer under both prongs of Albrecht (2019+1,-6).  First, the Incretin plaintiffs couldn’t point to any “newly acquired information” that would allow a unilateral label change in the first place.  Some of what plaintiffs relied on was not “new,” other material didn’t qualify as “information,” and none qualified as both.  The MDL Plaintiffs made no fewer than 16 separate attacks on the information the defendants submitted to the FDA and lost on every single one of them.  With plaintiffs unable to raise the pre-Albrecht “fact question” canard, Incretin examined and ruled that, on each issue, the defendants had the better of the argument.  In sum, the FDA had been all over the pancreatic cancer issue, and there wasn’t anything worthwhile that the Agency hadn’t already reviewed.  Further, that same extensive administrative record was also “clear evidence,” after Albrecht, that the FDA would not approve the warnings the plaintiffs demanded about the purported risk.  At best the FDA found the risk “indeterminate,” which did not meet the Agency’s own scientific standards for a warning change.  As for what the FDA knew, Incretin cut through that preemption Gordian Knot with the simple logical syllogism – if there was no “new” evidence withheld, then necessarily the FDA was “fully informed.”  Moreover, everything the FDA did, including denying a citizen petition, was within the scope of its lawfully delegated powers – including an FDA-authored article in a medical journal.  Finally, given the FDA’s obligation to act on information however received (see, Zofran, above), Incretin rejected another of the other side’s favorite anti-preemption arguments, holding that FDA inaction can, under the circumstances in Incretin, support preemption.  For its comprehensive rejection of attempts to misuse Albrecht to rolling back implied preemption, Incretin also makes our list.  And on top of everything else, Incretin held that the plaintiffs’ expert causation opinions were inadmissible under Fed. R. Evid. 702.  One or (usually) more of plaintiffs’ seven purported experts improperly relied upon outdated, incomplete, and cherry-picked data.  They changed methodologies in midstream without explanation, applied those methodologies inconsistently, and used unvalidated methodologies.  They ignored human epidemiology in favor of animal and in vivo studies.  They relied blindly on each other, and their analysis could not be tested or replicated.  Their litigation-generated opinions differed from their academic work and were based on information supplied by counsel.  Incretin featured all the usual junk science we are accustomed to seeing from the other side, and all seven of the offending witnesses were excluded.  We idolized Incretin here.
  10. In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1175 (S.D. Fla. Dec. 31, 2020). We bent the rules (by one day) for this one, which was decided on New Year’s Eve, 2020.  We may be fast, but we’re not that fast.  Besides, our post discussing this Zantac decision was also in 2021.  The Zantac MDL has a notably conscientious transferee judge who is ready, willing, and able to tackle tough issues.  We’ve blogged about no less than nine separate Zantac MDL decisions.  This one is the best of a pretty good lot, primarily because the issue involved, innovator liability, which poses an existential threat to non-generic pharmaceutical manufacturers.  The sprawling Zantac MDL includes plenty of plaintiffs who took only or mostly generic versions, and thus would face preemption claims (which they also lost) in suing the defendants that actually manufactured what they took.  So they brought innovator liability claims against the brand manufacturers, under the laws of no fewer than (and originally more than) 35 states.  In this Zantac opinion, plaintiffs lost – in every single state.  An “overwhelming national consensus” rejects innovator liability.  It didn’t matter whether the claim was viewed as a “product liability” or a “negligence” claim.  This sweeping rejection of a dangerous novel liability theory earns Zantac a spot on our annual best of list.  In addition to state law, Zantac also relied on another of our recurring favorites, that under the Erie doctrine, federal courts cannot make up new state tort liability “out of whole cloth.”  Plaintiffs from the two jurisdictions (Massachusetts (2018-1) and California (2017-1a)) allowing some form of innovator liability also lost, with Zantac adopting a personal jurisdiction argument first unveiled on this Blog in 2018:  because innovator liability does not turn on any activity at all that the defendant conducted in the forum state (but rather on FDA-approved labeling), the plaintiffs from those two states could not establish personal jurisdiction over the branded defendants under minimum contacts analysis.  Plaintiffs’ bizarre argument that California and Massachusetts law could apply extraterritorially also failed.  We zeroed in on Zantac here.

There you have it, our top ten picks as the best drug/medical device decisions of 2021.

But wait; there’s more.  Despite the pandemic, a lot of judges and lawyers did a lot of work during 2021.  In many of those cases, that work paid off for the right side of the “v.”  To recognize these additional pro-defense decisions, we have our annual list of runners up, the next ten most favorable 2020 decisions.

Honorable Mentions:  (11) Connell v. Lima Corp., 988 F.3d 1089 (9th Cir. 2021), was in the top ten until Albert (#3) happened.  Cornell reinforces the Biomaterials Access Assurance Act as a powerful defense for suppliers of medical device components by broadly interpreting its scope (bespoke components are protected, not just raw materials) and narrowly interpreting its exceptions (plaintiffs cannot voluntarily create a situation where they are “unlikely to recover full damages” by settling cheap with other defendants) (here).  (12)  Fajardo v. Boston Scientific Corp., ___ A.3d ___,  2021 WL 5989909 (Conn. Dec. 16, 2021).  Excellent state high court alternative design ruling if facing an extremist expert claiming everything using a particular material is defective.  Plaintiffs cannot change their tune and argue that a product made of the same material, and therefore defective according to their own expert, is a safer alternative design (too recent for a blogpost).  (13) Gall v. Smith & Nephew, Inc., 286 Cal. Rptr.3d 108 (Cal. App. 2021).  Relatively rare pro-defense California appellate decision.  FDA process violations held not genuinely equivalent to manufacturing defects and failure-to-report claims fail under the learned intermediary rule when the prescriber knows the risk (here).  (14) Black v. DJO Global, Inc., 488 P.3d 1283 (Idaho 2021).  Manufacturing defect claims dismissed where relevant device was no longer available.  Neither res ipsa loquitur nor malfunction theory can substitute for proof of defect where the claimed injury was a known risk of the product (here).  (15) Ideus v. Teva Pharms USA, Inc., 986 F.3d 1098 (8th Cir. 2021).  Another good learned intermediary rule case, affirming (2019+15).  The Nebraska learned intermediary rule extends to medical devices and does not include an exception requiring direct-to-patient warnings for contraceptive products (here).  (16) Frei v. Taro Pharmaceutical USA, Inc., 844 F. Appx. 444 (2d Cir. 2021).  Dismissals of dozens of amiodarone claims affirmed on TwIqbal grounds, including inadequate pleading of failure to report.  It seems sort of obvious that any reporting-based claim must at least identify some actual failure to report, but plaintiffs never learn (here).  (17) Carrozza v. CVS Pharmacy, 992 F.3d 44 (1st Cir. 2021).  Plaintiff could not pursue product liability claims against a pharmacist who properly filled a prescription.  Dismissal of other claims due to plaintiff’s inability to muster admissible expert testimony also affirmed (here).  (18) In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1234 (S.D. Fla. Dec. 31, 2020).  The next best of the many Zantac decisions (also on New Years’ Eve 2020) holds that plaintiffs could not evade generic preemption with a boilerplate “misbranding” claim since they could not privately enforce the FDCA.  To allow broad, vague misbranding claims would render preemption meaningless (here).  (19) In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2021 WL 5631687 (E.D. Pa. Dec. 1, 2021).  Summary judgment against all five bellwether plaintiffs after experts excluded for a litany of Rule 702 flaws largely involving differential diagnosis (here).  (20) Nelson v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2021 WL 3578874 (S.D. Miss. Aug. 6, 2021).  Rejecting any duty to warn of comparative risks between competing products and finding device label adequate as a matter of law.  Comparative claims were not allowed under state law and were bad from a policy standpoint (here).

Our 2020 collection of cases concludes with more near misses than usual – there were quite a few good post-Albrecht preemption cases in 2021, prompted by excellent regulatory facts in Pradaxa and gadolinium litigation; you can check them all out on our preemption scorecard – so here are the next tier of victories:  Vieira v. Mentor Worldwide, LLC, 845 F. Appx. 503 (9th Cir. 2021), et al. (here); Dunn v. Genzyme Corp., 161 N.E.3d 390 (Mass. 2021) (here); Graham v. Mentor Worldwide LLC, 998 F.3d 800 (8th Cir. 2021) (here); In re Zantac (Ranitidine) Products Liability Litigation, 512 F. Supp.3d 1278 (S.D. Fla. 2021) (here); In re Xarelto (Rivaroxaban) Products Liability Litigation, 2021 WL 2853069 (E.D. La July 8, 2021) (here); Lowery v. Sanofi-Aventis LLC, 2021 WL 872620 (N.D. Ala. March 9, 2021) (here and here); Plourde v. Sorin Group USA, Inc., 517 F. Supp.3d 76 (D. Mass. 2021) (here).

Looking backwards, we reviewed our prior lists of best and worst decisions.  Three intermediate appellate decisions from last year, Cavanaugh (2020+9), Steins (2020+10), and Zitney (2020+11), all had review denied by their respective state high courts.  Certiorari was denied in Brooks (above).  Gayle (2020+18) was summarily affirmed “[f]or substantially the reasons stated by the District Court.”  Gayle v. Pfizer, Inc., 847 F. Appx. 79, 80 (2d Cir. 2021).  We skimmed over a couple of earlier years of our top/bottom ten lists.  Nowell (2019+13) was affirmed, but the only issues appealed were relatively uninteresting state-specific statute of limitations issues.  Nowell v. Medtronic, Inc., 2021 WL 4979300 (10th Cir. Oct. 27, 2021) (unpublished, even in F. Appx.).  We didn’t see any other decision, pro or con, that involved any further appellate review.  Finally, the recurring Pennsylvania issue concerning the applicability of comment k in medical device cases, is no longer on appeal, as the case before the Pennsylvania Supreme Court, Ebert, became part of a global settlement.

Looking forward, from this year’s list, above, we already know that the New Jersey Supreme Court has accepted our eighth best case, Hrymoc, for further review.  See Hrymoc v. Ethicon, Inc., 261 A.3d 349-50 (N.J. 2021) (granting four petitions).  We’re also aware that all three of the federal district court opinions in his year’s top ten, Zofran, Incretin, and Zantac, are currently on appeal, although the Zantac appeal is limited to Illinois law.  Quite a few additional Zantac-related appeals are now pending.  Also on tap for 2022, even with the demise of Ebert, we know of three federal court certifications to state supreme courts that could produce significant decisions in 2022:  Glover, on failure-to-report claims in Connecticut; Blackburn (2021-3), on learned intermediary rule causation issues in Alabama; and Dearinger, on whether there is a direct-to-consumer exception to the learned intermediary rule in Washington.  An interesting appeal is also pending in the oddball case, Atchley v. AstraZeneca UK Ltd., 474 F. Supp.3d 194 (D.D.C. 2020), on whether drug and device manufacturers allegedly providing “free goods and cash payments” to corrupt officials in Iraq could be liable under the Anti-Terrorism Act for how funds thereby generated were supposedly diverted to terrorists.

Finally, on the administrative front, the most significant development of 2021 is the proposal by the Advisory Committee on Civil Rules of the Federal Judicial Conference to amend Fed. R. Evid. 702 to specify that the proponent of expert testimony bears the burden of proving all of that rule’s prerequisites to admission – and also to state in the notes that numerous decisions relying on outdated, pre-2000, and pro-admissibility decisions are wrongly decided.  We discussed these amendments (here) and (here).  If adopted, the Rule 702 amendments would probably take effect by the end of 2022.

An amendment to Fed. R. Civ. P. 16 to mention early plaintiff vetting as something a judge supervising mass tort litigation can “consider” has been made.  That hardly seems worth the effort to us.

Also, as we discussed here, the FDA finally completed work on its long-overdue “intended use” regulatory update.  While we’re not familiar with the state of play, both the now-you-see-it, now-you-don’t administrative flip-flops over a “totality of the evidence” test for intended use, and the FDA’s rather labored approach to First Amendment issues involving “off-label promotion,” provide grounds for post-adoption challenges to the FDA’s final rule.

We’re not aware of any pending national legislation with any significant chance of passage that would impact on prescription medical product liability litigation.

See you in 2022.

Material for Best/Worst webinar here.

Santa dropped off an early Christmas present. It was not crafted by elves. It was drafted by the Pennsylvania Supreme Court (five of its seven members, anyway), and it is so good that it is a last minute addition to our Ten Best list, which will arrive anon.

In Albert v. Sheeley’s Drug Store, Inc., 2021 WL 6062555 (Pa. Dec. 22, 2021), a wrongful death and survival action was brought after a man died from a fentanyl overdose. The theory of the case was that a pharmacy negligently permitted a son to pick up his mother’s fentanyl prescription. The son was a drug addict who engaged in dysfunctional drug-seeking behaviors, and that son shared the ill-gotten fentanyl with an addict friend – the decedent. Negligence enters the picture because the mother had entered instructions with the pharmacy that her prescription should not be dispensed to her son. She did not trust him. She was right.

The pharmacy argued that it should not be on the hook for a death that wouldn’t have happened but for the decedent’s illegal conduct. That defense is called in pari delicto, which translates to “in equal fault.” It is an equitable doctrine that precludes plaintiffs from recovering damages if their cause of action is based, at least in part, on their own illegal conduct. The pharmacy moved for summary judgment.

There was decent evidence (texts, etc.) that the decedent was in on the son’s scheme to get hold of the mom’s prescription drugs. The lower court, in a decision that we first blogged about here, seemed to adopt that inference and, therefore, applied the in pari delicto doctrine to bar any recovery on behalf of someone who overdosed on fentanyl illegally obtained from the defendant pharmacy by means of the fraudulent scheme involving presentation of a prescription under false pretenses. The defendant pharmacy won summary judgment.

But the evidence of the decedent’s knowledge that the son had hoodwinked the pharmacy was not completely buttoned down. One could choose to interpret the evidence in the record to contain gaps as to the extent to which the decedent actually knew the provenance of the fentanyl. The plaintiff (the father of the decedent, and executor of his estate) contended that the lower court should have given his side the benefit of the doubt and denied summary judgment. The case went up on appeal and was unanimously affirmed by the Superior Court. Then it went up the Pennsylvania Supreme Court.

The Pennsylvania Supreme Court’s decision in Albert is important because it is such a full-throated endorsement of the in pari delicto doctrine. The argument over the decedent’s knowledge was of no consequence. Whether or not the decedent conspired with the son to intercept mom’s fentanyl, the son knew he was ingesting fentanyl that had not been prescribed for him. Thus, the decedent committed the crime of illegal possession of a controlled substance not prescribed for him, which directly caused his death.

The plaintiff and dissent questioned the justice of this outcome, arguing that it put in place a harsh result based on a mere status crime, unduly broadened in pari delicto to bar valid claims under ridiculous circumstances, and was at odds with Pennsylvania’s system of comparative fault. None of those arguments won the day.

First, the decedent’s conduct was not a mere status crime. The claims on his behalf were not foreclosed because the decedent was a drug addict. Rather, the decedent knowingly ingested a controlled substance the he knew had not been prescribed for him. That is a crime. Some might choose to pooh-pooh that crime, might choose to focus on the problems facing drug addicts, and might choose to bemoan society’s inadequate response to widespread drug dependency, but none of that alters the fact that we are talking about a crime that is in the books and comes with severe sanctions.

Second, the plaintiff’s parade of horribles was not impressive. The plaintiff suggested that under the court’s broad application of in pari delicto, DUI defendants would skate away from responsibility if their victims did not possess valid driver’s licenses. The Pennsylvania Supreme Court rejected this slippery-slope argument. In pari delicto, as an equitable doctrine, is subject to reasonable limits. Plus, the conduct of the driver in not procuring a valid license played no real role in causing the injuries. The plaintiff in Albert never managed to conjure up a plausible case in which in pari delicto would do real injustice. Barring suits by users of illegal drugs whose criminal acts resulted in their own injuries falls squarely within the scope of the in pari delicto doctrine. Courts should neither condone nor encourage criminal conduct.

Third, because the doctrine of in pari delicto is grounded on illegal acts, it is not affected by comparative fault. Invocation of comparative negligence is a non sequitur. In pari delicto retains relevance in cases involving the plaintiff’s intentional wrongdoing, to the point of criminality. Perhaps the plaintiff’s premise is that drug addicts have lost their capacity for decision-making, so negligence rather than intentionality is at work. But the law has not embraced, and never will embrace, the notion that addicts are not responsible for their choices. To revert to the plaintiff’s DUI example, the law will never exonerate drunk drivers because they lacked control over their driving.

In Pennsylvania, in pari delicto is alive and well. Courts should continue to apply it appropriately and vigorously.

One need not think too hard to come up with examples from the current litigation landscape in which the in pari delicto doctrine should eliminate or at least cut back on claims on behalf of people whose illegal acts were the primary cause of their alleged injuries. Maybe there are very big examples. Perhaps the biggest.