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We’ve been reminiscing often lately about our days as a federal prosecutor. Part of that is pure nostalgia. Part of it is wondering about the road not taken. Part of it is explaining to others why the show Billions is so crazily unrealistic.

The Covid-19 lockdown has sent us scurrying through the streaming services in a search for diversions. Finally, at long, reluctant last, we started watching the show that friends recommended but that we swore to ignore. We are not yet halfway through the Billions catalogue, and our mouth is frozen in a gape of horror. The U.S Attorney in that show is a bizarre, scheming, masochistic, amoral schlub. We worked for three U.S. Attorneys and they were all models of restraint, legal skill, and rectitude. They bore no resemblance to the Dracula on this show that reduces high-level law and finance to gutter trash.

But, yes, it is fun trash.

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Back in our AUSA days, criminal defendants more often than not asserted their fifth amendment privilege against self-incrimination. They usually did not take the witness stand. Even though it is natural to wonder why an innocent person would not want to look the jurors in the eye and utter a loud denial of the accusations, the judge would instruct the jurors that they could not draw any adverse inference from the defendant’s decision to remain mum. Prosecutors get used to this modus vivendi. After all, it seems fair. Plus, we usually had oodles of other evidence to support a guilty verdict.

The rules are quite different in civil litigation. A defendant’s invocation of the fifth amendment right to remain silent usually will elicit the opposite jury instruction – that jurors can presume that the defendant’s answers would have been unfavorable to that defendant. We have to admit that our AUSA experiences made this outcome a bit surprising and we are still not fully reconciled to it.

But there are nuances.

One such nuance was well illustrated in the recent case of United States ex rel. Lokosky v. Acclarent, Inc., 2020 U.S. Dist. LEXIS 95404 (D.Mass. June 1, 2020). Lokosky was a civil case under the False Claims Act (the “ex rel. Lokosky” means that Lokosky was the relator who initiated the suit, ostensibly for the benefit of the republic). Lokosky has been a sales representative for a medical device company, and she claimed that her company fired her in retaliation for her efforts to halt off-label marketing that would have led to the filing of false reimbursement claims with the government.

To build her case, she submitted written questions to the company’s former CEO and Director of Sales. The ‘answers’ to those questions were mostly assertions of the fifth amendment. The relator wanted the court to allow an adverse inference to be drawn from those fifth amendment assertions. In a brief, but well-reasoned, opinion, the magistrate-judge refused such an inference.

The inference applies to parties, and these former employees were not parties. They had not been employed by the defendant company since 2011. There was no reason to believe the company exercised any control over them. They retained counsel independent of the case. The former employees did not seem to have any interest in the case, plus they had also asserted the fifth amendment in response to questions from the company.

The Lokosky court’s inquiry was fact-driven, rather than categorical. Based on the particular concatenation of facts in the case, the court could “not consider the adverse inferences to be worthy under all circumstances.”

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This has been an important concept in the gadolinium litigation and it delivered another preemption win in Javens v. GE Healthcare Inc., 2020 WL 2783581 (D. Del. May 29, 2020).  The changes being effected (“CBE”) label change process has strict limitations on when it can be used to add or amend warnings without prior FDA approval.  It’s not a magic wand that plaintiffs get to wield to make preemption disappear.  Rather, a drug manufacturer may be able to “add or strengthen” a drug’s warning if it has “newly acquired information of a causal association between the drug and a risk of harm.”  Id. at *3.  If a warning proposed by plaintiff doesn’t meet that criteria, it is not a CBE label change.  In that situation, federal law would prohibit the manufacturer from adding a warning that would satisfy state law.  Id. at *2. That’s conflict preemption.  That’s what happened here.

Before getting to the substance of the ruling, one of plaintiff’s arguments was that preemption, as an affirmative defense, could not be decided on a motion to dismiss.  Plaintiff argued that deciding the issue on the pleadings shifts the burden to plaintiff to affirmatively plead facts justifying the applicability of the CBE label change process.  Id. at *4.  The court, however, found that preemption as a primarily legal issue, could be properly considered at the pleadings stage.  Id.  The court identified numerous cases deciding preemption on a motion to dismiss, including the First and Second Circuits.  Id. at *5 (citations omitted).  As part of this argument, plaintiff also tried to argue that the Second Circuit decision relied on by the court (Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019)) was superseded by Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019) because Albrecht limited preemption to situations where defendant could demonstrate by “clear evidence” that the FDA would not have permitted the proposed label change.  But plaintiff missed that the issue here – whether the proposed label change could be done as a CBE – was not an issue in Albrecht.  In Albrecht, defendant conceded that the proposed change met the CBE requirements.  Id.  The question before the Court was whether defendant had demonstrated that the FDA would have rejected that proposed change.  We don’t get that far in Javens.

As in other gadolinium cases, plaintiff alleges that she suffered complications from gadolinium retention that was unwarned about in patients with normal kidney function.     Plaintiff cited numerous studies in her complaint that address gadolinium retention in animals and humans with normal kidney function.  Missing from any cited study was a causal link between gadolinium retention and any adverse side effect alleged by plaintiff.  Id. at *3.  In fact, plaintiff’s complaint included an allegation that the FDA was currently “working on determining the exact consequences of these new findings of gadolinium retention in patients with normal renal function.”  Id.  To be a CBE label change, defendant has to have new evidence of “a causal association between the drug and a risk of harm.”  Here, plaintiffs actually pleaded that the association is inconclusive, even to the FDA.  Adverse event reports (“AERs”) don’t change the analysis.  AERs may be considered new evidence, but they aren’t causation evidence.  Id.  Without evidence of a causal link, defendant could not have unilaterally changed its label.  The question of whether there is clear evidence the FDA would have rejected the change is never reached.  Plaintiff’s failure to warn claims are preempted.

Plaintiff’s design and manufacturing claims were also preempted based on well-established law that prohibits a manufacturer from making any major changes to a drug’s “qualitative or quantitative formulation” once it has been approved.  Id.  at *6.  Plaintiff argued that defendant manufactured a different product that was a safer alternative.  But, if plaintiff’s contention was that the product she used should have been re-designed to be like defendant’s other product, that’s not allowed without prior FDA approval.  A defendant can’t re-design an approved drug.  If plaintiff’s contention was that defendant should have sold the other product instead, that is the “stop-selling” rationale rejected by the Supreme Court in Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013).  Either way, it doesn’t save her claim.

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Yesterday afternoon, only a few minutes after we saw the storm warning and cut short our walk with the Drug and Device Law Little Rescue Dogs, a brief but violent thunderstorm crashed through our neighborhood in the western suburbs of Philadelphia. (We note, parenthetically, that the adjective “violent” describes our weather with unprecedented and escalating frequency – not that there is climate change, of course.) Our house was built the same year we were built, and our yard, like the rest of the neighborhood, is dotted with mature and massive trees. And we, unlike some of our neighbors, are lucky: we still can use the present tense in that sentence. Our next-door neighbors have a tree down across their back yard. Three doors down, where the family includes two tiny children, a tree crashed through the roof.   (Thank goodness, everyone is ok.) Thousands (including us, though we have a generator) remain without power a day later.

After the storm passed, we walked around the neighborhood.  Huge limbs littered the ground, many in the path we would have taken on our normal dog walk.  Which plays nicely into the theme of today’s post: in the face of a specific warning, it’s pretty hard to mount a credible claim that you weren’t warned.  A shout-out to Harley Ratliff of Shook Hardy for sending us the decision and for another great result.

We have posted previously about great warnings decisions from the Taxotere MDL, here and here.  As readers of this blog are aware, a plaintiff must satisfy two tests to prevail on a failure-to-warn claim: the plaintiff must prove that the warning was inadequate and then must prove that the inadequacy of the warning proximately caused her injuries.  Both of our recent posts dealt with the second element, “warnings causation,” a pet issue of ours in our practice and in our posts.  Today’s short but very sweet summary judgment decision doesn’t need to go beyond the first element, adequacy of the warning.

As the court explained, a label is adequate as a matter of law when it is “accurate, clear, consistent” and “conveys the unmistakable meaning as to the consequences of ingesting the drug.”  In re: Taxotere (Docetaxel) Prods. Liab. Litig., MDL No. 16-2470, 2020 WL 2747279, at *2 (E.D. La. May 27, 2020) (internal punctuation and citation omitted).  To defeat summary judgment, the court went on, the plaintiffs would need to offer expert evidence creating an issue of fact on the adequacy of the warning.

The plaintiffs in this MDL allege that the defendant’s chemotherapy drug, which they were administered to treat their breast cancer, caused them to suffer permanent alopecia (hair loss).  In 2015, the defendant updated the label to add a specific warning of this risk to the “Adverse Reactions” and “Patient Counseling Information” sections of the label and to the “Patient Leaflet.”  And every one of the 200 plaintiffs addressed by the defendant’s summary judgment motion was treated after the specific “permanent alopecia” warning was added to the label.  Slam-dunk, right?   Mixing sports metaphors, the plaintiffs tried a “Hail Mary” pass: they argued that the warning still was not adequate because it should have been included in the “Warnings and Precautions” section of the label.  As the FDA’s guidance document explains, the Warnings and Precautions section is “intended to identify and describe a discrete set of adverse reactions and other safety hazards that are serious or are otherwise clinically significant. . . .” (Emphasis in original.)

Now here’s the most fun part of the decision: the plaintiffs’ own expert, a ubiquitous plaintiffs’ regulatory mouthpiece, “repeatedly testified” that the risk of permanent alopecia should be addressed in either the ‘Warnings and Precautions’ section or the ‘Adverse Events’ section of the label: “I think in either section, as long as it . . . clearly and prominently warned of permanent hair loss, that’s what I care about.” Taxotere, 2020 WL 2747278 at *1, *3.  And so the plaintiffs attempted to backpedal.  As the court explained, rolling its eyes (as are we), “Unsurprisingly, Plaintiffs now back away from this opinions.  They aver that it [was] case-specific [in cases in which the plaintiffs’ treatment pre-dated the warning] and should not be considered along with the instant Motion.”  Id.  (In other words, the plaintiffs would have paid the expert to say something different if they realized that so many cases involved post-2015 ingestion.) The court wasn’t buying it:

The Court will not allow Plaintiffs to shield these nearly 200 cases from dismissal under this logic.  For months now, the parties and this Court have discussed the filing of this ‘fencepost’ (or omnibus) motion.  The parties agreed on the briefing schedule. Most striking, however, is that Plaintiffs’ expert testimony regarding placement of the alopecia warning is solely in the possession of Plaintiffs.  Plaintiffs had ample time and opportunity to identify and present expert evidence supporting their argument that permanent hair loss should have been addressed in the ‘Warnings and Precautions’ section of the label.  Yet Plaintiffs failed to do so.

Id.   And so the court held that, “because the label clearly and consistently warned of the precise injury Plaintiffs suffered,” it was adequate as a matter of law.  Summary judgment for the defendant. On 200 claims. A great win, and a lovely piece of smash-the-gamesmanship jurisprudence.  We understand that there is a companion decision, and we will tell you about that one next.

Meanwhile, it feels to us like it is getting harder and harder to navigate the land mines that the world is throwing in our path – the violence of this past week and the horrific event that precipitated it, the ongoing Covid-19 crisis, and the capricious and savage changes in weather.  We wish safety for all of you in the face of it all.

 

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For as long as we’ve been practicing law, litigation tourists plaintiffs, from far and wide, have flocked to bring suit in the downstate Illinois counties of Madison and St. Clair, despite their claims having nothing to do with the state of Illinois.  Yesterday, the Illinois Supreme Court – in Essure litigation – recognized that this practice is no longer permissible after the Supreme Court’s Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), personal jurisdiction decision.  In Rios v. Bayer Corp., ___ N.E.3d ___, 2020 WL 2963318, slip op. (Ill. June 4, 2020), some 160 Madison County tourists from over thirty states were told to go home by the unanimous court.

Struggling to find something, anything, Illinois-related to hang their jurisdictional hats on, plaintiffs dredged up various purported “contacts” that had nothing to do with their cases:  “clinical trials in Illinois,” us[ing] the state as a testing ground for [a] physician training program,” “orchestrat[ing] a marketing campaign in Illinois” – that kind of thing.  Rios, 2020 WL 2963318, at *2.  We knew this opinion was going to be good when the court dropped a footnote pointing out that different plaintiffs had tried the same thing in at least four other states.  Id. at n.1 (citing Missouri, New Mexico, Indiana, and Pennsylvania as examples).  Plaintiffs relied unsuccessfully on a pre-BMS intermediate appellate decision, M.M. ex rel. Meyers v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016) (our eighth worst case of 2016).

The Illinois Supreme Court was not distracted by either the factual smokescreen or the erroneous precedent.  BMS sounded the death knell for Madison County litigation tourism.  Even plaintiffs conceded that there was no “general” personal jurisdiction.  Rios, 2020 WL 2963318, at *4.  Then, BMS “foreclose[d] plaintiffs’ theory of specific personal jurisdiction.”  2020 WL 2963318, at *4.  BMS:

chided the state supreme court for permitting the exercise of specific personal jurisdiction without identifying an adequate link between the state and the nonresidents’ claims.  The drug was not prescribed to the nonresidents in [the state], they did not purchase it in [the state, and they were not injured by it in [the state].  The mere fact that other plaintiffs were prescribed, obtained, and ingested the drug in [the state] − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.

Rios, 2020 WL 2963318, at *5 (BMS citations and quotation marks omitted).  “[O]ut-of-state plaintiffs could pursue their claims elsewhere.”  Id.

The purported “contacts” the Rios plaintiffs asserted had no particular connection to their individual cases.  Rather, they were the same sort of generalized contacts rejected in BMS as creating a “loose and spurious” circus-mirror version of general jurisdiction.  “[T]he question here is whether the nonresident plaintiffs’ claims arise out of, or relate to, those activities in any meaningful sense of the terms.  We find that they do not.”  2020 WL 2963318, at *5.  None of the plaintiffs alleged any particular way in which s/he was affected by the clinical trials, the physician training, or the marketing program.

Yet plaintiffs fail to allege that either they or their physicians received [any] false information in Illinois, and as noted, these plaintiffs and their physicians do not reside in this forum. . . .  [T]he nonresident plaintiffs’ devices were not implanted in Illinois. And nothing in their complaints links [defendant’s] alleged failure to warn the nonresidents and their physicians to any activities that occurred or should have occurred in Illinois.

Id. at *5.  “[T]he nonresident plaintiffs do not allege that [defendant] trained their physicians in Illinois, and again, the nonresidents’ devices were not implanted in Illinois.”  Id. at *6.  And, on a claim-by-claim analysis, as to manufacturing defects, “[c]onspicuously absent . . . is any assertion that their . . . devices were manufactured in Illinois or that [defendant] did, or should have, established manufacturing procedures in Illinois.”  Id. at *5.

Those kind of generalized contacts, that any plaintiff from anywhere could just as easily allege, did not and could not establish specific personal jurisdiction for any individual plaintiff.

In short, the nonresident plaintiffs have identified no jurisdictionally relevant links between their claims and Illinois.  Where no adequate link exists between Illinois and the nonresident plaintiffs’ claims, it necessarily follows that Illinois lacks specific personal jurisdiction over defendants as to those claims.  For these reasons, we hold that plaintiffs failed to meet their burden of establishing a prima facie basis to exercise specific personal jurisdiction over defendants as to the nonresident plaintiffs’ claims.

Rios, 2020 WL 2963318, at *6.  Plaintiffs, go home!  Querentes ite domum!  Or in more current jargon, practice extreme social distancing.

Nor was it “reasonable” for any state to allow non-resident plaintiffs from all over to flock into its courts the way they had to Madison and St. Claire (and other) Illinois counties.

These factors weigh strongly against Illinois courts exercising specific personal jurisdiction over defendants for the out-of-state plaintiffs’ claims.  Illinois has no particular interest in resolving claims that did not arise out of or relate to activities that occurred here.  Plaintiffs’ interest in obtaining relief also does not weigh in favor of Illinois courts’ exercise of specific personal jurisdiction as to non-Illinois plaintiffs.  The nonresidents have not explained how Illinois could be a convenient location for this litigation when they were not implanted with their devices here and have identified no other activity that would connect their specific claims to Illinois.

Id. at *7.  Indeed, “many” of these litigation tourists were double-dippers – they “initiated duplicate actions in California” – so that “the interests of judicial economy are not furthered.”  Id.

In concluding, the Rios court administered a coup de grâce to the contrary M.M. decision – effectively erasing it from the law books.  “We therefore hold that M.M. does not reflect the law in Illinois and should no longer be relied upon.”  2020 WL 2963318, at *7.  “In sum, we conclude that the nonresident plaintiffs’ claims did not arise out of or relate to defendants’ in-state activities and, thus, Illinois courts lack specific personal jurisdiction over [defendant] as to the nonresidents’ claims.”  Id.

Thus, the long litigation nightmare that has been perpetrated in Madison and St. Clair counties should now come to an end.  Defendants – at least those who preserved jurisdictional objections – may now proceed to dismantle that unconstitutional system.  As the Supreme Court has held, defendants are “permit[ted] . . . ‘to structure their primary conduct with some minimum assurance as to where that conduct will and will not render them liable to suit.’”  Daimler AG v. Bauman, 571 U.S. 117, 139 (2014) (quoting Burger King Corp. v. Rudzewicz, 471 U.S. 462, 472 (1985)).  Defendants don’t have to expose themselves to the jurisdictions on ATRA’s list.  Even as to manufacturing defect claims, as long as potential litigation targets take their business to more business-friendly states, they can’t be sued by litigation tourists, except in those more congenial jurisdictions.

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Bexis has been writing amicus curiae briefs for the Product Liability Advisory Council (“PLAC”) for a long time.  He was introduced to PLAC by one of the best lawyers he (or anyone, for that matter) ever met, Edward W. “Neddie” Madeira, Jr., who recently passed away.  Fare thee well, Neddie, you are missed.

Back in 1996, Bexis filed a PLAC brief in the Pennsylvania Supreme Court on the relatively obscure subject of the admissibility of absence of prior incidents as relevant to causation and/or defect in a product liability case.  The result was Spino v. John S. Tilley Ladder Co., 696 A.2d 1169 (Pa. 1997), which held:

[T]here is little logic in allowing the admission of evidence of prior similar accidents but never admitting their absence. . . .  In adopting a rule allowing lack of prior claims evidence subject to the trial court’s discretion, we are careful to note that . . . evidence of the absence of prior claims is admissible as relevant to the issue of causation.

Id. at 1175.  The key to admissibility was the soundness of the defendant’s recordkeeping.  “[E]vidence of the non-existence of prior claims is admissible” where “the offering party has provided a sufficient foundation − that they would have known about the prior, substantially similar accidents involving the product at issue.”  Id. at 1174 (citing, inter alia, Espeaignnette v. Gene Tierney Co., 43 F.3d 1, 9 (1st Cir.1994)).

Negative evidence – lack of prior incidents – is not the kind of thing that comes up in our sandbox very often.  In twelve years of blogging we’d cited Spino exactly once, and not for this proposition (Spino also started Bexis on his ultimately successful decades-long effort to overturn a case called Azzarello, that was once the foundation of Pennsylvania product liability law).

But now we have LaPorte v. Vlad, 2020 WL 2840321 (Mass. App. June 1, 2020), in which the impressive manufacturing history of a drug proved decisive in beating a manufacturing defect claim based on – well, not much of anything other than the decedent developed osteomyelitis quite a while (five months, at least) after being injected with the defendant’s drug (Depo-Medrol, an injectable corticosteroid) in the same general area.  Id. at *1-2.  Of course, there was no direct proof (there rarely is) because “the vials of Depo-Medrol injected into [decedent’s] knee were not recovered.”  Id. at *2.

Plaintiff did not let a little thing like no direct evidence at all stand in the way of a lawsuit.  Instead, he took a flyer on an expert (named Flyer) who purported to perform a differential etiology that “the only medically reasonable explanation for the Staph A infection [the decedent] suffered after her injection of Depo Medrol is that the Depo Medrol vial was compromised during the manufacturing and/or delivery process.”  Id. at *3 (emphasis original).  The osteomyelitis allegedly developed from the staph infection.  Id.

Plaintiff’s problem was that the defendant only manufactured, but did not deliver, the drug into the hands of the prescribing physician, Vlad the injector.  That’s where the absence of prior incidents − Depo-Medrol’s sterling manufacturing history – proved decisive:

Beyond speculation that something might have gone wrong in the manufacturing, nothing in Flyer’s opinion addressed the details of the manufacturing process at [defendant].  The only, and undisputed, evidence regarding the manufacturing process itself was that [defendant’s] records showed that for the relevant period (indeed going back to 1959) all of the vials of Depo-Medrol manufactured by [defendant] had passed all requirements, including those for sterility, before leaving [defendant’s] control.

Id. at *3.  Plaintiff’s expert could blather all he wanted about “ruling” things out, but on the record evidence it was impossible to rule in a manufacturer-caused infection source in the first place.  “[P]laintiff has failed to come forward with any evidence upon which a reasonable fact finder could rely to conclude that the defect occurred before the product left [defendant’s] control, an essential element of product liability.”  Id. (citations and footnote omitted).  The omitted footnote is also interesting, because it also relies on the absence of other incidents:

[I]t is undisputed that none of [the medical defendants’] other patients suffered any ill effects from the Depo-Medrol shipped to and used by [them] during the relevant period. . . .  [Defendant] has satisfied its burden to demonstrate a lack of evidence that the specific Depo-Medrol prescribed to [decedent] was contaminated when it left [defendant’s] control.

Id. at *3 n.5 (citation and quotation marks omitted).

So the manufacturing defendant won affirmance of summary judgment, on the basis of a well-documented 50-year history of flawless manufacturing.  We note that this manufacturing history stands in stark contrast to the thousands of claims – that received nationwide attention − related to contamination of the generic version of Depo-Medrol (methylprednisolone acetate) once produced by the now-defunct New England Compounding Center.  To win this kind of motion, concerning this drug, in this venue (Massachusetts was ground zero for the NECC fiasco) is a truly notable accomplishment.

Good work by both the defendant (for over 50 years) and defense counsel, Jennise Stubbs, Dan Rogers, and Sonila Themeli, of Shook, Hardy, and Lisa Oliver White and Peter Kober, of Murphy & Riley, who were nice enough to send Laporte our way.

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Last Thursday, Richard Dean gave us yet another excellent guest-post on primary jurisdiction. That under-appreciated doctrine is to Richard what preemption is to Bexis, or what dog shows are to Rachel, or what Ian Fleming and Dashiell Hammett (whose birthdays coincided with Richard’s May 28 post) are to us.

We had selected primary jurisdiction with the 16th pick in our DDL draft and, as with the NFL draft, that position is often where you get real value – under-the-radar gems. Primary jurisdiction is seldom located at the front of our minds, but given that we defend heavily regulated products, maybe it should be.

As if to drive that point home, a recent case turned on primary jurisdiction: Colette v. CV Sciences, Inc., 2020 WL 2739861 (C.D. Cal. May 22, 2020). In Colette, the plaintiffs filed a class action made up of purchasers of cannabidiol (CBD) products, including sprays, oil drops, gummies, capsules, etc. It was a nationwide class, with California and Arizona subclasses. The plaintiffs alleged that the CBD manufacturer sold illegal products because they contained an illegal ingredient (CBD) and were improperly labeled as dietary supplements. The defendant moved to dismiss or, in the alternative, to stay the case under the primary jurisdiction doctrine.

Among other forms of relief, the plaintiffs sought a declaratory judgment that the defendant had misrepresented the products, as well as an injunction halting such allegedly unlawful conduct. But the plaintiffs faced a problem in pursuing such relief; they claimed that they were now wise to the alleged misrepresentations and would not buy any of the products going forward. Because the plaintiffs had made it clear they would suffer no future injury, they had managed to plead themselves out of declaratory or injunctive relief. They lacked standing.

As for whatever claims remained, the Colette court ultimately stayed such claims based on primary jurisdiction. Why? The court reasoned that whether the products were misrepresented or illegal was an issue of first impression that was complicated and that Congress had committed to the FDA to determine.

Unsurprisingly, the plaintiffs were distressed by the prospect of a stay. A stayed case is not a won case. It is probably not even a case with much settlement pressure. The plaintiffs leaned heavily on the FDA’s November 2019 issuance of warning letters to certain CBD retailers to establish the illegality of the defendant’s actions, but — as we’ve pointed out before – warning letters do not constitute final agency action. So what we have right now in terms of regulatory action is an ongoing thing that is difficult, that is committed to agency expertise, and that is on the verge of some sort of final agency action, probably in the form of a guidance. Why would a court want to get in front of that? That question is especially vexing when so many courts are facing it, and the proliferation of inconsistent judicial decisions seems inevitable. In sum, Colette looks like a case that cries out for application of the primary jurisdiction doctrine. Let the regulatory experts figure out the nuances before the blunt forces of judicial fiats or jury verdicts bang out rough justice.

The plaintiffs tried to derail operation of primary jurisdiction by arguing that any forthcoming regulatory action might not be retroactive and that, in any event, courts are peculiarly competent to preside over consumer fraud actions. The Colette court rejected those arguments. First, retroactive application of the FDA’s decision regarding CBD products appeared to be more likely than not. Second, unlike the consumer fraud cases cited by the plaintiffs, here “the FDA has yet to issue rules and is working feverishly to do so.”

Primary jurisdiction is, at bottom, an exercise of prudential discretion. Given the ongoing controversy over regulation of CBD products, the need for expertise and uniformity, and the likelihood that some degree of regulation/clarification was imminent, the Colette court concluded that the better part of prudence counseled in favor of staying the litigation (the parts that survived the dismissals based on lack of standing) on the ground of primary jurisdiction.

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. . . .And a few other claims too.  But the punitive damages decision jumped out at us as something we don’t see that often.  In fact, the court in Nunez v. Coloplast Corp., — F.Supp.3d –, 2020 WL 2561364 (S.D. Fla. May 20, 2020) only had conflicting precedent to go on.  But to the court’s credit, it called a strike, a strike.  That analogy works if plaintiff is the batter and we’re talking about a swing and a miss.  If the plaintiff is the pitcher in this scenario, then the court called a ball, a ball.  Plaintiff’s evidence was more than a bit outside.  If the plaintiff was in centerfield, she dropped the ball.  If the plaintiff was playing shortstop, the ball bounced through her legs.  We think you get the point.  It’s June and we are craving baseball season.  Or any live sporting event for that matter.  In the meantime, missing baseball made us recall a classic Looney Tunes.

Back to the case.  Plaintiff brought suit alleging complications following surgery with defendant’s surgical mesh medical device.  Defendant moved for summary judgment on all of plaintiff’s claims except for design defect.  Defendant won on each count it moved against.

First up – failure to warn.  The court reviewed the Instructions for Use (“IFU”) that accompanied the product and found them to adequate as a matter of law.  The court found that they covered the very injury plaintiff alleged she suffered, including data from clinical studies of those adverse events.  Id. at *4.  Plaintiff argued that the IFU were inadequate because they characterized the risks as “potential.”  However, relying on Eleventh Circuit case law, the court ruled that a product label need only “make apparent the potential harmful consequences.”  Id. (citation omitted).  Really any other result would be absurd.  Most risks are “potential,” not certain.  Not every patient experiences every side effect.  Some don’t experience any.  That’s the precise meaning of potential and drug labels would be misleading if they suggested otherwise.

Batting second – fraud-based and warranty claims.  The court saw these for what they were – “repackaged” failure to warn claims which failed for the same reasons.  Id.

Up third – negligent infliction of emotional distress.  Here the court found plaintiff did not satisfy the requirements of the claim.  An emotional distress claim is when plaintiff can demonstrate that she suffered a physical harm caused by a psychological trauma.  Here, there is no dispute that plaintiff alleges her physical injuries were caused by defendant’s medical device, not a psychological trauma.  Id. at *5.

Now that’s three strikes and in real baseball we’d say the pitcher retired the side – three up, three down.  But, there’s a fourth claim to resolve so we’re going to say –

Batting clean-up – punitive damages.  Under Florida law, for a plaintiff to recover punitive damages, she must demonstrate by “clear and convincing evidence” “that the defendant was personally guilty of intentional misconduct or gross negligence.”  Id.  “Clear and convincing” is a heightened standard of proof by which the “sum total of the evidence must be of sufficient weight to convince the trier of fact without hesitancy.”  Id.  That is the burden plaintiff carries at trial and carries to defeat a motion for summary judgment on punitive damages.  Defendant only has to point to the lack of sufficient evidence.  Id.

The court found that in the mesh MDLs, only one bellwether decision ruled on the issue at summary judgment denying the motion under Georgia, Mississippi, North Carolina, and Wisconsin law.  Id. at *6.  Based on that, a court in the Middle District of Florida in another mesh case recently ruled the same.  Id. (citation omitted).  The Nunez court, however, did not find any of those decisions dispositive because the punitive damages inquiry is a fact specific one.  And the facts here were not sufficient to meet the heightened “clear and convincing” standard.  Plaintiff relied on internal company documents that only discuss a different product, not the one used in plaintiff’s surgery.  The plaintiff did not demonstrate a connection between that product and the one at issue in the case, and the court was not willing to take that leap on its own.  Id.  Plaintiff only argued about what defendant “should have done” or “should have known.”  That was not enough.  Also, while punitive damages are “generally a fact-intensive inquiry,” they are no different than any other claim and a motion for summary judgment can be granted where no issues of disputed fact are found.

So, it’s four up and four down in our products liability version of baseball.  If we aren’t getting live baseball soon, this blogger will just have to re-watch the Orioles 1983 season.  Nothing soothes the soul like a little Cal Ripken Jr, Jim Palmer and Eddie Murray.

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This post is neither written nor reviewed by the Dechert side of the Blog.

The recent decision in McLaughlin v. Bayer Essure, Inc., 2020 WL 1625549 (E.D. Pa. April 2, 2020), is massive (28 Westlaw pages) and devoted largely to review of a special master’s determination of individualized statute of limitations issues for some fifty individual plaintiffs.  Id. at *1.  Those are precisely the sort of issues that we don’t blog about.  But amongst all the plaintiff-specific discussions is an important practice point:

The sham affidavit rule can apply to attempts to contradict not only prior deposition testimony, but prior written discovery as well.

We’ve blogged about the sham affidavit rule a number of times.  Briefly, the rule is that:

[A] party cannot create a genuine issue of fact sufficient to survive summary judgment simply by contradicting his or her own previous sworn statement (by, say, filing a later affidavit that flatly contradicts that party’s earlier sworn deposition) without explaining the contradiction or attempting to resolve the disparity.

Cleveland v. Policy Management Systems Corp., 526 U.S. 795, 805-06 (1999) (string citation omitted).  See also Perma Research & Development Co. v. Singer Co., 410 F.2d 572, 578 (2d Cir. 1969) (generally viewed as the seminal case on sham affidavits).

In McLaughlin, the MDL court had already decided statute of limitations issues as they pertained to “twelve exemplar plaintiffs.”  See McLaughlin v. Bayer Essure, Inc., 2019 WL 1382710 (E.D. Pa. March 27, 2019).  Using those rulings as a “framework,” the defendant sought summary judgment on statute of limitations grounds against another 50 plaintiffs based on the answers they had given in their “Plaintiff Fact Sheets.”  Id. at *1, 4.  Suddenly, those fact sheets, which were supposed to substitute for other forms of discovery, weren’t so factual any more.  In “response . . . numerous Plaintiffs submitted Declarations” that contradicted what they had said in their fact sheets.  Id. at *4.  The special master refused to apply the sham affidavit rule to plaintiffs’ mass disregard of their own sworn fact sheets, id., but the court rejected this recommendation.

Importantly, there was “no dispute . . . that the [fact sheets] answers are the equivalent of interrogatory responses and, thus, we treat [them] as interrogatory responses for purposes of the sham affidavit rule.”  Id. at *4 n.1 (citation omitted).  The MDL case management order governing fact sheets stated that “completed [fact sheets] shall be considered responses to interrogatories pursuant to Rule 33 of the Federal Rules of Civil Procedure and shall be governed by the standards applicable to written discovery.  McLaughlin v. Bayer Essure, Inc., 2019 WL 1382710, at *25 n.29 (E.D. Pa. March 27, 2019) (quoting prior order).  See also McLaughlin v. Bayer Essure Inc., 2019 WL 7593834 (E.D. Pa. Dec. 27, 2019) (addressing fact sheet verification requirement), adopted, 2020 WL 265565 (E.D. Pa. Jan. 15, 2020).  The court rejected the plaintiffs’ attempt to limit the sham affidavit rule to attempts to change oral deposition testimony:

[W]e cannot conclude that the sham affidavit rule is strictly limited to circumstances in which an affidavit or declaration contradicts prior deposition testimony and never applies to circumstances in which the affidavit or declaration contradicts a prior interrogatory answer.

McLaughlin, 2020 WL 1625549, at *6.

McLaughlin did not cite any prior precedent that was unambiguously on one side or the other of this question.  Plaintiffs (typically) cited no precedent in support of their narrowing argument.  The defendants’ sham affidavit cases, Zavala v. Wal Mart Stores, Inc., 691 F.3d 527 (3d Cir. 2012), and Martin v. Merrell Dow Pharmaceuticals, Inc., 851 F.2d 703 (3d Cir. 1988), did involve contradiction of written statements, but not exclusively, and did not focus on the issue.  McLaughlin, 2020 WL 1625549, at *5-6.

We thought we’d take a look.

It turns out that the Ninth Circuit has long approved the broader application of the sham affidavit rule.  “The [sham affidavit] rule applies to conflicts between affidavits and interrogatory responses as well as deposition testimony.”  School Dist. No. 1J, Multnomah County, Oregon v. ACandS, Inc., 5 F.3d 1255, 1264 (9th Cir. 1993).

Courts most commonly apply the sham affidavit rule to cases where a party submits an affidavit which contradicts the party’s sworn deposition testimony.  But the rule’s application has extended beyond depositions [and] . . . applies to conflicts between affidavits and interrogatory responses as well.

Tarleton LLC v. State Farm Fire & Casualty Co., 2014 WL 2126567, at *6 (D. Or. May 21, 2014), aff’d, 671 F. Appx. 505 (9th Cir. 2016).  Accord Gonzalez v. Ford Motor Co., 2019 WL 6122554, at *4 (C.D. Cal. Oct. 23, 2019) (“Plaintiff cannot create an issue of fact at summary judgment by contradicting his prior sworn deposition testimony and interrogatory responses.”); Whitsitt v. Amazon.com, 2019 WL 2715611, at *3 (E.D. Cal. June 28, 2019) (“the ‘sham affidavit’ . . . rule . . . applies to conflicts between affidavits and interrogatory responses as well as deposition testimony”) (citation and quotation marks omitted); Hesghiaian v. Bank of America, N.A., 2019 WL 3000649, at *3 (C.D. Cal. May 31, 2019) (“The general rule in the Ninth Circuit is that a party cannot create an issue of fact by an affidavit contradicting his prior deposition testimony” and ““The rule also applies to conflicts between affidavits and interrogatory responses.”) (citations and quotation marks omitted); Estrada v. US Bank, N.A., 2018 WL 8785205, at *3 (C.D. Cal. Nov. 26, 2018) (“[b]ecause this contradicts his prior interrogatory response, the sham affidavit rule may exclude his declaration”); Dubrin v. County of San Bernardino, 2017 WL 4339645, at *2 (C.D. Cal. Sept. 29, 2017) (“a party may not generate a declaration with ‘helpful facts’ that directly contradict prior harmful evidence in the same party’s own interrogatory responses or deposition testimony”) (emphasis original); Robles v. Agreserves, Inc., 158 F. Supp.3d 952, 981 (E.D. Cal. 2016) (“The ‘sham declaration’ rule applies to declarations that contradict not only prior deposition testimony, but also prior sworn interrogatory responses.”); Board of Trustees of the Ken Lusby Clerks & Lumber Handlers Pension Fund v. Piedmont Lumber & Mill Co., 132 F. Supp. 3d 1175, 1183 n.6 (N.D. Cal. 2015) (quoting Hilderman); Pinnacle Fitness & Recreation Management, LLC v. Jerry & Vickie Moyes Family Trust, 2012 WL 694471, at *2 (S.D. Cal. March 1, 2012) (“sham affidavit rule precluded [defendant] from creating a genuine dispute of material fact by contradicting its prior interrogatory answers”); Siskiyou Buckle Co. v. GameWear, Inc., 2011 WL 5999869, at *4 (D. Or. Nov. 30, 2011) (“Under the ‘sham affidavit’ rule, a party cannot create a triable issue of fact by introducing a sham affidavit that contradicts his prior deposition testimony or interrogatory responses.”); Premier Displays & Exhibits v. Cogswell, 2009 WL 8623588, at *9 (C.D. Cal. Dec. 23, 2009) (plaintiff’s “declaration, . . . which conflicts interrogatory responses . . ., is a sham affidavit”); Hilderman v. Enea TekSci, Inc., 2008 WL 2263058, at *1 (S.D. Cal. June 2, 2008) (“Under the ‘sham affidavit’ rule, a party cannot create a triable issue of fact by introducing a sham affidavit that contradicts his prior deposition testimony or interrogatory responses.”); Tudor Delcey v. A-Dec, Inc., 2008 WL 123855, at *14 (D. Or. Jan. 9, 2008) (“This rule . . . applies to conflicts between affidavits and interrogatory responses as well as deposition testimony.”); Lanard Toys Ltd. v. Novelty Inc., 511 F. Supp 2d 1020, 1034 (C.D. Cal. 2007) (“A party may not create an issue of genuine fact by submitting affidavits that conflict with prior answers to interrogatories.”); American Express Travel Related Services Co. v. D & A Corp., 2007 WL 3217565, at *17 (E.D. Cal. Oct. 29, 2007) (the rule “that a party should not be able to substitute an affidavit alleging helpful facts for earlier deposition testimony harmful to its case in order to avoid summary judgment . . . applies to conflicts between affidavits and interrogatory responses as well”); Rosales v. City of Bakersfield, 2007 WL 1847628, at *29 (E.D. Cal. June 27, 2007) (same as Amex); Gordon v. Virtumundo, Inc., 2007 WL 1459395, at *14 (W.D. Wash. May 15, 2007) (“the general rule in the Ninth Circuit is that a party cannot create an issue of fact by an affidavit contradicting his prior deposition testimony . . . applies to interrogatory responses”) (citation and quotation marks omitted), aff’d, 575 F.3d 1040 (9th Cir. 2009); Foster Poultry Farms, Inc. v. SunTrust Bank, 2007 WL 1113529, at *3 (E.D. Cal. April 13, 2007) (same as Amex); Cruz-Manjarrez v. City of Portland, 2006 WL 3931459, at *9 (D. Or. Jan. 12, 2007) (same as Tudor); Kibbee v. City of Portland, 1999 WL 1271868, at *4 (D. Or. Dec. 23, 1999) (sham affidavit “rule . . . applies to conflicts between affidavits and interrogatory responses as well”).

So has the Second Circuit.  In Reisner v. General Motors Corp., the court “disregarded those factual claims made by [plaintiff] after [defendant] moved for summary judgment, where those claims contradict statements made previously by [plaintiff] at his deposition, in his affidavits, and in response to defendants’ interrogatories.”  671 F.2d 91, 93 (2d Cir. 1982).

[A] party cannot escape summary judgment . . . by submitting self-serving affirmations that contradict prior testimony asserted in depositions, interrogatories, or affidavits.  Here, [defendant] has submitted two declarations, which at times directly contradict . . . prior sworn discovery responses.  Where the factual assertions in [these] declarations are in direct conflict with Defendants’ earlier discovery responses, and are not supported by other evidence, the Court has disregarded those assertions.

Shantou Real Lingerie Manufacturing Co. v. Native Group. International, Ltd., 401 F. Supp.3d 433, 438 (S.D.N.Y. 2018) (citing Reisner, other citations omitted).  Accord Intimate Bookshop v. Barnes & Noble, Inc., 2003 WL 22251312, at *9 (S.D.N.Y. Sept. 30, 2003) (disregarding declarations that “inexplicably contradict statements [plaintiff] made in its complaint, its answers to defendants’ interrogatories, through its experts’ reports and in deposition testimony”); Mazzuocola v. Thunderbird Products Corp., 1995 WL 311397, at *9 (E.D.N.Y. May 16, 1995) (“Factual assertions made in an affidavit submitted in opposition to a motion for summary judgment may be disregarded if those assertions are contradicted by earlier statements in response to interrogatories.”).

The Seventh Circuit has taken the same position in a footnote.  In Donohoe v. Consolidated Operating & Production Corp., the court noted:

The district court did not consider this affidavit, because it contradicted [the party’s] earlier responses to an interrogatory. . . .  The court’s refusal to consider the affidavit was appropriate.

982 F.2d 1130, 1136 n.4 (7th Cir. 1992) (citations omitted).  Accord Gates v. Board of Education of City of Chicago, 2017 WL 4310648, at *9 (N.D. Ill. Sept. 28, 2017) (citing Donohue as establishing that “[c]ourts have extended this rule to disregard affidavits that contradict interrogatory answers”), aff’d in part and rev’d in part on other grounds, 916 F.3d 631 (7th Cir. 2019); Viasystems Technologies Corp., LLC v. Landstar Ranger, Inc., 2011 WL 2912763, at *3 (E.D. Wis. July 15, 2011) (“The ‘sham affidavit’ rule prohibits litigants from creating sham issues of fact with affidavits that contradict their prior sworn testimony, . . ., such as answers to interrogatories.”).

The Fourth Circuit apparently reached the same result in a short per curiam opinion:

[Defendant] has presented no evidence . . . apart from his own bald and self-serving allegations, which contradict his previous response to an interrogatory and are insufficient to avoid summary judgment.

Angel Medical Center, Inc. v. Abernathy, 1 F. Appx. 217, 218 (4th Cir. 2001) (citation omitted).

District courts in the Sixth Circuit have followed a similar rule.

While [most] cited cases dealt with affidavits that contradict prior deposition testimony, “[t]he sham affidavit rule precludes [a party] from creating a genuine dispute of material fact by contradicting its prior interrogatory answers.”  Indeed, the “sham affidavit” rule may be even more appropriate where a party submits contradictory interrogatory responses because those responses, unlike deposition answers, are generally provided after considerable thought and drafted with the assistance of counsel.

Thompson v. Bruister & Assocs., Inc., 2013 WL 1092218, at *5 (M.D. Tenn. March 15, 2013) (quoting Dunavant v. Frito Lay, 2013 WL 816673 at *4 (M.D. Tenn. March 5, 2013)).

In the Eleventh Circuit, an affidavit was stricken due to its “inherent inconsistency” with both the plaintiff’s “sworn response to the interrogatory” and the plaintiff’s “initial complaint.”  Baggett v. Rehau, Inc., 2009 WL 10674316, at *5 n.9 (Mag. N.D. Ala. Oct. 15, 2009), adopted, 2010 WL 11530355 (N.D. Ala. Jan. 21, 2010), aff’d, 411 F. Appx. 280 (11th Cir. 2011).  So make sure MDL plaintiffs have signed and verified their complaints, too.

In the District of Columbia Circuit, Jones v. D.C. Water & Sewer Authority, 2016 WL 659666 (D.D.C. Feb. 18, 2016), followed the Ninth Circuit’s Multnomah decision, and held “[w]ith [plaintiff] having failed to offer any reason why his post-deposition declaration should be credited over his sworn interrogatory responses, the Court concludes that it is insufficient to bolster his allegations about what protected activity.”  Id. at *9.

The sham affidavit rule has been applied to bar statements conflicting with prior sworn written statements in state court as well  The Texas Supreme Court explicitly applied the rule to contradictions of prior written statements made under penalty of perjury:

Other sworn evidence also contradicts [plaintiff’s] affidavit. . . .  These documents were made under the penalties of perjury, and they contradict [the] affidavit. . . .  Under these circumstances, the district court did not abuse its discretion by relying on the tax documents as the equivalent of sworn statements for purposes of the sham affidavit rule.

Lujan v. Navistar, Inc., 555 S.W.3d 79, 90-91 (Tex. 2018) (citations omitted).  See Williams v. Precision Coil, Inc., 459 S.E.2d 329, 337 n.12 (W.Va. 1995) (“when a party has given clear answers to unambiguous questions during a deposition or in answers to interrogatories, he does not create a trialworthy issue and defeat a motion for summary judgment by filing an affidavit that clearly is contradictory”); Taylor v. Richard Stockton College, 2019 WL 1111417, at *1 (N.J. Super. App. Div. March 11, 2019) (plaintiff “also failed to explain why he did not raise this contention in his complaint or his answers to interrogatories.  Under these circumstances, we treat plaintiff’s subsequent certification for what it was, a ‘sham affidavit’ that contradicted his earlier certified statements.”); Meco, Inc. v. Township of Freehold, 2011 WL 1376687, at *6 (N.J. Super. App. Div. April 13, 2011) (applying sham affidavit rule to declaration that contradicted interrogatory answer).  Finally, in a mass tort context a Delaware trial court held:

The sham affidavit doctrine fits squarely within this notion of summary judgment practice. . . .  [I]t is not too much to expect of a plaintiff that he will be prepared to offer definitive testimony in interrogatories or at deposition regarding the factual bases for his claims against specific defendants.  Absent extraordinary circumstances, a plaintiff should be bound by his sworn testimony.

In re Asbestos Litigation, 2006 WL 3492370, at *4 (Del. Super. Nov. 28, 2006) (disregarding conflicting affidavit regarding “product nexus”).

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There was a time when we posted frequently about attempts to impose liability for injuries allegedly caused by the use of a generic prescription drug. Much of the attention has been directed to trying to pin liability on the company that developed the drug originally, even when the plaintiff took another company’s generic version. When it comes to the liability of the manufacturer of the generic drug that the plaintiff actually took, it seemed like things were pretty settled. The Hatch-Waxman Act requires generics to have labels matching the label of the NDA holder’s drug and does not allow the use of the CBE to go beyond it—cutting off the Levine rationale for limited preemption on warnings claims. Add these to the inability of a generic manufacturer to change the design of its drug, generic manufacturers have generally not been liable absent a failure to timely update its label to match the NDA holder’s label—and even that situation can be preempted in some courts. This combination of dead ends and hard roads has been a main driver for the push against NDA holders and innovators in the dozen years since the Conte abomination. Similarly, although there are still occasional decisions where states’ high courts officially join the ranks of the super-majority, the learned intermediary doctrine has been so widely accepted now that it seems like a long time since this was a hot topic.

Pennsylvania has been one of the strongest states on learned intermediary, so it is bit surprising to see the issue of whether there is an exception to the learned intermediary doctrine under Pennsylvania law as dispositive in a case. This is doubly so when the case involves claims against a generic drug manufacturer. That is what we have in Polt v. Sandoz, Inc., ___ F. Supp. 3d ___, No. CV 16-2362, 2020 WL 2730931 (E.D. Pa. May 26, 2020), where an earlier ruling on a motion to dismiss for preemption left plaintiff with enough of an opening to pursue “extensive discovery” and make the court decide the remaining issues on summary judgment three years later. (Thanks to our friends at Greenberg for passing on the decision.) The basic facts are as follows. The plaintiffs’ mother took defendant’s generic cardiac drug off-label for years and ultimately died from a pulmonary event that was disclosed as a risk in the label. The drug’s label matched the label of the NDA holder’s drug and there was no allegation that it was manufactured incorrectly. The drug, however, had a federal regulatory requirement for a medication guide, which the manufacturer is supposed to provide to pharmacies to be provided, in turn, to patients when they fill a prescription. One of the prescribers, although aware of the relevant pulmonary risk like the other two prescribers, claimed not to know the drug was being prescribed off-label or that it had a medication guide. Plaintiffs’ remaining claims thus turned on whether Pennsylvania law—not federal law—imposed a duty on the generic manufacturer to provide a warning to patients through a medication guide, even though Pennsylvania law otherwise focused the duty to warn inquiry for prescription drugs solely on the learned intermediaries. This ends up being a preemption issue, at least as the court framed it.

We can largely skip over the remaining warnings claims focused on the prescribers—the package insert matched the branded one and the prescribers knew the risk—to get to the purported claim based on warning the patient. If Pennsylvania did not recognize such a claim this circumstance—which would require creating a new exception to the learned intermediary doctrine—then a claim based on failing to comply with a duty would be preempted. (Frankly, the court’s lead-in on the preemption playing field was a bit off, missing the import of Mensing and injecting inapplicable law on parallel claims, but it got there.) Citing the McDaniel case out of the Sixth Circuit (discussed here and lauded as a 2018 honorable mention winner here), the court noted that most decisions on this issue had found preemption under Buckman because the applicable state law usually does not recognize “an underlying state tort law duty” to provide a medication guide for the benefit of patients.

As alluded to above, Pennsylvania’s history of recognizing the learned intermediary doctrine went back a long time—at least to the 1971 decision of the Pennsylvania Supreme Court in the Incollingo case. The court recapped some of that history—but not the more recent decisions—before acknowledging that Pennsylvania had only ever recognized one exception to the learned intermediary doctrine even though other states (or federal courts predicting state law) had made up others. Because plaintiff did not claim any recognized exception applied, we do not have to get into whether the court was right about there being any Pennsylvania exception. Instead, plaintiff urged the creating of a new court-created exception based on certain FDA regulations.

The Court will reject this suggestion for three reasons: (1) it would break new ground and significantly expand liability under Pennsylvania law; (2) even if adopted, it would be inapplicable in this case; and (3) it would be a misuse of negligence per se, which does not operate to create a new duty.

The first reason drew on a combination of the Erie restraint doctrine we tout from time to time—particularly when courts ignore it in creating new state court duties—and Pennsylvania courts’ own “reluctance” to expand tort liability without legislative action. Thus, “the Court will decline the invitation to alter Pennsylvania’s social policy calculus as it relates to the liability of manufacturers engaged in the sale of prescription drugs.”

For the second reason, the court acknowledged that the FDA regulations would need to essentially remove the prescriber from her typical role as learned intermediary. With this drug—unlike certain cases with contraceptives—there was no evidence to suggest the patient could receive it “without a learned intermediary weighing the risks and benefits.” For plaintiffs’ mother, three different physicians had done that in deciding to prescribe her the drug. Thus, without deciding that Pennsylvania would adopt any exception, the urged exception would not apply.

The last reason took the court some time to explain, but is actually fairly straightforward. Calling a claim negligence per se and claiming that a federal duty has been violated does not change what state duties do or not exist. Pennsylvania does not impose a duty to provide medication guides. Rather, it requires warnings for prescription drugs go to the learned intermediaries. Nothing about negligence per se—again, we will refrain from commenting on the larger issue of whether negligence per se based on FDA regulations can impose liability for claims like this—changes what duties exist under state law.

So, it looks like the scattered but continuing attempts to impose liability with this generic versions of this drug have failed again. Along the way, the strict application of the learned intermediary doctrine in Pennsylvania has been re-endorsed and preemption shows its strength. It would be nice if it had not taken an extra three years to get there. It seems to us that the court might have determined the non-existence of the purported claim under Pennsylvania law that plaintiffs needed to avoid preemption without three years of extensive, and presumably costly, discovery. Perhaps future courts facing similar issues will be emboldened to take, well, bold action at the 12(b)(6) stage.

 

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Here’s another guest post by friend-of-the-blog, Dick Dean of Tucker Ellis.  Dick is a big fan of primary jurisdiction (if only more courts shared his enthusiasm), and this post deals with some recent Supreme Court precedent that is helpful to such arguments, and that might otherwise have been missed.  As always our guest bloggers deserve 100% of the credit (and any blame) for their ideas.

**********

Timing is everything in life.  On April 29, after I finished reading Steve McConnell’s post playing off of the NFL draft, I started reading Supreme Court cases decided within the last few days.  By chance the first one I looked at was Atlantic Richfield v. Christian, —S.Ct.—, 2020 WL 1906542 (April 20, 2020).  It does not have to do with our sandbox; it is a CERCLA Superfund case.  But when I read it, I immediately thought of primary jurisdiction (the 16th pick in in Steve’s post) though that term is never used in the case.  It is not a classic primary jurisdiction case which involves prudential deference by a court to an agency with specific expertise on an issue before the court.  However, the underlying rationale of the doctrine was implicated in Atlantic Richfield by statutory scheme, since Congress gave the EPA specific powers relevant to the issue before the court (remediation of Superfund sites).  The case was resolved on that statutory basis.

Atlantic Richfield bought the Anaconda Copper Smelter in Montana at a deep discount hoping to turn it into something profitable. That attempt failed miserably.  It turns out that what it had bought was soon to be a Superfund site.  Atlantic agreed to a remediation plan with the EPA which is to continue to 2025. Then a group of 98 Montana landowners sued Atlantic in Montana state court for restoration damages under Montana law. Plaintiff’s remediation demands went substantially beyond what the EPA had ordered, for example, plaintiffs proposed that the land have a maximum contamination level of 15 parts per million of arsenic. The EPA had prescribed 250. There were many other remedies sought beyond what was in the plan Atlantic challenged the lawsuit.

The first issue was whether CERCLA barred this action. The trial court and the Montana Supreme Court said no.  The U.S. Supreme Court agreed.  The Court held that CERCLA deprived state courts of jurisdiction of claims brought under the Act but that it did not “displace state court jurisdiction over claims brought under other sources of law.”  Since the claims for restoration was under state law, it was not displaced.  The second question was whether the landowners needed EPA approval to seek remedial action.  The Superfund law provides that when a remediation plan was underway “no potentially responsible party” could undertake separate remediation unless it was authorized by the EPA.  So this part of the case turned on a determination of whether the land owners were “potentially responsible parties” under the Act.  The Supreme Court found that they were.  In sum, the landowners could sue in state court and were not barred from doing so by the CERCLA remediation but they could not sidestep the EPA.  It was not exclusive jurisdiction because the suit could proceed if the EPA allowed it but it was the equivalent of primary jurisdiction by statute.

In Steve’s post he referenced the use of primary jurisdiction in our sandbox.  He embedded posts discussing a number of food labeling and advertising cases.  While those are clearly the most numerous primary jurisdiction cases implicating the FDA within the last ten years, there are over 500 other primary jurisdiction cases involving the FDA.  (You can’t say much when discussing a 16th round pick).  There have been a number of cases finding primary jurisdiction where the claim was related to or premised on the assumption that a drug was safe and effective.  Not only does the FDA have significant medical and scientific expertise to bring to bear on whether a drug is safe and effective, Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 654 (1973), it is the only entity that is authorized to make such decisions.  Weinberger v. Hynson, Westcott & Dunning, Inc. 412 U.S. 609, 627 (1973).  So it is not surprising that claims implicating that decision have been dismissed or side-tracked by primary jurisdiction.  National Ethical Pharmaceutical Assn. v. Weinberger, 503 F.2d 1051 (4th Cir. 1974) (attempt to challenge FDA determination of what was or was not a new drug could proceed only after a formal ruling from the FDA); Israel v. Baxter Laboratories, Inc., 466 F.2d 272 (D.C. Cir. 1972) (action by drug manufacturer that competitor and others conspired to keep drug off market by preventing fair consideration required remand and consideration by FDA to determine safety and efficacy).

From approximately 2000 to 2010, plaintiffs’ lawyers often tried to influence or modify the course of FDA generated recalls.  More specifically, they would request that courts change language in a recall already issued to be more expansive.  Courts generally declined those requests since the issue in a recall is “what is the appropriate dissemination of medical information to the consuming public.”  Clark v. Actavis Group hf, 567 F. Supp.2d 711 (D.N.J. 2008).  And since that is a medical issue it is within the province of the FDA, and courts should defer to that expertise.  Those cases are discussed in “Out of Your Jurisdiction: Why FDA Recalls and Courts Do Not Mix” in IADC Drug, Device and Biotechnology Newsletter (August 2011).

Most recently the doctrine has been advanced in state court opioid litigations against the pharmaceutical companies alleging improper marketing or advertising.  The companies argued that courts should stay proceedings until completion of studies ordered by the FDA regarding specific opioids.  Those cases are discussed in Stapleton “In Defense of the Hare: Primary Jurisdiction Doctrine and Scientific Uncertainty in State-Court Opioid Litigation,” 86 U. Chi. L. Rev. 1697 (Oct. 2019).

16th draft picks may not be as exciting as a top 5 pick, but they can make big plays helping to win games.

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