Search results for: pradaxa

This year has seen a lot – and most of it would not fall into the positive category.  The pandemic; severe wildfires in the U.S. and Australia; record setting tropical storms in the Atlantic; social unrest over police brutality; explosion in Beirut.  Unfortunately, we could go on.  Even more unfortunate is the fact that all of us tend to focus on the negative.  It’s not hard to do with today’s media coverage.  But there is a flipside.  Anti-racist books are topping bestseller lists.  Animals are being adopted by the hundreds of thousands in America.  People are finally listening to their parents and washing their hands.  Drive-in movie theaters made a comeback.  John Krasinski’s “Some Good News.”  Companies from Ford and GM to Apple to your local distillery shifted production to make much needed masks, ventilators, and hand sanitizer.  And Hamilton the movie lived up to the hype.

That’s the world in general.  Here in the DDL world, our 2020 “p” word isn’t pandemic.  It’s Pradaxa, and preemption, oh and pummels.  The defense has had a lot to be happy about in the Pradaxa litigation.  We’ve been bringing you consistent wins since January (here’s a collection).  Now here is one more to add to the slate – Silverstein v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 U.S. Dist. LEXIS 188176 (S.D. Fla. Oct. 7, 2020).

It’s a lengthy decision that goes into extensive detail about the studies, analyses and science that were submitted to the FDA during and after the approval of the drug.  See id. at *36-*88.  Since the court found none of it to be “newly acquired evidence” that would support a CBE label change, we’re going to skip the details and focus on the legal conclusions.

Plaintiff suffered a significant gastrointestinal bleed while on Pradaxa, an anticoagulant, and alleged that the drug was defective because defendant did not adequately warn that blood plasma concentrations should be monitored and that certain patient characteristics, such as renal impairments and concomitant use of other drugs, could increase the risk of severe bleeding.  At the summary judgement stage, the primary issue was whether plaintiff could survive preemption because the manufacturer could have submitted a revised warning under the Changes Being Effected (“CBE”) regulations.  To make a CBE label change, however, the manufacturer would have to have “newly acquired information” – information not previously provided to the FDA – that demonstrates “risks of a different type or greater severity or frequency than previously included in the submission to FDA.”  Id. at *89-90.

We’ve already given away the ending – the court rejected the contention that the manufacturer had the evidence to support a CBE label change.  Before reaching this conclusion, the court took a slightly less defense-friendly view on the burden of proof.  Acknowledging that most other courts to examine the issue have held that plaintiffs bear the burden to prove that the manufacturer obtained newly acquired information to support a label change, this court took a more middle of the road position.  Id. at *31.

I find that Plaintiffs should bear the initial burden of identifying the specific information that they assert [the manufacturer] acquired after the FDA approved [the drug] and should have used to modify the [drug’s] label. Once Plaintiff points to this specific information, [the manufacturer] bears the burden of proving that it does not meet the definition of “newly acquired information” under the CBE regulation. This allocation of burdens avoids making [the manufacturer] prove a negative – that it acquired no new information after [the drug] was approved that would have justified a CBE modification.

Id. at *32-33.  As the lengthy recitation of evidence shows, plaintiff carried their burden of proof by pointing to all sorts of supposedly new analyses, papers, etc.  But so too did the manufacturer.  The court found several points persuasive.  Such as that the FDA had approved Pradaxa’s labeling on “19 separate occasions” without requiring the warning Plaintiff wanted and after reviewing much of the evidence plaintiff argued was newly acquired.  Id. at *84.  Also, when the FDA approved Pradaxa it was already aware of the inconclusive evidence regarding whether stroke risk went down at higher levels of plasma concentration.  So, the evidence plaintiff relied on did not reveal a risk of a different type to fall under the CBE regulations.  Id. at *95.  Even viewing the evidence in “a light most favorable to plaintiff,” id. at *98, despite preemption being a question of law, the evidence did not support a conclusion different from what was known at the time of approval.  Id.  Moreover, to support a CBE label change, the evidence also must be scientifically reliable.  “A CBE change cannot be rooted in conjecture or hypothesis.”  Id. at *20-21.  Plaintiff’s uncorroborated, unpeer-reviewed, and unreplicated sources were not sufficiently scientifically reliable to be newly acquired information.  Finally, the type of risk at issue – a major bleed – was known by the FDA and was included in the label which “conclusively shows that it was submitted to the FDA.”  Id. at *109.

Because the court concluded that none of the evidence put forth by plaintiff was “newly acquired,” it dd not have to reach the issue of whether the FDA would have rejected the proposed label change to conclude the plaintiff’s claims were preempted.  Id. at *111.  The court did, however, address defendant’s alternate argument that the Pradaxa label was adequate as a matter of law.  Plaintiff’s first mistake was relying on Dr. Plunkett for label adequacy.  Because she is not a medical doctor, “[s]he does not, and presumably cannot, opine on how a treating physician would interpret and respond to the [drug’s] label.  Id. at *113.  Even so, what plaintiff was asking the court to do is require that the manufacturer not only warn of the risk, but also the importance of and how to monitor for the risk.  Under Florida law, a manufacturer “need not warn about the specific manner in which the injury may occur.”  Id. at *114.  Because the label contained “accurate, clear, and unambiguous warnings” regarding bleeding, therapeutic monitoring, and increased risk to patients with renal impairment – it was “sufficient to educate a reasonable treating physician that Pradaxa presented” the precise risk at issue.  Id. at *115.  Therefore, the warnings were adequate, and defendant was entitled to summary judgment on all counts.

So, we know Pradaxa goes in the 2020 win column.  But, will the 2020 Halloween rare full moon, blue moon end up as just a picturesque backdrop for outdoor parties or Night of the Living Dead?  Given how the year is going . . . .

Today we have another guest post from friend-of-the-Blog, Dick Dean at Tucker Ellis.  He’s familiar with the ongoing Pradaxa litigation and is pleased with the preemption pummeling Pradaxa plaintiffs have been receiving.  Here’s his post about yet another favorable decision from the state-court Pradaxa proceedings in Connecticut.  With decisions like this, who needs snap removal?  As always, our guest posters deserve 100% of the credit (and any blame) for their work.

**********

No commentator or blog has more precisely and persistently probed preemption and its “newly acquired information” component than has the Drug and Device Law Blog.  And the Blog has done it with poetry, or at least alliteration.  If you went right to the story and didn’t savor the headlines you missed:  “Post-Albrecht Preemption Pummels Pradaxa Plaintiffs,” followed shortly by “Post–Albrecht Preemption Persistently Pummels Pradaxa Plaintiffs.”  But what started this parade was “Plaintiff’s Pyrrhic Pradaxa ‘Victory’,” reporting on Roberto v.  Boehringer Ingelheim Pharmaceuticals, Inc., No. CPLHHDCV166068484S, 2019 WL 5068452 (Conn. Sup. Ct. Sept. 11, 2019).  The Roberto court found a labeling claim about the bleeding risk from a blood thinner preempted because there was no newly acquired information on a general bleeding risk that would have warranted a CBE label change.  But the trial court also found that there was sufficient evidence to sustain a verdict of a heightened risk of bleeding in GERD (gastroesophageal reflux disease) patients, specifically.  Indeed, the court concluded in Roberto that it was unclear whether information bearing on the GERD risk had been submitted to the FDA.  But the Pyrrhic Victory post recognized that the bigger picture was the general bleeding risk, and that there were only a few GERD cases in this litigation.  So the GERD finding was a pyrrhic victory.

But now even that plaintiff’s Pyrrhic Pradaxa victory has been put out to pasture.  No longer are there GERD outliers that escape preemption.

In Estep v. Boehringer Ingelheim Pharmaceuticals, Inc., No. X03 HHD CV17-6075319S, 2020 WL 5290777 (Conn. Sup. Ct. Aug. 25, 2020), the same court that decided Roberto considered a follow-up GERD case, which had an “expanded record” on the newly acquired information issue that had allowed the Roberto plaintiff to escape preemption.  Id. at *7.  The Estep Plaintiff likewise claimed the new information on the GERD issue was a European label and a 2013-2014 medical journal article.  The court again found that these items showed reasonable evidence of different or greater risks not stated in the U.S. label.  Id. at *8.  But that left the issue of “newness.”  The definition of “newly acquired information” uses phrases like “not previously submitted to the Agency” and “previously included in submissions to the FDA.”  21 C.F.R. §314.3(b).  Defendant argued that it had submitted data to the FDA that were equivalent to what plaintiff cited in the European label and the journal article—specifically, it relied on reports of bleeding in GERD patients.  Id. at *9.

Plaintiff in Estep argued that the information submitted to the FDA had to be “tethered to a proposed label change” in order to qualify as “previously submitted” to the agency.  Id.  That novel argument was to no avail.  The Court found that a straightforward application of the rules of statutory construction supported the defendant’s position.  It then looked closely at the information submitted to the agency to determine whether it was “equivalent to the claimed newly acquired information.”  Id. at *9.  The defendant pointed to several reports submitted to the FDA prior to the original approval in October 2010 that showed gastritis-like symptoms, defined to include GERD, were associated with an increased risk of GI bleed.  Id. at *13.  The court then cited almost an entire page of tables and charts linking bleeding risks in gastritis-like symptoms, which had been submitted.  Id.  In addition, in the “expanded record” defendant showed that it had submitted the very European label relied upon by plaintiffs to the FDA in September 2012, after approval but before a December 2013 label change and before plaintiff’s bleed in February 2015.  Id.

Estep is a significant decision.  It is the first holding that hard data submitted without a specific request for a label change can defeat a claim of newly acquired information.  Not that it should make any difference, but it’s another plaintiff propaganda point put down, and recognized for what it is, a distinction without a difference.

Estep stands in stark contrast to Evans v. Gilead Sciences, Inc., No. 20-cv-00123-DKW-KJM, 2020 WL 5189995 (D. Haw. Aug. 31, 2020), which the Blog discussed here last month.  That post noted the adverse warning holding in Evans that “…even if there was little or no ‘newly acquired information’ relevant to Evans’ claim, that did not make it impossible for Gilead to change its….label.”  Id. at *11.  The opinion in Estep provides a detailed refutation explaining why Evans was erroneous.  2020 WL 5290777 at *10-*11.  Estep cited to the FDA’s comments supporting the rule change in 2008 adding the concept of “newly acquired information.”  Those comments pointed out that allowing sponsors to change labeling for a product without limitation based on previously submitted information would undermine the FDA label approval process.  Id. at *11.

If a plaintiff is going to allege an inadequate warning because a CBE could have been made, then the CBE regulation’s newly acquired information prerequisite must be confronted—not glossed over.  Estep also provides an excellent summary of the law in regard to pleading “newly acquired information.”  Id. at *5-*6.  Once a defendant makes an initial showing of a preemption defense, then a plaintiff must specifically identify the “newly acquired information” he relies upon.  Numerous posts on this blog have treated this issue.  In addition to the “Pummels” posts, see “Online Reviews Are Not ‘Newly Acquired Evidence,” “On Newly Acquired Evidence,” “‘No Newly Acquired Evidence’ Argument On Implied Preemption Gaining Traction,” and “Plaintiffs Have Burden To Plead Newly Acquired Evidence.”  As the Blog’s post about Evans discussed, that decision stumbled badly on this increasingly key pleading issue—ignoring many cases in the last three years directly on point while citing to a 2018 Ninth Circuit decision having nothing to do with “newly acquired information.”  2020 WL 5189995 at *10.

Estep underscores what an outlier decision Evans truly is.

Lyons v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 5835125 (N.D. Ga. Sept. 29, 2020), was a wrongful death action alleging that the anticoagulant drug Pradaxa was defective and not accompanied by adequate warnings that blood plasma concentrations should be monitored and that certain patient characteristics, such as age, renal impairments, and concomitant statin use, could increase risks of severe bleeding. The design defect claim turned out to be wholly premised on the alleged failure to warn, and the failure to warn claim turned out to be wholly preempted. Thus, the Lyons case is consistent with other Pradaxa cases arriving at the same result, and represents a sound application of the SCOTUS Albrecht opinion. (We discussed these Pradaxa cases here and here, for example.)

To try to get around the preemptive effect of an FDA-approved drug label,the plaintiff in Lyons contended that the drug manufacturer could have submitted a Changes Being Effected regarding the needs for plasma monitoring and paying attention to certain patient characteristics. But the Lyons court rejected this contention because there was no “newly acquired information” supporting the new warnings and, in any event, the extensive record of information exchanges between the manufacturer and the FDA provided “clear evidence” that the FDA would have rejected the proposed new warnings.

The issues of newly acquired information and likely rejection by the FDA go together, of course. All of the supposedly new papers, analyses, emails, European labels, etc. regarding the drug’s safety either contained information the FDA already had, or were not so much new information as mere “trial balloons.” There was simply no basis furnished by the plaintiff to suggest that the FDA would have seen fit to add warnings to the label. Moreover, based on all this information, the FDA had twice rejected some of the warnings, reasoning that “independent risk factors for bleeding … do not need to be specifically in the label” because “we do not want the [label] to become too long to be useful.”

One of the more interesting aspects of Lyons is the issue about whether the judge or jury decides the issue of “newly acquired information.” In Albrecht, SCOTUS decided that it is up to the judge, not the jury, to determine whether the FDA would have rejected the proposed warning. That means summary judgment is possible on that issue. But the plaintiff in Lyons argued that, despite Albrecht, “newly acquired information” is an issue for the jury. That position would go a long way toward making summary judgment impossible – the plaintiff’s goal. Like other courts that have tackled this point, the Lyons court held that the logic of Albrecht means that whether something is “newly acquired information” must be decided by the court, since that issue is usually a predicate for the issue of likely FDA rejection. Applying this analysis, the Lyons court granted the defendant summary judgment.

Inasmuch as Lyons falls in line with other cases, perhaps its ruling does not constitute newly acquired information. But it is helpful and reassuring nonetheless. Clear evidence of judicial rationality is always welcome.

Not long ago, in our “Post-Albrecht Preemption Pummels Pradaxa Plaintiffs” post we discussed several recent favorable preemption decisions in product liability litigation involving that drug:  Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (Mag. W.D. Mo. March 16, 2020), Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 1704646 (Conn. Super. March 13, 2020), Ridings v. Maurice, 2019 WL 8223599 (W.D. Mo. Oct. 20, 2019), and Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452 (Conn. Super. Sept. 11, 2019).

Those were all favorable cases, but they were all by trial-level courts, and thus subject to the vagaries of the appellate process.  How about a similar decision from the other end of the appellate process?  Thus, we present Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., ___ A.3d ___, slip op., 2020 WL 2121063 (Conn. May 4, 2020).

Boone was an appeal from a trial that produced a defense verdict.  The opinion addresses several rather case/product-specific issues before it gets to the preemption topic that is near and dear to our blogging hearts.  Thus, we’ll pass over pages *2-11 of the Connecticut Supreme Court’s opinion (which resolve disputes over spoliation and rebuttal evidence).

Boone unanimously affirmed the trial court’s grant of a preemption summary judgment motion against “a design defect claim related to the defendants’ failure to develop and market a reversal agent.”  2020 WL 2121063, at *12.  This claim ran afoul of what we call the “Mensing independence principle” – “The relevant inquiry, [Mensing] held, was whether the defendants ‘‘could independently do under federal law what state law requires. . . .”  Id. at *14 (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011)) (emphasis supplied by Boone).

The preempted claim, which really isn’t a “design defect” since it doesn’t involve any aspect of the actual product’s design, see id. at *12 n.32, was that the defendant should not have sold the drug at all until it had also developed and obtained FDA approval for a different drug.  As the Boone court recognized, id. at *14, this claim was also preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  Moreover, footnote 32 is itself interesting, since usually courts steer away from deciding constitutional issues when they can avoid them.  But in Boone, “[b]ecause we conclude that the trial court properly granted the defendants’ motion for summary judgment on federal preemption grounds,” the court did not address whether a claim was stated under Connecticut state law.  Preemption was evidently an easy call in Boone.

Boone recognized that, despite a purported presumption against preemption, the logic of Mensing and Bartlett “compels” preemption.  Plaintiff was using state law to hold one drug’s FDA approval hostage to the agency also approving a second drug.  That theory self-evidently depended on the FDA acting to approve the second drug – which required preemption.  “[I]t is enough to hold that when a party cannot satisfy its state duties without the [f]ederal [g]overnment’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 [preemption] purposes.’’  Boone, 2020 WL 2121063, at *14 n.34 (quoting Mensing, 564 U.S. at 623-24) (emphasis added by Boone).

In order to cure the design defect alleged by the plaintiff, the defendants would have had to bring [the second drug] to market before the [alleged injury occurred].  Because there is no dispute that [the second drug] was not approved by the FDA until [later], the defendants could not have satisfied their alleged state law duty to the decedent without marketing an unapproved drug in violation of federal law.

Id. at *15.

Plaintiff unsuccessfully argued “that the test for preemption set forth in Mensing and Bartlett is inapplicable to present case because those cases do not involve brand-name drugs.”  Id.  No dice.  While the “different levels of control” that branded and generic manufacturers exercised over their labels “informed the [supreme] court’s analysis . . ., the nature of the underlying test remained consistent:  whether the defendant ‘‘could independently do under federal law what state law requires.”  Id. (once again quoting and emphasizing Mensing independence principle).  Boone agreed with the holding in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), that, ‘‘contrary to [the plaintiff’s] contention that the impossibility preemption in Mensing and Bartlett is limited to generic drugs, we view Levine, Mensing, and Bartlett as together stating the same test for impossibility preemption.’  Boone, 2020 WL 2121063, at *15 (quoting Yates, 808 F.3d at 296-97).

Along the way, Boone rejected the plaintiff’s argument (which readers will recognize from our previous Pradaxa preemption pummels plaintiffs post) that Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), somehow confined the preemption inquiry in branded drug cases to the so-called “clear evidence” test.  Boone made clear that “clear evidence” was only a piece of the implied preemption puzzle:

The plaintiff in the present case asserts that a recent United States Supreme Court case explaining that particular standard, [Albrecht], stands for the broad proposition that impossibility preemption ‘‘only applies when a defendant can affirmatively show that it attempted to get the FDA to allow the safer alternative proposed by the plaintiff and the FDA affirmatively and officially rejected it.’’ (Footnote omitted.)  We disagree. The clear evidence standard in [Levine] applies only when a defendant seeks to prove that compliance with a state law obligation remains impossible notwithstanding its ability to act unilaterally under federal law.

2020 WL 2121063, at *13 n.33 (emphasis original).  The clear evidence test applies when drug manufacturers “could have satisfied their state law obligation to provide a label with an adequate warning by unilaterally making label amendments.”  Id. (citing FDA CBE regulation).  Because the plaintiff’s preempted theory was not something that could be addressed by a CBE label change, “Albrecht is inapposite.”  Id.

The plaintiff’s last-ditch, state-of-the-art argument against preemption in Boone also failed.  Whether or not it was “technologically feasible” to seek FDA approval of the second drug, doing so still required the FDA to act to grant approval.  That pesky Mensing independence principle sank the plaintiff once again.

Although such practical considerations may sometimes limit the options available to a manufacturer; that fact is inapposite to the question of whether marketing [the second drug] would have required the FDA’s ‘‘special permission and assistance.”  For similar reasons, we are also unpersuaded that the FDA’s subsequent approval of [the second drug] is dispositive.  The possibility that the FDA would have looked favorably on an earlier application does nothing to alter the fact that, at the time of the decedent’s death, the defendants were prevented from unilaterally marketing [the second drug] under federal law.

Boone, 2020 WL 2121063, at *15 (quoting Mensing, other citations omitted).  Boone agreed with earlier decisions (including Maurice) that had held similar claims preempted.  Id. at *15 n.38 (reaching “same conclusion” as Ridings v. Maurice, 2019 WL 4888910, at *6 (W.D. Mo. Aug. 12, 2019), and Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 849081, at *13 (M.D. Ga. Jan. 2, 2018), and giving the “but see” to In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1395312, at *3 (E.D. La. April 13, 2017)).  We agree that the Xarelto decision is wrongly decided.

Unless the plaintiff wants to appeal Boone to the United States Supreme Court – go ahead make our day, after Bartlett we can imagine what the Court would do with this theory – this is the end of the appellate line.  Further, given the Connecticut Supreme Court’s reasoning in Boone, we’re cautiously optimistic that it will uphold the later Connecticut state decisions in Roberto and Adkins, which are wending their way through the appellate process.  While the arguments aren’t all identical, at least two of those plaintiffs’ major contentions (generics are different and Albrecht) bit the dust in Boone.

Finally, we are gratified to see implied impossibility preemption applied to “you should have made a different/additional drug” claims.  The same preemption rationale that Boone adopted should also be fatal to the claims we discussed here, that the drug that reduced AIDS from a death sentence to a treatable chronic condition was “defective” because the defendant didn’t make a “better” drug sooner.  Any defect claim predicated on the possible FDA approval of a different drug necessarily depends on action by the FDA, and is thus preempted under the Mensing independence principle.

Two of longest recent entries in our Post-Levine Drug/Vaccine Preemption Cheat Sheet are Pradaxa wins.  Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., slip op., 2020 WL 1704646 (Conn. Super. March 13, 2020) (#106), and Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (Mag. W.D. Mo. March 16, 2020) (#108).  There’s also a third recent decision, Ridings v. Maurice, 2019 WL 8223599 (W.D. Mo. Oct. 20, 2019) (which we’ll call “Ridings 0”), that was a procedural precursor to the more recent Ridings opinion.  Between them, these recent Pradaxa wins provide some useful guidance about how to approach branded prescription drug preemption motions in the new post-Albrecht, “matter of law” world.  We’ll go through them in order.

Note:  many of the factual rulings in these cases are similar (sometimes identical) to a Pradaxa decision we already blogged about last September, Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452 (Conn. Super. Sept. 11, 2019) (#96).  Today, we’re mining these opinions for more broadly applicable propositions, so this post won’t go into nearly the item-by-item detail that our Roberto post did.

In Ridings 0, the court had to reconsider a prior decision that had held preemption of the plaintiff’s warning claims to be a jury question due to disputed issues of fact.  2019 WL 8223599, at *1-2 (discussing Ridings v. Maurice, 2019 WL 4888910 (W.D. Mo. Aug. 12, 2019)).  The court recognized the obvious – that the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), required those disputed issues to be decided by the court.  Ridings 0, 2019 WL 8223599, at *2 (“To the extent that the Court’s order mandat[es] the submission of the preemption question to the jury, it is contrary to Albrecht.”).  Thus, the court had to create a process for undertaking the preemption analysis.

For those of you who might be making similar procedural suggestions, here’s what the Ridings 0 court came up with:

  • Since “fact-finding” was involved, the decision would not be made solely on the summary judgment record.
  • Rather, the court set a preemption hearing at which “witnesses (including expert witnesses)” would be examined and “factual determinations based on credibility and persuasiveness” would be made.
  • The hearing would “require two stages of analysis,” with a shifting burden of proof.
  • “First, [plaintiff] must show that ‘newly acquired information’ existed such that [defendant] could unilaterally change its label in accordance with the CBE regulation.”
  • Second, if plaintiff established newly acquired information, the defendant “may still establish an impossibility preemption defense by presenting “clear evidence” that the FDA would have rejected the labeling change.”

2019 WL 8223599, at *2-3.

This process led the Ridings court to conclude all of the plaintiff’s warning claims were preempted.  Ridings, 2020 WL 1264178, at *23 (“all of [plaintiff’s] remaining claims are preempted by federal law”).  But before we get to the preemption analysis, here are a few more procedural steps that Ridings took:

  • “To keep the hearing focused on the actual issue in the case, the Court thus required [plaintiff] to specifically identify the warning (or warnings) that he believed should have been given by [defendant].” Id. at *4.

This requirement is significant, since plaintiffs love for their warning claims to be a constantly moving target.  Consider it a collateral benefit of preemption.

  • Because “it was not the usual practice to ask a party to prove a negative, . . . the best practice was to view the question of preemption in drug litigation as involving a shifting burden.”  Id.
  • First, the “defendant must make an initial prima facie showing of preemption for the warning it did provide.”   This step was undisputed, since “the warning label for [the drug] in effect at the time [plaintiff] was using [it] had been approved by the FDA.”  Id.
  • Once the defendant puts preemption at issue, “a plaintiff then bears the burden of coming forward with evidence sufficient to conclude that the defendant could and should have availed itself of the [CBE] regulation[] and given a different warning.”  Id.
  • If plaintiff establishes the prerequisites to application of the CBE regulation, then “the defendant then bears the burden of coming forward with ‘clear evidence’ that the FDA – even if presented with such ‘new’ evidence – nonetheless would have rejected the warning(s) advocated by the plaintiff.”  Id.
  • The hearing was conducted in accordance with “the standards associated with bench trials.”  Id.
  • Following the hearing, “the parties submitted their respective proposed findings of fact and conclusions of law.”  Id.

Ridings, 2020 WL 1264178, at *4.  So if a post-Albrecht court asks “what now” in response to a preemption motion, the Ridings litigation provides a road map for how to get from here (motion filed) to there (hopefully, dismissal).

The substantive preemption portion of Ridings is 35 pages (18 Westlaw star pages) long.  Here are some highlights that we find useful for defendants pursuing implied impossibility preemption in a post-Albrecht world.

  • In general, “under Mensing and similar cases, federal law preempts any state law claim requiring a drug manufacturer to change its labeling” subject to “limited opportunities [for] a drug manufacturer to unilaterally change a drug label that can, in some cases, effectively undercut any claim of impossibility.”  Ridings, 2020 WL 1264178, at Id. *12.
  • “[T]he determination of preemption will often require the Court to make factual determinations based on competing and contradictory evidence.”  Id. at *14 n.27.
  • “[T]he issue of ‘newly acquired information,’ [requires that] the Court consider[] whether there is adequate proof that [defendant] was in possession of such information, and that such information was reasonable evidence of an association of a serious hazard with [the drug] sufficient to require [defendant] to unilaterally revise its label to include a warning.”  Id. at *15.
  • “[N]ewly acquired information must provide reasonable evidence of a causal association of a clinically significant adverse reaction linked to a drug. A clinically significant adverse reaction has a significant impact on therapeutic decision-making, such as a risk that is potentially fatal or otherwise serious.”  Id. (regulatory citations and quotation marks omitted) (emphasis original).

This is another point that warrants emphasis.  In some situations, the requirement of a “clinically significant” risk can be of critical importance.

  • The FDA’s requirement that “there must be sufficient evidence of a causal association between the drug and the information sought to be added” enforces the Agency’s objective of preventing overwarning.  Id. (citation and quotation marks omitted) (emphasis original).
  • “[S]tudies concluding that it ‘remains unknown’ whether a drug is linked to a particular adverse reaction or risk or that ‘further studies are required to address possible clinical consequences’ do not constitute reasonable or well-grounded scientific evidence of ‘clinically significant adverse effects’ under the CBE regulation.”  Id.

That’s another ruling with broad importance, since these kind of tentative studies are frequently all plaintiffs have in prescription drug product liability litigation.

  • While “it is clear that newly acquired information may encompass a new analysis of old data . . . studies published after a plaintiff’s injury are not relevant to constitute newly acquired information.”  Id. (citations and quotation marks omitted).
  • “[A] claim that a drug label should be changed based solely on the information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.  Id. at *16 (citation and quotation marks omitted).
  • “[W]arnings approved for a foreign label are not in and of themselves newly acquired evidence when they are based on consideration of substantially similar information. Foreign drug labeling is the product of different and distinct regulatory standards and decisions.”  Id. at *17.
  • [R]ejection of bad ideas is as important to the process as the confirmation and embracing of good ideas.  [A withdrawn patent] was a bad idea that simply did not pan out.  It does not constitute newly acquired evidence under the CBE regulation.”  at *18.
  • An article concluding “that there is no single . . . optimal benefit-risk [point] for all patients . . . does not establish any “risks of a different type or greater severity or frequency.”  Id. at *20 (citation, footnote, and quotation marks omitted).
  • “[P]reliminary discussions do not provide reliable evidence of new risks. They are essentially uncorroborated trial balloons.”  Id.

We think that Ridings is thus brimming with favorable points and usable quotes.  In particular, we recommend the holdings that articles concluding only “we’re not sure” and “conduct more research” and “preliminary discussions” are all too tentative to be newly acquired information, and thus insufficient to prevent preemption are important, since so much of the other side’s arguments are based on taking precisely this sort of material out of context.

Finally, Ridings took a stab at “clear evidence” as an alternative holding.  Even though the defendant hadn’t submitted to the FDA the language that plaintiff claimed was necessary to have an adequate warning, Ridings found “clear evidence” that the FDA would not have allowed it.  Ridings, 2020 WL 1264178 at *21.  As we’ve pointed out elsewhere, plaintiffs now claim that Albrecht requires actual submission and rejection of a warning proposal for “clear evidence” to exist.  Not so – at least on the well-developed regulatory record in Ridings:

[T]he Court wishes to be clear – it should not always be the case that simple inaction by the FDA in light of submitted data will always be “clear evidence” that the FDA would reject a particular warning.  In this case, however, in light of the known issues and the ongoing give-and-take between [defendant] and the FDA on these issues . . . the FDA’s continued inaction does represent clear evidence under these facts.

Id. (emphasis original).

The other major recent Pradaxa opinion is Adkins, 2020 WL 1704646, decided by the same judge who issued Roberto.  As we would expect, Adkins does a lot of quoting from and citing to Roberto.  However, Adkins also adds some independently useful points.  First, Adkins rejects the plaintiff’s argument that, by only addressing the “clear evidence” prong of impossibility preemption, Albrecht impliedly eliminated all other bases for preemption.  Not at all:

The plaintiff claims that in this context a “state law claim is preempted only when there is ‘clear evidence’ that the FDA would not have approved a change to the drug’s label.” . . .  This statement . . . is not correct.  There are actually two theories of preemption. . . .  The first, or threshold, theory addresses whether the pharmaceutical company had authority under federal law to change the label on its own to conform to the plaintiff’s state law demands.  If it did not, then it would also be impossible for the company to comply with state law.

Adkins, 2020 WL 1704646, at *2 (footnote omitted).  Plaintiff’s warning claims must navigate the “lengthy and complex” CBE regulation, of which “newly acquired information” is “the key component.”  Id. at *3 & n.4.  Albrecht didn’t have to address the requirements that the FDA wrote into its CBE regulation because the defendant in that case “conceded that the FDA’s CBE regulation would have permitted [it] to try to change the label.”  Id. at *4 (quoting Albrecht).  Further, a plaintiff cannot simply declare ex cathedra the s/he has “newly acquired information” – the “basic adversary nature of our judicial system” affords defendants the right to dispute plaintiffs’ claims of purportedly newly acquired information.  Id. at *4 n.6.

Also, after Albrecht, a “factual dispute” does not end, but only begins, the court’s inquiry:

[T]he plaintiff’s brief repeatedly asserts that the court should deny the summary judgment motion because there are factual disputes, implicitly suggesting that these factual disputes should be resolved at trials. . . .  These positions are obviously contradictory [with Albrecht].

Adkins, 2020 WL 1704646, at *5 (footnote omitted).  All aspects of preemption post-Albrecht, not just “clear evidence,” are legal questions for judges to decide.  Id. (“[I]t seems unlikely that the Supreme Court would hold that the first prong is triable to the jury while the second prong is not.  Both prongs involve complicated legal analysis,”).  Interestingly, Adkins relies in part on Ridings 0 for support of this proposition.  Id.

Adkins followed the same shifting burden of proof as previously stated in Roberto, and similar to that utilized in Ridings (although Ridings was not decided on summary judgment):

For a case, such as the present one, arising on summary judgment, our courts have traditionally applied a burden-shifting approach in which the defendant must initially make a showing of entitlement to judgment as a matter of law and the plaintiff must then show a genuine issue of material fact.  That approach applies even when the defendant seeks summary judgment on an affirmative defense.

Adkins, 2020 WL 1704646, at *6 (citations omitted).  “[T]here is no need to assign a burden of proof and the court’s only task is decide how the law applies in this context.”  Id.  The defendant rebuts any “presumption against preemption . . . by showing that the plaintiff’s proffer does not constitute newly acquired information.”  Id.

Adkins evaluates essentially the same purported “newly acquired information” as Roberto and Ridings, so we won’t repeat what we’ve already covered in discussing those cases.  Adkins did criticize plaintiff for indiscriminately claiming all sorts of things as “newly acquired information” and not adequately briefing most of them.  Id. at *6-7.  Typical plaintiff behavior in our experience.  From our non-Pradaxa-specific vantage point, the rest of Adkins is notable chiefly for coming to the same conclusion about medical literature with “further study” conclusions as previously stated in Ridings:

[T]he commentary’s rather tentative statement . . . and its conclusion that its proposal for monitoring “lends itself to further clinical trials” do not establish newly acquired information with any reliability.  The article presents a proposal rather than making a finding. . . .  Given the inconclusive nature of the commentary . . . it is simply unclear what change to the label the [article] would have permitted the defendants to make.  The court concludes that [it] does not constitute newly acquired information.

Adkins, 2020 WL 1704646, at *13 (citations and footnote omitted).

Ridings and Adkins are chock full of useful propositions and refutations of plaintiffs’ overreaching post-Albrecht procedural arguments.  Like the Gadolinium litigation we’ve discussed recently, the factual and legal weaknesses of the plaintiffs’ Pradaxa preemption positions confirm the statement we made last year about why we think Albrecht, on balance, will be quite beneficial to defendants.  “In 95% of preemption cases (at least), we think defendants have the better side of the regulatory record, thus we should win most straight-up preemption arguments.”

We were going back through some old cases the other day and came across a gem from our hometown court right here in in San Francisco.  It caught our eye because it deals with an angle of federal preemption on which we have written before and which we think is underappreciated, so we’re going to write about it again.  The issue is implied preemption, more specifically implied preemption where the plaintiff cannot produce “newly acquired information” supporting the drug warning that the plaintiff claims a drug manufacturer should have added to its labeling.  This is a pathway to implied preemption separate and apart from introducing “clear evidence” that the FDA would not have allowed the warning purportedly required by state law.

We will get more into these two pathways in a minute, but it all matters because of the FDA’s Changes Being Effected regulations and ultimately Wyeth v. Levine, where the Supreme Court held that a drug manufacturer could comply with both federal drug regulation and state-law duties to warn by unilaterally strengthening its labeling under the CBE regs.  No impossibility, no preemption.

We have always thought that the Supreme Court was far too generous in its reading of the CBE regulations and the extent to which they actually allow drug manufacturers to change their labels.  But even taking Wyeth v. Levine at face value, it was not the end of implied preemption.  Prescription drug manufacturers most commonly try to invoke implied preemption with “clear evidence” that the FDA considered and rejected the warning purportedly required by state law.  The example that most readily comes to mind is Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018), where the Seventh Circuit held that federal law preempted the plaintiff’s state law warnings claims because the FDA had repeatedly instructed the company not to add the warning that the plaintiff wanted.

There is, however, more than one way to skin a cat.  Another avenue to implied preemption is to argue that the drug manufacturer could not have changed the drug warnings as the plaintiffs command because there is no “newly acquired information” to support the warning.  That too is grounded in the CBE regulations, which do not allow additional warnings based on information already submitted to the FDA when the drug labeling was approved.

This was the way to summary judgment late last year in a Pradaxa case in California state court.  See Pradaxa Cases, No. CJC-16-004863, 2019 WL 6043513 (Cal. Super. Ct. Nov. 8, 2019).  We have written on Pradaxa cases before—most recently Roberto v. Boehringer Ingelheim here, and another post here covers “newly acquired information” cases, too.  The California summary judgment order is the most succinct, particularly in setting forth a very helpful two-prong framework.

Like all Pradaxa plaintiffs, the California plaintiff alleged that the product—which is an anticoagulant—placed her at an increased risk of bleeding, and that the defendant manufacturer should have warned more strongly about that risk.  The court, however, found those claims to be impliedly preempted.  Here is the quote that you will want to focus on:

Warning preemption analysis is a two-prong analysis, assessed by the Court.  (See Merck Sharp & Dohme Corp. v. Albrecht (2019) 139 S. Ct. 1668, 1676. . . .)  “First, the plaintiff must show that there existed ‘newly acquired information’ such that the defendants could unilaterally change the label pursuant to the CBE regulation without FDA approval. . . .”  . . . Second, “if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.”

Pradaxa, 2019 WL 6043513, at *2 (some citations omitted).  We saw this two-prong formulation for the first time in Roberto, but we repeat it here because it so cleanly captures two avenues to implied preemption in one gloss.  The plaintiff has to produce “newly acquired information” to support the demanded change.  And it can’t be just any old evidence—it has to be meaningful, concrete, and not previously submitted to the FDA:

“[N]ewly acquired information” is defined as: “data, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” (21 C.F.R. § 314.3(b) [emphasis supplied].)

. . . [I]t also cannot be rooted in conjecture or hypothesis. Rather, it must conclusively establish, by scientifically valid measurable and statistically significant data, that the different or increased risks are actual and real.

Id. at *3.  If the plaintiff cannot make this showing, i.e., demonstrate that the CBE regs can apply in the first instance, only then does the burden shift to the defendant to produce “clear evidence” that the FDA would not have permitted the proposed stronger warning.

From there, it was a short walk to summary judgment.  Plaintiffs produced evidence that they claimed would support a stronger warning, but with regard to all of it, the court found (repeatedly) that the manufacturer “submitted this information to the FDA before Pradaxa’s warning was initially approved.”  Id. at *4-*5.  The information therefore was not “newly acquired” and it could not support a label change under the CBE regulations.  Because the manufacturer therefore could not have complied with the alleged state law duties without violating federal law, the state law claims were preempted.

Not every case will involve the same factual and regulatory history as Pradaxa, but we still think these are very useful cases in understanding and applying implied preemption.

Various plaintiff-side consortia have taken it into their heads to sue every manufacturer of so-called “novel oral anticoagulants” because these products, gasp, can cause serious, and sometime fatal, bleeding incidents.  Fortunately, on the whole the plaintiffs haven’t done so well with these cases – losing almost all the trials – because jurors can be taught the dictionary definition of “anticoagulant.”  Thus, it was initially disturbing to us to read that a Connecticut state court recently upheld a plaintiff’s verdict in a Pradaxa case, Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., No. CPL-HHD CV16-6068484S, slip op. (Conn. Super. Sept. 11, 2019) (yeah, we sent it to Westlaw, but it hasn’t shown up there yet).

Then we read it.

Sure, the plaintiff scraped by with somewhat oddball verdict in a somewhat oddball case – the plaintiff had a history of gastroesophageal reflux disease (“GERD”) − but on two major issues, preemption and punitive damages, the plaintiff didn’t get what he wanted at all.  Thus, here’s another dictionary definition:

Pyrrhic victory n. A victory that is offset by staggering losses.  [After Pyrrhus]

American Heritage College Dictionary, at 1115 (3d ed. 2000).

On the merits of the underlying claim, plaintiff received a ridiculously high half million dollars on a warning claim that was almost certainly bogus.  He tried to get around the learned intermediary rule with a self-serving (and uncorroborated) claim that:

while waiting at the doctor’s office, . . . he saw a pamphlet on [the drug] and asked a nurse about it.  Ultimately, the plaintiff had a discussion with [the prescriber] and decided to change to Pradaxa.

Slip op. at 8.  That didn’t succeed in ousting the rule altogether – since it is still a prescription drug – but it conveniently provided plaintiff a second bite at the causation apple:

[A]ccording to the evidence, if the plaintiff had known that there was an increased risk of bleeding for a patient with a history of GERD, he would not have asked to switch to Pradaxa.  Although this testimony relied on the benefit of hindsight, the testimony was admissible and the jury was entitled to credit it.

Id.

The prescriber, of course knew all about the risks of bleeding – knowledge that usually precludes warning causation − but from his “general” (that is, “not specifically mention[ing] GERD”) description of his informed consent practices, “the jury could have reasonably inferred from it that [the prescriber] would have mentioned the increased bleed risks for patients with a history of GERD if the label had disclosed that risk.”  Id. at 10-11.  It was a “close call,” but there was “minimally sufficient evidence” to establish a basis for a jury to believe that a different warning could have made a difference.”  Id. at 11.  Significantly, plaintiff failed to prove the usual claim that we see advanced in this type of case:

In contrast, there is no similar testimony from the plaintiff that he would have rejected [the drug] if he learned that its label required blood monitoring. Thus, there is insufficient evidence to sustain the verdict on the theory that the absence of warnings about blood concentration and monitoring was a cause in fact of the plaintiff’s injury.

Id. at 12 n.5.

The plaintiff also supposedly proved medical causation – although we think the result in Roberto was simply  wrong under Connecticut law.  The bleed was caused by plaintiff’s GERD (specifically, by an ulcer) and there was no evidence that the drug caused the ulcer.  The Court held that but for causation didn’t matter; that plaintiff could recover “by showing that [the drug], even if not the original cause of the bleed, made it more severe.”  Id. at 14.  Plaintiff had expert testimony that plaintiff “at least was less likely to develop” a bleed compared to some unstated “different anticoagulant” – the drug “[m]ade it worse, exacerbated it.”  Id.

Roberto tellingly cited nothing to support this reasoning, and in fact the Connecticut Supreme Court has rejected just such “increased risk” causation testimony.  We discussed in this post how that dumbed down approach to causation is not sufficient in product liability, where the product must actually cause the risk, and remains controversial even in “lost chance” medical malpractice cases where it originated.  We cited Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005), as one of the decisions refusing to permit mere “increased risk” causation in any circumstance.  Boone held:

[The plaintiff] must show . . . that the decreased chance for successful treatment more likely than not resulted from the defendant’s negligence.”  Thus, in order to satisfy the elements of a lost chance claim, the plaintiff must first prove that prior to the defendant’s alleged negligence, the decedent had a chance of survival of at least 51 percent.  Once this threshold has been met, the plaintiff must then demonstrate that the decedent had a decreased chance for successful treatment and that this decreased chance more likely than not resulted from the defendant’s negligence.  Accordingly, it is not sufficient for a lost chance plaintiff to prove merely that a defendant’s negligent conduct has deprived him or her of some chance; in Connecticut, such plaintiff must prove that the negligent conduct more likely than not affected the actual outcome.

Id. at 18 (citations and quotation marks omitted) (emphasis original).  Plaintiff’s “at least was less likely” thus shouldn’t cut it in Connecticut.  Roberto cites no testimony indicating that Boone’s more likely than not standard was satisfied, so we think the entire verdict should have fallen on causation grounds.  We’re not even sure the court in Roberto realized it was being asked to allow a Boone-barred increased risk causation theory.

So through the first 15 pages of Roberto, we were not happy at all.  Then we got to punitive damages.

The jury found that punitive damages were appropriate.  Id. at 3.  But under Connecticut law, the court decides how much to award.  Id. at 18 (citing Conn. Gen. Stat. §52-240b).  The court awarded the princely sum of one dollar, explaining that the jury had been hoodwinked, calling out the expert that did it, and finding no evidence to justify such damages.

[T]he court must state that it simply does not credit the testimony of Dr. Plunkett. . . .  Although Plunkett was entitled to review company documents . . ., the court believes that Plunkett engaged in unreliable mind-reading in concluding that the company put sales over safety.  The court views the company’s documents and emails very differently. . . .  [T]t is entirely appropriate for employees of a for-profit company . . . to consider topics such as cost and sales.  If a pharmaceutical company cannot make a profit selling a drug, the company would likely withdraw the drug, with all its attendant benefits, from the market.

Roberto, slip op. at 18-19 (footnote omitted).  The court utterly rejected the opinions of plaintiff’s expert on this issue:

This case is not one in which a company, motivated by greed, proceeded to ignore safety standards, defy government regulations, or disregard scientific literature in order to put an unreasonably dangerous or socially worthless product on the market.  On the contrary, all experts agreed that [the drug] provides significant benefits in reducing the risk of a stroke, with all its devastating consequences.  Fortunately, the plaintiff himself achieved this benefit and did not suffer a stroke.

Id. at 20 (footnote omitted).  That “[t]he FDA has never recalled the product and instead has approved the label some eighteen times . . . without more . . . should preclude an award of any significant punitive damages.  Id. at 21.  But there was more, and the court surveyed the evidence, concluding:

Unless the defendants are required to ignore all of these experts, articles, authorities, and examples, there is no basis for any significant punitive damages.  Accordingly, the court awards [punitive damages] in the amount of $1.

Id. at 22 (citations omitted).  Given this conclusion, it may have been more appropriate to grant judgment n.o.v. against the claim for punitive damages, but the $1 award is the functional equivalent – and the appellate standard of review is probably abuse of discretion.

And then we come to preemption.  As already mentioned, plaintiff pursued two warning-related claims, the plaintiff-peculiar GERD claim on which the court found sufficient evidence to support the verdict, and the blood monitoring claim typically advanced by all plaintiffs, which failed.  The preemption ruling in Roberto was similar.

First, “three days after the verdict,” Albrecht was decided, meaning that the excuse that preemption was for the “jury’s consideration” vanished.  Id. at 23 n.16.  Thus, the court had to decide the issue itself:

[T]he court views it as its obligation to decide the preemption issue in the first instance rather than merely pass it on to the appellate courts or have the parties waste resources taking an appeal that would result in a remand to this court to decide the very matter that the court can decide today.

Id.

In so doing, Roberto made a number if interesting preemption-related legal rulings.  Preemption in prescription drug cases involves a “two-pronged” test, the first requiring the plaintiff to establish that prerequisites to use of the CBE regulation, such as “newly acquired information” were satisfied, and the second being the so-called “clear evidence” directly at issue in Albrecht.

Post-FDA approval preemption analysis proceeds in two stages. . . .  “[I]f the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

Id. at 27-28 (quoting Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 661 (S.D.N.Y. 2017), aff’d, 919 F.3d 699 (2d Cir. 2019)).  See Id. at 28 n.9 (discussing burden of proof issues and concluding “it is fair to expect the plaintiff to come forward with the newly acquired information in question”).

The court (correctly, we believe) viewed Albrecht as applying to all preemption questions presented by either prong.  Thus whether “newly acquired information” existed was also a question of law.  Id. at 29-30.

The phrase “newly acquired information” is the key component of the CBE regulation. . . .  [I]f there is no newly acquired information, then the manufacturer is under no duty to change its label and related state failure to warn claims are preempted.

Id. at 25-26 (citations omitted).

Although the issues and analysis on the first prong of the preemption test, involving newly acquired information, are not identical to those involved in the second, clear evidence prong, it seems unlikely that the Supreme Court would hold that the first prong is triable to the jury while the second prong is not.  Both prongs involve complicated legal analysis.

Id. at 30 (footnote omitted).  The court also demurred on the supposed “presumption against preemption,” concluding that after Albrecht, it was “unclear whether the presumption applies in this situation,” particularly since “the FDA contemplated that the CBE regulation would be used ‘sparingly.’”  Id. at 31 (citation omitted).

Reviewing the case law, Roberto arrived at some conclusions concerning what could, and could not, be “newly acquired information”:

Information previously known to the manufacturer, but not submitted to the FDA, may constitute “newly acquired information,” provided that the information meets the other CBE requirements.  And, as the regulation suggests, “[n]ewly acquired information” can include either new data or new analyses of previously submitted data.  However, any claim that a drug label should be changed based solely on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.

Id. at 30-31 (citations and quotation marks omitted).  Further, because the FDA does “not allow a change to labeling to add a warning in the absence of reasonable evidence of an association between the product and an adverse event,” the Agency “contemplate[s] that the CBE regulation would be used sparingly.”  Id. at 32 (citation and quotation marks omitted).

Finally, the CBE regulation’s “newly acquired information” prerequisite was not predicated on a contemporaneous request for a label change:

First, the regulation itself does not require a specific request for a label change. . . .  Second, one can assume that the FDA, as a public agency, will . . . request a label change if the circumstances warrant.  Indeed, . . . the FDA has a statutory obligation to do so. Third, the defendants cannot be faulted if they exercise caution in submitting a study to the FDA even though they are not sure whether it merits a labeling change.

Id. at 54-55 (citations omitted).

As to the claims most Pradaxa plaintiffs bring – concerning some blood plasma concentrations and the monitoring of same – the court held that no “newly acquired information” existed to permit the manufacturer’s resort to the FDA’s CBE regulation, as of plaintiff’s January, 2014 claimed injury.  Roberto, slip op. at 50.  “The opinion goes through a plethora of Pradaxa-specific information, that anyone interested in the details can read, but:

In sum, after review of the numerous articles and reports identified by the parties in their briefs, the court concludes that there was no newly acquired information that would have allowed the defendants to make a label change on their own on the topics of Pradaxa blood concentration levels or blood monitoring.  Accordingly, the court finds these claims preempted.

Id. at 34-50.

But as discussed at the beginning of this post, the plaintiff had a second warning claim specific to his situation – lack of a warning about greater bleed risks to GERD sufferers like himself – indeed, that GERD claim “was the only claim for which there was sufficient evidence to prove causation in fact.”  Id. at 50.  As to this claim, the timing of the defendant’s submission to the FDA was “unclear.”  Id. at 55.  Thus, “the court cannot conclude that the GERD information was previously submitted to the FDA.”  Id. at 56.  The second prong of preemption also was not satisfied.  “[T]he defendants’ argument amounts to a second prong ‘clear evidence’ claim” that lacked either proof of what information the FDA received or a definitive FDA disapproval of a warning change.  Id. at 56-57.  Since it does not appear that the defendant asserted a “clear evidence” defense to plaintiff’s GERD claim, that claim survived preemption.

Thus, the favorable preemption holding in Roberto is applicable to the majority of Pradaxa plaintiffs asserting claims concerning blood concentration and monitoring (at least for injuries predating January, 2014).  Only those few Pradaxa plaintiffs with GERD-related claims can make use of the second, adverse ruling.  A Pyrrhic plaintiff’s victory indeed.

Finally, for those who are gluttons for punishment, Roberto rejected largely case-specific new trial arguments concerning non-FDA-approved drug dosages, misconduct by plaintiff’s counsel, and evidence of foreign GERD labeling.  Id. at 57-62.  The defense also lost a Connecticut-specific “phantom damages” argument concerning recovery of medical charges that were billed but then written off by the government.  Id. at 62-65.

Happy birthday, Bob Marley. (We mean the transcendent reggae singer, not the Maine comedian.) Now let’s get together and feel alright about another good personal jurisdiction decision, In re Pradaxa, No. CJC-16-004863 (Cal. Super. Ct. Jan. 31, 2019). The case strikes a blow against California litigation tourism. There were some awful decisions out of California on this topic in the past. Call this new decision a redemption song.

A bunch of non-California residents claimed injuries from Pradaxa, and sued a number of corporate defendants associated with the medicine’s manufacture and sale. But none of those corporate defendants was incorporated in California, nor did they own, lease, or maintain any property in the Golden State. The defendants challenged personal jurisdiction. The plaintiffs did not even argue that there was general personal jurisdiction over the defendants. The Bauman case thoroughly foreclosed that notion. Instead, the issue was whether the SCOTUS BMS decision left any room for jammin’ the out of state defendants into a California court via specific personal jurisdiction.

Remember, the plaintiffs took the medicine outside California. So what bases could the plaintiffs lively up themselves to show that their claims related to or arose out of the defendants’ contacts with California? The plaintiffs did what some other plaintiffs have done by exploiting the existence of an in-state clinical trial of the drug. If the mere existence of clinical trials does the trick, then the SCOTUS BMS case is a dead letter for pharma companies, since clinical trials often take place in big (and plaintiff-friendly) states. That would be a crazy baldhead result, given that BMS itself involved a pharma defendant. The Pradaxa court was too smart for that. It looked to the qualitative and quantitative nature of the clinical trial in California, and concluded that, in the grand scheme of things, questions relating to 32 in-state clinical trial sites in one massive clinical trial were “too attenuated to support the exercise of specific jurisdiction.” All non-resident Pradaxa plaintiffs were consequently dismissed from the California mass tort for lack of specific personal jurisdiction under BMS. Their exodus is our freedom time.

Since it is a sure thing that forum-shopping plaintiff lawyers will continue to pursue the clinical trial angle, you should pay heed to the factors the California court considered in finding the clinical trial insufficient to establish specific jurisdiction: (1) the forum state was not overrepresented in the trial, and (2) the alleged problems with the trial did not relate to the claimed inadequacies in the warnings. The plaintiffs made much of the fact that there had to be corrections made to label with respect to the adverse event reports out of the California clinical trial, but the “negligible changes in the data” could not support claims. (E.g., the hazard ratio for a life-threatening bleed went from 0.80 to 0.81.). The court was not impressed by the plaintiffs’ argument.

But we are impressed by the rigor and clarity of the court’s reasoning. If corporate defendants can earn such a good and sensible result in San Francisco, we all have cause for optimism. Hallelujah. Don’t worry about a thing. Could you be loved? Every little thing is gonna be alright. And never give up. We offer congratulations, gratitude, and a tip of the cyber hat to Eric Hudson at Butler Snow, who argued and won the motion.

By the way, speaking of congratulations, and speaking of never giving up, today is the birthday of another pop star. In fact, according to an MTV Europe poll in 2008, he is the “Best Act Ever.” We won’t tell you who he is; you’ll have to click on the link at the end. Of course, since we’re telling you to click on a link, you might have some idea what awaits you. Feeling dread? Don’t. Embrace the wonderful, sheer inanity of the Best Act Ever.

Confident prescribing physicians and implanting surgeons are the best “learned” intermediaries.  They’re experienced at what they do and aren’t intimidated by plaintiffs’ counsel and their threats of malpractice claims if they don’t testify the way plaintiffs want them to.  Confident learned intermediaries stand by their medical decisions.  Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different.  Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases.

Continue Reading Confident Learned Intermediaries Defeat Warning Causation

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, see:  here, 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, 535 F. Supp.3d 1157 (N.D. Ala. 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.