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I can make a hat, a brooch, or a pterodactyl.  Of course, that’s a famous line from the movie Airplane!  But, it seems to have taken on a new meaning now that we aren’t out and about like we use to be.  After work, weekends, before work, lunch hour.  All of these used to be errand-running times.  Being told you’re out of toothpaste at 9:30 at night used to be a major inconvenience, but it was a problem that could be fixed with a quick trip to a 24-hour drug store.  Adjusting dinner plans to grill outdoors because it was unexpectedly sunny and 70 was an easy food store stop on the drive home from work.  Now, you may be waiting two weeks for a food delivery and hoping you haven’t forgotten anything really essential, like toothpaste.  But, on the flip side, being quarantined has led to some creative repurposing of whatever you happen to have sitting around the house.  For instance, we’ve seen masks made from anything from Crown Royal bags to kippahs.  Mother’s Day is around the corner. Need flowers?  Got old encyclopedias or outdated text books.  The pages can be accordion pleated and turned into a vase of flowers for mom.  What about all those extra wine corks you’ve amassed during quarantine.  Did you know you can glue them together in a crisscross pattern to make a trivet?  And, if you’re cleaning out your closet, don’t throw out all those ties you aren’t wearing.  They can be turned into glass cases (or really cases for anything).  That stack of old t-shirts can become shopping bags (no sewing required) or braided into hair bands.

And repurposing is sort of what we want to do with today’s case.  We’re going to toss out the ultimate ruling on defendant’s summary judgment motion and save to use another day its learned intermediary analysis.  Heinrich v. Ethicon, 2020 WL 1916877 (D. Nev. Apr. 17, 2020) is a transvaginal surgical mesh case that was remanded from the MDL in West Virginia.  One of the remand court’s first tasks was to decide the pending summary judgment motion.  After plaintiffs withdrew several of their claims, the motion was limited to plaintiff’s strict liability failure to warn claim.  Id. at *1.  The primary issue – whether the learned intermediary doctrine applied.

The reason that’s an issue is because the Nevada Supreme Court has yet to rule on the issue in a pharmaceutical or medical device case.  We think that’s splitting hairs since that court did adopt the learned intermediary doctrine in a pharmacist liability case and we don’t understand how it would apply to a pharmacist and not a manufacturer.  Fortunately, the Nevada District Court didn’t see a difference either.  The rationale in the pharmacist case (Klasch v. Walgreen Co., 264 P.3d 1155 (Nev. 2011)) was that a “pharmacist does not owe a duty to warn a customer of a medication’s generalized risks because the physician who prescribed the medication is in the best position to do so.”  Heinrich, at *3.  The same policy reasons that supported adopting the doctrine as to pharmacists support applying it in products liability cases against manufacturers:

The medical device manufacturer, like the pharmacist, is not in the best position to weigh the risks and benefits of using the device in a particular patient. Rather, “the physician is in the best position to understand the patient’s needs and assess the risks and benefits of a particular course of treatment.”

Id. (quoting Talley v. Danek Med., Inc., 179 F.3d 154 (4th Cir. 1999)).  Therefore, the court predicted Nevada would adopt the learned intermediary doctrine for medical device manufacturers.

There was also a second dispute as to the doctrine – whether it was an affirmative defense.  Plaintiff argued that it was and that therefore, defendant bore the burden of proving that plaintiff’s physician was adequately warn.  Defendant argued that the learned intermediary does not shift the burden of proof but rather “defines the scope of their duty to the plaintiffs.”  Id. at *2.  Plaintiff relied primarily on dicta in an old muddled, plurality opinion by the Nevada Supreme Court (we’ve discussed that case here).  But that overlooks that in deciding Klasch, the court adopted the doctrine “in terms of defining the scope of the pharmacist’s duties.”  Heinrich, at *4.  The court found further support for defendant’s position in the consistent Nevada rulings stating that the “plaintiff must prove the element of causation in a strict liability case.”  Id. Therefore, the court also predicted that Nevada would not consider the learned intermediary doctrine an affirmative defense and would keep the burden of proof on plaintiff.  Id.

That’s where our discussion of the case comes its most useful conclusion because the rest explains why there is a genuine dispute regarding the adequacy of the warnings based on the testimony and changed practices of plaintiff’s physician.  That portion of the case is fairly case specific, so we don’t view it as undermining the real takeaway here – Nevada would adopt the learned intermediary doctrine in products liability cases.  We think we’ll have ample reasons to repurpose that nugget – at least until the Nevada Supreme Court has the opportunity to reach the same conclusion itself.

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Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”).  That approach originally led us to 21 U.S.C. §337(a), the FDCA’s “no private enforcement” provision, which we later successfully repurposed to support preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

It also led to reliance on other limitations on negligence per se in other states.  We’ve already discussed Kentucky’s limitation of negligence per se to claimed violations of state, as opposed to federal, enactments.  We also had success with legislative intent arguments in Florida and Wisconsin, and with a licensing statute argument in Virginia.  Now, it turns out that some anti-negligence per se seeds we planted in Texas found some fertile ground.

In Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334 (Tex. Dist. June 7, 1999), aff’d on other grounds, 2000 WL 991697 (Tex. App. July 20, 2000), a Texas trial judge in a Bone Screw case rejected FDCA-based negligence per se allegations every which way but loose.  “The pertinent question is whether the duties set forth in the federal law are analogous to those set forth in the local tort law.”  Baker, 1999 WL 811334, at *8 (quoting Johnson v. Sawyer, 47 F.3d 716, 729 (5th Cir. 1995)).  Thus, under Texas law, Baker held that the plaintiff:

must do more than simply denominate his claim for violations of the FDCA as a negligence per se claim.  [He] must demonstrate that the regulations in question establish suitable standards of conduct under preexisting, independent Texas tort law.

Id.  The plaintiff in Baker could not do so.  FDCA-based negligence per se flunked the criteria for allowing use of negligence per se established in Perry v. S.N., 973 S.W.2d 301 (Tex. 1998).

First, “the FDCA does not establish the sole duty of a manufacturer.”  Baker, 1999 WL 811334, at *9 (footnote omitted).  “While the FDCA is more precise than these general concepts, it varies significantly from common law negligence.  The Court in Perry cautioned against applying negligence per se if it causes a “great change” in the law.  Id.  “[A]bsence of a corresponding common law duty weighs against adopting negligence per se in the FDCA regulations.”  Id.  “[T]he [FDA’s] regulations do not merely serve to define more precisely what conduct breaches the common law duty.  To the contrary, a new and more stringent duty would be imposed.”  Id.

Second, FDA regulations do not “clearly define[] the prohibited conduct.”  Id. at *10 (quoting Perry).  That was particularly true of claims alleging off-label promotion:

This factor weighs against the imposition of tort liability.  The FDCA, MDA, and FDA guidelines are not clear about prohibited conduct. . . .  Therefore, it is difficult for a manufacturer to know exactly when the activities are promotional or scientific/educational.

Id. (quote from FDA guidance document omitted).

Third, negligence per se in Texas is improper where it would convert negligence into “liability without fault.”  Id.  Under the FDCA “the manufacturer’s acts may result in [FDA enforcement] if no scienter is shown.”  Id.  In product liability cases:

the negligence per se theory is surplusage if [plaintiff] prevails on . . . common law negligence or strict liability claims.  If [plaintiff] cannot succeed on either of these issues, an issue is raised as to the culpability of Defendant’s conduct. . . .  Therefore, applying negligence per se may create liability without fault that causes injury.

Id.

Fourth, “the only inquiry for the jury” in FDCA-based negligence per se “is whether the defendant violated the statute and, if so, whether this was a proximate cause of plaintiff’s injuries.”  Id. (citation omitted).  Thus, any FDCA violation could impose liability “without regard to the condition of the device itself (assuming provable causation).  The device could be absolutely safe (i.e., free from defects and not tainted by negligence), but [defendant] would still be liable.  Id.  This type of liability violated Perry’s rejection of negligence per se where it “would impose ruinous liability disproportionate to the seriousness of the defendant’s conduct.”  Id.

Fifth, a relevant factor “is whether [plaintiff’s] injury is a direct or indirect result of the violation of the statute.”  Baker, 1999 WL 811334, at *11.  “This factor also supports” rejection of negligence per se because an alleged FDCA violation “does not prove that the device was unsafe and therefore caused [plaintiff’s] injury.”  Id.  The claimed liability:

is too attenuated to impose liability automatically through a per se cause of action.  It may be an unreasonably dangerous and defective device, a manufacturer’s negligence, or the negligence of a learned intermediary that would directly cause plaintiff’s injury in this type of case, but it is not a failure to follow administrative regulations.

Id.

Since the Bone Screw litigation concluded, other courts applying Texas law have followed Baker’s thorough analysis.  In Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591 (W.D. Tex. 2002), involving a drug rather than a device, plaintiff asserted negligence per se based on purported FDCA violations “by providing inaccurate information in their warnings, informational materials and package inserts.”  Id. at 594.  Starting, as Baker did, with Johnson v. Sawyer, Hackett recognized that “[c]ourts are not required to find negligence per se from a violation of a federal statute, particularly where the violation would not give rise to liability under state common law.”  Id.  “Because the FDCA does not provide for a private cause of action, many courts have held plaintiffs cannot seek to enforce it through negligence per se tort actions.”  Id. (citing three Bone Screw cases).  Hackett adopted Baker’s rationale.  “The Court finds the Baker Court’s application of the Perry factors persuasive and declines to create a new cause of action, particularly in a case where the Plaintiff has been so lackadaisical in pursuing his novel theory of liability.”  Id. (citations omitted).

Baker was also persuasive in Jackson v. Kim, 2004 WL 6040969 (E.D. Tex. Sept. 27, 2004):

Because the [statute] does not provide for a private cause of action, this Court is not inclined to enforce such standards through negligence per se tort actions. . . .  [O]ne Texas court has held the FDCA and FDA regulations do not give rise to a negligence per se cause of action under the standard . . . established in Perry. . . .  The Court finds the Baker Court’s application of the Perry factors persuasive and declines to create a new cause of action.

Id. at *4.  Without citing Hackett, Kim reached a virtually identical result – even though Kim was not an FDCA-based case, but rather a Fair Debt Collection Practices Act case.  See Bruce v. Nationstar Mortgage, 2015 WL 728028, at *4 (N.D. Tex. Feb. 19, 2015); Bent v. Mackie Wolfe Zientz & Mann, P.C., 2013 WL 4551614, at *6 (N.D. Tex. Aug. 28, 2013); Thompson v. Hughes, Watters & Askanase, LLP, 2013 WL 4441979, at *9 (N.D. Tex. Aug. 20, 2013) (all dismissing FDCPA cases for similar reasons).

In Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007), another prescription drug case, plaintiffs primarily pursued warning claims, but those claims failed to overcome the Texas statutory presumption of adequacy in Tex. Civ. Prac. & Rem. C. §82.007(a)(1).  2007 WL 4042757, at *2-3.  Holland made short work of an FDCA-based negligence per se, based on prior precedent.  “Texas courts also refuse to recognize a cause of action for negligence per se based on violations of the Food and Drug Cosmetic Act (“FDCA”) and FDA regulations.”  Id. at 3 (citing Hackett).

More recently, in a generic drug case that (like the Bone Screw litigation) involved claims concerning off-label use, Monk v. Wyeth Pharmaceuticals, Inc., 2017 WL 2063008 (W.D. Tex. May 11, 2017), rejected FDCA-based negligence per se as inconsistent with Texas law.  Following Baker, Hackett, and Holland, Monk dismissed the negligence per se allegations.

[U]nder the applicable factors set forth by the Texas Supreme Court, the FDCA and FDA regulations did not give rise to a cause of action for negligence per se under Texas law . . . .  The Court is persuaded by the cases cited by Defendants, and agrees that Texas law likely does not recognize a cause of action for negligence per se based solely on the violation of the FDCA and FDA regulations.

Id. at *8 (citations omitted).  Monk rejected several arguments in favor on FDCA-based negligence per se.  First, the action failed as a matter of law.  “[A]ll of these cases, despite being postured as summary judgment decisions, conducted a legal (not factual) analysis of negligence per se claims.”  Id.  Non-Texas cases (primarily the infamous Oklahoma Howard decision) weren’t “binding in any respect” and were “countered by other out-of-circuit decisions that reach the opposite result.”  2017 WL 2063008, at *8.  Finally, while another judge had let FDCA-based negligence per se claims survive dismissal, negligence per se was “never analyzed” so those orders were “not an affirmation of the validity of these claims.”  Id.

Finally, several weeks ago, we saw Sweezey v. C.R. Bard, Inc., 2020 WL 1237394 (N.D. Tex. Mar. 12, 2020), which disposed of a negligence per se claim against a medical device manufacturer on the same basis, that “’Texas courts . . . refuse to recognize a cause of action for negligence per se based on violations of the FDCA and FDA regulations.”  Id. at *1. Since the plaintiff in Sweezey “d[id] not dispute that his negligence per se claim is based on Defendants’ alleged violations of the FDCA and FDA regulations . . ., the Court grant[ed] summary judgment as to Plaintiff’s negligence per se claim.”  Id. (citing Monk, Jackson, Hackett, and Baker).

It’s hard for a defendant to “win” a mass tort because of the mass.  But plaintiffs (or their counsel) will think twice if they think that their litigation is producing precedents that will negatively impact future cases.  From Buckman on down, that was how the Bone Screw litigation was litigated, and the fate of FDCA-based negligence per se claims in Texas is one more example that Bone Screw was a defense win.

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Are moisturizing lotions cosmetics or drugs?  They say on TV that lotions “lift and moisturize,” but does that move them into the “Drug” column of the “Food Drug and Cosmetic” ledger?  We will hazard a guess that lotions are usually cosmetics, but what if the manufacturer adds an SPF factor?  We would then say that our moisturizing lotion is now a drug—regulated by FDA monographs that apply to sunscreens.  How about shampoo—drug or cosmetic?  Or the cleansing bar that is dissolving day by day in our shower?  We would say those are cosmetics, too.  But again, it can be complicated.  What if the shampoo is medicated for dandruff, or our shrinking cleansing bar includes antibacterial agents or benzoyl peroxide for acne?  That would probably make them drugs, or maybe both.  What would you think about an ordinary bar of soap made from fat and alkali, such as lye?  Drug or cosmetic?  The answer is neither—soap is soap, and it is regulated by the Consumer Product Safety Commission, not the FDA.  Go figure.

We’re having a little fun here, but the category into which a product falls makes a huge difference in how the product is regulated and how litigation over that product will play out.  And much of that relates to the application of Bexis’ favorite section of the Food Drug and Cosmetic Act—Section 337(a), which gives the United States the sole authority to police violations of the FDCA.  That is to say, there is no private right of action.  See Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

Take for example a consumer class action that recently met its demise in California, Somers v. Beiersdorf, Inc., No. 14-cv-2241, 2020 WL 1890575 (S.D. Cal. Apr. 15, 2020).  In Somers, the plaintiff staked her claim on her characterization of moisturizing lotion as a “drug,” and she lived to regret it.  That is because her self-styled “drug” case ran headlong into Section 337(a) and implied federal preemption.

Here is what happened.  The plaintiff bought a particular brand of lotion on the Internet and sued the lotion manufacturer claiming that the sale was an “unlawful business practice or act” under California’s Unfair Competition Law.  Id. at *1.  Her basis was that the lotion was a “drug” sold without the approval of the FDA.  The difference between a drug and a cosmetic depends on the intended use.  Under the FDCA, “cosmetics” are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  Id. at *2 (citing 21 U.S.C. § 321(i)).  On the other hand, “drugs” are articles “intended to affect the structure or any function of the body of man.”  Id. (citing 21 U.S.C. § 321(g)(1)).

With these definitions in mind, the examples with which we started this post make more sense (although we will not attempt to explain why soap gets special treatment).  For the defendant in Somers, it made sense to move for summary judgment on two bases—(1) that by alleging the sale was “unlawful” because it violated the FDCA, the plaintiff was privately enforcing the FDCA contrary to federal law (i.e., federal preemption); and (2) that the lotion was a cosmetic, not a drug.  Id. at *1.

As much as we would like to debate whether this lotion was a cosmetic or a drug, the district court granted summary judgment on the first argument—federal preemption.  The plaintiff had only one basis for her claim—that the lotion was a drug and that its sale therefore violated the FDCA.  In other words, the plaintiff pleaded herself into a preemption corner:

Plaintiff’s Third Amended Complaint—which repeatedly references provisions of the FDCA—makes clear that she is suing [the defendant] because its decision to sell the . . . Lotion violated the FDCA. . . .  She alleges, for example, that “Defendants engaged in illegal conduct by unlawfully making skin firming representations about its . . . Lotion that resulted in its being deemed a drug under FDA regulations, but did so without obtaining required FDA approval through the FDA NDA [New Drug Approval] process.” . . .  There is no reasonable way to construe this allegation except as an attempt to privately enforce the FDCA, enforcement that has been committed by law to the FDA.

Id. at *3 (emphasis added).  Because federal law allows only the FDA to enforce the FDCA, the plaintiff’s state-law claim purporting to do the same thing was preempted.  Id.

None of the plaintiff’s arguments could avoid this result.  First, the plaintiff argued that she was not enforcing FDCA, but was enforcing California’s Sherman Act, a state statute that prohibits the sale of “any new drug” unless the drug has “been approved . . . under . . . the federal act.  Id. at *4 (citing Cal. Health & Safety Code § 111550).  The district court rejected this argument as circular, observing that “a drug can only be unlawful under the California statute if it violates the FDCA.”  Id.

Second, the plaintiff unsuccessfully drew comparisons to food labeling litigation, where some California plaintiffs have been allowed to pursue claims under state laws creating “parallel obligations.”  Id.  We are aware of those cases, and we have roundly criticized the California Supreme Court’s “food” jurisprudence here and here.  This, alas, was not a food case.  It was a “drug” case, and drug approval is firmly and uniquely within federal power.  Id.  Moreover, even the wrongly decided California food cases conclude that state food labeling laws are not preempted “to the extent they ‘do not seek to enforce the FDCA.’”  Id.  Here, the plaintiff was overtly purporting to enforce the FDCA, so her claim was preempted no matter what.  Id.  In coming to this conclusion, the district court relied on another recent lotion qua drug case that likewise found state-law claims preempted, Borchenko v. L’Oreal USA, Inc., 389 F. Supp. 3d 769 (C.D. Cal. 2019).  You can read our take on Borchenko here.

Our takeaway is that the plaintiff’s attempt to “foodify” cosmetic litigation in California was a legal failure.  The district court closed with this flair:  “Because Congress has given the FDA a monopoly on FDCA enforcement in the New Drug Approval context, [the plaintiff’s] claims are preempted.  As other courts have recognized, ‘the [FDCA’s] public enforcement mechanism is thwarted if savvy plaintiffs can label as arising under a state law for which there exists a private enforcement mechanism a claim that in substance seeks to enforce the FDCA.’”  Id. at *5 (quoting Loreto v. Proctor & Gamble, 515 F. App’x 576, 579 (6th Cir. 2013)).  A true and correct result.

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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.”

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Personal jurisdiction seems to be the defense tool du jour in mass torts. The Bauman and BMS SCOTUS cases brought a new dawn. But let’s not forget the biggest hammer in the defense toolbox: preemption. How nice to lay eyes on a case that applies both of these defenses.

Doe v. Bausch & Lomb, Inc., 2020 WL 1164189 (D. Conn. March 11, 2020), is a products liability action involving the Trulign Toric intraocular lens. Those lenses are manufactured by Bausch & Lomb (“B&L”) and are used to treat cataracts. They are Class III medical devices approved for sale by the FDA. The patient had the Trulin lenses implanted in her eyes. She and her husband sued B&L and various corporate B&L affiliates/holding companies/etc, alleging that the lenses malfunctioned, causing her to suffer loss of visual acuity in both eyes, complete loss of depth perception, extreme photosensitivity, limited ability to see at night, and double vision. She also claims that she suffers continuously from the loss of balance, vertigo, headaches, extreme eye pain, eye fatigue, and tearing. Some of the defendants moved to dismiss for lack of personal jurisdiction, and all moved to dismiss on substantive grounds, including preemption.

The allegations as to any contacts the various corporate affiliates had with Connecticut were “at best, vague.” The plaintiffs said these defendants transacted business “in the United States, including in the District of Connecticut; have substantial aggregate contacts with the United States, including within this District; engaged and are engaging in conduct that has and had a direct, substantial, reasonably foreseeable, and intended effect of causing injury to persons throughout the United States, and specifically in this District where the devices were sold to Plaintiff’s doctor; and, Defendants purposely availed themselves of the laws of the United States.” Such vague allegations simply don’t cut it. Nor was it enough to allege that “Although Defendants have recently acknowledged some of the risks and dangers of Z Syndrome and some related complications resulting from the Lenses in the 2016 Instructions for Use, Defendants did not disclose and still have not fully disclosed the seriousness of the issue.” These are less than minimal pleadings of minimal contacts.

The inevitable back-up maneuver by the plaintiffs was to try to impute contacts via “alter ego.” The plaintiffs summarily asserted that “there existed a unity of interest in ownership between certain Defendants and other certain Defendants such that any individuality and separateness between the certain Defendants has ceased and these Defendants are the alter ego of the other certain Defendants and exerted control over those Defendants.” There were competing affidavits.

Under Connecticut law, “a court will disregard the corporate structure and pierce the corporate veil only under exceptional circumstances, for example, where the corporation is a mere shell, serving no legitimate purpose, and used primarily as an intermediary to perpetuate fraud or promote injustice.” That is a high hurdle. The plaintiffs could not get over that hurdle. The plaintiffs’ conclusory allegations, even coupled with an affidavit, provided no basis for the Doe court to disregard the corporate structure of any defendant. That took care of personal jurisdiction for most of the corporate affiliates. Ba-bye.

Note that we said “most.” One affiliate was kept in because it had been part of the case transferred from another jurisdiction pursuant to § 1404(a). It was necessary for the transferor court to find that defendants are subject to personal jurisdiction in the transferee district for a case to be transferred there pursuant to § 1404(a). According to the Doe court, a fair reading of the transfer decision makes clear that the transferring court held the view that the case could have been (and perhaps should have been) brought in Connecticut. Therefore, that defendant was stuck in the case courtesy of the law-of-the-case.

On to the substantive defenses. Connecticut is one of those enlightened states that passed a product liability statute: the Connecticut Product Liability Act (“CPLA”). (Why doesn’t Pennsylvania, with its mish-mosh of incoherent product liability doctrine, follow suit?) The defendants sought to dismiss the claims purportedly brought pursuant to Connecticut common law because those claims are barred by the CPLA, which is the “exclusive remedy for claims falling within its scope.” A plaintiff cannot assert a common law claim for product liability under Connecticut law. The claims at issue — strict liability in tort; negligence; breach of warranty, express or implied; breach of or failure to discharge a duty to warn or instruct, whether negligent or innocent; and misrepresentation or nondisclosure, whether negligent or innocent— were obviously product liability claims. Moreover, “the CPLA excludes all claims for personal injury caused by the warnings, instructions, marketing, packaging or labeling of any product.” Ba-bye, common law claims.

The defendants also sought dismissal of all claims on the ground that they were preempted by the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). A Class III device, such as the Trulign Toric intraocular lens, is subject to the rigorous pre-market approval process of the FDA. As most of you can probably recite from memory, the MDA contains an express preemption provision:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a).

You doubtless also recall that federal law impliedly preempts state law claims if those claims are based solely on violations of FDCA requirements. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 353 (2001). In other words, “a litigant’s [state law] claim may be impliedly preempted when the state-law claim is in substance (even if not in form) a claim for violating the FDCA—that is, when the state claim would not exist if the FDCA did not exist.” And now, as pretty much always, we confront the dreaded “parallel claim” exception. Between those claims that are expressly preempted and those that are impliedly preempted is an “extremely narrow” class of claims that are not preempted. “The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such claim would be impliedly preempted under Buckman).” Plaintiffs must advance a state law claim that parallels federal law “but which … is not wholly derivative of federal law.”

That exception did not apply here. It could not save the failure to warn, negligence, or manufacturing defect claims. Why? Under the CPLA, “[a] product seller may be subject to liability for harm caused to a claimant who proves … that the product was defective in that adequate warnings or instructions were not provided.” The plaintiffs predicated their failure-to-warn claim on a purported duty to warn owed to the patient or her doctors. But the plaintiffs failed to identify any FDCA requirement directing the defendants to provide warnings to consumers or physicians separate and distinct from their disclosure obligations to the FDA or the use of FDA approved labels. Accordingly, to impose such a duty under the CPLA would be to impose requirements “different from, or in addition to” FDCA requirements and this claim is therefore expressly preempted by § 360k(a).

The plaintiffs also alleged that the defendants failed to abide by their FDA reporting obligations. (To wit, the defendants “ignored and neglected [their] responsibilities to the FDA and the conditional approval [they] had received to market the Trulign Lenses when [they] failed to timely file adverse event reports ….”). This claim is impliedly preempted because it is wholly derivative of the FDCA. The plaintiffs never identified any duty under Connecticut law that required the defendants to warn or communicate adverse event reports to the FDA so as to give rise to a parallel claim.

Under the CPLA, product liability claims include actions based on theories of negligence. Here, again, the plaintiffs alleged that the defendants were negligent insofar as they failed to report adverse events to the FDA, and that such failures deprived the patient or her doctors of information that would have stopped their use of the Trulign Lenses. Whatever the FDCA requires with respect to adverse event reporting, under Connecticut law, manufacturers do not have a duty to report adverse events to regulatory entities such as the FDA.

On to the almost always spurious manufacturing defect claim. The plaintiffs alleged that “[t]he Lenses were not manufactured in conformity with the manufacturer’s design or in conformity with the FDA approved design that Defendants had submitted to FDA. ” The defendants argued that this allegation, and the others surrounding it, were conclusory. The judge agreed. The plaintiffs also alleged that asymmetric vaulting, known as “Z-Syndrome,” is a post-operative complication unique to the Trulign and Crystalens lenses, that the plaintiff was diagnosed with Z-Syndrome, and that the Z-Syndrome caused her pain and suffering. That is a consequence, not a defect. The plaintiffs never managed to allege that the plaintiff’s lenses suffered from any specific manufacturing defect. Nor did they identify which FDA approved specification was allegedly not met. This, it was not preemption that did in the manufacturing defect; it was the TwIqbal failure to plead specific, plausible facts. Ba-bye.

The plaintiffs also brought three counts alleging violations of California statutes: Deceit by Concealment, California Civil Code §§ 1709, 1710; a violation of Cal. Bus. & Prof. Code §§ 17200, et seq. ; and a violation of Cal. Bus. & Prof. Code §§ 17500, et seq.. Those statutes have long been the bane of corporate defendants doing any business in the Golden State. But not this time. The plaintiffs’ brief in opposition to the motion to dismiss “devote[d] exactly six sentences to these causes of action. They cite no authority, provide no analysis and summarily assert that the claims are adequately pled. They do not address the Defendants’ preemption argument in the context of these statutes at all.” Because those claims derived from the same nucleus of factual allegations—the failure to warn and the failure to report adverse events— the plaintiffs failed to establish the parallel claim exception. Ba-bye to the California claims. And it follows, ba-bye to the loss of consortium claim.

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Nope, we didn’t bury the lead.  Today we are talking about a generic, negligence per se, warnings case that wasn’t decided on preemption grounds.  No Mensing.  No Buckman.  No preemption of any kind.  Normally that would make us a little nervous, but no need.  It was the learned intermediary doctrine’s day to be the hero.

Plaintiff’s husband was prescribed generic amiodarone for treatment of his atrial fibrillation.  Cook v. Par Pharmaceutical, Inc., 2020 WL 1891256, at *2 (N.D. Ala. Apr. 16, 2020).  Plaintiff alleged that her husband did not receive a medication guide with the drug and if he had, he would have been aware that he was being prescribed the drug off-label and would have discussed its risk with his doctors.  Id. at *2-3.  Of course the defendant raised preemption as a defense, but the court opted to examine its learned intermediary argument first.  And as it turns out, that was enough.

Plaintiff’s negligence per se case was based on Alabama’s “little” FDCA which incorporates the federal Food, Drug, and Cosmetic Act’s labeling requirements.  Id. at *4.  Those labeling requirements, as of 1998, included patient labeling known as medication guides.  The FDCA requires manufacturers to “ensur[e] that Medication Guides are available for distribution to patients by either: (1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers…or (2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers….”  Id. (quoting 21 C.F.R. § 208.24(b)(1)-(2)).  Plaintiff argued that these regulations established the manufacturer’s duty of care to warn patients directly.  As some courts have pointed out, the FDA requires distribution of medication guides to the distributors, not the end users.  See Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1252 (N.D. Ala. 2014).  So, to the extent plaintiff alleged that the FDA regulations impose a duty on manufacturers to ensure that consumers receive medication guides – they don’t.  But, that wasn’t the direction this court took either.

Rather, the court focused on the manufacturer’s actual duty under Alabama law – the duty to “provide adequate warnings to the [physicians] who prescribe the drug.”  Cook at *4.  A duty that was not displaced by the FDA’s medication guide regulations.  In fact, the FDA explicitly stated as much:  “the written patient medication information provided [in the medication guides] does not alter the duty, or set the standard of care for manufacturers, physicians, pharmacists, and other dispensers.”  Id. at *5 (quoting Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998)).  By requiring medication guides, the FDA did not intend to affect state tort duties.  Therefore, neither the FDCA nor the Alabama Code in any way constrain the learned intermediary doctrine or change Alabama law which measures the adequacy of a prescription drug warning not by its effect on the consumer, but by its effect on the physician.  Id. at *5 (citation omitted).

Not being able to sidestep the learned intermediary doctrine, plaintiff tried to argue that ruling on the learned intermediary doctrine was premature because the court had not yet evaluated whether the warnings provided to plaintiff’s prescribing physician were adequate.  But that’s not a pertinent issue.  All of plaintiff’s failure to warn allegations were based on the failure of plaintiff’s husband to receive a medication guide.  Therefore, the only issue before the court was that “as a matter of Alabama law, [defendant] had no duty to provide a medication guide to [plaintiff’s husband], and that is the only duty at issue in this case.”  Id.  The warning provided to the doctor was irrelevant.

It may be that preemption gets more of the spotlight in generic drug cases, but sometimes it’s nice to sing the praises of a different hero.  Because if we are talking about things we’ve learned from the Covid-19 crisis, we have to include that heroes come in all shapes and sizes.  So, we too take a minute to extend our thanks to everyone on the front lines – all the medical professionals and staff, the pharmacy and grocery store workers, the food pantry volunteers, the trucker drivers, the farmers, the scientists, the police and fire fighters, the factory workers making protective gear, the college student who shops for her elderly neighbor, and anyone who is giving back to ease someone else’s burden.  Thank you all.

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We are certain that profound revelations – scientific, economic, and political – will arise from the Covid-19 crisis. For now, we comment on bits of knowledge we have gained so far. We have learned, spending 24 hours each day with our dogs, that they bark 20 hours each day. We have learned that the concept of “mealtimes” lacks relevance. We have learned that we must read enough to be equipped to protect ourselves and our loved ones but that we need to stop reading when anxiety overtakes all else. And we have learned to look for the good news.

Regular readers of this blog will recall that we posted, a month or so ago, about a decision from the Taxotere MDL, granting summary judgment to the defendant because the plaintiff could not meet her burden of proving so-called warnings causation; in other words, she had not adduced evidence that a different or stronger warning would have altered her physician’s prescribing decision. With thanks to defense counsel Harley Ratliff for sending it to us, today’s case is another bit of good news in the same vein. In In re Taxotere (Docetaxel) Prods. Liab. Litig (June Phillips), 2020 WL 1819665 (E.D. La. Apr. 7, 2020), the plaintiff, who suffered from an aggressive form of breast cancer, again alleged that the defendant had not adequately warned that its chemotherapy drug could cause permanent hair loss. The defendant moved for summary judgment on the warnings claim.

The court reiterated that, under Louisiana law, the learned intermediary doctrine defines a prescription drug manufacturer’s duty to warn.  Under the doctrine, a manufacturer has a duty to warn only the prescribing physician. A manufacturer has no duty to provide warnings to the patient – that is the physician’s job. Against this backdrop, a plaintiff must satisfy a two-pronged test to prevail on a failure-to-warn claim: she must prove both that the manufacturer’s warnings were inadequate and that “this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff’s injury.” Phillips, 2020 WL 1819665 at *2 (citation omitted). As we always emphasize (often for naught) when we brief this issue, because causation is an element of a warnings claim, it is the plaintiff’s burden to prove it – it is not the defendant’s burden to prove the absence of the causal link.  To satisfy this burden, as the court explained, “the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that, but for the inadequate warning, the treating physician would not have used or prescribed the product.” Id. (internal punctuation and citation omitted).

In this case, the physician testified that there were no other adequate options for treating plaintiff’s cancer, because the other available drugs were known to be cardio-toxic. The plaintiff suffered from a preexisting cardiac condition, and she was 75 years old, and the risk of cardio toxicity is greater in patients over the age of 65. As such, the physician testified that he would not have administered the other available drugs to the plaintiff even if he had been warned that permanent hair loss was a risk associated with the defendant’s product.

On this record, the court granted summary judgment for the defendant on the failure-to-warn claim, correctly holding that the plaintiff could not satisfy her burden of proving causation.  We applaud this result. We should mention that the court did go off on a “frolic and a detour” before signing off, commenting that the plaintiff had not “rebutted” the absence of warnings causation with any “evidence suggesting that she would have looked for another oncologist” had she been warned of the risk of permanent hair loss. Id. There is no room, in a correct analysis, for discussion of such “rebuttal,” because the warnings that were or were not communicated directly to the plaintiff are irrelevant under the learned intermediary doctrine.   Any other conclusion would render the doctrine meaningless.

But all’s well that ends well, and this case ends with a well-deserved win for the defendant. Stay safe, and we’ll keep you posted on decisions on both sides of the “warnings causation” scale.

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With apologies to Mick Jagger and Keith Richards (who wouldn’t have jurisdiction either, being UK citizens), that is what the Sixth Circuit told a pack of Spanish plaintiffs recently in In Re DePuy Orthopædics, Inc. ASR Hip Implant Products Liability Litigation, ___ F.3d ___, 2020 WL 1482384 (6th Cir. March 27, 2020).

All companies with overseas affiliates should pay attention to this one, and so should counsel representing them.

This appeal arose from multi-district litigation, and in typical MDL excess, the plaintiffs typically named not only the manufacturer of the medical device, but several corporate affiliates, including at least one overseas entity.  So far, so good (or bad), but after the MDL had been going on for a while, foreign plaintiffs decided to get in on the act.  Id. at *1 (“Foreign plaintiffs, by contrast, brought the twelve suits at issue in this appeal.”).  They used direct filing, which we’ve warned defendants about before.  Id.

That was in 2012.  In the meantime, as we discussed here, the defendants had won a forum non conveniens motion, except the MDL judge,

conditioned its dismissal of these suits on the defendants’ submitting to the jurisdiction of a Spanish court, on their waiving any limitations defenses, and on their satisfying any final judgments for the plaintiffs.

Id. at *2.  Plaintiffs took an appeal.  Id.  Not until the current appeal eight (maybe seven) years later was the subject matter jurisdiction issue of foreigners on both sides of the “v.” recognized – by the Sixth Circuit sua sponte (meaning, for you non-lawyers, “on its own with no help from the parties”).  Id.

Here’s the problem.  The diversity rules are different when a lawsuit involves somebody from a different country.  Section “1332(a)(2), grants jurisdiction over a civil action between “citizens of a State and citizens or subjects of a foreign state[.]”  That didn’t apply here because “citizens of a State” were not sole parties on either side of the “v.”  Section 1332(a)(3), grants jurisdiction over a civil action between “citizens of different States” even when “citizens or subjects of a foreign state are additional parties[.]”  That didn’t apply because there were no U.S. citizens on one (the plaintiff side) of the “v.’  See DePuy Orthopædics, 2020 WL 1482384, at *2.  Since no provision of the diversity statute provided a basis for jurisdiction – subject matter jurisdiction was lacking:

Section 1332(a) thus does not give federal courts jurisdiction over this fact pattern.  That rule dooms diversity jurisdiction in these cases.  The complaints allege that the plaintiffs . . . are residents of Spain and citizens of either the United Kingdom or Spain.  Yet at least one defendant . .  is incorporated in the United Kingdom and has its principal place of business there.  On these facts, the plaintiffs cannot satisfy §1332(a)(2) or (a)(3).  Section 1332(a)(2) will not work because citizens of foreign states fall on both sides of the dispute and so complete diversity is lacking.  And §1332(a)(3) will not work because citizens of different states do not fall on both sides. While some other defendants are citizens of a state, the plaintiffs identify no state-citizen plaintiffs. . . .  The district court thus could not exercise diversity jurisdiction.

Id. at *3 (citation omitted).  So the actions, as filed did not confer subject matter jurisdiction in the federal courts.

Both sides tried to find some way around this problem.  Plaintiffs tried to amend on appeal to add a Magnuson-Moss consumer fraud claim based on federal subject matter jurisdiction.  Id.  That failed because, (1) “defective allegations of jurisdiction” cannot be cured under 28 U.S.C. §1653 by substantive amendments to complaints; and (2) courts “have rejected arguments that medical devices qualify as “consumer products” covered by the Magnuson-Moss Warranty Act.” Id. at *4 (citations omitted).

Defendants tried to distinguish forum non conveniens situations, but that failed because:  (1) the Sixth Circuit “definitively decided that it lacks jurisdiction”; and (2) the conditions imposed by the district court on defendants constituted an independent exercise of jurisdiction that now had no basis.  Id. at *5.

Adios.  The action was remanded to the district court so that it could be dismissed.  Id. at *6.  In effect that meant that the defendants ended up getting more than they bargained for.  Not only were the actions dismissed, but they were dismissed without any of the preconditions to forum non conveniens (submission to jurisdiction in Spain; waiving the statute of limitations defense) that the defendants had been forced to agree to.  The district court could not impose such conditions without any basis for jurisdiction.

The lesson to be learned by this case is the one stated by the Sixth Circuit at the outset, “it ‘behooves parties to be meticulous in jurisdictional matters.’”  DePuy Orthopædics, 2020 WL 1482384, at *1 (quoting Prime Rate Premium Financial Corp. v. Larson, 930 F.3d 759, 765 (6th Cir. 2019)).  That means many defendants will have another weapon – and a strong one when applicable − for dealing with foreign plaintiffs.  We doubt that the DePuy Orthopædics is all that unusual, particularly in MDLs, in including overseas defendants among the roster of parties being sued.  There have been a fair number of so-called corporate “inversions” among drug and device manufacturers.

Since foreign plaintiffs usually just copy existing complaints by rote, the situation facing the Sixth Circuit here – all foreigners on the plaintiff side and mixed foreign and domestic corporate defendants – can be expected to recur.  If defendants are aware, they can pounce at a time of their choosing (subject matter jurisdiction is never waived) on foreign litigation tourists who make the same mistake as the plaintiffs in DePuy Orthopædics.

Happy hunting.

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The DDL blog is no friend of the forum defendant rule – the exception to removability of diverse cases.  You wouldn’t find us lamenting if it suddenly disappeared because it would take with it busloads of litigation tourists who would no longer have any incentive to sue a forum defendant – often a nominal defendant – just to force out-of-state defendants to endure litigation in a state court handpicked by plaintiff.  However, as we noted in our most recent post on the issue of snap or wrinkle removal, if the forum defendant rule is sticking around, so too must removal before service.  Fortunately, the Fifth Circuit becomes the third appellate court to adopt the defense “plain language” approach which is quickly becoming the overwhelming majority view.

The “forum defendant rule” provides that

[a] civil action otherwise removable solely on the basis of [diversity] may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.

28 U.S.C. § 1441(b)(2)(emphasis added).  So, by way of example assume a Kansas plaintiff files suit in Pennsylvania against an Indiana drug manufacturer and a distributor who has a principal place of business in Pennsylvania.  There is complete diversity but the case stays in state court thanks to the forum defendant despite its almost assuredly minimal ties to events that give rise to the suit.  That is unless the Indiana defendant can remove the case before the Pennsylvania defendant is served.  That’s what the statute says and that’s how the Second, Third and now the Fifth Circuit read and apply it.

Texas Brine Company, L.L.C. v. American Arbitration Association, Inc., — F.3d –, 2020 WL 1682777 (5th Cir. Apr. 7, 2020) is not a drug/device case, but it did involve a Texas plaintiff, a New York defendant, and two Louisiana defendants sued in state court in Louisiana.  Before the Louisiana defendants were served, the New York defendant removed the case to federal court.  When plaintiff challenged the removal, the court was asked to decide whether the “plain language” of the statute was unambiguous and whether it would lead to an “absurd result.”  Id. at *3.

The language of the forum defendant rule is pretty plain and unambiguous, so plaintiff argued that snap removal was an absurd result.  Id.  Plaintiff contended that Congress’s intent in adding the “properly served” language was to prevent plaintiffs from naming forum defendants simply to defeat diversity.  Plaintiff’s solution was that the language should be ignored when a plaintiff really and truly intends to pursue its case against the forum defendants.  Gee, do you really promise, pinky swear, cross your heart?  We’re sure that’s a standard courts want to enforce.

As the Fifth Circuit explained, however, “absurdity is not mere oddity.  The absurdity bar is high, as it should be.  The result must be preposterous, one that ‘no reasonable person could intend.’”  Id. (quoting Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 237 (2012)).  We’re sure McConnell would have some wonderfully humorous examples of absurdities versus oddities if this was his post, but given that we are living in a worldwide pandemic that is shutting down nations which in part has led to Tiger King becoming an international phenomenon the bar for absurdity has risen significantly this year.

Under any circumstance though, snap removal doesn’t rise to that level.  The Fifth Circuit found that removal before service “is at least rational.”  Even if Congress failed to appreciate the effect the “proper service” provision would have, that does not make it absurd.  Id.  Like both the Second and Third Circuits, the Fifth Circuit concluded that “a reasonable person could intend the results of the plain language.”  Id.  Such reasons include limiting gamesmanship, providing a bright-line rule (service v. plaintiff’s intent), and “to protect out-of-state defendant from in-state prejudices.”  Id.  This takes us back to our prior point – if you are going to have the forum defendant rule which in modern practice has led to litigation tourism, out-of-state defendants need a bright-line rule to counter plaintiffs’ forum-shopping games.

The unambiguous language of the statute, and giving meaning to each word, means that the forum defendant rule “is inapplicable until a home-state defendant has been served” and “until then, a state court lawsuit is removable” where complete diversity exists.  Id.   And, the court found no “exceptional circumstances” that warranted creating an exception to the exception that would require reading into the statute a “reasonable” time to effect service on the forum defendant.  Id. 

With the growing body of authority on the defense side which may even sway districts with prior not so favorable interpretations – by all means, snap remove.

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Happy non-tax day.

A new workplace makes for a new workday. Thanks to the pandemic, the new workplace is home. With the many beckonings of family or chores or television or, most seductive of all, the refrigerator, the workday at home is filled with interruptions. We Big Law drones learned long ago that our jobs are not bounded by 9 a.m. and 5/6 p.m. Still, there are usually some reasonable endpoints. But in the time of the coronavirus, any line of demarcation between home and work has been erased. The new routine is to dial into a bed-headed conference call at 7:30 in the morning. (We waited for the person taking roll call to ask who was wearing pants. Didn’t happen. But a couple of nights ago SNL went and did that joke, so now it’s inevitable.) Then we proceed through our intermittent tasks through lunch, second lunch, snack time, dinner, and deep into the night.

And then there are weekends. Or are there? Doesn’t it all now seem like one long, claustrophobic slog?

Deprived of the usual dissipations, we find ourselves exchanging lists of bingeworthy tv shows with friends and colleagues. (Well, not quite all of our colleagues, as you will soon see.) Everybody else on Facebook and Twitter is suggesting series to plow through, so we here at the DDL Blog will follow suit.

As the aggregator of these suggestions, we get to go first, and hereby lay claim to the program on almost everybody’s curdled lips, Tiger King (Netflix). It is just as bizarre as you’ve heard. Who knew there was a cadre of big cat owners out there? Who knew that there are more tigers in captivity in the USA than prowl the wild in the great wide world? Tiger King assaults you with one crass astonishment after another until you grow numb. There is even something in it for the attorneys, as you witness the assembly by a federal prosecutor of a case involving unlawful trafficking in animals — oh, and attempted murder for hire. As lawyers, we are always ready to admire public speaking. In Tiger King, you will see and hear a eulogy unlike any other. Go ahead and fire up Tiger King on your screen. Join the national conversation. But be prepared to shed any hopes you ever had for our miserable species. (Determined not to miss a buck, the makers of Tiger King recently put up an additional episode. But it is merely Joel McHale catching up with some of the players. We learned two things: 1. Joe Exotic was an even worse human being than we thought, and 2. Modern dentistry can really work wonders.)

After Tiger King, a Stephen King story about a shape-shifting demon sounds like a snooze. But The Outsider (HBO) is gripping stuff – certainly through its first half, which reeks of mystery and terror. As too often happens with King’s tales, the landing – the explanation/resolution – is not exactly stuck. Still, if the choice is between continuing onto the next episode of The Outsider or reading yet another court bulletin on coronavirus closings, we know what button you’ll push on the remote.

Then there are the suggestions we collected from our fellow DDL bloggers. Let’s begin with the anglophilic contingent.

Rachel Weil is making her way through Downton Abbey for the second time. The well-heeled Edwardians survived the Spanish flu with style. And wouldn’t a spot of tea feel good right now? And yet we cannot linger at Highclere Castle too long. Bringing us back to the modern era (sort of), Rachel mentioned the availability of Broadway shows on the web. Let’s face it: Rachel is in every respect our cultural superior.

Michelle Yeary has been watching The English Game and Peaky Blinders, both on Netflix. We’ve heard others praise the former, and we ourselves can vouch for the latter. The star of Peaky Blinders, Cillian Murphy, is often listed as a possible next Bond. Are we the only person who thinks the Peaky Blinders theme song sounds like The Wire’s?

Enough with old Blighty. Is America capable of producing anything worth watching? (And watching. And watching.)

John Sullivan had good things to say about The Patriot (Amazon Prime). The protagonist is a CIA operative folk singer in Amsterdam posing as piping company salesman while dealing with depression and trying to stop Iran from getting nuclear weapons. He relieves his depression by singing in the Amsterdam streets and cafes, but gives away the details of his CIA operations in his lyrics. He also pushes a poor guy in front of a bus – twice. We’re betting John is not a huge Downton Abbey fan, especially given that his second selection was Narcos Mexico. Mr. Bates might’ve had a brush with the law, but he was no El Chapo.

Eric Alexander agreed on The Patriot, and is now watching Hunters (Amazon Prime). We have to admit that we gave up on Hunters. How can a cast that includes both Al Pacino and Carol Kane go wrong? Watch and discuss. Has there ever been a better villain than Dylan Baker? Eric is also watching Baby Yoda.

If Sullivan and Alexander seem to favor Amazon Prime, it doesn’t look like Steven Boranian will cancel his HBO subscription anytime soon. He is taking a cringe-walk through Curb Your Enthusiasm episodes. Next comes Veep. Boranian sees to be taking the sensible approach of looking for laughs in the midst of the ongoing pestilence.

We saved Bexis for last. He doesn’t watch tv. Really. Or almost really. After some poking and prodding from your disbelieving correspondent, Bexis grudgingly admitted that he had watched an old UConn women’s basketball game (April 7, 2013: UConn 83, Notre Dame 65). He also extolled the virtues of something called “books.” Yeah, as if. (If what we are doing here is analogous to those “Staff Recommendations” you’d find on a shelf at the now-defunct Blockbuster video stores, then Bexis is like the uber-eccentric staffer, invariably named Neville or Nat, who put up DVDs of “Roach! The Musical of Franz Kafkas’s Metamorphosis” and a documentary on “How Fish Do Laundry.”)

Notice anything remarkable about these suggestions? Nobody mentioned the Mt. Rushmore dramas of The Sopranos, The Wire, Mad Men, or Breaking Bad. And nobody listed that last great Monoculture achievement, Game of Thrones. Perhaps the assumption is that everybody has seen them. We might add Deadwood and The Shield to the canon viewing list. Succession is also a nasty but tasty pleasure. Nor did anyone mention some of the recent series about which there has been so much chattering: Zero Zero Zero (Amazon Prime) and Devs (Hulu). Perhaps all that proves is that we DDL bloggers are conservative. And not young.

Good luck out there. Keep washing your hands.

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