One recent night, three-plus months into our ongoing solitary confinement, we found ourselves laughing very hard at a classic Road Runner cartoon.  We especially loved the moment when Wile E. Coyote stepped off a cliff then froze in mid-air as knowledge of his fate dawned on him.  That image popped into our mind as we read today’s case, in which plaintiffs learned that the incautious testimony of their own expert was fatal to hundreds of their claims.  The case, In re Taxotere (Docetaxel) Prods. Liab. Litig., 2020 WL 3487594 (E.D. La. June 1, 2020) is the latest in a series of great decisions from the Taxotere MDL and the second involving the same expert.  (You can read our earlier posts here and here and here.)  A shout-out to Shook Hardy’s Harley Ratliff, who is racking up these victories.

Plaintiffs in this MDL allege that the defendant’s breast cancer drug caused them to suffer permanent alopecia (hair loss) and that the defendant did not adequately warn of this risk.  According to the plaintiffs’ expert, whom we have previously described as a “ubiquitous plaintiffs’ regulatory mouthpiece,” the duty to provide such warnings was triggered on December 15, 2006.  On that date, in a presentation at a major breast cancer conference, a prominent doctor identified a statistically significant link between the drug and permanent alopecia.  But fourteen hundred plaintiffs in this MDL took the defendant’s drug before December 15, 2006. The defendant moved for summary judgment on every one of those plaintiffs’ failure-to-warn claims, based on the plaintiffs’ expert’s opinion that there was no duty to warn before that date.

Now here’s the best part: the plaintiffs asked the court to “disregard” their own expert’s opinion. They argued that the opinion was “tailored” to the claims of three bellwether plaintiffs who took the drug after December 15, 2006.  (In other words, had the expert realized that so many plaintiffs had taken the drug before December 15, 2006, his “tailoring” would have fashioned a different start date for duty to warn.)  The plaintiffs argued that the expert’s opinion was “case-specific” to the three bellwether cases and shouldn’t be considered in connection with the summary judgment motion.

As before, the court wasn’t buying it.  It again held, “These assertions fall flat. For months now, the parties and this Court have discussed the filing of this [omnibus] motion. The parties agreed on the briefing schedule. Plaintiffs had ample time and opportunity to identify and present expert evidence disputing the damaging testimony from [their regulatory expert]. Yet Plaintiffs failed to do so.” Taxotere, 2020 WL 3487594 at *2.

The court held that, under Louisiana law, the plaintiffs had “failed to create an issue of fact regarding whether Defendants . . . had a duty to warn prior to December 15, 2006,” given that their “own expert testified that Defendants’ duty arose on this date.” Id. at *3.  (Because the laws of numerous jurisdictions applied to the claims at issue, the court analyzed only Louisiana law for purposes of the decision, reserving decisions on cases governed by other states’ laws.)  According to the court, the plaintiffs had pointed to “scant evidence” of earlier knowledge on the part of the defendant, “an issue on which Plaintiffs carry the burden of proof” – that “rather than provide the Court with an unequivocal expert opinion that creates an issue of fact on the scope of Defendants duty to warn, Plaintiffs point[ed] the Court only to equivocal evidence in the record, all of which leaves the court guessing.”  Id. at *4.  Because the plaintiffs had failed to create an issue of fact, the court granted summary judgment on all cases to which Louisiana law applied.

We absolutely love this stuff.   We spend much of our professional life fighting rampant abuses by MDL plaintiff lawyers, and we relish the “comeuppance” of plaintiffs’ own tactics sinking their claims. The court asked the parties to provide a chart defining the relevant standard for all of the other jurisdictions at issue, and we will keep you posted on any rulings that result. Meanwhile, stay safe out there.

Not long ago, an EPL (evil plaintiff lawyer) relayed to us that, based on reading our posts, another EPL had assumed we had a particular political view.  As we laughed at the notion, we pondered the issues of assumption and incomplete information.  Much like the old quip about what happens when you assume, many assumptions are not just wrong, they can be really wrong.  The incidence of incorrect assumptions seems to increase with the less information the assumer has and, we posit, a tendency to not seek out information.  In terms of politics, we tend not to air our views too openly, but there have certainly been clues.  (While we use plural pronouns, we do not all have the same views about law, grammar, or punctuation, let alone politics.)  It is true that we tend not to discuss many of the cases that grab headlines in the lay press and when we do, like last week’s post on Bostock, we focus on the legal principles applicable to our sweet spot rather than simply cheering (out loud).  Similarly, were we to discuss a recent decision on a certain (current) member of Congress versus a fictitious heifer, we would probably ruminate on the role of social media in product liability litigation, the Sullivan decision, or the reluctance of most judges to deter frivolous litigation through cost-shifting sanctions.  Even though we have scoresheets, we care less about who wins than we do about underlying legal principles, rigorous legal analysis, and maintaining the proper roles for various players in our complicated federal system and Constitutional republic—concepts one might lump under the banner of “the rule of law.”  Why else would we note when a decision in favor of a drug or device manufacturer applied the wrong analysis or point out typographical errors in published decisions?  Either we are believers in process or we are just kindof jerky.  Maybe both.  Lacking access to our internal editing and banter, the readers will just have make assumptions on incomplete information.

That was all a highly contrived device to get to the English v. Bayer Corp., — F. Supp. 3d. –, 2020 WL 3454877 (W.D.N.Y. June 25, 2020), decision.  We have posted on a number of Essure decisions from various federal courts, most of which have found broad preemption of claims against the manufacturer of this PMA contraceptive device, like this one.  English involved three separate plaintiffs lumped together and dismissed together on what the court labeled preemption.  We will start with our assumptions and incomplete information, with dashes of misdirection and foreshadowing.  We do not know why these three plaintiffs were together in a single case filed in 2019, but we do know their devices were implanted between 2009 and 2011, that one of them had sued before, and that the complaint did not offer any specifics on which of a laundry list of alleged possibility injuries they suffered.  From this, we assume these plaintiffs had no significant injuries, their claims were time-barred, and they were brought in the hope of resolution without much effort, as sometimes happens with the later cases thrown into an MDL.  Those assumptions, correct or not, do not affect our read of the decision or, as far as we can tell, the decision itself.

Rather than assert design defect claims—which are usually easy pickings with PMA preemption—the plaintiffs mostly asserted the sort of atypical claims that some courts have let slip past both Riegel express preemption and Buckman implied preemption.  Our view about the near mythical status of such “parallel claims” has been voiced a number of times, like here and here.  After recapping the basic legal framework, the court noted

[M]ultiple federal and state courts nationwide have previously dismissed, on express and/or implied preemption grounds, claims involving the Essure device which are nearly identical to those asserted by plaintiffs. The Court finds no reason to depart from this consistent and well-settled precedent.

Id. at *2 (citations omitted).  The court then walked through the asserted claims.  What the court did not note was that the decisions it cited (and we omitted above), including one applying New York law, had been issued before this case was brought.

First up was the purported “negligent training” claim, which was predictably a mishmash of allegations apparently not focused on the doctors who treated these plaintiffs.  The court started looking at whether the asserted claim sought to “impose obligations beyond those mandated by the FDA” without first looking at whether the asserted claim was cognizable under state law.  New York does not have a failure to train claim against medical device manufacturers, so the court concluded there could be no parallel claim to get past express preemption.  Id. at *3.  The simpler route is that a 12(b)(6) motion is for “failure to state a claim on which relief can be granted,” which means the lack of any recognized state law claim (or any right of action under federal law) should end the inquiry before preemption.  A little Erie restraint can be thrown in for good measure.  The result is the same, but, like we said before, we care about process.

Next up was the purported claims for failing to report adverse events to FDA.  New York did not recognize such a claim.  Id.  If this was a just a step to arguing that the warnings should have been changed because of the adverse events that were allegedly not reported, then it was expressly preempted.  Calling it by another name—negligent risk management—did not save the claim based on the same alleged conduct. Id.

The remaining claims for misrepresentation and breach of express warranty were treated together.  Quoting the decision we discussed here, the court started with the principle that express preemption applies to any claim, however denominated, “based on written or oral statements whose content falls within the parameters of FDA-approved labeling.”  Id. at * 4 (citation omitted).  Plaintiffs did not allege “any statements by defendants that substantively stray beyond those approved by the FDA.”  Id.  It was unclear whether the court took this failing as an indication that plaintiffs did not actually advance these claims or that whatever they were pushing was not going to be a parallel claim.  Either way, they were dismissed:

In sum, plaintiffs’ attempts to distinguish their claims to bring them outside of the scope of the preemption provisions of the Medical Device Amendments to the FDCA, or otherwise to state plausible parallel claims under the laws of New York State, are unavailing.

Id.

With the dismissal of all asserted claims, two issues were left.  First, the plaintiffs sought leave to amend.  As we have noted before, plaintiffs tend to get more than one strike when it comes to 12(b)(6) dismissals, even when preemption is the driving force for the dismissal.  Perhaps these plaintiffs assumed they would get another shot at pleading non-preempted claims.  They did not submit the redlined proposed amended complaint required by local rules, but the court considered the merits anyway.  The merits showed amendment would be moot because it just added a new claim based on the same factual allegations and added other “extraneous” factual allegations cut and pasted from another case’s complaint.  Id. at *5.  Again, maybe the plaintiffs assumed the court would not read the complaint find references that gave away the cutting and pasted.  If so, then they were wrong.  We would note that the decisions the court cited finding preemption of similar claims (and the one it cited that did not) were all decided before this case was filed, so it would make sense that plaintiffs did not get more chances to plead New York claims that were not preempted.

The last issue was also one of timing.  As mentioned above, one plaintiff had sued before and had her case dismissed. Defendants sought costs under Fed. R. Civ. P. 41(d), a provision that seems to be raised prior to a voluntary dismissal more often than it results in a ruling on the merits.  Although the plaintiff indigence meant she did not have to pay the defendants’ costs of defending her claims in English, the discussion was instructive.  This plaintiff suggested “that she or her attorney failed to adequately investigate her claims before filing the 2018 lawsuit”—also after the cited preemption decisions—“and that she later decided she preferred to litigate in a forum with the opportunity for multidistrict litigation.”  Id. at *6.  This betrayed a number of incorrect assumptions and apparent lack of diligence in trying to gain important information.  It also revealed the thinking that an MDL proceeding—and there was not one here—allows legal defects in plaintiff’s case to escape notice until some group settlement can take place.  Ultimately, the result in English does little to deter that model of litigation, at least as long as 41(d) only allows the imposition of costs against plaintiffs and not their lawyers.  Not to get too political.

Why does that last half-inch of conditioner seem to last as long as the entire rest of the bottle? This question is merely the philosophical beginning of our morning ablutions. The time is not billable. Pity. But rinse and renewal are not irrelevant to our thinking. Fresh face, fresh mind. Some of the best ideas penetrate our noggin before we head downstairs.

Maybe some plaintiffs and their lawyers get their ideas over the bathroom sink. Consider the recent case of Critcher v. L’Oreal USA, Inc., 2020 WL 2311890 (2d Cir. May 11, 2020). Someone somewhere, whether it was a lawyer or one of the putative class members, noticed that there was a dollop of skin cream that just wouldn’t come out of the bottle. That cream, bought and paid for, was not usable. Frustrating? Sure. Fraud? Oh, come on. Maybe the lotion couldn’t escape the bottle, but a fraud claim animated by that sticky truth couldn’t escape preemption.

The plaintiffs claimed that the volume amounts listed on the skin cream bottles were lies. The “creams are not fully accessible.” Plaintiff lawyer entrepreneurs and defense hacks all learned in law school that for every wrong there is a remedy (now that’s a lie), and the plaintiff lawyers in Critcher located that remedy in the consumer protections laws of New York, Florida, Kansas, Missouri, Texas, Nevada, Maryland, and Michigan. The plaintiffs’ theory was that these state laws required an additional disclosure on the skin cream packaging, “indicating that some cream cannot be retrieved or that the cream that is accessible is less than the net quantity displayed on the package label.”

The Critcher trial court dismissed the class action complaint on three grounds: (1) preemption by the Food Drug and Cosmetic Act (FDCA), (2) preemption by the Fair Packaging Labelling Act, and (3) “no reasonable consumer” could have been deceived. Permit us a word on that last point. We all know about the recalcitrant goop at the bottom of the bottle. It doesn’t want to exit. We knew that before we dropped the bottle in our shopping cart (real or virtual). Also, whatever happened to self help? There are ways of getting at that stuff. But if you disgustedly tossed the bottle in the rubbish bin and fired up a class action lawsuit – well, you’re a very particular sort of person.

The plaintiffs appealed to the Second Circuit. That court saw the FDCA preemption as so clear that it affirmed on that ground alone, not needing to get to the other issues at all. Skin creams are cosmetics. Congress installed an expansive preemption provision covering cosmetics: “no State or political subdivision of a State may establish or continue in effect any requirement or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter.” The Second Circuit summarized this provision to mean that the FDCA preempts “any state law that provides for labeling requirements that are not exactly the same as those set forth in the FDCA and its regulations.” (Emphasis in original).

Did the plaintiffs’ theory that the skin cream bottles were functionally underfilled survive the FDCA preemption provision? Nope. Not even close. The plaintiffs’ proposed disclosure would clearly be different from and in addition to the FDCA requirements. That conclusion was supported by other court decisions. That conclusion was supported by common sense. Weren’t the Critcher plaintiffs just as stuck in preemption as the cream was stuck at the bottom of the bottle?

Yes.

But first, the weekly Covid-19 digression.

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We decided to extract something good from this lockdown. We planted a vegetable garden. We baked bread. We finally laid our hands on Cocchi Americano and can now make a proper Vesper. We did some Pilates. (Okay – we helped move a Pilates reformer.) And we vowed to read novels that have been on our to-do list for the last (shudder) 40 years. Brothers Karamazov and Bleak House, here we come. But our first assignment was to tackle three 19th Century authors we had somehow managed to avoid: Thackeray, Tolstoy, and Trollope. Call them The Three Towering T’s of the Baggy Novel.

We liked Vanity Fair well enough. It is a fascinating example of a writer apparently losing control of a main character. Becky Sharp is meant to be thoroughly despicable. But she’s the most interesting one in the book by a country mile. She’s talented and charming. (In the recent movie version, Reese Witherspoon played Becky Sharp. Big surprise: Witherspoon’s version of Becky isn’t so villainous.) It is only by lobbing in a suggestion around page 850 that Becky possibly murdered someone that Thackeray clinches the moral case against Becky. Similarly, in War and Peace, we felt little warmth for Tolstoy’s obvious stand-in, Pierre. To our eyes beclouded by 21st Century cynicism, flinty Prince Andrey is the more interesting figure. But, in any event, we almost forgot all of the characters after Tolstoy drowned us in his theory of history in pages 1300-96. Trollope’s Orley Park was our favorite of the three doorstop novels. First, it took up a mere 820 pages – a breeze compared to the others. Second, Orley Park is about a lawsuit involving forgery of a will. Trollope knew a little something about the legal system. That knowledge did not result in unqualified admiration. Trollope offers the following thoughts on the most talented barrister in the case:

“Considering the lights with which he had been lightened, there was a species of honesty about Mr. Chaffanbrass which certainly deserved praise. He was always true to the man whose money he had taken, and gave to his customer, with all the power at his command, that assistance which he had professed to sell. But we may give the same praise to the hired bravo who goes through with truth and courage the task which he has undertaken. I knew an assassin in Ireland who professed that during twenty years of practice in Tipperary he had never failed when he had once engaged himself. For truth and honesty to their customers – which are great virtues – I would bracket that man and Mr. Chaffanbrass together.”

Now, some of you might equate lawyer Chaffanbrass to modern day corporate defense hacks. But isn’t his profile at least as applicable to plaintiff lawyers who whip up all species of prejudice against their opponents, whether or not there is any connection to the issues ostensibly at hand?

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It would take more than the great Chaffanbrass to steer clear of preemption in the Critcher case. The plaintiffs contended that “the state laws implicated by their claims would merely impose labeling requirements consistent with those already in the FDCA – that is, not ‘different from’ or into addition to’ the FDCA requirements.” The plaintiffs argued that there are general FDCA requirements that labels not be “false and misleading in any particular” and that containers not be “formed, or filled to be misleading.” The problem with this position is that the FDA has already promulgated regulations specifically setting out information on labels necessary to avoid misleading consumers. Some of those regulations involve the net quantity of the product in a container. That specificity, coupled with the Congressional “broad, categorical statement of preemption in the FDCA” meant that the plaintiffs’ requested relief looked like “additional” and “different” requirements that would “disrupt what Congress intended to be a uniform – and federally led – regulatory scheme.”

The plaintiffs also argued that the skin cream labels were “defective” – even aside from being misleading. But that argument was a post hoc maneuver to elude preemption; it was not included in the complaint. Moreover, a new label on the cause of action could not erase the reality that the claim was about the label. And that labeling claim could not “avoid the sweeping force of the FDCA.”

The Second Circuit affirmed the district court’s dismissal of this blemished lawsuit.

It’s a case that pre- and post-dates the IVC Filters MDL– Ocasio v. C.R. Bard, Inc., 2020 WL 3288026 (M.D. Fla.  Jun. 18, 2020).   In fact, this case got through summary judgment and Daubert rulings in Florida before being transferred to the MDL in Arizona in 2015.  Upon its return to Florida, only two substantive claims remained – negligence and strict liability design defect.  Id. at *1.  Those and a claim for punitive damages.  In the pre-MDL days, the court had ruled that Plaintiffs had set forth enough evidence for the question of punitive damages to be a triable issue.  Id.  But, a funny thing happened while this case was bouncing between opposite ends of the Sun Belt – circumstances changed and with them, so did plaintiffs’ punitive damages hopes.

First up, the court had to decide which state’s law to apply – Arizona or Florida.  Defendant took the position it didn’t matter because punitive damages were barred by both states.  So the court decided to examine both.  By statute in Arizona, a manufacturer cannot be liable for punitive damages if the product at issue was designed and manufactured “according to the terms of an approval, . . clearance, . . . or similar determination of a government agency.”  Id. at *3 (citing A.R.S. § 12-689A.1).  There is no dispute that the IVC filter plaintiffs allege caused their injuries was cleared by the FDA.  Plaintiffs, however, rely on an exception to that rule whereby if the manufacturer “…[i]ntentionally, and in violation of applicable regulations as determined by final action of the government agency, withheld from or misrepresented to the government agency information material to the approval or maintaining of approval of the product,” the ban on punitive damages does not apply.  Id. (citing A.R.S. § 12-698B.2).  They argued that the exception applied because they had demonstrated that the manufacturer withheld safety testing data from the FDA.  Id.  But the misrepresentation exemption requires “a finding by the FDA that it has been defrauded.”  Id.  If it didn’t, you’d be hearing a whole lot about Buckman and fraud-on-the-FDA being preempted right about now.  But because Arizona requires that the FDA must have made its own fraud/misrepresentation finding – all the court had to do was acknowledge that no such finding existed here.  No punitive damages under Arizona law.

Florida does not have the same type of bar to punitive damages for FDA approved products that Arizona does, but it does provide that punitive damages cannot be awarded if the defendant

establishes, before trial, that punitive damages have previously been awarded against that defendant in any state or federal court in any action alleging harm from the same act or single course of conduct for which the claimant seeks compensatory damages. For purposes of a civil action, the term “the same act or single course of conduct” includes acts resulting in the same manufacturing defects, acts resulting in the same defects in design, or failure to warn of the same hazards, with respect to similar units of a product.

Id. (citing § 768.73, Fla. Stat.).  Here is the change in circumstances.  While Ocasio was pending in the MDL, the MDL court held a bellwether trial in Sherr-Unia Booker v. C.R. Bard, Inc., No. CV-16-00474-PHX-DGC (D. Ariz.). The jury awarded $2 million in punitive damages in that case.  Id So, having been hit with punitive damages in that case, defendant argued they were not available to the plaintiffs in Ocasio.

Plaintiffs’ first argument in response was that the issue was not yet ripe – that the issue of whether punitive damages were available or not is a matter for post-trial.  Id. at *4.  But this argument is inconsistent with the plain language of the statute which provides that punitive damages are unavailable if the defendant proves “before trial” that they were previously awarded.  Id.  According to its legislative history, one of the goals of the statute is to “reduce[ ] the number of cases where punitive damages might be awarded to plaintiffs.”  Id. Therefore, the court agreed the issue needed to be decided before trial.

That issue was twofold – were punitive damages previously assessed in an action “alleging harm from the same act” and if so, were they adequate.  On the first question, the court ruled in the affirmative.  The MDL trial involved an IVC filter of the same design as the one at issue in this case.  Id.  at *5.  The filters were treated the same by plaintiffs’ experts and they had the same predicate device.  Because the “ claims of the plaintiffs in both cases revolve around the same family and type of filter, and concern Defendants’ conduct with respect to these filters,” defendant has established that punitive damages were previously assessed against it for the “same act.”  Id.

Which left only the issue of the adequacy of the prior award.  Florida’s statute provides

In subsequent civil actions involving the same act or single course of conduct for which punitive damages have already been awarded, if the court determines by clear and convincing evidence that the amount of prior punitive damages awarded was insufficient to punish that defendant’s behavior, the court may permit a jury to consider an award of subsequent punitive damages. In permitting a jury to consider awarding subsequent punitive damages, the court shall make specific findings of fact in the record to support its conclusion. In addition, the court may consider whether the defendant’s act or course of conduct has ceased. Any subsequent punitive damage awards must be reduced by the amount of any earlier punitive damage awards rendered in state or federal court.

Id. at *4.  Plaintiffs, however, did not present “clear and convincing evidence” that the first award was inadequate.  What plaintiffs established back in 2015 was that there were sufficient facts to create an issue as to whether punitive damages should be awarded.  But that is no longer the issue.  Those facts “do[] not provide insight as to whether the two million dollars in punitive damages already awarded . . . is sufficient or insufficient.”  Id. at *6.  Instead, the only relevant evidence offered was by defendant – that it had stopped selling the product.  Without clear and convincing evidence, punitive damages could not be awarded under Florida law.  When/if this case proceeds to trial – it will be without a claim for punitive damages which should mean it will be without evidence that would only be germane to punitive damages.  The kind of evidence that steers a trial away from real issues like causation in favor of sideshows on profits and the evils of big pharma.  The Sun Belt states may be taking a beating in the press right now for their handling for the covid-19 pandemic, but we laud their punitive damages positions.

Today we’re updating our readers on new developments this month relating to three of our prior posts.

First, back in March we reported on an “Advocate’s General’s opinion” in a case before the European Court of Justice (“ECJ”).  See the original post for details, but the plaintiff was asserting the radical claim that EU principles of “non-discrimination” meant that, once any member state adopted a rule that expanded liability, all other member states had to follow that rule so that no plaintiff was “discriminated against” on the basis of residency in the EU.  Fortunately, as we discussed in March, the Advocate General rejected that theory – and we were informed that the ECJ itself almost always respected the Advocate General’s views.

The ECJ has now decided the case.  See RB v TUV Rheinland LGA Products GmbH, ECLI:EU:C:2020:453, slip op. (E.C.J. June 11, 2020).  As we had hoped, the plaintiff lost, however, the ECJ avoided passing judgment on the wildly expansive theory that the Advocate General had rejected.

Instead, the court held that the plaintiff lost on a preliminary issue.  The case involved a product liability insurance policy, issued in France to a French medical device manufacturer (now bankrupt), and according to the ECJ that set of facts did not implicate EU law (as opposed to member state law) at all.  The anti-discrimination “provision is intended to apply independently only to situations governed by EU law in respect of which the Treaties lay down no specific rules on non-discrimination.”  Slip op. at ¶31.  That was not the case here:

[I]t is clear that there is not, in EU secondary law, any provision which imposes an obligation on the manufacturer of medical devices to take out civil liability insurance designed to cover risks linked to those devices or which regulates, in one way or another, such insurance.

Id. ¶37.  That’s because the EU’s product liability directive “does not impose any obligation on the manufacturer of such products to take out civil liability insurance against any harm,” nor does it “seek exhaustively to harmonise the sphere of liability for defective products beyond the matters regulated by that directive.”  Id. ¶¶41-42.  The other directive the plaintiff asserted, concerning “services in the [EU] internal market,” “does not apply to financial services such as insurance.”  Id. ¶42.

Further harming the plaintiff’s case were her particular facts – her product use occurred solely in the nation in which she resided.

[I]t is clear that the applicant in the main proceedings, a German citizen who seeks the payment of insurance compensation for harm caused by the insertion of breast implants in Germany, the Member State in which she resides, has not made use of her freedom of movement. Consequently, there is no specific connecting factor linking the situation at issue in the main proceedings and the freedom of movement of Union citizens.

Id. ¶49.  Nor did the dispute have any effect on the “free movement of goods.”  Id. ¶¶52-55.

Thus, the plaintiff lost on the first issue.  Id. ¶59-60.  With no basis to apply the EU’s overarching anti-discrimination principle to what the ECJ found to be a local dispute, “there is no need to examine the other questions.”  Id. ¶61.  Thus, the court did not reach the Advocate General’ favorable interpretation of anti-discrimination that we described in our prior post.

Second, last July we expressed satisfaction – but not surprise – that the Administration’s attempt to regulate drug advertising through the Centers for Medicare & Medicaid Services (“CMS”) failed in court.  See Merck & Co. v. United States Dept. of HHS, 385 F. Supp.3d 81 (D.D.C. 2019).

Again, to our satisfaction (but not surprise), that ruling has now been affirmed.  Merck & Co. v. United States Dept. of HHS, ___ F.3d ___, 2020 WL 3244013 (D.C. Cir. June 16, 2020).  The District of Columbia Circuit was not about to allow two routine housekeeping provisions, 42 U.S.C. §§1302(a), 1395hh(a)(1), to create authority for CMS to do something it had never done before in its decades of existence – regulate the content of prescription drug advertising.  Even with the benefit of “deference” under Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), the “blunderbuss operation” of CMS’ ham-handed administrative power grab failed in a unanimous decision.  2020 WL 3244013, at *4.

Even if drug pricing could be considered an “efficiency” under general administrative regulations, “[t]o qualify as administering the Medicare or Medicaid statutes, a program of such intrusive regulation must do more than identify a hoped-for trickle-down effect on the regulated programs.”  Id.  “[F]or a regulation to be “necessary” to the programs’ “administration,” the Secretary must demonstrate an actual and discernible nexus between the rule and the conduct or management of Medicare and Medicaid programs.”  Id. (regulatory citations omitted).

The court of appeals agreed that CMS’s mandatory pricing information simply wasn’t very accurate:

[CMS] was unaware of any State that had adopted the wholesale acquisition cost as the applicable price, and [conceded] that it was “unlikely” any had.  Moreover, . . . [CMS] does not contest that the vast majority of Medicaid beneficiaries pay at most a nominal copayment for prescription drugs.  And, again, [CMS] made no finding that Medicaid consumers were generally aware of any relationship between what they pay and the wholesale acquisition cost.

Merck, 2020 WL 3244013, at *6.  Thus, the mandatory disclosures were, at best, useless.  CMS “fails to show that any substantial number of Medicare or Medicaid consumers would pay the” price to be disclosed.  Id.

And other aspects of the CMS rule could well be worse than useless:

[CMS] candidly acknowledged that the disclosure could just as well backfire.  Consumers, intimidated and confused by high list prices, may be deterred from contacting their physicians about drugs or medical conditions, and may be discouraged from using beneficial medications.

Id.

The CMS mandatory disclosure was also fatally overbroad.  While spun as an attempt to administer Medicare and Medicaid, it was in fact “directed at the general public.”  Id. at *7.  That “further increase[d] the distance between the Disclosure Rule and any actual administration of those programs,” and “open[ed] another fissure between the required disclosure and the programs’ administration.”  Id.

Finally, the appellate court agreed with our longstanding view that this administrative overreach suffered from a “Brown & Williamson problem.”  Specifically, “courts should not lightly presume congressional intent to implicitly delegate decisions of major economic or political significance to agencies.”  Merck, 2020 WL 3244013, at *7 (citing FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), multiple times).

[CMS’s] construction of the statute would seem to give it unbridled power to promulgate any regulation with respect to drug manufacturers that would have the arguable effect of driving down drug prices − or even healthcare costs generally − based on nothing more than their potential salutary financial benefits for the Medicare or Medicaid program. This suggests a staggering delegation of power, far removed from ordinary administration.

Merck, 2020 WL 3244013, at *7.  If irony were not already dead with this Administration, we could comment at greater length about the purported “party of limited government,” but we won’t.

Instead, we’ll move on to Merck’s discussion of another of our favorite topics – First Amendment protection of truthful pharmaceutical promotion.  In addition to all the above, Merck recognized that this government-enforced mandatory disclosure −

at least implicates a substantial constitutional question concerning the government’s authority to regulate the public speech of companies just because some percentage of the audience is involved in a governmental program from which the businesses indirectly derive financial benefit.

Id. (citation omitted).  The “implications of the authority claimed” were Owellian – threatening “broad [governmental] power to decide” the circumstances under which “any particular drug may be used for any particular purpose.”  Id. (citation and quotation marks omitted).

Thus CMS’s disclosure rule received the DC Circuit’s (figurative) penalty flag, with a holding that:

[N]o reasonable reading of the Department’s general administrative authority allows the Secretary to command the disclosure to the public at large of pricing information that bears at best a tenuous, confusing, and potentially harmful relationship to the Medicare and Medicaid programs.  Although the Secretary’s regulatory authority is broad, it does not allow him to move the goalposts to wherever he kicks the ball.

Id. at *8.  We hope this is the last we have to write about the government’s benighted attempt to appear to be “doing something” about pharmaceutical prices.

Third, we authored a screed last July entitled simply “Wrong Court,” in which we excoriated the Third Circuit for taking it on itself to predict, in the absence of any supporting state court authority, that state law would consider an Internet website that acted as the online equivalent of a shopping center to be a “seller” for product liability purposes.  See Oberdorf v. Amazon.com Inc., 930 F.3d 136 (3d Cir. 2019) (purporting to apply Pennsylvania law).  Just as the Merck case exemplified bureaucratic empire-building, we thought that Oberdorf was a poster child for improper federal court usurpation of the creation of state law:

[F]rom day one, the DDL Blog has been foursquare in our opposition to federal courts adopting expansive state-law theories of liability in diversity jurisdiction cases.  The Third Circuit violated fundamental Erie principles in its rush to liability in Oberdorf, and that needs correcting.

Thankfully, the en banc Third Circuit stepped in, which automatically vacated the offending 2-1 panel decision.  Oberdorf v. Amazon.com Inc., 936 F.3d 182 (3d Cir. 2019).  Bexis then helped write an amicus brief that (among other things), made the Erie point.  See Brief of the Chamber of Commerce of the United States of America and the Pennsylvania Chamber of Business and Industry as Amici Curiae Supporting Appellee Seeking Affirmance, Oberdorf v. Amazon.com Inc., 2019 WL 5541081 (filed Oct. 24, 2019).

We’re now pleased to report that the en banc Third Circuit implicitly agreed with us that the panel had overstepped its Erie bounds.  Instead of deciding the “seller” question itself – thus aggravating the Erie error − it chose to certify the legal question to the Pennsylvania Supreme Court:

This is an issue of first impression and substantial public importance, yet we cannot discern if and how § 402A applies to [defendant].  We are, as a result, unable to predict how the Pennsylvania Supreme Court would rule in this dispute.

Oberdorf v. Amazon.com Inc., ___ F. Appx. ___, 2020 WL 3023064, at *4 (3d Cir. June 2, 2020).

Further the bloggers sayeth not – at least at this point.

We have always puzzled over why pre-service removals are the least bit controversial.  We are referring to what are known as “snap removals,” or removals to federal court before any forum defendant has been served.  They are one way to comply with the removal statute’s forum defendant rule.  It’s pretty simple:  Even when you have complete diversity of citizenship and the amount in controversy exceeds the jurisdictional minimum, you still cannot remove a case to federal court “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).

“Properly joined and served.”  That is the key language, and as far as we are concerned, it is pretty clear that the presence of a forum defendant will not preclude removal jurisdiction so long as the case is removed before any forum defendants has been “properly served.”

A district court in Indiana recently agreed with us.  In Whipkey v. Eli Lilly &Co., No. 1:20-cv-00450, 2020 WL 3248472 (S.D. Ind. June 16, 2020), the plaintiff sued a citizen of Indiana in Indiana state court, but the defendant removed the case to federal court before the plaintiff served the complaint.  The district court denied the plaintiff’s motion to remand and ruled that “the language of § 1441(b)(2) is unambiguous and must control.”  Id. at *2.

This district court joins multiple others who have similarly applied the forum defendant rule exactly as it was written (another recent example is this case), and there are a couple of noteworthy thing about Whipkey.

First, the district court rejected a so-called “purpose-driven” interpretation of section 1441(b)(2).  As the “interpretation” goes, the purpose of the forum defendant rule is to preserve the plaintiff’s choice of forum where the defendant is local, and allowing removal before service would undermine that objective.  Id.  Whether you like the forum defendant rule or not—and we are on record as not being fans—we have extreme difficulty with allowing a statute’s purported “purpose” to override its unambiguous statutory language.  The district court in Whipkey experienced that same difficulty and held that the “statutory text must control.”  Id. at *3.

Second, the district court declined to create an exception for cases in which the sole defendant is a forum defendant.  To be honest, we had never heard this argument before.  But regardless, the district court ruled that prohibiting snap removals where the sole defendant is a forum defendant “is not a natural reading of the text [of section 1441(b)(2)].”  Id. at 4.  Again, the plain text controlled:  “[W]e are not in a position to ignore the plain meaning of the statute.  [¶]  Accordingly, we now join our sister district courts in the Seventh Circuit as well as the Second, Third, and Fifth Circuit Courts of Appeals that have concluded that § 1441(b)(2) permits a forum defendant to remove before service of process.”  Id. at *4 (citing Texas Brine Co. v. American Arbitration Ass’n, Inc., 955 F.3d 482, 485-87 (5th Cir. 2020); Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 706-07 (2d Cir. 2019); Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147, 153-54 (3d Cir. 2018)).

Many thanks to Barry Boise at Pepper Hamilton for sending this order our way.  It’s a good one to file away.

 

Here’s another guest post by Reed Smith’s Dean Balaes.  This one looks into a major (but not too recent) post-Albrecht drug preemption case.  Can’t have too many of those!  As always, our guest posters deserve all the credit (and any blame) for their writings.

**********

There is no hiding the fact that federal preemption is a sword that cuts deeply into the other side of the “v.”’s mass tort business prospects.  In the context of state-law failure-to-warn claims, such actions are sometimes held preempted under the Supremacy Clause of the U.S. Constitution, especially when the FDA acts on a manufacturer’s label and requires manufacturers to comply with the FDA’s language.  See Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019).  In other words, by virtue of the FDA approving a manufacturer’s label through its rigorous control process, state-law failure-to-warn claims are preempted by the federal agency’s judgment call as to what is and is not included.  Bad news for the coffers of the other side of the “v.” and great news for the interests of fairness.  One recent case cited in the Blog’s newly acquired information post illustrating the aforementioned tension is Mahnke v. Bayer Corp., ___ F. Supp.3d ___, 2020 WL 2048622, at *3 (C.D. Cal. March 10, 2020).  The Blog mentioned Mahnke briefly in a previous post.  It has since been designated to be published in F. Supp., so it is worth a closer look.

As many of the Blog’s readers know, one of the takeaways from Albrecht is that to bring an unpreempted state-law failure-to-warn claim about a branded drug, one must plead a labeling deficiency that the manufacturer could have corrected using the “changes being effected” (“CBE”) regulation.  To avoid conflict with federal requirements, the plaintiff would need to show that a manufacturer could have unilaterally changed its label because “newly acquired information” arose about evidence of a causal association between a drug in question and a clinically significant adverse reaction.  See Klein v. Bayer Healthcare Pharm. Inc., No. 218CV01424APGEJY, 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019).  The newly acquired information, however, must have been available to a manufacturer after the FDA approved of the label in question, but before a plaintiff last used the drug.  See Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019).  Only after such facts are sufficiently pleaded will the Court turn its attention to the manufacturer and ask whether the manufacturer satisfied its burden to show by “clear evidence” that the FDA would not have approved of the labeling changeSee Wyeth v. Levine, 555 U.S. 555 (2009).

In Mahnke, the defendant defeated (once again) a state-law failure-to-warn claim related to an FDA-approved gadolinium-based contrast agent (“GBCA”) administered intravenously to enhance the quality of magnetic resonance imaging (“MRI”).  For those readers pondering the question:  what exactly is gadolinium good for?  Look no further.  Gadolinium is a rare earth material used in conjunction with an MRI exam because it is inherently opaque to magnetic resonances.  But elemental gadolinium can be toxic.  It cannot be introduced into the body without being bound to a chelator, which prevents gadolinium from having adverse interactions with tissue while preserving gadolinium’s contrast enhancing property.  The chelator also permits the kidneys to eliminate GBCAs from the body after the MRI exam.

Plaintiffs in these cases claim that GBCAs spontaneously undergo de-chelation, allowing elemental gadolinium to escape.  Think salt.  It’s essential to life, but only when the sodium and chlorine are bound to one another.  Bodily contact with either sodium or chlorine in their elemental forms is not recommended.  De-chelation allegedly increases the risk of Nephrogenic Systemic Fibrosis (“NSF”), a rare scleroderma-like cutaneous disorder.  The FDA has found no evidence of any of these problems in people with healthy kidneys – therein lies the preemptive rub.

In Mahnke, Plaintiff never alleged that gadolinium caused NSF and did not claim to have NSF – or even weakened kidneys.  Instead, it was alleged that by taking a GBCA drug to assist in MRI imaging, the Plaintiff with normal kidney function suffered gadolinium “toxicity,” a nebulous term that means whatever plaintiffs want it to mean.  Allegedly, the manufacturer should have warned of a nebulous “risk of gadolinium retention toxicity” to “individuals with healthy kidneys.”  2020 WL 2048622 at *2.

Mahnke questioned the other side’s failure-to-warn theory, observing that:  (1) the FDA tied the manufacturer’s hands from changing its label to incorporate gadolinium retention toxicity, even if the manufacturer so desired;  (2) even if the FDA permitted a manufacturer unilaterally to change its label under federal law, the FDA would not have approved this change;  and (3) any newly acquired information “must have been available to the manufacturer after the FDA approved the relevant label on August 19th, 2010, but before the plaintiff last used [the drug] on May 1st, 2015.”  Id. at *2-3.  The rationale for this nearly five-year window is simple causation:  plaintiff could not have been injured by lack of “newly acquired information” when plaintiff was injured before the information ever existed.

The other side pleaded that the “newly acquired information” was merely gadolinium being retained in the body following injection of a GBCA.  Id. at *1.  Big whoop.  That only stated the obvious.  That is, gadolinium is retained in the body before a healthy renal system removes it.  Mahnke held that the other side “did not connect the dots between gadolinium retention in [a healthy] body and a clinically significant adverse reaction,” i.e., gadolinium toxicity.  Id. at *3;  see also McGrath v. Bayer HealthCare Pharm. Inc., 393 F. Supp.3d 161, 169 (E.D.N.Y. 2019) (“[r]reports and studies that discuss the fact of gadolinium retention but do not reach any conclusions regarding the adverse effects or risks associated with gadolinium retention in patients with normal renal function do not plausibly allege the existence of newly acquired information that could have justified Defendants’ revising the drug label through the CBE regulation”;  internal quotations marks omitted).

Plaintiff pointed to two pieces of supposed newly acquired information that could have triggered use of the CBE regulation:  two review papers published in 2016 and 2018 collecting research regarding GBCAs.  Id. at *3.  But the 2016 and 2018 research papers were “published outside of the relevant time frame” (i.e., August 2010 through May 2015).  Id.  Any newly acquired information alleged by Plaintiff “must have been available to [defendant] after the FDA approved the relevant label on August 19, 2010, but before Plaintiff last used [the product] on May 1, 2015.”  Id.;  see also Goodell, WL 4771136, at *4.  Moreover, both articles failed “to establish the requisite connection in the body and a clinically significant reaction in patients with normal kidney function,” discussing only the effects of GBCAs in patients with advanced kidney disease—not normal renal function.  Id. at *4  (meaning these articles will not be enough in a case without Mahnke’s timing problems).  Thus, the Court concluded that the articles do “not constitute newly acquired information warranting invocation of the CBE regulation.”  Id.  To otherwise rule against the manufacturer would impose the unreasonable requirement that one should have “pieced together” vague research standing for a different proposition to “conclude[] that gadolinium is toxic when de-chelated in patients with normal renal function,” so accordingly the other side failed to meet their burden to plead a labeling deficiency that the manufacturer could have corrected.  Id.

Beyond their failure to warn claim, the other side also (unsuccessfully) alleged a design defect.  Application of Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), outside of the generic context was conclusive.  Thus, the Court agreed with the defendant that plaintiffs failed to articulate a theory of liability that avoids preemption.  The bottom line is that the defendant successfully fended off inappropriate claims from the other side of the “v.” trying to gin up “newly acquired information” where none actually existed.

The only claim that survived is whatever vague piece of a warranty claim that might exist outside of the Defendant’s warnings.  But on the plus side, that fragment of a claim makes Mahnke non-appealable.

 

This week we are pleased to report on yet another breast implant case in which a plaintiff’s effort to circumvent preemption failed. In Diodato v. Mentor Workdwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), the plaintiff brought manufacturing defect, breach of warranty, and failure to warn claims that were typically skimpy in terms of laying out what federal law/regulation/specification the defendant allegedly violated.

The plaintiff had breast implants placed in 2014, experienced some symptoms (including a lump in her breast) in 2019, and had the implants removed at which time the left implant was found to have ruptured. Based on that concatenation of facts, the plaintiff alleged that the “hole” in the implant must have been due to a manufacturing defect and must have existed at the time the implant left the possession of the manufacturer and was simply undetected by the implanting physician because the manufacturer failed to warn the doctor to inspect the implant before surgery.

It turns out that there was a great big hole in the plaintiff’s legal theories.

In a blessedly concise opinion (we’re noticing a lot of that during this pandemic lockdown – it almost makes up for the horrible Covid dreams and Covid digestion problems) the Diodato court summarized the preemption analysis nicely: for claims against a class III medical device to survive, they must rest on conduct that both violates the federal scheme and also would give rise to recovery under state law even absent the federal violation. The court also wasted a minimum of time and ink in rejecting the plaintiff’s conclusory allegations, observing that “The Complaint does not disclose the foundation for Plaintiff’s belief that the rupture existed at the time the implant left Mentor’s possession. Likewise, the Complaint includes no discussion of Mentor’s manufacturing process or of any warnings Mentor provides.”

In concluding that the plaintiff’s manufacturing defect claim was preempted, the Diodato court held that “The Complaint alleges that a hole existed at the time the implant left Mentor’s possession, and reasons that the alleged existence of such a hole necessarily implies a manufacturing defect. However, in a case involving a Class III medical device, it is not enough that the plaintiff allege the existence of a deficiency. In addition, the plaintiff must allege ‘how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.’” So much for the manufacturing defect claim.

The failure to warn and warranty claims also flunked. Again, there was no alleged divergence between the defendant’s conduct and FDA requirements. Moreover, the Diodato court emphasized that the plaintiff entirely failed to address the product’s FDA-approved warnings, which specifically warn of rupture and notifies physicians that they should carefully inspect the MemoryGel implant before implantation for rupture or holes.

The Diodato court’s conclusion that these claims were preempted seems straightforward and inevitable, but is nonetheless important because so many breast implant claims seem to follow this same playbook. You might even call the Diodato case a gift from God. (That is what Diodato literally means.). It is hard for breast implant plaintiffs to get around preemption. Check that; it is almost always impossible.

All that being said, the dismissal in Diodato was without prejudice: “Though Plaintiff has failed to state a claim, the Court is not convinced that any amendment is certain to be futile.” Perhaps we will see an amended complaint. Perhaps (Probably?Certainly?) it will meet with an identical, preempted fate.

Congrats to the victorious defense team, which includes Dustin Rawlin, Monee Hanna, and Rachel Byrnes (all of Tucker Ellis) and Craig Thompson (Venable).

If, like this blogger, you had small children in the early 2000s, subconsciously you may have read today’s title with a Scottish brogue.  That’s because it might recall a scene from Shrek where Mike Myers (Shrek) and Eddie Murphy (Donkey) are having a philosophical conversation about the many and varied attributes of ogres.  “Ogres are like onions. . . . Onions have layers. Ogres have layers. You get it.”  We get it.  We also get that this reference might be coming to mind because having lived through the Shrek years, we recently introduced the now teenagers to So I Married an Axe Murderer.   Instead of talking about onions and layers, we are now subject to “We have a piper down” and “Look at the size of that boy’s head” butchered in a bad Scottish accent (not only by the kiddos).  It also means the teens have been introduced to the Bay City Rollers, which let’s face, everyone should be.

That’s what at least one of us here at the DDL blog thought of when we read the decision in Bayer Corporation v. Leach, 2020 WL 3118509 (Ind. S. Ct. Jun. 12, 2020).  Complaints are like onions, they have layers.  And having layers means courts have to consider each layer on its own merits.  The theories and causes of action alleged in a complaint need to be peeled back and examined independently.  You don’t get to lump it all together.  That’s what the Indiana Supreme Court said too.

The case involves the multiple claims of 36 women who allege they were injured by the medical device Essure, an implantable birth control device.  Id. at *1.  Essure is a PMA medical device and our blog is full of posts about the many preemption wins in Essure litigation (in the dozens).  Here, defendant moved to dismiss the complaint on both the insufficiency of the pleadings and on preemption grounds.  The motion was denied by the trial court who allowed an interlocutory appeal.  That appeal was decided at the end of 2019 with the court upholding the denial.  See Bayer Corporation v. Leach, 139 N.E.3d 1127 (Ind. Ct. App. 2019).  Both the trial court and the appellate court looked at the pleadings and the preemption arguments only in the context of plaintiffs’ manufacturing defect claim.  While defendant argued that other claims were not adequately pleaded and/or were preempted, both courts held that because “the manufacturing-defect claims are viable, we need not address any other legal theory.”  Id. at 1130 n.3.   Because the complaint was not completely “devoid of allegations upon which relief could be granted,” defendant was not entitled to a dismissal of anything.  Id. at 1135.

That’s an all or nothing standard and complaints aren’t an all or nothing proposition.  Complaints have layers.  Let’s just start with causes of action – of which there are often many.  Those causes of action require different allegations, are premised on different facts, and are based on different laws.  To say one was sufficiently pleaded tells you nothing about any of the others.  What about the grounds for a cause of action – there can be several.  We’ve seen many courts determine that a plaintiff could only proceed on a failure to warn claim to the extent it wasn’t premised on the product’s labeling or that a plaintiff couldn’t maintain the part of her design defect claim that was based on a stop selling argument.  Complaints have layers in part because plaintiffs make many and varied claims.  Sometimes, not all of them stick.  Whittling down the size and scope of a complaint at the pleadings stage can have a tremendous impact on the size and scope of a case overall.  If all that is left after a motion to dismiss is a manufacturing defect claim, you’ve likely drastically reduced the amount of discovery that is needed and the case may even be positioned to resolve quickly.

The Indiana Supreme Court didn’t say all that, but they did unanimously reverse and remand the case to the appellate court with instructions for it to “address the viability of each claim.”  Bayer v. Leach, 2020 WL 3118509 at *1 (emphasis added).  The court noted that this was a complex litigation in which plaintiffs “allege several sets of operative facts, amounting to several discrete claims.”  Id. at *2.  Already, we are beyond a one size fits all rationale.  Rather, “[i]n a complaint with multiple claims, the viability of a single claim does not immunize a separate, deficient claim from judgment on the pleadings.”  Id.  Nonviable claims are supposed to be disposed of and the litigation is supposed to proceed only as to those that survive.  Complaints have layers.  You can’t have one good claim propping up a load of bad ones.  That would be like balancing “an orange on a toothpick!

We’ll leave you with Eddie Murphy’s final words on the whole ogres are like onions thing – “You know, not everybody likes onions.”  So true of complaints as well.

Since we were involved in the Medtronic Infuse wars, we’ve been quite aware of Justice Gorsuch’s textualist views towards statutes since he wrote Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  In Caplinger he got a close look at the damage the Supreme Court had done to the plain meaning of the Medical Device Amendments’ preemption clause, 21 U.S.C. §360k(a) in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Suffice it to say that he didn’t like it one bit, but because he was then a mere member of the Tenth Circuit, he had to attempt to apply it.  We’ve been through all the details twice, first in our February, 2017 post on then-nominee Gorsuch’s views on preemption, and again in our “Lohr Has Two Shadows” post the following October.  We’ll just jump right to the conclusion that then-Judge Gorsuch reached in Caplinger:  he couldn’t “help but wonder if perhaps some of those rules [in Lohr] warrant revisiting and reconciliation.”  Caplinger, 784 F.3d at 1340.

Then, in the interim, the Supreme Court abolished the “presumption against preemption” in express preemption cases, upon which the Lohr majority so strongly relied.  See Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016).

Gorsuch the textualist has shown forth bright and clear recently – in an opinion that, oddly, was joined by all the quondam defenders of Lohr in preemption cases.  In determining that “sex,” as used in Title VII of the 1964 Civil Rights Act meant exactly what it said, we had a heaping helping of the textualist principles that we hope the Supreme Court will apply whenever it finally takes another look at LohrSee Bostock v. Clayton County, Georgia, ___ S. Ct. ___, 2020 WL 3146686 (U.S. June 15, 2020).  If readers want the scoop on the substantive impact of Bostock, here’s a good link.  Our interest, as drug/device defense lawyers, is in what the Court had to say about the proper way to interpret statutes (such as §360k(a)).

First:

When the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest.  Only the written word is the law, and all persons are entitled to its benefit.

Bostock, 2020 WL 3146686, at *3.  Second:

You can call the statute’s but-for causation test what you will − expansive, legalistic, the dissents even dismiss it as wooden or literal.  But it is the law.

Id. at *11.  Third:

Nor is there any such thing as a “canon of donut holes,” in which Congress’s failure to speak directly to a specific case that falls within a more general statutory rule creates a tacit exception.  Instead, when Congress chooses not to include any exceptions to a broad rule, courts apply the broad rule.

Id. at *11.  Fourth:

This Court has explained many times over many years that, when the meaning of the statute’s terms is plain, our job is at an end.  The people are entitled to rely on the law as written, without fearing that courts might disregard its plain terms based on some extratextual consideration.

Id. at *14 (citations omitted).  Fifth:

[T]that a statute has been applied in situations not expressly anticipated by Congress’ does not demonstrate ambiguity; instead, it simply demonstrates [the] breadth of a legislative command. . . .  [U]nexpected applications of broad language reflect only Congress’s presumed point [to] produce general coverage − not to leave room for courts to recognize ad hoc exceptions.

Id. (citations and quotation marks omitted).  Sixth:

Ours is a society of written laws. Judges are not free to overlook plain statutory commands on the strength of nothing more than suppositions about intentions or guesswork about expectations.

Id. at *18

The preemptive language of §360k(a) is about as broad in the prescription medical product liability litigation context as “sex” is in the context of Title VII.

[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.

Or, as then-judge Gorsuch put it in Caplinger, “Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.”  784 F.3d at 1337.  Thus, we look forward to the Court taking a Bostock/Caplinger textualist approach to §360k(a) the nest time it encounters medical device preemption.

And the same goes for “snap removals” – another instance where plaintiffs (less successfully than in Lohr) have sought to induce courts to ignore the plain language of a federal statute.

Oh, and one last thing.  Here’s a Bostock quote for Wyeth v. Levine, 555 U.S. 555 (2009), and that Court’s result-oriented analysis of implied preemption and the history of the FDCA:

All we can know for certain is that speculation about why a later Congress declined to adopt new legislation offers a “particularly dangerous” basis on which to rest an interpretation of an existing law a different and earlier Congress did adopt.

Bostock, 2020 WL 3146686, at *12 (citations omitted).