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Enborg v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 51601 (E.D. Cal. March 21, 2022), is the pelvic mesh case of the week, and it involves a variety of plaintiff challenges to the defendant’s experts. That fact in itself is interesting. Usually it is the defense side that challenges expert opinions. Maybe the plaintiff side is smarting from the recent trend of defense verdicts in mesh cases. Desperate times call for desperate measures.

Several of the rulings in Enborg are common to numerous mesh decisions out there, but there is a favorable decision about Rule 30(b)(6) deposition testimony not being a judicial admission that we have not seen addressed before in any detail. Even in pelvic mesh world, there really can be new things under the sun. There is also a more detailed and nuanced discussion of challenges to a defense regulatory expert, particularly regarding testimony about testing, than is normally the case in mesh decisions.

The Enborg court ruled against the defendant on some issues, due to adverse (and awful) MDL decisions, but the defendant won more of these issues than is normally the case. Once again, remand courts facing actual trials tend to render better rulings than MDL courts that treat the litigation as a settlement mill. Finally, because warning claims were out of the case, a number of opinions were excluded as irrelevant.

Let’s get to the key rulings.

The plaintiffs tried to foreclose a defense materials expert from testifying that the mesh does not degrade in vivo. The court held that the defense expert identified the relevant data and appropriate methodology, so his opinions passed muster. But the plaintiff contended that those expert opinions should stay out of the case because a defense 30(b)(6) witness had testified that degradation can occur. The Enborg court rejected the plaintiff’s position, holding that the testimony by the 30(b)(6) representative was an evidentiary admission, not a judicial admission. The jury could hear both the 30(b)(6) and expert testimony and sort any possible conflict out for themselves. Moreover, the Enborg court reasoned that the expert’s opinion that the mesh was not suffering from any quantifiable degradation while in vivo was not necessarily in irreconcilable conflict with the 30(b)(6) testimony that surface degradation can occur. Consequently, the court denied the plaintiffs’ motion to exclude the expert testimony.

The defense also proffered a urogynecologist who would testify that the mesh implant did not cause the alleged injuries. The plaintiffs endeavored to shut down such testimony because the expert had last implanted the mesh device in question 15 years ago and most of his experience was with other devices. The court held that the expert had plenty of experience (200 implants) with the device and such experience, along with his education could support general causation opinions. Nevertheless, the court held that the urogynecologist’s “limited — and dated — clinical experience” with the device meant that he could not opine about specific issues of biocompatibility, degradation, pain, and erosion.

Another defense expert was an ob-gyn who had been retired since 2015. The plaintiffs argued that this expert had been out of the game too long and should not be permitted to testify about the device’s safety and efficacy, as well as the issue of degradation. The court held that the expert’s clinical experience and literature review made his opinions sufficiently reliable and sufficiently helpful for the jury.

The defense also sought to bring in an expert who would explain the 510(k) clearance process to the jury. As we have mentioned many times before, the problem is that the pelvic mesh MDL court made a hash out of the FDA 510(k) clearance issue, ruling that such clearance had nothing to do with safety and that any mention of it would confuse the jury. As the defendant argued in Enborg, the MDL court’s reliance on the SCOTUS Lohr opinion was misplaced. The Lohr case looked at unclassified, pre-1976 comparators that had undergone no safety review, whereas the post-1976, class II comparators used in securing 510(k) clearance for pelvic mesh had undergone safety screening. The defendant implored the Enborg court to “exercise its inherent authority to disagree with the MDL court.” Obviously, that is a tough ask. We have seen some mesh remand courts push back against the MDL 510(k) ruling after those courts see how the unfairness plays out in trial. The Enborg court was not prepared at this point to push back, but made its exclusion of 510(k) evidence “subject to the caveat that Plaintiffs do not seek to show that [the defendant] failed to comply with regulations pertaining to premarket review.” That is some consolation. Further, the Enborg court reserved ruling on whether the defense expert could opine that the particular mesh in question went through “a review process that is different from — and meaningfully more rigorous than — mere 510(k) clearance.”

There is fundamental unfairness if a plaintiff expert criticizes the extent of premarket mesh testing while the defense expert is muzzled from pointing out that the premarket mesh testing fully complied with 510(k) requirements. The plaintiff in Enborg seemed to be exploiting precisely that unfairness. The trick is for the plaintiff regulatory expert to say that the limited premarket testing fell short of industry, rather than regulatory, standards. To our eyes, the plaintiff expert was a wolf (regulatory) expert in a sheep (industry) expert disguise. Thus, the Enborg court was right to be suspicious, as it viewed the plaintiffs’ position “as something less than a full-throated renunciation of regulatory evidence as to the adequacy of premarket testing.” The Enborg court said that it will revisit this issue depending on where the plaintiff expert’s testimony goes. Will the plaintiff open the regulatory door? Heck, in our view, the moment the plaintiff expert discusses her qualifications she will blow the door off its hinges.

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FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation.  21 U.S.C. §337(a).  That is the foundation on which prescription drug and device preemption is built. However, preemption is about the interplay between federal and state law requirements and where the latter must cede to the former.  When two federal statutes are at issue, the question is one of preclusion rather than preemption.  It’s a little bit po-tay-to versus po-tah-to, but the Supreme Court made sure to draw the distinction in POM Wonderful v. Coca-Cola Co., 134 S.Ct. 2228 (2014), and since we do not want to suggest that POM Wonderful had any effect on preemption, we restate the distinction here.

The other thing that distinguishes the case we are going to address today is it is not a products liability case, but rather a Lanham Act case – essentially marketing litigation between competitors.  That is what POM Wonderful was about as well, but in the food context rather than drugs and devices, and it found the FDCA was not preclusive.  Since POM Wonderful is not a SCOTUS decision we would rave about, we keep an eye on cases that examine the interplay between the FDCA and the Lanham Act just to make sure nothing creeps over to the products liability area we are focused on.  So far, so good.  While case specific holdings on the issue vary, the general principle is that if a Lanham Act claim challenges an FDA policy choice, meaning the court has to interpret or enforce FDA regulations, it is barred.  If it doesn’t, it’s not.  That does not stray too far from “no private enforcement” to keep us at night.

The most recent case to examine the intersection between the Lanham Act and the FDCA is Ciccio v. SmileDirectClub, LLC, 2022 U.S. Dist. LEXIS 49562 (M.D. Tenn. Mar. 21, 2022).  We gather from the opinion that the court has entertained numerous pleadings motions and discovery disputes that it did not rehash in this most recent decision, nor did it want to “belabor the details” of the case again.  But we think we got the gist.  Defendant sells plastic aligners for orthodontic use.  Orthodontists brought a Lanham Act claim against defendant alleging their misleading marketing deceived consumers into purchasing the aligners as an alternative to traditional orthodontic treatment which they allege the devices were not.  Id. at *3-4.  While plaintiffs’ claims survived earlier motions to dismiss, defendants brought this new motion to address the narrow issue of whether claims based on the allegation that defendant “improperly marketed itself as in compliance with federal regulations governing dental devices” were adequately pleaded.  Plaintiffs’ claim boils down to an allegation that defendant’s marketing misled consumers to believe the aligners were FDA approved when they were in fact not.

As a representation about FDA-approval status was not squarely addressed in POM Wonderful, defendants argued the claims in Ciccio “more seriously intrude on FDA’s prerogatives under the FDCA” such as to make the case more akin to Buckman than POM Wonderful.  Nothing would make us happier than a Lanham Act dismissal based on Buckman, but Ciccio is not that case.  Courts to have looked at the issue have gone both ways.  Ciccio at *19-20.  Here the court was persuaded that plaintiffs’ claims were not that defendant had “violated the FDCA or [ ] any general duty to disclose” whether a product is FDA-approved, but rather that their marketing was “misleading in a way that could have been, but was not, rectified by such a disclosure.”  Id. at *21.  If you can remedy the problem by disclosing, doesn’t that create a duty to disclose?  While that does make us wonder, we’ll leave that alone for now because we have an amendment to our Buckman statement above – Nothing would make us happier than a Lanham Act dismissal based on Buckman, but Ciccio is not that case – yet:

It may be that, once the facts of SmileDirect’s dealings with the FDA are established and in the record, the plaintiffs will be unable to state any theory of the case under the [Tennessee Consumer Protection Act] TCPA that would avoid Buckman-type preemption because any such claim would improperly call on this court to intrude on the FDA’s decisionmaking.

Id. at *29-30.  Yes, we know the court here was talking about plaintiff’s state law claim which is a matter of preemption as opposed to preclusion.  But the analysis should equally apply to the Lanham Act and preclusion. If the facts, in this case or another, ask the court to “improperly intrude” on FDA decision-making, such claims are preempted and/or precluded.  We retain our ability to rest easy that POM Wonderful and its progeny have left untouched the foundation of drug and device products liability preemption.

 

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In a recent post, we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.”  In Robinson v. Ethicon, Inc., 2022 WL 614919 (S.D. Tex. March 2, 2022), the court held that the expert “cannot take the final step of opining that the product was ‘misbranded’ or ‘adulterated,’ as these are impermissible legal conclusions.”  Id. at *6.  We think that this is a fact pattern that recurs with sufficient frequency that it would be worthwhile to collect other precedent to the same effect.

The first case was easy.  Robinson cited In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 3286439 (S.D. Ohio Aug. 1, 2021), which held that “no expert . . . may offer legal opinions, such as that the [defendant’s device] was ‘misbranded.’”  Id. at *8.  However, that trail stopped there, as Davol cited general appellate precedent precluding expert opinions on questions of law.  Id.  We’re not going there, because a comprehensive collection of such cases already exists in §10.06 of Bexis’ book.  Here, we’re focusing on expert opinions misusing these FDA terms of art.  And we found another decision from that same MDL to the same effect.  See In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 3617152, at *2 (S.D. Ohio Aug. 16, 2021) (identical language; adding that “experts may not offer other legal opinions, such as the meaning of the statutory or regulatory scheme surrounding medical devices”).

So we ran a search.  High on the list was Tsao v. Ferring Pharmaceuticals, Inc., 2018 WL 3649714 (S.D. Tex. April 19, 2018).  A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug.  Id. at *12-13.  However, Tsao also recognized the general proposition that experts throwing around FDA terms like “misbranding” and “adulteration” were spouting inadmissible conclusions of law:

Finally, [the expert’s] opinions that the [the drug] was “misbranded” or “adulterated” are inadmissible legal conclusions.  The Federal Rules of Evidence do not permit an expert to render conclusions of law, because such testimony cannot properly assist the jury in understanding the evidence or determining a fact in issue.  Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.  The court must remain vigilant against the admission of legal conclusions to uphold its own function in charging the jury regarding the applicable law. . . .  [The expert’s] opinions that [the drug] was adulterated, misbranded, or false and misleading under the FDA regulations should be excluded as inadmissible legal conclusions.

Id. at *13 (citations and quotation marks omitted).

In Sadler v. Advanced Bionics, LLC, 2013 WL 1385376 (W.D. Ky. April 3, 2013), the defendant successfully moved to preclude the other side’s expert from letting loose a litany of legal conclusions, including that the device at issue was “adulterated”:

Defendant moves the Court to preclude [the expert] from rendering improper legal conclusions by testifying that the devices were “adulterated” and “defective,” or that Defendant acted “unconscionably,” “recklessly,” or “illegally”. . . .  To the extent [he] proposes to testify using these terms in a way that expresses a purely legal conclusion or a personal opinion beyond the proper scope of expert testimony, such testimony is inadmissible.  Consistent with the Court’s contemporaneous and prior rulings on this issue, [he] shall not use terms such as “adulterated,” “defective,” “unconscionably,” “recklessly,” or “illegally” at trial.

Id. at *6.

The same issue arose in In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 5145546 (N.D. Ill. Aug. 31, 2015), and produced the same result:

[T]he court declines to permit [plaintiffs’ expert] to offer an opinion that the [devices] are “adulterated” and “misbranded” under the FDA regulations.  Legal opinions by experts are inadmissible. . . .  [N]ot even the FDA may declare unilaterally that a label is false or misleading and thus that a drug is misbranded; it must proceed to court for a judicial determination in an enforcement action.

Id. at *18 (citations and quotation marks omitted).

Similar expert testimony has also been offered, and repeatedly rejected, in pelvic mesh cases.  See Tyree v. Boston Scientific Corp., 54 F. Supp.3d 501, 543 (S.D.W. Va. 2014) (pelvic mesh case; excluding expert’s assertion that the “devices misbranded as a result of failure to furnish information requested” by the FDA); Foster v. Ethicon, Inc., 2021 WL 4476642, at *8 (D.S.D. Sept. 30, 2021) (expert “opinions on misbranding” would not “assist the jury in deciding a fact in issue”); Sanchez v. Boston Scientific Corp., 2014 WL 4851989, at *36 (S.D.W. Va. Sept. 29, 2014) (“misbranding” opinion excluded; “testimony on whether or not [defendant] complied with the FDCA would constitute an impermissible legal conclusion rather than an expert opinion”); In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, 2014 WL 186872, at *19 (S.D.W. Va. Jan. 15, 2014) (expert’s “misbranding” opinions excluded as “not helpful to the jury and they will confuse and mislead the jury”).  See Eghnayem v. Boston Scientific Corp., 57 F. Supp. 3d 658, 694 (S.D.W. Va. 2014) (following Sanchez); Hall v. Boston Scientific Corp., 2015 WL 868907, at *29 (S.D.W. Va. Feb. 27, 2015) (same).

Finally, we came across several opinions excluding expert opinion on “adulteration” and/or “misbranding” in other circumstances.  United States v. Caputo, 374 F. Supp.2d 632, 646 (N.D. Ill. 2005) (in criminal misbranding/adulteration case, expert could “not testify about whether Defendants met their obligations under the [FDCA]”); Mause v. Global Household Brands, Inc., 2003 WL 22416000, at *4 (E.D. Pa. Oct. 20, 2003) (purported expert precluded from “offering an opinion if a product was misbranded” because “[i]t is for the Court, and not an expert, to decide whether the law is violated”); United Phosphorus, Ltd. v. Midland Fumigant, Inc., 173 F.R.D. 675, 687-88 (D. Kan. 1997) (excluding expert “misbranding” opinions in FIFRA pesticide case).

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When Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), was decided, we included it as both our best decision of 2019, and as our sixth worst case.  To us, Albrecht’s holding that all preemption issues are questions of law for the judge to decide overcame the uncertainties created by Court’s tinkering with the “clear evidence” preemption test.  We explained our attitude thusly:

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.  Courts can no longer cop out, or kick the can down the road, with the excuse of “disputed” facts.

Today’s case, In re Fosamax (Alendronate Sodium) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 855853 (D.N.J. March 23, 2022), is further confirmation that our initial analysis of Albrecht was spot on.

Just as the previous Fosamax MDL judge had back in 2013, the current Fosamax MDL judge found all of the plaintiffs’ claims (only warning claims appear now to be at issue) preempted – only this time as a matter of law under Albrecht.  The decision is 87 pages long, but well worth the read.

We’ll try to boil down to a single paragraph the rather complex facts and regulatory history that produced Fosamax.  Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” − femur fractures.  The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.  Over the years, evidence that this risk was real accumulated, and the manufacturer provided a large quantity of material to the FDA.  In 2008, the manufacturer sent a lengthy prior approval supplement (“PAS”) seeking to add the risk of “stress fractures” to both the “adverse reactions” and “precautions” sections of Fosamax labeling.  The FDA’s April, 2009, formal “complete response letter” authorized the adverse reaction change, but not the precaution revision, due to insufficient data for the latter, and also turned down  “stress fracture” as a description of the risk.  At the FDA’s suggestion, the manufacturer withdrew that supplement, but kept trying.  Over a year and a half later, in October, 2010, industry-wide data finally convinced the FDA that the risk was scientifically established, and the agency ordered a label change adding atypical femur fractures to the precautions section of every drug in the bisphosphonate class.  2022 WL 855853, at *4-7.  In reality, things are a lot more complex, but the foregoing should be enough for our purposes.

Plaintiffs, of course, argued that the defendant manufacturer should not have waited for the FDA in actually making the label change.

The first intriguing aspect of Fosamax is its discussion of summary judgment standards when the determination is a question of law.  Instead of factual disputes being for a jury, they simply preclude preemption as a basis for summary judgment.  Id. at *10.  Fosamax placed more emphasis on the shifting burden of persuasion, first being on the moving party and then shifting to the non-movant.  Id.

Once the movant adequately supports its motion pursuant to Rule 56(c), the burden shifts to the nonmoving party to go beyond the pleadings and by [its] own affidavits, or by the depositions, answers to interrogatories, and admissions on file, designate specific facts showing that there is a genuine issue.

Id. (citation and quotation marks omitted).  “Credibility determinations are the province of the factfinder,” id., which in preemption cases after Albrecht is the judge.

In deciding all of the 500 or so Fosamax plaintiffs’ claims were preempted, Fosamax addressed the full panoply of post-Albrecht preemption questions – and the plaintiffs lost every one of them.

First, was the status of Wyeth v. Levine, 555 U.S. 555 (2009).  Plaintiffs claimed that Albrecht overruled Levine on the nature of “clear evidence” of preemption.  They lost.  The Levine standard was “not overrule[d], but merely clarified and expounded upon” in Albrecht.  Fosamax, 2022 WL 855853, at *10.  Thus, the Levine premise that preemption may be established by evaluating what the FDA “would have” done if faced with a label change, survives.  Id. at *12.  Plaintiff’s contrary position – that the “manufacturer must have actually requested a label change that the FDA then expressly rejected” – was “specious.”  Id. (emphasis original).  Fosamax observed that, of the “dozens” of decisions since 2019, not one court has interpreted [Albrecht] to establish a new standard for impossibility preemption requiring actual agency or manufacturer action.”  Id. at *12.

[Albrecht] uses the language of ordinary evolution rather than reversal and overruling. . . .  [T]he “universal” standard that a manufacturer need not submit a PAS and CBE to the FDA to preserve its preemption defense remains intact after [Albrecht]. . . .  In the end, it is, of course, the Supreme Court’s prerogative alone to overrule one of its precedents.  But it is difficult to reconcile the Court doing so when no party disputed [Levine]’s clear evidence standard on appeal, when the question before the Court was who should apply that standard, not whether the standard should survive, and when the Court itself held that its decision “flow[ed] from [its] precedents.”  139 S. Ct. at 1678 (emphasis added).  Accordingly, like all other courts having considered the issue, I find that [Albrecht] does not overrule [Levine].

Id. at *12-13 (other citations and footnote omitted).

Second, do the preemption holdings of the Supreme Court’s generic drug decisions in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), apply to prescription drug preemption as well?  Answer:  yes.  “Essentially, a defendant must show that it could not have unilaterally changed its label in any way to add the warning required by state law.”  Fosamax, 2022 WL 855853, at *11.  See Id. (quoting Mensing regarding “possibilities” and impossibility preemption).  Likewise, Mensing’s holding that preemption does not turn on a “defendant’s failure to ask the FDA” for help applies to all drug litigation – meaning, in Fosamax, it had no obligation to seek further meetings with the FDA.  Id. at *29.

Plaintiffs’ argument is essentially that Defendant could have, perhaps, theoretically, changed the FDA’s decision had Defendant somehow insisted on engaging with the Agency or invoked an available procedural mechanism rather than withdraw its [supplement], but “the possibility of [that] possibility” is certainly not enough to “defeat[] pre-emption.”

Id. (quoting Mensing, 564 U.S. at 626 n.8) (emphasis original).

Third, the defendant “fully informed” the FDA about the relevant risk.  That question was not before the Supreme Court in Albrecht, and both the Supreme Court and then the Third Circuit remanded the case rather than make any factual determinations themselves.  Fosamax, 2022 WL 855853, at *13.  The “basic inquiry” is whether, at the time of the 2009 complete response letter, “the FDA had all the information it deemed necessary to decide whether to approve or reject the proposed warning.”  Id. at *14 (citation and quotation marks omitted).  An extensive record established that the manufacturer “promptly” responded to all FDA requests and provided everything that the FDA needed.  Id. at *14-17.  Notably, “Plaintiffs d[id] not point to any specific instance in which Defendant failed to provide any timely and relevant information.”  Id. at *17.  Moreover, the FDA itself, in an amicus brief filed in Albrecht, “agreed” that the defendant provided all “relevant scientific data” to the agency.  Id. at *15.  That carried the day:

Because the FDA alone is the arbiter of which data and information is or is not material to its decision to approve or reject a change to a drug’s label under [Albrecht], the FDA’s view of the evidence matters.

Fosamax, 2022 WL 855853, at *17 (citation, footnote, and quotation marks omitted).

Fourth, whether or not constituting “final agency action” for extraneous purposes, such as administrative appeals, the FDA’s complete response letter was preemptive “federal law” on which preemption could be based.  Such a letter reflects the “FDA’s complete review of the data submitted.”  21 C.F.R. §314.110(a)(3).  Plaintiffs’ contrary argument was “misplaced for several reasons.”  Id. at *18.  For one thing, Albrecht cited that same regulation, which authorized complete response letters, as an example of “formal” FDA power.  2022 WL 855853, at *18 (citing Albrecht, 139 S. Ct. at 1679).  Nor need an FDA action be “final” to be “formal” for preemption purposes under Albrecht – Fosamax recognized that p-side argument for what it was – a bogus attempt to divest FDA actions of any preemptive effect:

[F]or preemption purposes, it is mostly irrelevant whether the [complete response letter] is of a merely tentative or interlocutory nature. . . .  [I]f Plaintiffs’ position were to prevail, no CRL could ever carry preemptive effect because all CRLs require some subsequent action on the part of the manufacturer, and preserve some procedural mechanism to further engage with the FDA, even if futile.

Id. (citation and quotation marks omitted).  Plaintiffs’ argument “would abrogate the very preemption effect of the federal regulation . . . that the FDA promulgated pursuant to congressional authority.”  Id. (citation omitted).

Fifth, while informal FDA communications are not preemptive in and of themselves under Albrecht, they can be quite relevant to a full understanding and accurate determination of the preemptive effect of FDA actions – such as a complete response letter – that are “formal” and thus do give rise to preemption.  Various FDA emails and other contacts demonstrated that the FDA issued its complete response letter because the FDA believed that the scientific data were insufficient to support the warning at issue, and was not merely a quibble about the term “stress fracture,” as plaintiffs contended.  Fosamax, 2022 WL 855853, at *19-24.  These materials demonstrated, among other things, that “the FDA clearly understood the type of fracture at issue.”  Id. at *22.

This point is important because it rejected plaintiffs’ position (which we’ve seen raised in other cases) that, after Albrecht, informal FDA communications should be disregarded altogether (at least when contrary to the plaintiffs’ preferred  position).

Defendant does not argue that the FDA’s informal communications themselves establish preemption, only that they “shed light on” the meaning and scope of the CRL, which is “Law” with preemptive effect.  I agree that it is appropriate to consider the communications for that limited purpose.

Id. at *24 (citation and quotation marks omitted).  “[I]nformal communications between the FDA and drug manufacturers should be considered in the preemption analysis.”  Id. (citation omitted).  The FDA’s formal complete response letter “does not tell the whole story without the proper context gleaned from other FDA communications.”  Id. at *25.  “In particular, it is appropriate to consider, and credit, the positions the FDA took in the amicus brief that the government filed in Albrecht itself.  Id. at *26.

Sixth, it matters that, under, 21 U.S.C. §355(o)(4)(A), the FDA was obligated to respond to any information it received, from any source, that demonstrated need for an additional warning.  Thus, contrary to plaintiffs’ argument, it was not “dispositive” that the complete response letter did not include “explicit discussion of the science” and “causation.”  Fosamax, 2022 WL 855853, at *26.

Plaintiff’s argument in this context must be rejected out of hand. . . .  [E]ven if I were to accept Plaintiffs’ position, one must assume that the FDA had reasonable evidence warranting a Precautions warning, but was so troubled by Defendant’s use of the term “stress fracture” that it rejected a warning without offering any suggestions or revisions.  To make such an assumption would effectively overlook the FDA’s raison d’etre to regulate drug safety, [and] its independent legal duty to notify a manufacturer as soon as it “becomes aware of new safety information that [it] believes should be included in the labeling of a drug” and “initiate discussions to reach an agreement … on labeling.”

Id. at *27 (citing §355(o)(4)(A)).  Since FDA actions are entitled to a “presumption of regularity,” Fosamax refused to credit any argument that assumed the FDA would not do what §355(o)(4)(A) required the agency to do.  That FDCA provision “imposes an ‘obligation to initiate a label change’ if the FDA believes one is warranted.”  Id.  Thus, the only valid inference why the FDA’s complete response letter did not require a label change had to be that the science was not there:

The more likely scenario is that the FDA’s actions taken in this case convey doubts that the Agency had about the underlying science, a deficiency no revision or edits could solve; hence, the Agency did not propose any.  The FDA’s subsequent inaction − it did not mandate a label change until October 2010, despite substantial ongoing review both internally and by the Task Force − confirms its then-existing perspective on the science, not that it was merely troubled by Defendant’s phraseology of its proposed warning.

Fosamax, 2022 WL 855853, at *27 (citations omitted).

This rationale also addresses a key, recurring point.  After enactment of §355(o)(4)(A), there was no longer such a thing as unexplained FDA inaction – as the Supreme Court relied on in Levine, 555 U.S. at 572 (the facts of which predated that amendment).  The affirmative obligation that the FDCA now imposes on the agency, when added to the previously discussed “completeness” requirement in §314.110(a)(2), precluded the negative inference from FDA inaction that plaintiffs advocated.  2022 WL 855853, at *27.  As Fosamax demonstrates, absent proof of withheld information, the inference now to be drawn from FDA rejection of a proposed warning is that the science did not support the warning.  Id. (only valid inference was that “the FDA was unconvinced of the causal link”).

Taken together, these provisions warrant the following inference as to the FDA’s intention when it issued the [complete response letter]:  the Agency did not believe there was reasonable scientific evidence of a causal association between bisphosphonate use and atypical femoral fractures, or else it would have suggested edits to that end, or simply mandated a warning using language that the FDA thought was more appropriate.

Id.  With courts required by Albrecht to evaluate preemption as a legal conclusion, the kind of p-side smokescreen that they tried in Fosamax should fail every time under the current regulatory scheme.

Seventh, in rejecting plaintiffs’ position that the manufacturer should have filed a “CBE” (changes being effected) warning change despite the FDA’s action, id. at *29, Fosamax held that there was no “newly acquired information” allowing the defendant to do so – confirming the lack of such information as an independent ground for preemption.  “The CBE process permits a drug manufacturer to unilaterally add a Precautions warning to its label, but only if ‘newly acquired information’ provides ‘reasonable evidence of a causal association of a clinically significant adverse reaction linked to a drug.’”  Id. (regulatory citations omitted).

The “newly acquired information” prong “is ‘part and parcel of the broader legal [preemption] question,’” id. (quoting Albrecht, 139 S. Ct. at 1680), thus “it is incumbent upon this Court to decide,” and is not a question of fact left to juries.  Id. (citation omitted).  “[T]he CBE process does not exempt the proposed change from the FDA’s substantive requirements, nor does it eliminate FDA jurisdiction.”  Id.  If the FDA had been “fully informed” of the basis for the proposed label change, as Fosamax had already determined, there could be no “newly acquired information” that would support a CBE label change:

[A]s a matter of procedure, in order for Defendant to proceed with the CBE process after the FDA rejected its PAS – [the manufacturer] was required to produce data indicating a greater-than-previously-known risk of [the relevant risk], which could establish “reasonable evidence” of a causal association. . . .  [E]ven though the FDA’s then-ongoing review was arguably more thorough than any review it might have conducted under the CBE process − the Agency was compiling data from multiple manufacturers . . . a variety of new reports, revisiting old ones, conducting its own analyses, and working with outside experts on the Task Force − it did not uncover definitive evidence linking [the drug] to [the relevant risk] to a greater extent than Defendant originally indicated.

Id. at *30.  The FDA being “fully informed,” as required by Albrecht’s “clear evidence” analysis, necessarily precluded the existence of “newly acquired information” that would support a CBE submission.  Id. at *30-31 (facts surrounding FDA review of Fosamax “impl[y] no new risks or correlations of which the FDA was not already aware”) (citations omitted).  That a clear evidence finding precludes “newly acquired information” is logical because the same FDA scientific standards apply to both.  “[T]he FDA’s review of Defendant’s CBE amendment would not have been any less rigorous than its review of Defendant’s PAS” (prior approval supplement).  Id. at *32.

Eighth, submission of a “futile” CBE supplement is not a prerequisite to preemption under Albrecht.

[A manufacturer] need not do so [“submit a CBE amendment, regardless of futility”] merely to preserve its preemption defense.  A manufacturer is under no obligation to use the CBE process to change the Precautions section of its label for any reason other than reasonable evidence of a causal association.

Fosamax, 2022 WL 855853, at at *32 (citations omitted).  To condition preemption on the filing of questionable CBE submissions with the FDA would be absurd.  “A contrary rule would incentivize manufacturers to submit a CBE amendment regardless of risk magnitude or scientific justification, which would impose an undue burden on the FDA.”  Id.  Encouraging manufacturers to seek baseless warnings is contrary to the FDA’s intent to prevent overwarning, as recognized in Albrecht.

[T]he FDA does not approve CBE amendments simply out of an abundance of caution, as Plaintiffs seem to suggest.  The Agency regulates drug labels for precisely the opposite reason: so as not to cause meaningful risk information to lose its significance. . . .  Indeed, while it is important for a manufacturer to warn of potential side effects, it is equally important that it not overwarn because overwarning can deter potentially beneficial uses of the drug by making it seem riskier than warranted and can dilute the effectiveness of valid warnings. . . .  Accordingly, Defendant could not have met the relevant CBE criteria had it submitted a Precautions warning through that regulation after the FDA rejected its PAS.

Id. (citations and quotation marks omitted).

Thus, the entire MDL (consisting only of warning-based claims at this point) was dismissed as preempted.  Fosamax is every bit as much of a preemption tour de force as was In re Zofran (Ondansetron) Products Liability Litigation, 541 F. Supp.3d 164 (D. Mass. 2021), which was our top-ranked trial court-level decision of 2021.  Fosamax is chock full of favorable preemption reasoning, so we recommend that all our readers who are involved in prescription drug preemption litigation sit down and read (or have an associate analyze) the whole thing.  It’s that good.

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Today we report on Thornton v. Tyson Foods, Inc., — F.4th —-, 2022 WL 727628 (10th Cir. 2022)—a favorable express-preemption decision under the Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601–695, that is directly applicable to medical-device cases. Although decided under a different statute, Thornton makes clear that the FDCA bars state-law claims challenging labeling statements approved by the FDA through the premarket approval process—even if those statements are allegedly false and the relevant state prohibits “misbranding.”

The plaintiffs in Thornton sued several meat manufacturers, alleging that they falsely labeled their beef products as “Products of the USA” when those products were in fact made from cattle raised and sometimes even slaughtered abroad. According to the plaintiffs, the purportedly false labels violated New Mexico’s consumer-protection law.

The Tenth Circuit held that the plaintiffs’ claims were expressly preempted by 21 U.S.C. § 678, which—in language akin to that used in 21 U.S.C. § 360(k)(a) with respect to medical devices—prohibits states from imposing meat-labeling requirements that “are in addition to, or different than those” imposed by federal law.

Because the FMIA requires that the Department of Agriculture approve the labels affixed to meat products much as the FDCA requires that the FDA approve the labeling that accompanies medical devices with premarket approval, and because the FMIA and FDCA’s respective preemption provisions are indistinguishable in relevant part, what the Tenth Circuit concluded with respect to claims challenging meat labels applies equally to claims challenging device labels.

Under the FDCA, the manufacturer of a medical device that requires premarket approval must obtain FDA approval of the device’s labeling, and the FDA may approve proposed labeling only if it “is neither false nor misleading.” 21 U.S.C. § 360e(d)(1)(A). So too with respect to meat labeling under the FMIA, which bars the sale of meat products unless their labeling has been approved by the Department of Agriculture, which approves only those labels that it determines are “not false or misleading.” 21 U.S.C. § 607(d).

As already noted, the Thornton plaintiffs claimed that the defendant beef manufacturers violated New Mexico’s state consumer-protection law by falsely labeling their products “Products of the USA” despite being made from cattle raised and sometimes slaughtered abroad. The problem for plaintiffs was that the Department of Agriculture had approved those labels pursuant to a guidance document under which a product’s label “may bear the phrase ‘Product of the U.S.A.’ if the product is processed in the U.S.” Thornton, 2022 WL 727628, at *2 (cleaned up). Because the Department’s approval of a label under the FMIA is a determination that the label “is not false or misleading” (id. quoting Cohen v. ConAgra Brands, Inc., 16 F.4th 1283, 1288 (9th Cir. 2021)), any state-law claim that the label is misleading would necessarily rest on “a requirement different from” the federal requirements and is therefore expressly preempted by § 678’s prohibition of state-law meat-labeling requirements that “are in addition to, or different than those” imposed by federal law. Id. at *4.

Echoing an argument that we see in medical-device litigation, the Thornton plaintiffs insisted that their false labeling claims did not rest on a state-law requirement different from the federal requirements—and thus were not preempted—because New Mexico law, like federal law, prohibits misbranding and a meat product is misbranded under both New Mexico and federal law if its labeling is “false or misleading in any particular.” 21 U.S.C. § 601(n)(1). The Tenth Circuit rightly rejected the argument, explaining that because the Department of Agriculture “has already determined that defendants’ labels are not deceptive or misleading under federal law,” the “defendants’ products are,” as a matter of federal law, “not misbranded” and any state-law determination to the contrary is preempted. 2022 WL 727628, at *5.

This point needs to be emphasized whenever plaintiffs in a medical-device case argue that their claims escape preemption under 21 U.S.C. § 360k(a) because the device’s purported labeling defect renders the device misbranded. That argument—the argument that state-law claims do not impose requirements different from, or in addition to, the requirements imposed by federal law because both state and federal law prohibit misbranding—proceeds at too high a level of generality. Yes, both state and federal law prohibit misbranding, but if the FDA has approved a device’s labeling through the premarket approval process, that labeling cannot be challenged under state law, even if it might otherwise be deemed false or misleading.

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Back by popular demand, here is the mesh case of the week: Clowe v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 46387 (N.D. Texas March 16, 2022). There is a bit of same-old-same-old in this case, but there is also something new.

Let’s start by getting through the same-old. The plaintiffs (the wife suffered the injury and the husband sued for loss of consortium) had abandoned many of their claims, including manufacturing defect, warranties, consumer protection, and unjust enrichment. What remained was the usual duet of design defect and failure to warn. The Clowe court confronted the (again usual) issue of whether the plaintiff side was proposing a safer alternative design, which Texas law requires for a design defect claim, or was actually proposing an entirely different product, which would mean the design defect claim could go no further. As the Clowe court observed, “Under Texas law, Plaintiffs must propose a safe and feasible alternative design to the alleged defective design, not different procedures or strategies entirely.” Think of the difference between a motorcyclist suing over injuries sustained in an accident. If the plaintiff says that the motorcycle should have had a better steering system, there might be a case. But if the plaintiff says the injuries would have been avoided if the motorcycle had instead been a car, that’s an entirely different product, not a safer version of the product at issue. With the latter scenario, the design defect claim goes bye-bye.

In Clowe, the plaintiff’s expert proposed four alternative ways of addressing the plaintiff’s pelvic problems. One involved an entirely different sort of surgery, called the Burch procedure, and the Clowe court held that such surgical procedure was not an alternative product. But the Clowe court held that there was a factual issue as to whether the three other proposed alternatives, which employed different materials, were safer alternative products We know from our own involvement in mesh litigation that the proposed safer alternatives are neither safer nor feasible alternatives, so we think the Clowe judge afforded the plaintiff and her experts too much leeway. Be that as it may, the design defect claim is headed toward the jury, even though it probably shouldn’t. In our view, this part of the Clowe opinion is rather disappointing.

But the Clowe court’s handling of the failure to warn claim meets with DDL blog approval. The core issue turned on warning causation under the learned intermediary rule. The prescribing physician testified that he was already aware of all the relevant risks. A warning that included everything the plaintiff lawyers wanted would have made no difference. The prescribing physician “testified with unmistakable clarity that even if [the] IFU contained a more detailed explanation of risks, he would still have recommended using the [mesh] device to treat Clowe.” The plaintiff lawyers had managed to extract some testimony from the prescriber that he would have read with interest any additional information about the mesh product’s complication rates. This ploy often works at doctor depositions. What doctor is going to disclaim any curiosity about additional information? But the plaintiff side had not met its burden of proving that the additional information would have altered the prescribing decision. No difference means no failure to warn claim. The defense won summary judgment.

Now we get to the new, interesting issue in the Clowe case. The Clowe court presented an unusually thorough discussion reaching the pro-defense position that loss of consortium is not available when the plaintiff and her spouse were not married at the time of the alleged injury. The Texas Supreme Court has not yet addressed this issue, so the Clowe court needed to make an “Erie guess.” To the extent that Texas courts, or courts discussing Texas law, discussed loss of consortium claims, they consistently said that a loss of consortium claim arises from intentional or negligent conduct “toward the marital relationship.” Meanwhile, courts from other jurisdictions have generally “denied recovery for loss of consortium where the injury occurs before marriage.” Armed with these precedents, the Clowe court predicted that “the Texas Supreme Court, more likely than not, would preclude a loss of consortium claim when the alleged injury predated the marriage.” Thus, even though the plaintiff in Clowe alleged that they “maintained an intimate relationship before the injury occurred [and] the injuries [Clowe] suffered as a result of the surgeries still interfere with their relationship,” the Clowe court dismissed the loss of consortium claim because the injuries antedated the date of marriage. We here at the DDL blog doubt we’ve ever covered that permutation before. Given the thorough discussion of pertinent case law in Clowe, if we (or our readers) ever do encounter this fact pattern, starting with Clowe will save our clients some time and money.The fact that pelvic mesh cases can still teach us something is both surprising and oddly invigorating.

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These days, you are probably expecting a vaccine post to be about Covid.  And while we are sure we are not done with litigation in that field, for today at least we thought we would harken back to a good, old-fashioned, garden variety vaccine products liability case and some tried and true preemption.

The plaintiff in Herlth v. Merck & Co., Inc., 2022 WL 788669 (D. Conn. Mar. 15, 2022), was 15 years old in 2013 when her mother consented to plaintiff receiving the Gardasil vaccine.  Plaintiff alleges generally fine health before the first dosage, but she began experiencing dizziness, elevated heart rate, and other symptoms after her second dosage and never received the third dosage.  Id. at *1.  Plaintiff’s grouping of symptoms has been diagnosed as Postural Orthostatic Tachycardia Syndrome (POTS) and chronic fatigue syndrome (CFS).  POTS is a condition that affects the body’s ability to adjust heartrate, especially when moving from a lying to a standing position.  Id. at *2.  Before brining the current suit, plaintiff filed a petition under the Vaccine Act, 42 U.S.C. § 300aa-10 et seq. in Federal Claims court, as is required by the Act.  That claim was dismissed for “insufficient proof.”  Id.  Her current lawsuit brought claims under the Connecticut Product Liability Act (CPLA) and for common law fraud.  Subsumed under the CPLA claim were claims for failure to warn, manufacturing defect, and negligence.  All plaintiff’s claims were either preempted or failed TwIqbal.

The analysis for failure to warn involving a vaccine is the same as for a prescription drug.  The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval.  But a vaccine’s label can be changed unilaterally by the manufacturer under the “changes being effected” (CBE) regulation to reflect “newly acquired information” concerning warnings and adverse reactions, among other things.  Id. at *3.  Therefore, plaintiff’s failure to warn claim is preempted unless “she has pleaded a labeling deficiency that [defendant] cold have unilaterally changed in accordance with the requirements of the CBE regulation.”  Id.

The first part of the preemption analysis, therefore, is whether plaintiff has alleged any new information regarding the type of injury she alleges she sustained that post-dates the FDA’s approval of the vaccine in 2006 and pre-dates plaintiff’s use of the drug in 2013 – after all it is not enough for there to be new information, the alleged failure to warn must also be alleged to be a cause of plaintiff’s injury.  Id. at *4.  In examining the complaint, the court found it “replete” with allegations about potential risks of the vaccine but that “most bear no relation to [plaintiff’s] alleged injuries.”  Id.  With respect to POTS, plaintiff cited to several journal and news articles, many of which were from years after plaintiff took the vaccine.  When the court took a closer look at those from the relevant time period,

some describe no more than a theoretical relationship between Gardasil and POTS, while others consist of case reports from individual patients. Several do not specifically relate to POTS or her other injuries, and others do not appear to specifically relate to the Gardasil vaccine.

Id.  Plaintiff had not pleaded newly acquired information containing “reasonable evidence” of a causal association between the vaccine and her alleged injuries and therefore, her failure to warn claim was preempted.

Plaintiff tried to dodge this pleading deficiency by arguing that in Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019), the Supreme Court clarified that preemption was an affirmative defense and therefore the burden is on the defendant to show the non-existence of newly acquired information.  Id. at *5.  What Albrecht actually clarified was the standard for showing “clear evidence” that the FDA would not have approved plaintiff’s proposed labeling change – part two of the preemption analysis should plaintiff establish the existence of newly acquired information in part one.  In Albrecht, part one had been conceded.  The Court made no findings regarding the pleadings requirements where part one is most definitely in dispute, like in this case.

Plaintiff’s second attempt to skirt preemption was to argue that because the Vaccine Act expressly preempts design defect claims against vaccine manufacturers, Congress “impliedly” decided not to preempt failure to warn claims.  Id.  But the court could find no basis to “infer” that when Congress made it “harder to sue a vaccine maker for design defect that it must have intended to open the floodgates to suing vaccine makers for a failure to warn.”  Id.  Conflict preemption often co-exists with express preemption.

While plaintiff tried to allege a manufacturing defect, she did not allege that the vaccine she received deviated from the standard vaccine.  Rather, plaintiff alleged that the vaccine contained ingredients or toxins that were not disclosed – but those allegations were as to the vaccine generally, not as to any flaw in the manufacturing process.  What she was really alleging was a “design defect claim dressed up as a manufacturing defect claim.”  Id.at *6.

Next, plaintiff’s complaint “lumped” together a number of “disparate theories” under the “general header of ‘negligence.’”  Id.  Most the court found dismissed by it its rulings on failure to warn, manufacturing and design defect.  What remained were claims for fraud and misrepresentation.  Plaintiff alleged both fraud to consumers via direct-to-consumer advertising and fraud to medical providers – but both failed to satisfy Rule 9’s heightened pleading requirements.

To the extent any fraud claims were based on “incomplete warnings,” they were dismissed on the same grounds as failure to warn.  As to marketing or DTC claims, plaintiffs could only identify one advertising campaign that ran before plaintiff took the vaccine.  Plaintiff claims the ads discussed the efficacy of the vaccine in preventing cervical cancer but makes contradictory allegations about whether the ads also disclosed side effects.  Id. at *8.  Regardless, plaintiff

does not allege any specific statements in the ad that were made with knowing falsity. Instead, what she describes is a perfectly ordinary advertisement, highlighting a product’s strengths while deemphasizing its weaknesses. Without more specificity, the complaint does not demonstrate with particularity or plausibility that the ad was either false or misleading.

Id.  Moreover, for fraud claims, Second Circuit law requires plaintiff “allege facts that give rise to a strong inference of fraudulent intent.”  Id. at *7.  Further, that intent cannot be based on a “general profit motive” common to all companies.  Id.  Plaintiff made only conclusory allegations about profit motive, so her fraud claims failed on this basis as well.  Id. at *8.

With respect to fraud directed to medical providers, plaintiff’s claims were even more vague.  While it mentions marketing and presentations made to doctors, the complaint “does not specifically allege how any of these marketing efforts reached [plaintiff’s] pediatrician.”  Id. at *9.  So, this claim fails for lack of a causal connection to plaintiff’s injuries.

Plaintiff also made a fraud-on-the-FDA claim which failed to meet Rule 9’s pleading requirements – but more importantly is preempted by Buckman.  Id.

That left plaintiff’s negligent misrepresentation claim which was “nearly indistinguishable” from her fraud claims – and therefore suffered the same fate.  Id. at *10.

Finally, plaintiff alleged a separate cause of action for common law fraud, but the court found the only claim available in Connecticut for products liability is the CPLA.  Id.

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As we mentioned in last year’s comprehensive “Survival of the Vaxxest” blogpost on the constitutionality (for over a century) of governmental vaccine mandates, there is no appellate precedent requiring any sort of religious exemption to such mandates.  Freedom of religion does not mean freedom to infect everyone else.

While some jurisdictions allow exceptions to mandatory vaccination for “religious” reasons, that’s a matter of grace, not any sort of constitutional requirement.  No appellate court has ever required such an exemption, and that has been litigated a lot.

Here are the Supreme Court decisions on point.  Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) (affirming the constitutionality of criminal enforcement of a vaccine mandate that had no religious exemption; no religion-specific argument raised); Prince v. Massachusetts, 321 U.S. 158, 166-67 (1944) (“The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.”); Employment Div., Dept. of Human Resources of Oregon v. Smith, 494 U.S. 872, 888-89 (1990) (“compulsory vaccination laws” not subject to “strict scrutiny” through “[t]he First Amendment’s protection of religious liberty”).

Today we report on more developments along those lines, from New York – which learned the hard way a few years ago from a measles outbreak caused by anti-vaxxers misusing religious exemptions, and thus abolished religious exemptions altogether.  First, the Supreme Court has now repeatedly rejected attempts to enjoin New York’s governmental vaccine mandates.  See Keil v. New York, NY, 2022 WL 660611 (U.S. March 7, 2022); We the Patriots USA Inc. v. Hochul, 142 S. Ct. 734 (2021); Dr. A v. Hochul, 142 S. Ct. 552 (2021).  That means that all New York City and State employees will now be treated equally by their vaccine mandate, and that nobody can claim religion as a basis for seeking special treatment not available to the rest of us.

The Supreme Court’s most recent denial came in an appeal of Keil v. City of New York, 2022 WL 619694 (2d Cir. March 3, 2022):

We further hold that the district court properly determined, in applying rational basis review, that there were “no facts before it on which it could conclude that the Citywide Panel’s process was irrational in any way or infected with hostility to religion.”

Id. at *4.  Kiel only made the rubble bounce, given the Second Circuit’s previous decisions in We the Patriots USA, Inc. v. Hochul, 17 F.4th 266 (2d Cir. 2021).

In contrast, [the vaccine mandate] requires all covered employees who can safely receive the vaccine to be vaccinated.  It applies whether an employee is eager to be vaccinated or strongly opposed, and it applies whether an employee’s opposition or reluctance is due to philosophical or political objections to vaccine requirements, concerns about the vaccine’s efficacy or potential side effects, or religious beliefs.  The absence of a religious exception to a law does not, on its own, establish non-neutrality such that a religious exception is constitutionally required.

Id. at 282.

Another recent vaccine mandate decision out of New York is Dr. A. v. Hochul, ___ F. Supp.3d ___, 2022 WL 548260 (N.D.N.Y. Feb. 23, 2022), which is essentially a remand from We the Patriots.  This latest opinion is particularly interesting to us because the anti-vax plaintiffs seized upon one of our favorite tools – FDCA-based preemption – in an attempt to stop the Empire State’s vaccine mandate.  They failed.

The unsuccessful preemption claim in Dr. A sought to use the federal COVID-19 regulation implementing the federal government’s vaccine mandate on medical personnel (something we discussed towards the end of our post, here) offensively against New York State’s vaccine mandate.  That regulation “requires healthcare facilities that participate in the federal Medicare and Medicaid programs to ensure that their covered staff are fully vaccinated against COVID-19.”  2022 WL 548260, at *3 (citation omitted).  The straw these plaintiffs grasped was that part of the federal regulation “recogniz[ing] that ‘in some circumstances, employers may be required by law to offer accommodations for some individual staff members.’”  Id. at *4 (quoting 86 Fed. Reg. 61555, 61572 (HHS Nov. 5, 2021)).  Because the federal mandate contemplated exemptions in a general sense, the Dr. A plaintiffs argued that it required granting their exemptions in this particular instance.  Id.

Didn’t work.  Plaintiffs’ biggest problem was that the regulation’s preemption provision established a floor, not a ceiling for state-law vaccine mandates:

The CMS Mandate states that it is intended to “preempt[] State and local laws to the extent the State and local laws conflict with this rule.”  86 Fed. Reg. at 61613.  However, this preemption provision is limited to “any State or local law providing for exemptions to the extent such law provides broader grounds for exemptions than provided for by Federal law.”

2022 WL 548260, at *4.  Their second biggest problem was that, because they had to argue implied preemption (given the “floor” nature of regulation’s express preemption), they faced the presumption against preemption, which still exists in at least some implied preemption cases.  Id.

Thus, the Dr. A plaintiffs got nowhere with their preemption claim.

To be sure, plaintiffs are correct that the CMS Mandate speaks in terms of both “accommodation” and “exemption.” . . . But these features of the CMS Mandate and its accompanying litigation fall far short of establishing a likelihood of success on the merits of a conflict preemption claim. . . .  Although the Supreme Court . . . made reference to the fact that the CMS Mandate includes “exemption” language, the Court did not consider the question of religious accommodation at all.  Absent a direct ruling on that particular legal issue, the Second Circuit’s pre-existing conclusion; i.e., that [the federal mandate] “does not require employers to violate Title VII” despite forbidding “exemptions,” must still control.

Id. (citations omitted).

The general statement in the federal vaccine mandate that various exemptions “may” apply did not create any entitlement to an exemption for these (or any other) particular plaintiffs.  All that regulation required was that state mandates comply with Title VII of the Civil Rights Act – the “existing federal law” referenced in the regulation.  Id. at *5.

Nowhere does the text of the CMS Mandate express a requirement that an employee with a sincere religious objection be provided an exemption instead of some other accommodation, whether under Title VII or any other federal anti-discrimination law.

Id.  Further, even if the regulation provided some sort of “remedy,” that remedy was to pursue a Title VII claim, which not one of these sixteen plaintiffs had ever done.  Id. (“the remedy for that harm would most likely be found in filing a properly exhausted Title VII claim”).

Finally, plaintiffs’ attempt to rely directly on the Free Exercise Clause failed because, as we – and more importantly the Supreme Court – have previously stated, the constitution does not require religious exemptions to vaccine mandates.

[E]ven assuming one or more plaintiffs were actually denied unemployment insurance based on their refusal to be vaccinated . . ., the burden would then fall on plaintiffs to demonstrate that the State singled out religious objectors (as opposed to those who might have refused vaccination on other grounds) to satisfy [the Supreme Court’s] “valid and neutral law of general applicability” test.

Id. at *6 (emphasis original).  But as we pointed out at the beginning of this post, the New York mandate was completely neutral.  It didn’t allow any religious or other philosophical exemption at all, much less “singling out” religious anti-vaxxers for disparate treatment.

We noticed a footnote in Dr. A that one of the original plaintiffs dropped out when s/he moved to another state after being fired for refusing to comply with the mandate.  2022 WL 548260, at *1 n.1.  If the rest of these plaintiffs feel so strongly, they should do the same.  And conversely, the State of New York (and other pro-vaccination states) should encourage medical personnel of the opposite persuasion – those looking for sane governmental COVID-19 policies, largely vaccinated patient and co-worker populations, higher wages, and better benefits – to move to New York from other states.

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This post is from the non-Winston & Strawn side of the blog.

As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before.  We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see Hugh Jackman and Sutton Foster in The Music Man on Broadway.  Jackman is the Dowager’s idol, and we fear we are reaching the end of such outings, so a tinge of pathos colors this much-anticipated excursion.  All that aside, The Music Man is a weird show.  It is about a con artist who sells innocent townspeople a bill of goods for something he never intends to deliver.  But love and morality (and the magic of musical theatre) triumph, and that which never was suddenly is.

No such magic resurrects plaintiff’s claims in today’s case.  Reddick v. Medtronic, Inc., 2022 WL 715494 (5th Cir. Mar. 9, 2022) an unreported decision out of the Fifth Circuit, is the affirmance of a trial court case that made both our PMI Preemption Scorecard and our Twiqbal cheat sheet.  In Reddick, the plaintiff was implanted with a total of five medical devices – a defibrillator and associated devices, all manufactured by the defendant – to treat his heart (not musical) rhythm disorder (which he was later found not to have at all).  Three of the devices were Class III devices, which meant that they underwent the FDA’s full premarket approval (PMA) process.  It also meant that common-law product liability claims related to those three devices were subject to Riegel’s express preemption analysis.  The other devices were Class I or Class II devices, cleared for marketing without the full PMA process (the class II devices were subject to the 510(k) clearance process), and, under Lohr, the MDA’s express preemption provisions did not apply to them.

The plaintiff filed suit in Louisiana state court, and the defendant removed the case to the Eastern District of Louisiana.  The plaintiff alleged that his devices began malfunctioning about four years after they were implanted and continued to malfunction until they were removed.  He asserted four claims under the Louisiana Products Liability Act (“LPLA)”—defective construction, defective design, failure to warn, and breach of express warranty.  He also alleged that the defendant had breached its contract with him.  The trial court dismissed the LPLA claims that targeted the Class III devices, holding that they were preempted under the MDA, and granted 12(b)(6) dismissals of the LPLA claims addressed to the Class I and II devices.  Separately, the court granted summary judgment on the contract issue, holding that there was no contract between the parties.  The plaintiff appealed, resulting in today’s decision.

LPLA Claims:  Class III Devices   

The plaintiff argued that his LPLA claims were not preempted as to the Class III devices.  As the court explained, Riegel requires a two-pronged analysis to determine whether claims are expressly preempted by the MDA:  first, the court must determine “whether the federal government has established requirements applicable to [the medical device].”  Reddick, 2022 WL 715494 at *2 (internal punctuation and citation omitted.)  Class III devices subject to PMA “automatically” satisfy the first prong.”  Id.  Second, the court evaluates whether the claims are “parallel” claims that escape preemption.  “A state law claim is ‘parallel’ if it provides a damages remedy premised on a violation of FDA regulations.”  Id. at *2 (internal punctuation and citations omitted).  The court emphasized that, even if a plaintiff has asserted a ‘parallel’ claim, a district court may dismiss the claim if it is “impermissibly conclusory and vague.”  Id. at *3 (citation omitted).

The court held that the plaintiff’s four LPLA claims, as addressed to the Class III devices, were not adequately-pled “parallel” claims because all were “impermissibly conclusory and vague.”  Id.  In his defective design and defective construction claims, the plaintiff alleged only that the devices were defective “upon information and belief,” without providing factual support.  While he alleged that some of the devices were subject to recalls, he did not plead that his particular devices were subject to the recalls or that the recalls were related to the particular adverse events he experienced.  He also cited evidence of a new recall and alleged that this recall supported his claims, but the court held that it could not consider evidence that was not before the district court when it made its decision.

The court held that the plaintiff similarly failed to provide sufficient factual support to save his failure-to-warn claim.  He alleged only the defendant dis not warn him “regarding [its] unreasonably dangerous and defective products,” but he did not identify any FDA-approved warnings or allege that the defendant departed from them.  Id. at *4.

Finally, the court agreed with the district court that the warranty claim was preempted.  Under the LPLA, a claim of breach of warranty must be pled with particularity.  While the plaintiff asserted that the defendant breached an oral “lifetime warranty” on the defibrillator and a separate warranty on one component, he did not “reproduce any specific warranty in his pleadings or specify its precise source, and he did not allege that he was induced to use [the] devices” by any warranties.  The court concluded, “. . . [W]e agree with the district court that all four of [the plaintiff’s] LPLA claims are too conclusory to state a parallel claim that avoids” express preemption.  Id.

 Thus, plaintiff was in big trouble – that starts with “T,” rhymes with “P,” and stands for “preempted” (h/t Bexis!).

 LPLA Claims:  Class I and II Devices

The court next turned to the district court’s 12(b)(6) TwIqbal dismissals of the plaintiffs LPLA claims addressed to the Class I and II devices.  The court explained that “[a] successful action under the LPLA requires four elements: (1) that the defendant is a manufacturer of the product; (2) that the claimant’s damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product ‘unreasonably dangerous’; and (4) that the claimant’s damage arose from a reasonably anticipated use of the product by the claimant or someone else. Under the third element, a product may be ‘unreasonably dangerous’ under any one of LPLA’s four liability theories.”  Id. 

 As to the Class I and II devices, the plaintiff alleged only defective design.  But, under Louisiana law, a product is defectively designed only if “at the time the product left its manufacturer’s control, there existed an alternative design for the product that was capable of preventing the claimant’s damage, and the likelihood that the product’s design would cause the claimant’s damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product.”  Id. (internal punctuation and citations omitted).  The plaintiff did not plead that there was a safer, feasible alternative design for any of the Class I and II devices at the time they left the defendant’s control.  There was a paragraph in the complaint headed “Facts and Alternative Design,” but that paragraph asserted that a more “conservative” external heart monitor should have been used instead of the implantable defibrillator.  As the court explained, that “concern[ed] the choice of treatment made by [the plaintiff’s] medical team, not a design decision by [the defendant].”  As such, the court held, the plaintiff had not pled the elements of his “defective design” claims, and the district court’s dismissal was proper.

Breach of Contract

Finally, the court turned to the plaintiff’s breach of contract claim.  The court agreed with the district court that the record contained no written agreement between the plaintiff and the defendant, and that the plaintiff was not a third-party beneficiary of the defendant’s contracts with the hospital where the implant procedure was performed.  Nor was there an oral agreement.  The plaintiff argued that an oral contract was formed when he read the defendant’s web site, which promised continuous service support for the devices.  Not so, according to the court:  formation of a contract under Louisiana law requires a “meeting of the minds,” and the plaintiff cited no evidence suggesting that the defendant intended to be bound by any agreement with the plaintiffs.  The court concluded, “That dooms [the plaintiff’s] claim.  With no contract, there was no breach.”  Id. at *5.

And there you have it.  No fanfare, no brass band – just a pointed and tidy affirmance of a correct decision.   We’ll talk to you soon and tell you all about the show.  In the meantime, stay safe out there.

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Litigation tourist plaintiffs have been taking it on the chin lately when it comes to personal jurisdiction.  Here’s another example.  Durham v. LG Chem, Ltd., 2022 WL 274498 (11th Cir. Jan. 31, 2022), is not a drug and device case and not precedential (note: the Fed. Appx. reporter is no more), but is nonetheless notable because it considers and rejects the other side’s latest (but hardly greatest) jurisdictional arguments.

Durham involved an allegedly exploding lithium battery that had been used in an e-cigarette.  Plaintiffs have been attempting to make a mass tort out of this fact pattern, but generally failing – at least against battery makers – due to the batteries having been included in the e-cigarettes by unrelated third parties, such as vape shops.  In Durham, litigation tourist plaintiffs, from Missouri, Ohio, Arizona, and Pennsylvania, brought suit in Georgia where the overseas defendant’s American subsidiary was located.  Id. at *1.

After a couple of other plaintiffs lost jurisdictional motions, these plaintiffs wanted either to hightail it to their “home districts” or else rely on a “new” jurisdictional theory – that that the district court’s jurisdiction over foreign parties was broader than that of a Georgia court” because it could consider the overseas defendant’s “contacts with the United States as a whole.”  Id.  The district court not only refused any transfer, since the plaintiffs had chosen their forum and were now stuck with it, but also flatly rejected these plaintiffs’ novel nationwide contacts jurisdictional theory.

That’s why we’re discussing it.  Somebody on the other side is putting in time and effort to invent these novel theories for mass tort litigation, so we expect our side will see this one again.  Be ready.

Plaintiffs appealed to the Eleventh Circuit – and lost again.

Only the novel jurisdictional theory was on appeal, since plaintiffs abandoned their transfer request.  Plaintiffs’ argument was based on a supposed difference between the “Due Process guarantee” of the Fifth Amendment, governing federal law, versus the Fourteenth Amendment governing the states.  Id.  We blogged about that, here several years ago, finding overwhelming precedent supporting the proposition that, as long as plaintiffs were asserting state-law causes of action under diversity jurisdiction, the relevant Due Process clause was found in the Fourteenth Amendment.

Nonetheless, with their other personal jurisdictional arguments failing right and left, plaintiffs keep trying.  Durham suggests that they may (at least against overseas defendants) start pushing some made-up difference between the two amendments’ identical Due Process language.

Durham began its analysis with Fed. R. Civ. P. 4, because “[p]ersonal jurisdiction starts with service of process.”  2022 WL 274498, at *2 (citation omitted).  Under Rule 4 (as we had discussed in our prior post) only federal causes of action where Congress has expressly authorized nationwide service of process involve a nationwide contacts analysis.  “Under Rule 4(k)(2), service of process can establish personal jurisdiction over a defendant that ‘is not subject to jurisdiction in any state[],’ but only ‘[f]or a claim that arises under federal law.’”  Id.  Thus, the overseas defendant here was not served under any federal statute, but rather under the Hague Convention.  Plaintiffs’ Hague detour failed.

But the Convention does not authorize nationwide service − it is merely a mechanism for serving parties outside the United States in partnering countries.  Accordingly, the Hague Convention does not give a district court personal jurisdiction over a party notwithstanding its lack of contacts with the forum state.

Id. (citations omitted).

Since personal jurisdiction in diversity cases like the Durham plaintiffs brought is based on state law, so is personal jurisdiction analysis.  “When personal jurisdiction is premised on the forum state’s long-arm statute, the relevant due process concerns emanate from the Fourteenth Amendment, and courts consider the party’s contacts with the forum state.”  Id. (citations omitted).  That the Supreme Court had purportedly dropped “hints” based on its reluctance to resolve Fifth Amendment issues in Fourteenth Amendment Due process cases, id. at *3, didn’t mean a thing.

These unresolved questions are irrelevant to this appeal.  It is true that the Supreme Court has been careful not to conflate the due process requirements of the Fifth and Fourteenth Amendments.  But, here, there is no question that the relevant amendment is the Fourteenth and the relevant forum is Georgia.  Thus, we have no occasion to consider whether an analysis under the Fifth Amendment would lead to a different result.

Id.

The way we – and the court in Durham – look at things, unless and until Congress enacts a statute providing for nationwide service of process in federal diversity litigation (plaintiffs should not hold their breath), there’s no reason to entertain any Fifth Amendment-based personal jurisdiction arguments in any case where federal subject matter jurisdiction is based on diversity of citizenship.  Thus, to the extent that future tort plaintiffs grasp at the straw of Fifth Amendment personal jurisdiction, that argument doesn’t get to first base, since its fundamental premise is fatally flawed.  Applicability of the Fifth Amendment does not come about simply by being in a “federal court,” but rather by the assertion of some “federal” basis for the plaintiff’s causes of action.

And even then, as we also discussed in our prior post, there is no reason to believe that the constitution itself (as opposed to a federal statute expanding the scope service of process) treats personal jurisdiction any differently – since the Supreme Court’s Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), decision, heavily relied on a Fifth Amendment case, Walden v. Fiore, 571 U.S. 277 (2014), that involved a plaintiff asserting a purely federal cause of action, that being a Bivens constitutional tort.

So plaintiffs’ novel Fifth Amendment personal jurisdiction argument fails for both procedural (not applicable to diversity cases) and substantive (no difference between Fifth and Fourteenth amendments).  Make a note of it.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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