As 2020 ended, our loyal readers joined us in reviewing our worst decisions of the past year – true superspreaders of litigation against our clients – and our best decisions of the past year, which we termed “tort pandemic countermeasures.”

As we do each year, we’re pleased to announce that four of your bloggers (Bexis, Eric Alexander, Steven Boranian, and Rachel Weil) will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2020” on Thursday, February 4 at 1 p.m. EST to provide further insight and analysis on these cases.

This program is presumptively approved for 1.5 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.

The program is free and open to anyone interested in tuning in, but you do have to sign up in advance, which you can do here.


Albert Einstein supposedly said, “Insanity is doing the same thing over and over again and expecting different results.”  He may not have, but the point is well taken.  We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved (“PMA”) medical devices with vague, boilerplate complaints.  Haven’t they heard about preemption and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)?  Have some lawyers skipped continuing legal education for over a decade?

Which brings us to Naquin v. Medtronic, Inc., 2020 WL 7060150 (E.D. La. Dec. 2, 2020).  The plaintiff sued over an implantable defibrillator that allegedly failed prematurely.  Id. at *1.  The complaint, which attacked no fewer than seven products comprising or related to this Class III, PMA device, id. at *2 & n.11, featured such boilerplate as:  “Upon information and belief [defendant] violated FDA laws and regulations by fraud, recklessness, gross negligence and negligence.”  Id. at *1 n.7 (quoting complaint).  Plaintiff sued under Louisiana’s product liability statute and for breach of contract.  Id. at *2.

Not surprisingly, the defendant raised preemption.  As to each of the plaintiff’s product liability claims, the court in Naquin agreed.  Plaintiff admitted that six of the seven products (or maybe components, the opinion, and probably the complaint, are not very clear) he was suing over had gone through PMA,  Id. at *5.  As to the one remaining device:  (1) plaintiff “does not allege at any point in his complaint that he used [it]”; and (2) “nowhere in the complaint is [that device] alleged to have been defective or caused harm in any specific way.”  Id. at *4 n.24.

To avoid preemption, plaintiffs suing over PMA devices have to allege so-called “parallel” claims asserting an FDCA violation that parallels a traditional state-law tort claim.  Id. at *6 (“After Riegel, parallel state-law claims are the sole survivors of the broad sweep of federal preemption.”).  In the Fifth Circuit where Naquin chose to sue:

A complaint will be insufficient when it fails to “specify the manufacturing defect,” “specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury,” or “tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.”

Id., 2020 WL 7060150 at *6 (quoting Bass v. Stryker Corp., 669 F.3d 501, 509 (5th Cir. 2012)).

Not even close.

“In conclusory fashion, [plaintiff] alleges that his ‘state product liability claims do not create requirements that are different from or greater than the FDA requirements.’”  Id.  How?  Plaintiff couldn’t say.  “He fails to identify any defect in the manufacturing process or any violation of federal regulations that caused his injuries.”  Id.  Instead, plaintiff squawked about “res ipsa loquitur.”  Id.  But res ipsa loquitur “does not ‘tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.’”  Id. (quoting Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011)).  When pressed, plaintiff was forced to “admit” that “[t]he exact cause of the failure is not yet known or determined.”  Id. (footnote omitted).

As for violations, plaintiff offers only more word salad that the defendant “is in violation of FDA regulations because [it] has not been truthful about the products that are the subject of this litigations [sic].”  Id. (quoting plaintiff).  “In another example of [plaintiff’s] conclusory pleading, he alleges that, ‘[defendant] has not been truthful in its advertising, brochures, websites, services, etc.,’ and that “[defendant] has made express warranties that go beyond the FDA approval.’”  Id. (footnote omitted).  That’s actually two examples, but who’s counting?  Boilerplate could not defeat preemption:

Since [plaintiff] has not adequately alleged a parallel state-law claim that [defendant] violated a federal regulation and such violation caused his injuries, he does not have a claim against [defendant] as a manufacturer of medical devices that is not preempted by federal law.

Id., 2020 WL 7060150 at *6.

But wait – plaintiff also alleged a breach of contract claim that defendant is liable, not as a manufacturer, but “in its capacity as a provider of services.”  Id. at *7.  Okay, maybe that escapes preemption (maybe it requires an expert affidavit under Louisiana law, but that’s not discussed), but once again the complaint is boilerplate.

In order to proceed with this claim, [plaintiff] must amend his complaint to state with specificity the basis of the legal relationship, who is the obligor, what performance was promised, how the contract was breached, and what damages have resulted.

Id., 2020 WL 7060150 at *7.

So how good is that contract claim?  Well, in writing this post we noticed that Westlaw has flagged Naquin as having been appealed.  That indicates that the contract claim, as well, was not worth the paper it was pleaded on, and that plaintiff appealed rather than attempt to amend the complaint.

Here’s another quasi-guest post by Reed Smith’s blogger-in-training Dean Balaes.  This one provides a critique of the scary Park doctrine, aptly described here as “Frankenstein’s Monster,” that allows imposition of criminal liability on corporate officers for illegality they didn’t even know about.


In 1816, Mary Shelley and Lord Byron entered into a wager to see who could create the greatest horror story.  Shelley envisioned a scientist who was determined to create life yet was horrified by what he had made.  The story of Frankenstein’s monster illustrates how even the most well-intentioned moral intuitions dance on the precipice of becoming total abominations.  Enter the Park doctrine—a protean attempt at limitless liability.

Prosecutors tend to make the claim that the problem with corporate social responsibility is that there is not enough of it.  Those opposing them argue that Park is a legal abomination because an individual can be held liable without prosecutors establishing proof that he or she acted with intent or negligence, and indeed even if such corporate official did not have any actual knowledge at all of, or participation in, the charged offense.  See FDA Regulatory Procedures Manual, section 6-5-3.  The ramifications of such a conviction include substantial monetary fines and exclusion from federal health care programs.  With stakes this high and Constitutional concerns at play, greater limitations should be imposed on Park—namely, a strict constructionist approach.

The Origins of the Park Doctrine

Most commentators trace the roots of Park to a 1943 criminal doctrine espoused in United States v. Dotterweich, 320 U.S. 277, 281 (1943).  In Dotterweich, the government charged Buffalo Pharmacal Company, Inc. and Joseph Dotterweich, its general manager, under strict liability provisions of the FDCA.  Id.  “For some unexplainable reason[,]” the jury did not find the corporation guilty, but only the officer acting on its behalf, even though no evidence of the officer’s guilt was presented.  United States v. Buffalo Pharmacal Co., 131 F.2d 500, 501 (2d Cir. 1942).  After reviewing the FDCA’s liability provisions, the Act’s definition of “person,” and congressional intent, the Second Circuit overturned the conviction.  Dotterweich, at 279.  In identifying Buffalo Pharmacal Company, Inc. as the “person” who committed the harm, the Second Circuit understood that only the corporate, non-natural person sold the adulterated and misbranded goods.  Id.

The Supreme Court disagreed and interpreted the statutory definition of “person” to also mean a corporation’s officers.  Dotterweich, at 278.  In disregarding contemporary notions of criminal justice and the corporate form, Dotterweich relied on the public welfare nature of the FDCA to impose a general and heightened duty on officers.  “[T]he only way in which a corporation can act is through the individuals who act on its behalf.”  Id.  Consequently, Dotterweich allowed criminal liability even when there is no proof of an individual’s wrongdoing, reasoning that, if the corporation is found guilty so too must be its employees.  Doubling down on Dotterweich,  United States v. Park relied on Dotterweich’s “responsible relation” test and held that strict liability under the FDCA may be imputed to a corporate officer who “had, by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so.”  421 U.S. 658, 674 (1975); see also United States v. Brittain, 931 F.2d 1413, 1419 (10th Cir. 1991) (stating in dicta that Park may apply to officers even in the absence of mens rea because the “willfulness or negligence of the [subordinate] would be imputed to [the officer] by virtue of his position of responsibility”).

Limiting Park Through Statutory Construction

The Park doctrine inflates the boundaries of statutorily imposed duties applied to corporations that are normally the entities responsible for compliance therewith.  Consequently, instead of the corporation being held responsible for alleged violations, the doctrine extends statutory duties to a new class of defendants not mentioned in the statute:  the “responsible corporate officer.”  Because of this expansion, one should ask whether statutes expressly contemplate responsible corporate officers.

Since 1943 when Dotterweich was handed down, cases have mirrored the approach in Dotterweich to increase statutory liability under a variety of statutes.  See People v. Roscoe, 87 Cal. Rptr. 3d 190 (Cal. App. 2008) (interpreting “[a]ny operator of an underground tank system” to also include an officer “even where the corporation itself is also found to be the operator”); see also United States v. Hodges X-Ray, Inc., 759 F.2d 557, 560-61 (6th Cir. 1985) (relying on the definition of “manufacturer” under the RCHSA as “any person engaged in the business of manufacturing, assembling, or importing of electronic products” and arguing that because the individual defendant was the major shareholder of the company, it was “self-evident” that he was included in the definition).

A strict construction of the California Health and Safety Code in Roscoe, however, would suggest that the statute does not contemplate a legislative intent to permit liability for responsible corporate officers.  87 Cal. Rptr. 3d at 194 (“[S]ection 25299, subdivision(a)(6) does not limit liability to a single operator; rather it imposes liability on ‘[a]ny operator.’”)  Still, the court felt free to expand the definition of “operator” and determined that “[t]his broad language could be read as supporting imposition of liability on both the corporate officer and the corporation when appropriate.”  Id.

The “when appropriate” language is worrisome because it relies on prosecutorial and judicial benevolence.  Prosecutors often cite the aphorism that “ignorance of the law” is no excuse, but how could this be fair when innocent individuals are faced with a doctrine as arbitrary as prosecutorial discretion?  Remember another aphorism:  “a grand jury would indict a ham sandwich, if that’s what the prosecutor wanted.”

In the absence of express statutory language, relying on prosecutorial and judicial restraint is a dicey proposition for well-intentioned (and innocent) individuals hoping to protect their liberty interests.  For this reason, courts should be limited in applying Park to statutes that expressly contemplate responsible corporate officers.  For example, the Clean Water Act states that “[f]or the purpose of this subsection, the term ‘person’ means, in addition to the definition contained in section 1362(5) of this title, any responsible corporate officer.”  33 U.S.C. § 1319(c)(6) (2006).  In Clean Water Act cases, there is an obvious signal to courts (and individuals working in that sector) that the imposition of responsible corporate officer liability is applicable.  Legislatures know how to enact a responsible corporate officer doctrine, if and when they intend to do so.

Without clear boundaries on how Park is applied, continued expansion of the doctrine means a greater expansion of what is a “public welfare offense.”  Prosecutors will maintain that everything can be a public welfare offense and wait for egregious instances where the doctrine can be applied (and expanded).  This expansion strains fiduciary duties imposed on officers under the seminal Caremark decision.  In In re Caremark Int’l Inc. Derivative Litig., 698 A.2d 959, 967, 971 (Del. Ch. 1996), an individual will incur liability for failing to prevent compliance breaches where he or she knowingly failed to discharge fiduciary obligations.  Directors must take steps to insure reporting systems exist in the organization that are designed to provide timely and accurate information so that the board may make informed judgments.  Caremark understands directors must delegate monitoring tasks, and therefore, be protected from reliance on bad acts and insufficient reports by subordinates.

Park disregards this notion.  In Park, the Court emphasized a “positive duty” on “individuals who execute the corporate mission” to “seek out and remedy violations” and “a duty to implement measures that will insure that violations will not occur.”  Park, 421 U.S. at 672.  As a result, under Caremark, an officer may be deemed to be responsible and free from civil liability in the exercise of his or her internal oversight duties, yet at the same time be deemed irresponsible and subject to criminal prosecution under Park, when in both instances the officer did not know or could not have prevented a subordinate’s public welfare offense.


A line from the notorious Yates Memo is salient here because it attempts to justify the Park doctrine in light of Constitutional due process concerns by bemoaning the difficulty of criminalizing individuals:  “In large [institutions] where responsibility can be diffuse and decisions are made at various levels, it can be difficult to determine if someone possessed the knowledge and criminal intent necessary to establish their guilt beyond a reasonable doubt.”  In other words, Park is an end run around the “reasonable doubt” standard itself.  The one-sided applicability of Park responsibility rings hollow when one considers the fact that the same complaint can be made about government agents.  When in law school, this author was struck by a remark from an Assistant United States Attorney who was asked: “What is justice?”  He responded: “Whatever I think is justice.”  In the spirit of fairness, should the shroud of Park be expanded to government actors too?

We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020).  Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.

Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior P-side analysis of Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), we’ve seen.  We do note a significant omission, however.  The phrase “newly acquired information” appears only once in the article, 75 Food & Drug L.J., at 348, and only in passing.  Thus, the article tacitly buys into the other side’s largely rejected position that there is no separate basis for preemption based on this prong of the FDA’s changes being effected (“CBE”) regulation.  However, since the article does not analyze this issue, we won’t either, except to say that courts have just about universally treated lack of “newly acquired information” as an independent basis for preemption, also decided as an issue of law under Albrecht, with the plaintiff having the initial burden of identifying the “information” that allegedly satisfied this requirement.  E.g., Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., ___ F.3d ___, 2021 WL 41897, at *5-6 (4th Cir. Jan. 6, 2021); In re Avandia Marketing., Sales & Products Liability Litigation, 945 F.3d 749, 760 (3d Cir. 2019); Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., 239 A.3d 1175, 1194 n.33 (Conn. 2020); see generally our post here.

Turning to what the Lindenfeld article does discuss, it focuses (p. 355) on the Supreme Court’s explication of the “clear evidence” requirement in Albrecht:  that in cases “like” Wyeth v. Levine, 555 U.S. 555 (2009), a defendant must have evidence “show[ing] that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”  139 S. Ct. at 1678.  Except for one thing. . . .

That thing is the Lindenfeld article’s complete omission of Albrecht’s limitation of this reasoning to cases “like” Levine.  Thus, the article conclusively assumes that all “clear evidence” cases are “like” Levine – which would be OK for a P-side piece, except we object to this being done sub silentio.  Maybe that approach will prevail, but right now, the only on-point precedent is to the contrary.  Cerveny v. Aventis, Inc., 783 Fed. Appx. 804, 808 n.9 (10th Cir. Aug. 9, 2019) (case was not “like” Levine because of third-party regulatory activity that independently caused the FDA to reject the same warning the plaintiff had proposed.  Admittedly, that’s a only footnote in a non-precedential decision, but it’s the only thing so far on this particular point.

The Lindenfeld article parses Albrecht’s language into five parts:  “[(1)] the drug manufacturer [(2)] fully informed the FDA [(3)] of the justifications for the warning required by state law [(4)] and that the FDA, in turn, informed the drug manufacturer [(5)] that the FDA would not approve changing the drug’s label to include that warning,” which it characterizes as “extremely positive” from the plaintiff’s point of view.  75 Food & Drug L.J., at 356.  Since the Blog designated this part of Albrecht our sixth worst case for 2019, we don’t entirely disagree.

The Lindenfeld article’s first proposition is that Albrecht effectively threw out Levine’s requirement of “clear evidence” that the FDA “would have rejected” the label change that any particular plaintiff is advocating – calling “hypothetical preemption” “nearly dead,” and arguing instead that the defendant must “actually” have proposed, and had rejected, the same label change that the plaintiff wanted.  75 Food & Drug L.J. at 356.  That, of course, is akin to saying no “clear evidence” preemption ever – because what plaintiff’s counsel will be so inept not to propose something different than what the FDA is already on record as having nixed?  If the Court in Albrecht had intended there to be no preemption, then it would have said so, and the opinion would have been a lot shorter.  This overstatement ties in, we think, to the article’s prior 86ing of Albrecht’s prefatory “like Levine” limiting language.  A lot of cases aren’t “like” Levine and thus can involve the FDA “informing” manufacturers (including defendants) of rejected warning language even in the absence of a particular entity’s submission.  Two such examples are rejections of citizen’s petitions (what happened in the Cerveny case cited above) and FDA implementation of classwide labeling covering multiple similar drugs in one fell swoop.

Another example is the FDA’s “own” inaction under 21 U.S.C. §355(o), which the Lindenfeld article mentioned earlier (pp. 349-50), but then does not discuss again until much later.  If the FDA was sitting on “new safety information” that would have authorized it under §355(o) to “promptly notify” a defendant manufacturer of the need for a label change and did nothing, then that would seem like a good basis for concluding, in the absence of an actual submission, that the FDA “would have” rejected a label change under the original Levine version of the “clear evidence” test.  There’s no law on this fact pattern yet, and it might not be forthcoming, because the cleanest route to preemption on this set of facts appears to be the “newly acquired information” prong of the CBE regulation, rather than making essentially the same argument based on §355(o).

In any event, the Lindenfeld article’s almost interment of the Levine version of “clear evidence” seems to us, at minimum, to be premature.  “Albrecht is better understood as a clarification of the impossibility standard in [Levine] rather than as a repudiation of it.”  Dolin v. GlaxoSmithKline LLC, 951 F.3d 882, 888 (7th Cir. 2020.

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

Ridings v. Maurice, 444 F. Supp.3d 973, 998 (W.D. Mo. 2020) (emphasis original).  We think there’s life in this part of Levine yet.

The next proposition of the Lindenfeld article is that the preemptive “force” of an FDA rejection of a citizen petition “is uncertain.”  75 Food & Drug L.J. at 357.  That’s true, and always has been.  Some courts have allowed plaintiffs another bite at the apple, even after some plaintiff-side group tried and failed – under identical scientific standards − to get the FDA to make the same label change.  But as the article conceded, id. at 358 & n.117,  several appellate decisions (including the aforementioned Cerveny decision) have not.  That post-Albrecht courts have largely “sided with defendants” is not surprising.  The citizen petition process is a formal one, 21 C.F.R. §10.30, and thus provides the “official administrative record for an FDA decision” that Albrecht finds to be an appropriate basis for preemption.  139 S. Ct. at 1680.

The Lindenfeld article asserts that this view “runs against the plain language of Albrecht” that “it must be the manufacturer who proposes the change.”  75 Food & Drug L.J. at 358 (emphasis original).  But that position ignores both Albrecht’s “plain language” that the Albrecht description of “clear evidence” is applicable only to cases “like” Levine and the facts of Albrecht itself – which involved class labeling.  See In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268, 278 (3d Cir. 2017) (in 2010, “FDA announced that it would require all bisphosphonate manufacturers to add information regarding the risk of atypical femoral fractures”) (emphasis added), vacated, 139 S. Ct. 1668 (2019).  That the Supreme Court in Albrecht remanded, rather than reversed, alone establishes that this assertion is incorrect.  The manufacturer need not have itself proposed the label change for it to be preemptive.

The Lindenfeld article next addresses the language in Albrecht about defendants “fully infom[ing]” the FDA.  75 Food & Drug L.J. at 359-61.  The article recognizes that “a number of courts have held that Buckman [v. Plaintiffs Legal Committee, 531 U.S. 341 (2001),] precludes, at the clear evidence stage, inquiries into sufficiency of a manufacturer’s submissions to FDA.”  75 Food & Drug L.J. at 360 (footnote omitted).  This is, frankly, the hardest part of Albrecht to reconcile, since neither the majority nor the concurrence ever cite Buckman.  The article takes the position that “it is abundantly clear that plaintiffs emerged from the high Court triumphant on this issue” and that “plaintiffs who believe that defendants were less than forthright with FDA” are free to ignore Buckman’s preemptive effect.  75 Food & Drug L.J. at 360-61.

We don’t think so, and so far, neither have the courts.  Albrecht does not give plaintiffs free reign to discard prior FDA rejections of their positions.  After Albrecht “the FDA, and only the FDA, can determine what information is ‘material’ to its own decision to approve or reject a labeling change.”  Avandia, 945 F.3d at 759 (emphasis original).  In our view that goes for both sides.  We think that what this “fully informed” language means is much less than plaintiffs being “triumphant.”  Rather, it means that, where the FDA has rejected a label, it is for the FDA to decide − perhaps by citizen petition, perhaps by other means – whether the information on which it acted was complete.  We have already mentioned that happening in one case.  By contrast, the Lindenfeld article has over 200 footnotes, but none supporting its plaintiffs were “triumphant” statement.  While we believe that the Buckman/Albrecht interface is an open question, plaintiffs haven’t won anything yet.

The next section of the Lindenfeld article is not as controversial.  It is that a defendant seeking preemption must have informed the FDA of the “justifications” for a label change strengthening a warning.  To the extent that preemption doesn’t turn on routine submission of “adverse event reports,” 75 Food & Drug L.J. at 361, we’re not going to disagree.  “[S]tacks” of unanalyzed documents, 362, don’t cut it after Albrecht, if they ever did.  But this aspect of Albrecht is not that important, because it overlaps substantially with the other CBE requirement that there be “newly acquired information” sufficient to support any supplemental label change.  The question of how “fully informed” the FDA was is more properly – particularly given the Buckman issue – decided by answering the question of whether newly acquired information exists.  See, e.g., Gayle v. Pfizer Inc., 452 F. Supp.3d 78, 88 (S.D.N.Y. 2020) (“adverse event reports, without any analysis indicating causality, cannot constitute ‘newly acquired information’”).  The preliminary CBE requirement of newly acquired information is where we see issues of adequate factual basis for a label change being hammered out – not “clear evidence.”

Finally, Albrecht requires sufficient FDA “communicat[ion]” of any denial.  Here is where we are constrained to agree with the Lindenfeld article.  Loosy-goosy preemption arguments based on informal FDA statements, or telephone calls, aren’t likely to succeed after Albrecht.  Not that this kind of argument had great success before.  E.g., Reid v. Johnson & Johnson, 780 F.3d 952, 964 (9th Cir. 2015); Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 250 (3d Cir. 2008).  But there is still a contradiction here that the Lindenfeld article has difficulty dealing with.  In listing the kinds of FDA activity that were preemptive, Albrecht, 139 S. Ct. at 1679, included a citation to 21 U.S.C. §355(o)(4)(A), which as mentioned above, includes the FDA’s power to require label changes on its own initiative.  We’re not sure what this means either, so we agree with the article that there is “ambiguity” here that potentially supports preemption.  See Ridings, 444 F. Supp.3d at 998-99 & n.24 (“FDA’s continued inaction does represent clear evidence under these facts”).

In discussing Albrecht’s “policy implications,” the Lindenfeld article repeats its over-enthusiastic conclusion that “hypothethcal preemption” is “no longer viable.”  75 Food & Drug L.J. at 363.  Again, that’s a function of ignoring the Court’s “like” Levine qualifier.  Where the sole regulatory actor was the defendant, and the sole activity was whether to change the label – the facts of Levine – “would have rejected” arguments may well be precluded by Albrecht.  Extending such a preclusion to instances of a much fuller regulatory record, however, is an aspirational, not actual, reading of Albecht.  The article goes on to state, however:

Albrecht does leave many important questions unanswered.  As explained, the preemptive force of citizen petitions remains unclear.  And while the Court did state defendants must have provided FDA with “full information,” it is unclear exactly what that necessarily entails.  It is also unclear if courts will consider FDA inaction as sufficient under the Albrecht test.

75 Food & Drug L.J. at 363-64 (footnotes omitted).

Agreed.  But does Albrecht take a “bright line” id. at 365-66, approach to preemption?  Here we part ways.  Frankly, we wish it had.  But for the reasons discussed above it doesn’t.  Even at its most definite, when discussing FDA actions with “force of law,” 139 S. Ct. at 1679, there is still the citation to §355(o).  Where that regulation is in play, is it still a case “like” Levine?  We can’t say for sure, and we can think of good arguments why it’s not, and shouldn’t be.

Will the Lindenfeld article’s position on Albrecht, if accepted, “overwhelm” the FDA?  The article, of course, says no.  Food & Drug L.J. at 367-68.  But the FDA has throughout its history operated informally, on the basis of administrative back and forth.  Albrecht’s emphasis on “formal” rejection of label changes as a barrier to preemption certainly could encourage liability-adverse manufacturers to push for final FDA action, which would put more strain on the FDA’s limited resources.  Cf. 75 Food & Drug L.J. at 364 (FDA has “only 100 professional employees to monitor over 11,000 drugs) (citing 12-year-old law review article).  It certainly won’t help for the Agency to be pushed to make more “formal” administrative dispositions than it has had to in the past.

Finally, the Lindenfeld article observes that defendants retain other “avenues” of preemption.  75 Food & Drug L.J. at 368-69.  We agree.  However, for the reasons already discussed in this post, we think those avenues are more substantial than major/moderate changes (which include all design changes), highlights, black box warnings – all of which the article acknowledges are “virtually always” or “automatically” preempted.  Id. at 368.  We think that newly acquired information, citizen petitions, class labeling, and other matters discussed herein also provide fertile preemption grounds.

Nor can we agree that, because “virtually across-the-board” preemption applies to generic drugs, id. at 369, that it “it makes sense to impose a difficult preemption regime on manufacturers of brand name drugs.”  Id.  That argument stands FDA regulation on its head.  Branded drugs have to go through extensive clinical trials, and all the other steps required to obtain a full New Drug Applications.  Generic drugs have none of that, and simply piggy-back on the efforts of branded manufacturers affirmatively to prove their products’ safety and effectiveness.  The NDA isn’t an exception to the FDA’s safety requirements.  Rather, “it is federal safety review.”  Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008) (emphasis original).  Indeed, this closing contention sounds more like an argument for innovator liability – which we detest – than one against preemption.

This post is from the non-Reed Smith side of the blog.

We posted last week about In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020), a decision that came in just time to take a sport on our Worst of 2020 post.  Just as we were expressing our displeasure with that decision, the court entered another ruling.  This time on standing and this time far from all bad.

Last week’s decision — In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2021 U.S. Dist. LEXIS 5908 (D.N.J. Jan. 12, 2021) (“VLI 2”) — focused on 2 putative class actions:  one for economic loss and one for medical monitoring.  Defendants moved to dismiss on the grounds that plaintiffs lack standing.  Specifically, that plaintiffs failed to allege an injury in fact and/or an injury that was traceable to each defendant and that plaintiffs improperly assert claims under the laws of states in which they do not reside or were injured.

On the first point, the court concluded that plaintiffs had met their burden of alleging an injury fact.  The crux of plaintiffs’ claims are allegations that the generic drug at issue was contaminated with potential carcinogens.  Id. at *16.  On that basis, plaintiff asserted three theories of economic loss – receipt of a worthless product because they failed to receive the benefit of their bargain, receipt of a less valuable product for the same reason, and the cost of purchase replacement medication.  Id. at *41.  The opinion walks through the key Third Circuit decisions on the issue and finds support for plaintiffs’ first and third theories.  Plaintiffs bargained for a “pure, unadulterated, properly branded, and cGMP compliant generic drug,” id., which they alleged they did not receive.  On that ground they allege the product was worthless and therefore seek recovery of their full out-of-pocket expenditures.  As that is a concrete method for a factfinder to value their claims, plaintiffs have alleged an injury in fact.  Id. at *45.    Likewise, the difference in the cost of the product at issue and a replacement drug is calculable and also sufficient to confer standing.  Id. at *46.  Plaintiff’s second theory, that the drug was “less valuable,” was not sufficient because plaintiffs did not provide a method to value it other than “mere conjecture.”  Id.

On the medical monitoring claim, the court found that exposure to toxic substances was sufficient for conferring standing.  Id.  at *49-50.  While defendants were able to point out certain speculative parts of plaintiffs’ complaint, the court found that the specific allegations of exposure were enough to satisfy the requirements of standing, leaving for another day the “legal sufficiency” of the causes of action.  Id. at *51.

Having found injury in fact, the court next examined whether plaintiffs’ allegations demonstrated that the claimed injuries were fairly traceable to all of the defendants.  This is where plaintiffs ran into a problem.  Both the economic loss and medical monitoring class action complaints named several defendants against whom no named class representative alleged a traceable injury.  The traceability requirement is to ensure that the plaintiff is challenging the actions of the defendant, not some third-party.  Id. at *52.  It does not rise to the level of proximate cause needed to succeed on the merits, but some causal relationship is needed.  Id. Moreover, the requirement is not relaxed in a class action.  In other words, the class cannot rely on injuries suffered by unidentified class members.  Id. at *53.

Thus, in order to establish standing in the class action context, for each named defendant, at least one named plaintiff must be able to allege an injury traceable to that defendant.

Id.  In VLI 2, for many defendants the only allegations against them are “conclusory allegations that lump Defendants together.”  Id. at *55.  Allegations that “defendants” sold or distributed the product generally do not show that a named plaintiff has alleged injury traceable to a specific defendant.  The court also rejects plaintiffs’ de facto market share liability allegations.  Injury cannot be traced to distributor “simply because of its dominant position in the market.”  Id. at *56.  Plaintiffs cannot assert claims against defendant without specific facts tying their purchases to the defendant’s sales, nor can they rely on unidentified purchases by unidentified class members.  Therefore, plaintiffs did not have standing against numerous of the defendants.

Finally, the named class representatives asserted claims under the laws of all fifty states, the District of Colombia, and Puerto Rico, but they represent only twenty-one states.  Id. at *59.  Plaintiffs argued that unnamed class members need not establish standing.  That is correct but is not the issue raised by defendants.  The question before the court was whether the named plaintiffs had standing to assert claims under the laws of states in which they do not reside and/or were not injured.  The answer is: no.  Id. at *58.  As noted in relation to traceability, the fact that the suit is a class action does not relax the requirements of standing.  “Standing is not dispensed in gross.”  Id. For each alleged claim, plaintiffs must have a named plaintiff with standing.  Because they do not, claims based on the law of states without a class representative were dismissed.

The court is taking defendants’ motions to dismiss one issue at a time and plans to author a series of opinions.  Number 2 was certainly an improvement over Number 1.  Let’s hope the trend continues.

Today’s guest post is from Wendy Lumish and Daniel Rock of Bowman & Brooke.  We sought them out because they wrote  a successful amicus curiae brief in the case they discuss.  That case is a major win for all Florida defendants, bringing Florida summary judgment practice into the Twenty-First Century.  As always our guest posters are 100% responsible for what they write, deserving all the credit (and any blame).


This guest post is pleased to report on a change in Florida law that replaces a nearly insurmountable fifty-year-old summary judgment standard.

Based on a 1966 decision from the Florida Supreme Court, a party moving for summary judgment in Florida for decades had the burden of “conclusively” disproving the non-moving party’s theory of the case.  See Holl v. Talcott, 191 So. 2d 40, 45-47 (Fla. 1966).  Under this standard, even speculative evidence was sufficient to defeat motions for summary judgment.

To illustrate how bad it could be, here is one example from the product liability context.  In Clark v. Gochenaur, 623 So. 2d 561 (Fla. 1st DCA 1993), a worker sued a truss (support beam) manufacturer after he fell from a roof truss that allegedly broke.  The defendant examined what it believed to be the subject truss and provided evidence that it was not defective − it had not broken.

The plaintiff did not file a response.  But instead argued there was conflicting evidence as to whether the truss the defense examined was the one from which the plaintiff fell.  The manufacturer replied that if the truss examined by the defense was the wrong one, then the plaintiff had no evidence that any truss broke and caused his injuries.

The Clark court found that since the defendant did not conclusively prove the identity of the truss from which the plaintiff fell, summary judgment was improper.  Thus, even without any evidence of defect or that the defect caused his injuries, the plaintiff was permitted to get to a jury based on speculation that, although the only truss that was identified was not defective, there still might have been a defect.

Thankfully, Clark and other similar cases will very likely soon be relics from a past dark era of Florida law.

On December 31, 2020, the Florida Supreme Court issued a rule change that will bring Florida in line with the majority of jurisdictions across the country. The amended rule includes the following language:

The summary judgment standard provided for in this rule shall be construed and applied in accordance with the federal summary judgment standard articulated in Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); and Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).

In re Amendments to Fla. Rule of Civil Procedure 1.510., No. SC20-1490, 2020 WL 7778179, at *4 (Fla. Dec. 31, 2020).  This rule change has been issued in tandem with  Wilsonart, LLC, v. Miguel Lopez, No. SC19-1336, 2020 WL 7778226 (Fla. Dec. 31, 2020).

In its opinion amending the rule, the court noted that the rules of civil procedure are meant “to secure the just, speedy, and inexpensive determination of every action.”  In re Amendments, 2020 WL 7778179, at *2.  When it came down to picking which rule better achieves this purpose, the court’s choice was clear:  “[T]he federal summary judgment standard is more rational, more fair, and more consistent with the structure and purpose of our rules of civil procedure.”  Id.   The rule will take effect on May 1, 2021, after a time period for public comment.

This rule change will impact nearly every civil case in Florida.  Although there are countless ways the new rule might play out in the courts, the court highlighted three “particularly consequential differences” that are worth keeping in mind.

First, there are compelling similarities between a motion for a directed verdict and a motion for summary judgment, which has led federal courts to state that the inquiry under each is the same—whether the evidence presents a sufficient disagreement to require submission of the issue to the jury.  Florida courts, on the other hand, have repeatedly declined to recognize this similarity.  Instead, they accepted the fact that a case may survive summary judgment only to be disposed of at the directed verdict stage—after the parties have already gone through the expense of trial.  This inconsistency surely encouraged defendants to settle cases they should have won before trial.

Second, in federal court, the moving party meets its initial burden if it shows the district court that there is an absence of evidence to support the nonmoving party’s case.   Again, under Florida law, a moving party under the prior standard would have had to “conclusively” disprove the nonmovant’s theory of the case.

Third, under federal law, the nonmoving party must do more than show some metaphysical doubt as to the material facts in order to survive summary judgment.  However, a nonmovant could survive summary judgment under Florida law with any evidence—even “trivial” and “incredible” evidence.

By bringing Florida in line with the federal rule, we expect that the state’s courts will more seriously consider motions for summary judgment, which can only be a good thing for defendants.

Plaintiffs tend to assert a bunch of different claims.  For prescription medical device cases, setting aside preemption, our experience is that plaintiffs do best—that is, avoid summary judgment and directed verdict—with design defect (strict liability or negligence) claims.  One reason for that is that it tends not to be hard to make up some theory, working backwards from the alleged injury, of how the design posed a risk and it could have been made better.  There also tend to be experts out there who will support these hindsight exercises.  Another reason is that law on design defect is pretty inconsistent in various ways.  Is the focus on the device, the defendant’s conduct, or the doctors who use it?  Does a risk-utility test or a consumer expectations test apply?  What about comment k?  What about alternative design?  Does the plaintiff have to identify a specific defect and prove that the defect caused the injuries?  Can the plaintiff just say the device caused the injuries and shift some burden to the manufacturer to disprove that or establish that the device had benefits exceeding its risks (in the abstract)?  How does the choice of the physician about what type of device to use or how to use it, especially with implanted devices, play into all this?  Faced with so many decisions—again, we are not even including preemption in the mix here—some courts seem to throw up their hands and say “Eh, there are jury questions here” without drilling down on what the law requires and what evidence the plaintiff has.

We think, of course, that such punting is shameful.  We also have some thoughts about what design defect law should require for prescription medical devices, especially if you care about encouraging innovations and the quality of medical care.  See here, for instance.  One thought is that it is better to have a risk-utility test than a consumer expectation test.   Consumer expectations makes more sense with consumer products—things you might buy at a store—not with complicated medical devices available only with the prescription of a licensed medical professional, and that cannot be sold absent specific regulatory clearances/approvals.  Unfortunately, some states apply a consumer expectation test for the latter category of products too.

Nevada is one of those states and we recall winning summary judgment there in a prescription (implanted) medical device that included a design defect claim.  One argument raised in the summary judgment motion was that design defect claim failed because the warnings were adequate as a matter of law.  In granting summary judgment on design defect, and on warnings, the court never reached this issue.  We cannot say the lack of a decision on that issue haunted us in the years since, but we ran across a case where an appellate court applying Nevada law did address this argument with an implanted prescription medical device.  Miller v. DePuy Synthes Sales, Inc., No. 19016821, 200 WL 7258638 (9th Cir. Dec. 10, 2020), affirmed summary judgment for the defendant manufacturer in an orthopedic implant case.  We commented on the decision below here and, unfortunately, the Ninth Circuit decision is unpublished.

Nonetheless, we thought the affirmance deserved a little virtual ink.  The decision is light on fact, but our prior post reveals the critical fact:  the surgeon concluded “there was a delayed union of the bones and that the device was broken, because the Plaintiff was weight bearing.”  Nevada law dictated that a “consumer’s reasonable expectation may be influenced by warnings that accompany a product,” id. at *1, so the relevant warnings would have to affect the expectations on issues of delayed healing, weight bearing, and breaking the device.  They did:

Here, the package inserts that accompanied the device were more than adequate to satisfy the consumer-expectation test.  [The manufacturer] provided a warning insert with the device indicating it could fail if the healing process is delayed, regardless of whether the patient put weight on the healing bone. The warning further indicated that all implants are subject to repeated stresses in use and can break at any time. Even assuming [plaintiff] complied with [the surgeon’s] instructions and did not put weight on his healing leg, the product’s warning put a reasonable consumer on notice that in the worst case, the device could fail from wear fatigue.


The court did not proceed to belabor why the warnings were sufficient to require summary judgment.  But we will.  Per the law the court had quoted, the plaintiff has to prove the device “fail[s] to perform in the manner reasonably to be expected in light of its nature and intended function and [is] more dangerous than would be contemplated by the ordinary user.”  Id. (citation omitted).  If the label makes clear that the device could fail and that such failure could harm the patient, while providing instructions on how to reduce the risk of failure, then a reasonable consumer should have understood the circumstances under which the device could fail and that injuries could result.  That means the device did not fail to meet reasonable expectations and was not defectively designed, even though it had more than a 0% risk of failure.  Whether the consumer at issue is the doctor or the patient, it cannot be reasonable to “expect” 100% success with surgery, whether or not it utilizes an implanted medical device.  Surgeons tend not to offer money back guarantees with their surgeries.  A patient, faced with such an offer, might reasonably conclude something was amiss.  Instead, in maybe 99.99% of non-emergency surgeries, the patient first signs an informed consent form identifying risks and disclaiming that promises of success have been made.


Late last year we awarded our #10 spot on our Worst of 2020 post to In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020) (“VLI”).  At that point the decision was brand new, and we promised a more in-depth analysis.  Here it is.

VLI fits neatly into our ongoing critique of MDL practice, where all too often the law – particularly pertaining to preemption – is distorted to become a settlement tool.  Since thorough briefing is another aspect of MDL practice (one with which we have no gripe), it’s hard to understand how VLI could possibly otherwise describe the then-11-year-old Wyeth v. Levine, 555 U.S. 555 (2009), decision as “the latest, single-most, on-point Supreme Court case for preemption of the FDCA in a pharmaceutical context.”  2020 WL 7418006, at *7.  It’s not, by a long shot.

The Supreme Court has issued three newer prescription drug implied preemption decisions:  Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019); Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013); and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and VLI cites none of them.  These omissions are particularly troubling, as Albrecht in particular spent several pages revising the mess that was the Levine decision.  See 139 S. Ct. at 1676-78 (beginning with “[w]e begin by describing” Levine).  We can’t think of the last time we’ve seen the Supreme Court expend the kind of ink it did in Albrecht going through a prior precedent (Levine) almost line by line.  Thus, contrary to VLI, Levine is certainly not the “latest,” nor after Albrecht is it particularly “on point.”

From this poor foundation flows an equally questionable preemption rationale.  The claims at issue were “negligence per se, strict liability-defective design, breach of express warranty, fraud misstatement and negligent misstatement and state consumer-protection laws.”  2020 WL 7418006, at *7.  VLI lets all of them skate by.  VLI did so precisely by failing to apply more recent United States Supreme Court precedent.

To reach this result, VLI relies upon what it describes as “the traditional presumption against preemption of state law.”  Id. at *9.  That’s interesting, because this language quoted verbatim from a prior unpublished decision of the same court:  Tigert v. Ranbaxy Pharmaceuticals, Inc., 2012 WL 6595806 (D.N.J. Dec. 18, 2012).  We took a look at Tigert, as well, due to its common authorship.  Sure enough, the presumption against preemption was all over Tigert – cited no fewer than six times.  See 2012 WL 6595806, at *1 (“the presumption against preemption obtains in this case”); *3 (praising Desiano v. Warner Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2006), for “first f[inding] that the ‘presumption against preemption,’ . . . attached to the plaintiff’s claims because they fell within . . . ‘a sphere in which the presumption against preemption . . . stands at its strongest’”); *4 (criticizing Lofton v. McNiel [sic] Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012), for “[s]kirting the question of whether the presumption against preemption applied” and “overlook[ing] these critical differences when it failed to recognize the applicability of the presumption against preemption”); at *5 (the source of the “traditional presumption against preemption of state law” language quoted in VLI).

What has happened since Levine and Tigert?

The effective abolition of the presumption against preemption, that’s what.

First, in Mensing, an implied preemption case, four justices went on record in favor of abolishing the presumption against preemption altogether.  See 564 U.S. at 621-23 (“courts should not strain to find ways to reconcile federal law with seemingly conflicting state law”).

Second, in Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016), the Court abolished the presumption against preemption in express preemption cases, holding that, when a statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.”  See our post here.

Third, the Third Circuit in Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018), refused to follow P.R. v. Franklin unless the Court did so in a product liability preemption case.  See our post here.

Fourth, in Albrecht, the Court did just that − its aforementioned multi-page restatement of Levine conspicuously omitted any reference to any “presumption” and instead retreated to the Court’s earlier language about merely an “assumption” that “historic police powers” should not be “superseded.”  See our post here.

So the primary reason why we’re critical of VLI is that its failure to apply current United States Supreme Court preemption precedent resulted in a decision that was obsolete the day it was written.

But there’s more.  VLI takes a “narrow” view of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  2020 WL 7418006, at *9 (again quoting from the unpublished Tigert decision).  Thus, it refused even to hold negligence per se claims preempted.  Id. at *9-10.  However, by its nature negligence per se takes “a legislative enactment or an administrative regulation which is adopted by the court as defining the standard of conduct of a reasonable man.”  Ries v. National Railroad Passenger Corp., 960 F.2d 1156, 1158 (3d Cir. 1992) (quoting Restatement (Second) of Torts §288B(1) (1965)).  In an FDCA-based negligence per se claim, it is thus hard to view the FDCA violation as anything other than the “critical element in [a plaintiff’s] case” so that the “duty” that negligence per se defines “exist[s] solely by virtue of the [MDA] . . . requirements.”  Buckman, 531 U.S. at 353.  Once again, the reason negligence per se survived in VLI is reliance on the obsolete presumption against preemption:

[T]he Supreme Court in Buckman “reached concerns of interference [with the FDA’s regime] only after first finding that . . . the traditional presumption against preemption of state law did not apply.”  Thus, this Court ruled in Tigert that “the Supreme Court’s narrow ruling in Buckman is unstable ground on which to rest a finding of preemption.”  . . . “Because of its important role in state regulation of matters of health and safety, common law liability cannot be easily displaced in our federal system.”

2020 WL 7418006, at *9 (citations omitted).

Thus VLI ruled, contrary to Third Circuit precedent, that Buckman does not preempt FDCA-based negligence per se.  In one of Bexis’ Bone Screw cases, the Third Circuit held (pre-Buckman):

[Plaintiffs’] interpretation of per se liability would allow private plaintiffs to recover for violations of a federal statute that creates no private cause of action and, in fact, expressly restricts its enforcement to the federal government.  Plaintiffs’ theory would undermine section §337(a) by establishing a private, state-law cause of action for violations of the FDCA. . . .  We do not believe the concept of per se liability supports such a result.

In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999) (various citations omitted).  This is still good law in the Third Circuit – if anything being amplified by Buckman.

Other New Jersey federal and state case law have similarly held that tort claims with an embedded element dependent on FDCA violations are preempted by virtue of Buckman and §337(a).  Most directly on point is the New Jersey Supreme Court in Cornett v. Johnson & Johnson, 48 A.3d 1041, 1054  (N.J. 2012), holding that because negligence per se “depend[s] on the alleged violation of a federal requirement,” it is “functionally equivalent to a claim grounded solely on the federal violation” and thus preempted under BuckmanId. at 1054.  As VLI did not cite any FDCA preemption cases more recent than Levine, it did not address Cornett.  Considerable other precedent reached the opposite result from that in the underlying Tigart decision – that punitive damages claims with a fraud on the FDA predicate are preempted.  McDarby v. Merck & Co., Inc., 949 A.2d 223, 275 (N.J. Super. App. Div. 2008) (“Although there are differences between the fraud-on-the-FDA claim asserted in Buckman and [plaintiff’s] punitive damage claim premised on the withholding of information . . ., we find the single focus upon fraud on the FDA in each to be sufficiently similar to warrant the application of Buckman to this case.”); Mendez v. Shah, 28 F. Supp.3d 282, 303-05 (D.N.J. 2014) (punitive damages based on purported fraud on the FDA preempted by Buckman); Johnson v. Draeger Safety Diagnostics, Inc., 2013 WL 3788937, at *7 (D.N.J. July 19, 2013) (“common law fraud claim is based upon statements allegedly made by Defendant . . . to the FDA”  preempted by Buckman); Nelson v. Biogen Idec Inc., 2013 WL 1700918, at *3 (D.N.J. April 19, 2013) (same as Mendez); Stanger v. APP Pharmaceuticals LLC, 2010 WL 4941451, at *4 (D.N.J. Nov. 30, 2010) (following McDarby); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859, at *8 (D.N.J. Dec. 15, 2009) (claims with an element of “showing a fraud on the FDA” would “fl[y] in the face of the PMA process” and are therefore preempted); accord Atkinson v. Luitpold Pharmaceuticals, Inc., 448 F. Supp.3d 441, 450-52 (E.D. Pa. 2020) (rejecting Tigart and following Buckman and Lofton).

Similarly, by not considering BartlettVLI erroneously let the design defect also escape preemption, despite any design change constituting a “major” change that would require prior FDA approval and thus is preempted.  Bartlett stated:

Once a drug – whether generic or brand-name – is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.

570 U.S. at 477 (citation and quotation marks omitted).  State-law design defect claims are “impossible” to comply with “[b]ecause [defendant] was unable to change [the drug’s] composition as a matter of both federal law and basic chemistry.”  Id. at 475.

Finally, VLI extended it erroneous reliance on a presumption against preemption to an express preemption claim directly controlled by P.R. v. Franklin when it decided a matter of first impression – preemption under the Drug Supply Chain Security Act, 21 U.S.C. §§360eee to 360eee-4, since some of the claims in VLI attacked how these drugs were handled post-manufacture.  This statute contains a broad express preemption clause:

Uniform national policy. . . .

(a) Product tracing and other requirements

. . . [N]o State or political subdivision of a State may establish or continue in effect any requirements for tracing products through the distribution system (including any requirements with respect to statements . . ., or verification, investigation, disposition, notification, or recordkeeping relating to such systems . . .) which are inconsistent with, more stringent than, or in addition to, any requirements applicable under section 353(e) of this title or this part (or regulations issued thereunder). . . .

21 U.S.C. §360eee-4(a) (emphasis original).  That language is even more emphatic than the express preemption language in the Medical Device Amendments.  However, this section also contains a savings clause for “[s]tate requirements related to the distribution of prescription drugs if such requirements are not related to product tracing.”  §360eee-4(e).

Quoting Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), VLI rejected any preemption at all because it would “‘have the perverse effect of granting complete immunity from’ products liability claims to an entire industry, so long as the actors complied with basic tracing requirements.”  2020 WL 7418006, at *11.  VLI thus interposed the savings clause to nullify the statute’s preemptive language – without any underlying state requirement to trigger it − finding nothing at all in the plaintiffs’ MDL complaints was preempted.  Id.  In keeping with VLI’s overall anachronistic approach to preemption, it did not acknowledge the Supreme Court’s more recent rejoinder to this sort of reasoning in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008):

The dissent would narrow the pre-emptive scope of the term “requirement” on the grounds that it is “difficult to believe that Congress would, without comment, remove all means of judicial recourse” for consumers injured by FDA-approved devices.  But, as we have explained, this is exactly what a pre-emption clause . . . does by its terms.  The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.

Id. at 326 (citations omitted).

And yes, once again, VLI was “guided” by a presumption against preemption that, as already discussed, no longer exists:

Finally, the Court is guided by the presumption against preemption in this case.  Although the preemption clause arguably could be subject to more than one interpretation − and could potentially be read more broadly, as defendants urge − the Court chooses to read the clause in a way that disfavors preemption.

2020 WL 7418006, at *11.

Another of our long-standing concerns about MDL litigation is the absence of meaningful appellate review of decisions about key issues like preemption until years later, after a defendant loses some bellwether trial, when by then so much time and effort has been expended that the appellate court is pressured to affirm lest all that go to waste.  One can only hope that the pendulum that has swung against the presumption against preemption since Mensing continues in that direction and produces more binding precedent that cannot be ignored, even in VLI.

A couple of times in recent weeks we have discussed pelvic mesh cases where a central issue was whether the cases were time-barred by a statute of limitations or repose. (See here and here.) There is a reason why this issue crops up persistently. The pelvic mesh litigation started off as a mass tort MDL. By itself, it represented a pretty big chunk of the federal civil docket. There have been many trials and many settlements, but it remains a mass tort. Why? For some plaintiff firms, particularly those of the more opportunistic, parasitic varieties, it is easier to milk an existing mass tort than to go out and do new factual investigation or legal research. Think of the heaps of lawyers who show up (virtually, now, one supposes) at monthly asbestos docket calls, droning on, adding to the background hum of a machinery designed to grind out settlements. If justice and reality play any role in this industrial process, then it is purely by accident.

Defense lawyers and judges (but not usually plaintiff lawyers) fret over how to cut off the “tail” of a mass tort. It has to end, somehow. If not, why would any sentient defendant settle? It’s a matter of time. No wonder, then, that statutes of limitations and repose come out of the toolbox. They might have been just as available and valid much earlier in the litigation. But that was before the defendants started to settle. After settlements, courts start viewing the holdout plaintiffs, not the defendants, as the recalcitrant parties. Time to spank them with time-bars, right? It should be.

In Kelly v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 1874 (N.D. Iowa Jan. 6, 2021), the court dismissed a pelvic mesh case based on Iowa’s two year statute of limitations. Let’s be frank: this was a clear-cut case of a plaintiff who waited way too long. She had the implant in 2004, and shortly afterwards began experiencing the very injuries that animated her complaint filed in 2014. The plaintiff argued that the clock did not start until a doctor told her in July 2014 that the mesh caused her problems. That is a hard argument to swallow, inasmuch as she hired a lawyer for this case in 2013 and filed the complaint in February 2014. (Did she file the case before she knew she had one? Hmmm.). More to the point, the court held that the “plaintiff was aware of facts and had reason to believe by 2010 at the latest that some defect in the TVT implant may be causing her ongoing and worsening conditions. Such facts reasonably should have prompted her to begin seeking information at that time.” Even a minimum of such information-seeking would have unearthed an FDA public health notification regarding pelvic mesh. A lawsuit would have followed shortly. How do we know this? Because thousands of lawsuits were filed.

The Kelly court saw no basis to apply equitable estoppel against the defendants due to fraudulent concealment. The plaintiff had plenty of facts to put her on notice, and there wasn’t an ounce of justifiable reliance, Thus, the defendants were not barred from asserting a statute of limitations defense, and the plaintiff was barred from pressing her claims because they were simply too late.

That ruling, reasoning, and outcome are all well and good. What makes the Kelly case particularly interesting is the plaintiff’s effort to evade the statute of limitations defense on unusual procedural grounds. A nontrivial part of the record supporting the court’s application of the statute of limitations was the deposition of the plaintiff. That deposition was taken by an independently contracted attorney for defendants’ counsel’s firm. (There have been many contract attorneys on both sides in the mesh litigation.) That independent contractor attorney was admitted in West Virginia (where the MDL was located), but she had not made an appearance in the Kelly case, which ended up in Iowa. Based on that alleged procedural foot-fault, the plaintiff moved to strike the portions of her testimony used by the defendants to support the statute of limitations motion.

In the hurly-burly of an MDL, it is completely understandable how an attorney might forget to file an appearance in one of the thousands of cases. It happens. Nevertheless, one does, perhaps grudgingly, have to award points to the plaintiff’s lawyers for seizing upon such a technicality. It was clever. It was also unsuccessful.

To begin with, it was not quite clear that the out of state (West Virginia in an Iowa case) attorney’s taking of a deposition without filing an appearance violated any rule. The issue was as obscure as it was technical. But even putting aside this obscure, technical issue, the Kelly court refused to grant the plaintiffs’ motion to strike. The nonappearance of the deposing attorney could not conceivably have prejudiced the plaintiff. First, the plaintiffs did not object to the attorney’s appearance at the time of the deposition. Second, the plaintiffs previously submitted testimony from the same deposition. Third, the plaintiffs raised this issue only now, a year and a half later, when parts of the plaintiff’s testimony were potentially unfavorable to her. Fourth, the plaintiffs did not seek to jettison all of the plaintiff’s deposition testimony, but rather, only the parts that supported the defendant’s summary judgment motion. Last, the plaintiffs did not object to the deposition of the husband, which was conducted by the same lawyer on the same day.

Thus, the Kelly court concluded that the plaintiffs’ motion to strike was “more so an attempt to editorialize plaintiff’s deposition testimony” rather than to redress any issue relating to the defense lawyer’s appearance. Or, as our high school freshman year Religion teacher, Fr. Kilcarr, would have called it, the plaintiff was practicing situational ethics. Moreover, the drastic remedies the plaintiffs sought far outweighed the harm, if any, that the plaintiffs sought to redress. The Kelly court denied the plaintiffs’ motion to strike, granted the defendants’ summary judgment motion, and dismissed the case with prejudice.

A lot of us are working on MDLs. A lot of us are looking for ways to cut off the tail of vampiric litigation. A lot of us are looking for ways out for our clients, including statutes of limitations and repose. We hope that not a lot of us have occasionally flubbed the filing of appearances in cases. But for those of us who have, Kelly offers some comfort that the price of such flubs needn’t be severe.

Sometimes it can be easy to believe that a random thought can conjure a real-life response.  Such as when you imagine yourself taking a vacation to someplace warm and tropical (not at all brought on by mid-January temps in the Mid-Atlantic) and suddenly every other commercial you see has a palm tree, a hammock, and white sands.  For a brief second, it’s like your television is talking directly to you.  We understand in this day and age of targeted advertising based on search history it’s a little less remarkable, but nonetheless.

So too do we here at the DDL blog sometimes post on a topic only to have a decision directly on point come down just a short time later.  That is precisely what happened with our post Are Defendants Entitled to Jurisdictional Discovery?  A little less than one month later, the District of Utah answered that question in the affirmative in Young v. Bridgestone Ams. Tire Operations, 2021 U.S. Dist. LEXIS 3053 (D. Utah Jan. 6, 2021).  We refer you back to our earlier post for additional authority on the subject, which has since been updated with Young, and our thoughts on why such discovery is supported by Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).

In Young, plaintiffs were injured in an automobile accident which they alleged was caused by a defective tire on the vehicle that struck them.  Young, at *2.  Plaintiffs’ complaint contained 71 separate allegations regarding personal jurisdiction but none that actually demonstrated that plaintiffs’ cause of action arises out of defendant’s contacts with Utah.  For example, while alleging the tire was marketed and sold in Utah, plaintiffs offered no supporting details such as when or where the sale occurred or who made the purchase.  So, defendant moved to dismiss and requested permission to conducted limited jurisdictional discovery to determine

whether the Plaintiffs can establish any specific connection between any actions by [Defendant], the specific product at issue, and the accident that forms the basis of Plaintiffs’ cause of action.

Id. at *3.  Currently, all that is known is that the tire was designed in Ohio and manufactured in Canada, neither of which support jurisdiction in Utah.  Id.  Defendant, however, supported its motion with an affidavit setting out the general process by which defendant’s product is distributed and facts regarding defendant’s business activities in Utah.  Id.  While not spelled out in the opinion, court filings indicate that defendant sells most of its product to original equipment vehicle manufacturers or to distributors outside of Utah.  See Docket No. 11.

Therefore, the court concluded that evidence may exist to refute plaintiffs’ jurisdictional allegations and since that evidence is not in the possession of defendant, it is entitled to conduct discovery to challenge plaintiffs’ allegations.  Young, at *4.  If defendant’s contentions are accurate, the discovery is likely to bear out either that defendant did not sell the tire in Utah or that plaintiffs cannot meet their burden of proof that it was sold in Utah.  Because the discovery will aid the court in addressing the motion to dismiss, defendant’s request was granted.

Side note:  many of plaintiffs’ 71 personal jurisdiction allegations go to general jurisdiction which defendant challenged in its motion as well.  Reading between the lines, we don’t think the court was very interested in plaintiffs’ general jurisdiction arguments, keeping the focus squarely on the actions of the defendant as they relate to the specific product at issue.