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One of the blogposts that generated a lot of “Thanks, I needed that” responses from our readership was our 2022 post, “Remote Depositions in MDLs.”  For that reason, we have updated it by adding references to additional MDL orders on that subject that have been entered since early 2022.  We pay particular attention to MDL orders because, due to their stakes, every procedural jot and tittle is gone over with a fine-toothed comb.  The “litigate everything” mentality in MDLs produces the most comprehensive consideration of issues that arise in remote depositions generally.  We asked one of our crack legal assistants to look for additional MDL orders during this time frame to see what MDL transferee judges – advised by the parties – have had to say most recently about the conduct of remote deposition.

Continue Reading Remote Depositions in MDLs 2.0
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We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight.  A learned intermediary case before the California Supreme Court?  For your ever-vigilant DDL bloggers, that is like Thanksgiving and Christmas wrapped into one! 

Who will be giving thanks after the California Supreme Court decides Himes?  We don’t know, but it sure was a good show.

To recap, Himes is before the California Supreme Court on a question certified from the Ninth Circuit.  As we detailed here, the issue is how plaintiffs in prescription medical product, failure-to-warn cases can meet their burden of proving warnings causation under California law.  In a failure-to-warn claim against a prescription medical product manufacturer, is the plaintiff required to show that a stronger warning would have altered the physician’s decision to prescribe the product?  Or can the plaintiff establish causation by showing that the physician would have informed the plaintiff of the stronger warning and that a prudent person in the patient’s position would have declined treatment? 

Our initial take on these issues still applies: 

It’s an important question.  Time and again, we have seen cases where there is no evidence that stronger warnings would have had any impact on the physician’s prescribing physician, which should be, and often is, the basis for summary judgment under the learned intermediary doctrine.  The essence of the doctrine is that a prescription medical product manufacturer’s duty to warn runs to the physician—the learned intermediary—not the patient.  Thus, if there is no evidence that stronger warnings would have had an impact on the physician, the plaintiff cannot prove that an alleged inadequacy in the warnings caused his or her injury. . . .

But what about cases where the plaintiff says, sure a stronger warning would not have influenced my doctor, but what about me?  If my doctor had informed me, I would not have consented to the treatment.

An engaged California Supreme Court confronted the issues with aid of highly capable counsel, both of whom were swinging for the fences.  What do we mean by that?  Well, the questions certified to the California Supreme Court were couched in terms of the plaintiff’s causation burden.  So we were surprised when the plaintiff’s counsel spent most of his time arguing that the learned intermediary doctrine should not apply at all and that the duty to warn should run to the patient—and only the patient—whenever the manufacturer has not provided sufficient warnings to physicians.    

That’s just crazy talk.  Plaintiffs in failure-to-warn cases always allege that the manufacturer’s warnings were not sufficient.  The plaintiff’s argument therefore would essentially read the learned intermediary doctrine out of the law.  Or, as the Ninth Circuit held when it certified the questions, “Because the adequacy of warnings is always challenged in failure-to-warn claims, ‘[i]f the learned intermediary rule became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate in California.’” Himes v. Somatics, LLC, No. 21-55517, 2022 WL 989469, at *4 (9th Cir. Apr. 1, 2022) (quoting Sanchez v. Bos. Sci. Corp., 38 F. Supp. 3d 727, 734 (S.D. W. Va. 2014) (applying California law)).

That, however, is where counsel placed his marker, with emphasis on respecting and preserving patient autonomy.  Counsel even went so far as to assert that the California Supreme Court had endorsed this view in TH v. Novartis, the California case that adopted innovator liability.  Justice Kruger interrupted at this point to assert that TH v. Novartis did not really hold that and did not decide that issue.  She posited instead that there are different kinds of duties, and that a prescription medical product manufacturer can discharge its duty to warn by warning physicians—the learned intermediaries—who are best positioned to communicate warnings to patients.  Is there not an intermediate step that should consider what a reasonably prudent doctor would tell his or her patient? 

Counsel replied no, the consumer has the right to know the risks.  Justice Corrigan agreed, but asked how the Court should ensure as a matter of policy that the patient actually would know if not through a learned intermediary.  How would a duty running directly to the patient work?  Counsel replied that the manufacturer could fulfill its duty with direct-to-consumer advertising, which provoked some skepticism.  Justice Corrigan noted that the fulfillment of a medical product manufacturer’s duty to warn should not depend on what she watches on TV.  Justice Jenkins observed that counsel was suggesting a solution that was “antithetical” to the learned intermediary doctrine, which acknowledges that physicians are in the best position to advise their patients regarding the risks of treatment.  The plaintiff wanted the manufacturer to take on that duty.

Counsel argued that a manufacturer would take on that duty only if it were negligent in warning physicians.  There is that crazy talk again.  If a manufacturer provides adequate warnings, there is no liability and no need for any learned intermediary rule in the first place.  In other words, the plaintiff’s argument would render the learned intermediary rule superfluous—if the manufacturer failed to provide adequate warnings, it owes a duty directly to the patient; but if it gave adequate warnings, there is no need for the doctrine at all.  Either way, the learned intermediaries may as well go for a cup of coffee, because they don’t matter anymore.   

Justice Groban picked up on this apparent inconsistency:  The plaintiff was arguing that the physician should be part of the equation through informed consent, but that when it came to warnings causation, only the plaintiff’s decision-making process mattered.  Finally, we get to causation, and counsel argued that it was a decision for the jury.  The jury could hear from the physician and hear from the plaintiff, and then decide for itself whether the plaintiff would have consented to the treatment if the manufacturer had given the physician a stronger warning.  Justice Groban observed (as we have in multiple blogposts on this topic) that the plaintiff would win 100 percent of the time, because plaintiffs will always say that, “had they known” of the risk, they would not have granted consent. 

The balance of the plaintiff’s time was spent on whether the standard should be an objective standard or a subjective standard.  Should the plaintiff have to prove that a stronger warning would have altered the decision of a reasonably prudent patient under similar circumstances?  Or can plaintiffs meet their burden with their own subjective, 20/20 hindsight testimony that they would have declined treatment had the manufacturer provided a stronger warning? 

Counsel argued that the standard should always be subjective, subject only to the jury’s right to not believe the plaintiff.  Multiple justices tested this, asking for example whether an objective, reasonably prudent standard would adequately preserve the plaintiff’s remedy, as it does in medical malpractice cases.  Justice Evans asked how it would work with exceedingly rare side effects that physicians would not reasonably be expected to communicate to patients.  Counsel answered that it was all for the trier of fact, with the patient’s testimony subject to cross examination, just like in any other product liability case. 

That led to probably the most on-point observation of the day:  Justice Kruger noted that consumers purchasing the “average consumer product” are in a different position from patients seeking medical treatment from physicians—i.e., learned intermediaries. 

Defense counsel started by asking the Court to hold that a plaintiff in a failure-to-warn claim must offer evidence that a stronger warning would have altered the physician’s prescribing decision.  Remember how we said that both sides swung for the fences?  This is the defense version.  It is the traditional and most analytically sound restatement of the learned intermediary rule, under which the warnings causation inquiry begins and ends with the prescribing physician.  We happen to agree with this rule, since it is most faithful to how prescription medical care is actually provided, and it is the only way to invest responsibility for warning patients with the party in the best position (or even the only position) to do so—the prescribing physician.  It also happens to be the rule followed in the vast majority of jurisdictions. 

The California Supreme Court tested this argument, too.  Justice Kruger asked, in a couple of different ways, whether a rule that focuses on physicians needs also to leave room for patient autonomy.  Counsel acknowledged the importance of patient autonomy, but emphasized that there are multiple competing concerns.  These are prescription drugs that patients cannot decide to take on their own.  They need prescriptions, and physicians are not mere gatekeepers—they are learned intermediaries.  The warnings are directed to them, and they apply their experience and training to interpret those warnings for patients.  It would be speculation under these circumstances to allow patients to prove causation with their own subjective, hindsight testimony that they would not have consented to the treatment had they known all the risks.  Counsel also emphasized that the Court should presume that physicians will listen to their patients when making prescribing decisions, which further protects patient autonomy. 

The core of the defense argument was this:  Allowing plaintiffs to prove warnings causation with evidence of a stronger warning’s purported impact on patients, as opposed to physicians, comes at a cost.  Liability for prescription medical device manufacturers will be subject to significant hindsight bias, under which plaintiffs who have already suffered injuries will always say that they would not do it again.  Extending the duty to warn to patients, even indirectly, will also result in overwarning, which will not improve outcomes and threatens real harm to patients who will forego treatment.  Liability will rely on speculation—instead of looking at a prescribing physician’s actual practices, we will instead base liability on the speculative impact of a hypothetical stronger warning on a patient’s conduct years after the fact. 

Justice Corrigan noted that the Court understood all that, but would it not be sufficient to instruct a jury that it should decide causation under a reasonably prudent standard.  Counsel replied no, because that would build a house of cards.  The jury would have to consider what a reasonably prudent physician would have told a patient if the manufacturer had provided a stronger warning.  Then, it would have to consider the impact of that hypothetical conversation on the patient in a but for world.  And a jury is susceptible to same hindsight bias as the plaintiff.  The Court should instead do what other courts have done and look at what the prescribing physician actually did with knowledge of the risk.  That is not speculation. 

Justice Groban was struck by the parties’ stark positions.  The plaintiff was arguing that only the patient’s decision-making process mattered and that the learned intermediary rule should not apply at all.  The defendant was arguing that only the physician’s decision-making process mattered.  Both were degrading the notion of informed consent, which is a dialogue under which the patient makes a decision.  Was defendant presenting the “physician as god” and saying that the patient is irrelevant?  Counsel replied that the plaintiff’s argument was presenting the “lawyer as god” in a world where manufacturers would rarely, if ever, win summary judgment.  (Again, counsel for both sides were high quality, but we have to say, the “lawyer as god” retort was pretty good.) 

Multiple justices questioned counsel on whether they should be cutting the patient out of the equation and whether the traditional formulation of the learned intermediary rule would leave patients without a remedy.  Justice Kruger again came back to the objective standard:  Why is an objective standard not the solution to hindsight bias, as it is in medical malpractice cases?  Counsel replied that patients would still have sufficient remedies, including potentially against their physicians. And, we don’t need an objective standard because we can look at the actual conduct of prescribing physicians and whether they continued to prescribe the product to their patients, even when aware of the risk. 

Entertaining arguments all around, and we have a few observations with which to close.  First, we will say again (as Justice Groban observed) that counsel on both sides were going for the home run.  The Court was looking more for a double, a compromise position that would acknowledge meaningful roles for both the patient and the physician in the decision making process.  We imagine the Court’s draft opinion reflects this evident, even obvious desire for a middle ground, wherever that may lie. 

Second, we will not hazard a guess at the outcome, but we would be shocked if the Court were to hold that the learned intermediary doctrine evaporates when the manufacturer fails adequately to warn the physician.  The learned intermediary doctrine exists because plaintiffs allege that manufacturers have failed adequately to warn, and it sets the standard for proving causation where the warnings are directed to the learned intermediary, not the patient.  Crazy talk.  We do not think the Court is rethinking the learned intermediary doctrine on a fundamental level.  It will likely stick to the certified questions and tell us what to do with warnings causation. 

Third, we would also be surprised if the Court embraced a subjective standard, under which a plaintiff could get to a jury, in every case, with her own hindsight testimony that she would not have consented to treatment if she had known about a risk that she has already experienced.  The Ninth Circuit rejected that view when it certified the questions to the California Supreme Court, and the Court’s multiple acknowledgements that it understands hindsight bias and such suggest that it will reject a subjective standard, too. 

We expect an opinion within 90 days.  We will keep you posted.

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The issue of the state of mind or intent of a party can play out a number of ways based on the nature of the case.  In the criminal context, proof of the mens rea of the defendant is typically an element in the statutory definition of the crime.  In a civil contract case, whether the parties had a meeting of the minds and how one party actually interpreted disputed provisions can be central issues to decide.  In an employment case, it may be the issue of whether the stated reason for taking an adverse employment action was mere pretext for the real reason.  In the product liability context, the focus can be on the plaintiff’s assumption of risk or the defendant’s alleged reckless indifference to the risk of the harm that allegedly befell the plaintiff.  Because plaintiffs in large-scale drug and device try cases to get punitive damages, the latter is a recurring issue in our cases.

Back in the day, well before The Case of Thorns gave rise to tort law and tort law eventually gave rise to product liability claims, some trials were decided based on the use of oath helpers, purportedly upstanding citizens who would swear that one party was good and honest and, thus, should prevail.  The oath helping could touch on all manners of state of mind, such as “Ruprecht is telling the truth that he thought it was his pig” or “Rolfe was not acting in self defense when he slew kind Alfred.”  In American jurisprudence, the distaste for this overtly classist practice—nobles tended to have better oath helpers than commoners—morphed into something called the “ultimate issue rule.”  Because juries decided disputed facts, no witness was supposed to stray into direct testimony on a deciding issue, which was seen as “usurping the province of the jury” with “empty rhetoric” from the stand.  This history is set out in the Advisory Committee Notes to Federal Rule of Evidence 704, which abolished the unwieldy ultimate issue rule in federal civil and criminal trials when it was adopted in 1975.

The 2011 to present version of the Rule provides:

Rule 704. Opinion on an Ultimate Issue

(a) In General — Not Automatically Objectionable. An opinion is not objectionable just because it embraces an ultimate issue.

(b) Exception. In a criminal case, an expert witness must not state an opinion about whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense. Those matters are for the trier of fact alone.

On its face, the abolition applies to opinion testimony from both lay and expert witnesses, although the exception is just for experts in criminal cases.

The Notes also contain a fairly familiar explanation that references oath helpers:

The abolition of the ultimate issue rule does not lower the bars so as to admit all opinions. Under Rules 701 and 702, opinions must be helpful to the trier of fact, and Rule 403 provides for exclusion of evidence which wastes time. These provisions afford ample assurances against the admission of opinions which would merely tell the jury what result to reach, somewhat in the manner of the oath-helpers of an earlier day. They also stand ready to exclude opinions phrased in terms of inadequately explored legal criteria. Thus the question, “Did T have capacity to make a will?” would be excluded, while the question, “Did T have sufficient mental capacity to know the nature and extent of his property and the natural objects of his bounty and to formulate a rational scheme of distribution?” would be allowed. McCormick §12.

We first ran across this language back in 2000 when posed with the issue how to prevent a plaintiff expert, qualified in some discipline relevant to at least some issues in the case, from offering what amounted to a second opening from the witness stand, replete with all manner of “opinions” on what the defendant drug manufacturer knew, why it did what it did, and how not doing what it did not do was proof of bad intent.  We used to call this “intentology” testimony and, when we first looked, the authority for excluding it was as thin as the basis for admitting it, even though many courts had admitted it over faint objection.  Although we offered a number of arguments for why the plaintiff experts should not be allowed to sprinkle in all their musings on intent in the course of their testimony, the one that has been the most impactful in helping to create a line of federal MDL decisions since 2000 is that experts should not be permitted to usurp the jury’s function with this sort of thinly veiled advocacy.  After our first two decisions on this issue from the In re Diet Drugs MDL, a number of individual decisions followed suit, but it was the published decision from the In re Rezulin MDL as part of broader Daubert challenges that really got things rolling in MDL after MDL. 

We detailed the first eleven years of this line of cases here.  With credit to Kelly McNeill, we can present a mini-survey of federal decisions since 2011, focused on MDL and MDL remand cases, which makes it clear that the exclusion of expert opinion on the state of mind of a corporate defendant is the decidedly majority position.

                        FIRST CIRCUIT

  • In re Zofran (Ondansetron) Prod. Liab. Litig., No. 1:15-MD-2657-FDS, 2019 WL 5685269, at *9 (D. Mass. Nov. 1, 2019) (MDL excluded plaintiff expert’s challenged opinions; “Inferences about the intent or motive of parties or others lie outside the bounds of expert testimony.”) (citing In re Solodyn (Minocycline Hydrochloride) Antitrust Litig., 2018 WL 734655, at *2 (D. Mass. Feb. 6, 2018); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 547, 551 (S.D.N.Y. 2004); In re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323, 1337-38 (S.D. Fla. 2010)).

                        SECOND CIRCUIT

  • In re Mirena IUD Prod. Liab. Litig., 169 F. Supp. 3d 396, 479–80 (S.D.N.Y. 2016) (MDL excluded frequent flyer plaintiff expert’s opinions on the “intent, motives or states of mind of corporations, regulatory agencies and others,” but permitted testimony on “what information was in [defendant’s] possession” and the intent of defendant or FDA when “clearly indicated in public documents”).

                        THIRD CIRCUIT

  • Zimmer Surgical, Inc. v. Stryker Corp., 365 F. Supp. 3d 466, 497 (D. Del. 2019) (“Expert testimony as to intent, motive, or state of mind offers no more than the drawing of an inference from the facts of the case … and permitting expert testimony on this subject would be merely substituting the expert’s judgment for the jury’s and would not be helpful to the jury.”).
  • In re: Tylenol (Acetaminophen) Mktg., Sales Pracs., & Prod. Liab. Litig., No. 2:12-CV-07263, 2016 WL 4039271, at *8 (E.D. Pa. July 28, 2016) (MDL excluded frequent flyer plaintiff expert’s opinions; citing a number of decisions on the same expert, including Heineman v. American Home Products Corp., No. 13–cv–02070–MSK–CBS, 2015 WL 1186777, at *12 (D. Colo. Mar. 12, 2015) (excluding Dr. Blume’s opinions about defendants’ state of mind); In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 950, 964-965 (D. Minn. 2009) (“There is no indication in the record that the jury here would require special assistance to interpret the documents on which Dr. Blume bases her opinion that Pfizer was more worried about bad publicity than safety. Because the jury is equally capable of evaluating this particular evidence, Dr. Blume’s opinion on this matter must be excluded.”); Chandler v. Greenstone Ltd., No. C04–1300RSL, 2012 WL 882756, at *1 (W.D. Wash. Mar. 14, 2012) (excluding Dr. Blume’s opinions on defendants’ state of mind, intent, or knowledge); Johnson v. Wyeth LLC, No. CV 10–02690–PHX–FJM, 2012 WL 1204081, at *3 (D. Ariz. Apr. 11, 2012) (excluding Dr. Blume’s opinions on defendants’ motive, intent, knowledge, or other state of mind)).

                        FOURTH CIRCUIT

  • A number of decisions from 2013 forward by the judge overseeing multiple pelvic mesh MDLs expressed similar rulings that broadly excluded intent opinions.  For instance, in Eghnayem v. Bos. Sci. Corp., 57 F. Supp. 3d 658, 670 (S.D.W. Va. 2014), aff’d 872 F.3d 1304 (11th Cir. 2017), the court stated:

First, as I have maintained throughout these MDLs, I will not permit the parties to use experts to usurp the jury’s fact-finding function by allowing an expert to testify as to a party’s state of mind or on whether a party acted reasonably. See, e.g., Huskey v. Ethicon, Inc., 29 F.Supp.3d 691, 702, 2:12–cv–05201, 2014 WL 3362264, at *3 (S.D.W. Va. July 8, 2014); Lewis, et al. v. Ethicon, Inc., 2:12–cv–4301, 2014 WL 186872, at *6, *21 (S.D.W. Va. Jan. 15, 2014); In re C.R. Bard, Inc., 948 F.Supp.2d 589, 611, 629 (S.D.W. Va.2013). Although an expert may testify about his or her review of internal corporate documents solely for the purpose of explaining the basis for his or her opinions—assuming the opinions are otherwise admissible—a party’s knowledge, state of mind, or other matters related to corporate conduct and ethics are not appropriate subjects of expert testimony because opinions on these matters will not assist the jury.

                        FIFTH CIRCUIT

  • Greger v. C.R. Bard, Inc., No. 4:19-CV-675-SDJ, 2021 WL 3855474, at *9 (E.D. Tex. Aug. 30, 2021) (remand case precluded plaintiff expert from opining on the defendant’s “subjective intent, motives, or internal decision-making involved in [product] testing,” while permitting opinions on defendant’s “objective actions or inactions with respect to [product] testing, and the sufficiency thereof”).

                        SIXTH CIRCUIT

  • In re E. I. du Pont de Nemours & Co. C-8 Pers. Inj. Litig., 345 F. Supp. 3d 897, 902–03 (S.D. Ohio 2015) (“Courts have typically barred expert opinions or testimony concerning a corporation’s state of mind, subjective motivation, or intent.”) (MDL No. 2433)

                        SEVENTH CIRCUIT

  • In re Fluidmaster, Inc., Water Connector Components Prod. Liab. Litig., No. 14-CV-5696, 2017 WL 1196990, at *24 (N.D. Ill. Mar. 31, 2017) (MDL excluded plaintiff expert on “the motivations, intent, and state of mind of a corporation,” noting “[t]he jury will not be aided by Plaintiffs’ expert speculating about why Defendant made design changes and outsourcing decisions”).

                        EIGHTH CIRCUIT

  • Clinton v. Mentor Worldwide LLC, No. 4:16-CV-00319 (CEJ), 2016 WL 7491861, at *11 (E.D. Mo. Dec. 30, 2016) (“The question of corporate motive, intent, knowledge or state of mind is one for the jury, not for an expert . . . . Recitation of defendant’s own corporate documents does not fall within the purview of expert testimony under Federal Rule of Evidence 702.”) ( remand from MDL No. 2004); Kruszka v. Novartis Pharms. Corp., 28 F. Supp. 3d 920, 937 (D. Minn. 2014) (“The Court agrees with the parties that Dr. Vogel may not proffer an opinion relating to what individuals at Novartis thought about information found in certain internal documents or about their motivations regarding those documents.”) (remand from MDL No. 1760).

                        NINTH CIRCUIT

  • Stanley v. Novartis Pharms. Corp., No. CV1103191JGBOPX, 2014 WL 12573393, at *6 (C.D. Cal. May 6, 2014) (“[T]he opinions of [expert] witnesses on the intent, motives, or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise.”) (remand from MDL No. 1760).

                        TENTH CIRCUIT

  • Fischer v. BMW of N. Am., L.L.C., No. 18-CV-00120-PAB-MEH, 2020 WL 9259705, at *6 (D. Colo. Mar. 10, 2020) (non-MDL exclusion of plaintiff expert’s opinion on defendant’s intent) (citing In re Rezulin and Wells v. Allergan, 2013 WL 7208221, at *2 (W.D. Okla. Feb. 4, 2013)), aff’d sub nom. Fischer v. BMW of N. Am., LLC, No. 20-1399, 2021 WL 5458444 (10th Cir. Nov. 23, 2021).

                        ELEVENTH CIRCUIT

  • In re 3M Combat Arms Earplug Prod. Liab. Litig., No. 3:19MD2885, 2021 WL 765019, at *42 (N.D. Fla. Feb. 28, 2021) (MDL excluded plaintiff expert on defendant’s “state of mind, including his opinion as to what 3M ‘hop[ed],’ had ‘no idea’ about, and what 3M knew or did not know.”).

  * * *

Now the issue of the admissibility of expert testimony on a defendant’s state of mind is pending before the Supreme Court in a drug case.  Not product liability, mind you, but a criminal prosecution for importing meth, Diaz v. United States. (The Ninth Circuit’s unpublished opinion is here.)  As we noted up front, Fed. R. Evid. 704(b) precludes expert opinion on “whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense.”  After conviction, Diaz appealed to the Ninth Circuit on four grounds, three of which were pretty much walkovers due to the defendant’s procedural failings below.  The fourth related to the admission of “the government expert’s modus operandi testimony on drug trafficking organizations’ use of unknowing couriers.”  Slip op. at 5-6.  Diaz had offered a “blind mule” or “unknowing courier” defense and the government responded with testimony from an expert (who had testified many times in similar cases before the same judge), whose testimony was determined to be reliable.  On appeal and we presume below, Diaz offered an additional argument under Rule 704(b):

Finally, Diaz argues that testimony that drug trafficking organizations rarely use unknowing couriers is the “functional equivalent” of a prohibited opinion on mental state. This is contrary to our precedent. Diaz is correct that the Fifth Circuit has adopted this view, see, e.g., United States v. Gutierrez-Farias, 294 F.3d 657, 663 (5th Cir. 2002), but we have allowed such testimony so long as the expert does not provide an “explicit opinion” on the defendant’s state of mind, see, e.g., United States v. Gomez, 725 F.3d 1121, 1128 (9th Cir. 2013) (citation and internal quotation marks omitted), and the expert did not do so here.

Slip op. at 6-7.

The Supreme Court accepted Diaz’s petition for cert.  It is unusual for the Supreme Court to accept cert on an issue addressed in one paragraph of an unpublished opinion, but the quote above from that opinion indicates that a circuit split has existed for at least ten years.  Coverage of the oral argument two weeks ago indicated that multiple justices questioned the relevancy of the expert’s testimony if, to avoid Rule 704(b)’s exception, the expert’s opinion did not address whether Diaz’s “did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense,” in this case whether she was an innocent dupe or a knowing courier of the meth.  Based on the questioning at oral argument, the tension is between expert opinion that does “not state an opinion about whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense” and expert opinion that is not relevant to the defendant at all.  In terms of graphic representation, does the Venn diagram of 401 and 704(b) have an area of admissible overlapping expert opinion testimony?

This made us think about the parallels to quasi-intent testimony presented in the sort of cases against our clients.  If the government’s expert in Diaz was, as advertised, testifying about the modus operandi of Mexican drug cartels in terms of their use of couriers of drugs across the U.S.-Mexico border, then the testimony was offered to show that a blind mule is as frequent as a sighted unicorn and, thus, Diaz’s contention that she did not know she was carrying meth must be bogus.  This is akin to what is sometimes referred to as pattern and practice evidence under Fed. R. Evid. 404(b)(2).  (Because we are not criminal lawyers, we can set aside a discussion of the notice requirement under 404(b)(3) when the prosecution tries to use such evidence in a criminal case.)  Yet, the pattern and practice at issue in this testimony was not that of Diaz, but of cartels and drug carriers.  Using the language of Rule 404, evidence of other acts (by others) was offered to prove “knowledge . . . absence of mistake, or lack of accident.”  For Diaz, the argument against admissibility is that the expert’s testimony indicated that an innocent carrier is a rarity, not whether Diaz knew she was transporting meth across the border.  In our cases, plaintiffs offer a few versions of expert opinion on the defendant’s intent based on the acts of others and data relating to probabilities, although the plaintiffs are not waiting for our clients to open the door to intent testimony.

For decades, plaintiff lawyers in drug and device product liability cases have beaten the “profits over safety” drum and have tried to have experts echo the phrase from the witness stand.  Of course, savvy judges see that direct expert testimony that the defendant did, in fact, put profits over safety in making some decision would be impermissible opinion on the defendant’s state of mind.  See In re Prempro Prods. Liab. Litig., 554 F. Supp. 2d 871, 881 (E.D. Ark. 2008) (discussing exclusion of plaintiff expert’s “editorial about pharmaceutical companies putting sales and marketing before science”), aff’d in pertinent part, rev’d in part on other grounds, 586 F.3d 547, 571 (8th Cir. 2009). One way to try to get around the prohibition of intent opinions is to offer expert evidence on the defendant’s conduct that, without saying what was in the heads of defendant’s decision makers, makes clear that good companies do not make the same decisions that defendant did because they put safety over profits.  This has been used, along with other antics, to get big punitive damages awards, which require an intent finding.    There is not much daylight between this testimony and the expert’s in Diaz in terms of the relationship to the defendant’s intent.  Both are framed in terms of the supposed intent of others to draw a contrast. 

Another way to try to get around the prohibition on expert opinion on the defendant’s state of mind involves statistical flim flam.  We have seen variants used in civil RICO, third party payor, and public nuisance litigation, among others, but it all follows a familiar pattern regardless of the theory of liability.  Based on analysis of data of orders, prescriptions, dispensation, reimbursement, etc., the statistician/economist/mouthpiece can opine, in essence, that it is overwhelmingly likely that the defendant’s actions were taken with the requisite intent or that it is overwhelmingly unlikely that they were taken for an innocent, non-culpable reason.  Again, regardless of how the expert comes up with the percentage (which is an issue for Rule 702), is there a fundamental difference in terms of relevance between an expert opining that 98% of drug carriers are not “blind mules” and an expert opining that 98% of off-label prescriptions result from intentional off-label promotion?  (Any opinion from an expert on why prescribing physicians, particularly physicians not in the case, prescribed specific medical products is inherently suspect anyway.)  We could go on.

We do not know what the Court will hold in Diaz in connection with the interplay between Rule 401 and Rule 704(b) in terms of expert opinion on the intent of individuals or entities other than the defendant.  We do strongly suspect, however, that the decision could provide ammunition to oppose the sort of veiled expert opinion on intent—itself a response to the twenty-plus year history of decisions prohibiting the unveiled variant. 

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In early Summer we will be attending yet another bench and bar conference on Multidistrict Litigations.  The organizer of the conference recently asked us to switch from a panel focusing on MDL problems to a panel discussing potential solutions.  Of course, we agreed, because we’re all about being cooperative and constructive. Right?  Not really. Grousing is easier than fixing.  That’s especially true on this topic.  Any reader of this blog has been subjected to our incessant criticism of MDLs – the warehousing of meritless cases, the asymmetrical discovery, and the grinding settlement machinery.  When we scan the MDL landscape, we see a lot more dysfunction than efficiency. 

But every once in a while, we see an MDL court take charge, get things right, and commence the crucial process of separating the wheat from the chaff.  There is almost always way more chaff than wheat. 

We wish the decision in In re Paraquat Products Liability Litigation, 2024 U.S. Dist. LEXIS 57124 (S.D. Illinois Feb. 26, 2024), involved prescription drugs or medical devices, but it’ll do. Plaintiffs claimed injuries from exposure to Paraquat.  The court early on entered a case management order (CMO) relating to “Deceased Plaintiffs’ Submissions and Cases Based on Implausible Theories of Proof.”  The MDL court tells us that the CMO reflected the court’s concern “about the presence of cases on its docket that present implausible or far-fetched theories of liability, and therefore would not have been filed but for the availability of this multidistrict litigation.”  

How nice to have a court that actually recognizes the if-you-build-it-they-will-come problem with MDLs, and actually is bothered by it.  The court identified four categories of implausibility: (1) no information concerning their exposure to the product in question, (2) no medical evidence to support a diagnosis of the relevant injury, (3) claims “to have used [the product] in a form in which it never existed,” and (4) “other evidentiary issues.”   

To rid the docket of garbage cases, the court entered an order requiring 25 plaintiffs to produce follow up discovery to show exposure to Paraquat.  What was the result?  Nine of the 25 plaintiffs selected for discovery ended up dismissing their cases.  That is a dropout rate just shy of 40%, which is the percentage of frivolous cases in most MDLs we have labored in, at least by our (skeptical) lights. Those dismissals “only reinforced the Court’s concern about the proliferation of non-meritorious claims on the docket of this MDL.” 

Indeed.  

The court then asked a Special Master to take a closer look at the inventory to look for evidence of Paraquat exposure. It turns out that there was precious little of such evidence.  The court then rather charitably allowed that this “may be because such proof  does not exist, or it may instead be because the relevant documentary evidence is in the possession, custody, or control of a third party.”  Would you care to guess how we’re placing our bet?

The MDL court decided to get down to real business. It ordered each plaintiff in the MDL to produce documentary exposure and dosage information, and to subpoena third parties if necessary. Put up or shut up.  

That is a great MDL order.  Is there any hope of squeezing something like that in proposed Fed. R. Civ. P. 16.1?  One can dream. 

We do not think that the Paraquat MDL is an aberration in terms of the high percentage of meritless cases. But it is an aberration in terms of having a Judge who very quickly got very serious about forcing plaintiffs to show they had actual cases, and that they weren’t merely parking lawsuits with the hope of extracting settlement dollars after doing no work and having no valid claims.  

We intend to discuss the Paraquat MDL at the bench and bar conference.  It shows that the defense-side’s persistent grousing about junk inventories is valid.  But, even better, it shows how early vetting and putting plaintiffs to their proofs can lighten the docket considerably.  

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Here is the latest guest post from our Reed Smith colleague, Kevin Hara. He examines whether a prevailing party in litigation can recover, as “costs,” the expenses of witness depositions conducted remotely – a question that has arisen with increasing frequency since the COVID-19 pandemic prompted a general trend towards use of remote depositions. Since our clients could be on either side of this issue, Kevin’s research addresses both sides. As always, our guest bloggers deserve all the credit (and any blame) for their efforts.

Continue Reading Guest Post – Are Remote Deposition Costs Recoverable by the Prevailing Party?  Maybe, Yes, Maybe, No.
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We’ve discussed decisions applying preemption under the Public Readiness & Emergency Preparedness Act (hereafter “PREP Act”), 42 U.S.C. §247d-6d, on several occasions since the COVID-19 pandemic began.  At this point, some four years after the COVID-19 pandemic declaration, we believe that sufficient PREP Act preemption precedent has accumulated, and that the caselaw is sufficiently favorable to the defense position in product liability litigation, that we should start scorecard for PREP Act preemption in the product liability context.

This favorable state of legal precedent is not surprising, given the PREP Act’s broadly preemptive language concerning products used to combat COVID-19.  That language becomes effective upon a federal declaration of public health emergency.  42 U.S.C. §§247d(a), 247d-6d(a)(1), which in this instance occurred on March 17, 2020.  85 Fed. Reg. 15191 (HHS 2020).  Under the PREP Act, a “qualified countermeasure” includes any “biological product” (such as vaccines) used “to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease).”  42 U.S.C. §247d-6d(a)(2)(A)(i).  The PREP Act also contains strong “liability protections” for “covered countermeasures” and “covered persons,” which are defined terms:

(1) Covered countermeasure

The term “covered countermeasure” means −

(A) a qualified pandemic or epidemic product (as defined in paragraph (7));. . . . [or]

(C) a . . . biological product . . . that is authorized for emergency use in accordance with [pertinent portions of the FDCA.]

42 U.S.C. §247d-6d(i)(1). The term “biological product” includes vaccines.  42 U.S.C. §262(i)(1).

(2) Covered person

The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means −. . .

(B) a person or entity that is −

(i) a manufacturer of such countermeasure;

(ii) a distributor of such countermeasure;. . . or

(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

42 U.S.C. §247d-6d(i)(2).  Obviously, a vaccine manufacturer is a “covered person.”

For both “covered persons” and “covered countermeasures” the Act provides extensive preemption:

(8) Preemption of State law

During the effective period of a declaration . . ., or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act.

42 U.S.C. §247d-6d(b)(8).

This language reflects “clear congressional intent that the prescribed remedies be exclusive.”  Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580, 587 (5th Cir. 2022).  “To encourage voluntary participation in the distribution of these countermeasures, the Secretary of [HHS] invoked the [PREP Act], to provide legal immunity for the individuals and organizations who provided these countermeasures to the public.”  Leonard v. Alabama State Board of Pharmacy, 61 F.4th 902, 905 (11th Cir. 2023).  The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005:

To encourage the expeditious development and deployment of medical countermeasures during a public health emergency . . . [by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . .  In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.

“The PREP Act & COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures” 1, 1 (Cong. Res. Serv. April 13, 2022) (available here) (emphasis added).  See, e.g., Cannon v. Watermark Retirement Communities, Inc., 45 F.4th 137, 139 (D.C. Cir. 2022) (quoting this publication).. “The purpose of the PREP Act, as supplemented by the amended PREP Act declaration, was to encourage covered providers to implement covered countermeasures as quickly and broadly as reasonably possible without fear of liability.”  Mills v. Hartford Healthcare Corp., 298 A.3d 605, 630 (Conn. 2023) (citation omitted).  “Under this plain, clear, and unambiguous language, the PREP Act was designed to prevent lawsuits that would arise from the physical provision of covered countermeasures to the end-user.”  Pugh v. Okuley’s Pharmacy & Home Medical, 224 N.E.3d 619, 2023 WL 5862281, at *3 (Ohio App. Sept. 11, 2023).

To be clear, many of the cases just cited will not appear in our scorecard because they do not involve product liability at all – or, as stated in the statute, the “administration” of any “countermeasures.”  PREP Act preemption has not been extended to, for example, nursing homes allegedly failing to use countermeasures (e.g., Cannon, supra); doctors claimed to have committed malpractice in non-COVID-19 aspects of treating patients who also happened to have the disease (Mills, supra); or workplace injury litigation concerning the production, but not administration, COVID-19 countermeasures (Pugh, supra).  None of those situations involves the type of claims that our clients retain us to defend.

In litigation against a “covered person” over a “covered countermeasure,” the PREP Act has one exception to its preemptive scope, a statutory cause of action for intentional misconduct.  42 U.S.C. §247d-6d(d)(1).  We’re not aware of anyone purporting to try that yet, since it’s quite difficult to pursue.  In case someone does, here are the prerequisites to bringing such a claim.  First, a plaintiff must seek recovery for “death or serious physical injury” − no medical monitoring garbage allowed – “proximately caused by willful misconduct.”  Id.  “Willful misconduct means “an act or omission” done:  “(i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.”  Id. §247d-6d(c)(1)(A).  Second, the claim can only be filed in the United States District Court for the District of Columbia before a special three-judge panel.  Id. §247d-6d(d)(5), (e)(1).  Third, the government must have already brought an enforcement action against the defendant for the claimed conduct.  Id. §247d-6d(c)(5)(A).  Fourth, any private action for willful misconduct claim must be accompanied by both (i) specified sworn verifications signed by both the plaintiff and a plaintiff’s expert and (ii) “certified” medical records supporting causation.  Id. §247d-6d(e)(4).  Fifth, before filing, a plaintiff must have sought and been denied compensation through the PREP Act’s administrative alternative to litigation (Countermeasures Injury Compensation Program (“CICP”)).  Id. §247d-6e(d)(1).  Sixth, the willful misconduct allegations must be pleaded with specificity.  Id. §§247d-6d(c)(1)(A), (e)(3).  Seventh, plaintiffs are not entitled to discovery until after motions to dismiss have been decided.  Id. §247d-6d(e)(6).

With that, here is our scorecard:

  • Kehler v. Hood, 2012 WL 1945952 (E.D. Mo. May 30, 2012).  Motion to dismiss third-party indemnification claims granted.  PREP Act immunity bars claims related to vaccinations.  Pre-COVID.
  • Parker v. St. Lawrence County Public Health Dep’t, 954 N.Y.S.2d 259 (N.Y. App. Div. Nov. 1, 2012).  Dismissal of all claims affirmed.  Lack of parental consent to vaccination preempted.  Pre-COVID.
  • Casabianca v. Mount Sinai Medical Center, 2014 WL 10413521 (N.Y. Sup. Dec. 2, 2014).  Motion to dismiss denied.  The decedent was never administered a vaccine or received any other influenza countermeasure.  Therefore, his malpractice claim would not be dismissed.  Pre-COVID.
  • Avicolli v. BJ’s Wholesale Club, Inc., 2023 WL 5862281 (E.D. Pa. April 7, 2021).  Summary judgment denied.  An issue of fact remained whether that product (hand sanitizer) allegedly causing harm had been manufactured and sold after the HHS declaration of emergency, and thus not in response to the emergency.
  • Perez v. Oxford University, 2022 WL 1446543 (Mag. S.D.N.Y. April 11, 2022), adopted, 2022 WL 1468438 (S.D.N.Y. May 10, 2022).  Motion to dismiss granted.  The only possible claim for alleged complications of vaccination under the PREP Act is for willful misconduct.  Since plaintiff has not brought such a claim, the action must be dismissed, because this court has no jurisdiction.
  • Arbor Management Services, LLC v. Hendrix, 875 S.E.2d 392 (Ga. App. June 22, 2022).  Denial of motion to dismiss affirmed.  Plaintiffs’ allegations solely concerned nursing home visitation, staffing, recreation, and socialization, rather than the administration of a “covered countermeasure” such as a drug, device, or other object as identified in the PREP Act emergency declarations.
  • Storment v. Walgreen, Co., 2022 WL 2966607 (D.N.M. July 27, 2022).  Motion to dismiss granted.  Vaccines are covered countermeasures.  An allegation that the plaintiff fainted after receiving a vaccine is preempted, since it cannot be divorced from the process of  administering the vaccine.  Plaintiff may seek recovery through the federal countermeasures fund.
  • T.C. v. Pfizer, Inc., 2022 WL 17578871 (S.D. Cal. Nov. 9, 2022), aff’d, 2024 WL 511872 (9th Cir. Feb. 9, 2024). Motion to dismiss granted.  Vaccines are covered countermeasures.  Defendant is facially immune from suit in this Court under the PREP Act.
  • Iannelli v. Citrus Memorial Hospital, Inc., 2022 WL 20690949 (Fla. Cir. Nov. 15, 2022).  Motion to dismiss denied.  PREP Act preemption requires covered injuries caused by use or administration of covered countermeasures, not the failure to use countermeasures.
  • Goins v. Saint Elizabeth Medical Center, 640 F. Supp.3d 745 (E.D. Ky. Nov. 19, 2022).  Motions to dismiss granted and denied.  All claims against manufacturers and pharmacies distributing COVID-19 vaccines, including battery, are preempted.  Vaccines are covered countermeasures.  “Administration” of a vaccine thus refers to the logistical work it takes to provide it.  Absent allegations that the physician and hospital defendant were involved with the vaccination, those claims are not dismissed and are remanded.  Claims concerning post-vaccination medical treatment are not preempted.  Affirmed in part and reversed in part, 2024 WL 229568, below.
  • Cowen v. Walgreens Co., 2022 WL 17640208 (N.D. Okla. Dec. 13, 2022).  Motion to dismiss granted.  Vaccines are covered countermeasures.  That plaintiff intended to get a flu, not a COVID-19, vaccine does not change that the claimed injuries are related to the COVID-19 vaccine plaintiff allegedly received by mistake.  Plaintiff’s it-could-have-been-a-different-vaccine argument is rejected.
  • Politella v. Windham Southeast School Dist., 2022 WL 18143866 (Vt. Super. Dec. 28, 2022).  Motion for judgment on the pleadings granted.  Clams that the plaintiff’s child was vaccinated without parental consent are related to and dependent on the vaccination and within the scope of PREP Act preemption.
  • Wilhelms v. ProMedica Health Systems, Inc., 205 N.E.3d 1159 (Ohio App. Jan. 18, 2023).  Grant of motion to dismiss reversed.  A factual question remained whether plaintiff’s bedsores were causally related to the defendants’ use of a respirator as a COVID-19 countermeasure, or whether the cause was unrelated general medical care.
  • Hansen v. Brandywine Nursing & Rehabilitation Center, Inc., 2023 WL 587950 (Del. Super. Jan. 23, 2023).  Motion to dismiss denied.  Plaintiff did not allege administration of a countermeasure, which would have been preempted, but only basic infectious disease prevention, which would be necessary whether or not COVID-19 was involved.
  • M.T. v. Walmart Stores, Inc., 528 P.3d 1067 (Kan. App. April 28, 2023).  Partial denial of motion to dismiss reversed and all claims dismissed.  Vaccines are covered countermeasures, and all persons involved in administration of vaccines are covered persons.  Plaintiff cannot allege that an approved COVID-19 vaccine was not actually a vaccine.  Judicial notice supplies the facts plaintiff failed to plead.  Negligence claims, including those of action and those of omission, are covered by the PREP Act when they are causally related to the administration or use of a covered countermeasure.  No exception to PREP Act preemption exists for informed consent claims.  Claims alleging violation of parental consent rights are preempted since they are causally related to the vaccination.  Complete preemption cases have no bearing on the defensive preemption at issue here.
  • Santo v. Genesis Healthcare, Inc., 2023 WL 3493880 (Del. Super. May 16, 2023).  Motion to dismiss denied.  Except for one allegation relating to personal protective equipment, plaintiff’s complaint relates to general nursing home infection prevention unrelated to COVID-19.  Defendant can seek summary judgment against the one claim if plaintiff pursues it.
  • Gibson v. Johnson & Johnson, 2023 WL 4851413 (E.D. Pa. July 28, 2023).  Motion to dismiss granted.  All claims against the manufacturer of the COVID-19 vaccine administered to the plaintiff prisoner are dismissed.  PREP Act immunity precludes federal False Claims Act claims.  PREP Act preemption extends to affiliated corporations of vaccine manufacturers.
  • Maupin v. Klein’s Pharmacy & Orthopedic Appliances, 2023 WL 5334034 (Ohio C.P. Aug. 7, 2023).  Motion to dismiss denied.  Although a dispensing pharmacy is a PREP Act distributor, the pleadings do not establish whether the administering employees had the training and certifications necessary to be “qualified persons” under relevant PREP Act declaration amendments.
  • Bird v. State, 537 P.3d 332 (Wyo. October 26, 2023).  Summary judgment affirmed.  All claims brought by state prisoners are preempted.  The state could order vaccination, and vaccines are covered countermeasures.  Conduct that is negligent or reckless in administering a COVID-19 vaccine is immune from suit and liability for both federal and state law claims.
  • Estate of Carter v. Cambridge Sierra Holdings, LLC, 2023 WL 8351512 (C.D. Cal. Oct. 20, 2023).  Motion to dismiss denied as to PREP Act preemption.  Pleadings did not establish that nursing home was a covered person making a choice to allocate or administer countermeasures.
  • Garcia v. Welltower OpCo Group LLC, 2023 WL 8047821 (C.D. Cal. Nov. 15, 2023).  Motion to dismiss denied.  Plaintiffs do not allege the administration of any government-identified form of COVID-19 countermeasures, therefore the claims are not preempted.
  • Perez v. Ransome, 2024 WL 198908 (M.D. Pa. Jan. 18, 2024).  Motion to dismiss granted.  Vaccines are covered countermeasures.  All claims against vaccine manufacturer and prison vaccine administrator are preempted, including allegations of synergistic injury.
  • Goins v. Saint Elizabeth Medical Center, Inc., 2024 WL 229568 (6th Cir. Jan. 22, 2024).  Dismissal affirmed in part and reversed in part.  PREP Act preemption bars all claims concerning the decedent’s vaccination.  Claims involving other allegedly negligent treatment not involving COVID-19-related medical care not preempted.  Partially reversing 640 F. Supp.3d 745, above.
  • Baghikian v. Providence Health & Services, __ F. Supp.3d __, 2024 WL 487769 (C.D. Cal. Feb. 6, 2024).  Motion to dismiss granted.  All claims against manufacturers of antiviral medicines used to treat COVID-19 are preempted.  Just as vaccines are covered countermeasures, so are antivirals.  Informed consent claims are preempted.  Plaintiffs fail to state a willful misconduct claim, and could not bring it in this court.
  • Fust v. Gilead Sciences, Inc., 2024 WL 732965 (E.D. Cal. Feb. 22, 2024).  Motion to dismiss granted.  All claims against manufacturers of antiviral medicines used to treat COVID-19 are preempted.
  • Happel v. Guilford County Board of Education, ___ S.E.2d ___, 2024 WL 925471 (N.C. App. March 5, 2024).  Grant of motion to dismiss all claims affirmed.  Preemption extends to all claims relating to vaccinations, including informed consent claims.  Plaintiffs have not brought a willful misconduct claim.
  • Willsey v. United States, 2024 WL 1012956 (S.D. Ind. March 8, 2024).  Motion to dismiss granted.  The United States is also a covered person against which all claims relating to vaccination are preempted.  Claims that the government collaborated with pharmaceutical companies during the COVID-19 pandemic to develop vaccines and encouraged Americans to take them relate to vaccines and their rollout and are preempted.  The PREP Act applies regardless of good faith.
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The orders denying untimely, post-remand attempts to amend complaints in the Taxotere litigation are piling up, and it doesn’t get old.  We recently reported on one such denial in the Northern District of California.  In recent weeks, district courts in New York, North Carolina, and Tennessee (among others) have joined in.  Today we report on three of those decisions.

Continue Reading More Taxotere Remand Courts Deny Untimely Amendments
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Lately we have been thinking that perhaps nothing stirs a plaintiffs’ lawyer more than a product liability mass tort except an economic loss class action. 

Why?  Money, for one.  Control, for another. 

We regularly complain that plaintiffs’ lawyers save money by doing little-to-nothing to investigate their clients’ personal injury claims in product liability MDLs.  It may not be much, but plaintiffs’ lawyers do have to do a little work in product liability mass torts.  They advertise for clients (misleadingly or otherwise), enter into attorney-client relationships, and pay some filing fees (even if the complaint mis-joins numerous unrelated plaintiffs).  Then as the litigation progresses, they should be consulting with their clients about key litigation developments and perhaps, at some point, they even develop their clients’ evidentiary cases. 

But in economic loss class actions, plaintiffs’ lawyers do even less.  They just need to find a few named class representatives—friends, relatives, and neighbors are readily-available candidates—to say they purchased a product that was purportedly misleading and allegedly “worthless” (or at least “worth less” than they paid).  Indeed, every one of the purported class representatives in this case were also plaintiffs in another class action, brought by the same lawyers, making the same claims about a different brand of the same type of product several years earlier.  Cf. Woodhams v. Pfizer Inc., No. 18-CV-3990 (JPO), 2019 U.S. Dist. LEXIS 54478, 2019 WL 1432769 (S.D.N.Y. Mar. 29, 2019).

By picking their clients, rather than the other way around, plaintiffs’ class action lawyers don’t need to bother with advertising for clients, and they can represent thousand or hundreds of thousands of putative class members without having to actually deal with all those folks as individuals.  That gives plaintiffs’ lawyers a lot more control over how they run these cases, requires a lot less file-keeping and financial outlay, while at the same time holding the promise of sizeable potential returns in the form of their attorneys’ fees taken out of the class recovery.  From a plaintiffs’ lawyers’ perspective, what’s not to love?

Woodhams v. GlaxoSmithKline Consumer Healthcare Holdings (US), LLC, No. 18-CV-3990, 2024 U.S. Dist. LEXIS 51550, 2024 WL 1216595 (S.D.N.Y. Mar. 31, 2024), fits the economic loss class action mold.  It is a story that started six years ago, in 2018, with some less-optimal summary judgment rulings along the way.  But the ultimate ending of the Woodhams story is good for the defense:  Class certification denied.

The Woodhams tale began with a putative nationwide class action brought by several class representatives on behalf of purchasers who allegedly were misled into paying a premium for “Maximum Strength” cough syrup between 2016 and 2018. 

The Maximum Strength cough syrup label clearly—and accurately—stated that a dose was 20 ml, and also that each such dose contained 20 mg per 20 ml of dextromethorphan and 400 mg per 20 ml of guaifenesin. 

The Regular Strength cough syrup label clearly—and accurately—stated that a dose was 10 ml, and each such dose contained 20 mg per 10 ml of dextromethorphan and 200 mg per 10 ml of guaifenesin. 

In other words, if you bought the Regular Strength product and took a single dose, you would get 20 mg of dextromethorphan and 200 mg of guaifenesin, whereas if you bought the Maximum Strength product and took a single dose, you would get 20 mg of dextromethorphan but more guaifenesin (400 mg).  As the Maximum Strength label clearly—and accurately—stated, this “maximum strength claim [was] based on [having] maximum levels of active ingredients per dose” pursuant to FDA regulations.

Even though the respective labels correctly told consumers how much to take and what active ingredient amounts they would get in each dose, and even though the Maximum Strength formula had the maximum strength allowed by the FDA per dose of dextromethorphan and guaifenesin, the class action lawyers said the Maximum Strength label was misleading because the dosage sizes were different between the products, meaning the Maximum Strength was less concentrated than the Regular Strength product.  Got that?  Good, because we don’t.

Anyway, the Woodhams court began by recognizing that the named plaintiffs haled from different states (California, Colorado, Michigan, Missouri, New York), and that it thus had to apply the consumer protection and unjust enrichment laws of each state where each plaintiff allegedly bought the Maximum Strength cough syrup.  Despite that, the court viewed the states as using effectively the same “reasonable consumer” standard to evaluate whether the Maximum Strength label was misleading.  See, e.g., Ebner v. Fresh, Inc., 838 F.3d 958, 965 (9th Cir. 2016) (“Claims under the [California Consumer Legal Remedies Act and California Unfair Competition Law] are governed by the ‘reasonable consumer’ test. Under this standard, Plaintiff must show that members of the public are likely to be deceived. This requires more than a mere possibility that [the] label might conceivably be misunderstood by some few consumers viewing it in an unreasonable manner. Rather, the reasonable consumer standard requires a probability that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.”).

So were the named plaintiffs deceived by “Maximum Strength” and did the deception cause them to make their purchase? 

When asked in deposition whether they would consider a dose of the Maximum Strength cough syrup to be “maximum strength” if it contained the maximum quantity of active ingredients per dose permitted by the FDA, the plaintiffs responded affirmatively.

Despite this, the Woodhams court denied summary judgment on the ground that “Maximum Strength” still might be deceptive because, in the judge’s view, “Maximum Strength” potentially signaled both the maximum quantity of active ingredients per dosage, and the maximum concentration of active ingredients per bottle.  That is perhaps an example of a court substituting its judgment for that of the purported actual purchasers, and we think incorrect.

The Woodhams court also evaluated whether the named plaintiffs had sufficient evidence that they purchased the Maximum Strength cough syrup given that they did not have receipts, and given that none of their drug store loyalty/rewards accounts reflected purchases of the cough syrup.  Here, the court said that testimony about purchases was sufficient to get to the jury for all but one of the named plaintiffs.

This is another ruling we take issue with, because we think all the named plaintiffs had enough contradictions and problems with their testimony to tank all of their claims.  The plaintiffs who survived summary judgment testified in deposition to purchases omitted, or different, from the complaint or their interrogatory responses, or to purchases that did not show in their loyalty/rewards accounts (because every single one of them supposedly was in a hurry or forgot to use their card when the cough syrup was purchased).  The testimony excerpts are far from convincing, even on the cold, hard page, but the court though there was enough to let the proof of purchase (or product ID) issue go to the jury.  (The plaintiff who was dismissed on summary judgment gave testimony that the court viewed as hypothetical:  although she was “certain” she purchased the Maximum Strength cough syrup, that certainty was because if it was on the shelf, she would have “gone for it,” and she admitted she did not know if Maximum Strength was on the shelf when she made her purchase in “October or November of 2016.”) 

Fortunately, these same inconsistencies came back to haunt the named plaintiffs on class certification. 

Turning to the Rule 23(a) factors, the court recognized that the named plaintiffs’ typicality, and adequacy to represent the class, would be hurt by the unique defenses applicable to them—namely, that the credibility issues raised in the defendant’s summary judgment motion would “unacceptably detract from the focus of the litigation to the detriment of absent class members.”  The court denied class certification because it concluded

[T]hat Plaintiffs would have to devote substantial attention to overcoming their damaging deposition testimony and addressing concerns regarding their credibility on material facts, including whether they even purchased [the Maximum Strength cough syrup] during the relevant time period. Taken together, these issues render Plaintiffs inadequate class representatives. The Court thus concludes that the Rule 23(a) prerequisites are not met, and therefore that Plaintiffs’ motion for class certification must be denied. Accordingly, the Court does not reach the question of whether Plaintiffs have met the Rule 23(b) requirements.

So, is it all’s well that ends well with our tale?  The denial of class certification is effectively the end of the lawsuit.  But it took six years, and came long after certification was denied in a nearly identical lawsuit, Al Haj v. Pfizer Inc., No. 17 C 6730, 2020 U.S. Dist. LEXIS 51658, 2020 WL 1330367 (N.D. Ill. Mar. 23, 2020).  So, probably not.  Good result in the end, but all’s not quite well, even if it ended well.

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Before we dive into today’s case, Avrin v. Mentor Worldwide LLC, 2024 WL 115672 (C.D. Cal. March 15, 2024), we offer two preliminary observations:

1. We love to hear from our readers.  Sometimes we get emails commenting on a post.  Often, those comments arrive in the form of gushing reviews. That’s nice.  Less often, people gripe about a post, telling us that we got something wrong, or elided over some complexity, or descended into rank punditry.  Guess what? That’s nice, too.  If lawyers suffer hurt feelings from criticism, they are in the wrong business.  Sometimes clients express gratitude for providing a user-friendly resource for spelunking into difficult legal issues.  That’s nice.  Last week a prospective client during a pitch meeting showered the blog with praise.  That’s not only nice, but gives us hope that the prospective client will soon become an existing client. And sometimes colleagues send us cases that are interesting and blog-worthy.  That’s not only nice, it’s a huge help. Our gratitude is enormous, and not quite fully captured by our usual tip of the cyber cap at the end of a case discussion (and which you will see at the bottom of this post). 

2. Express preemption for medical devices applies to manufacturing defect claims.  We’d like to think that is a self-evident proposition.  But we encounter many plaintiff lawyers and, sadly, some courts, that think that while express preemption might put the kibosh on design defect and warning claims, manufacturing defect claims somehow escape preemption.  We are working on several cases where our preemption notion eliminated every product liability claim … save for manufacturing defect.  We also have cases where manufacturing defect was the only claim, as if the plaintiff thought that such leanness or restraint would avoid a preemption headache.  To be sure, the manufacturing defect claims are occasionally design defect claims in disguise.  Moreover, most manufacturing defect claims never get to the finish line, because there is simply no evidence of any deviation from design specs.  Rather, the manufacturing defect claim presumes that an alleged malfunction itself proves the manufacturing defect.  Wrong. But wouldn’t it be splendid if we could head off all those debates by embracing our old friend, preemption?

That’s what the court did in Avrin.  The plaintiff alleged that she developed Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) from implantation of the defendant’s textured breast implants.  (The name of the injury is not great from the perspective of a defendant contesting medical causation.) The plaintiff alleged that the process of producing the defendant’s textured shell produces adulterated implants with excessive silicone debris fragments and particles that remained on the implants in violation of the FDA’s quality system regulation and current good manufacturing practice (CGMP) requirements. 

It’s not hard to see how the plaintiff was trying to evade 21 USC section 360k(a), which bars any claim that would impose any health safety oriented  requirement on a Pre-Market Approved (PMA) medical device (which the class III breast implants are) that is “different from, or in addition to, any requirement” developed by the FDA. The plaintiff’s proposed evasion follows the “parallel claim” route, in which the plaintiff asserts that the medical device violates both federal and state law.  A parallel claim must navigate the “narrow gap” between merely enforcing federal law or contradicting it, neither of which is permissible. 

The plaintiff’s manufacturing defect claim attacks the process by which the defendant manufactures the implants at issue. As such, the claim would require the defendant “to have manufactured, designed, or marketed the [implants] in a manner different from, or in addition to, the FDA’s PMA of the [implants].”  The plaintiff argued that she was not asking to impose any requirement different from or in addition to the federal regulations; rather, her claims paralleled federal requirements that products be manufactured in conformance with CGMP and not be “adulterated.”  

This maneuver is nothing new. It seems to be part of the current plaintiff lawyer playbook. Sometimes they get away with it. Sometimes they don’t. 

Avrin is in the latter, happier, sane category. The Avrin court reasoned that “saying the implants were ‘adulterated’ does not invoke a magic word that automatically saves plaintiffs’ claims from preemption.”  If the plaintiff succeeded in her lawsuit, she would force the manufacturer to stop using the precise manufacturing process approved by the FDA.  Moreover, because her claim was that the process caused not only her breast implants to be “adulterated,” but many or all of the relevant implants to be adulterated, the lawsuit would “encourage, and in fact require, lay judges and juries to second-guess the balancing of benefits and risks of a specific device to their intended patient population — the central role of FDA — sometimes on behalf of a single individual or group of individuals.”  

It’s good to know that “magic words” such as manufacturing defect, adulteration, or CGMP do not make medical device preemption disappear.  Chalk Avrin up as one for the good guys, and be ready to cite it the next time your client gets hit with the manufacturing defect/adulteration evasion. 

The plaintiff also alleged failure to warn. There was a choice of law question as to whether California or Colorado law applied.  California might have recognized a claim for failure to warn based on failure to report adverse events (boo/hiss), while Colorado law would not. The plaintiff was a resident of Colorado, Colorado had the greater interest in having its law applied to its citizens, so Colorado applied, and, therefore, the failure to warn claim was a goner.  

We are grateful to Dustin Rawlin for sending this case our way, and we congratulate him, Monee Hanna, Rachel Byrnes, and the entire Nelson Mullins team for earning such an excellent result.

Photo of Michelle Yeary

So plaintiffs learned in the In re: Gardasil Products Liability Litigation, MDL 3036, 2024 WL 1197919 (W.D.N.C. Mar. 20, 2024).  Try as they did in 550-paragraph and 120-page complaints to muddle their claims, the court cleared away the muck and found what was left was almost all preempted by the Vaccine Act.

While pending motions to dismiss were stayed when the MDL first was created, the court gave defendants permission to file two bellwether Rule 12 motions.  Defendants chose a case under New York law and one under North Carolina law.  Defendants moved to dismiss all design defect and manufacturing defect claims and certain failure to warn and fraud claims.  To put defendants’ preemption claims in context, the court provides a thorough summary of the Vaccine Act.  Most importantly pointing out that the Vaccine Act creates a “no-fault compensation system funded by vaccine manufacturers.”  Individuals who allege injury as a result of a vaccine can file a petition for compensation in Federal Claims court.  The quid pro quo for this compensation system, “is the provision of significant tort-liability protections for vaccine manufacturers.”  Id. at *6.  Those protections include preemption of design defect claims and of direct-to-consumer failure to warn claims.  Id. 

The preemption of design defect claims is so clear cut that plaintiffs did not argue against it.  Rather, they argued that they were not making such claims.  Even going so far as to tell the court at oral argument that they “scrubbed the word “design” from the complaints in response to [defendants’] earlier successful motions to dismiss.”  Id. at *7.  But a global search and replace for the word design wasn’t persuasive for the court.  “[T]he Court must look at the true nature of the allegations, not just how Plaintiffs have self-described their claims.”  Id.  That analysis led the court to find several design defect claims that plaintiffs tried to hide under negligence or manufacturing defect causes of action:

  • Claims that the ingredients in the vaccine are dangerous is a design defect claim.  Because the FDA approved those ingredients, an attack on them is an attack on the design of the product.  Id.
  • Claims that the vaccine was not properly developed or inadequately tested challenge the design of the product.  Inadequate testing is a “not an independent wrong.”  Rather, because the vaccine was approved based on that testing, it is an “attack on the design of the approved vaccine.”  Id. at *8.
  • Allegations that a product is not safe and effective “is effectively an allegation that the entire design of the vaccine is defective.”  Id.

Similarly, in their manufacturing cause of action, plaintiffs alleged, upon information and belief, that the defendants failed to comply with manufacturing specifications and protocols required by the FDA.  Id. at *10.  While that is the technical definition of a manufacturing defect, what plaintiffs allege in support is that the “vaccine recipe itself, not any specific instances of improper manufacturing, is the problem.”  Id.

A claim that all the doses of a vaccine are inherently and unreasonably dangerous when manufactured as intended is not a “manufacturing defect” claim. Rather, it is an allegation of a “design defect,” which is barred by the Vaccine Act.  Id. (emphasis in original).

Therefore, plaintiffs “upon information and belief” manufacturing allegations are contradicted by their own allegations that the dangerous ingredient is in every vaccine on the market.

On failure to warn, the Vaccine Act only allows claims for failure to warn medical providers.  Claims premised on failing to warn plaintiffs, their parents, or the general public, direct-to-consumer claims, are expressly barred.  Id. at *8-9.  The wording of the Act says there is no liability in a civil action “solely due to the manufacturer’s failure to provide direct warnings to the injured party.”  Id. at *9.  Having lost on this issue in every other federal court, this time plaintiffs tried to argue that “solely” meant a direct-to-consumer failure to warn claim could proceed here because plaintiffs were also alleging a failure to warn medical providers.  The court “decline[d] the invitation to reach such an absurd result.”  Id. Plaintiffs’ interpretation would “nullify the prohibition” on direct warning claims.  So, only failure to warn the learned intermediary survives.

The last claim at issue was for fraud.  To the extent plaintiffs’ fraud claims were premised on an alleged failure to warn, they suffer the same fate as plaintiffs’ failure to warn claims—no fraud directed to plaintiff.  Id. at *11.  Plaintiffs tried to argue that the statutory prohibition did not include intentional tort claims, but once again the court found plaintiffs’ interpretation “would significantly undermine, if not fully eliminate” the quid pro quo established by the Act.

With respect to fraud on medical providers, plaintiffs’ complaints fail to meet the heightened pleadings standard of Rule 9.  Plaintiffs conceded they had not pleaded the time, place, or content of any allegedly fraudulent statements made to plaintiffs’ medical providers, but tried to blame that lapse on doctors not liking to talk to plaintiffs’ lawyers.  Neither we nor the court thought much of that excuse. The court found the failure to plead these essential elements “dooms their claims.”  Id. at *12.  That left only plaintiffs’ fraudulent concealment claims which the court determined was to be held to a more lenient pleadings standard.  Further as the discovery on this claim would overlap with the permitted failure to warn medical providers claim, the court sort of a took a no harm, no foul approach leaving for summary judgment the differences of proof needed for the two claims.

The court also denied any leave to amend as pointless given the advance stage of the case.  So, these claims are gone and what remains is a significantly pared down case.