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The complaint in Robinson v. Ethicon Inc., Action No. H-20-3760 (S.D. Tex.) was filed in 2013.  To put that in perspective, Amazon’s first Alexa-enabled device, the Echo, wasn’t on the market.   There’s a good chance you weren’t running your phone on 4G yet.  And, if you were using earbuds with your phone, you were still untangling their wires.  The selfie-stick had yet to be invented.   We only had one Avengers movie.  We hadn’t yet heard of The Good Place or The Marvelous Mrs. Maisel, in fact original programming on Netflix only just began in 2013 (House of Cards).  This lawsuit was filed before binge-watching??

And while all of that was coming to be – Robinson sat in the Ethicon pelvic mesh MDL.   Until last year when it was remanded to Southern District of Texas.  And that’s around the time plaintiff realized she didn’t have the expert evidence she needed on alternative design.  So, plaintiff offered two “supplemental” reports from experts designated in the MDL.  The reports were not really “supplements,” but rather entirely new opinions by generic experts based on information that was available at the time they authored their original reports.  Fortunately, the remand court saw through the disguise and struck the reports as untimely  (see post here).  Which teed up defendants’ motion for summary judgment and the subject of today’s post.

To start, having had their expert reports on alternative design stricken, plaintiff’s first argument was that Texas law does not require evidence of a safer alternative design in medical device cases.  Robinson v. Ethicon Inc., 2021 U.S. Dist. LEXIS 210191, *9-10 (S.D. Tex. Nov. 1, 2021).  It is accurate that the Texas products liability statute states that the section on safer alternative designs does not apply to drugs or devices, but that statute also states that it does not supersede Texas common law which does require proof of a safer alternative design in drug/device cases, notwithstanding the statutory exclusion.  Id. at *10.  Because plaintiff’s design defect claim is a common law claim, the requirement applies.  Id.

Plaintiff alleged seven different alternative designs, but upon closer inspection none fit the bill.  The first four were actually alternative procedures or alternative products, neither of which is the same as an alternative design.  Plaintiff focused her response on whether these different procedures/products had less risk or were economically or technologically feasible at the time of plaintiff’s surgery.  But that did not answer the question raised by defendants – whether they were different products or procedures.  Plaintiff failed to offer evidence that the alternative procedures/products she was relying on and the product used in her surgery were “essentially the same kind of product and procedure” with the distinction being only “one of degree.”  Id. at *15.

Plaintiff’s fifth alternative design was one she offered for the first time in response to defendants’ motion for summary judgment and one for which she had no evidence that it would have prevented her injuries.  Id. at *16-17.  Plaintiff attempted to rely on testimony from her implanting surgeon that he primarily used the alternative product.  But his testimony did not include anything about whether that product was a viable alternative for plaintiff or carried other risks.

[N]either the court nor the jury can make the logical leaps needed to go from this snippet of testimony to the conclusion that a [different product] was a safer alternative design, even viewing the testimony in the light most favorable to Robinson.

Id. at *17.  Not to mention, it was also a different product, so this alternative design failed on two grounds.

For alternative design number 6, plaintiff argued that the same device could have been manufactured with larger pores and that meshes with larger pores cause less complications.  To support her argument, plaintiff provided evidence that defendant submitted a premarket approval application to the FDA for a mesh with larger pores, but the product was never approved.  Id. at *18-19.  Under Texas law, an alternative design must “be capable of being developed.”  Id. at *21.  Lack of FDA approval is clearly an obstacle to development, but the court left open the possibility that a plaintiff with expert evidence that “the FDA likely would have approved this design” may be able to support a safer alternative design.  What such expert testimony would need to be is just speculation since plaintiff here did not have a regulatory expert.  Id. Plaintiff also had no evidence from a case-specific expert that a mesh with larger pores would have been safer for her.  Generic expert testimony on the safety of larger pores did not suffice.  Id. at *20.

Finally, as a seventh alternative design plaintiff offered a device made from a different material.  Unlike design number 6, the FDA has approved the use of this material for mesh but not for the treatment of urinary incontinence which is what plaintiff was treated for.  Plaintiff, citing an old Bone Screw case (talk about days before binge-watching, back then we had to watch commercials!), tried to rely on off-label use.  Id. at *22.  The court seemed to have the same question we did – so what:

Thus, while the court agrees with [plaintiff] in general that physicians often use their medical training and expertise to prescribe a drug or possibly use a product in a way that the FDA has not approved, it is unclear practically how that impacts the proposed alternative designs in this case and [defendant’s] obligations under FDA regulations.

Id. at *25.  So, here to plaintiff was lacking either a regulatory expert on “capable of development” or a case-specific expert on “likelihood of preventing plaintiff’s injury.”  Without any alternative design evidence, plaintiff’s design defect claim failed.

That left the court to decide plaintiff’s negligent misrepresentation claim which appears to be a failure to warn claim.  So, defendant argued it should be dismissed based on the learned intermediary doctrine.  Id. at *29-30.  Unfortunately, plaintiff’s implanting surgeon testified that he only warned plaintiff about risks in the product’s Information for Use which did not include the risk of chronic or long-term pain.  Had the warnings been included he would have provided them to plaintiff who testified she would not have agreed to surgery with the device.  Id. at *31-32.  So, eight and one-half years after filing suit, a lone failure to warn claim survives.  Just think, in another eight and one-half years maybe we’ll finally have those flying cars we were promised in the 60s.

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Plaintiffs like to file complaints that join multiple plaintiffs in a single action. They think that doing so gives them added leverage in settlement discussions. They think that because they know that if they get to a jury, a jury is—no matter the evidence—more likely to find in favor of the plaintiffs and against the defendant if multiple people claim to have suffered similar injuries as a result of using the defendant’s product.

In Bergman v. Johnson & Johnson, 2021 WL 5028417 (D. Minn. 2021), two plaintiffs claiming injury from pelvic mesh implants sued the manufacturer for failure to warn of the risks allegedly associated with its devices. The two plaintiffs received different devices in separate procedures performed by different doctors in different hospitals five years apart. Each plaintiff claimed to have suffered a variety of injuries, but there was only partial overlap between their alleged injuries.

The defendant moved to sever the plaintiffs’ respective claims, arguing that the claims did not meet the standard for joinder. The court granted the motion and severed the plaintiffs’ claims.

Federal Rule of Civil Procedure 20 allows plaintiffs to join in one action “if (A) they assert any right to relief jointly, severally, or in the alternative with respect to or arising out of the same transaction, occurrence, or series of transactions or occurrences; and (B) any question of law or fact common to all plaintiffs will arise in the action.”

Although both plaintiffs claimed to have been injured by pelvic mesh products manufactured by the defendant, the Bergman court held that the plaintiffs’ claims did not “aris[e] out of the same transaction, occurrence, or series of transactions or occurrences.”

The court found that plaintiffs’ claims were “similar but not the same” given that they involved different injuries allegedly caused by different pelvic mesh products implanted in different procedures by different doctors in different hospitals at different times. The court concluded that given those differences the plaintiffs’ respective claims did “not arise from a single transaction or occurrence.” 2021 WL 5028417, at *2–3.

The court rejected the plaintiffs’ contention that “the common transaction or occurrence was the Defendants’ marketing campaign for their pelvic mesh products” because, said the court, “the marketing of medical devices is a personal, doctor-by-doctor undertaking” and the plaintiffs did not even attempt to show that the “interactions between” the defendant’s “marketing personnel” and the plaintiffs’ respective doctors “were the same.” 2021 WL 5028417, at *3.

The court might well have added that doctors evaluate warnings and select particular medical devices and drugs based on each patient’s medical history and current condition, which will never be the same in different patients. Given such necessarily individualized decision-making—which is the very basis for the learned-intermediary doctrine—it is hard to imagine any product-liability case involving prescription medical products in which the joinder of two plaintiffs’ claims is appropriate.

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There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease that has wrought much controversy and dysfunction: the Riegel “parallel claim” exception to medical device express preemption. Thankfully, like an efficacious vaccine or a non-horsey paste therapeutic, the Fifth Circuit prevented further spread of the malady. (Yes, we are aware that a Fifth Circuit panel recently stayed the federal vaccine mandate, so we’ll not push the disease-fighter analogy too far.)

The case under consideration today is Naquin v. Medtronic, Inc., 2021 U.S. App. LEXIS 31121 (5th Cir. Oct. 18, 2021). The plaintiff claimed that an implantable cardiac defibrillator (ICD) was defective. What was wrong with it? As James Bond muttered in the great pretitle sequence in Goldfinger, “Shocking. Positively shocking.” A shocking defibrillator is a bad thing. It needed to be replaced. The plaintiff sought damages under the Louisiana Products Liability Act (LPLA) under the theory of defective construction, defective design, failure to warn, and breach of express warranty. The plaintiff also alleged that the defendant breached a contract in which the defendant promised to provide reliable 24/7 service. So basically the plaintiff threw in every possible theory available under the Louisiana statute. And then some. Perhaps the plaintiff lawyers should be congratulated for not including trover and replevin.

The defendant filed a motion to dismiss based on express preemption via the Medical Device Amendments Act, which says that no state may impose safety requirements on a Class III medical device if such requirements are different from or in addition to the federal requirements. The ICD was a class III medical device that had undergone the rigorous premarket approval process. It was clear that the plaintiff’s complaint “would require a jury to decide whether there existed an alternative design for the product that was capable of preventing [the plaintiff’s] damage and whether the safety benefits of that design outweighed the burden on the manufacturer of adopting such alternative design.” The complaint also asked the jury to rewrite the federally approved warning. Such Louisiana “standards” (a jury verdict would amount to state “standards”) relate to safety and would be preempted to the extent that they are different from or in addition to the FDA’s requirements.

Inevitably, the plaintiff invoked the Riegel “parallel claim” exception, which calls off federal preemption if the claim is created by state law and perfectly parallels federal requirements. If the state requirements are truly parallel, nothing is in addition or different. The district court in Naquin was unimpressed by the invocation of the parallel claim exception and dismissed the complaint. The plaintiff appealed.

We are used to reading appellate court discussions of the parallel claim exception that focus on how a plaintiff must thread the needle by relying on state law – it cannot be a private cause of action premised on the federal requirements – while being completely consistent with federal law. But here, the Fifth Circuit’s analysis was simple because the complaint hardly said anything. A plaintiff must plead facts supporting what is, in essence, an exception to a defense. As the Naquin court held, “parallel state law claims fail if they are pleaded in an impermissibly conclusory and vague fashion.”

Why did the Naquin complaint fail this rather basic test?

First, the complaint “baldy asserts that the [ICD] lead was adulterated, defective, malfunctioned, and failed.” That is not good enough. And the complaint does not get any less conclusory even when it pretends to supply the requisite details.

Second, the complaint alleged that the defendant, in violation of FDA regulations, used “nonconforming material.” But the complaint nowhere stated “how a violation of federal regulations produced a manufacturing or design defect or how a specific defect caused [the plaintiff’s] alleged harms.”

Third, the failure to warn claim was conclusory, simply asserting that the products “are unreasonably dangerous because an adequate warning about the product has not been provided concerning the numerous problems, and malfunctions of these products and their component parts.” What warning? How did the lack of such warning cause anything?

Fourth, the plaintiff “failed to reproduce any specific warranty in his pleadings or specify its precise source.” All there was on warranty in the complaint was hollow bloviation, and the pleadings “failed to identify when, where, or how [the defendant] made the alleged warranty, instead listing a variety of alleged sources in conclusory fashion.” Relatively late in the proceedings, as part of an endeavor to fend off the motion to dismiss, the plaintiff referenced an advertisement on the defendant’s website, but still failed to “identify a specific web page or specific warranty terms.”

Finally, the plaintiff’s appeal of the dismissal of the breach of contract claim (which struck us as an inordinately silly claim) was a goner because the district court’s dismissal of that claim was accompanied by an invitation to replead it. The plaintiff never accepted that invitation. A failure to replead after being granted leave to replead constitutes a forfeiture of any such claim on appeal.

The Fifth Circuit affirmed dismissal of the complaint in Naquin. In doing so, it cut back on the parallel claim exception, demanding real substance and specificity. If you hold up the deficient allegations in Naquin against those in a case you are defending, you might find that you have a solid ground for dismissal. File a motion. Do your part to fight the craziness.

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We’ve seen many plaintiffs allege that drug and/or medical device manufacturers committed “fraud on the FDA” and bemoan that Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), prevents them from recovering based on such allegations.  Buckman still doesn’t prevent them from trying every form of evasive legal chicanery known to man to include such claims.  But what plaintiffs complain about overwhelmingly isn’t fraud, and most of the time the FDA already knows about whatever a plaintiff alleges was concealed, and imposed no regulatory sanctions for it.

In our Bone Screw cases – which gave rise to Buckman – the FDA looked at everything (sundry allegations concerning improper “predicate devices” in §510(k) clearances) and never found any fraud.  Instead, the agency re-examined the issue and retroactively down-classified all “pedicle screw spinal systems” as Class II devices, which was (at worst) precisely the classification they had originally received through the purportedly “fraudulent” applications.  See Orthopedic Devices: Classification, Reclassification, & Codification of Pedicle Screw Spinal Systems; Extension of Comment Period, 63 Fed. Reg. 40025 (FDA July 17, 1998).

More recently, time and time again we’ve encountered plaintiffs complaining about supposed failure to report adverse events to the FDA when, in fact, the adverse events were already reported to the FDA (sometimes by FDA-authorized alternative means) or at worst, a late report did not result in any adverse FDA action.  At best, plaintiffs are arguing for a stricter interpretation of some FDA regulation than the FDA itself uses.  At worst, the purported “fraud on the FDA” is simply a figment of the pleader’s imagination, with no facts to support the allegations.  For instance, among failure-to-report claims we find:  Weaver v. Ethicon, Inc., 2017 WL 680725, at *7 (S.D. Cal. Feb. 21, 2017) (plaintiff “has not presented specific instances of actual adverse events that Defendant failed to report”), aff’d, 737 F. Appx. 315 (9th Cir. 2018); Paturzo v. Boston Scientific Corp., 2017 WL 8220600, at *5 (C.D. Cal. April 21, 2017) (the “complaint must include allegations of actual adverse events that Defendants did not report”); Grant v. Corin Group PLC, 2016 WL 4447523, at *7 (S.D. Cal. Jan. 15, 2016) (same); Caton v. Stryker Sustainability Solutions, Inc., 2015 WL 12426110, at *8 (C.D. Cal. May 12, 2015) (“Plaintiff has not pled that Defendants had any reports”); Bueno v. St. Jude Medical Inc., 2013 WL 12142536, at *4 (C.D. Cal. Sept. 24, 2013) (plaintiff “merely baldy asserts that Defendants failed to report”); Felger v. Smith & Nephew, Inc., 222 F. Supp.3d 746, 755 (D. Alaska 2016) (no unreported events identified); Cline v. Advanced Neuromodulation Systems, 17 F. Supp.3d 1275, 1286 (N.D. Ga. 2014) (“Plaintiff does not clearly allege that Defendant outright failed to file an MDR for these events”); Simmons v. Boston Scientific Corp., 2013 WL 12130261, at *4 (C.D. Cal. Jan. 14, 2013) (“bald” failure-to-report allegation).  We’re sure if we did more than just lift case quotes from Bexis’ book, we’d find plenty more where these came from.

To put the plaintiffs’ almost-always-made-up fraud-on-the-FDA claims further into perspective, we offer the recent decision, United States v. Carter, 15 F.4th 26 (1st Cir. 2021), where the government successfully prosecuted a claim for fraud on the FDA.  Carter exemplifies what fraud on the FDA really looks like, and Carter bears no resemblance to the trivial pursuits that plaintiffs allege in civil actions.

Carter involved the concealment of unlicensed pharmaceutical manufacturing in guise of “pharmacy compounding.”  The defendants were company executives charged, and convicted, under 18 U.S.C. §371 for “interfering with and obstructing” the ability of the FDA properly to oversee their company’s practices.  15 F.4th at 29.  The case was on appeal by the government because after the defendants were convicted, the district court entered post-judgment verdicts of acquittal.  Id.  We blogged about that decision here.

The Court of Appeals in Carter reversed and reinstated the fraud-on-the-FDA convictions.  Id.

So what were the defendants convicted of doing?  To explain that requires a little background in FDA regulation of pharmacy compounding.  Pharmacy compounding has a long history and is an entirely legitimate practice.  Ordinarily the states regulate the practice of pharmacy, but since compounding involves modification of prescription drugs, it can fall within the general purview of the FDA, particularly when performed on a large scale.

We’ve touched on pharmaceutical compounding in the blog, here and here for example – but mostly in connection with the First Amendment decision, Thompson v. Western States Medical Center, 535 U.S. 357 (2002), which invalidated an FDA prohibition on advertising by compounding pharmacies.  The FDA had imposed a ban-speech-first method of preventing compounding pharmacies from morphing into unregulated drug manufacturers and undermining the FDA’s regulatory scheme − which as we’ve explained elsewhere is very similar to what the FDA has been doing with off-label speech for decades.

After losing the Western States case, the FDA came back with non-speech-related metrics (which it could also do for off-label promotion) to determine when a pharmacy was making an “inordinate” amount of not-really-compounded products.  The chief thing that the FDA looked at was whether a particular pharmacy sold compounded drugs for patients whose physicians had actually written prescriptions specifying a compounded version of a drug.  Shortly after Western States:

[The FDA] reiterated that, for enforcement purposes, [it] would continue to draw a line between, on the one hand, compounders that operated like traditional retail pharmacies . . . and, on the other hand, compounders that operated like manufacturers. . . .  The FDA . . . specified that one of the factors it would consider in determining whether a compounder fell into this latter category of manufacturers was whether it compound[ed] drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.

Carter, 15 F.4th at 36.  Carter involved fraud on the FDA primarily in evading this “valid prescription” requirement through various forms of anticipatory compounding in the absence of existing prescriptions.

Here is what the jury looked at in convicting the Carter defendants of criminal fraud on the FDA.

First:

[T]he defendants agreed to participate in a conspiracy by which [the company] would regularly misrepresent to the FDA that it was shipping its compounded medications to customers . . . pursuant to valid, patient-specific prescriptions.  Yet, . . . the company was processing the customers’ orders for those medications without there being any such prescriptions.

Carter, 15 F.4th at 31.

One of the acts of conspiracy for which the jury convicted the defendants involved a practice called “backfilling,” meaning that the company:

allowed customers to place their first order for medications without supplying any prescriptions or patient names.  [It] then collected from customers the roster of patient names to whom these customers ended up prescribing and administering the medications on site.

Id.  Thereafter, the company either “attached such a [patient] roster . . . retrospectively” or “used it to process a subsequent order by the same customer” – in both instances making it appear that orders had been filled “only after” receiving valid prescriptions.  Id.

Another aspect of the conspiracy involved inventing prescriptions out of thin air by:

  • process[ing] orders using the names of celebrities or fantasy characters that customers had supplied, such as “Michael Jackson” and “Wonder Woman”;
  • us[ing] the names of customers’ staff members or those of previous patients that customers had supplied;
  • Us[ing] a given patient name for multiple medications and for multiple units of the same medication in a single order.

Carter, 15 F.4th at 32.

A third method of avoiding the FDA’s prescription limits did not bother with fake prescriptions at all.  Rather:

[The company] processed some customers’ orders using just the names of those institutional customers . . . even though the customer was a hospital or medical facility that would then itself later dispense the drug to a patient and thus was not itself a patient for whom a prescription had been issued.

Id.

Thus, the indictment of these defendants alleged:

that [they] helped [the company] deploy these methods despite knowing that the company was representing to the FDA that it was a compounding pharmacy that dispensed drugs only pursuant to valid prescriptions for individual patients and therefore was not subject to the FDA’s [good manufacturing practice] regulations that govern drug manufacturers.  In setting forth this allegation, the indictment highlighted several statements allegedly made by the defendants that purportedly showed their awareness of both the alleged scheme and the regulatory background in which [the company’s] scheme was taking place.

Carter, 15 F.4th at 32.  See also Id. at 32-33 (describing the evidence at trial that supported the convictions).  “The jury found [the defendants] guilty of the §371 [conspiracy to defraud the FDA] count each faced.”  Id. at 33.

On appeal, the defendants didn’t really deny having done the things for which the jury convicted them – except as a subsidiary point.  Instead, they pursued the same legal impossibility theory that had succeeded in the district court.  This time, however, they lost.  They claimed that, after Western States, there was “no discernible federal law” for them to violate, and that the FDA’s prosecutorial discretion based on filling pre-existing prescriptions was merely “guidance” lacking force of law.  Carter, 15 F.4th at 36.  Essentially, the defendants argued that their elaborate ruse to disguise their lack of prior prescriptions from the FDA was unnecessary, because the prior prescription “safe harbor” from enforcement didn’t really exist, given that the FDA was powerless to act.

First, Carter held that, even if the FDA had mistakenly disavowed regulatory authority that it actually had in the wake of Western States, that mistake was “not written in stone.”  Id. at 42.  Rather, the FDA could correct that error “at any time.”  Id.  Indeed these fraudsters by their deceit may well have “lulled the agency into not determining that it needed to reverse course.”  Id.  Thus, “impossibility” by virtue of mistaken disavowal of actual authority bit the dust as a matter of law.  We’ll skip the lengthy discussion in Carter of why that theory also failed on the specific facts of that case.

The second prong of impossibility postulated that the FDA had “abstained from exercising its regulatory authority over compounders as a result of its uncertainty about its own authority” even in the absence of a specific disavowal of such authority.  Carter, 15 F.4th at 45.  That failed, as well:

[W]e do not find persuasive the notion that it was legally impossible for the defendants to have conspired to interfere with a government function just because it was unclear during the life of the conspiracy whether the government had that function or understood itself to have it. . . .  [W]e do not see how it would be legally impossible for the defendants to conspire to trick the government into wrongly concluding through misrepresentations about [the company’s] means of operating that it could not be regulated pursuant to that function.

Id. at 46.  Instead, the defendants had been convicted of “an alleged conspiracy to trick the FDA into thinking that a company subject to its regulatory authority was operating differently than it was in order to conceal the fact that its actual manner of operating would make it subject to more intensive regulatory oversight.”  Id.  In other words, the defendants could not take advantage of their own hoodwinking the FDA into thinking they were operating in a legal gray area, when in fact they had gone well beyond any gray area.  There was “no basis for concluding that the ambiguity about the FDA’s authority . . . precluded it from being reasonably clear at the relevant time that the defendant’s conduct was criminal.”  Id. at 47 (citation and quotation marks omitted).

We go back to the facts that established fraud on the FDA.  It’s hard to get around all those faked prescriptions.

The convicted defendants’ related Due Process claim failed for essentially the same reasons.  Id. at 48.  “[T]he uncertainty . . . regarding FDA authority does not preclude it from being reasonably clear that a conspiracy to pass off [the company] as a kind of compounding pharmacy that it was not − through the stratagems detailed [above] − was one prohibited by §371.”  Id. at 49.

Predictably, the defendant’s throw-away argument challenging the factual basis of the fraud on the FDA failed.  When you email your employees to remind them that “[a]ll names must resemble ‘real’ names no obviously false names! (Mickey Mouse),” id. (emphasis original), it’s hard to convince an appellate court, or a jury, that there was no fraudulent intent.

So we return to where we started.  There’s a damn good reason why private plaintiffs are not, and should not, be allowed to assert fraud on the FDA.  99% of the time the allegations are false, trivial, or based on a regulatory interpretation that the FDA does not share.  Without the FDA taking enforcement action, a private plaintiff cannot prove materiality, since the FDA itself cannot be deposed.  And as for the remaining 1% − Carter demonstrates what the Supreme Court held in Buckman Co. v. Plaintiffs Legal Committee:  “the federal statutory scheme amply empowers the FDA to punish and deter fraud against [it], and this authority is used by [the FDA] to achieve . . . [its] statutory objectives.”  531 U.S. 341, 348 (2001).  We’re strongly pro-defense, but we in no way defend what the jury concluded happened in Carter.

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Here’s something we’ve never seen before in a mass tort MDL.  In In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2021 WL 3375941 (E.D. Pa. Aug. 3, 2021), two former MDL plaintiffs who had suffered summary judgment against their claims were allowed to rejoin the MDL – to assert legal malpractice claims against their former attorney – who also happened to be a member of the group of attorneys controlling litigation decisions on the plaintiff’s side of the Zoster.

Previously, these plaintiffs had been bounced because they filed their action well after the expiration of Pennsylvania’s two-year personal injury statute of limitations.  “[E]specially telling” were statements that the recipient plaintiff made to his employer shortly after his vaccination:  that he was suffering a “[r]ash from shingles vaccine” and that he had “developed a dry cough and some fever which persists.”  Juday v. Merck & Co., 730 F. Appx. 107, 111 (3d Cir. 2018) (affirming summary judgment).  Eight months after losing that appeal, plaintiffs, represented by “new counsel,” sought to vacate the summary judgment entered against them.  In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 329 F.R.D. 151, 153 (E.D. Pa. 2018), aff’d, 799 F. Appx. 137 (3d Cir. 2020).  Plaintiffs now claimed that “that their original counsel did not seek to take any depositions or propound any discovery before [defendant] moved for summary judgment.”  Id. at 154.  No dice:

We will not allow plaintiffs to be relieved from the judgment entered against them because of buyers’ remorse after their prior counsel made a deliberate, maybe improvident, decision in a lawsuit.  Under the present circumstances, mere dissatisfaction with one’s counsel’s decisions and unhappiness about an adverse result is not a basis for undermining the finality of judgments.

Id. at 155 (citation omitted).

So plaintiffs brought a legal malpractice action.  But they did more than that – they sought to intervene in the MDL that had already expelled them once.  The MDL judge allowed it, since the elements of legal malpractice require the plaintiff to prove a “case within a case,” that the original action would have succeeded but for the defendant attorney’s malpractice.  2021 WL 3375941, at *1.  The evidence required to do that resided, if at all, in the MDL:

[I]t is clear that [plaintiffs’] malpractice action involves common questions of law and fact with this multidistrict litigation.  Both deal with issues related to the design and effect of [the product], the warnings provided, and whether there is a causal connection between [the product] and various illnesses allegedly sustained by the vaccine recipients.

Id. at *2.  The court therefore modified the in-place protective order so that these malpractice plaintiffs could “obtain essential discovery in their pending lawsuit.”  Id. (requiring plaintiffs to agree in writing to be “bound by all the terms and conditions of the Protective Order”).

Even more recently the Zoster MDL judge expanded these plaintiffs’ access to include expert, as well factual, discovery.  In re Zostavax Zoster Vaccine Live Products Liability Litigation, 2021 U.S. Dist. Lexis 192687, at *3 (E.D. Pa. Oct. 6, 2021) (since “none of the parties in the MDL objects to providing [plaintiffs access to expert discovery, the court sees no compelling reason why a non-party should block access when, as here, the discovery is not in the possession of that non-party”).

That reference to a “non-party” underscores the most interesting fact of this litigation, from a defense-oriented point of view.  The attorney these plaintiffs are suing is simultaneously a member of the MDL’s “Plaintiffs Executive Committee.”  Id. at *3 & n.3.

Although it may not matter in the context of the Zoster MDL, since these plaintiffs’ situation could well be idiosyncratic, the presence of legal malpractice plaintiffs in an MDL, who are suing the same attorneys running that side of the MDL, raises interesting ethical issues that defendants should keep in mind.  Blowing the statute of limitations is a classic basis for both summary judgment and an ensuing legal malpractice claim.  There is a distinct possibility that our opponents could face a conflict of interest when the same evidence that might help the MDL plaintiffs’ cases generally might also simultaneously strengthen legal malpractice cases against the same attorney(s) making “executive” decisions for the plaintiffs as a whole.

And what if it’s not just one case, but instead a significant number of MDL-associated malpractice actions?  We got within shouting distance of something similar years ago in the Bone Screw litigation where certain attorneys tried to “park” over a thousand plaintiffs’ cases in a state court in Tennessee.  Counsel stipulated to a “universal date of discovery” that was more than one year before those actions were filed, which was problematic, given that Tennessee has an unusually short one-year statute of limitations.  Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805, 806 (Tenn. 2000).  The ensuing mass statute-of-limitations dismissal happened so late in the litigation that malpractice lawyers were never involved (unlike Zoster), but potential malpractice liability on that kind of scale could definitely affect how an opposing attorney chooses to litigate a mass tort.

And nothing prevents the same situation from arising again in a contemporaneous MDL.  Consider a decision we’ve blogged about already.  In In re Taxotere (Docetaxel) Products Liability Litigation, 995 F.3d 384 (5th Cir. 2021), the MDL plaintiffs defined their “injury” – “permanent” hair loss – as “an absence of or incomplete hair regrowth six months beyond the completion of chemotherapy.”  Id. at 387.  But they simultaneously filed cases on behalf some number of plaintiffs more than a year after that objectively measureable six-month period elapsed (Louisiana also has a one-year statute of limitations):

[W]e look to when the injury was sustained to determine when the prescription period began to run.  As a matter of law, the injury of “an absence of or incomplete hair regrowth six months beyond the completion of chemotherapy” is sustained when, six months after the completion of chemotherapy, a person has an absence of or incomplete hair regrowth.  Here, six months after the completion of chemotherapy, Appellants knew their hair loss had persisted for that length of time. . . .  We agree with the district court that Appellants’ claims are facially prescribed.

Id. at 390.  The plaintiff-side decision to define MDL-wide injury in terms of “six months” undoubtedly left a lot of other Taxotere plaintiffs likewise “facially prescribed.”  Maybe there was no other choice but to define injury in this way, but malcontented plaintiffs, similar to those encountered in Zoster, might not believe it.  Are there enough malcontents to make a difference?  We have no way to tell, but anything that discomfits the other side might be an advantage to ours.

But any significant number of Zoster-style malpractice plaintiffs asserting claims against attorneys running the plaintiff side of any MDL would create serious conflict of interest issues.  As we mentioned earlier, that creates a dynamic wherein every effort to enhance the merits of the MDL plaintiffs’ overall claims would also increase the potential malpractice exposure of those same attorneys who have to decide what to do.  We have no idea what an MDL judge might do when faced with such a conflict of interest, since Zoster is the first instance we’re aware of that injected legal malpractice issues into an MDL.  But in such a situation, defendants might be able to do more than simply pass the popcorn and watch the show.

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With November representing the 18th month of socially distanced litigation, we thought we’d take a look at what courts have said about remote (usually Zoom) depositions.  Like it or not, we think they’re here to stay.

Yes/No

The first question is whether or not to have them.  Can one side impose them unilaterally?

The answer is “yes” – at least during the pandemic.  We start with Rouviere v. DePuy Orthopaedics, Inc., 471 F. Supp.3d 571 (S.D.N.Y. 2020) – a medical device product liability case we discussed here.  Notwithstanding the plaintiff’s objection to a Zoom deposition of the defendant’s employees, Rouviere found plenty of prejudice to justify a protective order:

The hardship that would be caused to [defendant’s] witness(es) and its counsel by an in-person deposition is obvious.  There is a significant health risk to [everyone] if the deposition were to proceed in person. . . .  “[S]ocial distancing does not guarantee a safe deposition environment.  Thus, holding a deposition in a room with a witness, counsel and a stenographer present would place everyone in the room at risk.

Id. at 574-75 (citations and quotation marks omitted).

There is an exception.  A party cannot seek a Zoom deposition of a witness in another country where that procedure is contrary to that country’s law.  In Inventus Power v. Shenzhen Ace Battery, ___ F.R.D. ___, 2021 WL 4477940, at *7 (N.D. Ill. Sept. 30, 2021), the court held:

[W]ith respect to depositions, it is undisputed that the law of China prohibits depositions – voluntary or compelled – for use in foreign courts within the borders of People’s Republic of China without permission from Chinese authorities through the Hague Convention procedures.  Courts have recently confirmed that this prohibition extends even to remote testimony.

Id. at *7 (citations and quotation marks omitted).  See Document Operations, L.L.C. v. AOS Legal Technologies, Inc., 2021 WL 3729333, at *4 (5th Cir. Aug. 23, 2021) (“discovery order cannot stand” when entered in “contravention” of discovery treaty with Japan) (unreported).  For an example of a properly conducted international remote deposition, see Calhoun v. Google LLC, 2021 WL 4123979, at *5 (N.D. Cal. Sept. 9, 2021).

Concerning documents, Rouviere advocated pre-shipped documents, “or using modern videoconference technology to share documents and images quickly and conveniently.”  Id. at 575 (quoting United States ex rel. Chen v. K.O.O. Construction, Inc., 445 F. Supp.3d 1055, 1057 (S.D. Cal. 2020)).  We’re not 100% sold on this aspect of remote depositions, since giving documents to deponents in advance also gives them the means to know what’s coming.  If our side is defending depositions (as in Rouviere), that’s great; but if we’re taking them, not so good.  We often catch plaintiffs in lies with social media, surveillance video, worker’s compensation documents, and just plain medical records, and we’d like to keep doing it.  We describe the courts’ fix for this issue below.

Nor was it a serious concern in Rouviere that counsel were not comfortable with remote technology.  “[T]here are training and informational videos available online and vendors who host videoconferenced depositions are available.”  Rouviere, 471 F. Supp.3d at 575.  Assuming there would be some delays, the court granted an extra hour of deposition time.  Id.  Accord Y.M. v. Beaumont Unified School Dist., 2020 WL 8611032, at *3 (Mag. C.D. Cal. Dec. 11, 2020) (granting two additional deposition hours due to Zoom depositions proceeding more slowly).  Cf. ABA Model Rule of Professional Conduct 1.1, comment 8 (2012) (lawyer’s ethical duty of competence includes “relevant technology”).

An objection based on inability to judge the witness’ “demeanor” remotely also failed.  First, if that objection were sufficient, no remote depositions would take place, making the rule providing for them (Fed. R. Civ. P. 30(b)(4)) “meaningless.”  Rouviere, 471 F. Supp.3d at 575.  Second, since any in person deposition would require masking, remote depositions were actually superior in terms of demeanor observation:

If an in-person deposition were to be held in New Jersey, as Plaintiffs propose, then those in attendance at the deposition would need to wear masks. . . .  The witness’s wearing of a mask eliminates many of the advantages of observing the witness at an in-person deposition; however, if the witness were to be deposed remotely . . ., the witness would not need to wear a mask, giving Plaintiffs’ counsel the opportunity to observe the full face of the witness.

Id. at 576.  Accord, Joffe v. King & Spalding LLP, 2020 WL 3453452, at *6 (S.D.N.Y. June 24, 2020) (“there can be no question that mask-wearing and distancing significantly diminish the value of in-person testimony”).  Any extra expenses caused by a remote deposition would be split 50/50.  Rouviere, 471 F. Supp.3d at 576 (this is unusual).

Rouviere was followed in Mosiman v. C & E Excavating, Inc., 2021 WL 1100597 (Mag. N.D. Ind. March 23, 2021), where the plaintiff was demanding that his deposition be conducted remotely, with the defendant resisting.  The magistrate judge agreed with the plaintiff and entered a protective order.  COVID-19 health concerns constituted “good cause” under Fed. R. Civ. P. 26(c).  Id. at *2.  “Courts all around the country have found that the health concerns created by the COVID-19 pandemic are a legitimate reason to take a deposition by remote means.”  Id. (citing United States ex rel. Adams v. Remain at Home Senior Care, LLC, 2021 WL 856876, at *2 (D.S.C. March 8, 2021); Valdivia v. Menard, Inc., 2020 WL 4336060, at *1 (Mag. N.D. Ill. July 28, 2020); Sonrai Systems, LLC v. Romano, 2020 WL 3960441, at *3 (Mag. N.D. Ill. July 13, 2020)).

A remote deposition also “adequately” permitted credibility assessment.  “[M]any courts have determined that remote video depositions provide a sufficient opportunity to evaluate a deponent’s nonverbal responses, demeanor, and overall credibility.”  Id. at *3 (citing or quoting Rouviere, Learning Resources, Inc. v. Playgo Toys Enterprises Ltd., 335 F.R.D. 536, 539-40 (N.D. Ill. 2020); Pursley v. City of Rockford, 2020 WL 6149578, at *2 (Mag. N.D. Ill. Oct. 20, 2020)).

[I]n the context of the COVID-19 pandemic, depositions conducted by video conference may allow counsel to better assess a deponent’s demeanor than they could in person.  During a remote deposition, the deponent need not wear a mask to prevent the spread of COVID-19 among in-person participants.

Macias v. Monterrey Concrete LLC, 2020 WL 6386861, at *6 (E.D. Va. Oct. 30, 2020).  See also Sonrai, 2020 WL 3960441, at *4 (“ability to assess witness credibility would arguably be enhanced if the depositions are conducted via video because masks would not be necessary”); Reynard v. Washburn University of Topeka, 2020 WL 3791876, at *6 (Mag. D. Kan. July 7, 2020) (“the chance that [counsel] will be able to observe [the witness] is much higher if the deposition is conducted remotely rather than in person” due to masking).

Similarly to Rouviere, lack of technical competence failed as an excuse to oppose remote depositions in Faford v. Grand Trunk Western Railroad Co., 335 F.R.D. 503 (E.D. Mich. 2020):

The defendant says its witnesses are not technologically literate and cannot get to a place where videoconference equipment is available, either for preparation with counsel or for the depositions.  But Zoom conferences can be conducted from a smart phone, and defense counsel has not alleged that its witnesses do not enjoy even that basic feature of modern technology.

Id. at 505.  Accord List v. Fiedler, 2020 WL 5988514, at *9 (Mag. D. Minn. Oct. 9, 2020); Broiler Chicken Antitrust Litigation, 2020 WL 3469166, at *3 (Mag. N.D. Ill. June 25, 2020).

Other courts finding COVID-19 health concerns constitute “good cause” for remote depositions in contested cases include:  Rivera v. Parker, 2021 WL 3076412, at *3 (N.D. Ga. May 18, 2021) (“the Court remains hesitant to require non-vaccinated deponents in the high risk or ‘at risk’ categories to appear in person for a deposition”); Matter of Tara Crosby LLC, 2021 WL 1699883, at *4 (Mag. E.D. La. April 28, 2021) (“no other courts have yet begun to require deponents attend deposition in-person despite the release of vaccinations”); In re RFC & ResCap Liquidating Trust Action, 444 F. Supp.3d 967, 971 (D. Minn. 2020) (“[u]nder the circumstances, COVID-19’s unexpected nature, rapid spread, and potential risk establish good cause for remote testimony”); Swenson v. GEICO Casualty Co., 336 F.R.D. 206, 211 (Mag. D. Nev. 2020) (citing “widespread use of video depositions during the pandemic”), objections overruled, 2020 WL 8871311 (D. Nev. Aug. 26, 2020); Faford, 335 F.R.D. at 505 (rejecting continuance; attorneys must “adjust”); Grano v. Sodexo Management, Inc., 335 F.R.D. 411, 414 (Mag. S.D. Cal. 2020) (“As it is unknown how long the COVID-19 crisis will impact depositions and other in person meetings, it is likely that future noticed depositions for other parties’ witnesses also will be conducted by remote technology.”); Antares Maritime Pte Ltd. v. Board of Commissioners of Port of New Orleans, 2020 WL 7022752, at *2 (Mag. E.D. La. Nov. 30, 2020) (“the COVID-19 pandemic is requiring attorneys and litigants all to adapt to a new way of practicing law”) (citation and quotation marks omitted); Patterson Dental Supply, Inc. v. Pace, 2020 WL 10223626, at *4 (Mag. D. Minn. Nov. 5, 2020) (“no question” that COVID-19 is a valid reason for remote depositions); Macias, 2020 WL 6386861, at *3 (“health risks related to the ongoing COVID-19 pandemic are good cause to conduct depositions remotely”); List, 2020 WL 5988514, at *8 (deponent “at increased risk for severe illness from COVID-19 based on his age and his underlying medical conditions”); H & T Fair Hills, Ltd. v. Alliance Pipeline L.P., 2020 WL 5512517, at *2 (Mag. D. Minn. Sept. 14, 2020) (“Remote depositions are the best safeguard against COVID-19”); Grupo Petrotemex, S.A. de C.V. v. Polymetrix AG, 2020 WL 4218804, at *2 (D. Minn. July 23, 2020) (“acknowledg[ing] the indisputable health risks connected with travel and in-person gatherings during this pandemic”); Reynard, 2020 WL 3791876, at *3 (court “not persuaded by [the] argument that the risks surrounding COVID-19 are improving”); Broiler Chicken, 2020 WL 3469166, at *7 (COVID-19 risk “transcends the particular circumstances of each” witness); Joffe, 2020 WL 3453452, at *6 (“in-person depositions pose a significantly greater risk of COVID-19 transmission than a remote deposition”); Thom v. Garrigan, 2020 WL 3405714, at *3 (W.D. Wis. May 21, 2020) (“there are health and safety risks with in-person depositions, even with the safety measures proposed by defendants”), reconsideration denied, 2020 WL 3403123 (W.D. Wis. June 19, 2020); Learning Resources, 2020 WL 3250723, at *3  (“health concerns created by the COVID-19 pandemic create ‘good cause’ for the entry of an order requiring that [a witness’] deposition take place by remote videoconference”); Doyel v. ATOS IT Solutions & Services, Inc., 2020 WL 6528421, at *2 (Mag. C.D. Cal. June 15, 2020) (rejecting delay as alternative to remote depositions); Townhouse Restaurant, Inc. v. NUCO2, LLC, 2020 WL 3316021, at *1 (Mag. S.D. Fla. May 5, 2020) (“in light of the CDC’s recommendations that people stay at home as much as possible”); Chase-Morris v. Tubby, 130 N.Y.S.3d 599, 603 (N.Y. Sup. 2020) (“a majority of recent cases addressing COVID-19 issues have denied a party’s attempt to have in-person depositions”).  But see Howland v. Smith, 2020 WL 4890080, at *6 (Mag. E.D. Mo. Aug. 20, 2020) (witness with history of evading deposition could not use COVID-19 as another excuse).

Thus, it is evident that, for the duration of the COVID-19 epidemic at least, remote depositions are the “new normal” in discovery.  Rouviere, 471 F. Supp.3d at 574 (quoting In re Broiler Chicken, 2020 WL 3469166, at *5).  See also Swenson v, 336 F.R.D. at 209 n.4; List, 2020 WL 5988514, at *9; Carmon v. Saks Fifth Ave. LLC, 2020 WL 5701892, at *2 (E.D. Mo. Sept. 24, 2020); H & T Fair Hills, 2020 WL 5512517, at *3; Wilkens v. ValueHealth, LLC, 2020 WL 2496001, at *1 (Mag. D. Kan. May 14, 2020); Patterson Dental, 2020 WL 10223626, at *4; Grupo Petrotemex, 2020 WL 4218804, at *2; Chase-Morris, 130 N.Y.S.3d at 604.

Occasionally, case-specific circumstances, even during the pandemic, have supported in-person depositions.  In a suit over forged checks, where a bank’s corporate designee would be required to handle and review the original, and not merely a copy, of the instrument at issue, an in person, rather than remote, deposition was ordered, although the location was changed so that the witness would not have to travel.  See Provident Savings Bank, F.S.B. v. Focus Bank, 2020 WL 6196132, at *3 (E.D. Mo. Oct. 22, 2020) (also setting conditions and imposing costs).

Eventually, however, the pandemic will end, as will the need for masking at in person depositions.  It remains to be seen whether courts will remain willing to require remote depositions over a party’s objection when no longer supported by health concerns.  See Pruco Life Insurance Co. v. California Energy Development, Inc., 2021 WL 5043289, at *3 (Mag. S.D. Cal. Oct. 29, 2021) (notwithstanding COVID-19, denying demand for remote deposition of “controversial” witness where the parties believe the other is “dishonest”).  On the other hand, another judge has stated:

There is every reason to hope, however, that some of the lessons learned during the pandemic will invoke changes of practice which, in addition to being healthy habits, also make economic and practical sense in the post-pandemic or even post-COVID-19-vaccine world. One of those current practices that may need re-evaluation is the practice of flying attorneys, clients, and deponents around the country or the world just to take a deposition.

Brooks v. Pikes Peak Hospice, 497 F. Supp. 3d 985, 987 (Mag. D. Colo. 2020).

How

Another group of questions concerns how to conduct remote depositions via Zoom and similar platforms.  Although a party can be required to take depositions remotely, it cannot be forced to surrender the procedural safeguards that Fed. R. Civ. P. 30 provides.  See Raiser v. San Diego County, 2021 WL 118901, at *6 (Mag. S.D. Cal. Jan. 13, 2021) (defendant cannot be forced to proceed waive its right to a qualified deposition officer), adopted, 2021 WL 2886048, at *8 (S.D. Cal. July 9, 2021) (“Defendants should not be the ones devoting their energy and incurring litigation costs when it is Plaintiff who is violating procedure.”).

Courts vary on whether remote depositions preclude counsel from conducting in-person deposition preparation with witnesses they represent, should they so desire.  Broiler Chicken allowed counsel for the witness to be present:

Courts do not speak to how a lawyer must prepare a witness when they allow a witness to be deposed by remote means. They say the deposition can proceed remotely under Rule 30(b)(4) and leave it up to the lawyer and the party or the witness to decide how the witness will be prepared for the deposition.

Broiler Chicken, 2020 WL 3469166, at *4.

Likewise, an order to conduct a deposition remotely addresses the location of the deposing counsel – it does not necessarily preclude counsel representing the witness from being present with that client.  “[The parties] and their counsel, however, can choose . . . whether or not they want to be with the witness in person when the witness gives a deposition by remote means.”  Id.  Similarly in Antares, if the remote witnesses “elect to have their in-house counsel physical present during the taking of the deposition, this Court will not prevent their attendance.”  2020 WL 7022752, at *5.  However, any counsel physically present must “participate by separate video means to ensure that they are within the screen and visible to opposing counsel.”  Id.  Another example is Moses Enterprises, LLC v. Lexington Insurance Co., 2021 WL 329210 (S.D.W. Va. Feb. 1, 2021), in which “it was not an unreasonable request” to delay remote depositions “slight[ly]” so that “counsel [could] prepare the witnesses and attend the depositions in person.”  Id. at *5.

On the other hand H & T Fair Hills prohibited counsel for the witness from being present.

[Depositions] must be conducted remotely by video conferencing technology and none of the participants may be in the same room (in person with another participant), without further Order from this Court.

2020 WL 5512517, at *4 (footnote omitted).  So at least one case holds that “remote” as to one means “remote” as to all, in terms of counsel’s attendance.

Documents are also a recurring issue.  Citing Rouviere, Mosiman found concerns about the handling of documents unpersuasive as a reason to preclude remote depositions altogether.

While many documents may complicate the deposition process, . . . document-intensive depositions can be effectively conducted using remote means.  In fact, Zoom has a function for screen sharing documents, which allows for greater efficiency during depositions.  Furthermore, there are other methods that can be utilized to increase the efficiency of the process. For example, sending Bates-stamped exhibits to deponents prior to the depositions.

Id. (citations and quotation marks omitted).  Accord, Chen v. K.O.O, 445 F. Supp.3d at 1057 (recognizing “challenges to the legal community during this pandemic” but finding that “voluminous and highly detailed exhibits” do not preclude remote depositions); Antares, 2020 WL 7022752, at *4 (similar); Reynard, 2020 WL 3791876, at *5 (similar); Grupo Petrotemex, 2020 WL 4218804, at *3 (similar); Sonrai, 2020 WL 3960441, at *4 (similar).  In Adams v. Remain at Home, the court ordered, with respect to documents:

Before displaying the document to the deponent, counsel must first (1) identify it for the record, (2) have it labeled as an exhibit, (3) provide a copy electronically to all other lead counsel, and (4) obtain confirmation that all other lead counsel received the document.

2021 WL 856876 at *2 (footnote omitted).

In Broiler Chicken, 2020 WL 3469166, the court addressed our concern – mentioned above – about the handling of documentary exhibits for remote depositions.  It recognized and resolved concerns about remote deponents obtaining an unfair advantage by prohibiting recipients of pre-prepared packets of deposition documents from taking a sneak peek ahead of time:

[I]f the questioning attorney wants to use electronic exhibits at the depositions, then that attorney should deliver those exhibits in hard copy (or in whatever form the deponent and her or his attorney wants) to the deponent and/or the deponent’s attorney before the deposition, and those exhibits should not be opened by the recipient(s) until the deposition starts.  The deponent can be asked under oath at the beginning of the deposition whether she or he looked at the exhibits before the deposition began, and the envelope or container in which the exhibits were delivered even can be opened for the first time on screen, if necessary.

2020 WL 3469166, at *11.  Similar steps were taken in Joffe v. King & Spalding LLP, 2020 WL 4361754 (S.D.N.Y. July 9, 2020):

The Designated Recipients [of remote deposition documents] shall keep the package and its contents sealed until the deposition begins and shall only unseal the package and any of the contents of the package on the record, on video, and during the deposition when directed to do so.

Id. at *3.  After the deposition, the deponent had two days to return all documents.  Id.

Nor did Broiler Chicken allow the requesting side to impose its preferred remote platform on other litigants.  “Plaintiffs should not be allowed unilaterally to determine the remote video deposition platform. The parties should agree on the remote video deposition platform to be used. If they cannot do so, then the Court will decide.”  Id. at *12.

In Townhouse Restaurant, 2020 WL 3316021, the court entered a procedural order hammered out with the parties that covered many aspects of Zoom depositions:

  • The federal and local rules of civil procedure apply at all times, prohibiting speaking objections and mid-deposition witness contact.
  • The court reporter may administer the oath to the deponent remotely.
  • Only the parties and their counsel may be in the same room as any participant, unless all parties agree.
  • The court reporter’s transcript is the sole official record of the witness’s testimony.
  • Remote depositions conducted using Zoom, WebEx or a similar videoconferencing platform, with the court reporter as host.
  • Any party who wants can hire an independent videographer, but is responsible for the cost and must provide copies to all other parties at its expense.
  • Unless a videographer attends, the court reporter records the witness using the platform’s recording technology.
  • The court reporter/videographer, announces when recording is on or off.
  • The platform’s video recording of the deposition is the same as a videographer’s recording and can be used at trial.
  • No participant can use private communication (“chat”) during the deposition to contact the witness. Chat is used only to share documents.
  • No participant can text, message, email, or otherwise communicate with a witness.
  • All cellphones must be placed in silent mode, with notifications disabled to avoid disruption of the deposition.
  • The witness and all counsel and must identify themselves and must leave their cameras on during the deposition, except for breaks.
  • All documents or other exhibits, except those intended as impeachment, shall be shared with all counsel at least two days prior to the deposition, and shall be premarked.
  • By at least the day before the deposition all documents must be provided to the court reporting service.
  • All impeachment materials must be shared using the platform’s technology at the point they are first introduced.
  • If the witness loses connection, or cannot access the platform, the witness may participate telephonically.

Id. at *1-2.  See Tara Crosby, 2021 WL 1699883, at *4 (E.D. La. April 28, 2021) (similar list of remote deposition protocols, with looser document timing).  See also Broiler Chicken, 2020 WL 3469166, at *12 (“there should be no unrecorded or at least unnoted conversations between the witness and his or her attorney during a remote deposition while the witness is on the record”).  Further, these types of orders abound in multi-district litigation, and may well be worthy of their own post.

Unlike  Rouviere, most courts have required any excess costs incurred by reason of a remote deposition to be borne by the party demanding this procedure.  See Chabot v. Walgreens Boots Alliance, Inc., 2021 WL 949443, at *4 (Mag. M.D. Pa. March 12, 2021) (“the costs of copying and shipping exhibits will continue to lie with the noticing party”); Sonrai, 2020 WL 3960441, at *4 (party demanding remote deposition responsible for extra costs).

Enforcement of remote deposition orders can be problematic where the deponent is not in the same judicial district as the litigation.  In Russell v. Maman, 2021 WL 3212646, at *2 (Mag. N.D. Cal. July 29, 2021), a California court concluded that it lacked jurisdiction to sanction a non-party resident of New York to failure to appear for a remote deposition.

Then What?

After a remote Zoom deposition is completed, how can it be used?  Given the speed at which litigation moves, there is a lot less law on what happens to remote discovery after it is completed than there is about whether and how do conduct Zoom depositions.

In Alcorn v. City of Chicago, 336 F.R.D. 440 (Mag. N.D. Ill. 2020), the plaintiff tried to use videoconferencing recording technology to record remote virtual deposition, without hiring a certified videographer to complement the court reporters (who were present).  The court reporters were not videographers, and thus not willing to certify that aspect of the transcripts.  Plaintiff was not allowed to cut corners in this way:

Plaintiff’s proposal in this case is untenable.  If permitted, Plaintiff would obtain a certified transcript of the recording but an uncertified video recording of the deposition.  Yet, Plaintiff seeks to use both the transcript and the recording as equals at her discretion.  As a result, the process outlined in the Federal Rules of Civil Procedure to ensure the integrity of the deposition would be bypassed. . . .  There would be no certification that the Zoom video recording accurately captures the testimony of the deponent.  Plaintiff’s proposal essentially seeks an end-run around the procedures outlined in Rule 30.

Id. at 442.  “Nothing in Rule 30 allows a party to engage in a secondary recording or transcription of a deposition, and treat that recording as the equivalent of a certified deposition.”  Id. at 443.  After determining that an uncertified Zoom transcript would have no evidentiary value, Alcorn did permit the plaintiff (and the defendant if it so chose) to make an informal copy for his own use – “us[ing] the “Spotlight” function on Zoom, which will focus the camera view solely on the witness for the entirety of the deposition,” id. at 444-45, as opposed to “gallery” or “speaker” view.  Id.

Belated attacks on the remote deposition process have not succeeded.  In Cannon v. Anderson Business Advisors, LLC, 2020 WL 10224631 (Mag. D. Nev. July 29, 2020), the court refused to entertain allegations of witness coaching during a remote deposition where the moving party waited until after the filing of a summary judgment motion to raise such unsupported allegations.

Plaintiff did not promptly act regarding any suspicions of unethical conduct: plaintiff did not seek relief until over a month after the deposition and until after the defendant filed its motion for summary judgment.  Plaintiff has not presented any evidence that defendant’s counsel acted unethically or coached the witness during the deposition.

Id. at *2.

In Broiler Chicken, the court agreed that a videotaped trial deposition “does not need to show both the witness and his or her lawyer,” 2020 WL 3469166, at *11, rejecting that objection to later use of the testimony.

Finally, in Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation v. Ethicon, Inc., 2020 WL 9887566 (N.D. Ga. Dec. 4, 2020), the necessity to take the plaintiff’s expert’s deposition via Zoom unfortunately opened the door for the plaintiffs to get away with an extensive “errata sheet” (see our general post here) that cleaned up the expert’s testimony.

[The expert] is a German native who speaks English as a second language.  In addition, [his] deposition was conducted via ZOOM. . . .  [E]xcerpts of the deposition transcript tend to show that language was at least a factor given [the expert’s] German accent. Plaintiffs also point out that the 444-page transcript contains numerous instances where the audio was muffled or inaudible, which Plaintiffs explain contributed to the need to supplement [the] deposition testimony.

Id. at *6.  The MDL court denied the defendant’s objections to all eighteen of the challenged errata “revisions.”  Id.

More decisions on the use of Zoom deposition evidence at trial will certainly happen as the mass of COVID-19-induced remote discovery works its way through ongoing litigation.  We’ll keep a lookout for them.

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Thanksgiving is somehow just around the corner. Your bloggers are, of course, thankful for you, our loyal readers. And we want to give you – or at least those of you who may need more CLE credit before year-end — something to be thankful for as well. So we are pleased to announce that Reed Smith is once again offering its virtual “Life Sciences CLE Week” starting this Monday. (See below for information on jurisdictions in which credit is offered.) Reed Smith typically offers this program annually as an intimate, in-person event for clients, but is pleased to offer this COVID-revised version to a broader audience.

Two of your bloggers, Bexis and Rachel Weil, will be kicking things off on Monday, November 8, at noon Eastern Standard Time with an hour-long presentation on “Rule 702 – Don’t Say Daubert,” examining the amendments to F.R. Evid. 702 recently proposed by the Civil Rules Committee of the Federal Courts. In addition to explaining what the amendments are intended to do, Bexis and Rachel will discuss the problems that led the committee to conclude that amendments were necessary. We will also describe how these amendments are helpful to defendants in prescription medical product liability litigation, and what defendants and their counsel can do to help get them enacted.  To get in the mood, you can read our eponymous post on the subject, here.

The next day (Tuesday), at 3-4:00 p.m. EST, our colleagues Michael Galibois and Geoff Young will then offer a discussion on “Biometrics: What Life Sciences and Digital Health Companies Need to Know About the Evolving Litigation and Regulatory Landscape.” Currently, companies must navigate a patchwork of U.S. state and municipal biometric laws that govern the collection and use of biometric data. One such statute provides for a private right of action, significant statutory awards – reflecting thousands of dollars per violation – and is considered “ready-made” for class action treatment. Michael and Geoff will discuss how you can best protect yourselves from significant exposure with limited defenses to many of these laws.

Next up, on Wednesday, November 10, at 1-2:00 p.m. EST, our colleagues Nan Halstead and Vicki Tankle will present on “Health Care Fraud and Abuse in a Digital World.” This session will cover nuanced health care fraud and abuse and privacy risks associated with the development of, and investment in, health information technology tools, build guides, and resources. It will be geared towards drug and device manufacturers and technology companies and will provide attendees with an understanding of what constitutes health information technology; how the federal anti-kickback statute, the federal false claims act, HIPAA and other laws apply in the digital world; and best practices for compliance.

Finishing off the week, on Thursday, November 11, at 12:30-1:30 p.m. EST, our colleagues Anette Gaertner, Lisa Chiarini, and Sidharth Kapoor will discuss “Artificial Intelligence, Intellectual Property and the Life Sciences Industry – What Next?” Companies are increasingly using smart systems for a variety of applications, including assistance with drug discovery and pharmaceutical and medicinal product development. In the wake of the U.S., European, and Australian decisions regarding the DABUS “creativity machine” and its inventions, questions relating to the protection of AI-generated work products are gaining more prominence. This session will provide an update on recent developments, including whether AI systems can themselves conceive of inventions, who can apply for patent protection, and who should be designated as the inventor.

Finally, be sure to mark your calendar for December 14, 3-4:00 p.m., EST,  for our rescheduled session on “Tales from the Trenches: Lessons Learned from Two Trial Victories During the Pandemic,” presented your very own Steve McConnell and Eric Alexander, as well as occasional guest blogger Marilyn Moberg, and our colleagues Shana Russo, Ryan Blake, and Monika Holser. Two of Reed Smith’s product liability trial teams recently won defense verdicts for their life sciences clients. In this session, trial team members will reflect on key lessons learned while litigating in person during the pandemic, and offer takeaways life sciences companies can apply in both their current and post-pandemic product litigation appearances.

Each webinar is presumptively approved for 1.0 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.

To register, or for more detailed information on the credit offered for each session, please visit the registration page.

Photo of Steven Boranian

We told you that if anti-vaxxers found a sympathetic court in their quest to declare government vaccine mandates unconstitutional, we would let you know.  Well, we did not think it would be so soon.  And we surely did not think that the sympathetic court would be the United States Supreme Court.

Don’t get the wrong idea.  SCOTUS has not declared government vaccine mandates unconstitutional, and the more-than-one-hundred-year-old precedent affirming the constitutionality of government vaccine mandates is under no imminent threat.  See Jacobson v. Massachusetts, 197 U.S. 11 (1905).  The constitutionality of such mandates is not even really before the Supreme Court.

So what gives?  The Supreme Court denied an application for injunctive relief filed by the plaintiffs in Does v. Mills, the First Circuit case on which we reported a couple of weeks ago.  That is the case where the plaintiffs sued to enjoin Maine’s mandate that its healthcare workers be vaccinated against certain contagious diseases—including COVID-19.  The Supreme Court usually does not provide reasoned opinions when it denies a request for an injunction.  Here, however, Justice Barrett and Justice Kavanaugh filed a concurrence stating that extraordinary relief is not appropriate where it would require merits review of a question of first impression “on a short fuse without benefit of full briefing and oral argument.”  Does v. Mills, No. 21A90, 2021 WL 5027177, at *1 (Oct. 29, 2021).  In other words, people should not read the denial order as commenting on the merits of the dispute.

So the plaintiffs lost, but the real story here is that three justices dissented and would have granted the injunction on the basis that Maine’s vaccine mandate for healthcare workers does not provide for religious exemptions.  Id. at *1-*4.  Recall that the plaintiffs made this same argument in the First Circuit, but the First Circuit reasoned that the Maine rule did not selectively burden any religiously motivated conduct while exempting comparable secular conduct.  The rule applies uniformly, and it has only one exemption—a medical exemption that prevents the rule itself from posing a health risk.

The First Circuit’s reasoning may, in the end, carry the day.  To the extent a contrary ruling would discourage vaccination and result in illness and death that is preventable, that would be a poor outcome for the sake of public health.

Three justices of the Supreme Court apparently would have it that way.  According to the strongly worded dissent written by Justice Gorsuch and joined by Justice Thomas and Justice Alito, the Maine rule is not neutral and generally applicable, thus calling for strict scrutiny.  The problem for them is that the rule provides for some exemption, but not a religious exemption, thus creating an unequal field:

Under this Court’s precedents, a law fails to qualify as generally applicable, and thus triggers strict scrutiny, if it creates a mechanism for individualized exemptions.  . . . .  That description applies to Maine’s regulation.  The State’s vaccine mandate is not absolute; individualized exemptions are available, but only if they invoke certain preferred (nonreligious) justifications.  . . .  From all this, it seems Maine will respect even mere trepidation over vaccination as sufficient, but only so long as it is phrased in medical and not religious terms.  That kind of double standard is enough to trigger at least a more searching (strict scrutiny) review.”

Id. at *2 (citations omitted).  It seems then that an absolute mandate that provided for no exemptions of any kind (such as the one at issue so long ago in Jacobson v. Massachusetts) would not have raised the dissenters’ collective eyebrow.  It was the provision of a medical exemption without a companion religious exemption that triggered comment.

The dissenters would apply strict scrutiny for a second reason:  A law is not neutral and generally applicable if it treats “any comparable secular activity more favorably than religious exercise.”  Id.  That is the example we gave before:  A state should not prohibit large religious gathering while permitting rock concerts or trade shows of comparable size.  Maine allows healthcare workers with medical exemptions to take alternate measures, such as the use of protective gear and regular testing.  It does not, however, make those same measures available to those who resist vaccination for religious reasons.  Id.

The dissenters thus would apply strict scrutiny and would find Maine’s particular mandate unconstitutional.  In their view, the mandate does not represent the least restrictive means to achieving a compelling interest, which leads to this somewhat chilling quote:

I accept that what we said 11 months ago remains true today—that “[s]temming the spread of COVID-19” qualifies as a “compelling interest.”  [citing Roman Catholic Diocese v. Cuomo.]  At the same time, I would acknowledge that this interest cannot qualify as such forever.  Back when we decided Roman Catholic Diocese, there were no widely distributed vaccines.  Today there are three.  At that time, the country had comparably few treatments for those suffering with the disease.  Today we have additional treatments and more appear near.

Id. at *3.  This quote reminds of anti-vaxxers who argue that the risks of vaccination against childhood diseases are roughly equal to the risks of getting the diseases themselves, so why bother.  Even if that were true, the risk of getting childhood diseases today is low because of vaccines.  Just because they are available and effective does not mean that we don’t need that anymore.  Moreover, so long as potentially fatal diseases exist, the government will have an interest in preventing illness and death, and the wide availability of vaccines does not diminish that interest.

No one is arguing that Maine has to provide religious exemptions from vaccination against polio or measles.  Indeed, no appellate court since Jacobson has held that any vaccine mandate must have a religious exemption; and since California and New York both eliminated religious exemptions in the decade before COVID-19, the issue has been litigated recently.  As Bexis explained here, the dissenters’ view is unprecedented.

For reasons that are strangely political, COVID-19 is different.  The Maine plaintiffs did not prevail, but they got the attention of three Supreme Court justices, plus two others who wrote that they concurred with the denial of the injunction on procedural grounds only.  Three plus two equals . . . .  Hmm.  Stay tuned.

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We tend not to post much on appellate statute of limitations decisions.  There are a few reasons for that.  First, they are often very fact-specific, rarely delivering holdings with clear applications to other cases.  Second, because they can be fact-specific and plaintiffs are known to plead around defenses, good decisions on motions to dismiss are also the exception.  When SOL is raised on summary judgment, there can an inclination for judges who have overseen a case for a while and have trial on the horizon to find disputed facts for the jury to resolve.  Third, while decisions on statute of limitations do get appealed, the appellate decisions do not seem to get published much unless there is another issue decided on appeal, which might end up as the focus of our post.

When the defendants were dismissed in a hernia device product liability case called Nowell a few years ago, our posts focused on the federal district court’s prediction that New Mexico would adopt the learned intermediary doctrine for prescription medical device cases. See here and here.  The decision even merited an honorable mention on our 2019 top ten list because of that.  But the district court also held the plaintiff’s claims to be time-barred.  On appeal, the Tenth Circuit did not even address the merits, but affirmed on statute of limitations.  Nowell v. Medtronic, Inc., No. 19-2072, 2021 U.S. App. LEXIS 32207 (10th Cir. Oct. 27, 2021).  We like the decision precisely because it does seem applicable to other cases in our space.  While the court predicted that New Mexico would apply the discovery rule to product liability claims—something that, on its face, plaintiffs should like—its application of the discovery rule to the facts of the case as set out in the operative complaint rejected anti-SOL arguments we see frequently.

For those who handle cases involving implanted medical devices, the basic facts here should seem pretty familiar.  The plaintiff had defendants’ hernia mesh device implanted in October 2010.  Six months later, she had a revision surgery, at which time it was noted that the mesh had begun to “pull away” from the edges of where it had been placed.  Id. at *2.  For close to three years after this second surgery, plaintiff complained of pain in the area of the mesh, but did not have any diagnostic studies until March 2014.  That CT scan noted cysts “in the area associated with the mesh,” which required a drainage procedure.  Id.  Pain continued for another seven months, leading to a second CT on October 6, 2014, that revealed a fluid collection associated with the mesh that suggested infection.  Id. at *3.  Two days later, the surgeon who had performed the prior two surgeries recommended a third to remove the mesh device.  Plaintiff sued a day short of three years after the removal recommendation and, predictably, claimed that it started the three-year SOL clock for her product liability claims.  Id. at *16.

New Mexico courts had adopted the discovery rule for various personal injury (and other) claims, but not for product liability.  Even though the parties agreed that the discovery rule should apply, the court still had to predict (as a federal court sitting in diversity should) if New Mexico’s high court would adopt the discovery rule for product liability claims.  We will not dwell on that part of the decision.  The application is more interesting to us, especially given that the New Mexico Supreme Court had previously specified that inquiry notice should focus on the plaintiff’s knowledge of the factual bases of a claim—“Were the rule otherwise, the discovery rule would postpone accrual in every case until the plaintiff consults an attorney.”  Id. at *8 (citation omitted).  If that quote were amended to “until the plaintiff sees lawyer advertising or consults with the attorney who took her case,” then it would address arguments routinely raised in the sort of serial product liability that drug and device manufacturers face these days.

Plaintiff did not go quite that far, at least on appeal.  Instead, her main argument was that her three years to sue did not start until her “doctor identified the problem giving rise to the cause of action” and told her about it when recommending the third surgery.  Id. at *14.  A key consideration was that, although SOL is an affirmative defense, the discovery rule in New Mexico requires the plaintiff to establish “that if she had diligently investigated the problem she would have been unable to discover the cause of her injury.”  Id. at *15 (citation omitted).  Plaintiff tried to rely on the absence of a clear indictment of the device as the cause of her problems relayed to her by treating physicians prior to October 8, 2014, when she was advised to have it removed.  She argued that an earlier accrual date “would be unjust [because] [w]hen your doctor tells you that your injury is not cause by surgical mesh it is not reasonable to expect you to sue the surgical mesh company.”  Id. at *16.  We can almost hear the plaintiff’s deposition testimony if the case got that far.  The defendant might like the substantive admission “no doctor ever told me the mesh caused my problems” and the SOL admissions that “I understood from the doctors that mesh pulling away from the repair, cysts associated the mesh, and a fluid accumulation around the mesh were bad and could be related to the mesh.”  To these, the plaintiff would counter with a self-serving “but no doctor ever advised me that the mesh was defective,” something she learned from her lawyers (if the instruction not to answer came too late) and her retained experts.

Even without this hypothetical testimony—but with a declaration from plaintiff that the district court was within its discretion to exclude—the Tenth Circuit saw the issue with plaintiff’s approach.  “[S]he seeks to shift the burden concerning the discovery of the cause of her injury from her shoulders onto that of her treating physicians.  This she cannot do.”  Id. at *17.  A “definitive” medical opinion on the cause of the plaintiff’s alleged injuries is not needed to start the clock.  Id. at **18-19.  (Indeed, we have seen many, many plaintiffs sue without a definitive diagnosis of any claimed injuries, let alone that they were due to the defendant’s product.)  Moreover, as noted above, she had to prove a diligent investigation would not have revealed the alleged cause of her injuries before she claims to have discovered it.  She could not do it on this record, which did not include any investigation of the reason for her second surgery, the cause of her on-going pain for close to three years after her second surgery, or the cause of the cysts revealed on the CT she got more than three-and-a-half years before suing.  Id. at **20-21.  This was more than enough to put her on inquiry notice, regardless of whether she admitted in her pleadings that her physicians used magic words in describing diagnostic findings or recommended interventions.  While the facts may change slightly in future cases, defendants facing untimely cases should benefit from the Tenth Circuit’s rejection that the plaintiff has to have heard certain words from a treating physician for the clock to start.

The appellate court was also not swayed by the argument that the language in her complaint that October 8, 2014, was the first time a doctor informed her of a problem with the mesh device meant that she should not have discovered the cause of her alleged injuries before then.  The former did not mean she “never knew there was an issue with the mesh” before that conversation.  Id. at *22.  That assertion was not included, let alone supported, in her operative complaint.  As such, she sued too late even with the discovery rule.  (Her implied warranty claim was also untimely, because the statute provides that the claim accrues with the delivery of the purchased good and there is no discovery rule.  Id. at **25-27.)

We can see where plaintiffs would go with this to try to get past a motion to dismiss.  They would load up their complaints with additional self-serving statements about diligent efforts and the inability to ascertain their injuries and the link to defendant’s product until sometime within the SOL period.  Or they would just omit the dates needed to determine whether the claims were timely.  An astute court should not fall for the former given TwIqbal and should cut off the latter by granting a motion for a more definite statement under Fed. R. Civ. P. 12(e).

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Maybe we’ll keep writing about Covid-19 cases as long as there is Covid-19. That’s a depressing thought. It is depressing because Covid-19 continues to harm so many lives, both in terms of destruction and diminution. It is also depressing because so many legal challenges to Covid-19 regulations are frivolous. You might even say those challenges lack a rational basis.

The plaintiffs took the kitchen sink approach in Dixon v. DeBlasio, 2021 U.S. Dist. LEXIS 196287 (EDNY Oct. 12, 2021). The Mayor of New York City issued emergency orders requiring “covered entities” to prevent unvaccinated persons from remaining in certain indoor facilities for prolonged periods of time. The plaintiffs claimed that these emergency orders violated their rights under the Thirteenth and Fourteenth Amendment and also constituted an uncompensated taking under New York law. They sought a preliminary injunction.

Dixon did not involve vaccine mandates, though the plaintiffs suggested that the indoor restrictions had a similar effect and that such effect was fully intended. As we have written before about challenges to Covid-19 vaccine mandates, the key is the standard of review. Plaintiffs try to subject the regulations to strict scrutiny. If they fail they are left with only rational basis review. That is bad news for the plaintiffs, because under the ancient and wise SCOTUS decision in Jacobson, they surely lose. The government can undertake reasonable measures to protect public health. The government can even require vaccinations. The Constitution is not a suicide note.

To cut to the chase, the Dixon court held that rational basis review applied, and that the indoor restrictions were rational. The plaintiffs lost. Why? Even if Covid cases were declining in NYC, they were still numerous enough, the Delta variant threatened to increase that Covid rate again, airborne transmission is more likely in crowded indoor spaces, and there is a legitimate concern about placing the hospital system under stress from a surge in Covid cases.

To be sure, the plaintiffs in the Dixon case took a shot at showing irrationality and inconsistency in the emergency orders. For example, the plaintiffs argued that the exemptions for short-term athletic or entertainment performances by nonresidents made no sense. The court disagreed, deeming the exemptions to be well tailored accommodations allowing a small group of individuals to pursue their professions while still limiting their ability to spread or contract Covid.

Let’s take a mercifully quick look at the plaintiff’s theories supporting strict scrutiny, and see why the Dixon court shot them down.

    Equal Protection

The plaintiffs alleged that the emergency adversely affected two protected classes, African Americans and Hispanics, who have lower vaccination rates. But the plaintiffs’ position “is unable to withstand the simple observation that all unvaccinated individuals, regardless of race, religion, or national,origin, are treated the same” under the orders in question. The orders were facially and racially neutral, there was no evidence of discriminatory animus, and disparate rates of vaccination could be remedied by people deciding to get vaccinated.

    Freedom of Religion

Places of worship are not covered entities, so there was no plausible argument that religion was being targeted. If anything, the contrary was true. The emergency orders were facially neutral and there is ample Second Circuit authority that schools can exclude unvaccinated children from schools, even if religion was the reason why the kids were not vaccinated. Similarly, the orders do not force anyone to get vaccinated in contravention of their religion. Rather, they “merely place reasonable restrictions on those who choose not to get vaccinated, given the current dynamics of the global pandemic.”

    Freedom of Bodily Health and Integrity

Since the Jacobson decision, courts have consistently “rejected the idea of a fundamental right to refuse vaccination.” And these emergency orders “are not forcing New Yorkers to get vaccinated. They are merely placing restrictions on those who choose not to.”

Freedom of Association

The plaintiffs “want to stand in solidarity with others who are refusing to get vaccinated.” Huh? They can go ahead and hang out with other flat-earthers. What they cannot do is inflict their unvaccinated presence on others in certain specifically defined places.

    The Right to Pursue a Chosen Occupation

The orders do not prohibit anyone from practicing their profession or conducting their business. We all live with certain restrictions on our employment. Do health regulations per se prevent restauranteurs from doing business? That would be a silly argument. And while it might be a pain for restaurants to set up outdoor seating, it is usually doable, not impossible. More importantly, it is sensible.

    Thirteenth Amendment

Really? Slavery? The plaintiffs complain that the orders force some of them to check identification and vaccination records, and that constitutes forced servitude. The plaintiffs obviously never heard Bob Dylan sing about how you have to “serve somebody.” Employees at bars and nightclubs are required to check IDs for age. Many lawyers are (shudder) forced to do some pro bono. We are having a hard time deciding whether invocation of the Thirteenth Amendment to challenge this sort of thing is dumb or offensive. Okay, it’s both.

    Unconstitutional Taking

The plaintiffs themselves “barely raise this issue.” Good thing, too. There was certainly no wholesale taking of property here. At most, the plaintiffs seemed to allege “a non-categorical regulatory taking of their property.” Moreover, the emergency orders were effective for 30 days. Any economic impact was limited, speculative, and temporary. Moreover, it is old hat for courts to uphold police power/health regulations even when they adversely affect recognized real property interests.

The plaintiffs lobbed in other, even weaker, arguments. We said earlier that the plaintiff threw everything including the kitchen sink into their complaint. In truth, they also included the little washtub sink that squats next to the washing machine. The plaintiffs invited the New York federal court to overrule century-old precedent from SCOTUS cabining the meaning of the privileges and immunities clause. (We’re talking about the Slaughterhouse cases. SCOTUS probably got the issue wrong, but old precedents have more force than innovations, no matter how logical or adorable.) Amazingly, the New York court declined that invitation.

We were taught a long time ago that you do not strengthen stupid legal arguments by surrounding them with other stupid legal arguments. But maybe stupid legal arguments like hanging around with other stupid arguments. It is sort of like the Dixon plaintiffs’ freedom of association argument.

Drug & Device Resources

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