In Hayes v. University Health Shreveport, LLC, 2022 WL 71607 (La. Jan. 7, 2022), the Louisiana Supreme Court ruled that a hospital – or any other private employer – may impose an absolute vaccination requirement and fire any employee who fails to comply. The case involved medical centers that notified all employees that they were required to be fully vaccinated against Covid-19 by October 29, 2021. Employees not vaccinated by the specific time were subject to disciplinary action, including mandatory use of leave time and, ultimately, termination. This policy permitted exceptions to the vaccine mandate if there were valid religious and medical reasons. Thirty-nine employees subsequently filed a lawsuit seeking injunctive relief and a declaratory judgment that the vaccination mandate was unlawful.

In the eyes of the Louisiana Supreme Court, the issue was a simple one because the plaintiffs were at-will employees. That means that an employer is at liberty to dismiss an at-will employee and, reciprocally, an at-will employee is at liberty to leave the employment and seek other opportunities. So, while you might think that the vaccine mandate by a medical employer is especially necessary and appropriate, that fact actually hardly matters in this case.

To be sure, at-will employment rights are tempered by federal and state provisions, both constitutional and statutory. For example, an employer cannot engage in racial discrimination against at-will employees. Be that as it may, none of those limitations helped the anti-vaxxer employees in the Hayes case. The plaintiffs’ constitutional arguments were premised on a right to refuse medical treatment and a right to privacy. But both of those rights under Louisiana law are triggered by governmental action. Here, the employer was a private, nongovernmental entity.

As far as we can tell, Hayes is the first Covid state supreme court decision on this point. The outcome seems clear and decisive. But to get to that outcome, the Louisiana Supreme Court had to reverse a rogue appellate court decision. The trial court in Hayes had ruled in favor of the employers. But the Court of Appeal reversed, holding that termination of employment, notwithstanding the at-will employment doctrine, would have unlawfully abridged the employees’ constitutional rights. The Court of Appeal remanded to the trial court with instructions to enter a temporary restraining order against the vaccination requirement. The employer then filed a writ application with the Louisiana Supreme Court, requesting that the Court of Appeal’s decision be stayed. The Supreme Court granted the stay, and then reached its decision on the merits, reversing the Court of Appeal. The trial court’s ruling was reinstated, meaning that the employees’ action was dismissed and the employer was entitled to terminate employees for failure to comply with the vaccine mandate.

Today’s case is not a drug or device case, but a COVID nursing home case.  We are not blogging on the underlying substance of the case but rather on plaintiff’s motion to remand after a snap removal.  The case – Carroll v. Comprehensive Healthcare Management Services – is pending in the Western District of Pennsylvania.  So, the result should not really come as a surprise since the Third Circuit was the first federal appellate court to approve snap approval.  See Encompass Ins. Co. v. Stone Mansion Restaurant Inc., 902 F.3d 147 (3d Cir. 2018).  But the Western District opinion does explore and shoot down the latest arguments plaintiffs have developed to oppose snap removal – or removal before service.

In Carroll, plaintiff was an Ohio resident and defendants were either citizens of Pennsylvania or New York.  2022 U.S. Dist. LEXIS 6092, *6 (W.D. Pa. Jan. 12, 2022).  There was no dispute that the case satisfied the requirements for diversity jurisdiction, only whether defendants being at home in the forum were permitted to remove.  According to Encompass, the answer is yes.  Plaintiffs made three arguments to attempt to get around the Third Circuit precedent.

Argument number 1 – Encompass is an outlier.  Plaintiff wanted the court to “disregard” the Third Circuit decision as “legally unsupportable” and an “outlier.”  Id. at *15.  It is neither.  Ignoring that all three circuit courts to have addressed the issue have all agreed that 28 U.S.C. §1441(b)(2) permits forum defendants to remove a case before service, plaintiff argued that various district courts have disagreed.  But those cases are not controlling, and Encompass is.  Plaintiff attempted to make the same arguments that were already rejected by the Third Circuit. Id. at *16-17.  With a score of three to zero in favor of snap removal in the appellate courts, arguing those decisions are outliers feels a bit like a Hail Mary.

Argument number 2 – the Supreme Court has rejected snap removals.  Certainly, if the Supreme Court had decided this issue, we would have blogged about it.  You won’t find it on the DDL blog because it hasn’t happened.  The case plaintiff cites is Home Depot U.S.A., Inc. v. Jackson, 139 S. Ct. 1743 (U.S. 2019).  That was a case about whether a third-party counterclaim defendant was a “defendant” who could remove a case under the general removal statute.  In dicta, the Court mentioned the forum defendant rule prevents diversity removal where “any defendant is a citizen of the State in which the action is brought.”  Home Depot, 139 S.Ct. at 1749.  The Court was only using the forum defendant rule “as an example of a limitation on defendants’ right to remove.”  Carroll, at *17.  Because the Court did not include the language from §1441(b)(2) regarding proper joinder and service, however, plaintiff appears to want the district court to infer that the Supreme Court dropped that requirement from the statute.  Considering the forum defendant rule was not even before the Court, plaintiff’s interpretation is too far-flung.

Argument number 3 – defendants filed their federal and state court notices in the wrong order.  To remove a case, a defendant must file a timely notice of removal, provide written notice to all parties, and file a copy of the notice with the state court.  Id. at *18.  It was undisputed that defendants completed all three steps.  Plaintiff took issue with the order in which they were done.  The removal statute provides that the notice to the parties and the notice to the state court shall be given “[p]romptly after the filing of such notice of removal.”  28 U.S.C. §1446(d).  According to the electronic dockets, defendants’ notice of removal was filed in the federal court at 8:07pm and the notice to the state court was submitted at 7:13pm – 54 minutes earlier.  Id. at *21.  Plaintiff wanted the court to invalidate the removal because the state court notice was not filed “promptly after” the federal notice.  In rejecting this argument, the court held that

the common law refused to concern itself with the fractions of a day, presuming for convenience that all acts done on the same day were done at the same instant.

Id. at *22 (citation omitted).  Moreover, even if the statue is read to require a precise order, “failure to proceed in that precise order [is] a technical, non-prejudicial defect that does not justify remand.”  Id. at *23 (citation omitted).  There was some question as to whether the time on the state court docket was the actual time of filing, but regardless, this technicality could not be used to defeat an otherwise proper removal.

In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s limited and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more.  Lohr had justified its specificity gloss on the broad statutory term “requirement” by relying on that presumption:

In all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, . . . we use[] a “presumption against the pre-emption of state police power regulations” to support a narrow interpretation of such an express command.

518 U.S. 470, 485 (1996).

In Two Shadows, we pointed out that this presumption has since been abolished, in express preemption cases, by Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. 115 (2016) (“Franklin”).

The plain text of the [preemption clause] begins and ends our analysis. . . .  And because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. at 125.

Without that presumption, we argued, Lohr had no basis for holding that Congress had meant anything less than it had said in §360k(a).  Or, as the Supreme Court held more recently, in a non-preemption context, “[w]hen the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest.  Only the written word is the law, and all persons are entitled to its benefit.”  Bostock v. Clayton County, Georgia, 140 S. Ct. 1731, 1737 (2020).

Yet, after Franklin, courts seemed very slow in applying the abolition of the presumption against preemption to Lohr itself.

Until now.

We recently hammered the Eighth Circuit when we thought it was wrong about Fed. R. Evid. 702 in a non-prescription medical product case.  Thus, it’s only fair that we hail that same court when it gets something right.  Thus, we’re pleased to bring to your attention Pharmaceutical Care Management Association v. Wehbi, 18 F.4th 956 (8th Cir. 2021) (“PCMA”), the first decision to recognize expressly what we thought was obvious in Two Shadows – that Franklin overruled Lohr as to the presumption against preemption in the context of express preemption.

PCMA involved something altogether outside our sandbox – express preemption under ERISA and/or the 2003 statute that created “Medicare Part D.”  Id. at 964.  While the substantive effect of such preemption is important to a lot of folks (the case attracted nine amici curiae briefs on behalf of literally scores of amicus parties), that’s not our interest on this Blog.  We’re interested in the presumption against preemption – particularly as Lohr applied it.

In PCMA “the parties dispute whether we should invoke a presumption against preemption in this case given that both ERISA and Medicare Part D feature express preemption provisions.”  18 F.4th at 967.  One side – the defendants – “rel[ied] on a line of Supreme Court cases invoking a presumption against preemption in the face of an express preemption provision,” id., specifically Lohr and New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Insurance, 514 U.S. 645, 654-55 (1995).  Long-time Blog readers may recognize both of these decisions from our first-ever blogpost on the presumption against preemption some fifteen years ago.

The other side in PCMA – the plaintiff – argued that “the [Supreme] Court overruled these cases in [Franklin], where it stated that “because [that statute] contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause.”  18 F.4th at 967.

PCMA expressly “agree[d] with” the plaintiff that Franklin had overruled Lohr (and the other case) specifically on the presumption against preemption.  Id.

The defendants argue that because Franklin did not expressly overrule prior precedent, we should not extend it to express preemption provisions such as ERISA’s that the Court has historically treated as subject to a presumption against preemption.  But . . . we [have] extended Franklin to the express preemption provision in [the Federal Aviation Act], despite indications that prior to Franklin the Court treated [the FAA’s preemption provision] as subject to a presumption against preemption. So too here, we will follow Franklin and invoke no presumption against preemption when applying the express preemption provisions in ERISA and Medicare Part D.

18 F.4th at 967 (citations omitted).  PCMA specifically rejected the plaintiff’s argument that “ that the court should “leav[e] to [the Supreme] Court the prerogative of overruling its own decisions” because it had already done so.  Id. (quoting Rodriguez de Quijas v. Shearson/American Express, Inc., 490 U.S. 477, 484 (1989)).  PCMA thus becomes the first published court of appeals decision to recognize (to use a non-Dr. Who idiom) that Franklin turned Lohr into the emperor that now wears no clothes.

We applaud the Eighth Circuit for repudiating jurisprudential flabbiness of the sort we decried in Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. 2018), where the Third Circuit – buying the same “prerogative of overruling its own decisions” argument – would not admit that Franklin had tossed Lohr’s presumption against preemption analysis into the dustbin of history.  Id. at 782 n.9 (refusing to abandon the presumption until the Supreme Court repeated itself in a “product liability” case involving “the historic police powers of the States”).

As we discussed at length back in 2006, the Supreme Court never applied the supposed “presumption against preemption” in any sort of principled manner.  Thus, the Court rightly abolished it for express preemption cases in Franklin.  We believe that the Court implicitly did the same thing for implied preemption cases by omitting any reference to such a “presumption” in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), but that’s a topic for another post.

Today’s somewhat unusual guest post is by Reed Smith‘s Matt Loughran.  It concern’s the Supreme Court’s 6-3 decision to permit the government to continue enforcement of its requirement that healthcare workers (at least those in facilities that accept Medicare/Medicaid, which is most of them) be vaccinated to avoid infecting themselves and their patients with COVID-19.  First, we recognize that we may be too strident in discussing what we consider the Court’s unprecedented judicial triumphalism − the view that courts and litigation can solve social problems better than the coequal branches of government − particularly its interference with the government’s response to a public health emergency, so we are republishing (with permission) this post, which originally appeared hereSecond, we are publishing this post on a Sunday, which we don’t often do, so as not to disrupt our usual blog rotation.


The CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule survived its initial trip to the U.S. Supreme Court on January 13 with a per curiam 6-3 decision that stayed injunctions placed on the rule by federal district courts in December.

The Supreme Court took the rare action of holding oral argument and then issuing a full opinion (with dissents) on the emergency stay application that had been brought by the Centers for Medicare & Medicaid Services (CMS), asking the Court to allow the agency to enforce the rule while it challenges to its validity continue in the lower federal courts.

The Court was definitive that the rule as published falls within the authority of the Secretary of Health and Human Services to promulgate based on the statutory authority conferred by Congress through the Social Security Act (SSA). Specifically, the court found that the various statutory provisions within the SSA allow the Secretary to impose conditions of participation on the receipt of Medicare and Medicaid funds that are necessary in the interest of the health and safety of individuals who furnish services reimbursable under those programs and the federal program beneficiaries that they serve.

However, the Court’s opinion still leaves some questions unanswered about whether the rule will be enforceable in Texas and whether eventually some facilities may be exempted.

Questions remain for Texas

CMS had asked for stays of two preliminary injunctions entered in legal challenges brought by 24 states in the U.S. District Courts for the Western District of Louisiana and the Eastern District of Missouri. The Supreme Court’s decision stays those preliminary injunctions pending review by the respective federal appeals courts. It makes the rule enforceable across covered health care entities—i.e., those certified providers and suppliers subject to the Rule—nationwide, with the exception of Texas.

Initially the U.S. District Court for the Northern District of Texas declined to enter an injunction in the case because the federal court in Louisiana had issued a nationwide injunction that covered the field. However, the U.S. Court of Appeals for the Fifth Circuit limited that nationwide injunction to only those 14 states involved in the Louisiana case. Texas, despite residing within the Fifth Circuit and subject to the dictates of that appeals court, was not one of the states enjoined by the Fifth Circuit’s order.

In response to the Fifth Circuit’s narrowing of the injunction, the federal judge in Texas reopened the state’s motion for a preliminary injunction and granted that motion for the duration of the case. The Supreme Court’s per curiam decision makes no mention of the Texas case and specifically orders a stay of only the Missouri and Louisiana injunctions as those were the only two orders before the Court.

On January 14, the CMS appealed the Texas injunction to the Fifth Circuit and asked the district court to stay the injunction, the same relief that was granted with regard to the other injunctions by the Supreme Court. It its brief supporting the motion, the CMS identified how the Supreme Court’s ruling addresses every reason that the federal judge had originally given for imposing the injunction in the Texas challenge in the first place.

The district court has ordered Texas to respond to the CMS motion by Tuesday afternoon, January 18 and will likely rule on the request shortly thereafter. However, until the district court or the Fifth Circuit act, the injunction remains in place in Texas. The CMS issued guidance on January 14 telling survey agencies to begin enforcing the rule everywhere except Texas.

Deadlines extended for challenger states

As originally written the rule has a two-phase compliance structure with staff at impacted facilities required to receive a first dose of vaccine by December 5, 2021 and a second dose by January 4, 2022.

Because of the nationwide injunction that was entered in the Louisiana case, the CMS had initially delayed the compliance dates for the rule. In guidance published December 28, 2021, after the nationwide injunction was narrowed by the Fifth Circuit, the CMS reset those deadlines for the 25 non-challenger states plus the District of Columbia and the U.S. Territories, none of whom were covered by an injunction. Among those states are California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, and Wisconsin. The new compliance deadline for those states plus the District of Columbia and the territories are January 27, 2022 for staff to receive the first dose of the vaccine and February 28, 2022 for staff to receive the second dose.

Even after the Supreme Court’s opinion, those deadlines still apply for the non-challenger areas. However, given that the 24 states that were covered by injunctions reviewed by the Supreme Court have only recently been placed under the rule, the CMS gave facilities in those states a little more time to comply. Under the new guidance, the facilities in Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia and Wyoming have until February 14 to have their staff receive their first dose of vaccine and until March 15 to be fully compliant.

As noted above, Texas is still under an injunction so there is no compliance date for facilities in that state. Florida is the only other state to have challenged the rule, having filed its own case in the U.S District Court for the Northern District of Florida. However, that both the district court and the U.S. Court of Appeals for the Eleventh Circuit have refused to enter an injunction on the rule in that challenge. As a result, Florida remains in the group of 25 states that must begin compliance with the rule by January 27, 2022.

Dissent noted statutory differences

One other wrinkle was presented by the Supreme Court’s action that could have some bearing on the outcome of the challenges to the rules. In his dissenting opinion, Justice Clarence Thomas identified statutory provisions defining five of the impacted facility types as not including the “health and safety” language the Court relied on to anchor its claims that Congress conferred authority on the CMS to promulgate the rule.

According to the dissent, these five types of facilities include:

  • Intermediate Care Facilities for Individuals with Intellectual Disabilities
  • Inpatient Psychiatric Hospital Services for Individuals Under Age 21
  • End-Stage Renal Disease (ESRD) Facilities
  • Home Infusion Therapy (HIT) suppliers
  • Critical Access Hospitals (CAHs)

The per curiam opinion addressed the statutory difficulty from Justice Thomas in a way that could lead to some problems down the line as the federal appeals courts work through the merits of the claims against the rule. In a footnote the court addressed the dissent by saying: “[E]mployees at these facilities—which include end-stage renal disease clinics and home infusion therapy suppliers—represent less than 3% of the workers covered by the rule.”

Additionally the Court noted that “We see no reason to let the infusion-clinic tail wag the hospital dog, especially because the rule has an express severability provision.”

It is that last statement about the severability provisions of the rule that could lead to trouble in the future. If the lower courts decide that Justice Thomas is right about the statutory provisions and decide to exclude those five provider types from the rule, the majority of the court, including Justice Brett Kavanaugh and Chief Justice John Roberts, could be convinced to sever those provider types from the rule and leave the rest of the rule intact.

How the lower courts handle this and what the Supreme Court has to say when the merits of the case invariably end up on its docket will settle the issue. However, as of this writing, providers in the 21 enumerated categories of the rule who are resident in the 49 states, D.C. and the U.S. territories must be ready for enforcement of the rule by state survey agencies.

For a more detailed review of what enforcement and compliance will look like, please see our prior coverage of the rule.


 2021 has come to a close, and our loyal readers joined us as we reviewed the best and worst drug/medical device decisions of the year.

 As we have done for a number of years, now, we are delighted to announce that we will be presenting a free 90 minute CLE webinar on “The good, the bad, and the ugly: The Best and Worst Prescription Drug/Medical Device Decisions of 2021” Friday, January 21 at 12:30 PM ET.  Bloggers Bexis, Rachel Weil, Eric Alexander, and Stephen McConnell are set to provide an exciting in depth analysis and insight into these cases.    

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

The webinar is free and open to anyone who wishes to view, just be sure to register by clicking here

We heard the other day from attorneys involved in the MDL direct filing, choice-of-law case that we wrote about a couple of weeks ago, Looper v. Cook Inc.  Engaging in this kind of dialogue is one of the joys of blogging, even when our friends and colleagues write to tell us we got something wrong.  To err is human, to blog is divine . . . or something like that.  Anyway, to the point, we reported to you that the district court in the Cook vein filter MDL had ruled that the defendants had waived their Lexecon rights by acquiescing to direct filing of complaints in the MDL.  It turns out it was the plaintiffs who lacked Lexecon rights—not the defendants, who did not object to trials in the MDL.  In our own defense, the Seventh Circuit’s opinion said “parties,” and our defense-centric minds defaulted to “defendants.”  Lesson learned.  We also should emphasize that the Seventh Circuit expressly withheld judgment on the parties’ Lexecon rights; only the district court found a waiver.

Our overall points still hold true.  Direct filing of complaints in multidistrict litigation poses risks on jurisdiction, venue, and choice of law that all parties—on both sides of the v—should weigh against the benefits.

Rules governing choice of law especially should not be controversial, which brings us to a more recent case that shows how choice-of-law rules are supposed to work.  In Bond v. Johnson & Johnson, No. 21-05327, 2021 U.S. Dist. LEXIS 243038 (D.N.J. Dec. 21, 2021), the plaintiffs sued after treatment with the defendants’ surgical mesh, but instead of filing in their home states of Michigan and North Carolina, they filed in the defendants’ home state of New Jersey.  Id. at *1-*2.  Should plaintiffs be able to avoid the laws of the states where they reside and underwent their surgeries merely by suing somewhere else?

That is what choice-of-law rules are meant to address, and unlike the Seventh Circuit in Looper v. Cook, the district court in Bond did not overthink it.  The Seventh Circuit jumped through multiple hoops to apply choice-of-law rules from jurisdictions where the civil actions at issue had never been.  By comparison, the district court in Bond followed the standard rules and applied the choice-of-law rules for the jurisdiction where the case was initially filed:  “Because ‘[t]his diversity action was initiated in the United States District Court for the District of New Jersey,’ the Court must apply New Jersey’s choice of law rules.”  Id. at *10.

New Jersey’s choice-of-law rules apply a strong presumption in favor of the law of the states where the plaintiffs incurred their injuries.  These plaintiffs resided in Michigan and North Carolina, and they had their surgeries there, which created a strong presumption that the substantive law of their home states should apply.  Moreover, factors related to the defendants’ places of business and product design in New Jersey did not outweigh that presumption.  Id. at *15-*21.

The district court therefore applied the substantive laws of Michigan and North Carolina, and the applicable law made a difference to the outcomes for these two plaintiffs.  (Their names, by the way, were Bond and Rosebush.  McConnell would surely find an Agent 007 reference for this pair, but we are not as clever.)

For the Michigander, “Michigan does not accept strict liability as the basis for a [products liability] claim,” so those claims went by the board with prejudice.  The district court dismissed the plaintiff’s warranty claims too because the plaintiff failed to allege that he provided pre-suit notice “upon discovering a breach,” which Michigan law requires.  Id. at *45-*48.  The district court analyzed the plaintiff’s allegations of design defect, manufacturing defect, and warnings defect under the plaintiff’s negligence claim, which Michigan law does recognize.  Id. at *22-*35.  The plaintiff, however, failed to allege facts establishing a defect under any of these theories, resulting in negligence being dismissed without prejudice.  Id.

For the North Carolinian, the analysis was more straightforward, as was the result—all claims dismissed with prejudice.  North Carolina “does not recognize strict liability in tort in product liability actions.”  Id. at *14-*15.  It is similar to Michigan in that regard, which explains a lot about why these plaintiffs sought to avoid those jurisdictions and why the defendants moved for summary judgment with regard to these plaintiffs.

The kicker, however, was North Carolina’s six-year statute of repose.  Statutes of repose are treated as substantive law for choice-of-law purposes, and if you have not checked out our 50-state survey on statutes of repose, you can find it here.  In short, a statute of repose limits the time within which an action may be brought, but it is entirely unrelated to the accrual of a cause of action.  It can bar a cause of action even before it has accrued.

North Carolina has a six-year statute of repose for personal injury actions arising from an alleged product defect, and the six-year period runs from the “the date of initial purchase for use or consumption.”  Id. at *36.  For this North Carolina plaintiff, that was the date of his mesh implantation surgery, and he filed his personal injury lawsuit more than six years later.  Id. at *38-*39.  Too late.  All claims dismissed.  Goodbye, Mr. Bond.  We give a shout out to David Johnson at Butler Snow for bringing Bond v. J&J to our attention.

Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports.

The plaintiff appealed that ruling to the First Circuit.

Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA. Rather than answer itself, the First Circuit asked the Massachusetts Supreme Judicial Court, the state’s highest court, to answer the question. In particular, the First Circuit asked the Supreme Judicial Court to answer the certified question of whether “a manufacturer’s failure to report adverse events to a regulator—such as one like the FDA—give[s] rise to liability under Massachusetts law.” Plourde v. Sorin Grp. USA, Inc., — F.4th —-, 2022 WL 99508, at *7 (1st Cir. 2022).

The Supreme Judicial Court is not obligated to accept the certified question, but it will likely do so—just as the Connecticut Supreme Court several months ago accepted a similar question certified by the Second Circuit in Glover v. Bausch & Lomb Inc., 6 F.4th 229 (2d Cir. 2021).

Without a substantive decision in Plourde, there isn’t much to say at this point. Nonetheless, a few brief observations…

First, it should be noted that the question certified by the First Circuit in Plourde is relevant only to the question of whether failure-to-report claims are expressly preempted by 21 U.S.C. § 360k(a), which bars states from imposing safety or effectiveness requirements on medical devices that are “different from, or in addition to,” the requirements imposed by federal law. If Massachusetts does recognize a state-law duty to report adverse events to the FDA, then a failure-to-report claim brought under Massachusetts law would constitute a “parallel” claim that avoids express preemption. That, however, says nothing about whether such a claim would also escape implied preemption under 21 U.S.C. § 337(a).  As the Supreme Court made clear in in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), a claim can be impliedly preempted by § 337(a) even if it is not expressly preempted by § 360k(a).

Second, as readers of this blog are aware, after a string of unfortunate decisions allowing failure-to-report claims to proceed—specifically, Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413 (2014)—the tide has turned. Since then, appellate decisions—including Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018), and Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. Ct. 2017)—have repeatedly held that failure-to-report claims are expressly or impliedly preempted by the FDCA, as Bexis’s 50-state survey shows.  In particular, this survey shows that the Massachusetts high court has already expressly rejected the imposition of reporting based tort liability in a non-product liability setting.  Roe No. 1 v. Children’s Hospital Medical Center, 16 N.E.3d 1044, 1052 (Mass. 2014) (failure to file mandatory child abuse reports).

Finally, in deciding whether Massachusetts recognizes a duty to report adverse events to the FDA, the Supreme Judicial Court will likely address the learned-intermediary doctrine, which holds that drug and device manufacturers have a duty to warn physicians not patients, and Restatement (Second) of Torts § 388 cmt. n, which states that a manufacturer can satisfy its duty to warn an end user by warning a third-party intermediary if the manufacturer can reasonably rely on the third party to convey the warning. Given that the FDA makes adverse-event reports public, if at all, by posting them to a passive database that must then be affirmatively searched for whatever information it contains, manufacturers cannot reasonably rely on the FDA to convey to physicians the information found in adverse-event reports—which, as held in Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016), are not warnings in any event.

We await word from the Massachusetts Supreme Judicial Court.

Some of our posts about challenges to Covid-19 vaccines or treatments might have been a bit … strident. It is hard to be otherwise when the cases involve such high stakes and so little merit.

But this time we will try to take our cue from the court in Frey v. Trinity Health-Michigan, 2021 Mich. App. LEXIS 6988 (Mich. Ct. App. Dec. 17, 2021). In that case, the court rejected a plaintiff’s request for a preliminary injunction requiring a hospital to administer ivermectin to a Covid-19 patient.

We have written about similar cases before. The Frey court embraced the better, majority rule in holding that a hospital could not be forced to administer ivermectin in violation of its protocols, but the Frey opinion is also noteworthy for its expressions of sympathy for, and understanding of, the plaintiff’s position.

The plaintiff in Frey brought the legal action on behalf of her father, who had contracted Covid-19, gone to the defendant hospital, been placed on a ventilator, received treatment per hospital protocols for Covid-19 (remdesivir, steroids, and antibiotics), but continued to decline. The defendant hospital’s protocols, consistent with the positions of FDA and CDC, did not permit the use of ivermectin to treat Covid-19. The daughter, as patient advocate, found a doctor who prescribed ivermectin for her father, though that doctor had not examined her father and had no admitting privileges at the hospital. The issue was whether the daughter could force the defendant hospital to violate its protocols and give her father ivermectin.

The plaintiff sought a preliminary injunction. The lower court denied the preliminary injunction and the case went up on appeal. The standard of review was whether the lower court had abused its discretion in denying the preliminary injunction. A trial court abuses its discretion when “it chooses an outcome outside the range of reasonable and principled outcomes.” In assessing whether to issue a preliminary injunction, a court must consider whether the applicant has proved all four of the following factors:

1. Irreparable harm will occur without the injunction;
2. The applicant is likely to prevail on the merits;
3. The harm to the applicant would outweigh the harm to the adverse party; and
4. The public interest favors the injunction.

The lower court in Frey decided that the plaintiff had not proved those four factors. The appellate court agreed. But before it plunged into its analysis, it took a moment to express sympathy for the plaintiff’s position: “At the outset, we observe that plaintiff’s position deserves much sympathy; we recognize she simply wishes that every attempt he made to preserve her father’s health.” It is hard to argue with that. When we were in high school, a classmate’s father was in a losing battle with cancer. At one point, he left the country to get Laetrile treatment. That treatment had been discredited in the USA, but we can well understand how one could be driven to desperate, long-shot measures.

That being said, the Frey court’s review was “confined to the narrow legal question of whether plaintiff has demonstrated the factors required for issuance of an injunction.” She had not.

First, the plaintiff could not show irreparable harm. By the time of the litigation, the plaintiff’s father was suffering from sequelae of Covid, but was no longer suffering from an active Covid infection. The treating doctors concluded that ivermectin was not medically indicated for the condition, could not provide any benefit, and could conceivably worsen the father’s health, even to the point of causing death. The plaintiff produced no affirmation of the use of ivermectin from any doctor who examined her father, and produced no evidence that her father’s condition would worsen without ivermectin.

Second, the plaintiff showed no probability of success on the merits. The key issue in the case was “whether the judiciary has the legal authority to compel a hospital to administer a drug, on an off-label use, that the hospital considers may harm its patient, and where that use is not sanctioned by the FDA and other health authorities.” No Michigan case law supplies such legal authority. (Indeed, our own dipping of toes into Michigan law suggests that Michigan allows hospitals to grant or deny privileges as they see fit. This posture suggests that there is no way a court could force a hospital to do anything recommended by a doctor with no privileges.) The plaintiff submitted a couple of New York orders that supported her position, but those orders cited no legal authority or reasoning. By contrast, a Texas case refused to order ivermectin treatment, and made the point that “[j]ust as we cannot legislate from the bench, we cannot practice medicine from the bench.” (We blogged about that Texas case here.) A Delaware court reached a similar result. (We blogged about that Delaware case here.) The Frey court concluded that Texas and Delaware got it right, and New York got it wrong.

Third, the court believed that the harm from denial of an injunction would be outweighed by the harm from issuance of an injunction. The Frey court foresaw “a flood of similar suits from other patients with Covid-19, not to mention other conditions, suing to obtain care that is contrary to hospital policies.” No thanks.

Finally, the Frey court held that an injunction forcing a hospital to administer a drug in violation of its protocols and the medical consensus would damage the public interest. Such an injunction would adversely impact the safe and effective development of medications and medical practices. It would also harm the stability of hospital administration and admitting privileges. The “public interest is best served by permitting physicians and hospitals to follow established procedures and use their professional judgment to determine appropriate medical treatment.”

Thus, the plaintiff proved none of the four factors necessary to secure a preliminary injunction. The plaintiff raised some new arguments on appeal. Typically, an appellate court will not even consider such arguments, but the Frey court heard them out and rejected them. For example, the Frey court declined “to recognize a civil right to treatment of Covid-19 with ivermectin.” The Frey court also declined to interpret the power of a patient advocate to extend to forcing “a hospital to administer medication that it believes would be contrary to a patient’s care.”

The plaintiff also argued that she had not been afforded due process by the trial court, which had dismissed her complaint sua sponte, with no notice and no opportunity to respond. The appellate court acknowledged that arguments and evidence might have produced a more useful appellate record, but also acknowledged that time was of the essence and the lower court reached the right result.

The Frey appellate court heard all the plaintiff’s arguments with patience and sympathy. But in the end, the Frye court was a court of law, and it applied the law correctly.

In In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL 2809, 2022 WL 43244 (E.D. Ken. Jan. 5, 2022), the MDL judge bifurcated discovery into two phases with general causation proceeding first.  At the close of expert discovery, plaintiffs move to exclude three defense experts and defendants moved to dismiss one plaintiff expert.  Plaintiffs went down swinging and defendants caught it right in the sweet spot.

The drugs at issue are in class that is generally used as a second-line treatment for diabetes.  Plaintiffs allege that the drug causes heart failure and related cardiac conditions.  At the request of the FDA, manufacturers conducted a cardiovascular outcomes study, a randomized controlled trial with multiple cardiac endpoints.  The result of the trial was that there was no statistically significant difference between the drug and placebo for any primary endpoint (cardiac death, non-fatal heart attack, non-fatal stroke) or secondary endpoint except for hospitalization due to heart failure.  Id. at *4.  Following the cardiac trial, the authors of the study explained that when you test for multiple endpoints, the more endpoints tested, the greater the likelihood of at least one false positive where the statistical significance is due to chance.  The authors cautioned that the outcome regarding hospitalization for heart failure warranted further investigation.  Id. at *5.  Further study was done in the form of observational studies and meta-analyses, none of which found an association between the drug and heart failure.  Id.   Trials of other drugs in the class also failed to show an association.

It is against that background that the court had to conduct its Daubert analysis.  The court’s primary focus was on the Bradford Hill causation analysis.  The Bradford Hill framework consists of nine factors used by epidemiologists to assess “whether an observed association may be causal.”  Id. at *1.  The court sets out and describes all nine factors.  Id. at *2.  We’ll focus on the analysis of each expert.

Defendants’ first expert was an endocrinologist – the type of doctor who treats diabetes.  Plaintiffs argued that he was not qualified to opine on whether the drug causes heart failure because he is not a cardiologist.  Id. at *7.  But he does prescribe medications to diabetics, including diabetics with heart disease, and must understand the risks and benefits of those medications.  Therefore, he was aware of the risks and benefits of and the scientific literature on the drug before becoming an expert in the litigation.  “Thus, [the expert’s] testimony in this case is about a matter growing naturally and directly out of research [he has] conducted independent of the litigation.”  Id. (citation omitted).

Defendants’ second expert was a cardiologist.  Plaintiffs’ primary challenge to this expert was an unsupported claim that he did not write his expert report.  They claimed it was “virtually identical” to another defense expert’s report.  However, both experts testified to never seeing each other’s reports or spoke to one another.  But they both are cardiologists who were asked to opine on the same issue – whether the drug can cause heart failure.  So, there was nothing untoward about them both citing the same sources.  Nor was it surprising that both reports used the same language when most of the phrases that plaintiffs point to are exact quotes from the relevant literature.  The experts did not copy from each other, they quoted the relevant scientific literature, of which there is not a lot.  Id. at *8.

Plaintiffs’ second attack on this expert is that he was not qualified to opine on how to correct multiple-endpoint studies to account for false positives.  But the doctor had extensive research experience including with clinical trials and as the head of a research laboratory.  Further, the expert explained his opinion on how the correction should be applied, a position supported by other scientists in the field.  Id. at *9.  If the jury were to accept his corrections, then the cardiac trial did not show any association and there is no need to conduct a Bradford Hill analysis.  If, however, the jury discounted the corrections, defendants’ expert’s opinion contained a thorough analysis of why the association does not rise to the level of causation.  Id. at *10.  Nor could plaintiffs support an argument that defendants’ expert failed to consider any study that he should have in reaching his conclusions.  Id. at *11.

The third defense expert challenged by plaintiffs was a pharmacoepidemiologist and based on his regular work and experience he was qualified to review the medical literature and opine on whether it established a causal connection between the drug and heart failure.  Using the reverse of their first argument, plaintiffs took issue with this expert not being a cardiologist.  But the court found he was not determining whether the patients in the studies had heart failure, rather the relationship between the heart failure diagnosed by others and the drug.  Id. at *12.  Next plaintiffs attacked the expert’s failure to undertake his own analysis of the raw data underlying the studies.  That is not a requirement for a reliable Bradford Hill analysis.  Nor was it an issue that defense counsel provided the expert with most of the literature where he also conducted his own searches to satisfy himself he had all relevant studies.  Id.  In fact, defendant’s expert reviewed plaintiffs’ experts’ reports and testified that he considered all the materials they had.  Id. at *13.

The court then turned to plaintiffs’ expert – a cardiologist who testified that using the Bradford Hill methodology, it was his opinion that the drug more likely than not is capable of causing heart failure.  Id. at *15.  However, neither the expert nor plaintiffs’ counsel “have been able to identify any other expert who has reached this opinion.”  Id.  Having used the same methodology as defense experts but being the only scientist – inside or outside the litigation – to reach that conclusion, the court was “wary that the method ha[d] not been faithfully applied.”  Plaintiffs’ expert had never published an article using the Bradford Hill analysis, nor written on it at all until this litigation.  Id.  Defendants argued that his analysis was flawed because he only considered the cardiac outcome trial and certain animal studies – no other human data.  Indeed, plaintiff’s expert testified that the one finding of a statistically significant increase “should be interpreted as cause and effect unless there is compelling evidence to prove otherwise.”  Id.  That flies directly in the face of the Bradford Hill criteria that there should be consistency of association – “has the observed association been repeatedly observed by different persons, in different places, circumstances, and times.”  Id. at *2.  The answer here is no.

Moreover, the authors of the cardiac outcomes study themselves did not come to the same conclusion as plaintiff’s expert.  They concluded the finding merited further investigation, not that it established causation.  Also, relying on and drawing conclusions from limited data lacks “scientific rigor.”  Id. at *16.  While plaintiffs’ expert chose to ignore the observational studies, he could not identify any defects in those studies to warrant their exclusion from consideration.  And certainly nothing to justify relying on pre-clinical animal studies over human data.  Id. at *17.   Finally, in an attempt to draw an analogy (the Bradford Hill criteria that asks whether exposure to analogous drugs causes the same outcome), plaintiff’s expert compared the drug at issue not to other drugs in the same class, but a different class of diabetes drugs known to worsen heart failure.  “In other words, [plaintiff’s expert] cherry picked [the analogous drug] as a comparison only because they have been shown to cause the outcome at issue.”  Id. at *18.  Results-driven analysis is not permitted.

This is a jam-packed opinion with critical analyses of four experts – three who considered the totality of the evidence and correctly applied the Bradford Hill criteria and one who went out on a limb and found himself very much alone – and excluded.

There are two main questions that surround the issue of all-vaccinated juries in the COVID-19 era.  The first is can you seek to exclude non-vaccinated persons from the venire for cause.  The second is do you want to.  At just about every CLE program we attend these days, whether in person or electronically, where judges or jury consultants are speaking about COVID-19 issues, we raise these questions.  The responses vary but in general, the answers to the first question have been that a significant number of courts are informally excusing unvaccinated persons from jury venires, typically through use of a questionnaire.

As to the second question, the answers we’ve received are all over the lot.  Unfortunately, things are changing rapidly, with widespread availability of vaccines now rendering obsolete jury research conducted even as recently as the end of 2020.  Our gut reaction – based entirely on stereotypical reasoning − is that vaccinated would-be jurors tend to be both more educated and better disposed to those who manufacture that type of product.  On the other hand, they’re more likely to be suspicious of corporations generally.  Unvaccinated potential jurors skew “conservative” – whatever that means these days – aren’t particularly respectful of either science or expertise, and thus are not likely to care much about things like FDA approval.

We bloggers can’t do much to elucidate the second question, but we can research the first.

Joffe v. King & Spalding LLP, ___ F. Supp.3d ___, 2021 WL 5864427 (S.D.N.Y. Dec. 10, 2021), is the most significant case on the question of vaccine-qualified juries.  It’s both a civil case (albeit having nothing to do with drugs, devices, or even product liability) and contains the most thorough discussion of the pros and cons of striking unvaccinated people as jurors for cause.  The Joffe decision, overruling the plaintiff’s objection to an all-vax jury, was driven by the practical consideration that very few courtrooms are physically large enough to accommodate the forms of social distancing that COVID-19 requires:

In an effort . . . to accommodate more trials, [this] trial was slated to be held in a regular courtroom, unmodified other than to provide jurors and other participants with at least three feet of social distance.  If an unvaccinated juror were to be selected, that juror’s social distance would have been expanded to six feet; the Undersigned’s courtroom could not have accommodated more than two unvaccinated jurors.

Id. at *1 (footnote omitted).  Barring unvaccinated jurors, in short, was the only way to get this judge’s – and probably most judges’ – courtroom back into the business of conducting jury trials.  “[E]xcluding unvaccinated persons as jurors would increase the likelihood that all trial participants (including the jury) would be safe and would minimize the probability that the trial would be interrupted by a juror testing positive for COVID-19 during the trial.”  Id. at *3.

As the legal basis for excluding unvaccinated persons from the jury venire, Joffe relied on 28 U.S.C. §1866(c), which provides that prospective jurors may be “excluded by the court on the ground that . . . [their] service as a juror would be likely to disrupt the proceedings.”  Joffe cited several reasons for considering unvaccinated jurors to be inherently “disruptive” during the pandemic:

  • “An unvaccinated juror would be considerably more likely to contract COVID-19 and to spread it to other jurors.”
  • “Many jurors may . . . feel unsafe or uncomfortable serving on a jury with unvaccinated individuals.”
  • “[A]nxiety may impair a juror’s ability to perform his or her duty by being a distraction from the proceedings, both during trial and during deliberations.”
  • “[I]f a juror were to be infected with COVID-19, not only would the juror jeopardize the safety of everyone around them, the juror and other jurors with whom the infected juror came into contact might have been required to quarantine, which could have disrupted the trial or otherwise caused scheduling and other logistical issues.”

2021 WL 5864427, at *5.

Joffe also ruled that barring unvaccinated persons from serving on juries did not violate the Jury Selection and Service Act (“JSSA”).  That act entitles federal litigants to juries drawn “from a fair cross section of the community.”  28 U.S.C. §1861.  To violate the statute’s “fair cross section” requirement requires those being excluded from service to be a “distinctive group,” due to their “systematic exclusion,” resulting in the venire “not [being] fair and reasonable” compared to the “community” at large.  2021 WL 5864427, at *6.  Relying on a criminal case, United States v. Moses, ___ F. Supp.3d ___, 2021 WL 4739789 (W.D.N.Y. Oct. 12, 2021), Joffe concluded that the unvaccinated population was sufficiently diverse and changing that it did not qualify as a “distinctive group.”

Because there are a multitude of reasons why an individual might be unvaccinated, the group lacks a basic similarity in attitudes or ideas or experience that defines and limits the group.  Moreover, membership in the unvaccinated group changes on a daily basis.  The claim that vaccination status is a “proxy” for individuals who hold a particular point of view is speculative at best. . . .  There is nothing to suggest that the viewpoints held by the unvaccinated will not be adequately represented by the vaccinated.

Id. at *6 (citations and quotation marks omitted).

In what seems to us something of a stretch, Joffe also determined that prohibiting unvaccinated jurors was not “systematic exclusion” under the statute because COVID-19 was an “external force,” not “due to the system of jury selection itself.”  Id. (citing United States v. Charles, 2021 WL 2457139, at *4 (S.D.N.Y. June 16, 2021), and United States v. Tagliaferro, 2021 WL 1172502, at *5 (S.D.N.Y. March 29, 2021), neither of which involved juror vaccination).

Joffe was interesting enough we decided to see what else was out there.  The only other civil cases we found are C.B. v. D.B., ___ N.Y.S.3d ___, 2021 WL 4696606 (N.Y. Sup. Oct 7, 2021), and Benaron v. Simic, 2021 WL 4464176 (D. Or. Sept. 29, 2021).  Neither has any analysis.  Benaron simply states, in a footnote at the end of an order dealing with other issues, that “[t]he Court intends to require that everyone who appears in the courtroom for trial (including . . . jurors) are fully vaccinated against COVID-19 at the time of trial.”  Id. at *10 n.13.  C.B., a child custody case, included in a list of COVID-19 restrictions that “[u]nvaccinated individuals can even be precluded from serving on juries before the U.S. Federal Court.”  2021 WL 4696606, at *2.  Cf. Hodor v. Home Depot U.S.A., 2021 U.S. Dist. Lexis 221231, at *6 (D. Md. Oct. 4, 2021) (mentioning that “[t]he parties unanimously agreed on the record to a jury pool that is vaccinated against COVID-19”); Carey-Powe v. Washington Metropolitan Area Transit Authority, 2021 WL 5504298, at *3 (D. Md. Oct. 1, 2021) (seeking the parties’ “agree[ment] to a jury pool that has been fully vaccinated against COVID-19”).

The rulings in the aforementioned Moses criminal case were similar to those in JoffeMoses decided “to excuse from the pool of prospective jurors summoned in this matter all individuals who are not vaccinated against COVID-19” over the prosecution’s objection.  2021 WL 4739789, at *1.  The analysis in Moses centered on the JSSA, with a finding “there is no basis to conclude that individuals who are unvaccinated against COVID-19 satisfy the standard for distinctive.”  Id. at *3.  It was “highly speculative” that the unvaccinated population shared a similar “attitude” that could create a “danger of . . . partiality or bias,” since “the group for example likely includes individuals who would like to be vaccinated but cannot be for medical reasons.”  Id. at *3.  Further, “[w]hether or not to be vaccinated is not an immutable characteristic, but an active choice made by a particular person for his or her own individual reasons.”  Id. at *4.  Nor was failure to vaccinate a “proxy” for any “distinctive group” – either racial or “point of view.”  Id.  “[I]ncomplete” statistics failed to establish the former, and “no data whatsoever” supported the latter.  Id.  As in Joffe, due to the heightened possibility of infection, unvaccinated jurors were “likely” to disrupt the expected “lengthy” trial:

[I]f an unvaccinated juror were to be exposed to a COVID-19-positive person at any point during the lengthy trial in this case, that juror would be lawfully required to quarantine for ten days.  No such quarantine requirement exists for vaccinated individuals.  As a result of the COVID-19 pandemic, this District . . . has a staggering backlog of jury trials that are ready to proceed.  It would cause massive disruption not just to the instant trial but to other trials . . . if the Court was required to manage multiple mandated quarantines.

Id. at *5.

That’s pretty much it, as far as significant analysis goes.  There are a number of other criminal cases in which the issue of juror vaccination is touched upon, but nothing comparable to the analysis in Moses – let alone in JoffeSee United States v. Muhammad, 2021 WL 4471594, at *4 (E.D. Va. Sept. 29, 2021) (observing “that the parties agreed to strike unvaccinated prospective jurors for cause”); United States v. Liberto, 2021 WL 4459219, at *8 (D. Md. Sept. 29, 2021) (mentioning the court’s policy of “seating only jurors who are vaccinated against the COVID-19 virus” in connection with denying a criminal defendant’s objection to “asking the jury venire’s vaccination status”); United States v. Donoho, 2020 WL 5350429, at *2-3 (W.D. Wis. Sept. 4, 2020) (mentioning “the promise of a vaccinated pool of jurors from which to draw” in criminal cases); United States v. Elder, 2021 WL 4137533, at *1 (E.D.N.Y. Sept. 3, 2021) (denying, in a two-sentence minute order, a criminal defendant’s objection “to the Court’s decision to exclude individuals who are not vaccinated against COVID-19 from the impaneled jury”); United States v. Bryant, 2021 U.S. Dist. Lexis 175499, at *1 (E.D.N.Y. Sept. 2, 2021) (same); United States v. Thompson, ___ F. Supp.3d ___, 2021 WL 2402203, at *4 (D.N.M. June 11, 2021) (dictum in confrontation clause case that “[t]he Court will not be inquiring about the vaccination status of potential jurors and witnesses”).