Back in the early days of the blog, when it was a Bexis/Herrmann operation, we wrote about the California Supreme Court decision that opened the floodgates to all that food litigation that now plagues that state − Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008).  We explained how the court In Farm Raised Salmon, created a roundabout way for California state-court plaintiffs to enforce the food provisions of the FDCA:

What it’s wound up with, with respect to food violation claims, is rather Rube Goldbergian . . .: (1) the FDCA allows state “little FDCA statutes” that incorporate identical food rules, but doesn’t otherwise authorize state-law (much less, private) enforcement; (2) California enacted a little FDCA statute, the Sherman Act, but that didn’t allow private enforcement either, (3) later, California enacted consumer protection statutes that did allow private enforcement, but did not specifically address food, so (4) California courts decided to incorporate globally into the consumer protection statutes any number of other statutes (such as the Sherman Act on food) that did not themselves contemplate private enforcement.

So, in California, “the Sherman Law incorporates all food labeling regulations . . . adopted pursuant to the FDCA.”  175 P.3d at 1175 (citation and quotation marks omitted).  In turn, the “unlawful prong” of the California UCL (“unfair competition law”) incorporates the “provisions of the Sherman” Act.  Id. at 1173-74.

As we discussed in the prior post, while 21 U.S.C. §337(a) is “clear evidence that Congress intended that the [FDCA] be enforced exclusively by the Federal Government,” Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001), California got around that using the “negative implication” of the food-specific 21 U.S.C. §343-1(a) allowing establishment of “identical state requirements.  175 P.3d at 1175.

Note – unlike §337(a), §343-1(a) did not address private enforcement, only actions by a “State or political subdivision of a State.”

After that, it being California, it was off to the races.

But should it be?

As we are fond of telling our readers, Buckman was unanimous in its preemption holding.  Well, another unanimous Supreme Court decision might just have something to say about the California food fight.

In Astra USA, Inc. v. Santa Clara County, California, 563 U.S. 110 (2011), the Court unanimously held that another federal statute that precluded private enforcement could not be evaded by a supposed “common law” that simply incorporated the federal requirements wholesale.

Astra involved a California County – a Medicaid “covered entity” – trying to get into the act of enforcing Medicaid “ceilings on prices drug manufacturers may charge.”  Id. at 113.  The plaintiff “conceded that Congress authorized no private right of action under [the Medicaid Act] for covered entities who claim” they were overcharged.  Id.  That’s the same as the FDCA.

But the Supreme Court takes private rights of action more seriously than the California Supreme Court did in Farm Raised Salmon.

[C]overed entities have no right of action under [the statute] itself.  Recognition of any private right of action for violating a federal statute . . . must ultimately rest on congressional intent to provide a private remedy.  Congress vested authority to oversee compliance with the [Medicaid] Program in HHS and assigned no auxiliary enforcement role to covered entities.

Id. at 117 (citations and quotation marks omitted).

So the plaintiff county claimed that, oh no, it was not asserting a statutory claim, but only a cause of action for third-party beneficiary contract, based on form Pharmaceutical Pricing Agreements (“PPAs”) that it conveniently interpreted as mirroring all of the federal requirements that Congress had precluded private parties from enforcing directly.  Id. at 117-18.  The Court wasn’t buying that end run around the private enforcement ban.

First, statutory provisions forbidding private enforcement cannot be evaded by elevating form over substance.  Just as the plaintiff county, and other covered entities, “ had no right to sue for overcharges under the statute itself,” it was “incompatible with the statutory regime” to allow them to sue “to enforce ceiling-price contracts running between drug manufacturers and the Secretary.”  Id. at 113.

Congress placed the Secretary . . . in control of [the Medicaid statute’s] drug-price prescriptions.  That control could not be maintained were potentially thousands of covered entities permitted to bring suits alleging errors in manufacturers’ price calculations. If [covered] entities may not sue under the statute, it would make scant sense to allow them to sue on a form contract implementing the statute, setting out terms identical to those contained in the statute.  Though labeled differently, suits to enforce [the statute] and suits to enforce PPAs are in substance one and the same.  Their treatment, therefore, must be the same, no matter the clothing in which [covered entities] dress their claims.

Id. at 114 (citations and quotation marks omitted) (emphasis added).

The PPAs merely “incorporate statutory obligations” and “contain no negotiable terms.”  Id. at 118.

A third-party suit to enforce an HHS-drug manufacturer agreement, therefore, is in essence a suit to enforce the statute itself.  The absence of a private right to enforce the statutory ceiling-price obligations would be rendered meaningless if [covered] entities could overcome that obstacle by suing to enforce the contract’s ceiling-price obligations instead.  The statutory and contractual obligations, in short, are one and the same.

Id. at 118 (emphasis added).  We see no difference between what the unanimous Supreme Court thereby forbade in Astra and the dodge allowed in Farm Raised Salmon.

Second, in Astra the court below had found this jerry-rigged form of private enforcement, once removed, “compatible” with statutory obligations because it “would spread the enforcement burden instead of placing it entirely on the government.”  Id. at 119 (quotation marks from reversed decision omitted).  The Supreme Court disagreed, because that was not what Congress had provided.  Rather, “spreading the enforcement burden . . . is hardly what Congress contemplated when it centralized enforcement in the government.”  Id. (citation and quotation marks omitted).

Nor could criticisms of federal “oversight” change the result.  Unless and until Congress amended the Medicaid statute, it conferred no enforceable rights on covered entities to sue over alleged overcharges themselves.

Congress did not respond to the reports of inadequate [federal] enforcement by inviting [covered] entities to launch lawsuits in district courts across the country. Instead, . . . Congress directed [the regulatory agency] to create a formal dispute resolution procedure, institute refund and civil penalty systems, and perform audits of manufacturers.

Id. at 121 (citation omitted).

We note that, nowhere in the Astra opinion does the word “preemption” appear, except in footnote 5.  There, the Court expressly “t[ook] no position on this issue.”  Id. at 120 n.5.  Thus, Astra was decided solely on the plaintiff attempting private enforcement having no enforceable interest, which seems akin to standing, although that word wasn’t used either.  That’s fine with us, since we’ve argued previously that the no-private-right-of-action language in §337(a) can also be enforced as a limitation on standing.

The usurpation of FDCA enforcement by private plaintiffs in California based on Farm Raised Salmon seems to us to be no different in substance, just a little more complicated, than the similar usurpation that the Supreme Court unanimously struck down in Astra.  In both situations, non-governmental plaintiffs seek to enforce “identical” federal standards under some other guise notwithstanding the statute’s express ban on private enforcement.  We don’t see “negative implication” from an FDCA provision expressly limited to “states” and “subdivisions” of states as any more persuasive than the third-party-beneficiary rationale that persuaded nobody in Astra.

In preemption cases, when the Supreme Court drops “we’re not deciding” footnotes like the one in Astra reserving issues, plaintiffs flock to them.  But the pro-preemption footnote in Astra?

Crickets.

For some reason, perhaps due to the difficulty of teeing up this defense in nominally “state law” litigation, we haven’t seen any cases making the analogy that we draw in this post.  Astra is now ten years old, and only one case has cited it in an FDCA context.  That was a footnote in City & County of San Francisco v. Purdue Pharma L.P., 491 F. Supp.3d 610 (N.D. Cal. 2020), stating only:

Nor does Astra USA, Inc. v. Santa Clara County, . . . which did not deal with state law claims that exist separately and independently of the subject federal statute.

Id. at 665 (footnote appended to “Buckman does not apply”).  So we’re not  even exactly sure what argument CCSF apparently rejected.

In the past decade, Astra seems to have sunk out of sight.  At least, we weren’t aware of it until recently, when we ran across it by accident.  We invite our defense-minded colleagues to give Astra another look.

We are in the midst of a multidistrict litigation in which the claims are even more frail than usual, the quality of the ‘inventory’ is even junkier than usual, and the pace of discovery regarding individual cases is even slower than usual. Nevertheless, the plaintiff lawyers (joined, sadly, by the court) frequently express exasperation with the defendants for not writing big, fat settlement checks so that we can get on with our lives and the plaintiff lawyers can move on to their next exercise in wealth redistribution.

Many of you have heard or lived this story before. Nevertheless, there is an amusing wrinkle. All parties in our case have been ordered to disclose the existence of any litigation funding arrangements and whether such arrangements could hamper the ability to settle. The defendants expeditiously filed statements that they were of aware no such litigation funding arrangements. But the plaintiffs have so far filed nothing. We wonder why. (Sorry. Let’s be honest: we do not wonder why; not one bit.)

This latest instance of the dog that didn’t bark got us thinking about litigation funding (which we have written about before, including here and here) and we stumbled across an interesting appellate decision that is almost two years old: Davis v. Oasis Legal Finance Operating Co., 2019 WL 4051592 (11th Cir. Aug. 28, 2019). A class of borrowers in Georgia filed suit against their lenders, claiming that the loans violated state usury laws. The loans were in relatively small amounts, typically less than $3000, and were to be repaid by any recoveries that the plaintiffs received in their personal injury lawsuits. That is, the obligations to repay were contingent upon success in the underlying lawsuits.

The defendant lenders moved to dismiss the case based on two points: (1) a forum selection provision in the loan agreements required lawsuits to be brought in Illinois; and (2) the loan agreements contained class action waivers. The plaintiffs contended that these two provisions violated Georgia public policy. The district court agreed with the plaintiffs. It then certified its decision for interlocutory review so that the Eleventh Circuit could decide the public policy issue before the case went further.

The Eleventh Circuit agreed with the district court and affirmed the decision that the forum selection and class action waiver clauses violated Georgia public policy. In doing so, the Eleventh Circuit recognized that public policy can be a tricky, even dangerous, ground for courts to rest upon in deciding cases. Or perhaps “ground” is the wrong word. It is too solid. The court cited an English case from 1824 characterizing the public policy defense as “a very unruly horse, and when once you get astride it you never know where it will carry you.”

For the past eleven years we have taught a law school class on litigation strategy. One of the things we cover is development and prioritization of themes. More than once, we have found ourselves counseling students that their proposed themes regarding public policy probably need to come after, and receive less emphasis than, more basic nuts-and-bolts themes such as the plain meaning of a contract or the language in statutes or jury instructions. We are reluctant to peg our fortunes on public policy predilections and we think most judges feel the same way. Granted, we attended the University of Chicago Law School and we teach at the University of Pennsylvania Law School — places harboring ample respect for nuts-and-bolts and a decent resistance to being flat-out nuts. From what we have heard, there might be some other places, possibly located in New Haven, where there is much more focus on public policy issues and the breeding of philosopher kings. But we digress.

In Davis, the court separately analyzed the public policy implications of the forum selection and class waiver provisions. The forum selection clause really did seem to run afoul of Georgia statutes clamping down on out of state lenders that “attempted to use forum selection clauses … to avoid the courts of the State of Georgia.” That is a pretty clear expression of public policy. How could the lender defendants get around that? One such statute referred to resolving disputes in the “county” in which the borrower resides or the loan office is located, and the defendants cleverly pointed out that Cook County, Illinois is, after all, a county. Note that we said “cleverly,” not “persuasively.” The Eleventh Circuit reasoned that, read in context, the Georgia statutes were clearly discussing courts in Georgia counties. So in answer to that old blues song that asks, “Baby, don’t you want to go/Back to that same old place/Sweet home, Chicago?” the Eleventh Circuit said, No.

The public policy analysis in Davis regarding the class action waiver was, to our eyes anyway, less compelling. It is true enough that the pertinent Georgia lending statutes set out that “a civil action may be brought on behalf of an individual borrower or on behalf of an ascertainable class of borrowers.” But, unlike with the forum selection issue, there was no expression by the Georgia legislature that bargaining away class actions was in any way problematic. That distinction did not win the day for the lenders. It was enough for both the district and appellate courts in Davis that the class action waiver would allow lenders “to eliminate a remedy than was expressly contemplated by the Georgia Legislature, and thereby undermines the purpose of the statutory scheme.” It does not take too much imagination to conceive of how this analysis might render it impossible for parties ever to bargain away something permitted by statute, and it is hardly self-evident that such a rule makes sense or sound policy.

But there it is. Public policy can be an “unruly horse.” Even so, if Georgia public policy regarding lenders is such a horse, the Davis court held that “it carries these borrowers safely to a Georgia courthouse.”

Talk to any realtor and they’ll tell you location is the key to any home search.  And normally when we rail against litigation tourists, location is pretty key to us too.  Plaintiffs can’t forum shop for “judicial hellholes” that have no relation to them or to the defendant.  So, you’ve probably heard us say plaintiffs can, and often should, bring their cases in their home states.  But occasionally, even that is not enough for personal jurisdiction.  That was the case in Brandon v. Wright Medical Technologies, Inc., 2021 WL 3134658 (D. Nev. Jul. 23, 2021).

At the time plaintiff filed her lawsuit she lived in Nevada and had for the last four years.  Prior to that she resided in California.  While living in California, plaintiff underwent hip replacement surgery during which defendant’s prosthetic hip device was implanted.  Plaintiff lived in California for another five years after her surgery.  After moving to Nevada, plaintiff had bloodwork done after which she had revision surgery to explant the device.  The explant surgery took place in California.  Id. at *1.    Defendant challenged personal jurisdiction in Nevada.

On general jurisdiction plaintiff could only allege that defendant sold thousands of devices in Nevada.  But nationwide sales are not enough to make a defendant “at home” in a jurisdiction. So, there was no general jurisdiction here.  Id. at *2.

The Ninth Circuit’s test for specific personal jurisdiction puts the burden on plaintiff to demonstrate that defendant purposefully availed itself of the privilege of conducting business in the state and that plaintiff’s claims “arise out of” or “relate to” the defendant’s forum-related activities.  Id. at *3.  If plaintiff meets her burden, then defendant must demonstrate that the exercise of jurisdiction would not be reasonable.  Id.  Plaintiff did not meet her burden on either of the first two parts of the test.

Purposeful availment does not mean simply putting a product into the stream of commerce. Id.  Nor was it sufficient for plaintiff to allege that defendant “transacted business” in Nevada.  To meet her burden, plaintiff needed to show that defendant designed the product for the Nevada market, advertised in Nevada, or had a distributor or sales agent in Nevada.  While the court could reasonably assume that a seller of “sophisticated medical devices” did some of these things, plaintiff did not allege them.  Id.

If that had been plaintiff’s only problem, perhaps it could have been cured through amended pleadings or some limited discovery.  But plaintiff failed prong two of the specific jurisdiction test as well.  Plaintiff could not demonstrate that her claims arose out of or were related to defendant’s contacts with the state, assuming they existed.  “[W]ithout [defendant’s] contacts with Nevada, Plaintiff would have still suffered her alleged injuries because she had surgery in California.”  Id. at *4.  The fact that plaintiff spent two years in Nevada with the device still implanted, while foreseeable, was a “unilateral act of a third party, lacking any direct connection between [defendant] and Nevada.”  Id.

The court distinguish the present case from the facts in Ford Motor Co. v. Montana Eighth Jud. Dist. Ct., 141 S. Ct. 1017, 1024 (2021).  There, plaintiffs may have bought their cars elsewhere, but their connection to the forum state went beyond simply residing there.  They used their cars in the forum states and suffered their injuries in their forum states.  Here, plaintiff had surgery in California, lived with the allegedly defective implant for five years in California, and returned to California for her explant surgery.  So not only did defendant have systematic contacts with Nevada, but plaintiff’s connection to Nevada regarding her claims is also weak.  “Jurisdiction is lacking without an affiliation between the specific controversy and the forum.”  Id.  Plaintiff does not have that here.  So even if the plaintiff is a state resident, jurisdiction still fails if everything concerning the product occurred in other states.

All of us are long-time defenders of prescription medical product manufacturers, and some of us are veterans of the vaccine wars of the 1980s and 1990s involving DPT vaccine and thimerosal.  We are big fans of vaccines and the tremendous health benefits they have bestowed on humanity, and are mystified by the alliance between anti-vaccine fringe elements and the COVID-19 virus that has politicized the public health response to the worst pandemic in a century.  It has gotten to the point where some people would prefer to risk dying of COVID-19 because they perceive the “get vaccinated” message as coming from the opposite side of the political spectrum.  Such suicide-by-virus is occurring despite the widespread availability of safe and free vaccines that are:  (1) almost 100% effective at preventing hospitalization and death from COVID-19; and (2) over 90% effective at preventing any COVID-19 infection at all (a third vaccine is somewhat less effective (67%-85%), but only requires one jab and is easier to store and transport).

COVID-19 itself looks to be fatal in about 1.7% of cases (610,952/34,533,179 according to Johns Hopkins, as of this writing).  That’s about 1 in 60.  With only about half of the population of the United States vaccinated (and a current jab rate of around half-a-million a day), that means somewhat over 160 million Americans are fully vaccinated.  The latest surge, driven by the extremely contagious delta (Δ) variant has resulted in “breakthrough” COVID-19 infections in already vaccinated people.  According to the CDC, by the end of April:

A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported. . . .  Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.

At that point, “approximately 101 million persons in the United States had been fully vaccinated.”  That works out to a risk of breakthrough infection of around one in 10,000, a risk of hospitalization from breakthrough infection of around one in 100,000, and a risk of breakthrough death of about one in 600,000.  You do the math.

So the COVID-19 pandemic in the country (and more gradually, the world) is changing.  It’s now become a pandemic of the unvaccinated, with every report we’ve seen of hospitals – and mortuaries − filled with almost entirely people who were either vaccine ineligible or, worse, who were eligible but had simply declined to get vaccinated.  As a result, all of us, vaccinated or not, are likely to face the “return of the mask.”  Unfortunately, too many people can’t be trusted to get vaccinated for the good of all of us, and many of those same people also can’t be trusted to mask themselves voluntarily.  So everybody has to mask.

And things can get worse.  Children, more than four million of them, have already been infected by COVID, representing 2.2% of national hospitalizations and 0.7% of deaths.  That’s despite almost all schooling having been conducted remotely for over a year.  According to American Academy of Pediatrics statistics, this pediatric death rate is more than twice the flu, and pediatric infections have tripled in recent weeks.  But this fall, with in-person schooling resuming, the current trajectory means that large numbers of vaccine ineligible children, exposed to COVID-19 from unvaccinated family members, will attend school, thereby putting at risk everyone else in the schools − other children (and their family members), teachers, and school staff.  As the president recently said, “This is an American tragedy.”

In sum, the time has come to turn to mandatory COVID-19 vaccination, which as we discuss below has been done through the country, mostly in schools, during epidemics for over a century.  Recently, over fifty health-related organizations, including the American Medical Association, the American Nursing Association, and the American Pharmacists Association, have endorsed mandatory vaccination for all health care and elder care workers:

Due to the recent COVID-19 surge and the availability of safe and effective vaccines, our health care organizations and societies advocate that all health care and long-term care employers require their workers to receive the COVID-19 vaccine. This is the logical fulfillment of the ethical commitment of all health care workers to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.

Joint Statement in Support of COVID-19 Vaccine Mandates for All Workers in Health and Long-Term Care.  The federal government has started the process of creating vaccine mandates for federal workers and federal contractors.  New York City and the state of California are likewise considering mandatory vaccination for public workers.  Many corporations are making vaccination mandatory for their employees, led by Disney, Walmart, and Google.  We look forward to mandatory COVID-19 vaccination for common-carrier travel as well, since this is the only avenue allowing safe, unmasked travel in airplanes, trains, and busses.  While we swear by masks, we have also been known to swear at them.

So we’re putting our research where our mouths are.  What follows should save anyone defending against anti-vaxxers some time and money.

Anti-vaxxers will sue, of course, like they did in Bridges v. Houston Methodist Hospital, 2021 WL 2399994 (S.D. Tex. June 12, 2021), and as they have for well over a century.  But they have, and should, lose − again as they have for well over a century.  Mandatory vaccination has been recognized as constitutionally permissible for that long, even at the height of the substantive due process era.  While some jurisdictions allow exceptions to mandatory vaccination for “religious” reasons, that’s a matter of grace, not any sort of constitutional requirement.  No appellate court has ever required such an exemption, and that has been litigated a lot.

We further note that most of the older cases involve smallpox vaccine that, unlike COVID-19 vaccines, actually infected people with a less serious disease (cowpox, where the “vacc” in “vaccination” comes from) to prevent something much worse.  Thus COVID-19 vaccines are, if anything, a fortiori from smallpox precedent, since they are non-infectious.

The key case is Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905).  During a smallpox outbreak, a Massachusetts town, exercising power delegated to it by that state, imposed a mandatory vaccination requirement.  An anti-vaxxer of that time sued, “insist[ing] that his liberty is invaded when the state subjects him to fine or imprisonment for neglecting or refusing to submit to vaccination” and “that a compulsory vaccination law is unreasonable, arbitrary, and oppressive, and, therefore, hostile to the inherent right of every freeman to care for his own body and health.”  Id. at 26.  Those arguments lost 7-2.  Justice Harlan (the elder) held.

[T]he liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint.  There are manifold restraints to which every person is necessarily subject for the common good.  On any other basis organized society could not exist with safety to its members. Society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy.

Id. (emphasis added).  Jacobson thereby rejected the legal malarkey currently known as “sovereign citizen” theory.

Rather, “persons and property are subjected to all kinds of restraints and burdens in order to secure the general comfort, health, and prosperity of the state.”  Id. (citation and quotation marks omitted).  “Liberty” is “freedom from restraint under conditions essential to the equal enjoyment of the same right by others.”  Id. at 27.  “[T]hose who had no faith in vaccination as a mean of preventing the spread of smallpox . . . put in peril the health of the person vaccinated.”  Id. at 35.  Thus, the “fundamental principle of the social compact that the whole people covenants with each citizen, and each citizen with the whole people, that all shall be governed by certain laws for ‘the common good.’”  Id.  In other words, vaccine resistance need not be tolerated when it allows disease to spread and imperil others.

Under Jacobson, mandatory vaccination was in smallpox days, and is now in COVID-19 times, entirely constitutional.  “Upon the principle of self-defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members.”  Id.  Where a communicable disease is “prevalent,” and worse, “increasing,” “the court would usurp the functions of another branch of government if it adjudged, as matter of law, that the mode adopted under the sanction of the state, to protect the people at large was arbitrary, and not justified by the necessities of the case.”  Id. at 28.  Given, “the knowledge which, it is safe to affirm, in common to all civilized peoples touching smallpox and the methods most usually employed to eradicate that disease,” mandatory vaccination was neither “arbitrary” nor “unreasonable.”  Id.

Just as “quarantines” are a valid means of fighting disease (see this helpful Reed Smith resource guide), so is mandatory vaccination – no matter what anti-vaxxers might say:

If the mode adopted by the commonwealth of Massachusetts for the protection of its local communities against smallpox proved to be distressing, inconvenient, or objectionable to some, . . . the answer is that it was the duty of the constituted authorities primarily to keep in view the welfare, comfort, and safety of the many, and not permit the interests of the many to be subordinated to the wishes or convenience of the few. . . .  [I]n every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.

Jacobson, 197 U.S. at 27-28 (emphasis added).

Arguments that “attach little or no value to vaccination as a means of preventing” disease, or that claim “that vaccination causes other diseases,” must give way to the modern consensus.  Vaccines work.  “What everybody knows the court must know, and therefore the state court judicially knew, as this court knows, that an opposite theory accords with the common belief, and is maintained by high medical authority.”  Id. at 30.  It is not a court’s function to overturn a vaccine mandate.  “[T]he principle of vaccination as a means to prevent the spread of [disease] has been enforced in many states by statutes making the vaccination of children a condition of their right to enter or remain in public schools.”  Id. at 31-32 (string citation omitted).  What was “generally accepted” in 1905 is equally apropos today:

The common belief, however, is that [vaccination] has a decided tendency to prevent the spread of this fearful disease, and to render it less dangerous to those who contract it.  While not accepted by all, it is accepted by the mass of the people, as well as by most members of the medical profession.  It has been general . . . in most civilized nations for generations.  It is generally accepted in theory, and generally applied in practice, both by the voluntary action of the people, and in obedience to the command of law.

Id. at 34-35.  “We are not prepared to hold that a minority, residing or remaining in any [place] where [an epidemic disease] is prevalent, and enjoying the general protection afforded by an organized local government, may thus defy the will of its constituted authorities.”  Id. at 37.

As a result of the Supreme Court standing firm in Jacobson, smallpox has been entirely eradicated.

And the Supreme Court recognizes this success.  In the Bruesewitz case that we blogged about here, that radical liberal Justice Antonin Scalia observed that “the elimination of communicable diseases through vaccination became one of the greatest achievements of public health in the 20th century.”  Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226 (2011) (quotation marks and footnote omitted).  Justice Breyer, concurring, agreed.  “[R]outine vaccination is one of the most spectacularly effective public health initiatives this country has ever undertaken.”  Id. at 245.  The result of Bruesewitz:  the effective elimination of product liability litigation involving vaccines.

Bruesewitz did not cite the century-old Jacobson case, but many other courts have for the proposition the mandatory vaccination (we’re not addressing Jacobson’s application to any number of non-vaccine public health measures) is not subject to judicial challenge and does not violate any recognized constitutional rights.  “Jacobson . . . settled that it is within the police power of a state to provide for compulsory vaccination.”  Zucht v. King, 260 U.S. 174, 176 (1922) (Brandeis, J.).

Our Constitution principally entrusts “[t]he safety and the health of the people” to the politically accountable officials of the States “to guard and protect.”  Jacobson v. Massachusetts, 197 U.S. 11, 38 (1905).  When those officials undertake to act in areas fraught with medical and scientific uncertainties, their latitude “must be especially broad.”  Where those broad limits are not exceeded, they should not be subject to second-guessing by an “unelected federal judiciary.”

South Bay United Pentecostal Church v. Newsom, ___ U.S. ___, 140 S. Ct. 1613, 1613-14 (2020) (Roberts, C.J. concurring in denial of certiorari) (other citations and quotation marks omitted).  Nor are “compulsory vaccination laws” subject to “strict scrutiny” by “[t]he First Amendment’s protection of religious liberty.”  Employment Div., Dept. of Human Resources of Oregon v. Smith, 494 U.S. 872, 888-89 (1990).

[A parent] cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds.  The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.

Prince v. Massachusetts, 321 U.S. 158, 166-67 (1944) (footnotes omitted) (emphasis added).  The Court has also recognized that, to apply religiously-based “strict scrutiny” to attack something like mandatory vaccination, would also mean allowing similar attacks advocating all sorts of other, supposedly religiously-justified conduct, from polygamy, to peyote, to not paying taxes.  Employment Div., 494 U.S. at 879, 889 (collecting cases).

The argument “that [a state] mandatory vaccination requirement violates substantive due process . . . is foreclosed by” JacobsonPhillips v. City of New York, 775 F.3d 538, 542 (2d Cir. 2015).  A state may “protect the health and safety of public school children through extensive vaccinations.”

The endgame is widespread vaccination, which is necessary, indeed essential, to promote adequate immunity.  The importance of extensive vaccination should not be understated − the efficacy of vaccination relies on the theory of “herd immunity.”  In essence, once a critical mass of the population is immune to a particular disease, the chance that unvaccinated individuals contract that disease drastically decreases.

Nikolao v. Lyon, 875 F.3d 310, 318 (6th Cir. 2017) (citations omitted).  “We are hard-pressed to envision a more secular purpose than” “protect[ing] children from serious and avoidable diseases.”  Id.

[T]he Supreme Court has consistently recognized that a state may constitutionally require school children to be immunized.  This is not surprising given the compelling interest of society in fighting the spread of contagious diseases through mandatory inoculation programs.

Workman v. Mingo Cty. Board. of Education, 419 F. Appx. 348, 356 (4th Cir. 2011) (quotation marks and citations to cases cited above omitted).  See Caviezel v. Great Neck Public Schools, 500 F. Appx. 16, 19 (2d Cir. 2012) (“substantive due process challenge to [state] immunization requirement is defeated by Jacobson”).

State appellate courts have agreed.  “[C]ompelling vaccination is constitutional.”  People v. Ekerold, 105 N.E. 670, 672 (N.Y. 1914).  “There is little question that a state may adopt a program of compulsory immunization for school-age children.”  Davis v. State, 451 A.2d 107, 111 (Md. 1982) (citations omitted).  “[W]e consider the Federal question to be definitely settled in favor of the validity of the requirement of compulsory vaccination.”  Seubold v. Fort Smith Special School Dist., 237 S.W.2d 884, 888 (Ark. 1951).

[T]he statute in question, requiring immunization against certain crippling and deadly diseases particularly dangerous to children before they may be admitted to school, serves an overriding and compelling public interest, and . . . such interest extends to the exclusion of a child until such immunization has been effected, not only as a protection of that child but as a protection of the large number of other children comprising the school community.

Brown v. Stone, 378 So.2d 218, 222 (Miss. 1979).

“It is well established that laws mandating vaccination of school-aged children promote a compelling governmental interest of ensuring health and safety by preventing the spread of contagious diseases.”  Love v. State Dept. of Education, 240 Cal. Rptr.3d 861, 868 (Cal. App. 2018).  “[C]ompulsory immunization has long been recognized as the gold standard for preventing the spread of contagious diseases.”  Id. at 870.

[F]ederal and state courts, . . . have held either explicitly or implicitly that society has a compelling interest in fighting the spread of contagious diseases through mandatory vaccination. . . .  That interest exists regardless of the circumstances of the day, and is equally compelling whether it is being used to prevent outbreaks or eradicate diseases.  As stated in the statute on immunization requirements, the state’s objective is the eventual achievement of total immunization.

Brown v. Smith, 235 Cal. Rptr.3d 218, 226 (Cal. App. 2018) (citations and quotation marks omitted).  Our research was enlightening.  Indeed, one of the best analyses we found came from Georgia back in the early 1950s.

The ill effects of contagious disease, and its power to wipe out entire populations, is a matter of history.  Many of these scourges of the past have been completely dissipated by the preventive methods of medical science.  The purpose of the legislature in passing the [mandatory vaccination] statute . . . was to prevent the spread of these diseases, not only for the protection of those actually immunized but for the protection of others with whom they might come in contact.  The refusal of the defendants here to have their children vaccinated amounted to a transgression of the rights of others. . . .  Liberty of conscience is one thing.  License to endanger the lives of others by practices contrary to statutes passed for the public safety and in reliance upon modern medical knowledge is another.

Anderson v. State, 65 S.E.2d 848, 851-52 (Ga. App. 1951) (citation omitted) (emphasis added).  See Dalli v. Board of Education, 267 N.E.2d 219, 221 (Mass. 1971) (“compulsory or local option immunization laws” have been “universally upheld as proper exercises of the police power”); Wright v. DeWitt School Dist. No. 1, 385 S.W.2d 644, 647 (Ark. 1965) (“courts are not required to listen to conflicting evidence as to the need of vaccination”); Cude v. State, 377 S.W.2d 816, 819 (Ark. 1964) (“it is within the police power of the State to require that school children be vaccinated . . ., and that such requirement does not violate the constitutional rights of anyone”; guardian appointed to take custody of child); Mosier v. Barren County Board of Health, 215 S.W.2d 967, 969 (Ky. 1948) (given Jacobson, “little space will be devoted to the question that vaccination violates the constitutional rights of these children”); Sadlock v. Board of Education of Borough of Carlstadt, 58 A.2d 218, 220 (N.J. 1948) (taking “judicial notice . . . that vaccination is commonly believed to be a safe and valuable means of preventing the spread of certain diseases . . ., and that this belief is supported by high medical authority”); State v. Drew, 192 A. 629, 631 (N.H. 1937) (“A direct provision for vaccination, with a penalty for refusal to submit, is valid.”); Commonwealth v. Green, 168 N.E. 101, 101 (Mass. 1929) (“The requirement for vaccination has been held to be constitutional.”); Cram v. School Board. of Manchester, 136 A. 263, 263 (N.H. 1927) (summarily affirming under Jacobson); Barber v. School Board of Rochester, 135 A. 159, 160 (N.H. 1926) (“The constitutionality of vaccination statutes has been passed upon in many cases, and the uniform conclusion has been that they constitute a valid exercise of the police power of the state.”) (string cite omitted); People ex rel. Hill v. Board of Education of City of Lansing, 195 N.W. 95, 100 (Mich. 1923) (granting mandamus to enforce mandatory vaccination; “We think the board of health is to be commended, instead of condemned, for applying to the court to enforce its order.”); Spofford v. Carlton, 131 N.E. 314, 315 (Mass. 1921) (“the uniform policy of the commonwealth requires general vaccination as a preventative measure against the infection and spread of . . . dangerous and highly contagious diseases”); State v. Martin, 204 S.W. 622, 625 (Ark. 1918) (“an adult is not deprived of his liberty by the enforcement of a rule of a local board of health requiring the vaccination of all citizens”); Hagler v. Larner, 120 N.E. 575, 577 (Ill. 1918) (“in the event of a present or threatened epidemic” mandatory vaccination is “reasonable and should be upheld”); City of New Braunfels v. Waldschmidt, 207 S.W. 303, 304 (Tex. 1918) (“The contention that [mandatory vaccination] is inconsistent with the liberty guaranteed by the federal and state Constitutions” was “ completely repelled by the opinion . . . in Jacobson”); Herbert v. Demopolis School Board of Education, 73 So. 321, 322 (Ala. 1916) (“the long dominant opinion of professional men that [compulsory vaccination] is efficacious has merited and received the affirmative approval of legislative bodies and of courts throughout this country, as well as elsewhere generally”); Hill v. Bickers, 188 S.W. 766, 768 (Ky. 1916) (enforcing mandatory vaccination requirement; plaintiffs’ “unprofessional opinions jeopardize the health and lives of all the citizens of the county”; vaccination is “not to be decided according to the whims of laymen”); State ex rel. O’Bannon v. Cole, 119 S.W. 424, 428 (Mo. 1909) (“school boards in Missouri, in the event of a smallpox epidemic, or a threatened smallpox epidemic, have the right to enforce” mandatory vaccination); State v. Shorrock, 104 P. 214, 216 (Wash. 1909) (the state “has power to require all minors to attend the public schools, and to require them to be vaccinated before so attending”); Auten v. Board of Directors of Special School Dist. of Little Rock, 104 S.W. 130, 130 (Ark. 1907) (“we do not think there can be any ground for the contention that this requirement that pupils should be vaccinated before entering the schools was unreasonable and unnecessary”); State ex rel. Milhoof v. Board of Education of Village of Barberton, 81 N.E. 568, 569 (Ohio 1907) (“vaccination as a prerequisite to attendance upon the public schools, have been almost uniformly upheld and sustained by the courts, as a reasonable and proper exercise of the police power”); Stull v. Reber, 64 A. 419, 421 (Pa. 1906) (mandatory vaccination “is not only a justifiable but a wise and beneficent exertion of the police power over the public health”); F.F. v. State, 143 N.Y.S.3d 734, 742 (N.Y.A.D. 2021) (“recognizing “the significant public health concern” supporting “mak[ing] the vaccine requirement generally applicable to the public at large in order to achieve herd immunity”); C.F. v. New York City Dept. of Health & Mental Hygiene, 139 N.Y.S.3d 273, 287 (N.Y.A.D 2020) (“implementation of a vaccine mandate in order to control [an] outbreak is a reasonable and proper exercise of the police power, adopted, not only to protect those required to be vaccinated but for the protection of all of the people”) (citation and quotation marks omitted); Maricopa County Health Dept. v. Harmon, 750 P.2d 1364, 1369 (Ariz. App. 1987) (“exclusion of unimmunized pupils from school” held constitutional under Jacobson); Syska v. Montgomery County Board of Education, 415 A.2d 301, 303 (Md. App. 1980) (“the State has the right under the police power, without offending constitutional proscriptions, to require immunization for the protection of the public health and safety”); McCartney v. Austin, 298 N.Y.S.2d 26, 27 (N.Y.A.D. 1969) (“That [mandatory vaccination] statutes . . . are within the police power and thus constitutional generally is too well established to require discussion.”); Board of Education of Mountain Lakes v. Maas, 152 A.2d 394, 404 (N.J. Super. A.D. 1959) (“that there may be differences of opinion as to the necessity or efficacy of vaccination or immunization does not deprive the State of the power to enact legislation requiring compulsory vaccination or immunization”), aff’d mem., 158 A.2d 330 (N.J. 1960); In re Marsh, 14 A.2d 368, 370 (Pa. Super. 1940) (mandatory vaccination “upheld as a valid exercise of the police power of this Commonwealth”; willful refusal to vaccinate resulted in loss of child custody); Abney v. Fox, 250 S.W. 210, 213 (Tex. Civ. App. 1923), writ refused (“That an order requiring vaccination is not in violation of the Constitution is settled”); Commonwealth v. Aiken, 64 Pa. Super. 96, 102 (1916) (“The law requiring vaccination of children in the public schools is a proper one” and “vaccination may be compelled.”); McSween v. Board of School Trustees of City of Ft. Worth, 129 S.W. 206, 208 (Tex. Civ. App. 1910), writ refused (mandatory vaccination was “the exercise of police power for the protection of the health of the pupils of the public schools, and therefore” constitutional under both state and federal constitutions).  Cf. Matter of Christine M., 595 N.Y.S.2d 606, 618 (N.Y. Fam. Ct. Dec. 21, 1992) (finding parent’s failure to comply with mandatory vaccination law caused child to be “neglected” within meaning of child abuse statute).

Likewise, federal district courts recognize that, “[i]n this country there is a long history of disagreements − scientific and otherwise − regarding vaccinations . . ., and courts have repeatedly found that it is for the legislature . . . to choose between opposing theories within medical and scientific communities in determining the most effective way in which to meet and suppress public health threats.”  Doe v. Zucker, ___ F. Supp.3d ___, 2021 WL 619465, at *21 (N.D.N.Y. Feb. 17, 2021) (Jacobson citations omitted).  As we discussed in more detail, here, the district court in Klaassen v. Trustees of Indiana University, ___ F. Supp.3d ___, 2021 WL 3073926 (N.D. Ind. July 18, 2021), approved a university’s mandatory COVID-19 vaccination requirement, holding that, under Jacobson:

[S]tate and federal legislatures [enjoy] wide discretion to pass legislation in areas where there is medical and scientific uncertainty.  Based on this power, states and their authorized arms have historically adopted vaccination mandates. For instance, all fifty states and the District of Columbia have laws requiring students to receive certain vaccines before they may attend school.

Id. at *18-19 (citations, quotation marks, and footnotes omitted).

[T]he purpose of quelling the outbreak by encouraging county-wide vaccination, [is] a measure permitted in a variety of constitutional contexts by Jacobson and its progeny.  For that reason, too, the complained-of restrictions are distinguishable from those in [cases] which had nothing to do with vaccination.  Indeed, to the extent that Plaintiffs argue the Declaration was unconstitutional because it conditioned their children’s rights to attend school on becoming vaccinated, that contention is foreclosed by well-established precedent holding that mandatory vaccination laws are consistent with the Constitution,

W.D. v. Rockland County, ___ F. Supp.3d ___, 2021 WL 707065, at *28 (S.D.N.Y. Feb. 22, 2021) (citations omitted).  See Doe v. Zucker, 496 F. Supp.3d 744, 759 (N.D.N.Y. 2020) (“the public health concerns in maintaining high immunization rates for vaccine-preventable diseases and in avoiding outbreaks of communicable diseases provide ample basis for the newly enacted regulations”); V.D. v. State of New York, 403 F. Supp.3d 76, 87 (S.D.N.Y. 2019) (“[c]onditioning school enrollment on vaccination has long been accepted by courts as a permissible way for States to inoculate large numbers of young people and prevent the spread of contagious diseases”); W.B. v. Crossroads Academy-Central Street, 2019 WL 6257963, at *1 (W.D. Mo. Nov. 22, 2019) (“The most current State and Federal decisions also uniformly support vaccination requirements, including governmental advocacy of vaccinations, despite various scientific, religious, family autonomy and general libertarian objections by parents.”); Whitlow v. California, 203 F. Supp.3d 1079, 1083 (S.D. Cal. 2016) (“For more than 100 years, the United States Supreme Court has upheld the right of the States to enact and enforce laws requiring citizens to be vaccinated.”); Middleton v. Pan, 2016 WL 11518596, at *6-8 (Mag. C.D. Cal. Dec. 15, 2016) (rejecting a variety of constitutional attacks on mandatory vaccination), adopted, 2017 WL 10543984 (C.D. Cal. July 13, 2017); Schenker v. County of Tuscarawas, 2012 WL 4061223, at *12 (N.D. Ohio Sept. 14, 2012) (“It has long been recognized that local authorities may constitutionally mandate vaccinations.”); Scott v. Goodwin, 2010 WL 2926222, at *6 (Mag. W.D. La. June 29, 2010) (“Vaccinations are a legitimate and neutral method to prevent the spread of a contagious and/or dangerous disease in the [prison] inmate population.”), adopted, 2010 WL 2926233 (W.D. La. July 21, 2010); Boone v. Boozman, 217 F. Supp.2d 938, 954 (E.D. Ark. 2002) (“it cannot be questioned that compulsory immunization is a permissible exercise of the State’s police power”); Sherr v. Northport-East Northport Union Free School Dist., 672 F. Supp. 81, 83 (E.D.N.Y. 1987) (“one area in which religious freedom must be subordinated to the compelling interests of society involves protection against the spread of disease”); Hanzel v. Arter, 625 F. Supp. 1259, 1262 (S.D. Ohio 1985) (given Jacobson, “the immunization decision is not encompassed by the right of privacy”); Marsh v. Earle, 24 F. Supp. 385, 387 (M.D. Pa. 1938) (“it is for the legislature and not the courts to determine in the first instance whether vaccination is the best mode for prevention of” disease).  Cf. United States v. Schwartz, 61 M.J. 567, 570 (Navy-Marine Crim. App. 2005) (“There can be little doubt that the vaccination of service members has a valid military purpose.”), aff’d, 64 M.J. 199 (C.A. Armed Forces 2006); United States v. Chadwell, 36 C.M.R. 741, 749-50 (Navy B.R. 1965) (“If we may attach any value whatever to medical knowledge which is common to all civilized peoples, we must conclude on the basis of common knowledge that an order to take immunization shots is legal and necessary in order to protect the health and welfare of the military community and that failure to take such shots would represent a substantial threat to public health and safety in the military.”).

We arbitrarily researched only back to the 1905 Jacobson case.  However, there are dozens of earlier cases (including both New York and California) likewise affirming the constitutionality of vaccination requirements, going back to at least to Hazen v. Strong, 2 Vt. 427, 432-33 (Vt. 1830) (upholding tax to pay for vaccinations).  So in any jurisdiction, additional favorable older precedent may well exist.

What about the FDCA?  Well, for now COVID-19 vaccines are all available only through “Emergency Use Authorizations” (“EUAs”) governed by 21 U.S.C. §360bbb-3.  One of the required “conditions of authorization” for an EUA is informed consent, as “necessary or appropriate to protect the public health,” including “to the extent practicable” information concerning:

the option to accept or refuse administration of the product, [and] the consequences, if any, of refusing administration of the product.

21 U.S.C. §360bbb-3(e)(1)(a)(ii)(III).  Does the FDCA thereby imply that there actually is such an “option,” or only that information is to be provided in the event that such an option exists?

Bridges held that this provision “neither expands nor restricts the responsibilities of private employers” and “does not apply at all to private employers.”  2021 WL 2399994, at *2.  A recent “Memorandum Opinion for the Deputy Counsel to the President” also looked at this argument and concluded that §360bbb-3(e)(1)(a)(ii)(III):

concerns only the provision of information to potential vaccine recipients and does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to EUAs.  By its terms, the provision directs only that potential vaccine recipients be “informed” of certain information. . . .  In the sense used here, the word “inform” simply means to “give (someone) facts or information; tell”. . . .  Neither the statutory conditions of authorization nor the [individual vaccine] Fact Sheet itself purports to restrict public or private entities from insisting upon vaccination in any context.

Id. at 6-7 (citations omitted).  As a whole, §360bbb-3 “only has legal effect on a person who carries out an activity for which an authorization under this section is issued” and thus “expressly forecloses any limitation on the activities of the vast majority of entities who would insist upon vaccination requirements.”  Id. at 8.

Thus the “information” that persons receiving an EUA vaccine are entitled to under §360bbb-3(e)(1)(a)(ii)(III) could simply be the “consequences” − that if someone doesn’t get the vaccine, his or her employer is within its rights to terminate employment, or that a health/life insurer might charge a higher premium.  Memorandum Opinion at 12-13.  If Congress had wanted to preclude vaccine mandates, “Congress could have created such a restriction by simply stating that persons (or certain categories of persons) may not require others to use an EUA product.”  Id. at 9 (citations omitted).

[W]e also read [§360bbb-3] as giving FDA some discretion to modify or omit “the option to accept or refuse” notification, or to supplement it with additional in-formation, if and when circumstances change.

Id. at 11 (citing the “to the extent practicable” language).  Thus, “FDA’s responsibility to impose the ‘option to accept or refuse’ condition is not absolute” and can be “modif[ied] or omit[ted]” where “necessary or appropriate to protect the public health.”  Id. at 12.  In any event, any issue with §360bbb-3 disappears as soon as the COVID-19 vaccines receive full FDA approval.

Since we have the vaccine technology to prevent COVID-19 from becoming the next plague or influenza, recurring year after year, preservation of the public health demands that we use it while we still can.  For well over a century science deniers of various stripes have tried, but failed, to stop mandatory vaccination.  We fully expect them to keep trying – and to keep failing.  This post is our contribution to the cause.

The last time we wrote about vaccines, we received a lot of emails.  Vaccines are a hot-button issue for some, although we firmly believe they should not be.  Vaccines have prevented disease in millions and millions of people and are among the most important public health developments of all time.

When we wrote that post in 2019, we had no idea that vaccines would come to dominate global headlines, prompted by the COVID-19 pandemic.  Let’s be clear:  We think everyone who is able should be vaccinated.  If you have genuine questions, talk to a medical professional, not a TV personality or politician (from any party).  And by all means, do not at this point say you have a Constitutional right to refuse vaccination.  Because you don’t.  And that has been established for more than 100 years.

That is what a group of students at Indiana University learned when they recently moved for a preliminary injunction against a state university’s mandatory vaccine policy, and lost.  The case is Klaassen v. Trustee of Indiana University, No. 1:21-cv-238, 2021 U.S. Dist. LEXIS 133300 (N.D. Ind. July 18, 2021), and the 42-page order is among the most thorough and thoughtful orders on which we have written.

The University’s policy was not an impulsive decision.  The University convened a committee spearheaded in part by the Dean of the Medical School and populated by experts in medicine, public health, risk mitigation, law, and ethics.  Id. at *13-*14.  That process resulted in a policy requiring all students, faculty, and staff to be vaccinated before returning to campus.  Id. at *15.  The consequences are real—those who do not comply are essentially banned from campus.  But there are also multiple exemptions granted on a no-questions-asked basis, including religious exemptions, medical exemptions, medical deferrals, and exemptions for online enrollees.  Id. at *16.  The committee was also not writing on a clean slate.  Indiana has required that all public university students be vaccinated for multiple diseases since 1993.  Id. at *10.

What could be wrong with this?  Well, the students argued that the mandatory policy violated their right to substantive due process under the Fourteenth Amendment, which says that no state can “deprive any person of life, liberty, and property, without due process of law.”  Id. at *39.  “Substantive due process” means that the Fourteenth Amendment furnishes “an additional guaranty against any encroachment by the States upon the fundamental rights [that] belong to every citizen.”  Id. (quoting United States v. Cruikshank, 92 U.S. 542, 554 (1875)).  In other words, substantive due process is a “substantive limitation on the power of government to legislate.”  Id. at *40.

The standard of review is critical in substantive due process cases, and this case was no exception.  The students argued that they had a “fundamental right” to refuse vaccination, which triggered strict scrutiny.  Strict scrutiny is the highest level of constitutional scrutiny, under which the government’s infringement must be “narrowly tailored to serve a compelling state interest.  Id. at *41-*42.  In practice, a governmental body almost always loses under a “strict scrutiny” test.

The University, however, argued that neither the right to refuse vaccinations nor the right to a college education were fundamental.  As a result, any infringement on those rights should be judged under rational basis review, under which legislation is “presumed to be valid and will be sustained if the classification drawn by the statute is rationally related to a legitimate state interest.”  Id. at *42.  In practice, a governmental body almost always wins under when “rational basis” is the test.

The district court applied rational basis review, relying on the Supreme Court’s opinion upholding a smallpox vaccine mandate more than 100 years ago in Jacobson v. Massachusetts, 197 U.S. 11 (1905).  Although Jacobson, did not use the words “rational basis review,” the district court found that the Supreme Court applied rational basis review in all but name:

Though Jacobson was decided before tiers of scrutiny, it effectively endorsed . . . rational basis review of a government’s mandate during a health crisis.  . . . [¶]  This view remains consistent with the right at stake in Jacobsonthough a true “liberty” proved at stake—the right to refuse a vaccine during a smallpox epidemic—this interest in bodily autonomy, though protected by the Constitution, wasn’t fundamental under the Constitution to require greater scrutiny than rational basis review.

Id. at *54-*55 (emphasis added).  The district court also harmonized this holding with the Supreme Court’s more recent holding in Roman Catholic Diocese v. Cuomo, 141 S. Ct. 63 (2020), where the Supreme Court applied strict scrutiny to enjoin New York from imposing COVID-19 restrictions on religious services.  Id. at *51-*55.  In Cuomo, the right at stake—the right to religious worship—was a fundamental right.  Different ballgame.

Applying rational basis review, the district court upheld the University’s mandatory vaccine policy.  It came down to a balance of the students’ liberty against the relevant state interests, i.e., protecting public health:

“Stemming the spread of COVID-19 is unquestionably a compelling interest.”  Cuomo, 141 S. Ct. at 67 (majority opinion).  . . .  Recognizing today’s status of this pandemic, neither health professionals, government representatives, nor this court may say public health vis-à-vis COVID-19 has waned from being a legitimate state interest.  Improved it undoubtedly has—today seems a world altogether different from last year—but public health remains a legitimate interest of the state to pursue.

Id. at *68.  The students argued that their liberty interest weighed favorably against this government interest because “the pandemic is basically over.”  Id.  But the court quickly rejected that argument:  “Vastly improved, yes; out of the woods we aren’t, not on this record.”  Id. at 69.  The court was right, and how, as recent developments have only underscored.

The court also reminded the parties why the COVID-19 situation has improved—because of vaccines!  And it emphasized that the situation remains fluid, with virus variants being moving targets.  Id. at *70-*72.  The balance satisfied rationale basis review—the University has a rational basis to conclude that the COVID-19 vaccines are safe and efficacious, and its policy reasonably relies on the vaccine to prevent disease and “return to normal school functioning.”  Id. at *100.  As the court observed,

[W]hen reasonable minds can differ as to the best course of action—for instance, addressing symptomatic versus asymptomatic virus spread or any number of issues here—the court doesn’t interfere so long as the university’s process is rational in trying to achieve public health. . . . There is a rational basis for making distinctions here.

Id. at *103-*104.  Finally, the students who received vaccine exemptions—six of the eight plaintiffs—challenged the accompanying requirements that they wear masks and submit test result.  The court found no Constitutional deprivation there, either.  Neither implicates a fundamental right, and the requirements are rationally related to promoting health and safety.  Id. at *107-111.  Both vaccinated and unvaccinated people can still get the virus, and students have lived with mask mandates for more than a year.  There was nothing unreasonable about it.  Id. at *111-*113.

In the end, the unvaccinated students thought it was all about them, but they could not be more wrong.  “[T]he evidence reasonably shows that [unvaccinated people] aren’t the only ones harmed by refusing to get vaccinated: refusing while also not complying with heightened safety precautions could ‘sicken and even kill many others who did not consent to that tradeoff.’”  Id. at *116-*117 (emphasis added).

And that really is the point.  The recalcitrance of the few unavoidably impacts the many, if not through infection and death, then at least through the imposition of social distancing, masking (mandatory or otherwise), and other common-sense measures that the many would rather not endure.  These students correctly lost, although we suspect others will try.  Unfortunately.

A federal court has asked the supreme court of Washington to address the scope of that state’s learned-intermediary doctrine. In particular, it has asked whether Washington recognizes a “direct-to-consumer” exception to the doctrine.

Under the learned-intermediary doctrine, which has been adopted by every state other than West Virginia, a manufacturer of a prescription medical product satisfies its duty to warn of the risks associated with the product if it provides adequate warning to prescribing physicians. In short, manufacturers of prescription medical products must warn doctors, not patients.

The doctrine’s rationale is straightforward:  Medical products available only by prescription have complex risk-utility profiles that are difficult for lay persons to evaluate. Trained in medicine, familiar with the medical history of individual patients, and legally obligated to obtain informed consent before administering a treatment, doctors are best positioned to warn individual patients of the relevant risks in an intelligible manner.

Given that rationale, the doctrine is generally limited to prescription medical products—i.e., products that can be lawfully obtained only through a doctor. Accordingly, it typically does not apply to over-the-counter products.

Over the years, plaintiffs have sought to limit the doctrine even further, arguing that it should not apply when the manufacturer markets a prescription medical product directly to consumers. With the lone exception of New Jersey, no state that recognizes the doctrine has restricted it in that way. That makes sense. Even if a prescription product is advertised to potential patients, it still can be obtained only through physicians, who have the knowledge and duty to convey the relevant warnings to their patients.

Granting a plaintiff’s motion to certify the question, a federal district court has now asked the Washington supreme court whether that state’s learned-intermediary doctrine applies when a prescription medical product is marketed to potential patients. Although it recognized that “[t]he vast majority of state courts that have considered the issue have concluded that … the ‘learned intermediary’ doctrine should apply” in such situations, it concluded that the issue has sufficiently “far-reaching public policy and legal implications” to warrant certification of the question. Dearinger v. Eli Lilly & Co., 2021 WL 2805328 (W.D. Wash. 2021).

State supreme courts commonly agree to answer certified questions. It is not clear, however, whether Dearinger actually implicates the certified question. Although the drug at issue, Cialis, is marketed to consumers, the plaintiff is challenging the adequacy of its FDA-approved patient-information insert rather than the manufacturer’s consumer marketing. If the state supreme court accepts the certified question, we should know its answer later this year or early next.

A month ago we thought our country had turned the corner on Covid-19. Not so. The plague continues. Bad show, America. We’re sick of Covid, sick of reading about Covid, sick of the controversies, sick of the deprivations, and, most of all, sick of all the disease and death. We won’t say we’re sick of writing about COVID, because we’ve mostly left that to others. When the tongue of history tells the final tale of Covid, we suspect it will be a catalogue of human errors, with occasional hiccups of heroism and ingenuity.

Covid implicates science more than law, but we are lawyers and we know how to stick to our lane. (That is an out and out lie, of course. At the drop of a hat or mask we are happy to bloviate ignorantly and loudly about Covid lockdowns and anti-vaxxers.) Just as with public health measures, legal responses to Covid have had a mixed, perhaps mostly bad, track record in contending with Covid. Depressingly stupid laws have been passed and predictably silly lawsuits have been filed.

But the Public Readiness and Emergency Preparedness (PREP) Act was a singularly sensible response to Covid. We have written about the PREP Act before, but for a quick refresher, recall that the PREP Act provides that “a covered person shall be immune from suit and liability under Federal and state law with respect to all claims for loss caused by, arising out of, related to or resulting from the administration to or the use by an individual of a covered countermeasure if the [Secretary of Health and Human Services has issued a declaration permitting the administration of that covered countermeasure.]”. In a major health emergency, you don’t want hesitancy based on fears of liability. Ah, but how will the PREP Act be enforced in cases where things go wrong and all the sympathy goes to the injured party?

Cannon v. Watermark Retirement Communities, Inc., 2021 U.S. Dist. LEXIS 133613, 2021 WL 3033762 (E.D. Pa. July 19, 2021), is an interesting PREP Act decision from the Eastern District of Pennsylvania. It is also another example of the courts letting plaintiffs chip away at the ostensibly broad preemption that the Act and the HHS directives created.

Instead of suing over a nursing home patient catching COVID, the decedent here had COVID and was treated for it with an “experimental” drug combination, hydroxychloroquine and doxycycline. The estate alleged that the family was concerned about the experimental treatment because it was not FDA approved and had a history of causing heart problems, and that the decedent’s son explicitly declined to consent to the experimental treatment. The estate also contended that the treatment was not permitted to be used either outside of a hospital or on asymptomatic patients. But it was administered here just the same. Following this treatment the decedent allegedly “deteriorated” and died. The estate of the decedent brought a wrongful death and survival action against the senior community for negligence, negligence per se, and reckless and outrageous conduct.

The defendant senior community filed a Rule 12(b)(6) motion to dismiss based on PREP Act immunity. The court denied the motion to dismiss, reasoning that the treatment was not a “covered countermeasure” under the PREP Act because FDA’s emergency authorization was limited to persons who were hospitalized with COVID, and the decedent was never hospitalized. Thus, according to the court, the experimental treatment did not “fall within the clear, explicit, and limited scope of the drug’s FDA emergency use authorization.” That sounds almost like a presumption of non-immunity.

The defendant argued that PREP Act immunity also applies to the “misuse” of a covered countermeasure. The court disagreed because it interpreted “misuse” to be limited to nonuse or omission. What happened in Cannon was an affirmative misuse, not a nonuse or omission. We’re not sure this distinction makes sense either in terms of statutory interpretation or underlying policy, but there it is.

The defendant’s final defense was invocation of the PREP Act’s safe harbor provision, which extends immunity to circumstances in which a covered countermeasure was administered by someone who reasonably could have believed that the countermeasure was being used appropriately. The court held that on a motion to dismiss, where all inferences must be drawn in favor of the plaintiff, the court could not conclude that the defendants reasonably believed it was administering a covered countermeasure because the PREP Act’s definition of the “population” was unambiguous and the decedent fell outside it – she was neither hospitalized nor determined to be eligible for clinical trials.

It will be interesting to see whether the defendant in Cannon can make out facts supporting a reasonable belief that the countermeasures were appropriate. We wouldn’t be surprised if they ultimately do so. But in the meantime, the case goes on, with discovery and all the other expensive machinery of civil litigation. It is possible that the aims of the PREP Act are not being well served.

What happens when a plaintiff from Kentucky sues a New York company in Massachusetts?  The case gets tossed for lack of personal jurisdiction.  That is exactly what happened in Kingston v. Angiodynamics, Inc., 2021 WL 3022320 (D. Mass. Jul. 16, 2021).  It is what should have happened in Hammons v. Ethicon, Inc., 240 A.3d 537 (Pa. 2020), but instead that case was No. 1 on our list of worst decisions in 2020.  Fortunately, Massachusetts does not have the same open arms policy for litigation tourists that Pennsylvania does.

Plaintiff – who lives in Kentucky, had surgery in Kentucky, and who alleges to have suffered his injuries in Kentucky – sued the manufacturer of the catheter system implanted in him for the administration of chemotherapy medications.  Kingston, at *2.   The defendants are a parent and subsidiary company both of which are incorporated in Delaware.  Id. at *3.  The parent corporation is headquartered in New York where all executive level employees are located and all significant corporate decisions for both the parent and subsidiary are made.  Further, the individuals who carry out work for the subsidiary in the United States are all employees of the parent company.  Id.

Against this set of facts, the court was asked to decided plaintiff’s motion to remand based on her argument that defendants were forum defendants thereby defeating diversity jurisdiction and defendants’ motion to dismiss based on lack of personal jurisdiction.  Plaintiff’s motion was denied and defendants’ was granted.

The question of diversity turned on whether or not defendants could be considered to have a principal place of business in Massachusetts making them citizens of the state.  The court found it did not matter which test was used to determine where defendants’ principal place of business was – “nerve center test;” “center of corporate activity test;” or “locus of operations test.”  The result was the same.  Defendants’ principal place of business was New York.  Id.  As for the parent, plaintiff tried to argue that it had some employees in Massachusetts.  They were not high-level executives or corporate officers, and merely having employees in a location is not enough to make that location a principal place of business.  Id. at *4.  For the subsidiary, plaintiff tried to argue that it at one time had a principal place of business in Massachusetts, but even if that were true, it is undisputed that the company was purchased by its current parent years before the device at issue was implanted in plaintiff.  The subsidiary-defendant is wholly owned by the parent defendant and plaintiff offered no evidence to refute that the corporate decisions for the subsidiary are now made by the parent in New York.  Id.  Nor was it relevant to this issue that some FDA correspondence was addressed to the Massachusetts location or that defendants’ CEO owns a house there.  Massachusetts is a lovely place to own property.  Because defendant is not a citizen of Massachusetts, it had the right to remove the case to federal court and the motion to remand was denied.

Not surprisingly, most of the principal place of business discussion is directly relevant to the personal jurisdiction inquiry as well.  The court first examined the Massachusetts long-arm statute which allows the state to exercise jurisdiction over an individual who “transacted business in Massachusetts” where the plaintiff’s claim arises from the transaction.  Both factors must be satisfied.  Id. at *5.  The “arising from” requirement is essentially a “but for” causation test.  Id.  Again, plaintiff relied on the presence of some employees in the state, including some who work in research and development.  But that is not enough to support an assertion that plaintiff’s injury would not have occurred “but for” defendant’s activities in Massachusetts.  Corporate decisions were made in New York and the product was manufactured in New York.  Id. at *6.  Without an adequate nexus between plaintiff’s injuries and defendants’ in-state activities, she did not meet the requirements of the long-arm statute.  Id.

The court then moved on to general jurisdiction – where a defendant’s contacts with the state are so “continuous and systematic” as to render them at home in the forum state. Id.  For all the reasons previously discussed, defendants were not “at home” in Massachusetts and therefore, there is not general jurisdiction.  Id.

Finally, plaintiff argued the court should exercise specific jurisdiction over defendants.  Specific jurisdiction is only available “where the cause of action arises directly out of, or relates to, the defendant’s forum-based contacts.”  Id. at *7.  Plaintiff tried to rely on Ford Motor Co. v. Montana Eight Jud. Dist. Ct., ___ S. Ct. ___, 2021 WL 1132515, at *4 (U.S. March 25, 2021) but the court focused on the same distinction we focused on when we posted about that case Plaintiffs in Ford sued in their home jurisdictions:

Unlike here, the plaintiffs there were residents of the forum states, used the allegedly defective products in the forum states and suffered injuries when those products malfunctioned in the forum states.

Id.  In Kingston, plaintiff’s surgery took place in Kentucky during which a product manufactured in New York by a company headquartered in New York was implanted.  Additional surgery and alleged complications also occurred in Kentucky.  The fact that defendants had some research and development and regulatory affairs departments in Massachusetts is not sufficient to establish specific jurisdiction.  Defendants’ alleged contact with Massachusetts is neither “an important or material element of proof.”  Id.  at *8.  Because plaintiff could not demonstrate that defendant’s in-forum activities gave rise or related to her injury, she could not establish specific jurisdiction.  Id.

Plaintiff asked for leave to conduct jurisdictional discovery, but the court found that her allegations, even if proven, were too attenuated to state a colorable claim and therefore discovery would be futile.  Id. at *8-9.  All claims dismissed.

Still more Zantac MDL dismissal orders.

Today’s installment grants dismissal of the plaintiffs’ medical monitoring claims, and also sheds some light on the questionable factual basis of everything being asserted in this MDL.  As we’ve pointed out in our prior posts (such as this one), plaintiffs allege that the active ingredient in this drug could break down into an alleged carcinogen, particularly in warm or moist environments.  However, N-Nitrosodimethylamine (“NDMA”), the allegedly harmful breakdown product at issue, is ubiquitous, and anyone who consumes bacon, beer, or cheese has likely been exposed over the years to higher doses from these other sources.

That matters for medical monitoring claims, as In re Zantac (Ranitidine) Products Liability Litigation, 2021 WL 2682659 (S.D. Fla. June 30, 2021), demonstrates.  This Zantac decision booted most of a “master” class action complaint seeking medical monitoring and other purported economic losses.  Plaintiffs sought to create a litigation castle in the sky (no less than 638 counts) with a great many would-be classes (divided up by state and by defendant) in five general categories:  medical monitoring against branded manufacturers of prescription products; medical monitoring against branded manufacturers of over-the-counter (“OTC”) products; medical monitoring against generic manufacturers; medical monitoring against “store brand” sellers; and medical monitoring against “store brand” manufacturers.  Id. at *3.

Since many members of these putative classes undoubtedly took more than one of these products, some going back more than two decades, and many were without prescription, how plaintiffs would prove their respective exposures to each – an essential element of any medical monitoring claim − strikes us as entirely speculative.

Secondarily, plaintiffs filed a “consolidated, amended consumer economic loss class action” described as an action by 180 named plaintiffs:

in their individual capacities and on behalf of numerous classes . . . under various state laws stemming from the Defendants’ sale of prescription-strength ranitidine for approximately forty states.  Additionally, the Plaintiffs bring state class actions under approximately forty-three states’ laws for the Defendants’ sale of OTC ranitidine.

Id. at *4 (footnote omitted).  Another castle in the clouds.  We addressed the RICO aspects of this complaint here.

The preliminary skirmish on medical monitoring was whether two of the states as to which plaintiffs chose to bring claims – Indiana and Montana – would recognize a medical monitoring recovery by otherwise uninjured plaintiffs.  Unfortunately, a nearly 30-year-old intermediate appellate court in Indiana had allowed such a claim, Gray v. Westinghouse Electric. Corp., 624 N.E.2d 49 (Ind. App. 1993), so the defendants lost on Indiana.  2021 WL 2682659, at *8.  There being no equivalent support for medical monitoring in Montana, the court went with Erie conservatism and dismissed all the Montana monitoring claims with prejudice for failure to state a claim.  Id. at *9 (refusing to “expand[] Montana law in the manner that the Plaintiffs suggest”; “On no interpretation of Erie of which we are aware may a decision by a state trial court be credited as determining the law of the state”) (citation and quotation marks omitted).

The real fun begins with consideration of the “plausibility” of plaintiffs’ medical monitoring claims.

Although “[t]he law of medical monitoring varies across jurisdictions,” id. at *10, such “non-traditional torts” share several essential elements in common:  (1) exposure to a hazardous substance above normal levels; (2) in a threshold amount; (3) sufficient to create a significant increase in risk of a serious health condition; (4) for which medical monitoring exists that would facilitate early exposure; (5) which is different than routine medical testing anyone should get.  “[S]ome states require that testing procedures exist to detect diseases early, while others do not.”  Id. (discussing, inter alia, Florida law).

Plaintiffs’ claims failed, first, on the issue of “significantly increased risk.”  Id. at *11-12.  The “significant risk” analysis “raises two distinct questions.”  Id. at *12.  “First, . . . how much NMDA must a Plaintiff be exposed to before the Plaintiff has a significantly increased risk of cancer? Second, how much NDMA exposure have the Plaintiffs alleged?”  Id.  Plaintiffs’ verbose and Brobdingnagian complaint botched both prongs.  “Plaintiffs have failed to clearly plead just how much exposure the Plaintiffs received and how much exposure is needed to warrant the remedy of medical monitoring.”  Id.

The basic question is how much exposure to NDMA is allegedly the threshold exposure for “significant” increased risks of “cancer.”  Plaintiffs’ opposition papers used 3,000 nanograms (“ng”), but they did not clearly allege that as the threshold exposure for a “significant” cancer risks in the complaint itself.  Id.  Instead, they “alleged that the consuming of 96 ng each day, for seventy years, results in a .001% increase in the risk of cancer.”  Id. (emphasis added).

.001%?  Give us a break.  That’s entirely trivial.  1% is one in a hundred – so .1% is one in a thousand; .01% is one in ten thousand, and .001% is one in one-hundred thousand.  These plaintiffs are seeking test 100,000 people on the off-chance of detecting one early cancer, with no assurance that such testing would actually improve anyone’s prognosis.  And seventy years?  Zantac didn’t come on the market until 1981, and not one of the now over 20 Zantac MDL opinions mentions anything about pediatric use.

Nor do plaintiffs’ allegations account for “cancer” being anything but monolithic, but rather a catch-all term for a variety of metastatic conditions having different etiologies and tests for detection.

Only in an MDL would plaintiffs even think about making such absurdly overbroad allegations.  We offer, in contrast, our post, here, on punitive damages, requiring a “substantially certain” risk of harm.  The Zantac claims aren’t even in the same ballpark.

Fortunately this MDL judge doesn’t seem to be drinking the plaintiffs’ Kool-Aid.  Understandably the Zantac court required that “if the Plaintiffs equate a .001% increased risk with a significantly increased risk, then the Plaintiffs should clearly make that argument.”  Id.

The next point was how much NDMA exposure was actually alleged − from background consumption and allegedly from taking Zantac or generic ranitidine.  Once again, plaintiffs’ complaint fell short.  Like we’ve pointed out in our posts, “every human being consumes NDMA through eating, drinking, and even breathing.”  Id.  According to studies plaintiffs themselves cited, the background rate – “daily NDMA consumption levels” on the high end, was 510 ng/day in one study, 191 ng/day in another, and 179 ng in a third.  Id.  That’s from nearly two, to over five, times as much as the 96 ng/day rate that plaintiffs impliedly asserted could cause “significant” cancer risk (if taken daily for a lifetime).  Id.  In other words, background NDMA exposure significantly exceeds exposure allegedly caused by defendants’ products, according to plaintiffs’ own studies.

And it gets worse.

Plaintiffs’ argued for a purported “3,000 ng of NDMA per-dose” – that is, per Zantac/ranitidine pill – but that allegation was nowhere to be found in their 2,192-page complaint.  Id. at *4.

And it gets worse.

The chief study cited in plaintiffs’ complaint about alleged per-pill amounts of NDMA simply is no more.  “[A] red retraction notice appears on the top of the study.”  Id. (emphasis added).  As the opinion dryly puts it, “[i]f the Plaintiffs’ position is that the Court may conclude that the Plaintiffs have plausibly alleged a claim for medical monitoring based upon a retracted study, the Plaintiffs should clearly argue and explain that position.”  Id.

A second, even wilder, estimate – that each pill contained over 2,000,000 ng of MDMA – also bore no relationship to reality:

[T]he Court has been able to locate an allegation that each [drug] dose contained over 2,000,000 ng of NDMA. That number [was . . . arrived at . . . by heating [the drug] to 266 degrees Fahrenheit.  Pursuant to the Plaintiffs’ allegations, however, the temperature of the human body is 98.6 degrees, not 266 degrees.

Id. (emphasis added).  Even during the hottest day in the hottest place (Death Valley) in the recent record heat waves, the temperatures did not get within 100° of that temperature.  For obvious reasons, “the Court does not conclude that a test utilizing 266 degrees of heat plausibly establishes a significantly increased risk of cancer.”  Id.

Another hypothesis was that the drug breaks down in the stomach at body temperature (≈98.6°F) in the presence of food containing sodium nitrite.  Is that biologically plausible?  In a word, no.

In the absence of an explanation or context from the Plaintiffs, the Court endeavored to understand what, mathematically and scientifically, [the necessary amount] of sodium nitrite means.  The Court attempted to perform its own mathematical calculations to discern the amount of bacon necessary to collect [that amount] of sodium nitrite in the human stomach.  The Court’s own calculations estimated the amount of bacon to be necessary at around 25 pounds.

Id. at *15 (footnote omitted).  That’s another purported per dose calculation.  So, to reach the threshold exposure, all a putative class member would have to do is take each pill with food – 25 pounds of bacon per pill – and repeat each day for 70 years.

Although this scientific discussion takes place in Zantac in connection with estimating increased risk in the context of medical monitoring, the larger picture is also emerging – the plaintiffs’ increased risk calculations are generally unrealistic and wildly inflated.  It will be very difficult for them to get out of that hole.  The court suggested that they begin that attempt by “provid[ing[ context and explanation” for their numbers in any amended complaint that they subsequently file.  Id.

Good luck (not).

Because “[f]ourth and finally, the Court has been able to locate allegations about the amount of NDMA in [the drug] from tests performed by the FDA.”  Id. at *15.  The FDA’s unbiased testing once again severely undercuts plaintiffs’ numbers while simultaneously demonstrating variability that should be fatal to any putative class action:

The amount of NDMA found in the [the drug] was not equal across the Manufacturing Defendants. . . .  One Defendant’s [product] tested as having zero. . . .  Even if the Court were to utilize the highest amount of NDMA found by the FDA (360 ng) and assume that every Defendant’s ranitidine had that much NDMA, that number is still an order of magnitude lower than the 3,000 ng number argued in the Plaintiffs’ response.

The Court addresses one final point about the FDA’s findings.  In the FDA’s own words, the “NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.”

Id. (citations omitted) (emphasis added).  As mentioned above, medical monitoring in any state requires significant exposure above background levels.

And we’ve only covered the problems with plaintiff’s allegations concerning exposure per pill.

Plaintiffs likewise fail to allege plausibly the “frequency” of their exposures – that is, how often they took pills.  The Zantac complaint vaguely references “therapeutic doses.”  Id. at *16.  What’s that?  Plaintiffs’ pleading ensures that nobody knows.  They allege only that individual “[p]laintiffs “ingested [the drug] at various times as part of their treatment.”  Id.

Very enlightening.  That their 2,000+ page complaint lacks such basic information strongly suggests they can’t plead it – at least not in any form that could conceivably support class-wide proof.

There is no allegation as to the frequency of use, nor is there a reference to “therapeutic dosages.”  The Plaintiffs’ alleged class definitions similarly do not assist the Court, because the Plaintiffs define the class as being anyone “who used” ranitidine without qualification.

Id. at *16.  This is why we headlined this post with the “wheels coming off” the Zantac litigation – a combination of self-evidently fabulist general dosage calculations and utterly absent individual information concerning frequency of use.  Plaintiffs’ allegations wouldn’t even pass muster in asbestos litigation.

They get to try again, but this will be their third round of pleadings.  We hope “strike three” means “yer out”:

Plaintiffs may, of course, plead a substantial increase in the risk of cancer in whatever way they deem best, including through avenues other than NDMA exposure and NDMA frequency.  The Court’s ruling is merely that, as pled, the Court cannot conclude that the Plaintiffs have plausibly alleged a substantial increase in the risk of cancer.

Id. at *17.

On top of all this, plaintiffs’ allegations as to the current existence of a “diagnostic testing regime” that supposedly would help the plaintiff class get early cancer detection screenings was not plausibly factually alleged and thus got TwIqballed.  “The Plaintiffs’ allegation amounts to a ‘naked assertion devoid of further factual enhancement.’”  Id. (quoting Iqbal itself).  “[T]he Plaintiffs’ allegations are merely a recitation of the required elements.”  Id. at *18.

One wonders what plaintiffs did plead in all of these 2,000+ pages, since it certainly wasn’t the necessary elements of medical monitoring.

Beyond medical monitoring, plaintiffs re-raised their failure-to-report allegations involving the FDA, which the court had already indicated were preempted in an opinion we discussed previously.  We are reminded of a quote attributed (probably falsely) to Einstein:  “The definition of insanity is doing the same thing over and over again and expecting different results.”

In the Court’s Order Granting in Part and Denying in Part the Branded Defendants’ Rule 12 Partial Motion to Dismiss Plaintiffs’ Three Master Complaints as Preempted by Federal Law, the Court concluded that the Plaintiffs’ claims for failure to warn consumers through the FDA are pre-empted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), for the reasons that the Eleventh Circuit Court of Appeals outlined in Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017).  The Court dismisses the claims with prejudice for that reason.  In light of this ruling, the Court need not address arguments directed to the viability of the claims under state law and pleading deficiencies.

Zantac, 2021 WL 2682659, at *21.

As to the economic loss claims, plaintiffs were held to have Article III standing by reason of claimed economic injury.  Id. at *25-28.  Bexis, being a veteran of the Engle wars, has generally mixed feelings about standing arguments of this sort, because success in denying constitutional standing in federal court has led plaintiffs in some cases to try again in state court, without the defendant having any way to remove (there being no standing) to federal court.

Significantly, the court required plaintiffs asserting claims concerning prescription (as opposed to OTC) products to plead facts satisfying the elements of the learned intermediary rule.  That should be fatal to any class action, since learned intermediary rule issues are inherently individualized.

The Defendants argue that the Plaintiffs’ failure-to-warn claims concerning prescription [products] fail as a matter of law under the learned intermediary doctrine. This is so because Plaintiffs do not allege that their physicians were inadequately warned about the alleged cancer risk associated with [the drug], or that their physicians would have made different prescribing decisions if they had been warned.

Id. at *28 (citations and quotation marks omitted).  Once again, the plaintiffs’ already massive complaint was inadequate.

[T]he Court dismisses the Plaintiffs’ prescription-based claims [some 700 separate counts] without prejudice, and with leave to plead allegations that are specifically relevant to the learned intermediary doctrine.  This scope of leave is not broad, but rather extremely narrow and specific as to this discrete issue.

Id.

Finally, the court clears the way for the defendants to challenge other aspects of the plaintiffs’ economic loss complaint, specifically the applicability of “safe harbor provisions” in the consumer protection statutes of 24 states, and “[r]elatedly, [that] the Plaintiffs’ consumer protection, implied warranty, and unjust enrichment claims are barred, since the Defendants’ FDA-approved labels were presumptively lawful and not false or misleading.”  Id. at *29.  Also defendants may challenge plaintiffs’ unjust enrichment claims on the next go-round on various state-law grounds.  Id.

Defendants will have to “seek leave of Court” to do this at some “later stage of the litigation,” id., and we wonder if it will ever be necessary.  That’s because we’re not at all sure how many “later stages” of litigation there will be.  As discussed, the biggest takeaway from this edition of the Zantac chronicles is the evident scientific bankruptcy of the plaintiffs’ risk and causation positions.

The Drug and Device Law Rock Climber celebrated her birthday this week by acquiring a companion for the Irascible Rescue Pomeranian (you can read about him here). The new family member is a four-month-old Australian Shepherd mix, pure white with blue eyes.  We sense figurative ears perking up at this description, as dog- (and cat-) savvy readers are no doubt aware that this lack of pigmentation is genetically linked to deafness.  And, indeed, the puppy is totally deaf, “thrown in” as an extra when a previous owner purchased another puppy (not deaf) from his litter, then dumped because he was “too much trouble.”  Puppies born deaf have no idea that anything is “missing.”  Taught to understand sign language early, they lead full lives (this is a wonderful book about a deaf Great Dane) and they are exceptionally loving and rewarding for the right owners.  We can’t wait to meet our new “grand-dog” and to watch him blossom.

Deafness does not figure in today’s case (shocking, we know, that there is no logical transition), except to the extent that the plaintiffs turned a deaf ear to well-established preemption jurisprudence.  In Jankowski v. Zydus Pharmaceuticals USA, Inc., 2021 WL 2190913 (D.N.J. May 28, 2021), the defendants manufactured Amiodarone, the generic form of a last-resort drug used to treat ventricular fibrillation and ventricular tachycardia in individuals who were facing probable death and whose conditions did not respond to other available treatments.  The plaintiffs alleged that the manufacturer of the branded version of the drug had “aggressively and successfully” marketed its product for inappropriate off-label use as a first-line therapy,   Jankowski, 2021 WL 2190913 at *1, and that the defendants took advantage of this marketing plan and “directly benefited from the directing marketing of the [branded] drug for off-label uses” through increased sales of their products.

There is nothing we haven’t seen before, and we have already drawn lessons from this litigation.

The plaintiffs alleged that the defendants failed to provide, or make available for distribution, an FDA-required Medication Guide, thereby failing to inform doctors, distributors, and patients of the dangers associated with the drug and of the fact that it was not intended for use as a first-line treatment.  With this “hook,” the plaintiffs asserted a litany of product liability claims:  failure to warn, negligent off-label marketing and sale, negligence per se, manufacturing defect, and fraud.  The defendants moved to dismiss the complaint, arguing federal preemption and failure to state a claim.

The court began by providing background about “impossibility preemption,” which, as many of you are aware, preempts state law claims when it is “impossible for a private party to comply with both state and federal requirements.”  Id. at *2 (citation to Bartlett omitted). The court went on to explain Mensing’s holding that traditional failure-to-warn claims against manufacturers of generic drugs are preempted because only branded manufacturers can unilaterally change drugs’ labels – generic manufacturers’ labels are required to be identical to the labeling of the branded versions of their drugs.  Finally the court set the stage by citing Frei v. Taro Pharm. U.S.A., Inc., 443 F. Supp. 3d 456 (S.D.N.Y. 2020), which followed Buckman to hold that “when a plaintiff’s claims exist solely by virtue of the FDCA’s requirements, state law claims are impliedly preempted.”  Id. at *3 (internal punctuation and citations omitted).  (We have discussed Frei in these pages – here, for example, in our fifty state survey on “failure to report to the FDA” decisions – more about that in a minute – here and here).

Failure to Warn Claims

The plaintiffs asserted failure-to-warn claims sounding in both strict liability and negligence, relying on the defendants’ alleged failure to provide “Medication Guides” to circumvent the preemption of traditional failure-to-warn claims.  As in Frei, as the court explained, the plaintiffs “conflate[d] a failure to provide the Medication guide in sufficient numbers with misbranding of the drug, in an attempt to couch their failure to warn claims in traditional state tort law.”  Id. at *4 (internal punctuation and citation omitted).  And, as in Frei, the court held that the claim was preempted because the plaintiffs did not identify a parallel state law that required distribution of the Medication Guide.

Manufacturing Defect Claim

As we’ve learned already, “all claims that seek to change warnings concerning generic drugs, however, they’re pleaded – read, disguised – by plaintiffs are preempted.”

It was “clear that the existence of the FDA’s Medication Guide regulation [was] the gravamen of” the manufacturing defect claim.  Id.  The plaintiffs alleged that the failure to provide a Medication Guide violated the FDA’s “Good Manufacturing Practice for Finished Pharmaceuticals” regulation, and that failure, along with the failure “to implement a safer alternative design for the delivery of the Medication Guide” (anyone else’s eyes rolling at this nonsense?) rendered the drug “adulterated.”   Underscoring the obvious, the court stated, “First, Plaintiffs’ allegations here do not sound in defective manufacturing and may be dismissed on that basis.”  Id. at *5.

In addition, the court again found that the plaintiffs did not assert a state law claim that paralleled the FDA requirement, because New Jersey’s law addressing adulterated drugs deems a drug “adulterated” when it is used as the labeling suggests, and the Jankowski plaintiffs did not and could not seek to change the label on their drug.   The court concluded, “To the extent Plaintiffs plausibly allege a claim for manufacturing defect, Plaintiffs’ claim is preempted.”

Failure to Report Adverse Events to the FDA

The court explained, that “a manufacturer’s failure to report adverse events to the FDA can form the basis of a parallel claim that survives preemption,” in states that recognize such claims.” (Again, see our 50-state survey for much more on this.)  But New Jersey “is a jurisdiction that declines to recognize a separate state law duty to warn the FDA,” so there was no parallel state-law claim and, again, this claim was preempted.  Id. (citations omitted).   Even the claim were not preempted, as the court explained, the plaintiffs only “speculatively alleged that [the defendant] failed to report adverse events to the FDA” and did not “allege actual adverse events that [the defendant did not report to the FDA,” so the allegations failed to satisfy Twiqbal and the claim failed on that basis as well.

Negligent Marketing and Sale for Off-label Purpose

The plaintiffs claimed that the defendants took advantage of the branded manufacturer’s off-label marketing by “marketing, selling, and distributing [the generic drug] as a first-line therapy . . . without the Medication Guide” and that they failed to correct information appearing in in third-party prescribing reference sources.   Once again, the court held that Mensing “impossibility preemption” doomed the claims, because the plaintiffs alleged that the Medication Guide and third-party reference materials constituted labeling and defendants, as generic manufacturers, were not permitted to make changes to their drugs’ labeling.

Finally, the court dismissed the negligence per se claim, again premised on issues related to the Medication Guide, and the fraud claim, based on the defendants’ alleged failure to report adverse events and to correct misleading information in third-party reference materials, on the same airtight reasoning it had applied throughout the decision.   And so, with eyebrow firmly raised, the court thwarted the plaintiffs’ attempted end-run around federal preemption and dismissed the complaint, albeit without prejudice.  The court provided the plaintiffs “one final opportunity” to amend the complaint, and we’ll keep you posted on that.  In the meantime, stay safe out there.