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A doctor examines a vial containing a vaccine.

Two COVID-19 vaccines have been submitted for approval to the Food and Drug Administration. While this is an important step towards bringing the pandemic under control, the vaccine’s efficacy is limited unless an overwhelming majority of the population is vaccinated.

Current polling suggests that only a slim majority of people would choose to receive the vaccine. So, if large numbers of people are unwilling to receive the vaccine, what’s next? Can the government make vaccination mandatory? Established case law demonstrates that it’s legally feasible, but whether lawmakers choose to pursue such legislation is an entirely different question in the current political atmosphere.

The Current State of COVID-19 Vaccines

As two apparently safe and effective COVID-19 vaccines rapidly make their way through the Food and Drug Administration’s approval process—the FDA has scheduled a meeting on December 10th, 2020 to consider Pfizer’s emergency use authorization request, and Moderna’s request will be considered a week later—certain Americans (health care workers, residents of long-term care facilities) will likely begin receiving their initial dose [1] of the vaccines before the end of 2020. Initial doses of the vaccines are expected to be available to the general public by the spring of 2021.

Though this is good news, data suggests that government and health officials have a long way to go in convincing the public that the vaccines are safe and effective. Polls indicate that only a slight majority of Americans are currently willing to take the vaccine once available. This is unsurprising given the political polarization around vaccines generally, and the government’s COVID-19 response specifically. The frenzied pace at which these vaccines were developed may also cause skepticism.

As additional information about the vaccines is released, including the clinical trial data, the number of people willing to receive the vaccine should increase. However, if the government is unable to convince enough citizens to take the vaccine, could it actually require vaccination?

Why It Matters: Herd Immunity

The goal of any mass inoculation is to create herd immunity within the population, not just immunity within the individual vaccine recipients. Herd immunity refers to the point at which a threshold number of individuals in a population are immunized from a disease, making further spread of the disease unlikely, even among those not yet immunized. In other words, herd immunity provides protection even to those who are unable to take the vaccine, including the immune-suppressed, those with religious or philosophical objections to vaccinations, and in the case of the COVID-19 vaccines, children.

Experts estimate that at least 70% of the population will need to be vaccinated before herd immunity can be achieved. Could this gap—between the number currently willing to take the vaccination and the 70% needed to reach herd immunity—be closed through a mandatory vaccination program?

Mandatory Vaccinations Under State Law

Mandatory vaccinations have a long history the United States. In 1905, the Supreme Court, in Jacobson v. Commonwealth of Massachusetts, upheld a state statute mandating smallpox vaccinations against a constitutional challenge. 197 U.S. 11 (1905). The defendant in that case, Henning Jacobson, was found guilty of refusing to take the vaccine and fined $5. Id. at 14. Jacobson appealed the conviction, arguing that the statute was unconstitutional under various grounds, but principally, that the law was “unreasonable, arbitrary, and oppressive, and, therefore, hostile to the inherent right of every freeman to care of his own body and health in such way as to him seems best.” Id. at 26.

The Supreme Court rejected Jacobson’s arguments, holding that the inherent authority of the state under its “police power” permitted it to enact laws to “protect the public health and public safety.” Id. at 25. Furthermore, the Court wrote, the liberty under the Constitution is not “absolute… wholly freed from restraint.” Id. at 26.  The Court explained:

Society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy. Real liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own, whether in respect of his person or his property, regardless of the injury that may be done to others… The possession and enjoyment of all rights are subject to such reasonable conditions as may be deemed by the governing authority of the country essential to the safety, health, peace, good order, and morals of the community.

Id.

Unquestionably, Jacobson is “old law,” and it can rightfully be criticized for being overly broad in its language, but it remains good law. Page v. Cuomo, 2020 WL 4589329 (Dist. NY, August 11, 2020). Since the Supreme Court’s decision 115 years ago, “courts across the country have nearly uniformly relied upon Jacobson’s framework to analyze emergency public health measure put in place to curb” public health crises. Id. at 8; see also, Hickox v. Christie, 205 F. Supp.3d 579, 591 (D. N.J. 2016) (evaluating constitutional challenge to federal quarantine order asserted by a plaintiff returning to U.S. after treating Ebola patients abroad). Furthermore, all 50 states have legislation requiring vaccines in some form or another, usually mandating that students receive a vaccination (think measles, mumps, rubella) before attending school.

Mandatory Vaccinations Under Federal Law

While Jacobson supports a state’s authority to enact public safety laws, including mandatory vaccinations, the question of whether the federal government could impose similar requirements is more complex and unsettled. Unlike states, the federal government does not have inherent powers, such as the “police power.” Congress is limited to those grants of power found in the Constitution, and the Constitution provides no explicit authority for Congress to enact public health laws. 

Prior to 2012, Congress would likely have relied upon the Commerce Clause of the Constitution, Article 1, Section 8, Clause 3, which gives Congress the power “to regulate commerce with foreign nations, and among the several states” and which had been broadly interpreted to give Congress the authority to regulate both interstate and intrastate commerce. At its broadest, the Commerce Clause permitted regulation of even non-economic activity, as long as the activity had a “substantial economic effect” on interstate commerce. See NLRB v. Jones & Laughlin Steel Corp., 301 U.S. 1 (1937).   

Recently, however, the conservative Supreme Court has interpreted the Commerce Clause more strictly, striking down laws that would have previously been permitted under the Commerce Clause. In the landmark National Federal of Independent Business v. Sebelius, 567 U.S. 519 (2012), better known as the first Obamacare decision, the Supreme Court held that Congress could not require that individuals purchase health insurance, at least under the Commerce Clause. Id. The Court reasoned that requiring the purchase of health insurance was not the regulation of commercial activity, but rather, the regulation of commercial inactivity, and, accordingly, was not permissible under the Commerce Clause. Id.

The Court, though, did find that Congress had the authority under its taxing power to tax individuals that failed to purchase health insurance pursuant to the Affordable Care Act’s individual mandate, and it is this authority that would likely be relied upon if the federal government were to pursue a mandatory vaccination program. Under the current makeup of the Supreme Court, with Justice Amy Coney Barrett now replacing Justice Ruth Bader Ginsburg, it is unclear whether the Court in 2021 would come to the same conclusion as it did in 2012.

Mandating Vaccines in the Current Political Climate

Of course, none of this is to suggest that the either the federal government or state governments will absolutely institute mandatory vaccinations programs for the COVID-19 vaccines. Although the states almost certainly do, and the federal government may, have the authority to pass these types of public health laws from a legal perspective, they may be politically unviable.

So far, governing authorities have been hesitant to even mandate the wearing of masks for fear of political backlash. It is far more likely that the state and federal governments will exhaust all efforts to persuade citizens to voluntarily take the vaccine before passing laws perceived to be intrusive. However, if the government’s powers of persuasion are not effective in getting the vaccination rates high enough to reach herd immunity levels, more drastic measures could be taken.


[1] The vaccines of both Pfizer and Moderna require two doses, taken several weeks apart, to be effective.

The Missouri Supreme Court.

On November 3rd, 2020, the Missouri Supreme Court refused to hear an appeal from Johnson & Johnson and Johnson & Johnson Consumer, Inc. (“J&J”) in Robert Ingham et al. v. Johnson & Johnson, et al., letting stand a state appellate decision which affirmed a $2.2 billion jury verdict against the consumer giant and for women who claimed their ovarian cancer was caused by use of J&J’s talcum powder products.  The original jury verdict of $4.69 billion had been reduced by the appellate court upon finding that the Missouri trial court lacked personal jurisdiction over some of the non-resident plaintiffs’ claims in the suit.

J&J called the trial verdict “fundamentally flawed” and “at odds with decades of independent scientific evaluations confirming [their products were] safe…” They plan to appeal to the U.S. Supreme Court.

The original trial in Ingham, held in St. Louis, MO in 2018, was unique both because of its size and scope, and the plaintiff’s theory of the case. The claim, brought by 22 women, was based upon the plaintiffs’ use of J&J “Baby Powder” and other personal hygiene products containing the mineral talc.  In previous cases, plaintiffs had claimed that talcum powder was naturally carcinogenic, though in this landmark trial, the plaintiffs contended that J&J’s talcum powder products were actually contaminated with “asbestos fibers and other dangerous carcinogens,” and that J&J knew of their products’ contamination and failed to warn consumers of the dangers.

This argument has major implications for traditional defendants in asbestos litigation. At trial, Dr. William Longo, plaintiffs’ proffered expert, presented results of a simulation he conducted showing that as a result of the application of talcum powder, “dust” could be observed in the “breathing zone” of the product’s user. Another of plaintiffs’ experts, Dr. Jacqueline Moline, testified that asbestos could “travel throughout the bloodstream and the body, and can be found in every organ in the body…” Consequently, plaintiffs’ attorneys argued that their clients were exposed, and their ovarian cancers caused, by respiratory inhalation of asbestos fibers in the “dust,” in addition to internal absorption of the powder during application.

If the inhalation of asbestos fibers is a scientifically viable cause of ovarian cancer, as suggested by the plaintiffs’ attorneys in Ingham, then any manufacturer or distributor of asbestos or asbestos-containing products could theoretically see itself defending similar claims in the future. Of course, the latency period of ovarian cancer, which is unknown but estimated to be around 20 years, could limit the application of this theory to long-discontinued asbestos products.

J&J vehemently denied that its products were contaminated with asbestos fibers and they disagreed with the conclusions of plaintiffs’ experts. On appeal, J&J argued that Dr. Longo’s opinion “rested on insufficient facts and data, was not the product of reliable principles and methods, and did not reliably apply principles and methods to the facts,” and should have been inadmissible at trial. Although the Missouri appellate court held that the trial court did not abuse its discretion by admitting Longo’s testimony, this type of evidence is far from being universally accepted.

In early 2020, a federal court judge in New Jersey, presiding over the federal multidistrict litigation involving J&J’s talcum products’ link to ovarian cancer, limited the testimony of multiple expert witnesses, including Dr. Longo. Specifically, the court held that could not testify that women who used talcum powder were exposed to asbestos, as such an opinion was “unreliable.” Most importantly for other defendants, the court also held that Plaintiffs could not put before a jury their theory that inhalation of J&J talcum products can cause ovarian cancer, due to the insufficient evidence supporting the theory.

Rulings on these issues should continue to be monitored by any company alleged to have used asbestos or talcum powder in their products, services, or equipment.

The Novel Coronavirus.

Like everyone else, I was thrilled by Pfizer and BioNTech’s joint announcement of a COVID-19 vaccine that is 90% effective. That made me wonder what exactly is involved in developing and—most importantly—proving that a vaccine works and is reasonably safe. The Pfizer/BioNTech vaccine is in Phase III trials. What does that mean?

The Food and Drug Administration’s process for new drugs normally is complex and lengthy. It can easily stretch out for years and create reams of data. But the FDA can shorten that time when the need is especially great, which certainly is the case with COVID-19 vaccines.

There are several stages to vaccine development which involve exploratory research, multiple rounds of pre-clinical and clinical review, tracking side effects, manufacturing, and quality control. Clinical development has three phases:

Phase I: Small groups take the vaccine to test for safety, efficacy, and to determine the correct dosage.

Phase II: Hundreds of people with different characteristics (such as age and health status) take the vaccine to further understand how it works and whether it is safe.

Phase III: Thousands of people are given the vaccine.

All three phases are tightly controlled and monitored. The FDA reviews the results and may require additional testing or tracking of participants before it approves the vaccine for widespread use. Under various fast-track rules and other programs, the FDA can—and has—changed some of the three phase requirements, including how many people must participate and how long the trials last.

Pfizer and BioNTech will ask the FDA for emergency authorization later this month with just two months of data. The FDA has the authority to allow unapproved medical products to be used in an emergency when there are no adequate or approved alternatives.

As a citizen, I want an effective vaccine as quickly as possible. As a lawyer, I wonder what litigation will inevitably follow with claims that approvals were rushed or wrong. What if vaccines are made mandatory, as the New York Bar Association recommended just last week? Should drug manufacturers receive protections from suit to encourage COVID-19 vaccine development? Like everything this year, so much remains unknown.

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An empty conference room.

Recently, Nate Lindsey achieved a favorable result for a Rasmussen Dickey Moore client in a construction contract dispute that went to virtual arbitration. He discussed his experience with attorney Matt Jensen who also recently completed virtual alternative dispute resolution. Their experiences are captured here in these five quick questions for this month’s Cross-Examination. 

What was the format for your virtual hearing?

Nate: I appeared for an arbitration involving a construction contract dispute via Zoom. It involved three witnesses, a fair amount of documents, and lasted around four hours. This followed a very brief Zoom mediation where we didn’t make much progress coming to an agreement on the claim.

Matt: I had a mediation last week involving husband and wife plaintiffs and three defendants. Generally, the case involves a defectively designed home. We had taken the plaintiffs’ depositions already and the parties were all pretty well aware of the documents both sides thought were important.  We had initially planned on all of the parties gathering together by Zoom for the first round of talks. However, at the last minute, the mediator decided he only wanted to meet with the plaintiffs via Zoom in the initial meeting. Then he held a phone conference with all of the defendants before breaking off and calling each of us individually in successive rounds. 

Did you do anything different approaching the hearing since you knew it was going to be virtual? 

Nate: After the initial mediation, which was also through Zoom, I decided to find a little box to place my laptop on so I wasn’t looking down at the screen or camera. This felt a little more natural than the first call because I was eye level with screen and better centered. I tried to keep my notes and second screen with exhibits angled so that I was always facing my computer camera and never looking or turning away.

Matt: While I was pretty sure the mediator had already been provided with any important documents, I had scanned copies of everything I felt might be needed in a folder on my desktop just in case we needed to find something quickly. I also probably spent a little more time discussing the case with the carrier before mediation since there would nobody would be with me live. 

What went well during the hearing and what do you wish would have gone better? 

Nate: The only thing that didn’t go well was the arbitrator’s Zoom account started to boot us off during the final hour of the proceeding. I don’t think anyone knew why. Luckily, there was a backup account link ready to be used.  Having a “Plan B” for handling a virtual conference is highly recommended. 

Matt: The mediator decided that since we had already taken the depositions of the plaintiffs, there was no need to have the defendants present on Zoom. So, there were no opening statements and, while I am sure the mediator did a fine job of presenting our arguments, there was no opportunity for me to make those arguments directly to the plaintiffs. For reasons I will explain below, I think having the defendants in the initial Zoom meeting would have been beneficial. As for what went well, I did the mediation from my office where I had access not only to my computer but to my cell phone and a land line. This worked out well because when the mediator would call me on my cell phone, I could (usually) ring up the carrier on my land line so he could listen in. 

Do you think the virtual hearing was as effective as doing it in person? 

Nate: Generally, I think the format was fine for an arbitration where both parties knew we weren’t negotiating and we were presenting the case on the merits to the arbiter. I think had we have mediated in person, we would have been more likely to reach an agreement before the arbitration.   

Matt: For the right type of case, the Zoom mediation could work out pretty well. However, my case was further complicated by the unrealistic expectations of the plaintiffs in terms of their damages and the failure of their attorney to manage those expectations. So, my mediation was kind of doomed from the start. We did not settle and made very little progress towards settlement. I believe there is a chance we could have made greater headway if we could have met with the plaintiffs in person to explain why the law did not entitle them to the damages they were seeking. 

What’s your best piece of advice for an attorney approaching their first virtual hearing? 

Nate: The organization of lots of documents and preparing to present them on the screen is crucial. I handled it alright by myself, but I think I could have done even better had I used an administrative assistant or paralegal to help me with the share screen function and quickly locating documents. 

Matt: I agree with Nate on documents, but I think everything has to be a little more organized on the whole. There was at least one time when the mediator called me and I could not get the carrier on the phone.  So, having spent a lot of time with him discussing the issues in advance of the mediation was good because I pretty much knew how he was going to react to everything the mediator was telling me. 

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