Vaccines

Subscribe to Vaccines via RSS
Photo of Eric Hudson

We’re not bashful about our affinity for real science. It underpins our clients’ ability to develop life-saving drugs and devices, supports Rule 702’s role in keeping junk science out of courtrooms, and reflects the skeptical habits of mind that should matter to everyone. Shortly before his death in 1996, Carl Sagan discussed with Charlie Rose the dangers of a society where fundamental understandings of science and technology continue to diminish:

There [are] two kinds of dangers. One is . . . [t]hat we’ve arranged a society based on science and technology in which nobody understands anything about science and technology, and this combustible mixture of ignorance and power, sooner or later, is going to blow up in our faces. I mean, who is running the science and technology in a democracy if the people don’t know anything about it? And the second reason that I’m worried about this is that science is more than a body of knowledge. It’s a way of thinking. A way of skeptically interrogating the universe with a fine understanding of human fallibility. If we are not able to ask skeptical questions, to interrogate those who tell us that something is true, to be skeptical of those in authority, then we’re up for grabs for the next charlatan political or religious who comes ambling along. It’s a thing that Jefferson laid great stress on. It wasn’t enough, he said, to enshrine some rights in a Constitution or a Bill of Rights. The people had to be educated, and they had to practice their skepticism and their education.

Carl Sagan’s Last Interview. Fast forward, and today we’re discussing a case where the court quotes Carl Sagan and notes that, in the context of vaccines, science is “the best we have.”  Am. Acad. of Pediatrics v. Kennedy, __ F. Supp. 3d __, 2026 WL 733828 (D. Mass. Mar. 16, 2026).  Through a combination of good science and government oversight, the United States’ vaccination program has been a beacon for public health: 

Congress and the Executive have built—over decades—an apparatus that marries the rigors of science with the execution and force of the United States government. One extraordinary product of that apparatus has been the eradication and reduction of certain communicable diseases through the development and use of vaccines.  In the words of the Centers for Disease Control and Prevention (CDC), vaccines are one of the greatest achievements of biomedical science and public health.

Id. at *1 (cleaned up).  That success in the eradication of certain diseases is based on a rigorous method by which decisions about vaccine policy are made—“a method scientific in nature and codified into law through procedural requirements.” Id.  In this case, that rigorous and well-established method (both scientific and legal) was ignored.Continue Reading Injunction Granted against Revised Childhood Vaccination Schedule and Wholesale Reconstitution of Vaccine Advisory Committee

Photo of Stephen McConnell

A chunk of our family recently relocated to Indiana, a lovely state that spawned prominent Americans such as Orville Redenbacher, Eli Lilly, Larry Bird, David Letterman, Michael Jackson, and James Dean, and that possesses fine covered bridges, a suddenly fearsome college football team, and a remarkable library that houses, among other things, the original manuscripts…

Photo of Eric Hudson

A few months ago we posted about how the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) held up against challenges to COVID-19 vaccine mandates.  The decision—which upheld a smallpox vaccination order over 100 years ago—has fared very well. Jacobson’s recognition that “society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy” applies today as much as it did in 1905. Id. at 26.  Today’s post addresses another COVID-19 decision relying on Jacobson to uphold vaccine mandates instituted for healthcare workers.  Continue Reading Jacobson Remains Solid: Ninth Circuit Upholds Vaccine Mandate

Photo of Michelle Yeary

In the 1980s, when a wave of complicated, expensive, and hard to prove lawsuits against the vaccine industry threatened to drive many manufacturers out of the market and subsequently cause a public health crisis, Congress stepped in and enacted the Vaccine Act which created the National Vaccine Injury Compensation Program. It is designed to strike…

Photo of Lisa Baird

The intersection of the PREP Act federal immunity statute and constitutional law continues to shape the landscape of COVID-19 vaccine litigation.  In Searcy v. Pfizer, Inc., __ F. Supp. 3d __, 2025 U.S. Dist. LEXIS 186682, 2025 WL 2713736 (M.D. Ala. Sept. 23, 2025), the Middle District of Alabama addressed a wrongful death action…

Photo of Bexis

Have you ever heard of the “Presentment Clause” to the United States Constitution?  U.S. Const. Art. I §, cl. 2.  While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation.  That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.Continue Reading Presenting the Presentment Clause

Photo of Bexis

Back in 2021, COVID-19 vaccines were becoming widely available, and we saw the likelihood of vaccine mandates on the horizon.  We researched the legal implications, and it didn’t take us long to figure out that Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), is the 500-pound gorilla precedent in this area.  An anti-vaxxer in Jacobson claimed that Due Process precluded him from being prosecuted for violating a municipal mandatory smallpox vaccination order.  He lost:

[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.

197 U.S. at 26 (emphasis added).

But the Jacobson gorilla is a silverback – decided well over a century ago at a time when “Due Process” often meant something much different than it does today (Jacobson was decided in the same term as Lochner v. New York, 198 U.S. 45 (1905)).  Thus we devoted our “Survival of the Vaxxest” post to marshalling all of the precedent that had followed Jacobson during those 116 years, including several more recent Supreme Court decisions:  Employment Div., Dept. of Human Resources of Oregon v. Smith, 494 U.S. 872, 888-89 (1990); Prince v. Massachusetts, 321 U.S. 158, 166-67 (1944); Zucht v. King, 260 U.S. 174, 176 (1922), see South Bay United Pentecostal Church v. Newsom, ___ U.S. ___, 140 S. Ct. 1613, 1613-14 (2020) (Roberts, C.J. concurring in denial of certiorari).  We did that so that those defending vaccination requirements wouldn’t have to, since they might not have the kind of resources that we, as big-firm lawyers, do.

It is now over four years later.  How well did Jacobson weather the COVID-19 storm?

As this post demonstrates, pretty well.Continue Reading Jacobson Weathers Its Second Pandemic

Drug & Device Resources

Bexis’ Book

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