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

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

To all in-house counsel working in the pharmaceutical, medical device, biotech, and digital health industries: if you’re looking to complete a few final CLE hours before the end of 2025, we invite you to attend Reed Smith’s annual Virtual Life Sciences CLE Week, taking place from November 3 through November 7, 2025.

This week-long event

Today’s guest post is from Reed Smith’s Matt Jacobson. He addresses the latest and greatest result from litigation that has been generating favorable decisions nationwide applying various states’ so-called “blood shield” statutes (practically every state has one) that declare the use of human cells or tissue in medical treatment to be services rather than products, which has the effect of limiting liability to negligence. As always our guest posters deserve 100% of the credit (and any blame) for their work.

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Milovich v. Aziyo Biologics, Inc., No. 1:24-cv-01208-CL, 2025 U.S. Dist. LEXIS 50935 (D. Or. Feb. 24, 2025), involves Oregon’s human blood and tissue shield statute.  The Drug & Device Law Blog has written about similar cases before, but this one might be the best.  Blood shield laws have been around for over 60 years.  They sound like something that Dracula should fear, along with a knife through the heart, the sun, holy objects, and garlic.  But they are not something that should scare anyone who manufactures blood or tissue based products.  While states have different statutory language, the gist of blood shield laws is that blood transfusions and transplants are a service and not a sale (Dracula would agree he is performing a service), thus barring claims for breach of warranty and strict liability.

Continue Reading Guest Post – The Sun Is Not Setting on Oregon’s Blood Shield Statute

Today’s guest post comes from Reed Smith partner, Matt Jacobson. He discusses a new medical device case that puts the “Tw” in TwIqball – as in twisting a screw. The result is a total defense win, albeit with the “twist” that the plaintiff can try again, if he can. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.

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Have you ever heard that old idiom “having a screw loose” and wondered where it came from?  My guess is most of you have heard the saying, but never thought twice about its origin (well maybe Bexis has).  But since I have your attention, here is a small history lesson.  During the industrial revolution, if a screw from a machine came loose it meant that the machine was not behaving normally.  Since these machines were built for mass production, having a screw come loose would cause the entire machine to shut down, halting the process.  At least one person claims that Eli Whitney, famed for inventing the cotton gin, was the person to say this phrase first.  But I cannot verify that fact no matter how many internet searches I ran, so that will remain a mystery.   

Continue Reading Guest Post – Twlqbal in the E.D. Cal.- No Screws Loose There

To anyone who needs a few more CLE hours before the end of the 2024, we wanted to let you know that videotaped sessions from last week’s Reed Smith Annual Life Sciences Litigation CLE Week are now available on demand. Here are descriptions of the topics and the registration link.

340B Program: Update on

Bexis was a mere college freshman, and a Princeton football manager, on September 28, 1974.  In the first game of the season, Rutgers played Princeton at Princeton’s old (and rather decrepit) Palmer Stadium.  With about three minutes to go and Rutgers up 6-0, Rutgers fans swarmed the field and tore down both sets of goalposts.  When Princeton tied the game up with less than half a minute left, without goalposts we could not kick an extra point.  A two point conversion failed, and Rutgers escaped with a tie.

Not quite half a century later, Rutgers scored an actual win.  This time Bexis is pleased.  In Children’s Health Defense, Inc. v. Rutgers, the State University of New Jersey, ___ F.4th ___, 2024 WL 637353 (3d Cir. Feb. 15, 2024) (“CHD”), the Third Circuit affirmed the right of a publicly supported university to require COVID-19 vaccination as a prerequisite to its students’ in-person attendance.  We blogged about this outcome in the district court, and its precedential affirmance is even more significant.

Continue Reading Tear Down the Goalposts – Rutgers Wins

Personalized medicine is the wave of the future.  Whether treating disease or prescribing medical devices (or both), medical practitioners are taking individualized patient characteristics into account more and more as they treat their patients.  Cancer therapy can now be targeted at the genetic level, and some medical devices can now be created to match patient