Photo of Bexis

Bexis

Subscribe to Bexis's Posts

JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

Follow:Read more about BexisJames's Linkedin Profile

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

We expect that none of our readers need reminding about the disastrous Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), holding that Pennsylvania could constitutionally (under the Due Process Clause, at least) deem the mere act of registering to do business in Pennsylvania as “consent” that permits the Commonwealth’s courts to  assert general personal jurisdiction over foreign corporations without any other contact.

At this point, Pennsylvania remains the only state with a general jurisdiction consent-by-registration statute that reaches manufacturers of prescription medical products.  Illinois recently passed a more limited consent-by-registration statute, 735 Ill. Comp. Stat. 5/2-209(b)(5), 805 Ill. Comp. Stat. 5/13.20(b), that applies only to “hazardous substances,” so our primary focus for Mallory problems remains Pennsylvania.

There’s been a Pennsylvania legal development that could help some defendants prevent Mallory inspired forum shopping.  It’s a recent Pennsylvania state court medical malpractice venue decision – something that may fly under the radar for non-Pennsylvania, non-medmal defense counsel.  Of course, we at the blog live for bringing this kind of case to our defense colleagues’ attention (longtime readers may remember our early advocacy of what is now called “snap removal”).Continue Reading Recent Pennsylvania Decision Suggests Partial, Longer Term Response to Our Mallory Problem

Plaintiffs (or more properly, their lawyers) across the country have been filing no-injury class actions against over-the-counter (“OTC”) drug manufacturers on a variety of cooked-up theories that have little or nothing to do with the safety or efficacy of these drugs.  One such theory, that we have discussed several times, is that drugs that the FDA allows to be labeled as “rapid release” should be penalized, under state law, for using that purportedly “misleading” description.  This litigation is based on one study, done years ago, that found that some “rapid release” products did not dissolve any more quickly (or less so) than other products not bearing that designation. Continue Reading “Rapid Release” Class Action Dissolved

In his latest off-label use-related law review article in 2021, Bexis pointed out:

[A]lthough states have traditionally been recognized to have broad authority to regulate the practice of medicine, aside from occasional attempts to restrict use of abortifacients, state-law interventions restricting the off-label uses of prescription medical products have been infrequent.

James M. Beck, “Off-Label…

Today’s guest post is from Jamie Lanphear and Daniel Kadar, both of Reed Smith, who follow product liability events in Europe closely. They are discussing the implications of recent changes on the availability of attorney/client and work product privileges—called “legal professional privilege” in Europe—not only in Europe itself, but how European restrictions might find their way back across the pond to parallel litigation in the United States. As always our guest posters are 100% deserving of all praise (and any blame) from their posts.

**********

If you’ve ever found yourself grumbling about the breadth of U.S. discovery, you’re not alone. For U.S. lawyers, turning over reams of company documents is a familiar—if unwelcome—part of litigation. For most of our European colleagues outside of the UK, however, the idea of broad, adversarial discovery has generally not been a concern. That’s likely about to change. The EU’s new Product Liability Directive (PLD), which the blog has previously covered here, here, here, and here will expand disclosure obligations in product liability matters across the EU, and the implications for legal privilege—especially for in-house and U.S. counsel—are significant.Continue Reading Guest Post – The New EU Product Liability Directive: More Disclosure, More Risk for Privileged Communications

Every week Bexis circulates an email with new, bloggable cases, but sometimes there are more new decisions than blogging days, and cases get passed over.

Here are three (relatively) recent examples

Gonzalez v. International Medical Devices, Inc., ___ F. Supp.3d ___, 2025 WL 2054361 (W.D. Tex. June 20, 2025), arose from the plaintiff’s apparent…

Today we have a guest post on some recent developments on whether strict liability applies to software, apps, artificial intelligence, and other forms of electronic data, which depends, as this 50-state survey addresses, on whether such intangible items meet the common-law definition of “product.” It is by Reed Smith attorneys (and repeat guest posters) Mildred…

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