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
As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects. A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,”
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
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
In a series of what we entitled “reports from the front,” we discussed how the federal government asserted, and eventually won, the right to intervene in ongoing False Claims Act suits to seek their dismissal notwithstanding the objections of the “relators” who were ostensibly pursuing these actions in the government’s name. Basically, the relators claimed that, unless the government exercised its initial right to take over an FCA suit early on, the government lost all control over the relators, and they could essentially run wild using the government’s name. The Supreme Court rightfully rejected that view. United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419, 437-38 (2023) (government entitled to intervene and obtain dismissal of FCA action at any time on the basis of any “reasonable argument” regardless of the relator’s position).
However, three justices had more to add – they challenged that entire FCA private-attorney-general system as unconstitutional. Justice Thomas stated in dissent:
The FCA’s qui tam provisions have long inhabited something of a constitutional twilight zone. There are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation. . . . [T]he Court has held that conducting civil litigation for vindicating public rights of the United States is an executive function that may be discharged only by persons who are Officers of the United States under the Appointments Clause. A private relator under the FCA, however, is not appointed as an officer of the United States under Article II. It thus appears to follow that Congress cannot authorize a private relator to wield executive authority to represent the United States’ interests in civil litigation. The potential inconsistency of qui tam suits with Article II has been noticed for decades.
Polansky, 599 U.S. at 449-50 (Thomas, J., dissenting) (citations and quotation marks omitted). Concurring Justices Kavanaugh and Barrett agreed. “I add only that I agree with Justice Thomas that “[t]here are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.” Id. at 442 (concurring opinion).
Thus, we commented that “another front opens.”Continue Reading FCA Frontal Assault in Eleventh Circuit
Back in 2020, we encountered Gustafson v. Springfield, Inc., 2020 Pa. Super. Lexis 843 (Pa. Super. Sept. 20, 2020), a decision so bizarre that it reminded us of a Monty Python movie. That decision “employ[ed] a rationale, at once both paleolithically conservative and pro-plaintiffly radical, that would render any federal “tort reform” statute unconstitutional.” Gustafson involved a federal statute that preempted most tort litigation involving firearms, the Protection of Lawful Commerce in Arms Act of 2005, 15 U.S.C. §§7901, et seq., (“PLCAA”), and declared that the PLCAA violated the Tenth Amendment.
Since it did not involve prescription medical product liability litigation, the Blog did not follow Gustafson all that closely – our last mention of it was in 2021, noting that en banc reargument had been granted and the singular panel opinion had been withdrawn. However, the decision that resulted from the reargument was a mess. Gustafson v. Springfield, Inc., 282 A.3d 739 (Pa. Super. 2022) (en banc), produced no majority and five different opinions from the nine judges. Moreover, the overall result, which was to reverse the trial court’s dismissal of the suit, was contrary to the majority votes of the individual judges. How could that be? Here’s a brief description from a Pennsylvania appellate procedure article Bexis wrote about Gustafson:
The outcome in Gustafson thus differed dramatically from the votes of the nine en banc judges on the merits of the two issues. The outcome was 5-4 in favor of reversal, as four judges would reverse on constitutional grounds, and one judge would reverse solely on statutory grounds. On both of the two issues, however, the position advocated by the defendants was in the majority. Seven justices agreed that, factually, the Arms Act was applicable to the Gustafson plaintiffs’ claims. By a slimmer margin of 5-4, a majority of the Gustafson judges agreed that the Arms Act was constitutional.
J. Beck, “What Happens When Precedent Splinters? A Look at Gustafson,” Law.com (Nov. 17, 2022).
This bizarre result had one beneficial effect, it virtually forced the Pennsylvania Supreme Court to take the inevitable appeal in order to clean up the mess. Which it did. See Gustafson v. Springfield, Inc., 296 A.3d 560 (Pa. 2023) (granting review).
And last month, the Pennsylvania Supreme Court did indeed clean up the mess. See Gustafson v. Springfield, Inc., 2025 Pa. Lexis 442 (Pa. March 31, 2025).Continue Reading At Least Pennsylvania Is Not That Completely Different
The Supreme Court elucidated
The result for the defendant (a “distributor of ophthalmologic supplies”) in the False Claims Act decision, United States ex rel. Fesenmaier v. Cameron-Ehlen Group, Inc., ___ F. Supp.3d ___, 2024 WL 489708 (D. Minn. Feb. 8, 2024), was so terrible that something good ended up happening.Continue Reading FCA Verdict Slashed as Unconstitutional Excessive Fine
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
Last term the newly empowered conservative majority on the Supreme Court demonstrated to all that precedent is not so precedential, even when it had stood for nearly fifty years. They very nearly did it again, but just missed, targeting precedent on religious exemptions and vaccine mandates that has been around for more than twice as long.Continue Reading Vaccine Mandates and Religion at the Supreme Court