Constitutional Law

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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

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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

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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

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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

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We have tried to be pretty balanced in addressing a number of decisions over the last few months relating to lawsuits brought by the euphemistically labeled “vaccine hesitant” and their brethren who advocate aggressively for entitlement to “alternative” medical treatments like anti-parasitic (veterinary) drugs.  We have been restrained in treating these lawsuits as having been…

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We reported two weeks ago on the poorly conceived and ill-fated attempt by students to enjoin a public university from mandating COVID-19 vaccines.  There simply is no fundamental right under the Constitution to refuse vaccination, which has been firmly established for more than 100 years.  Now the Seventh Circuit has agreed.

Let’s be candid about…

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All of us are long-time defenders of prescription medical product manufacturers, and some of us are veterans of the vaccine wars of the 1980s and 1990s involving DPT vaccine and thimerosal.  We are big fans of vaccines and the tremendous health benefits they have bestowed on humanity, and are mystified by the alliance between anti-vaccine…

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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.
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