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If you ever needed proof that timing is everything, the Taxotere litigation has you covered.

Last month, a court denied summary judgment to the brand manufacturer, finding that it allegedly acquired “newly acquired information” post-dating Taxotere’s original FDA approval in 1996. This month, however, the very same court granted summary judgment to the manufacturers of docetaxel, the active ingredient in Taxotere, whose products were approved in 2011 via §505(b)(2) of the FDCA.   

The key distinction—the clock didn’t start running in 1996 for everyone. In re Taxotere (Docetexal) Eye Injury Products Liability Litigation, 2026 WL 123664 (E.D. La. Jan. 16, 2026).

To start, a §505(b)(2) approval is something of a hybrid between a New Drug Application (brands) and an Abbreviated New Drug Application (generics). It is available for drugs that differ from the RLD (reference listed drug) “in ways that are slight enough for the manufacturer to still rely on the RLD’s safety and efficacy data.” The manufacturer submits an NDA, but it “need contain only that information needed to support the modification(s) of the listed drug.  Unlike [generic] drugs, §505(b)(2) drugs are not required to use the exact same labeling as the RLD.” Id. at *2. So yes we are talking about generics. No, we are not talking about Mensing preemption.

The labels for both Taxotere and docetexal warned of “excessive tearing which may be attributable to lacrimal duct obstruction,” but plaintiffs argue it should have said more. Such claims are preempted, however, unless plaintiffs can point to newly acquired information that would have permitted a unilateral label change (i.e. without the FDA’s approval) under the FDA’s Changes Being Effected (“CBE”) regulation.  In the case of docetexal, plaintiffs argued that information that post-dated the original Taxotere approval but pre-dated the §505(b)(2) approvals should be considered newly acquired. Which if allowed would almost certainly have led the court to reach the same conclusion it did in December.

But here’s where we get a little help from the Fifth Circuit and the first Taxotere MDL. In Hickey v. Hospira, 102 F.4th 748 (5th Cir. 2024), which we talk about here, the appellate court found that “the newly acquired information inquiry centers on what happens after the FDA approves a §505(b)(2) drug.” In re Taxotere, 2026 WL 123664, *9 (emphasis in original). While the §505(b)(2) manufacturers can rely on the brand manufacturer’s safety and efficacy data, they don’t have a “right of reference” to it, meaning they don’t get to see all of it. You can’t say what is “new” if you don’t have a point of reference to compare it to. Id. at *8. That’s why their clock did not start in 1996. Instead, the Fifth Circuit said the proper “baseline comparator” for §505(b)(2) manufacturers is the “publicly available literature that existed prior to the §505(b)(2) manufacturers’ approval.” Id. at *10.

Once the right timing for the baseline was set, the rest of the decision is a standard CBE analysis—did the §505(b)(2) manufacturers have newly acquired information that post-dated the 2011 approval of their drugs that would have supported a unilateral label change. Id.  Without going into the details of the science, the answer was no. Id. at *10-14.

Under the CBE regulation, post-approval information qualifies as “newly acquired” only if it reveals “risks of a different type, or greater severity or frequency” than what was already known and disclosed at the time of approval. Id. at *10. That’s a high bar—and intentionally so. The FDA, not juries, decides what risks warrant warnings, and manufacturers can only change labels unilaterally when genuinely new safety information emerges.

Here, the science tells the same story it did before approval—just with more footnotes. And no, calling old data “new” doesn’t magically make it so. Relying on new articles that “summarize pre-approval literature” is simply repackaging existing knowledge. Id.at *13. If the post-approval literature confirms what was already known, that’s called confirmation, not innovation. And confirmation does not authorize a CBE label change. Because the manufacturers could not have changed their labels without prior FDA approval, plaintiffs’ state-law failure-to-warn claims collapse under impossibility preemption.

While different, the two Taxotere rulings are not contradictory. They’re chronological. And while we think the December ruling was strained on what constitutes newly acquired information, what may count for a product approved in 1996 does not automatically remain “new” forever. By 2011, the FDA had already seen it, digested it, and approved products with that knowledge in hand. When nothing new emerges after approval, manufacturers—brand or generic—cannot be faulted for failing to warn about risks the FDA already considered.

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Simply charging a price higher than what plaintiffs want for an effective and non-defective medicine is not a consumer protection violation, and a recent order in the Northern District of Illinois demonstrates that.  In Camargo v. AbbVie, Inc., No. 23-cv-02589, 2026 WL 115068 (N.D. Ill. Jan. 14, 2026), the district court dismissed a multistate class action alleging consumer protection claims for multiple reasons, but mainly because the plaintiffs got exactly what they paid for—even if they paid more than they would have liked for a life-improving product.  The court also ruled that federal patent law impliedly preempted the plaintiffs’ claims. 

In Camargo, residents of California, Connecticut, Indiana, and Michigan alleged that Humira’s list price was artificially inflated through a rebate-driven strategy with pharmacy benefit managers, thus forcing consumers who paid list price (or coinsurance based on list price) to bear “oppressive” costs.  They pleaded claims under the Illinois Consumer Fraud and Deceptive Business Practices Act (“ICFA”) and similar statutes in nearly thirty states.  The manufacturer moved to dismiss. 

To start, because the Illinois statute has no extraterritorial effect, the relevant transactions must have occurred “primarily and substantially” in Illinois.  But these plaintiffs lived out of state, and although they alleged that the pricing strategy was conceived and implemented in Illinois, that was not enough.  All the plaintiffs filled their prescriptions in other places, so the court dismissed the ICFA claims brought by these carpetbagging out of staters.  

Separately, the court found that two plaintiffs failed to plead damages under the ICFA.  Paying an allegedly “oppressive” price for a product, without more, is insufficient to establish a consumer injury, where the plaintiffs do not allege the product was worth less than the price paid or that they could have obtained a lower price elsewhere.  One plaintiff never paid the post-insurance “list” price, and another similarly failed to allege that Humira was defective or worth less than what he paid.  These failures provided independent bases to dismiss their ICFA claims.

There were more problems with the plaintiffs ICFA claims, namely the three-year statute of limitations.  Claims were time-barred to the extent premised on prices paid through 2018, when the plaintiffs purchased the product and their claims accrued.  Moreover, the “discovery rule” did not save the claim because the allegedly unfair prices were apparent at the time of payment, even if plaintiffs alleged did not know the defendant’s pricing strategy.

Beyond Illinois, recall that these plaintiffs were from California, Connecticut, Indiana, and Michigan.  But the complaint asserted no claims under Indiana or Michigan law, and the plaintiffs largely failed to defend other states’ claims, effectively waiving them. 

The court therefore focused on the California and Connecticut statutes, ultimately finding the allegations insufficient under each.  Under California’s Unfair Competition Law, plaintiffs alleged an “unfair” business practice, but the complaint did not plausibly allege anticompetitive effects.  To the contrary, it reflected the availability of alternatives and biosimilars.  Indeed, the California plaintiff switched to a biosimilar—undermining assertions of market foreclosure or harm to competition.  Under the Consumer Legal Remedies Act, a claim requires damages “as a result of an unlawful act.”  These plaintiffs alleged conduct that they did not like, such as alleged profit-maximizing and rebate practices they considered opaque.  But they alleged nothing unlawful.  The court dismissed both counts. 

The court found nothing wrong under the Connecticut Unfair Trade Practices Act either.  Under the CUTPA, “unfairness” is assessed by whether conduct falls within established concepts of unfairness, is immoral/oppressive, or causes substantial injury not outweighed by countervailing benefits and not reasonably avoidable by consumers.  Here, the Connecticut plaintiff in fact avoided paying Humira’s allegedly high prices, first through her insurance coverage and later by quitting the medication.  Even so, the plaintiffs alleged no statutory violation because “in any event, charging consumers higher prices, by itself, does not violate the CUTPA.”  Camargo, at *6. 

Most consequentially, the court held that plaintiffs’ pricing-based consumer claims were preempted by federal patent law to the extent they seek to penalize the manufacturer for charging “excessive” prices for a patented drug, citing Biotechnology Industry Organization v. D.C., 496 F.3d 1362 (Fed. Cir. 2007).  The court reasoned that penalizing high prices limits the full exercise of the exclusionary rights secured by patent law and therefore conflicts with congressional objectives, even though states generally may regulate unfair practices.

The plaintiffs cited the EpiPen MDL, where sales and antitrust claims were not preempted.  But their reliance on that case was unavailing because it involved allegations of monopolization conduct, deceptive marketing, and racketeering that independently supported state-law claims without targeting patent-derived pricing power.  Here, plaintiffs did not allege antitrust violations, exclusionary conduct against biosimilars, or deception.  To the contrary, they alleged that the manufacturer published its list prices, and at least two named plaintiffs used biosimilars, underscoring the absence of exclusionary practices.  As framed, the claims attack prices stemming from patent rights—squarely implicating patent law.

The court granted the manufacturer’s motion to dismiss on all claims, but without prejudice.  On this score, the court gave the plaintiffs until February 11, 2026, to file an amended complaint, but also cautioned that plaintiffs could do so if “consistent with their obligations under Rule 11.”  Camargo, at *9.  This court is clearly skeptical, for good reason. 

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We’ve only discussed Shady Grove Orthopedic Associates, P.A. v. Allstate Insurance  Co., 559 U.S. 393 (2010), a couple of times.  Shady Grove, displaced – in federal court – a variety of state-law limitations on class actions because those restrictions were at odds with Fed. R. Civ. P. 23, and in federal court federal rules properly enacted under the Rules Enabling Act, 28 U.S.C. §2072 (“REA”), control.  Thus, the plaintiffs in Shady Grove could bring state-law class actions in federal court that were barred in state court.

Earlier this week, in Berk v. Choy, 2026 WL 135974 (U.S. Jan. 20, 2026), a unanimous Supreme Court struck again, holding that a relatively common state-law restriction on medical malpractice claims – a requirement that the complaint be accompanied by an “affidavit of merit” signed by a doctor – did not apply in federal court because that requirement was beyond what was needed to satisfy Fed. R. Civ. P. 8.

The Court’s analysis in Berk seems equally relevant to the requirements of any federal rule.  First, the “Rules of Decision Act [28 U.S.C. §1652] dictates that state substantive law must yield if . . . a [federal] statute “otherwise require[s] or provide[s].”  Berk, 2026 WL 135974, at *3.  Second, the REA is such a statute, since it “authorizes“ the Supreme Court to “prescribe general rules of practice and procedure and rules of evidence,” §2072(a), “for district courts, [and] provides for the application of federal law.”  Berk, 2026 WL 135974, at *3 (citations omitted).  Thus, “a valid Rule of Civil Procedure displaces contrary state law even if the state law would qualify as substantive under Erie’s test.”  Id. (emphasis added).  As will become clear, we think that’s important.

Think about that again.  The Supreme Court just unanimously held that anything in state law, whether “procedural” or “substantive” goes out the door in federal diversity cases, to the extent that it “demands more,” 2026 WL 135974, at *4, than a federal rule – unless the rule itself exceeds the scope of the REA.  Id.

The state affidavit-of-merit requirement demanded more than Rule 8, since that rule has no requirement to include “evidence” (the affidavit) in a complaint.  Id. (“Under Rule 8, factual allegations are sufficient, but under the Delaware law, the plaintiff needs evidence too.”).  “The two rules thus give different answers.”  Id.  Nitpicking – that the affidavit was “a separate sheet of paper” from the complaint itself – was unsuccessful.  Id.  What matters is whether the state requirement and the applicable federal rule “address[] the same issue – and in doing so, impose[] a different standard.”  Id. (footnote omitted).  A number of more case-specific arguments made by the malpractice defendants also failed.  Id. at *5-6.

Those defendants’ final fallback position fared no better.  No, Rule 8 did not violate the REA because it was improperly “substantive.”  Id. at *6.

For purposes of the Rules Enabling Act, we use a modest test:  whether the Federal Rule really regulates procedure.  Or put differently, what matters is what the Rule itself regulates. . . .  In applying this analysis, we have rejected every statutory challenge to a Federal Rule that has come before us.

Berk, 2026 WL 135974, at *6 (citations and quotation marks omitted).  Berk had no trouble determining that Rule 8 – enacted as a Federal Rule of Civil Procedure – “really regulates procedure.”  Id.  While it had “practical effect on the parties’ rights,” it did not regulate “the rights themselves.”  Id.

Nor was Berk willing to change the Court’s long-standing refusal to evaluate the nature of the state law being displaced:

[Defendants] argue that determining whether a Rule is valid under the Rules Enabling Act requires asking a second question:  whether the displaced state law is substantive.  We rejected that approach eight decades ago and decline to reconsider it now.  On the contrary, we underscore that “the substantive nature of [a state] law, or its substantive purpose, makes no difference.

Berk, 2026 WL 135974, at *7 (citations omitted) (emphasis original).

So what can we take away from Berk?  Start with medical malpractice, the subject of the state legislation overturned (preempted?) in Berk.  Most p-side lawyers specializing in such cases wouldn’t be caught dead in federal court if they could help it.  Does that change?  Maybe some in the short term, but probably not in the long term.  Most malpractice cases are non-diverse to start with, and the sorts of malpractice plaintiffs likely to have trouble satisfying certificate-of-merit requirements don’t have very good cases anyway, so we question how many will want to “make a federal case” of it.

On the other side, if the states have the political will to do so, it wouldn’t be hard to fix the federal rules problem that did in this particular certificate-of-merit statute.  Just tie the requirement to something that the federal rules don’t reach.  A certificate/affidavit mandate as part of initial discovery might run afoul of Fed. R. Civ. P. 26(a)(2) governing initial disclosures.  So tie such mandates to something else.  The statute of limitations for medical malpractice could be 180 days, unless the plaintiff submits a certificate of merit, in which case it’s the same length it was before.  Or, because medical malpractice cases without certificates of merit are highly likely to be bogus, the damages cap for such cases is very low, whereas with the certificate, it is whatever state law now requires.  Because an amended certificate/affidavit mandate no longer has anything to do with anything a federal rule covers, it should have no trouble with Berk.

What else?  Well, here’s an interesting piece discussing how Berk might cause trouble for parties in federal court seeking dismissal of litigation under state “Anti-SLAPP” statutes. Nor should state restrictions on informal interviews with plaintiffs’ treating physicians apply in federal court in derogation of broader federal discovery rules.

But we hasten to point out that Berk implicates more than just the Federal Rules of Civil Procedure.  As we quoted at the beginning of this post, the Federal Rules of Evidence also stem from the REA and apply in federal court under the Rules of Decision Act.  That’s why Rule 702 is so important in federal prescription medical product liability litigation.  But other state-law evidentiary peculiarities besides expert testimony could well conflict with the Federal Rules of Evidence – particularly the liberal admissibility requirements of Fed. R. Evid. 401 and 402.  Rule 401 provides that “Evidence is relevant if . . . it has any tendency to make a fact more or less probable than it would be without the evidence.”  Rule 402 provides that “[r]elevant evidence is admissible” subject to a number of exceptions that do not include any form of state law.

In a prior post from a couple of years ago, we discussed the original Shady Grove decision in the context of a couple of ways that Pennsylvania evidentiary restrictions in product liability cases could be trumped by the broader admissibility standards of Fed. R. Evid. 401-02.  Berk only reinforces those arguments, with its repeated emphasis that, when federal rules are involved, whether the state law being displaced is “substantive” or “procedural” doesn’t matter a hill of beans.  Subsequent Pennsylvania developments only increase the importance of applying the Federal Rules of Evidence in federal court.  Since that post, the Pennsylvania Supreme Court has made Pennsylvania the only state in the nation where compliance with industry and governmental (in our sandbox read, FDA) standards is not even admissible in strict liability actions.  See Sullivan v. Werner Co., 306 A.3d 846, 862-63 (Pa. 2023) (plurality opinion), affirming, 253 A.3d 730, 747 (Pa. Super. 2021) (discussed in detail here).

Under Berk and Fed. R. Evid. 401-02, that evidentiary restriction should not apply in federal court.  And it hasn’t, even before Berk.  The Third Circuit has repeatedly held that the Federal Rules of Evidence govern in diversity product liability cases otherwise subject to state law.  E.g., Covell v. Bell Sports, Inc., 651 F.3d 35, 36-37 (3d Cir. 2011); Moyer v. United Dominion Industries, Inc., 473 F.3d 532, 546 (3d Cir. 2007); Diehl v. Blaw-Knox, 360 F.3d 426, 431 & n.3 (3d Cir. 2004); Rolick v. Collins Pine Co., 975 F.2d 1009, 1013 (3d Cir. 1992):

The issue to be decided here is whether the OSHA regulation is admissible in a diversity action as evidence of the standard of care owed by the defendants to the plaintiff. . . .  Since the question involves the admission of evidence in a federal court, the Federal Rules of Evidence control. . . .  We can think of no reason under the Federal Rules of Evidence why the OSHA regulation is not relevant evidence of the standard of care once it is determined, as we have done, that under Pennsylvania law the defendants could owe plaintiff a duty of care.

Rolick, 975 F.2d at 354.  See Kelly v. Crown Equipment Co., 970 F.2d 1273, 1278 (3d Cir. 1992) (strict product liability case; federal rule admitting subsequent remedial measures “is ‘arguably procedural,’ and therefore governs in this diversity action notwithstanding Pennsylvania law to the contrary”). NOTE: none of these cases involve prescription medical products. That’s because Pennsylvania has strictly enforced Restatement (Second) of Torts §402A, comment k (1965), and not applied strict liability to prescription products.

Berk only reinforces this Third Circuit precedent, so in Pennsylvania federal court product liability litigation, compliance evidence should be admissible regardless of Sullivan.  Thus, Third Circuit Rule 401-02 decisions in product liability cases applying Pennsylvania substantive law should apply, notwithstanding Sullivan. Federal standards on what‘s “relevant,“ rather than Pennsylvania’s exclusion of compliance evidence based on its peculiar (and probably “substantive”) reading of Restatement §402A.  As to the admissibility of compliance, Pennsylvania law plainly “demands more” than Rules 401-02 and when applied to compliance evidence would “give different answers” to admissibility.  Berk, 2026 WL 135974, at *4.  Since it can hardly be denied that Rules 401-02 “really regulate” evidence, that Pennsylvania might consider its more restrictive approach “substantive” is of no consequence.  Id. at *6.

To the extent that states have other restrictive evidentiary rules that disfavor defendants (statutes barring admission of seatbelt nonuse come to mind), a similar rationale should apply after Berk.

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Not quite three years ago, we co-authored a chapter in a Digital Health guide put out by International Comparative Legal Guides.  It bore the pithy title “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health.”  We continue to tinker with the principles of product liability law and monitor how they intersect with digital health, software, artificial intelligence, and other aspects of our increasingly abstract existence.  Our then-colleague Gerry Stegmaier with whom we co-authored the chapter still lives in the world of companies that develop software and AI platforms, so we thought it made sense to get his views again.  Perhaps because January invites retrospection (and because high tech years have at least a canine multiplier), we decided to see how we did with our predictions.  Being lawyers, our prior predictions were not overtly identified as such, but it is still possible to pull out the forward-looking statements we made with a probabilistic bent.

Our declared idealistic “aim to aid software developers in digital health and those that advise them in anticipating, preparing for, and responding to this potentially rapid changing liability landscape” was offered in the context of four general developments over the few years prior to early 2023.  First, many digital health products, medical devices and otherwise, were being developed, often by companies recently created to tackle digital health needs.  Second, a number of decisions had come out that tested the presumptive treatment of software as a licensed service or intangible, not a product.  See here, here, and here.  Relatedly, the creation of the high profile Social Media MDL (In re: Social Media Adolescent Addiction/Personal Injury Products Liability Litigation) meant that these issues were going to get increased attention.  Third, FDA had been in catch-up mode, issuing a number of guidance documents about software and medical applications that were arguably long overdue.  (The history of FDA regulation in this area is included in the second section here.)  Fourth, although not the focus of our chapter, the writing was on the wall that the EU was going to issue a directive treating software as a product for purposes of liability, which it ultimately did in October 2024.  While the U.S. does not tend to follow what the E.U. does on product liability, companies that hope to sell their products or license their technologies around the world do have to pay attention to such things. 

Taking our predictions in the order in which they appeared in the chapter, the first contains an implicit prediction:  “As healthcare continues to become more digital, the prevalence of devices reliant on software continues to grow.”  This was low hanging fruit, so to speak, but both trends have continued.  Public lists of FDA approvals and clearances since early 2023 include many software-driven devices.  In the “Device Innovation” section of its 2024 Annual Report, FDA’s Center for Devices and Radiologic Health identified eight examples of novel devices, of which four were software and two others utilized software.  We find that telling.

Next, we identified “a number of areas where the application of traditional U.S. product liability principles could differ with patient-facing digital health and software-driven medical devices.”  (Our apologies in advance for any confusion over the British spellings that carry over from the chapter in International Comparative Legal Guides.)

  • We noted the possibility for liability based on a post-sale duty to warn for digital health and software-driven devices “where the relationship with the end-used may continue post-sale and the ability to update software may go hand-in-hand with the ability to notify an end-user of a post-sale issue.”
  • We noted that software update abilities with prescription medical devices could mean that “the learned intermediary doctrine may not apply in some cases where the level of direct and/or continuing interaction between the manufacturer and patient undercuts the rationale for the doctrine.”
  • We postulated a poor preemption result for a PMA device when, “[i]n the case of a device with software that will be updated over time or where the device utilises AI or machine learning, some courts may doubt that the device at the time of the alleged injury was the same as what FDA had approved.”
  • “Lawsuits over injuries allegedly due to a failure of software in a medical device might also name entities that contracted with the device manufacturer to develop or update that software. A parallel may be seen in the history of suing manufacturer.”
  • We suggested that federal legislation could try to impose “limitations on liability” if civil litigation impeded innovation.
  • We also envisioned courts creating easier routes to liability without proof of defect or negligence in the situation where “software fails to perform as expected and there is no ability for it to be altered by anyone other than the manufacturer or its agents.”
  • Suits alleging product liability in the absence of “tangible physical injuries,” including under increased risk or medical monitoring theories.
  • “Given that product liability law has generally not applied to software, any imposition of product liability would entail making new state law.”

Addressing each of these in turn would make this post far too detailed and long to keep any reader’s attention, so we will summarize them and focus on a few.  The summary is that positions taken in litigation, decisions issued by courts, and who is getting sued over digital health, including devices driven by AI and software, are in flux.  We have been tracking them here and in other specific posts.  Litigation in this space has increased, but the relatively few decisions since early 2023 have not yet established any consensus.

On our point above about “new state law,” our chapter specifically looked to the Social Media MDL, finding it “highly likely that the issue of whether strict product liability applies to social media platforms, including the software that runs them, will be decided directly. Those decisions, potentially modified on appellate review, will inevitably influence the legal playing field for potential claims relating to digital health and software-driven medical devices.”  We do have decisions from that court, including In re Social Media Adolescent Addiction/Personal Injury Products Liability Litigation, 702 F. Supp. 3d 809 (N.D. Cal. 2023), discussed here, but we do not yet have a clear articulation of an adoption of rejection of new law for specific states.  Without speaking to the law of specific states consistent with Erie, that court denied a motion to dismiss asserted product liability claims because “plaintiffs adequately plead[ed] the existence of product components as to each alleged defect analyzed” under a novel approach focused on “functionality” instead of “tangibility” or other traditional measures of what constitutes a “product” for purposes of product liability.  We cannot say that this novel way of defining what is a product will have any legs,  Later, in the same MDL in the context of plaintiffs pushing public nuisance under what is fundamentally a product liability theory, the plaintiffs denied that they were asserting product liability claims at all and the court characterized the issue of whether the social media platforms were products as disputed.  Clearly, this is going to require more litigation, especially on appeal, to get some clarity.

As for our prediction on federal legislation, the pending AI Lead Act is certainly broader than a software version of the Biomaterials Access Assurance Act.  If enacted, it would create a federal cause of action, preempt some state laws, and definitely treat software as a product.  Until it is passed in some form, though, it is unclear how this will change the playing field.  The history of product liability litigation over PMA devices and other medical products with applicable express preemption provisions teaches that plaintiff lawyers will make a concerted and prolonged effort to erase any statutory limits on liability and damages.  We cannot help but see the chilling effect that the plaintiff bar’s on-going efforts to expand liability, both in terms of novel claims and new targets, can have on investment in developing new technologies in digital health.

Speaking of prolonged efforts, we also predicted that FDA would be issuing more guidance on software as devices and devices driven by software, even though it viewed its authority in this area as limited.  In its September 2022 Policy for Device Software Functions and Mobile Medical Applications, FDA promised to “continue to evaluate the potential impact these technologies might have on improving health care, reducing potential medical mistakes, and protecting patients”  Earlier this month, made good on its promise with two new guidances, which replaced guidances from September 2022 and September 2019, respectively, and a new draft guidance.  Briefly—because each could have a deep dive on its content and potential liability implications—the guidance on Clinical Decision Support Software reexamined “FDA’s oversight of clinical decision support software intended for health care professionals . . . as devices,” which is undoubtedly one of the hot development areas.  A big part of the guidance on General Wellness: Policy for Low Risk Devices is to help define which software is a device and which is merely an application to help people stay or become healthier without treating a specific disease.  FDA does not regulate the latter, so certainty on what is and is not a device is important but perhaps ephemeral.  The draft guidance Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations builds on a number of FDA statements over the last 19 months.  See, e.g., here, here, and here.  Draft guidances are subject to public comment, and FDA responses to those can be informative.  Sometimes, FDA’s draft guidances have stayed that way for years, taking on the same functional authority as final guidances, which are still considered “nonbinding.”  So, the short- and long-term impacts of this draft guidance remain to be seen. More generally, given that these three (draft) guidances were issued within four weeks of an Executive Order about setting a national policy on AI, it seems inevitable that the regulation of software as devices and devices driven by software will continue to be an area of change for the foreseeable future.

Our last two predictions were, frankly, pretty obvious in hindsight.  We said:

[S]oftware-development lifecycle best practices are likely to evolve further and familiarity with FDA’s risk classification schemes may be a useful starting point for many developers, regardless of whether their software is or may be a medical device.

***

In any event, medical device companies, software developers who work with them, and those who assist each with managing and responding to liability risks will benefit from greater understanding of and monitoring this emerging area of the law.

We continue to think these are sound predictions, even if made in early 2026.  In this space, risk minimization cannot be driven solely by traditional views about software—i.e., contractual limits were—or doctrinaire views about product liability.  We expect that digital health will continue to be area where legislators, regulators, litigators, and judges all play a role in setting the ground rules that will emerge over time.  As that happens, companies in this space have to take steps to minimize risks even while ambiguity and uncertainty remain about what those ground rules will be.  It would be a shame if the uncertainty hampers the development, deployment, and adoption of AI-powered products and services that will advance public health and the delivery of healthcare. 

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Our favorite aspect of being a prosecutor was the investigation phase. Snooping is fun.  Figuring out what the crook did and how he did it made us feel like Columbo or Mannix. (Surely those references are lost on anyone under 50. Maybe we should have alluded to Poker Face.) Surveillance, telephone records, and bank accounts often told quite a revealing story. Once we had the evidence, proving it up was relatively easy.  There is a reason why most criminal defendants plead guilty. There is a reason why fewer than 1% of federal criminal defendants get acquitted.  

By contrast, our least favorite aspect of civil litigation is discovery. It is asymmetrical, burdensome, and expensive.  Answering interrogatories, producing millions of pages, and squabbling over privilege logs are time-consuming and soul-destroying activities. There might be some important moments in the course of defending sixty company witness depositions, but what that drudgery mostly produces are transcript pages devoid of significance. It’s been said that death is easy, while comedy is hard. For us, trials are easy, while discovery is hard. 

Today’s case, Commonwealth of Pennsylvania v. Kurtz , 2025 WL 3670767 (Pennsylvania Dec. 16, 2025), is a criminal case that has implications for civil discovery.  Yes, with that case name, we were tempted to repeat that famous line from Conrad’s Heart of Darkness — “The horror, the horror!”) (oops – looks like we succumbed to that temptation) — but from our perspective (a former AUSA who now defends companies that make fine products), the Kurtz case harbors no horrors.  In fact, it is interesting, it is insightful, it is correct, and it might even be useful.   

Why is that? A defendant in prescription medical product liability litigation could find a plaintiff’s internet search history useful for any number of reasons.  For example, an internet search history could establish when a plaintiff knew enough to end the discovery rule’s tolling of the statute of limitations.  It could verify or debunk a plaintiff’s claim of being misled by something on the defendant’s website.  We remember a Baycol case in which a plaintiff claimed that the medicine caused her to suffer rhabdomyolysis, which, she said, made it hard for her to move at all.  Then we found a Facebook post where she bragged about recently winning a rodeo barrel race. Good times.  Howdy, dismissal. 

But discoverability of social media is a snap.  It is well established. (See our cheat sheet here.) Can a defendant discover a plaintiff’s history from the internet service provider (ISP), or from the search engine?  Expect a plaintiff to oppose such discovery, claiming some sort of privacy interest.

But if the litigation is in our home jurisdiction of Pennsylvania, then the Kurtz decision, an affirmance by the Pennsylvania Supreme Court in a criminal case, should defeat the plaintiff’s privacy claim.  That’s why we are bloviating about Kurtz today. It is an interesting case in its own right. To be sure, it concerns a horrific crime. Kurtz had been convicted of numerous offenses, including rape and kidnapping (involving five victims). Someone invaded a victim’s home, kidnapped her, and then raped her.  How was the villain caught? The Pennsylvania law enforcement folks did some excellent sleuthing.  From the facts of the crime, they deduced that the criminal knew details about the victim’s home and habits. The police obtained a “reverse keyword search warrant” for the records that Google generated during the week prior to the assault.  The warrant was not directed at a specific person’s activity, but instead targeted all searches performed on Google’s search engine relating to the victim’s name and address. Voila — the defendant had performed two such searches in the hours before the crime.  

By the way, expect to see more of this sort of use of ISP/search engine searches.   Surely, you’ve heard of cases in which a murder defendant ran searches on not-very-innocent topics. The slayer of Idaho college students had conducted internet searches on “rape,” “voyeur,” “forced,” and “sleeping.” Convicted murderer Brian Walshe used Google to look up ways to dismember and dispose of a body.  (Luckily for us, our own internet searches are on dull topics such as “Why won’t my sourdough starter start?” or “parking spots for fishing in Pickering Creek.”  You will not find inquiries about “best stabbing knives” or “how to make poisoned tiramisu.”)

It turned out that defendant Kurtz was a correctional officer who worked with the victim’s husband. The police obtained a DNA sample from the defendant (via a discarded cigarette butt), there was a match, there was an arrest, and then the defendant confessed to the rape (and four others). That is a pretty solid criminal case. Nevertheless, the defendant filed a motion to suppress the Google search (and all fruits of that allegedly poisonous tree). He lost that motion, then proceeded to trial.  The jury convicted him. Kurtz filed an appeal. The key issue on appeal was whether the Google search violated the defendant’s Fourth Amendment right against an unreasonable search and seizure.  If you listen to the excellent legal podcast, Advisory Opinions, you know that one unwritten rule in criminal appeals is that Bad Man Stays in Jail.  Kurtz’s appeal was never going to win. He seems an utter scoundrel. But at least he raised an issue that made good law for those of us who are Not a Bad Man. 

The Pennsylvania Supreme Court majority held in Kurtz that people who search the internet voluntarily provide that data to a third party, the search engine, and thus have no reasonable expectation of privacy in their Internet searches.  (Justice Mundy authored a concurrence. Only one Justice, Donohue, thought the defendant had a reasonable expectation of privacy in the Google searches.) The absence of a reasonable expectation of privacy means that there was no “search” under the Fourth Amendment. The “third party” doctrine holds that, generally, a person lacks an expectation of privacy under the Fourth Amendment in information or materials when that person exposes them to a third party. (We had a jolly time convicting a serial bank robber who had dropped off a bag at his ex-wife’s house. The bag contained, among other things, a list of banks robbed and to be robbed. The ex-wife – big surprise – did not like her ex-husband very much. She was delighted to hand the incriminating bag and list over to the FBI.)

The third party doctrine clearly came into play in the Kurtz case, as the terms and conditions of the search engine (here, Google) defeat any privacy expectation.  The court held that “what matters is that the user is informed that Google—a third party—will collect and store that information.  When the user proceeds to conduct searches with that knowledge, he or she voluntarily provides information to a third party. This express warning, in tandem with the more indirect indicators noted above, necessarily precludes a person from claiming an expectation of privacy in his or her voluntary internet use.”  

Thus, as alluded to above, Bad Man Stays in Jail.  And maybe, if you manage to do some of your own sleuthing, Phony Plaintiff Gets Skunked. 

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Every so often a summary judgment decision comes along that makes you wonder whether the plaintiff thought the rules of civil procedure were more like suggestions. Neal v. Smith & Nephew Inc., 2026 WL 87302 (W.D. LA Jan. 12, 2026), is one of those cases.

The facts are familiar product liability territory. Plaintiff underwent hip replacement surgery with defendant’s medical device. A component of the device fractured leading to metal on metal wearing that caused plaintiff to suffer adverse reactions and require revision surgery.  Plaintiff filed suit under Louisiana law which allows for four types of products liability claims – inadequate warning, breach of express warranty, construction or composition defect (aka manufacturing defect), and design defect.  Plaintiff’s warning and warranty claims were dismissed at the pleadings stage.  The case progressed through discovery and reached the summary judgment stage. So far, nothing unusual. Where things went sideways—spectacularly so—was proof.

Under Louisiana law (and really, under the laws of physics and logic), plaintiff’s manufacturing defect theory requires proof that at the time the product left the manufacturer’s control, the particular device materially deviated from the manufacturer’s specifications or performance standards or from otherwise identical products. Id.at *2. That proof typically comes from—brace yourself—expert testimony. Someone has to know what the specifications were and how the product failed to meet them.

Instead of an expert, plaintiff relied exclusively on her medical records. Those records may have demonstrated that the device failed and that plaintiff was injured. What they did not show were the manufacturer’s design or manufacturing specifications, much less how this particular device strayed from them. Medical records can tell you a lot of things. They can tell you a device fractured, loosened, or migrated. What they generally cannot tell you is how a manufacturing process went wrong inside a factory years earlier.

Faced with this rather obvious gap in proof, plaintiff argued she could obtain an expert if only she had more time. Which is a bold argument when discovery has closed, dispositive motions are pending, and—minor detail—no extension was ever requested. Id. at *3. The court was not interested in granting a summary judgment rain check. The time to ask for more discovery is before summary judgment, not after.

Plaintiff’s design defect claim fared no better. Again, plaintiff relied solely on medical records. And again, those records may have shown that the device failed. But under Louisiana law, that’s not enough. A Louisiana design defect claim requires proof of a feasible alternative design that would have prevented the injury. Medical records do not identify alternative designs. They do not compare engineering tradeoffs. They do not explain how a different design would have reduced risk without sacrificing utility. That’s expert territory, and plaintiff once again showed up without a passport. No expert. No alternative design. No design defect claim. Id.

Perhaps sensing the trouble ahead, plaintiff advanced a novel and unsupported theory: listing doctors on a witness list creates a genuine dispute of material fact. If only it were that easy. Merely identifying treating physicians does not magically transform them into design engineers or manufacturing experts. Treating doctors can testify about diagnosis, treatment, and causation within their medical expertise. They generally cannot testify about whether a medical device deviated from manufacturing specifications or whether a different design would have been safer, especially when no expert reports say they will. A witness list is not evidence. It is not testimony. And it is not a substitute for expert opinions that were never disclosed.

In the end, summary judgment was granted across the board. And really, it should not have shocked anyone. Manufacturing and design defect claims involving complex medical devices almost always require expert evidence. This case was no exception. Failure alone does not prove defect. Injury alone does not establish liability. And hoping the court will give you extra time you never asked for is not a sound litigation strategy.

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It’s now been about two-and-a-half years since the Supreme Court sided with forum-shopping plaintiffs in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023).  Mallory was, in places 5-4, and elsewhere 4-1-4, and everywhere extremely fact specific – to the point of including a defendant-specific image of its Pennsylvania contacts.  600 U.S. at 142-43.  The result – beyond Justice Alito’s concurrence discussing the Dormant Commerce Clause – gave that plaintiff a right to sue that defendant with extensive Pennsylvania contacts under a state statute the expressly deemed mere registration to do business as consent to “general jurisdiction.”  “To decide this case, we need not speculate whether any other statutory scheme and set of facts would suffice to establish consent to suit.”  Id. at 136.  Mallory relied on a century-old case, Pennsylvania Fire Insurance Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93 (1917), as “controlling.”  604 U.S. at 134.

It’s unclear if Mallory would even support general jurisdiction by consent under other Pennsylvania-related facts.  Cf. Webb-Benjamin, LLC v. International Rug Group, LLC, 192 A.3d 1133, 1135 (Pa. Super. 2018) (defendant registered in Pennsylvania, but never actually did business, subjected to general jurisdiction in suit over Canadian transaction the pre-dated the defendant’s registration).  Nor did Mallory suggest that “consent” could be inferred absence of express statutory authorization – even in Pennsylvania.  See Skolnick v. Evolution AB (Publ), 2025 WL 1208905, at *3 (E.D. Pa. April 24, 2025) (no general jurisdiction by consent where only affiliated corporations are Pennsylvania registered); Abira Medical Laboratories, LLC v. Freedom Life Insurance Co., 2025 WL 66687 (E.D. Pa. Jan. 10, 2025) (no general jurisdiction based on insurance company’s registration; the insurance statute “does not carry with it a consent to general personal jurisdiction in Pennsylvania on any claim brought by a private party on its own behalf”).

We first took a look at Mallory in the states after a year had passed in this post.  Today we’re picking up where that post left off.

First off, we note Illinois’ statutory adoption of a limited general jurisdiction by consent in August 2025, which provides:

A court may exercise general jurisdiction in any action arising within or without this State against any person who:

*          *          *          *

(5) Is a foreign business corporation that has consented to general jurisdiction in this State in accordance with subsection (b) of Section 13.20 or subsection (c-5) of Section 13.70 of the Business Corporation Act of 1983, but only if (i) the action alleges injury or illness resulting from exposure to a substance defined as toxic under the Uniform Hazardous Substances Act of Illinois, whether the cause of action arises within or without this State, and (ii) jurisdiction is proper as to one or more named co-defendants under subsection (a) of this Section.

735 Ill. Comp. Stat. 5/2-209(b)(5).  More than anything else, this statute seems crafted specifically (the “co-defendants” language gives this away) to preserve the ability of certain Illinois “hellhole” counties to host asbestos cases from plaintiffs who reside anywhere in the country.  This statute will have only limited impact in drug/device litigation since FDA-regulated products are expressly excluded from the referenced Hazardous Substances Act.  430 Ill. Comp. Stat. 35/13(4).

In Illinois cases not subject to the new statute (which does not appear to be retroactive), prior Illinois law rejecting registration-based consent to general jurisdiction continues to apply.  Franco v. Chobani, LLC, 789 F. Supp.3d 584, 602 (N.D. Ill. 2025) (“Nothing in Mallory demands a different result or upsets [existing Illinois precedent], which is based squarely on statutory interpretation.”); Cruz v. Robert Bosch Automotive Steering, LLC, 2024 WL 4333116, at *3 (N.D. Ill. Sept. 26, 2024) (“unlike the Pennsylvania law at issue in [Mallory], Illinois law does not require corporations registered as foreign limited liability corporations to agree to general jurisdiction in Illinois”) (citation omitted).

Post-Mallory, Connecticut law is a mess.  Federal courts remain bound by the pre-Mallory circuit decision in Brown v. Lockheed-Martin Corp., 814 F.3d 619 (2d Cir. 2016) (discussed at length here).  See Sociedad Concesionaria Metropolitana Du Salud S.A. v. Webuild S.P.A., 2026 WL 84524, at *6 (D. Conn. Jan. 12, 2026) (“The Connecticut Supreme Court has not interpreted [Connecticut’s statute] similarly, and Brown suggests that it would not do so.  For these reasons, Brown remains good law and is binding on this Court.”) (footnote omitted); Lopez v. Clear Blue Specialty Insurance Co., 2024 WL 4692287, at *3 & n.3 (D. Conn. November 6, 2024) (“no Connecticut statute that explicitly conditions registration of foreign corporations upon acceptance of the general jurisdiction”).  State trial courts are split, with some reaching the same result as Brown and Lopez, given the lack of express statutory language.

Most (but not all) Connecticut state trial courts, however, have reverted to pre-Bauman law, in reliance on a rather cursory discussion in Talenti v. Morgan & Brother Manhattan Storage Co., 968 A.2d 933, 855 & n.14 (Conn. App. 2009) (finding consent; ignoring due process).  See Insurance Co. of State of Pennsylvania v. Textron Aviation, Inc., 2025 WL 2701937, at *7 (Conn. Super. Sept. 16, 2025) (noting criticism of Talenti in Brown but concluding it was binding after Mallory); O’Leary v. Brook Haven Properties, LLC, 2025 WL 2701908, at *6-7 (Conn. Super. Sept. 16, 2025) (following Talenti despite being “troubled by the thin legal analysis”); Carrano v. Boehringer Ingelheim Corp., 2024 WL 3948911, at *10-13 (Conn. Super. Aug. 21, 2024) (same); State v. Exxon Mobil Corp., 2024 WL 3580377, at *16 (Conn. Super. July 23, 2024) (same, noting conflicts).  But see Nixon v. Ocean State Job Lot of Naugatuck, LLC, 2024 WL 4274106, at *10 (Conn. Super. Sept. 17, 2024) (following Brown because nothing in the relevant Connecticut statutes “expressly provides” for registration-based consent).  The issue has yet to be revisited by any Connecticut appellate decision.

In Iowa, the supreme court recently rejected registration-based general jurisdiction that would “include[e] suits for which traditional due-process principles would otherwise preclude a finding of personal jurisdiction”:

The answer is “No.” The relevant portions of [the statute] include no mention of “consent” or “jurisdiction,” much less “personal jurisdiction,” nor any synonyms. Yet these terms, all of which carry familiar legal meanings, are well known to our legislature. . . .  [I]f the legislature had chosen to require consent to personal jurisdiction from every foreign corporation that registers and appoints an agent in Iowa, the legislature could have said so in the same express terms. But it did not.

In short, [the statute’s] unambiguous text shows that the legislature chose not to require consent to personal jurisdiction from foreign corporations that register and appoint an agent for service. Moreover, even if [the statute] were ambiguous because it was susceptible to more than one reasonable interpretation as to the question before us (it is not), we would select the stricter interpretation, and we would still hold that compliance with Iowa’s registration-and-agent-appointment requirements does not constitute consent to personal jurisdiction in Iowa.

Kelchner v. CRST Expedited Inc., ___ N.W.2d ___, 2025 WL 3682990, at *6-7 (Iowa Dec. 19, 2025) (citations omitted).  As further support, Kelcher collected similar precedent from a half-dozen jurisdictions.  Id. at *7 (CO, IL, NE, NM, NY, WI).  This is an improvement over how things stood pre-Mallory, since at that point federal cases had placed Iowa “in the pro-consent minority.”

The Nevada Supreme Court reached the same result in Matter of Richard H. Goldstein Irrevocable Trust, 575 P.3d 72 (Nev. 2025).  Mallory was “not dispositive” of Nevada law.  Id. at 79.

Unlike the Pennsylvania statute addressed in Mallory, [Nevada’s statute] does not condition the privilege to do business in Nevada on consenting to general personal jurisdiction, so Mallory is inapposite.  This distinction, combined with Mallory’s statement that it “need not speculate whether any other statutory scheme and set of facts would suffice to establish consent to suit,” and the fact that Mallory is a nonbinding plurality opinion, undermines the broader interpretation for jurisdictional consent that [plaintiff] proposes.

Id. at 79-80 (citation omitted).  Thus, the trial court “properly concluded that [defendant] did not consent to personal jurisdiction by virtue of registering an agent and complying with” Nevada registration requirements.  Id. at 80.  Accord C.C. v. Rashid, 2024 WL 5200543, at *5 (D. Nev. Dec. 20, 2024) (“Mallory is . . . distinguishable from the present case in an important way: the Pennsylvania statute at issue in Mallory explicitly mentioned that by registering an agent in the state, an entity was consenting to personal jurisdiction, whereas [the Nevada statute] is silent as to personal jurisdiction.”); Finn v. LVGV, LLC, 2024 WL 4349287, at *2 (D. Nev. Sept. 30, 2024) (“The law in Nevada is not so clear as to allow this Court to conclude general jurisdiction is conferred by virtue of appointment of a registered agent.”) (citation omitted).

In Texas, the court of appeals concluded that, unlike the Pennsylvania statute in Mallory, the “unambiguous language” relevant Texas cannot be construed to support registration-based consent.  “[B]y registering to do business in Texas [defendants] did not impliedly consent to the exercise of personal jurisdiction over them by Texas courts in all cases.”  Certain Underwriters at Lloyd’s, London v. Henry Vogt Mach. Co., 712 S.W.3d 909, 924 (Tex. App. 2025).  Other Texas decisions since our last update concur.  State v. Yelp, Inc., ___ S.W.3d ___, 2025 WL 2936466, at *5 (Tex. App. Oct. 16, 2025) (following Underwriters; defendant’s registration application did not support “that [defendant] had consented to general jurisdiction”).

Mallory never sought to instruct how to read a state’s statutes or whether to intuit from them that they meant a registering business consented to general jurisdiction in the absence of a clear statement of that consent. . . .  Mallory has no effect on this court’s interpretation of the Texas non-resident corporation registration scheme and we decline the invitation to reinterpret settled Texas law.

Repairify, Inc. v. Opus IVS, Inc., 2024 WL 2205663, at *1 (Tex. App. May 16, 2024) (unpublished) (citations omitted).  Accord Office of Joseph Onwuteaka, PC v. Constant Contact, Inc., 2025 WL 1938775, at *1 (S.D. Tex. July 15, 2025) (“Having a registered agent in Texas is not a consent to general jurisdiction in the State.”) (citations omitted); Pruitt Tool & Supply Co. v. Noble Energy, Inc., 2024 WL 3745979, at *6 (Mag. S.D. Tex. July 9, 2024) (“Appointment of a registered agent for service of process and registration to do business in Texas are not exceptional circumstances that make a corporation at home in Texas.”) (citation omitted), adopted, 2024 WL 3744390 (S.D. Tex. Aug. 8, 2024); Morris v. Kansas City Railway, 2024 WL 3347379, at *4 (E.D. Tex. July 8, 2024) (“Mallory’s conclusion of implied consent to jurisdiction does not extend to the Texas long-arm statute.  In Mallory, the Supreme Court was explicit that its holding was limited to the specific Pennsylvania law at issue and the facts before it.”).

In California, two unpublished appellate decisions have rejected registration-based consent arguments since our last review of post-Mallory law.  Whispering Oaks Residential Care Facility LLC v. Cincinnati Insurance Co., 2025 WL 865999, at *1 (Cal. App. March 20, 2025) (“Mallory did not change the law in a significant manner relevant to this case because Mallory concerned the due process implications of a statute providing for consent to jurisdiction, while [California’s statute] did not provide for jurisdiction in California courts . . . independent of requisite minimum contacts with the state”), review denied (Cal. May 28, 2025); Chaganti v. Fifth Third Bank, 2024 WL 2859259, at *9 (Cal. App. June 6, 2024) (since “California does not have the same type of law that was at issue in Mallory,” a defendant does “not consent to personal jurisdiction in California by registering with the secretary of state and designating an agent for service of process”), review denied (Cal. Aug. 14, 2024).  See also A-List Marketing Solutions, Inc. v. Headstart Warranty Group LLC, 2025 WL 1674377, at *3 (C.D. Cal. May 7, 2025) “California does not require corporations to consent to general personal jurisdiction in that state when they designate an agent for service of process or register to do business.”) (citation and quotation marks omitted); Taferner v. Inspire Brands, Inc., 2025 WL 942498, at *9 (C.D. Cal. March 25, 2025) (“Plaintiffs have identified no such statute” since “California does not require corporations to consent to general personal jurisdiction in that state when they designate an agent for service of process or register to do business.”) (citation and quotation marks omitted); RMS NA, Inc. v. RMS (Australia) Pty Ltd, 2025 WL 592740, at *4 (S.D. Cal. Feb. 24, 2025) (same); Moran v. Altec Industries, 2025 WL 418225, at *2 (E.D. Cal. Feb. 6, 2025) (“California courts have concluded that the mere registration to do business in California and appointment of an agent for service of process cannot be construed as constituting broad consent to personal jurisdiction within the state.”) (citation and quotation marks omitted); Miller v. Nature’s Path Foods, Inc., 2024 WL 4177940, at *3 (N.D. Cal. Sept. 11, 2024) (“California, by contrast [to Mallory], has no such requirement”).

A recent South Carolina appellate decision rejected insurance registration as a basis for “consent” to general jurisdiction in Ormand-Ward v. Litt, ___ S.E.2d ___, 2025 WL 3466553, at *7 (S.C. App. Dec. 3, 2025)

[W]e conclude our appellate courts have not interpreted [the statute] as providing that an insurer, solely by complying with the statute’s requirement that it appoint the Director as its agent for service of process, has subjected itself to this state’s general jurisdiction.  Because [the statute] does not expressly provide that the insurer by complying with the statute agrees to be subject to the general jurisdiction of South Carolina courts and because our appellate courts have not interpreted the statute to confer jurisdiction, we hold the circuit court did not err by finding it lacked general jurisdiction over [defendant].

Id. at *7; see id. at *4-5 (distinguishing Mallory because the statute “does not expressly indicate that an out-of-state insurer agrees to submit to the general jurisdiction of this state merely by appointing the Director as its attorney for service of process in compliance with the statute.”).

A South Carolina federal decision similarly distinguished Mallory because binding precedent “plainly rejected the argument that foreign corporations who chose to obtain a certificate of authority in South Carolina have consented to general jurisdiction in South Carolina.”  Campbell v. Avis Budget Group, Inc., 2025 WL 1207776, at *3 (D.S.C. April 25, 2025).  “Unlike the Pennsylvania business registration statute at issue in Mallory, South Carolina’s business regulation statute does not contain a provision requiring that an out-of-state corporation consent to jurisdiction in the state’s courts as a condition of registering.  Accordingly, Mallory does not apply here.”  Id. at *4 (citation and quotation marks omitted).

An appellate court in Indiana rejected a Mallory-based jurisdictional argument regarding an insurance company’s registration in Cantor Fitzgerald, L.P. v. Federal Insurance Co., ___ N.E.3d ___, 2025 WL 3097329 (Ind. App. Nov. 6, 2025).  The Indiana statute at issue was nothing like the Pennsylvania statute in Mallory.

[T]he Pennsylvania statute at issue in Mallory was “explicit that ‘qualification as a foreign corporation’ shall permit state courts to ‘exercise general personal jurisdiction’ over a registered foreign corporation[.]”  Thus, the Pennsylvania statute made it clear that, by registering to do business in that state, a business was consenting to personal jurisdiction.  Similar language is notably absent from the [Indiana] Statute, and any opinion interpreting the Pennsylvania statute has no relevance.

Id. at *4 n.4 (citation omitted).

A North Carolina appellate court went the other way.  PDII, LLC v. Sky Aircraft Maintenance, LLC, ___ S.E.2d ___, 2025 WL 3466047 (N.C. App. Dec. 3, 2025), so held “[a]lthough North Carolina law, unlike Pennsylvania law, does not explicitly state that foreign corporation’s consent to personal jurisdiction as part of registering to do business in the state.”  Id. at *5.  Ignoring – not even citing – ample contrary North Carolina authority – PDII held that “same but no greater privileges” language sufficed after Mallory.  2025 WL 3466047, at *7.  “[W]e hold a foreign corporation that obtains a certificate of authority consents to general personal jurisdiction in North Carolina.”  Id.

Federal courts in North Carolina are split.  Espin v. Citibank, N.A., 2023 WL 6447231, at *4 (E.D.N.C. Sept. 29, 2023), provided the rationale that PDII then ran with.  Conversely, AGCS Marine Insurance Co. v. Crane & Equipment Financing Co., LLC, 2024 WL 3838380 (W.D.N.C. Aug. 14, 2024), held, applying prior precedent:

The Court disagrees.  In Mallory, the Supreme Court upheld a Pennsylvania law that explicitly required out-of-state corporations wishing to register with the Department of State (in order to do business in Pennsylvania) to consent to the exercise of general personal jurisdiction over them in Pennsylvania state courts.   No equivalent law exists in North Carolina.

Id. at *2 (collecting cases, including from our prior surveys).  Accord Haynes v. Rocky Mount Cycles, 2025 WL 300598, at *7 (E.D.N.C. Jan. 24, 2025) (“North Carolina’s insurance statute, like its business registration statute, lacks a ‘general personal jurisdiction’ clause”; “Accordingly, the court lacks general personal jurisdiction.”); Zhang v. United Health Group, Inc., 2024 WL 3576456, at *5 (Mag. W.D.N.C. June 28, 2024) (Mallory “is distinguishable from the present case, as North Carolina has no such statute compelling consent from corporations”), adopted, 2024 WL 3571740 (W.D.N.C. July 29, 2024), adhered to on reconsideration, 2024 WL 3643257 (W.D.N.C. Aug. 1, 2024).  Another post-Mallory mess.

Minnesota, as we pointed out, was also one of the “few” pre-Mallory adherents to registration-based consent.  That has continued after Mallory.  In Lynn v. BNSF Railway Co., 2025 WL 1860488 (Minn. App. July 7, 2025), review denied (Minn. Oct. 3, 2025), the court adhered to that prior case law, finding it “immaterial” that the Minnesota statute did not mention “personal jurisdiction.”  Id. at *3.  Accord Shawgo v. Counter Brands, LLC, 2025 WL 965096, at *5 (D. Minn. March 31, 2025) (registration equals consent in Minnesota).

The Fifth Circuit held that nothing in Mallory changed Mississippi precedent that does not allow registration-based consent to general jurisdiction.  Mallory only “analyzes what a state may require; we still must examine the state law to find what it does require.”  Pace v. Cirrus Design Corp., 93 F.4th 879, 899 (5th Cir. 2024) (applying Mississippi law).  “Mississippi law does not follow the consent-by-registration doctrine,” but rather “explicitly negates consent-by-registration.”  Id. (citation omitted).

Nothing in Mallory or Pennsylvania Fire supports that due process requires a state to assume personal jurisdiction over a corporation that has a registered agent. It is constitutional for a state not to do so. Thus, even though [defendant] is registered to do business in Mississippi, consent-by-registration does not apply.

Id.  Accord Antis v. SiriusPoint Specialty Insurance Corp., 2025 WL 465521, at *3 n.4 (S.D. Miss. Feb. 11, 2025) (“Mississippi rejects consent jurisdiction and prohibits a finding of personal jurisdiction merely because of the appointment and maintenance of a registered agent.”) (citation and quotation marks omitted).

Maryland never recognized registration as a basis of consent to general jurisdiction before Mallory.  It still doesn’t.

Mallory is irrelevant because Maryland does not have this requirement.  Maryland does require foreign corporations to register. . . .  But this statute explicitly provides that registration in Maryland “(1) [d]oes not of itself render a foreign corporation subject to suit in this State; and (2) [i]s not considered as consent by it to be sued in this State.”  Registering to do business in Maryland and appointing an agent for service of process are “of no special weight” in establishing personal jurisdiction.

Phillips v. British Airways, 743 F. Supp.3d 702, 710 (D. Md. 2024) (citations omitted).  Accord Lacks v. Ultragenyx Pharmaceutical, Inc., 768 F. Supp. 3d 705, 733 (D. Md. 2025) (“Registering to do business in Maryland does not subject a foreign corporation to the state courts’ general jurisdiction.”).

Kelly v. Vigilant Expeditionary Solutions, Inc., 2025 WL 2494533 (D.N.J. Aug. 30, 2025), distinguished Mallory as inapplicable to New Jersey’s corporate registration statutes, and relied on extensive prior precedent.

As other courts in this District have recognized, the [New Jersey statute] “does not contain express language that registration or the appointment of an agent constitutes submission to the “general jurisdiction” of New Jersey courts.  The Court, therefore, rejects Plaintiff’s arguments that the [statute] grants this Court general jurisdiction over Defendant.

Id. at *4 (citations and quotation marks omitted).  So did Cryopak, Inc. v. Freshly LLC, 2024 WL 4986818 (D.N.J. Dec. 5, 2024):

Plaintiff’s reliance on Mallory is inapposite because the registration statutes at issue are distinguishable, and unlike the express consent statute at issue in Mallory, New Jersey’s registration statute does not include such an express consent requirement. . . .  The fact that a state may write its corporation registration laws in a way that explicitly constitutes consent does not mean that every state corporation registration law necessarily does so.

Id. at *4 (citations and quotation marks omitted).  Accord Gardner v. Combs, 2026 WL 102897, at *4 (D.N.J. Jan. 14, 2026) (“Defendant . . . did not consent to personal jurisdiction simply because it is registered as a foreign business in the State of New Jersey”); Aequor Healthcare Services, LLC v. Meda Healthcare, LLC, 2025 WL 2938282, at *4 (D.N.J. Oct. 16, 2025) (“New Jersey’s statutes do not require consent, and this district has long understood − both before and after . . . Mallory − New Jersey’s statutes [are] categorically distinct from statutes that do require consent.”) (citations omitted) (emphasis original); Gu v. Wang, 2025 WL 660625, at *5 n.11 (D.N.J. Feb. 28, 2025) (mere registration insufficient in New Jersey for general jurisdiction; distinguishing Pennsylvania law); Gonzalez v. BAM Trading Services, Inc., 2024 WL 4589791, at *7 (D.N.J. Oct. 28, 2024) (“corporate registration with the state of New Jersey does not constitute consent to personal jurisdiction”); Abira Medical Laboratories, LLC v. Blue Cross & Blue Shield, 2024 WL 4345411, at *3 n.4 (D.N.J. Sept. 30, 2024) (rejecting argument “that an insurer licensed to do business in New Jersey is automatically subject to general jurisdiction here”) (collecting cases).

Attempts to expand Mallory to Tennessee have failed.  Dozier v. Alliance Global Solutions, LLC, 2024 WL 4445714 (M.D. Tenn. Oct. 8, 2024), conducted an extensive review of the relevant language of Tennessee statutes, and found neither “express” statutory consent language in the statute nor any prior expansive state-court construction.  Id. at *11.

[E]ven if it were clear that [the statute] applies to registered foreign corporations, the statute would still fall short of expressly conferring general jurisdiction in Tennessee over those corporations.  And that is the last nail in the coffin of the plaintiff’s jurisdictional argument.  As our sister district stated in Pritchard [see our prior post], “the issue of whether a corporation consents to jurisdiction by complying with this statute remains open to debate.”  But the applicable standard requires expressness or construction by state courts.  The court finds that Tennessee’s registration statute contains no express language affirming consent to general jurisdiction, and the Tennessee Supreme Court has not yet addressed the issue.  Therefore, the court finds that the current state of the law does not support the plaintiff’s jurisdictional argument.

Id. at *12 (citation omitted).  The day before, in Williams v. Cincinnati Lubes, Inc., 2024 WL 4437118 (M.D. Tenn. Oct. 7, 2024), the result was the same.  The court pointed out that Mallory was expressly based on the “explicit” – and at that time unique – language of the Pennsylvania statute, and that beyond that Mallory did not “not speculate whether any other statutory scheme and set of facts would suffice to establish consent.”  Id. at *3 (quoting Mallory, 600 U.S. at 134-35).  The court likewise relied on the prior Pritchard holding.  Id. at *4.

Nor has Mallory supported general jurisdiction by consent in Missouri, which has long since repealed the expansive statute applied in Pennsylvania Fire.  In Elliot v. HBO Home Entertainment Corp., 2024 WL 5119283 (E.D. Mo. Sept. 30, 2024), a Mallory “argument fail[ed] under Missouri law.”  Id. at *6.

It is true that, when a State’s laws provide that foreign corporations registering to do business in the state thereby consent to general personal jurisdiction, such consent to personal jurisdiction can be consistent with due process.  But under Missouri law, registration as a foreign corporation does not create an independent basis for exercising personal jurisdiction over a defendant.  Thus, even assuming in Plaintiff’s favor that [the moving defendant] − an entity registered to do business in Missouri − was the entity responsible for the conduct at issue . . ., there still is no basis for this Court to assert general jurisdiction over any Defendant.

Id. (citations, mostly to Mallory, omitted).  Accord Peeler v. SRG Global Coatings, LLC, 2024 WL 4008735, at *2 (E.D. Mo. Aug. 30, 2024) (“Missouri has no such law.  The plain language of Missouri’s registration statutes does not mention consent to personal jurisdiction for unrelated claims, nor does it purport to provide an independent basis for jurisdiction over foreign corporations that register in Missouri.”).

New York, as well continues to reject registration-based consent, as exemplified by Hanover v. One Communications (Guyana) Inc., 2025 WL 948116 (E.D.N.Y. March 28, 2025):

Plaintiffs’ contention is meritless.  As a preliminary matter, Mallory did not address general jurisdiction.  Instead, it addressed personal jurisdiction by express or implied consent.  Regardless, Mallory is wholly inapposite, as the Court’s decision was limited to “the state law and facts before [it].”  Namely, Pennsylvania law . . . “is explicit” that such registration “shall permit state courts to exercise general personal jurisdiction over a registered foreign corporation. . . .

By contrast, New York law is unequivocally clear. . . .   [T]he New York Court of Appeals has determined, under New York law, a foreign corporation does not consent to general jurisdiction in New York merely by complying with [New York’s registration provisions.  Although New York could condition the transaction of business within its borders upon consent to general jurisdiction, it has elected not to do so.  Accordingly, [defendant] has not consented to jurisdiction in New York.

Id. at *4 (citations, quotation marks, and footnote omitted) (emphasis original).  Accord Shorts v. Cedars Business Services, LLC, 767 F. Supp.3d 96, 105 (S.D.N.Y. 2025) (“the act of registering to do business . . . does not constitute consent to general personal jurisdiction in New York”) (citation and quotation marks omitted); Sokka International Enterprise Ltd. v. Oregon Tools, Inc., 2025 WL 964072, at *2 (E.D.N.Y. March 31, 2025) (“a foreign corporation does not consent to general jurisdiction in New York simply by virtue of registering to transact business in the state”) (citation omitted); Kamal v. Pressler, Felt & Warshaw, LLP, 2025 WL 919505, at *6 (S.D.N.Y. March 25, 2025) (“a foreign defendant does not consent to general personal jurisdiction in New York by registering to do business in the state”) (citations omitted); Reading v. Southwest Airlines Co., 2024 WL 4350740, at *2 (E.D.N.Y. Sept. 30, 2024) (“a foreign corporation does not consent to general personal jurisdiction in New York by merely registering to do business in the state and designating an in-state agent for service of process”) (citation and quotation marks omitted).

New Mexico courts also reject registration-based general jurisdiction.  In Bustos v. Ryder Truck Rental, Inc., 2024 WL 2260786 (D.N.M. May 17, 2024), held, following prior law:

Unlike each state statute discussed in Pennsylvania Fire and Mallory, New Mexico’s [statute] crucially does not say that registering to do business in New Mexico constitutes consent to general personal jurisdiction over the business entity.  In fact, the New Mexico Supreme Court recently and explicitly affirmed this reading of the statute. . . .  

Plaintiffs . . . argue that the New Mexico Supreme Court “got it wrong” in light of Mallory, which Plaintiffs argue specifically authorizes general personal jurisdiction over Defendant . . . because it is registered to do business in New Mexico. . . .  New Mexico does not follow the consent-by-registration doctrine.  Due process does not require New Mexico to assume a such a scheme.  Under New Mexico law and Supreme Court precedent, there is no general personal jurisdiction over Defendant . . . in the state of New Mexico.

Bustos v. Ryder Truck Rental, Inc., 2024 WL 2260786, at *8 (D.N.M. May 17, 2024) (citations omitted).  Accord M.D. v. CooperSurgical, Inc., 2025 WL 2711157, at *4 (D.N.M. Sept. 23, 2025) (being “authorized to conduct business within the State of New Mexico . . . alone, is insufficient to establish general jurisdiction over Defendant”) (citation and quotation marks omitted).

Virginia had never adopted registration-based consent prior to Mallory, and Mallory hasn’t changed that.  Shamburg v. Ayvaz Pizza, LLC, 2025 WL 2431652 (W.D. Va. Aug. 22, 2025), held:

Like Pennsylvania, Virginia has an out-of-state business registration statute. But unlike Pennsylvania, Virginia law does not require the out-of-state business to condition its registration on submitting to general personal jurisdiction.  Courts have limited the rule from Mallory to situations where a state’s business registration statute provides that a foreign corporation must consent to personal jurisdiction within the state as a condition of doing business.  Those cases explain that the Supreme Court’s holding concerns statutes that contain provisions requiring an out-of-state corporation to consent to jurisdiction in the state’s courts as a condition of registering.

Id. at *5 (citations and quotation marks omitted).  Further, “[t]he interpretation of Mallory Plaintiffs seek would vastly expand the scope of general personal jurisdiction.”  Id. at *6.

[U]nder that reading, any out-of-state corporation registered to do business in a state would be subjected to general personal jurisdiction regardless of where it was incorporated or had its principal place of business, and regardless of its contacts with the state. . . .  Plaintiffs point to no language in the Virginia statute that comes close to conditioning registration on submitting to the jurisdiction of Virginia’s courts.  And Plaintiffs point to no other source of state law interpreting the registration statute in that way.  The court concludes that, absent explicit consent to jurisdiction in Virginia’s business registration statute, there is no basis on which to conclude that . . . Defendants have impliedly consented to general personal jurisdiction in Virginia.

Id. (citation omitted).

A similar result under New Hampshire law occurred in Scher v. Suffolk University, 2025 WL 2693614 (D.N.H. Sept. 15, 2025).  Unlike Mallory, New Hampshire’s statutes “do not explicitly allow the state’s courts to exercise general jurisdiction over registered foreign corporations.”  Id. at 3 (citations omitted).  Unlike that ancient Pennsylvania Fire decision “no court has yet interpreted New Hampshire’s laws as consent to general personal jurisdiction” – indeed, “just the opposite” was true under prior law.  Thus, Sher concluded that the defendant “did not consent to general personal jurisdiction in New Hampshire when it registered as a foreign corporation and appointed an agent to receive process in the state.”  Id. Cf. Fitzgerald v. Circle Internet Financial, LLC, 2025 WL 2496068, at *4 (D.N.H. May 16, 2025) (allowing jurisdiction where defendant did not argue that its agent lacked authority to accept service).

Florida law continues to reject registration-based consent arguments.  Worldwide Aircraft Services, Inc. v. Anthem Insurance Cos., 2025 WL 3771274, at *1 n.1 (M.D. Fla. Dec. 31, 2025) (“although [defendant] has a registered agent in Florida, that does not give rise to general personal jurisdiction”); Fregoso v. Carnival Corp., 2025 WL 3009439, at *2 n.2 (S.D. Fla. Oct. 23, 2025) (“the Florida business registration statute does not require consent to general jurisdiction in Florida”; defendant is “not subject to general jurisdiction in Florida merely because it’s registered to do business here”) (citation and quotation marks omitted); Lugo v. SmartRent Technologies, Inc., 2025 WL 2443192, at *3 (M.D. Fla. April 29, 2025) (“Florida law does not contain such a [consent] requirement; distinguishing Mallory) (citation omitted).

Massachusetts remains hostile to registration based consent.

Registering as a foreign corporation in Massachusetts and designating a registered agent here does not, standing alone, confer general jurisdiction; that conduct merely adds some modest weight to the jurisdictional analysis.  Plaintiffs do not argue, and the court is aware of no binding or persuasive authority holding, that by registering and designating an agent pursuant to [Massachusetts law], a foreign corporation consents to the exercise of general jurisdiction in Massachusetts.

Licht v. Binance Holdings Ltd., 2025 WL 625303, at *29 n.37 (Mag. D. Mass. Feb. 5, 2025) (citations and quotation marks omitted), adopted, 2025 WL 624025 (D. Mass. Feb. 26, 2025).

Established Arizona law continues to reject registration-based consent after Mallory.  Benedict v. Indeed Corp., 2024 WL 3045231, at *2 (D. Ariz. June 18, 2024) (“Plaintiff alleges that Defendant maintains an office in . . ., Arizona, and that it is registered to do business. . . .  These facts, by themselves, do not establish jurisdiction.”) (citations omitted).

Utah also continues to preclude registration-based consent.

It is . . . unreasonable for the court to apply laws intended for local businesses, . . . to national corporations organized and chartered elsewhere by virtue of the company’s registration of an agent to receive personal service, mail, and other formal communications.  Under this same reasoning, this court has recognized that having a registered agent in state is insufficient to consent to general personal jurisdiction.

Atwood v. Dotdash Meredith Inc., 2025 WL 815118, at *7 (D. Utah March 13, 2025) (citation omitted).

Likewise, District of Columbia statutes do not support registration-based consent.  Huynh v. Air Canada, 2025 WL 522053, at *2 n.3 (D.D.C. Feb. 18, 2025) (“[plaintiff] does not so much as allege that the District of Columbia has a consent-to-jurisdiction statute in force.  And indeed, it does not:  the D.C. Code’s general jurisdiction provision reflects only the ordinary general jurisdiction principles”).

Registration-based consent to personal jurisdiction in Wisconsin remains “squarely foreclosed by binding precedent” after Mallory.  Hillstrom v. Best Egg, Inc., 2025 WL 2977985, at *1 (W.D. Wis. Oct. 22, 2025) (citation omitted).

On the other side of the ledger, Kansas law was “seriously murky” before Mallory.  Since Mallory, registration-based consent theories have prevailed.  American Food & Vending Corp. v. Goodyear Tire & Rubber Co., 2025 WL 2770651, at *4 (D. Kan. Sept. 29, 2025) (Kansas registration “operates as consent to general personal jurisdiction”); Factory Mutual Insurance Co. v. Flender Corp., 2025 WL 1810064, at *5 (D. Kan. June 30, 2025) (“[defendant] registered to do business in Kansas, precluding its personal jurisdiction argument”).

Georgia, as we discussed, was even worse, with a definitive high court determination that its registration statutes subjected foreign corporations to general jurisdiction by consent.  But language matters, and that conclusion has not been extended to other forms of Georgia registration that do not contain “similar language.”

Here, by contrast, the broker-dealer registration statute does not contain that language or any similar language.  Moreover, the Court is unaware of any Georgia court interpreting the broker-dealer registration statute as constituting a consent to jurisdiction.  Absent on-point case law or clear statutory language, Plaintiff cannot feasibly claim that Defendant had notice that it was consenting to jurisdiction when it appointed an agent for service of process in Georgia. . . .  As such, the Court cannot find that Defendant consented to jurisdiction when it registered as a broker-dealer in the state.

Shaver Law Group LLC v. Concorde Investment, LLC, 796 F. Supp.3d 1349, 1356 (N.D. Ga. 2025) (citations omitted).

It’s now been over 2½ years since Mallory was decided.  The overall lay of the land, as we discussed here, remains remarkably unchanged.  One state, Iowa, has since definitively rejected general jurisdiction by consent via corporate registration.  Two states, North Carolina (intermediate court of appeals) and Connecticut (various trial court decisions), now have precedent in state court that recognize consent-based registration – but federal courts in both states are both governed by binding pre-Mallory appellate precedent rejecting those theories.  All other states that rejected registration-based consent theories of general personal jurisdiction before Mallory (save Pennsylvania itself, and the limited new statute in Illinois) continue to do so, to the extent post-Mallory precedent exists.  Conversely, the remaining few states that recognized such jurisdiction before Mallory (Georgia, Minnesota, and Kansas) also continue to do so.

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We write a lot about the learned intermediary rule. It’s a fundamental aspect of the defense of drug and device cases, it’s grounded in the realities of the physician-patient relationship, and it tends to produce a lot of cases worth blogging about. We also refer to it as a rule (e.g., here, here, here, and here), rather than a doctrine, because that’s what it is.  We particularly like it when courts dismiss warnings claims based on the learned intermediary rule at the pleadings stage.   Today’s case is one of those. Plaintiff filed a shoddy complaint, was able to amend in response to an initial motion to dismiss, and then saw his warnings claims dismissed with prejudice under Alabama’s learned intermediary rule.

In McCrackin v. Rex Medical L.P., 2026 WL 66797 (N.D. Ala. Jan. 8, 2026), the plaintiff alleged he received an Option retrievable IVC filter in 2012. Twelve years later, he allegedly suffered complications when a “leg” from the filter fractured and penetrated a vein, with the further allegation that his spine grew around the fractured leg. He sued based on allegations that the device was marketed as permanent when it should have been temporary, and that there were not adequate warnings about the risk of “tilt, fracture, migration and/or perforation.” Id. at *1. Plaintiff previously obtained leave to file an amended complaint in response to an initial motion to dismiss, so this was his second bite at the apple. The defendant who marketed and distributed the device moved to dismiss.

Continue Reading Learned Intermediary Success at the 12(b) Stage in Alabama (plus a Double Whammy)
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Yesterday we did our annual best of/worst of CLE, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device and Vaccine Decisions of 2025”.  It was good fun for us presenters and hopefully at least mildly educational and entertaining for the audience.  (If you missed it, the video replay will be available later today at this link, and you can get CLE credit to boot). 

One thing that was striking about this year’s countdown was how many opinions involved expert exclusion and Federal Rule of Evidence 702—7 out of 20 cases.  Expert exclusion issues are a key part of our practice, of course, but these cases made their respective lists because they either recognized that the 2023 amendments to Rule 702 intended to halt overly permissive, let-it-all-in-and-let-the-jury-sort-it-out approaches to expert testimony, or they flagrantly got it wrong.

Today’s post is about another Rule 702 opinion, and in particular its Georgia state court analogue, OCGA § 24-7-702 (b).  Sterigenics U. S., LLC v. Mutz, 923 S.E.2d 176 (Ga. Ct. App. 2025) is a little bit older (October 31, 2025) and involves expert testimony on general causation in a so-called “toxic tort” case involving ethylene oxide (EtO) emissions from a sterilization facility.  But it has application to our pharmaceutical and medical device area, so it is worth a closer look.

The appeals in Sterigenics arose from eight bellwether cases in which plaintiffs alleged that exposure to EtO caused various cancers and birth defects.  The trial court had granted in part and denied in part motions to exclude expert testimony and for summary judgment, prompting cross-appeals from both sides.

As you would expect, in addition to establishing exposure to the alleged agent that cause harm, plaintiffs in Georgia must offer proof of general causation — that exposure to a substance is capable of causing a particular injury or disease — and proof of specific causation — that exposure to a substance under the circumstances of the case contributed to his illness or disease.

The core question before the Court was whether Georgia courts should adopt the Eleventh Circuit’s framework for evaluating the reliability of expert testimony on general causation under Georgia Rule 702(b), which is materially identical to Federal Rule of Evidence 702.  

The Court held, as a matter of first impression, that Georgia courts should indeed apply the Eleventh Circuit’s approach to Rule 702 and its approach to general causation in toxic tort cases derived from McClain v. Metabolife Intl., Inc., 401 F.3d 1233 (11th Cir. 2005).

On Rule 702, Sterigenics said all the right things:  Trial courts must act as gatekeepers and assess the reliability of proposed expert testimony; they must consider whether the expert’s methodology is sufficiently reliable; and the proponent of the expert testimony bears the burden of establishing that reliability or the testimony will not be admitted.

With the Rule 702 parameters established, Georgia agreed with McClain’s approach of dividingtoxic tort cases into two categories:

  • Category One: Cases in which the medical community routinely and widely recognizes that the chemical at issue is both toxic and causes the type of harm alleged (e.g., asbestos causing mesothelioma).  In such cases, courts need not undertake an extensive analysis of expert testimony regarding general causation (whether that agent is capable of causing the harm alleged to humans, at the exposure level established) and the focus shifts to specific causation (did the agent cause the harm in this instance.
  • Category Two: Cases where the medical community does not generally recognize the agent as both toxic and causing the alleged injury.  Here, plaintiffs must establish general causation through reliable expert testimony, with courts paying careful attention to the expert’s dose-response analysis and whether a harmful level of exposure has been identified.

The trial court had adopted a “third way,” treating EtO as falling between the two categories and admitting expert testimony that “any exposure” to EtO could cause harm without requiring a specific dose-response relationship.  The Georgia Court of Appeals rejected this, clarified that, while precise quantitative dose-response evidence is not required, experts must lay a reliable groundwork for determining the dose-response relationship or otherwise establish causation through accepted scientific methodologies.

On remand, the trial court must first determine whether EtO is routinely and widely recognized by the medical community as both toxic and causative of the alleged harms. If so, the focus shifts to specific causation (and the reliability of expert testimony regarding same).  If not, the court must rigorously assess the reliability of the plaintiffs’ general causation experts, including their dose-response analysis and consideration of alternative methodologies.

We applaud Georgia to the extent is has better aligned state practice with federal standards and reinforced the importance of rigorous judicial scrutiny of expert causation testimony.

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This is a defense blog.  Are we biased? Yes, we are. We come by that bias honestly, via temperament, principle, and client loyalty. We are happy to report on defense wins. If we report at all on plaintiff wins, it will be grudgingly and typically accompanied by heaping helpings of regrets and criticisms. 

Have we occasionally said unkind things about plaintiff lawyers? Sure. As private eye Philip Marlowe said in The Big Sleep, “I don’t mind if you don’t like my manners.  They’re pretty bad.  I grieve over them during the long Winter evenings.” Look, we hate asymmetrical discovery, we hate phony moral posturing, and we hate blatant forum shopping. But we do not hate plaintiff lawyers.  In fact, we count many plaintiff lawyers as respected colleagues and even good friends.  Of course, we fight hard against each other. We do not mind the occasional knife fight versus our foes on the other side of the v, just as long as a knife does not land in our back. Professionalism and civility should prevail. The plaintiff lawyers we battle are usually the best of the best. They are smart, creative, and relentless. When we prosecuted cases for the U.S. Attorney’s office in C.D. Cal., we had to admit that the criminal defense attorneys were better at cross-examination than we were. One reason for that was that in some cases cross-examination was all the defense had. Still, skill is skill, and must get its due. On the civil side, plaintiff lawyers are superb at conjuring up moral dramas or even romance sagas (the defendant seduced my client, lied to my client, hurt my client, and now is abandoning my client). A couple of the leading lights of the plaintiff MDL bar are infuriatingly good at making their endless discovery demands sound almost reasonable.

In any event, maintaining cordial relations with the other side can redound to our clients’ benefit in terms of courtesies and compromises. Occasionally, plaintiff lawyers have given us a heads’ up on upcoming litigation. We’ve attended a couple of plaintiff bar events, and they are just as substantive and far more fun than defense bar events. We know at least one drug company GC who wonders whether he should have gone the plaintiff route, if only to mix in more excitement into his life.

Last week, a plaintiff lawyer sent us a law review article he had written.  The plaintiff lawyer was Michael Gallagher. He is with Morgan & Morgan (“For the People”). His article is entitled “Snap Removal and the Absurdity Doctrine.” It appears in 55 U. Mem. L. Rev. 915 (Summer 2025). The article is well-written. It is short and clear. It certainly has a point of view.  As we have mentioned before more than once, law review articles are usually helpful to the extent they set forth the governing law, and much less helpful when they start telling you how things ought to be. That is true with Gallagher’s article, too, though it is helpful to get a preview of the plaintiff-side argument.

Let’s go back to first principles for a moment.  28 U.S.C. section 1441(b) establishes removal based on federal diversity jurisdiction, and subsection (2) provides that a civil action otherwise removable based on diversity “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” That is the forum defendant rule. The underlying theory is that the defense does not need to be in federal court to protect against local bias if one of the defendants is local. That theory makes us think of the last line in Hemingway’s The Sun Also Rises: “Isn’t it pretty to think so?”  The theory simply does not work in reality.  A Philly jury will still clobber an out of state defendant company even if a codefendant retailer is local. Heck, a Philly jury will clobber a company defendant that is located down the street from the courthouse.  Local-schmocal. 

From the perspective of corporate tort defendants, the real problem with state courts is that they too often lack either the appetite or resources to get rid of junk claims and junk science. Whether that is because of different procedures (e.g., FRE 702 vs Frye or whatever it is that California, Illinois, or Pennsylvania are doing), or elected judges or something else, being in federal as opposed to state court considerably changes the value of a case. Both sides know this. It is no wonder that a corporate tort defendant will seize upon any colorable basis to remove a case to federal court. It is no wonder that a plaintiff lawyer will seek to remand the case to state court.

Where does snap removal enter the picture?  Surely you noticed that section 1441(b)(2) precludes removal “if any of the parties in interest properly joined and served as defendants” is local. Snap removal happens when a defendant removes a case to federal court before the local defendant has been served. It is a race. When the plaintiff loses the race, the plaintiff cries foul and argues that snap removal is a dirty trick, or at least pure sophistry.

Or, as in Gallagher’s article, the plaintiff argues that the result is “absurd.” The article does a good job of collecting cases (all district courts) treating the “properly joined and served” language as a source of “mischief by defendants.” The article also discusses the absurdity doctrine as a “longstanding canon of statutory interpretation,” and cleverly lists Justices Brennan, Rehnquist, Stevens, O’Connor, Scalia, Kennedy, Sotomayor, Gorsuch, and Kavanaugh among those jurists who have recognized and applied the absurdity doctrine. That is a distinguished and varied group. But none of those jurists said that snap removal is absurd. More to the point, and as Gallagher’s article acknowledges, “Three circuits blessed this practice, while two circuits worried about it.”  No circuit court has read the practice out of the law. By our count, three circuits (Second, Third, and Fifth) have explicitly blessed snap removals, and another (Sixth) seems to have smiled upon it, albeit in a footnote.   

Why has the defense had the better of the argument on snap removal?  As Justice Kagan famously said, “we are all textualists now.”  The plain language of section 1441(b)(2) supports snap removal. To forbid snap removals would require an amendment of the law, which the Court cannot do, and which Congress has not seen fit to do.  Nor is there anything inherently “absurd” about snap removal.  As Gallagher’s article says, section 1441 was amended in 1948 to add the “properly joined and served” language to combat gamesmanship by plaintiffs. Plaintiffs were steering clear of federal court by naming local plaintiffs without serving them – because, all along, the plaintiffs had no real interest in going after the hapless local.

While we do not agree with Gallagher’s conclusion, we are grateful for his article. It is an honest and intelligent article. It cites the appropriate cases. It rehearses the expected counterarguments (snap removal is not absurd at all, or is not all that absurd, or it is up to Congress to fix the statute).  Gallagher certainly knows this topic well. Indeed, he has written a couple of other articles against snap removal. If you want to get ready to do battle on snap removal, reading Gallagher’s articles should be part of your preparation.

Not surprisingly, the scriveners on this highly-biased defense blog have also written some other articles on snap removal.  For example, Bexis back in 2019 discussed testimony before the Advisory Committee on the Civil Rules on whether anything needed to be done about snap removal. More recently, last month, the same ink-stained wretch penning this blogpost summarized a N.D. Fla. case that upheld snap removal.  In that case, the court held that the use of the snap removal did not bump against the “absurdity bar.” We do not think there is a level of absurdity or gamesmanship that would permit a court to ignore or rewrite 1441(b)(2), but it is clear that mere frustration of a plaintiff litigation tourist visit to state court is not it.     

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