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To all in-house counsel working in the pharmaceutical, medical device, biotech, and digital health industries: if you can use a few CLE hours, we invite you to attend Reed Smith’s annual Virtual Health Care Week, taking place from March 16 through March 19, 2026.

This four-day all-remote event will explore recent developments, challenges, and opportunities facing U.S. and multinational health care providers, life sciences companies, and industry investors.

The presentations will also be available for viewing on demand for registered attendees. However, CLE credit for on-demand viewing will only be available for those licensed in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia.

Here are descriptions of the topics and the registration link.

Regulatory Investigations in the Pharmaceutical Industry | Presented by Natasha Tardif, Jieni Ji, and Jeff Layne | This session will discuss how companies can limit their risk of becoming subject to regulatory investigations and how they can best prepare for when such investigations do take place.

Fraud and Abuse Enforcement in Health Care: Evolving Government Priorities and High Risk Areas in 2026 | Presented by Brian Bewley, Michelle Mantine, Katie Dunn, and David Bender | This session will provide an in-depth look at the DOJ, HHS-OIG, CMS, and SEC enforcement priorities for 2026—including the government’s deployment of AI-driven detection tools and novel applications of FCA liability—while providing practical guidance on compliance vulnerabilities across provider, manufacturer, and life sciences organizations.

Government Scrutiny of Gender Affirming Care: Risks and Considerations for Health Care Providers and Life Sciences Companies | Presented by Lesley Reynolds, Sarah Cummings Stewart, and Kristin Parker | This session will assess recent legal, regulatory, enforcement, and litigation developments relating to gender-affirming care in both the pediatric and adult contexts, including the steps taken in recent months to curtail transgender care for minors, even in states where it remains legal. 

Legal Considerations for Users and Suppliers of Health-Specific AI Model Ecosystems | Presented by Wendell Bartnick, Vicki Tankle, and Sung Park | This session will address how tech suppliers are offering scalable and flexible AI ecosystems targeted to health care and digital health companies, as well as sources and ways to mitigate regulatory and commercial risk from FDA, privacy, intellectual property, and other perspectives.

A Rise in Challenges at the NAD: A practical guide to how to keep your competitors honest in a predictable, cost-effective forum | Presented by John Feldman, Sarah Thompson Schick, and Julia Solomon Ensor | This session will explore how the National Advertising Division (NAD) process applies to pharmaceutical and medical device companies, examine recent cases and the types of claims at issue, and highlight strategies companies have used to effectively compete on a level playing field.

PBM Litigation Trends: Where Are We and Where Are We Going | Presented by Selina Coleman, Nick Rodriguez, and Megan Ali | This session will update pending litigation brought by the FTC, states, pharmacies, and putative classes against pharmacies, providers, payors, pharmaceutical manufacturers, and other interested parties that challenges PBM practices. 

Health Care Policy at an Inflection Point | Presented by Scot Hasselman and Matt Loughran | This conversational session will look ahead to cover federal priorities, constraints, and scenarios for 2026.

CLE Information for U.S.-licensed attorneys:

The session “Fraud and Abuse Enforcement in Health Care: Evolving Government Priorities and High Risk Areas in 2026” is presumptively approved for 1.5 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit are being filed in Colorado, Delaware, Florida, Georgia, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed.

All other sessions are presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit will be filed in Colorado, Delaware, Florida, Georgia, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed.

Please allow 4-6 weeks after the program to receive a certificate of attendance.

CLE Questions? Contact Learning & Development CLE Attendance

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We’ve blogged about aspects of the Model Drug Dealer Liability Act before. Over 20 states have enacted versions of the model act in an effort to shift liability for harm caused by illegal drugs to the drug dealers and traffickers who sell and promote illegal drug use.  Those are not normally the types of claims of interest to our readers. But, given that we’ve been blogging this week about fraudulent and harmful medical procedures and junk science in mass torts, maybe it’s no surprise that today’s decision deals with an attempt to use a version of the model act as a  vehicle for finding liability against a major distributor of legitimate, FDA-approved drugs. McKesson Corp. v. Bolton, 2026 WL 394505 (Ga. App. Feb. 12, 2026).

Continue Reading A Drug Dealer? Seriously?
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It must be bad plaintiff lawyer week here at the Drug and Device Law Blog.  Yesterday, we brought you a review of The Pain Brokers (One Signal Publishers 2026) and the sordid tale of ginned-up damages in the vaginal mesh litigation. 

Today we bring you The American Tort Reform Association’s 2026 report, The Junk Science Playbook: Exposing Mass Tort Litigation Tactics and its explanation about how mass tort plaintiffs’ lawyers do not simply “find” science; in many instances, they help manufacture it out of whole cloth. 

ATRA’s Report maps out a coordinated ecosystem that produces, launders, and weaponizes questionable scientific claims to drive mass torts and regulatory pressure.  That ecosystem includes those who create junk science (“merchants”) and those who launder and amplify it (“purveyors”).  The Report also points toward solutions—most notably, rigorous Rule 702 gatekeeping—to keep junk science out of court.

Those who don’t have to wade through our neck of the litigation swamp everyday just do not appreciate how bad things are, but this Report has some of the receipts.

The Merchants.

The report identifies “quasi‑academic” organizations whose classifications and studies repeatedly become centerpieces of mass tort advertising and expert reports, yet are regularly at odds with mainstream regulators.  Like the IARC, which only found one agent “probably not” carcinogenic out of nearly 1,000 examined, and which relies on working‑group members who not infrequently have conflicts of interest (like advisory ties with advocacy groups opposed to targeted chemicals). 

Then there are litigation‑aligned testing laboratories like Valisure, which Blog readers know is key to generating what the Report (understandably) labels “faux causation” data in litigations ranging from sunscreen to acetaminophen.  Or Emery Pharma, which markets its ability to design studies for product‑liability cases and then also supply the testifying plaintiff-side experts. 

And of course we have the agenda‑driven nonprofits dedicated to producing and promoting litigation‑friendly science, often funded by money from the plaintiffs’ bar that their work supports. 

The Purveyors.

Once the litigation‑driven “science” exists, there is a laundering pipeline to burnish it and clothe it with apparent legitimacy.  

To begin with, there is the scientific publishing industry, which is suffering an integrity crisis.  Recent years have shown a massive spike in retractions (over 10,000 papers in 2023 alone) and what the Report calls (again, with justification) the “predatory” open‑access journals that have impressive titles, but are pay-to-publish and without meaningful peer review. 

Next, nothing catches eyeballs or clicks like a good scary story, so after “scientific” journal publication, advocacy groups and their PR teams go into overdrive to convert niche papers and negligible results into mainstream health scares, with sometimes disappointingly credulous coverage by major news outlets.

As the media let loose, so does the lawyer advertising and the mass tort litigation.  So the “final step” in the playbook is the conversion of questionable research into courtroom testimony by frequent-flier plaintiffs’ experts.  These experts often may disregard contrary, mainstream science; manipulate or cherry-pick their data, and obscure their financial ties or litigation roles.  Seriously, some of these plaintiffs’ experts receive millions in fees.

Public Health.

We complain about the “litigation industry” regularly on this Blog, and litigation abuses are a problem in their own right.  But what really gets us is when those abuses spill over into hurting people, like the vaginal mesh plaintiffs misled into explant surgeries they didn’t need and their own doctors did not recommend.

The ATRA report identifies another space where litigation incentives are reshaping “science” in a way that will hurt people:  Vaccines.

The plaintiffs’ bar generally does not like the National Vaccine Injury Compensation Program (VICP), a no‑fault program funded by an excise tax on vaccines) that has paid more than $5.5 billion in compensation since 1986.  The VICP requires most vaccine‑injury claims to be brought administratively rather than via tort suits.

Plaintiffs’ lawyers do not rake in as much dough under the VICP as they do through the usual mass torts, so the Report identifies efforts to destabilize the program.  One such effort is by aggressively pushing to add autism as a compensable condition without scientific support, or stripping vaccines from the program in a way that could either bankrupt the fund or route claims back to the tort system, where plaintiffs’ lawyers stand to collect substantial contingency fees.  Another is by pressing for state‑law private rights of action for vaccine side effects (e.g., Texas’ 2025 law, with copycat bills in other states), which the advocates hope will punch holes in the federal preemption that applies to vaccines.  

Anything that uses bad science to mislead the public about vaccines will, inevitably, lead to more illnesses and more deaths from preventable diseases.

Solutions.

The ATRA Report closes with a suite of recommended reforms, most prominently that vigorous judicial gatekeeping based on Federal Rule of Evidence 702 (and state law equivalents) should be used to keep junk science out of the courtroom.  The 2023 Rule 702 amendments and post-amendment case law emphasize that:

  • The proponent bears the burden of proving admissibility by a preponderance of the evidence; there is no presumption of admission.
  • Courts must scrutinize not only an expert’s methodology and data, but also whether each opinion stays within the bounds of what that methodology can reliably support.
  • Reliability in both theory and application is the “hallmark” of admissible expert testimony.
  • Courts must probe more deeply than before; many prior decisions misapplied Rule 702 by re‑labeling reliability as going to “weight” rather than admissibility.
  • Red flags include causation theories that have not been independently validated in peer‑reviewed literature outside of litigation.

The Report also urges more courts not to take either side’s word for it and instead obtain their own, mainstream, credible, insight into the science by using Rule 706 to appoint neutral experts or technical advisors, or convening “science days” in complex MDLs, and requiring disclosure of litigation funding and lawyer involvement for studies cited in expert reports or regulatory proceedings.

Finally, the Report urges defendants to actively counter junk science rather than merely defend individual cases through aggressive discovery into communications and funding records to expose lawyer‑driven study designs or incomplete disclosures or—again, from yesterday’s post—outright illegal and nefarious schemes.

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In truth, this post is not so much a review as a full-throated endorsement.  We are telling colleagues that they need to read Elizabeth Chamblee Burch’s The Pain Brokers (One Signal Publishers 2026). Two things drive our enthusiasm for this book: cynicism and pride. 

First, let’s indulge our cynicism. The Drug and Device Law engages in no pretense of objectivity.  We are entrenched on the defense side and make no bones about it.  We represent product liability defendants and root for them to win even when we have no involvement in the case.  And we are sore losers.  We criticize what we consider to be bad decisions.  Sometimes we kvetch. Sometimes we find ourselves suspecting the other side of cheating.  

At this point we find ourselves making a callback to some recent posts. We quoted Abe Greenwald, an editor of Commentary, who often says that however bad you think things are, they are even worse. And in our post on the disqualification of a plaintiff firm in a talc case because that firm had hired a lawyer who formerly worked for the talc defendant, we grumbled that it was likely the tip of a rotten iceberg.  (Earlier this week the court denied the plaintiff firm’s request to pause the disqualification.) 

It is grindingly obvious that the problem with mass torts is that they are … massive. They are hard to handle. Moreover, mass torts offer opportunities for mass frauds.  For example, too many cases parked in Multidistrict Litigations never really get tested.  Product usage is sometimes faked, and injuries can be exaggerated to get a higher spot on the settlement grid.  

With little fondness, we remember the fen-phen litigation, where traveling echocardiogram doctors inflated the degree of heart valve regurgitation to gin up higher settlements.  Some doctors got in trouble.  But for every phony echocardiogram that was spotted, we bet another ten eluded detection. 

It’s not paranoia if they really are out to get you. 

The subtitle of The Pain Brokers is “How con men, call centers, and rogue doctors fuel America’s lawsuit factory.”  The particular lawsuit factory covered by the book was the vaginal mesh MDL in West Virginia. It was an enormous MDL, with several defendants, thousands of plaintiffs, some bellwether and remand trials, and large inventory settlements.  It ended up being a mass wealth transfer, crafted by a kakistocracy. As the book tells us, “[b]y 2014, pelvic mesh had become the holy grail of mass torts.”

The worse the injury, the higher the settlement would be.  That is the theory, anyway.  A plaintiff who had such serious problems (pain, infection, extrusion) with her mesh that she had to have it removed would be entitled to more money than someone who was living with the mesh intact.  It stands to reason, doesn’t it?

Enter a large cast of litigation villains with a scheme. Some were veterans of the wrong side of the criminal justice system. They (the “con men” in the subtitle) exploited what was then a back door unique to the District of Columbia, which permitted nonlawyers to have an ownership role in law firms.  The aim was to create mesh cases with high values. The intake procedure started with call centers armed with information about a woman’s mesh implantation.  (How they got that information is doubtless an ugly story.) They cold-called women and did everything possible to scare them into removing the mesh.  Following a script, the call centers told the women that the mesh was a ticking time bomb.  Some women thought the calls came from the mesh companies. Apparently nothing was done to disabuse the women of that mistake.  

The next step in the scheme was to connect the women to surgical centers that would arrange to fly the women (often across the country, usually to Florida) to undergo surgeries to “revise” or explant their mesh.  The women were told that they could not use medical insurance.  Instead, they were charged considerably more than going through insurance would have cost them. The women were sent agreements via Docusign, which permitted jumping through the documents to get right to the signature and initial pages. That jumping feature in Docusign can be convenient when you know what you are signing, but awful if you do not. Women ended up taking out high interest loans without even knowing it.  Their surgeries were performed with minimal medical consultation. There really were “rogue doctors” as stated in the subtitle. The women’s lawyers also seemed to offer them little legal consultation. (That fact had consequences for claims of attorney-client privilege.) Having their mesh removed, the women then entered the mesh litigation machine, lined up for settlement, and the subtitle’s “con men, call centers, and rogue doctors” took their cut. After that cut, some plaintiffs ended up with little money. 

Pelvic mesh plaintiff lawyers liked to call their clients victims. Some were. Some were victims because they had mesh removed from them that was performing perfectly well.  Their own, real treating doctors expressed surprise and disappointment that the patients had the pelvic mesh removed.  The problems (such as incontinence or prolapse) the women had that prompted the implants often returned. Often there was post-explant pain. Even if the mesh removal led to a higher settlement amount, the women were not getting much of whatever upside existed.  Instead, their health was harmed.  Also victimized were the defendants and the court system.  It is a depressing tale. 

Second, we arrive at our point of pride.  One of the heroes in the book is a former colleague, Barbara Binis.  She retired from Reed Smith a couple of years ago. She was a splendid trial lawyer and a master of litigation strategy. She had a way of getting after the truth. Her work unearthing the vaginal mesh fraud required sleuthing, persistence, and ingenuity.  Binis tracked down various players in the litigation scheme and took their depositions.  Some of those deponents were more than a little slippery, and some were defended by lawyers who took obstruction to new depths. Binis managed to expose the sleazy reality of the scheme. The wonder of it is that only one doctor was incarcerated.  Unfortunately, due to the statute of limitations, certain rigidities in the system, and some soft-hearted judges, most of the miscreants skated. 

But if the book might induce despair at the bent litigation lottery system (at one point one of the schemers mused over how to make a profit off of earplug, PFAS, and Camp LeJeune litigation), it also shows what a smart, determined lawyer can do to get to the truth.  The book’s documentation of Binis’s dogged pursuit of the schemers is inspiring.  Defense lawyers do not always have to play defense. If there is an opportunity for a defense lawyer to seize the initiative, do it. Meanwhile, the book also introduces us to a plaintiff lawyer who did his best to help some of the victimized women seek redress. It was an uphill run. No law school teaches the skills and strategies needed to nail fraud artists who manipulate the civil justice system.  

We want all our colleagues to read the book to know what is really going on in mass torts.  That knowledge will not merely feed cynicism; it will energize efforts to combat the schemers.  We also want judges and legislators to read the book.  Maybe understanding how the mass tort system lends itself to abuse might prompt decision-makers to try to stem such abuse. 

Meanwhile, some other jurisdictions opened up the same back door letting nonlawyers operate law firms.  Perhaps there were good intentions behind that move, but The Pain Brokers constitutes a cautionary tale. 

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This post is from the non-Butler Snow side of the blog.

Back in November, we told you the court in the In re Paragard IUD Products Liability Litigation wasn’t quite finished with plaintiffs’ effort to impose a post-sale duty to warn on a company that didn’t manufacture, sell, or even own the product when it was implanted. The court had dismissed the design defect claims against the successor company but requested supplemental briefing on causation for failure to warn. We suggested then that, absent wormhole technology, causation was going to be a problem. We recently came upon the warning ruling. Big surprise—summary judgment granted on causation.

As a reminder, the product was originally manufactured and sold by Teva. But in November 2017, the NDA was purchased by Coopersurgical. Coopersurgical moved for summary judgement in cases where plaintiffs’ IUDs were implanted prior to 2017, so manufactured and sold by Teva, but explanted after the change of ownership—at which time it was discovered the IUDs had broken. In re Paragard IUD Products Liability Litigation, 2025 WL 4092375, at *2 (N.D. Ga. Dec. 23, 2025).  

The claims at issue were brought under Florida law, so the court’s analysis started with recognizing that Florida is a learned intermediary state. That means the duty to warn runs to the prescribing physician, not directly to the patient. Plaintiffs attempted to sidestep that rule by arguing for a contraceptive exception—claiming that birth control products are uniquely marketed directly to patients and that physicians defer to patient choice. Id. at *3.  There is just one problem—Florida has not adopted a direct-to-consumer exception to the learned intermediary doctrine. In fact, two Florida courts have expressly rejected the concept. Plaintiffs only cited a Massachusetts case to support their argument. That may be interesting in Boston, but it is not binding in Florida.

So the learned intermediary rule applied. Which meant plaintiffs had to prove that a different warning to the physician would have changed something in a way that would have prevented their injuries.

Plaintiffs argued that by the time the successor company acquired the NDA, before the IUDs were removed, it knew the label did not adequately warn about device breakage. Therefore, say plaintiffs, defendant could and should have provided new warnings, before the IUDs were removed, via sales representatives, literature, dear doctor letters, etc. Then, say plaintiffs, their physicians would have reviewed the warnings, monitored for breakage, warned plaintiffs, attempted to mitigate the risk, and/or recommended early removal. Id. at *4.

But litigation does not run on plaintiffs say so. As it turns out, “[p]laintiffs’ allegations [were] not grounded in any evidence.” Id. Plaintiffs claimed that one of their physicians testified that had she known of the breakage risk she would have “been on the lookout” for it. However, the court actually read the testimony and concluded it did not say what plaintiffs claimed it said. Id. The doctor actually testified there was no resistance during her first attempt to remove the device. Plaintiffs’ spin was more aspirational than record citation. The actual testimony did not support finding causation. Id.

Plaintiffs offered no other factual support for their allegations. There was no testimony that a different warning would have caused a reasonable physician to notify the already-implanted patients of a breakage risk. No testimony that any alternative course of action would have been taken. No testimony that anything would have prevented these injuries. There was no evidence from which a reasonable jury could find that the defendant’s alleged failure to warn was the proximate cause of their injuries.

While the court did not wade into a broad rejection of post-sale successor duty to warn, it didn’t need to. Even assuming arguendo some duty could exist, plaintiffs still had to prove causation. And they couldn’t. Proof of causation requires actual evidence. Not speculation about what doctors might have done differently. On that point, the record was silent.

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As we’ve discussed before, Bexis was involved in the ALI proceedings that produced Restatement (Third) of Torts:  Liability for Economic Harm §8 comment g (2020), that disapproved of public nuisance claims against product manufacturers.

[T]he common law of public nuisance is an inapt vehicle for addressing the conduct at issue.  Mass harms caused by dangerous products are better addressed through the law of products liability, which has been developed and refined with sensitivity to the various policies at stake.

Id.  However, everything ALI does is persuasive, not binding, and not all courts choose to follow it, most notoriously the 2025 worst case of the year, City of Huntington v. AmerisourceBergen Drug Corp., 157 F.4th 547 (4th Cir. 2025).

But thanks to the Washington Legal Foundation, we’ve learned about a new Montana statute the fixed this problem, beyond the power of any wayward judge, by codifying the law of public nuisance to bar claims against the manufacturers of legal products (as well as prohibiting similar politicized claims).  The statute, passed in 2025, defines what can be a public nuisance

(1) A public nuisance is:

(a) a condition arising out of the use of real property that unlawfully interferes with a public right by endangering communal safety, being indecent to the community, or being offensive to the community; or

(b) a condition that unlawfully interferes with the public right to free passage or use, in the customary manner, of a navigable lake, river, bay, stream, canal, or basin or a public park, square, street, road, or highway.

Mont. Code §27-30-101(a).  That limits allowable public nuisance claims to their traditional scope − before the plaintiff lawyers started abusing mushy common law – injurious uses of land and interference with public means of transportation.

To make sure that there is no ambiguity, the statute also specifies what cannot be a public nuisance:

(2) The following nonexclusive list of actions or conditions may not be considered a public nuisance or be the basis for a public nuisance cause of action:

(a) an action or condition that is lawful;

(b) an action or condition that is authorized, approved, licensed, or mandated by statute, ordinance, regulation, permit, license, order, rule, or other similar measure issued, adopted, promulgated, or approved by a government entity. . . .

(e) the design, manufacturing, distributing, selling, labeling, or marketing of a product;

(f) the aggregation of individual injuries or private rights, including private nuisances. . . .

Id. at §27-30-101(b) (emphasis added).

This Montana statute should serve as a model in other states where plaintiffs have been allowed to hijack traditional public nuisance law in pursuit of novel and expansive industry-wide liability theories of liability.

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The Ninth Circuit has been grappling with specific personal jurisdiction ever since the Supreme Court altered the playing field ever so slightly in 2021 with Ford Motor Co. v. Montana.  That grappling includes an opinion published just last week, where the Ninth Circuit found specific personal jurisdiction over out-of-state medical providers.  The medical providers had not entered the forum state, and the care at issue occurred entirely outside the forum state.  But the providers had offices just outside state borders, and they transmitted prescriptions to pharmacies in the forum state.  That, according to the court, was enough to establish personal jurisdiction over the providers in a case alleging harm caused by those prescriptions.

The case is Cox v. Gritman Medical Center, No. 24-1947, 2026 WL 378500 (9th Cir. Feb. 11, 2026) (to be published in F.4th).  In Cox, a physician in Moscow, Idaho, treated a resident of Eastern Washington for six years and prescribed multiple prescription medicines over that time.  After the patient sadly died, allegedly because of a fatal overdose, her heirs sued the doctor and the clinic.  Again, the providers were entirely in Idaho, and they provided all the medical care at issue in Idaho, including determining which medicines to prescribe. 

The district court thus dismissed the complaint for lack of personal jurisdiction, but the Ninth Circuit reversed.  In the years leading up to Ford, the Supreme Court performed yeoman’s work in restoring discipline to the jurisprudence of personal jurisdiction.  The Bauman opinion in 2014 held that general personal jurisdiction would lie only where the defendant was “at home,” which for a corporation generally means the state of incorporation or its principal place of business.  The Supreme Court followed Bauman in 2017 with Bristol-Myers Squibb, which held that state courts cannot exercise specific personal jurisdiction over non-resident defendants for claims brought by out-of-state plaintiffs who did not buy or use the defendant’s product in that state.  

Then came Ford, which gave resident plaintiffs (not forum shoppers) some leeway in reaching out-of-state defendants based on forum contacts “related to” the alleged injury, as opposed to “arising out of.” 

For better or for worse, that leeway is what allowed the Ninth Circuit’s opinion in Cox.  According to the court, the Idaho physician and the Washington patient had a long-term relationship that “was intertwined with [the physician’s] relevant contacts with Washington.”  Cox, at *5.  What were those contacts?  Well, not much.  Sure, the physician treated the Washington patient for a long time, but the patient came to her in Idaho—not the other way around.  She also practiced at a clinic near Washington whose “business model includes serving patients throughout a rural region encompassing an area that spans Idaho and Washington.”  Id. at *6.  But such vague contacts are what Bristol-Myers Squibb shut down.  Even Ford famously cautioned that “relate to” does not mean “anything goes.”  To the contrary, the “relate to” prong still requires a close connection between the forum contacts and the injury. 

As far as we can tell, it came down to the prescriptions.  At the patient’s request, the physician electronically transmitted prescriptions to Washington pharmacies for the patient’s convenience.  Does that forum contact “relate to” the patient’s alleged injury?  We suppose it does, seeing as how the complaint alleged a prescription drug overdose.  It’s a stretch though.  An electronic transmission across state lines will not always be sufficient, but evidently it was here.  Compare Cox with another Ninth Circuit opinion that went the other way, Yamashita v. LG Chem, Ltd., which we covered here.  In that case, the out-of-state defendants shipped products through the forum state and sold products in the forum state, including some that contained components similar to those at issue.  Third parties sold the defendant’s product on the Internet, including in the forum state.  The Ninth Circuit, however, held that those forum contacts were not sufficient to support specific personal jurisdiction. 

It is difficult to square Cox with Yamashita.  Regardless, the practical impact of the Cox opinion is that it arguably expands the ways in which courts can exercise personal jurisdiction over out-of-state service providers.  So look out.  In the end, we take comfort in the Supreme Court’s admonition in Ford: “Some relationships will support jurisdiction without a causal showing.  That does not mean anything goes.  In the sphere of specific jurisdiction, the phrase ‘relate to’ incorporates real limits, as it must to adequately protect defendants foreign to a forum.”  Ford Motor Co. v. Montana Eighth Jud. Dist., 141 S. Ct. 1017, 1026 (2021).  The Ninth Circuit is still feeling out where those “real limits” lie. 

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Today’s guest post is from Nick Dellefave, an up and coming Holland & Knight litigator.  The Blog has rolled out a few posts on the latest edition of the Reference Manual on Scientific Evidence.  Nick adds to this opus with a dive into the intersection between scientific evidence, the role of trial judges, and this thing called “artificial intelligence,” which the Blog has also touched on from time to time.  As always, the guest poster deserves all of the credit and/or blame for the post.  (At a minimum, Nick gets some credit for allowing us to not have to write a post while on vacation.)

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As we covered last month, the new Reference Manual on Scientific Evidence is here, complete with a new chapter on Artificial Intelligence.  While the entire chapter should be required reading for litigators practicing in 2026, today we are focusing on one key subsection, titled “Judges as AI Gatekeepers.”  It offers a window into how courts will evaluate AI-generated evidence, and more importantly, where the pressure points are for both sides.  We thought it would be useful to pull out the key takeaways for practitioners who may be dealing with AI evidence sooner than they think.  This subsection has not drawn the attention of the climate science chapter, but it may end up being more impactful.

The Familiar Rules, Applied Unfamiliarly

Here is the good news: AI evidence will be evaluated under the evidentiary rules we all know and love.  The not-so-good news is that applying those rules to AI is anything but straightforward.  Under Federal Rule of Evidence 401, AI applications are essentially probability assessment tools, theoretically making them inherently relevant when offered to demonstrate whether something is “more or less probable.”  But Rule 403 gives courts plenty of room to exclude AI evidence when it risks unfair prejudice, confusion, or misleading the jury.  This is likely to be a prime battleground in determining the admissibility of AI evidence, as litigators and judges will rightfully ask whether the AI’s probative value is substantially outweighed by these dangers.

If you are challenging AI evidence, be ready to argue that certain outputs are too inaccurate or biased to be relevant, or that they are simply a poor fit for the purpose offered.  Courts may exclude AI evidence under Rule 403 precisely because juries tend to assume that if a computer said it, it must be true.  One need only look around at the epidemic of advertisers boasting “AI-powered” products to see this concept in action.  The imprimatur of “science” or “technology” can lend AI evidence a false authority it may not deserve.  Of course, with changes in jury attitudes about science and experts, it is hard to be sure how AI evidence will be received when its source is revealed.  If you are opposing AI evidence, hammer this point.  If you are the proponent, be prepared to show that the evidence is reliable and appropriately scoped for the purpose for which you are offering it.

Discovery Is Where the Action Is

The foundation for admissibility fights over AI evidence will be laid in discovery, which promises to generate its own fights.  Opponents seeking to challenge AI evidence will need access to the underlying algorithm, the training data, and knowledge of what is happening inside that machine-learning black box.  If you are challenging AI evidence, go after this information aggressively.  If you are the proponent, decide early on how you will address those requests, because rest assured, they are coming.  For more on this, see our recent discussion on Discovery of Artificial Intelligence Prompts. 

Of course, there is tension here with trade secret protection.  AI developers are not exactly eager to open up their proprietary algorithms for public inspection.  Courts have tools to navigate this: they can seal records, use protective orders, and exercise their general power to oversee how evidence comes in.  The Defend Trade Secrets Act (18 U.S.C. § 1835) also gives courts specific direction to protect trade secrets in relevant proceedings.  Attorneys should be prepared to negotiate protective orders and in camera review procedures.

Daubert, But Make It Complicated

Daubert as spelled out in the enhanced Rule 702 is, of course, the go-to framework for expert testimony, but applying its factors to AI is trickier than it sounds.  Every AI application is different: different algorithms, different machine learning methodologies, different training data.  This means AI issues are generally not going to be resolved the way DNA analysis was.  There will not be a single landmark case that settles the question of when AI evidence comes in.  Instead, expect adjudication for each application and each context.

The question of testability—the hallmark of Daubert/Rule 702 analysis—is complicated by the multiple inputs into an AI engine system.  The threshold question is: what exactly are we testing?  The sensors?  The algorithm?  The math?  The training data?  The system as a whole?  Similarly, credible peer review requires access to the underlying algorithm, parameter weights, and training data.  If the AI evidence being offered has not been meaningfully peer reviewed, and if that review did not include the underlying code and data, that is a vulnerability to exploit.

Error rates are another minefield.  Attorneys must ask whether error rates vary depending on whether the AI was tested using the relevant local population to which it will be applied, as opposed to a national population or idealized lab database.

Context and Bias: The Low Hanging Fruit

Attorneys should scrutinize whether the AI application is a good “fit” for the purpose for which it is proffered.  Is the AI application actually designed for the purpose it is being used for?  Some algorithms are built for one thing and then repurposed for another—with predictably dicey results.  The Manual’s authors cite the example of criminal risk assessment algorithms, which might be designed to determine who would benefit from alternatives to incarceration, but are probably inapt for use in sentencing determinations.  More applicable to readers of this blog, algorithms designed to model drug or device efficacy might be inapt for use in modeling the incidence of adverse effects.

Even when an algorithm is being used for its intended purpose, it may perform worse in certain contexts because of how it was trained.  An AI trained on one population may not achieve the same accuracy when applied to a different demographic.  If there is a mismatch between the training population and the population at issue in your case, that disparity is ripe for attack.

There is also the risk that neural networks rely on inapt factors—i.e., things they should not be considering—in making their predictions.  Judges are going to want to know whether inappropriate or unconstitutional factors were included, and whether any factors are working as proxies for suspect categories like race.  Demand disclosure of what factors are in the model and how they are weighted.  You may not get it easily, but in many cases, this is a fight worth having.

Deepfakes and the Importance of Witness Authentication

The Manual’s authors devote several pages to the problems posed by deepfakes.  Deepfake technology is only getting better, cheaper, and more accessible.  Practitioners should prepare for increased litigation over the authenticity of photos, videos, and audio recordings, as the mere availability of deepfake technology throws the authenticity of all types of evidence into doubt.

Under Rule 901, the proponent has to produce evidence sufficient to show the item is what it claims to be.  But here is the problem: your authenticating witness may not be able to tell whether the evidence is genuine or fake.  Deepfakes can shade human memory.  Archive systems can be hacked.  Digital forensic experts are going to be in high demand, and rightly so.

On the authentication front, there are some tools worth knowing about.  Federal Rules of Evidence 902(13) and 902(14), adopted back in 2017, provide for self-authentication of certified electronic records and certified data copied from electronic devices.  Items with cryptographic hashes may be authenticated under these rules, subject to the adverse party’s “fair opportunity to challenge.”  Although litigators may be accustomed to stipulating to the authenticity of electronic evidence, in this age of deepfakes, they should be increasingly wary of waiving these challenge opportunities without consulting a digital forensic expert.

So What Should You Actually Do?

If you are offering AI evidence, line up your expert testimony now.  As we have argued, admission of AI evidence likely requires the proponent to offer an expert who can speak credibly to the AI’s design, training, validation, and accuracy.  Your goal should be to simplify the foundational requirements and make the evidence as easy to admit as possible.  If you are opposing AI evidence, your job is the opposite: attack relevance and reliability, demand discovery of algorithms and training data, and prepare to cross-examine the software engineers who built the system.

We expect that AI evidence will continue to be an area where the rules are being written in real time.  Practitioners should understand that courts are going to face layered adjudicative challenges every time AI evidence comes up.  As the chapter’s authors put it, “the most important thing courts can do is ask careful and informed questions.”  That means the most important thing you can do as an advocate is be ready to answer them well.

Photo of Stephen McConnell

Who would’ve thought that Texas, of all states, would become a nannyocracy? The Lone Star State typically positions itself as the home of rough and ready folks who can take care of themselves.  Think Jim Bowie, Willie Nelson, or Bob Lilly, not Mr. Rogers, Mary Poppins, or Nanny McPhee. Texans don’t need the government telling them to steer clear of things that might pose risks.  Let California and Massachusetts hover over its meek, ready-to-be-victim citizens.  Texans are tough, and they’re fixing to get ready to clobber you if you lecture them on healthier lifestyles.  

So how to account for Section 9 of Texas Senate Bill 25, codified in Texas Health & Safety Code section 431.0815(a), which requires food and beverage companies to include conspicuous warnings on products that contain any of 44 listed ingredients (subject to some exceptions)?  As the folks on the excellent Commentary podcast would say, it gets even worse than that. Here is what the warning must say: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.”  Since when do Texans care what effete, warm-beer drinking, Speedo-wearing, surrender-monkeys say about anything? [WARNING: We are joking.  We admire all those countries.  We like visiting them. If our nation was going to mimic another country’s health warnings, those places would probably be the best ones to mimic.  But (1) it should be the Food and Drug Administration (FDA), not various and sundry states or, worse, state juries, that should do the mimicking, and (2) it turns out that Texas is not even accurately mimicking those countries’ health determinations, which is another reason why the statute should be enjoined.]

Section 9 contains a federal preemption provision that calls off the warning requirement if the FDA or United States Department of Agriculture issue a law or regulation pertaining to one of the 44 listed ingredients prohibiting or conditioning use or determining it to be safe or imposing a particular labeling statement.  Section 9 was to take effect on January 1, 2027. 

In American Beverage Ass’n et al. v. Paxton, 2026 WL 395513 (W.D. Texas Feb. 11, 2026), a collection of nonprofit entities representing manufacturers and marketers of consumer packaged foods and beverages filed a lawsuit challenging the Texas law.  The defendant is the Attorney General of Texas.  He is running in the Republican primary against incumbent Senator Jon Cornyn.  Paxton aims to win by out MAGA-ing Cornyn.  MAGA now includes MAHA (Make America Healthy Again), and, somehow, right-wing politicians (who used to abhor anything smacking of “international law”) find themselves allied with a science-rejecting Health and Human Services Secretary who hates vaccines and seed oils, tinkers with bear corpses, and brags about how he sniffed cocaine off toilet seats.  As the Tommy Lee Jones character mutters near the end of No Country for Old Men (set in West Texas), “signs and wonders.”

Section 9 seems flat-out silly, but being silly is not ordinarily enough to strike down a law (though such silliness can be a factor in the court’s analysis).  The smart folks at the ABA (those are the liquor folks, not the lawyer folks) and other associations came up with a variety of legal arguments.  The one that persuaded the court to enjoin Texas’s ballyhooed attempt to impose its own ingredient labeling requirements (again, partly borrowed from NATO allies that our government keeps insulting and tariffing) was — tada! — free speech. The court reasoned that the plaintiffs would likely win on the argument that Section 9 is barred by the First Amendment.  That is an important result, because the First Amendment attack is often available when the government tries to force certain kinds of speech. Admittedly, when we frame a motion against such forced speech, the First Amendment argument usually does not come, er, first, because we expect to run into judicial skepticism.  Vagueness, over breadth, and preemption usually get higher billing. But maybe this recent case should prompt us to rethink that. 

The court held that the Texas non-FDA labeling requirements are a form of “compelled speech” over a subject matter that is anything but settled and non-controversial.   A lot of the arguments between the parties focused on whether the case involved a content regulation that called for strict scrutiny, or whether it was a commercial speech case that called for intermediate scrutiny. The implicit assumption was that strict scrutiny would mean that the statute was dead, while intermediate scrutiny would mean that the ABA’s lawsuit was dead.  (You’ve doubtless heard the rubric “strict in theory, fatal in reality.”) That dichotomy turned out not to be true here, and how the court got there was interesting. 

The court held that strict scrutiny “likely applies” because the Texas labeling law is a content-based regulation of speech.  The law requires the plaintiffs to speak a particular message that “alters the content of their” speech, here a government-scripted message on food labels and online that must be clear and conspicuous.   The plaintiffs pointed out that the required warning is not even true, since not one of the four jurisdictions referenced in the legislation (Australia, Canada, the European Union, or the United Kingdom – note that there isn’t a single SEC football team in any of those places, and they probably cannot barbecue decent brisket) actually states that any of the listed ingredients are “not recommended for human consumption.”  For the court, the key is that Texas showed neither the compelling state interest nor the narrow reach necessary to survive strict scrutiny.  Adios, silly, bossy statute.  

The court made the smart move of ruling on alternate grounds.  That makes the AG’s appeal more difficult. Even if the case was viewed through the lens of the Central Hudson commercial speech standard, the Texas labeling requirement would not “pass muster.” That is, it flunks intermediate scrutiny.  Yes, the state has a “substantial interest in supporting the health and well-being of its citizens by promoting better ingredients in foods sold in Texas.”  But compelling sellers to warn consumers of a potential risk never confirmed by any regulatory body or of a hazard not known to more than a small subset of the scientific community does not “directly and materially” advance the government’s interest.  Moreover, forced speech is not a “narrowly tailored” approach. The state could spend its own resources in its own advertising campaign rather than force the plaintiffs to speak.  Market based solutions, including the speech market, are usually better. 

Other arguments offered by the plaintiffs fared less well. But that’s okay — a win is a win. The court held that the vagueness and preemption arguments did not meet the preliminary injunction threshold.  The obstacle preemption argument faces the dreaded presumption against preemption, which would require adjudication of the falsity of the compelled statements. See you at summary judgment. For now, it is too early for that, and maybe the court will never get there, because, as the court held, the plaintiffs likely will prevail on the First Amendment ground.  

In any event, the deprivation of a First Amendment right constitutes irreparable harm, and an injunction protecting First Amendment rights is always in the public interest.  Accordingly, AG and senatorial candidate Paxton is enjoined from enforcing Section 9. 

The lesson here is for companies to take the First Amendment argument seriously, as we have advocated, particularly as to off-label use. That lesson is actionable.  Less actionable is another lesson: as has become the case all too often in this republic,  the executive and legislative branches do too much, or do not enough, or simply do dumb. More and more, the only adult in the room is the judiciary.  

If you are interested in this sort of thing – and why wouldn’t you be? – take a look at our post on American Beverage Ass’n v. SF.  It was another First Amendment challenge to a food warning law by the ABA.  Other recent First Amendment food posts are here and here.   

Photo of Michelle Yeary

The recent decision in Cousin-Sabra v. Smith & Nephew, Inc., 2026 U.S. Dist. LEXIS 25576 (E.D.N.C. Feb. 5, 2026) is short and straightforward. So too, therefore, will be this post. What we have is an ambitious plaintiff who filed a products liability/medical malpractice case against her doctors and the manufacturer of the device they used in her rotator cuff surgery– and, before the ink was even dry, asked for the keys to the warehouse.

Before the parties even held their Rule 26(f) conference—and while multiple Rule 12 motions to dismiss were pending—the plaintiff sought leave to serve sweeping, full-bore (aka expensive) discovery. Not targeted discovery. Not issue-specific discovery. We’re talking “categories” of all kinds of documents and records that the court struggled to even call proper “requests.” Id. at *4-5. 

Courts can authorize expedited discovery, of course. But only if the request is reasonable “in light of the totality of the circumstances.” And here, the totality was not the plaintiff’s friend.

First, procedural posture matters. A lot. Expedited discovery is particularly disfavored when Rule 12 motions are pending. There’s a reason for that. The whole point of Rule 12 is to test the legal sufficiency of the complaint before the parties incur the time and expense of merits discovery. If plaintiffs could demand costly discovery before a court rules on pleading-based motions, Rule 12 would become little more than an academic exercise—an expensive prelude to discovery instead of a gatekeeper. In this case, the broad discovery could not be said to be needed to assist in preparing a response to the motions to dismiss.  Id. at *3.

Second, the requests were anything but “narrowly tailored.” The court had no difficulty seeing that the proposed early discovery was “sweeping in scope” and indistinguishable from “full-blown merits discovery.” Id. at *7. This wasn’t a scalpel; it was a trawling net. When a party seeking expedited discovery can’t even pretend to aim narrowly at a discrete issue, that’s usually a tell.

Third, there was no irreparable harm lurking around the corner.  Plaintiff’s argument was that early discovery was needed because the documents are in the exclusive control of the defendants and she needs them to prepare the prosecution of her case.  That’s not irreparable harm.  That’s just discovery in a products liability case. Id. at *7-8. 

Finally, plaintiff could not show any risk that evidence would be lost absent immediate production. At best plaintiff speculated that “automated retention systems” could cause materials to become unavailable. But speculation about hypothetical loss of evidence won’t do. Particularly where defendants acknowledge, as they did here, their preservation obligations. Id. at *8-9.

In short, every relevant factor cut the same way—no expedited discovery. The most efficient ruling can also be the most obvious one. And the easiest way to discovery should be to survive a motion to dismiss first.

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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