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A few months ago we posted about how the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) held up against challenges to COVID-19 vaccine mandates.  The decision—which upheld a smallpox vaccination order over 100 years ago—has fared very well. Jacobson’s recognition that “society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy” applies today as much as it did in 1905. Id. at 26.  Today’s post addresses another COVID-19 decision relying on Jacobson to uphold vaccine mandates instituted for healthcare workers.  

Continue Reading Jacobson Remains Solid: Ninth Circuit Upholds Vaccine Mandate
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As many of the Blog’s authors and readers wake up today, they will be in New York for the ACI Drug and Medical Device Litigation Conference.  Clearly, the choice of venue matters when it comes to a conference.  It also matters to plaintiff lawyers and the medical product manufacturers that they sue.  The infamous list of judicial hellholes is typically comprised of courts where the plaintiff lawyers do what they can to bring and keep cases that could have been brought elsewhere.  For our part, we have devoted many posts to issues that affect where defendants are subject to suit, including general and specific personal jurisdiction, forum non conveniens, joinder, misjoinder, and removal.  For many of these, the question is often focused on whether one state or another, or the non-state federal courts, should have the case.  It is far less common that the issue is where in the state a case should proceed.  Because where in a state the plaintiff lives or lived at a relevant time point is often not hard to determine in a product liability case, the interesting part of venue fights still often comes down to misjoinder.  We know that the plaintiff lawyers like multi-plaintiff cases for a number of reasons, including anchoring a case in a particularly nasty part of state based on one of many plaintiffs.  We also know that the days when a Mississippi plaintiff, for instance, could sue in any county in her state—resulting in more pending cases than residents in some counties—are largely in the past.

In re AstraZeneca Pharms. LP, No. 15-25-00088-CV, 2025 WL 3251532 (Tex. App. Nov. 21, 2025) (“In re AZ”), presents a different venue issue based on the permissive language of the Texas version of the False Claims Act, the Texas Health Care Program Fraud Prevention Act (“THFPA,” not our acronym).  The result of In re AZ is that the defendant gets to move the case from Harrison County (home of Marshall) to Travis County (home of Austin) based on the granting of a mandamus petition by an intermediate appellate court after the trial court denied a motion to transfer.  While the direct applicability of the decision is pretty narrow, its analysis speaks to principles that come up in personal jurisdiction challenges.  The decision also makes us ponder about possible venue provisions in state product liability statutes.  We start with the pondering.  We are not sure such provisions would be preferrable compared to the current free-for-all.  Sometimes, but not always, specialized state courts that hear all the “mass torts” or a high percentage of the coordinated proceedings can be plaintiff-leaning.  They also tend to be in urban centers that, despite some on-going changes in jury dynamics, can match up with the aforementioned hell holes, past and present.  Other than existing consolidation procedures and existing procedural options for an in-state defendant to try to move a case to its home county, there is not an obvious default destination in each state for product liability cases.  The logic of the venue provision in the Texas mini-FCA statute is presumably that the state HHS in Austin is the recipient of any allegedly fraudulent claims for Medicaid payments.

In re AZ involved a claim from a relator that the defendant violated the THFPA based on state-wide schemes involving alleged “kickbacks” for certain of its medications.  The State of Texas declined to intervene, which, at least with the federal FCA, can be a sign that the case is a reach.  The plaintiff—we will use the familiar term and keep it singular—sued in Harrison County.  Why?  Probably for similar reasons that cases are brought there that seem more appropriate for other courts or venues.  The relatively small east Texas county—its population is about 1/20 that of Travis County based on the last census—has no obvious prominence when it comes to deciding an allegedly statewide issue focused on claims submitted to the state agency in Austin.  The THFPA includes a venue provision that allows cases to be brought in Travis County or “a county in which any part of the unlawful act occurred.”  2025 WL 3251532, *1.  Without detail, the complaint alleged that “[u]pon information and belief . . . [the defendant’s] unlawful acts occurred, in part, in Harrison County.”  Id.  In response to a motion to transfer, the plaintiff amended to add a paragraph alleging, in general terms, that defendant’s sales reps targeted unnamed providers affiliated with facilities in Harrison County.  In response to a renewed motion, plaintiff identified some content in a brochure about one of defendant’s drugs that was allegedly found in the county.  The trial court denied the transfer.

On mandamus, the denial was evaluated on an abuse of discretion standard.  The appellate court was not deprived of jurisdiction by a proposed second amended complaint or plaintiff’s desire to do discovery to support venue.  Simplifying Texas procedural issues a bit, the propriety of denying the motion to transfer is measured at the time of denial.  Id. at *3-4.  We will not say more about that or the rejection of plaintiff’s laches argument, except that the latter involved the irony of plaintiff claiming Austin was less convenient for trial than Marshall.  The more interesting part to us is the appellate court’s finding of an abuse of discretion because plaintiff failed to carry her burden “to present prima facie proof that any part of the alleged unlawful acts occurred in Harrison County.”  Id. at *6.  Plaintiff’s conclusory allegations in the live complaint were disputed by defendant, so plaintiff was required to offer actual evidence.  (It seems to us that the heightened pleading standard for a fraud-based claim should also mean that allegations of fraudulent acts in a particular place that is essential to venue cannot be vague and conclusory.)

Plaintiff first tried to say the defendants had sales reps furthering the alleged kickback schemes within the county, but she offered no actual evidence to support that.  Next, she pushed an argument similar to what we have seen in the personal jurisdiction context—that the ability for someone in Harrison County to access defendant’s websites meant that the allegedly unlawful acts had occurred in the county.  It is hard to see how maintaining a website could ever be seen as engaging in acts in each county in each state.  Rather than address the broader question, the In re AZ court determined that nothing on the defendant’s websites conveyed an “offer” that could be seen as fitting within the plaintiff’s theory of liability.  “At most, the websites represent a general invitation to apply for some of the challenged nurse services.”  Id. at *5 (internal quote omitted).  Plaintiff’s last argument was that the mere fact the aforementioned brochure was found in the county was enough to connect the defendant’s alleged scheme to the county.  However, the websites were still needed to get from the brochure to anything allegedly connected to the scheme and, of course, they contained no offers.  Thus, this was another dead end.

The result of all of this is that the case goes to Travis County.  Perhaps we have spilled too much virtual ink on this issue, but we know that venue can be determinative.  We also know that there are other cases brought under the THFPA that mirror product liability claims against drug and device companies (e.g., any claims submitted for the product were fraudulent because it was inherently worthless because of alleged contamination or risks).  Those cases also tend to get brought in some of the 254 counties in Texas the plaintiffs like most.

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Today’s post is not from the Butler Snow side of the blog.

It’s five days post-Thanksgiving and if you are like the majority of us, there are still leftovers in your fridge. But according to food safety experts, yesterday was likely the last day for the turkey, mashed potatoes, stuffing, gravy, and casseroles.  Some legal theories are like those leftovers–they may have started out fine, but after enough time passes, you’re really just gambling with your health. Extending a post-sale duty to warn to a successor company that didn’t manufacture or sell a medical device when it was implanted is one such culinary adventure. It’s a doctrine that, if expanded any further, might as well come with its own hazard label: Warning: May cause logical indigestion.

And it’s an issue that the court in the In re Paraguard IUD Products Liability Litigation is grappling with.  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. 

Plaintiffs did not even bother to respond to the motion on design defect. There is simply no way Coopersurgical could have made any changes to the design of the device at any time material to these plaintiffs’ claims.  In re Paraguard IUD Products Liability Litigation, 1:20-md-02974-LLM, slip op., at  4 (N.D. Ga. Nov. 21, 2025).

On failure to warn, plaintiffs urged the court to adopt the Restatement 3d of Torts: Products Liability, §13(a), which creates a post-sale duty to warn for successor companies who have a “similar relationship with purchasers of the predecessor’s products.”  Id. at 5. However, Florida law applies to the cases at issue and Florida has not adopted §13. Therefore, defendant argued it would be an improper expansion of Florida law for the court to apply it here. During oral argument it became clear to the court that, putting aside the question of a duty to warn, there may be causation problems that were not fully briefed and which may be dispositive on the issue. So, the court requested further briefing on causation.

We’ll be on the lookout for further ruling after the supplemental briefing, but for now we will give you our unsolicited thoughts.  There are many things in life that make sense when done after the main event. Like reheating those Thanksgiving leftovers or sending a thank-you card. But issuing a post-sale duty to warn about an implantable medical device that was implanted years before you even owned the product? That’s not one of them. That’s more like being asked to apologize for a joke someone else told at a party you weren’t invited to.

Remember, Coopersurgical did not make the device implanted in these plaintiffs, did not sell the device implanted in these plaintiffs, did not profit from the device implanted in these plaintiffs, and, crucially, did not even own the product’s NDA until long after the device had been implanted. In this scenario, we agree with the judge that it is nearly impossible to discuss the duty without examining causation. Because whatever warning plaintiffs claim should have been made, the reality is Coopersurgical could not have issued that warning until long after plaintiffs’ doctors made the medical decision to prescribe the IUDs.    

Even if we play along with the idea that there can be a post-sale duty to warn imposed on a successor, causation immediately collapses. A warning issued years after implantation cannot possibly influence the prescribing decision of a surgeon who acted years earlier. Absent time-travel or wormhole technology, there is simply no causal pathway. 

Not surprisingly, we are not fans of post-sale duties to warn generally. But context matters. A post-sale duty to warn makes sense only when the party being saddled with the duty had some ability—actual, practical, temporal—to affect the risk. When the defendant purchased the NDA years after implantation, that ability is precisely zero. The entire concept of post-sale warnings assumes there is a practical way to reach users. That might make sense for toasters, leaf blowers, or lawn chairs. With IUDs, and many implanted devices, by the time a successor company enters the picture, the device is: already implanted, already functioning, and past the point where any newly added warning could possibly influence the clinical decision that put it there.

In the end, the law should stay grounded in reality. Post-sale duties should apply to those who had control at the time the risk could be avoided—not to those who merely entered the story years later. Because we can’t expect warnings to travel backward in time. Not even the Restatement contemplates that. And unless the defendant has secretly been hiding a flux capacitor, neither should the courts.

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Some of us are old enough to remember when the Kessler-led FDA attacked off-label use of prescription medical products by using archaic language in the agency’s “intended use” regulations (21 C.F.R. §§201.128, 801.4) to claim that a regulated entity’s mere knowledge that its products were being used off-label by physicians meant that those products were “misbranded” or “adulterated.”  He failed, and eventually those regulations were revised specifically to reject that reading.  Since 2021, they have included the sentence:  “provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm’s knowledge that such drug was being prescribed or used by health care providers for such use.”  Id. (emphasis added).  In the course of the rulemaking leading to this amendment, the FDA expressly disclaimed any mere knowledge standard.  85 Fed. Reg. 59718, 59720 (FDA Sept. 23, 2020); 82 Fed. Reg. 14319, 14320 (FDA March 20, 2017).  We discussed the process that led to that amendment several times, most recently here.

Unfortunately, the plaintiffs’ lawyers and other ideologues that are now running the DoJ, FDA (and other American health agencies) into the ground are at it again – despite the 2021 amendment.  Apparently, they will argue anything and everything in their attempt to prohibit any doctor anywhere from offering “gender-affirming care.”  Because such treatments involve off-label use of various drugs, the government is now offering absurd legal arguments seeking to prohibit doctors from using those FDA-regulated product off-label – without regard to how they would affect off-label use generally.  Recall that the Supreme Court has held:  “[O]ff-label use is generally accepted” under the law as a “necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001).  Interference with medical practice is precisely what the FDA is trying to do by reversing its off-label use positions.

Fortunately, the courts are rejecting this ideologically driven [b]administration regulatory flip-flop.  Specifically, they are rejecting the government’s attempt to restrict off-label use in the context of pretextual subpoenas that the Justice Department (“DoJ”) has issued, ostensibly to investigate “off-label promotion.”  In re Subpoena No. 25-1431-014, ___ F. Supp.3d ___, 2025 WL 3252648, at *17-19 (E.D. Pa. Nov. 21, 2025); QueerDoc, PLLC v. U.S. Dept. of Justice, 2025 WL 3013568, at *2 (W.D. Wash. Oct. 27, 2025); In re Administrative Subpoena No. 25-1431-019, 2025 WL 2607784, at *6-7 (D. Mass. Sept. 9, 2025).  The most recent, No. 25-1431-014 decision is by far the most extensive, so we will focus on it.

These cases all involve intrusive and expensive DoJ subpoenas issued against hospitals and other healthcare providers that offer gender-affirming care in states where such treatments are legal under state law.  The government’s position in No. 25-1431-014 was outlined by the DoJ’s Director of the Department of Justice’s Enforcement and Affirmative Litigation Branch, who asserted that:

a drug manufacturer or other person distributes a misbranded or unapproved drug simply by prescribing or administering an approved drug for an unapproved indication and to the extent these drugs are intended to treat gender dysphoria in minors, they constitute unapproved new drugs under federal law, and their distribution for that unapproved indication violates the [FDCA] and is a federal crime.”

2025 WL 3252648, at *18 (quotation marks omitted).

No way; no how.  “The Director’s assertion is wrong as a matter of law.”  Id.  The federal government does not regulate the practice of medicine – states do, and the medical treatments being “investigated” were legal in the state in question:

The practice of off-label prescribing . . . is lawful in Pennsylvania and clinicians “are free to exercise their professional judgement [sic] to prescribe [FDA]-approved drugs for any use they see fit.”

Id. (quoting Sommers v. UPMC, 185 A.3d 1065, 1072 n.6 (Pa. Super. 2018)).  “Even taken at face value, these concerns describe policy disagreements about the propriety of medical care left to the [states] since the Nation’s founding and not a federal crime under the Act.”  Id. at *17.

The government’s attack on off-label use:

rests on an admittedly unprecedented interpretation of the [FDCA].  The Department seeks to transform Congress’s regulation of the manufacture, distribution, and labeling of drugs into a vehicle for federal oversight of how physicians diagnose, treat, and counsel child patients.

Id.  As Buckman held, there is nothing illegal about off-label use:

Both the [FDA] and our colleagues long recognized off-label prescribing − the use of an approved drug for an unapproved indication − is lawful and beyond the Act’s reach.  Although the Act regulates a manufacturer’s distribution of drugs, it does not go further by regulating a doctor’s practice of medicine.”  Congress likewise expressly preserved state authority over medical practice, providing in part, “[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease.”  The Food and Drug Administration can only regulate the marketing and labelling of devices.  It cannot regulate what physicians do with the devices with respect to their patients.

2025 WL 3252648, at *17 (footnotes omitted).  In addition to citing Buckman and quoting 21 U.S.C. §396, these footnotes provide extensive additional authority.  That authority, and much more, on every off-label use-related point the No. 25-1431-014 opinion is found in James M. Beck, “Off-Label Use in the Twenty-First Century:  Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021).

Another error in the government’s position was “stretch[ing] the concept of ‘labeling’ to suggest ordinary clinical documents may qualify as ‘false or misleading labeling.”  This argument lacked any legal basis, since “labeling” is only issued by entities, such as “manufacturers, packers, or distributors,” that the FDA regulates, and the FDA does not regulate hospitals or doctors.  No. 25-1431-014, at *18.  Nor are medical care providers “part of the ‘chain of distribution’ of a drug.”  Id.  That was crazy talk:

This theory has no cognizable bounds; it defies both law and logic.  Accepting this interpretation would transform every act of treatment into a potential federal offense.  And be directly contrary to Congress’s mandate.

*          *          *          *

[T]he first clause simply restates [DoJ’s] assertion using an approved drug for an unapproved indication renders it an “unapproved new drug” and the second echoes the misbranding provision which requires manufacturer labeling to include “adequate directions for use.”  Neither theory governs physicians acting within their state-regulated scope of practice − prescribing or administering [FDA]-approved drugs in the exercise of professional medical judgment.  Misbranding liability, as Congress structured it, attaches to those who design, control, or disseminate a drug’s labeling − such as manufacturers and distributors − not to physicians engaged in patient-specific treatment.  Clinicians neither create a drug’s labeling nor define its “intended use” under the Act.

Id. (more footnotes omitted).  The DoJ’s position was an unprecedented, big-government power grab against the states’ authority to regulate the medical profession:

The prescription-drug framework rests on licensed practitioners exercising medical judgment rather than layperson-directed labeling.  Nothing in the Act treats a physician’s diagnosis, counseling, or prescription decisions as misbranding.  The DoJ’s disavowal of criminal intent thus conflicts with (and does not cure) the premise underlying [DoJ’s] belief off-label medical practice itself violates the Act.  We again cannot fathom where [DoJ’s] theory would lead in prosecutions of clinicians who exercise their learned judgment to find these drugs will help their child patients and the Commonwealth agrees with them.

Id.

Further, the DoJ attack on off-label use was indeed unprecedented.  The only authority DOJ offered in No. 25-1431-014 was completely inapposite – involving prosecutions of physicians for prescribing “drug[s] the Food and Drug Administration had not approved as safe for any use.”  Id. at *19 (emphasis original).  In sum:

The [DoJ] hopes to reinterpret Congress’s longstanding mandate in the Act to reach lawful clinical care.  Extending it so far would subvert Congress’s design, erase the long-recognized boundary between drug regulation and the practice of medicine, and intrude upon Pennsylvania’s sovereign authority to oversee the medical profession in the Commonwealth guaranteed under the Tenth Amendment.  Such an interpretation would seem to disregard the limits of Congress’s intent and risk undermining the physician-patient relationship and open, evidence-based communication about care − a result at odds with both Congress’s direction . . . and sound medical practice set by the Commonwealth.

No. 25-1431-014, at *19.

Yet another bogus legal proposition is lurking beneath the surface in No. 25-1431-014.  The DoJ also demanded production of individual “informed consent” documents in the subpoena.  Id. at *7.  It claimed these files were “relevant” to “prove . . . informed consent, and disclosure of off-label use is key to assessing whether the [target of the subpoena] concealed or downplayed risks.”  Id. at 13 (emphasis added).  While not addressed in the No. 25-1431-014 opinion, that’s also legally incorrect.  Federal informed consent standards only exist in the context of FDA-regulated clinical trials, and off-label use is not FDA regulated.  For authority on that point, see Bexis’ article, 54 UIC J. Marshall L. Rev. at 35-37, 92-93 & nn. 167-75, 481-84.  Like off-label use itself, the applicable informed consent standards are also a matter of state law, and state law overwhelmingly requires discussion of medical risks and benefits – not FDA regulatory status – in informed consent discussions.  The target in No. 25-1431-014 was a Pennsylvania hospital, and Pennsylvania’s informed consent law follows the majority view:

We see no reason to expand the information that surgeons traditionally impart to their patients to encompass a device’s FDA regulatory status.  We agree . . . that the FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery.  The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results.  The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure.  It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed regarding the procedure.

Southard v. Temple University Hospital, 781 A.2d 101 (Pa. 2001).  The same decision also calls out the misconception that, somehow, informed consent standards only applicable to federally regulated clinical trial standards should control:

[Plaintiffs] further rely on a line of cases involving clinical investigations which are conducted pursuant to FDA regulations (“Investigational Device Exemptions”, or “IDEs”).  The FDA permits such investigations in order to encourage the discovery of useful medical devices.   In turn, physicians who participate in an IDE voluntarily agree to abide by numerous procedures, including obtaining a patient’s informed consent of the proposed clinical testing.  [Plaintiff] was not a patient in one of these investigations.  [Plaintiffs] argue that surgeons who perform “experimental surgery” outside of these FDA-monitored investigations should not be held to a lesser standard of disclosure; rather, they too should be required to disclose the “investigational nature of the procedure”  [They] improperly equate the two situations.  Merely because a device is deemed “investigational” for purposes of an IDE does not establish that the device is “experimental” or “investigational” for all medical purposes. . . .  We therefore decline to subject those physicians who do not voluntarily participate in FDA clinical investigations to the purview of the FDA’s requirements for such investigations.

Id. at 107-08 (citations, footnotes, and quotation marks omitted).  For other decisions reaching the same result in numerous state-law informed consent cases, see 54 UIC J. Marshall L. Rev. at 84-86 & nn. 443-53, and several prior posts.  This argument, as well, represents a massive attempted federal encroachment on state law.

Because the legal underpinnings of DoJ’s attempt to subpoena patient records from health care providers under the pretext of investigating off-label promotion” that was “illegal” under the FDCA was 100% invalid, the subpoenas in question were invalid and stricken.  No. 25-1431-014, at *19.

Note:  for anyone who is interested, No. 25-1431-014 also conducted a detailed, six-factor analysis of the applicable privacy-related balancing test for subpoenas generally, under the Third Circuit’s controlling United States v. Westinghouse Electric Corp., 638 F.2d 570 (3d Cir. 1980), decision, and ruled against the government on that basis as well.  See No. 25-1431-014, at *19-33.

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It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that.  Too much food, too much drink, too much family, and not quite enough presents.  Or, at least, not enough of the right presents.  Or, maybe, lots of those veritable mixed bags.  You know – a six pack of Samuel Smith’s oatmeal stout (for the moment, we will forget about that ‘too much drink’ remark above), and a six pack of white tube socks.  You smile ruefully at the socks. Then you reach for the bottle opener.

Today’s case, Weider v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), is a mixed bag.  To be sure, it is mostly good. It contains a splendid class III, premarket approval (PMA) preemption decision by a magistrate judge.  At the same time, it is slightly spoiled by a case-specific negligent undertaking claim about post-implant testing surviving non-preemption challenges.  We’ve been talking in terms of holiday gifts, but tomorrow’s holiday is Thanksgiving, so let’s consider Weider in a different way. The application of preemption is like the delightful, satisfying turkey, spuds, stuffing, and cranberries.  But at the end, squatting in squalid loneliness on the plate is the lump of turnips.  Do we really have to eat that? We look over at Aunt Marie, who made the turnips, just like she has for 60 years.  Yes, we have to.

Let’s set the table. The product was a cochlear implant.  The plaintiffs were suing on behalf of their child, who had received the cochlear implant. They alleged that an inadequate seal permitted moisture ingress, which caused a short circuit in the medical device, which caused a malfunction, which caused permanent problems in terms of hearing and the patient’s ability to speak and learn. The plaintiffs’ first amended complaint (FAC) contained claims of manufacturing defect, design defect, breach of an implied warranty of merchantability, violations of New York General Business Law sections 349-50, negligent failure to warn, negligence, and loss of services. The defendant moved to dismiss the FAC on the grounds that it was preempted by federal law and/or otherwise failed to state a claim for relief. That motion succeeded — mostly. 

First, the plaintiffs failed to allege any manufacturing defect with sufficient specificity.  New York law, like most places, provides that a strict liability manufacturing defect claim be supported by a showing that the product did not perform as intended because of “some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction.” To get past the Riegel/Medical Device Amendments section 360k(g) express preemption of any requirement that is “different from, or in addition to, any requirement applicable to a medical device under the Food, Drug, and Cosmetic Act (FDCA) the plaintiff must hang a manufacturing defect on a violation of a state rule that is parallel to the federal rule.  The plaintiff in Weider failed that test. The FAC included a conclusory laundry list of purported Current Good Manufacturing Practice (CGMP) violations, including an alleged inconsistency, but that was not enough. It alleged that the silicone seal was “applied manually by manufacturing workers,” but that was not enough. The FAC also cited to a voluntary recall, but that bare fact was not enough. It certainly did not establish an unpreempted design defect.    

Second, the design defect claims facially challenged what the Food and Drug Administration (FDA) approved and were, therefore, preempted. Under New York law, “[t]o establish a prima facie case for design defect, the plaintiff must show that the defendant breached its duty to market safe products when it marketed a product designed so that it was not reasonably safe and that the defective design was a substantial factor in causing plaintiff[‘]s injury.”  The design defects alleged in the FAC were either too vague or actually sounded like manufacturing defects, but either way, the FAC’s allegations “directly challenge[] the FDA’s judgment in approving the allegedly defective” design “and thereby seek to “impose different or additional standards” on the product line “in violation of the MDA.”

Ditto for implied warranty.  The parties agreed that the warranty claim “rises or falls with the[] manufacturing defect and design defect claims.” So they fell.

Similarly, the negligent warning, consumer fraud, and fraud claims challenged FDA-approved warnings and were, again, preempted. The guts of these claims was that the defendant allegedly did not disclose the true failure rate of the cochlear implants. According to the plaintiffs, the disclosure of the true failure rates should have been included in various “consumer-oriented” statements. But the plaintiffs offered no allegations that the defendant made statements contrary to what the FDA approved. Moreover, even if New York law can be construed to mandate non-physician warnings, the FDCA does not. Consequently, the plaintiffs’ theory would impose a state requirement that is “different from, or in addition to” the FDA’s requirements.  Hello, FDCA preemption, goodbye claims.  

The negligent warning claim based on failure to report allegations was also preempted. Under New York law, device warnings go to learned intermediaries, not regulatory agencies.  The FDA is not a learned intermediary. After all, the FDA does not treat patients. Further, there is no basis to believe that a warning to the FDA “necessarily or even likely results in a warning to treatment providers.” A failure to warn claim under New York law would be “different from, or in addition to” a manufacturer’s duty to supply adverse event reports to the FDA. In any event, factually, the plaintiffs’ warning claims were conclusory and contradictory.  

So far, so good. Now we get to the turnips or, if you prefer, the not so good present. (Think of the Jelly of the Month club certificate that Clark Griswold gets in National Lampoon’s Christmas Vacation). The negligent undertaking claim rested on Restatement of Torts (Second) section 323, which provides that one “who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other’s person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking if (a) his failure to exercise such care increases the risk of such harm, or (b)the harm is suffered because of the other’s reliance upon the undertaking.” Call it the no-good-deed-goes-unpunished proposition. The plaintiffs contended that a sales representative of the manufacturer conducted “integrity testing” of the subject device and incorrectly concluded that it was working properly. The defendant did not contend that a negligent undertaking claim based on a representative’s testing of the device while implanted was preempted. Rather, the debate was whether there was any duty in this case. The defendant pointed to New York cases holding that a manufacturer is not generally responsible for how a physician uses a device and renders medical care, and that New York law does not recognize a duty to test.  But the Weider court concluded that the plaintiffs’ factual allegations about known problems with the testing were sufficient to state a negligent undertaking under New York law.  Thus, the negligent undertaking claims, as well as the claim for loss of services, were the only causes of action that escaped preemption in Weider.

In the spirit of the season, we will not grouse unduly about the survival of what we see as frail causes of action,  Instead, we’ll give thanks for the excellent preemption rulings. And you’ll be thankful that we are abstaining from any turkey or other fowl puns.

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Today’s guest post is from Dechert’s Chris McKeon who updates us on a rare application of the political question doctrine. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter.

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In our earlier post, we explored whether the political question doctrine can supply a jurisdictional off-ramp for design-defect claims against FDA-approved prescription drugs.  The district court in Caston embraced that idea in a seemingly novel way, holding that “pharmaceutical design defect claims challenging active ingredients necessarily implicate a nonjusticiable political question” because re-evaluating—years after the fact—FDA’s safety and efficacy determinations is “heavily scientific, and indeed economic and political, but not judicial.”  Caston I, 729 F. Supp. 3d 930, 946 (N.D. Cal. 2024). 

The Ninth Circuit has now weighed in.  In an unpublished and nonprecedential decision, the panel affirmed in part, vacated in part, and remanded—rejecting the district court’s political-question dismissal, affirming dismissal for lack of personal jurisdiction against one set of Defendants, and giving Plaintiffs a chance to re-plead Article III standing for their medical-monitoring theory against the remaining Defendants.  Caston II, No. 24-2920, 2025 WL 3205856 (9th Cir. Nov. 17, 2025).  The opinion returns this case to the well-trodden battlegrounds of products liability: jurisdiction, preemption, and standing.

The panel began by characterizing the political question doctrine as a “narrow exception” that applies only when adjudication will “certainly and inextricably” require courts to decide issues constitutionally committed to another branch.  Caston II, 2025 WL 3205856, at *1.  Citing Zivotofsky v. Clinton and Cooper v. Tokyo Electric Power, the panel held: “The district court erred in dismissing [Plaintiffs’] products-liability claims under the political question doctrine based on the FDA’s approval of mefloquine.”  Id.

Next, the panel leaned on a numbers-based approach, asserting that “[f]ederal and state courts have consistently adjudicated design-defect and failure-to-warn claims regarding FDA-approved pharmaceuticals without treating them as nonjusticiable.”  Id.  The panel pointed to Bartlett, Wyeth v. Levine, and Mensing—all cases that addressed preemption, not justiciability.  Id.  The takeaway is clear: in the panel’s view, the mere fact that a product is subject to FDA regulation does not convert ordinary tort claims into political questions, though the panel’s citations tally decisions rather than engage in the justiciability analysis.

What about the military overlay?  The panel was cautious: “It would be premature to invoke the political question doctrine based on the military’s approval of mefloquine.  [Plaintiffs] argue that their claims rest on [Defendants’] own conduct without requiring judicial review of military judgments.  At this stage, it is speculative to consider how the military dimension of the political question doctrine might come into play. The district court may revisit the issue at a later stage of this litigation.”  Id.  That leaves room for a properly developed government-contractor defense or a Baker v. Carr analysis if the record later shows that adjudication would intrude on the military’s decisions.  But the panel refused to assume that intrusion now.

At the very least, the panel affirmed dismissal of claims against the Roche Defendants for lack of personal jurisdiction.  Caston II, 2025 WL 3205856, at *2.  On specific jurisdiction, the panel emphasized the locus of ingestion and injury: “[Plaintiffs’] claims arise from their ingestion of mefloquine overseas and at East Coast military bases—not in California.”  Id.  Thus, Plaintiffs could not show that their injuries “arise out of or relate to” California-directed conduct by Roche.  In addition, allegations of national distribution and a California presence by a military agency were insufficient: “mere placement of a product into the stream of commerce, without more, is not purposeful direction toward the forum.”  Id. (citation omitted).

The panel held that Plaintiffs’ medical-monitoring allegations did not establish Article III standing but remanded to permit amendment “to clarify how the requested monitoring program would likely redress their alleged injuries.”  Id. (citation omitted).  Finally, the Greentech Defendants cannot obtain dismissal on preemption grounds—at least not under Mensing—as Greentech is not a generic manufacturer.  Id. at *3.

Bottom line, FDA regulation does not make routine pharma torts nonjusticiable, and without a record showing adjudication would certainly and inextricably intrude on another branch—military issues included—the political question doctrine inquiry is premature; the district court’s ruling will not stand, and Caston returns to familiar terrain where the ultimate outcome will turn on facts, other legal bases, and careful framing.

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Another two years have elapsed (since October, 2023) since we last updated our cheat sheet devoted to ediscovery for defendants.  That’s because finding good, pro-defense ediscovery decisions is a hard and time-consuming task – and getting harder.  Unlike most of our other cheat sheets and scorecards, cases involving defense discovery of plaintiffs’ social media can be found in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, anything where a plaintiff’s personal conduct could be relevant.  That means our various automatic Westlaw/Lexis searches designed to find drug- and medical device-related decisions aren’t nearly enough.  Ediscovery research is problematic because any search broad enough to be comprehensive also produces a lot of cases having nothing to do with the topic.  And as social media and text messaging becomes ever more ubiquitous, more and more cases mention it.  This time we had reviewed a thousand cases, and our cutoff was to some extent arbitrary.

But we bit that bullet, and this post contains our latest additions (also added to the cheat sheet itself) of ediscovery decisions that are both:  (1) on point, and (2) favorable to our side of the “v.”  We’re picky.  Each of the new cases below either allows essentially all the access to some plaintiff’s social media activity that a defendant sought, or imposes significant sanctions (such as spoliation) on a plaintiff who improperly failed to comply with social media discovery.  We have now compiled more than 250 decisions from some 40 American jurisdictions (and three Canadian provinces) – all supporting defendants’ rights to take discovery of plaintiffs’ social media.

We add our usual caution about defense-side social media ediscovery.  We continue to believe that it’s not a good idea for a defendant to follow the other side’s usual playbook – to make a broad request for everything social-media-related at the beginning of the case – instead send a preservation letter, or even better get a court preservation order.  Courts don’t tend to give defendants the same latitude as plaintiffs to make wide-ranging discovery demands, and the likely result is “no, that’s a fishing expedition.”  A defendant is much more likely to succeed with a blanket social media discovery demand once it has caught the plaintiff in some kind of chicanery – such as particular public social media content contradicting either plaintiff’s own discovery responses or some open-court representation − or when a plaintiff is found to be deleting or otherwise hiding social media activity.  Take the initiative and investigate.  Engage in some self-help (but don’t mislead anyone).  Once a plaintiff is caught, broader social media discovery follows more easily.

Thus, without hard evidence of the other side’s concealment, starting small, with less intrusive social media discovery is more likely to succeed.  If there’s potentially a lot out there, engage an ediscovery specialist and perhaps propose sampling – 5% or 10% of the entire universe of posts – as something less intrusive, but statistically likely to find uncover contradictory statements.  An active social media user (the kind most likely to generate useful information) usually has thousands of potentially discoverable items.

With these caveats, here are the latest favorable decisions allowing defendants to conduct ediscovery of plaintiff social media:

  • Kutz v. NGI Capital, Inc., 2023 WL 3790766 (D. Minn. June 2, 2023).  Plaintiff is ordered to produce social media, text messages, emails, and accompanying photographs within a set time period around the allegedly emotional events involved with the litigation.
  • Acon v. Long Island Gay & Lesbian Youth, Inc., 2023 WL 12073648 (Mag. E.D.N.Y. July 7, 2023).  Plaintiff claiming emotional distress ordered to produce social media content, including photos, videos, captions, comments, and messages, that:  (1) relates to the allegations in the complaint; (2) contains specific references to or depicts the emotional distress plaintiff claims or resulting treatment or (3) refers to or depicts an alternative potential stressor.  Plaintiff must also preserve all social media activity for the duration of the litigation and inform the defendant of all the social media platforms that she has used and all usernames.
  • Taneja v. Freitas, 2023 WL 4866452 (W.D. Wash. July 31, 2023).  Plaintiffs clearly incomplete production of their text messages warranted monetary sanctions.  Plaintiffs never explained how responsive messages were omitted.
  • Gibbs v. Abt Electronics, Inc., 2023 WL 6809610 (N.D. Ill. Oct. 16, 2023).  To investigate plaintiff’s mitigation of damages, defendant is entitled to full and complete discovery regarding plaintiff’s post-termination online job search efforts including ESI from the websites he utilized.
  • Johnson v. Estate of Hazen, 2023 WL 7186883 (Mag. D. Kan. Nov. 1, 2023).  Plaintiff is compelled to produce all his social media posts, including non-public posts to “friends,” since the date of the accident in question that relate to his physical abilities, activities, injuries, or lack thereof.
  • Ball v. Hudson Insurance Co., 2023 WL 8190152 (Mag. M.D. La. Nov. 27, 2023).  Plaintiff ordered to produce all social media posts from the date of the alleged accident to the present, relating to the accident; her physical injuries, medical treatment, and claimed disabilities or limitations; her job or employment status and ability to work; and reflecting capabilities inconsistent with her alleged injuries.
  • Wingo v. 3M Co., 2023 WL 8714499 (Mag. D. Minn. Dec. 18, 2023).  Plaintiffs’ failure to disclose social media and text messages was comprehensive, misrepresented, and allowed them to give contradictory deposition testimony.  Plaintiffs must explain why defendant should not recover its additional costs incurred in pursuing social media discovery.  Further failure to comply will result in plaintiffs’ claims being dismissed with prejudice.
  • Militante v. Banner Health, 2023 WL 12073895 (Mag. D. Ariz. Dec. 20, 2023).  Social media discovery is relevant to causation and extent of plaintiff’s alleged emotional injuries.  Discovery responses must include non-public social media.  That defendant had access to public social media does not excuse plaintiff from producing it.
  • S.C. v. Wyndham Hotels & Resorts, Inc., 2024 WL 21548 (N.D. Ohio Jan. 2, 2024).  Plaintiff ordered to produce a full download of her social media.  A full download is not burdensome, since social media will contain little if any privileged information, particularly since it predates the suit.  A confidentiality order is in place.  The social media activity is closely related to core issues, how the alleged illegal conduct began, and damages.
  • Cronick v. Pryor, 2024 WL 50194 (D. Colo. Jan. 4, 2024).  Sanctions imposed.  Plaintiff’s inexplicable failure to produce relevant social media content amounts to a willful discovery violation.  Her nonsensical reasons strongly suggest purposeful obstruction.  Plaintiff must pay defendant’s costs and an adverse inference of some sort will be given.
  • Johnson v. Knox County Schools, 2024 WL 2029196 (Mag. E.D. Tenn. Jan. 29, 2024).  Forensic examination of plaintiff’s cellphone ordered in light of unexplained disappearance of relevant text messages.  Production of missing messages from other persons has been incomplete.  From the results of that examination, plaintiff shall produce all relevant text messages.
  • Alsaadi v. Saulsbury Industries, Inc., 2024 WL 460050 (Mag. D.N.M. Feb. 6, 2024).  Plaintiff’s supplemental productions belie her statement that she has no more responsive text messages.  Parties are required to make a diligent search for responsive documents upon receipt of discovery requests.  Plaintiff apparently has not.  Plaintiff must produce the additional messages or certify exactly what  searches she has undertaken to find responsive information.
  • Doe 1 v. National Collegiate Athletic Assn., 2024 WL 643038 (S.D. Ind. Feb. 15, 2024).  Plaintiffs may not hold plainly discoverable ESI hostage to the defendant agreeing to limits that they demanded on other material.  Plaintiffs shall produce an export of all information associated with each of their social media accounts, including any private messages.  Automatic production is not burdensome.  Privacy concerns can be addressed through protective orders and sealing.
  • Lin v. Solta Medical, Inc., 2024 WL 858750 (N.D. Cal. Feb. 15, 2024).  Since plaintiff claims the occupation of “social media influencer,” all of her social media posts, public and private are relevant to her claimed damages and must be produced, including accounts plaintiff claims are jointly owned and operated.  Plaintiff must also identify any omitted social media accounts.  Plaintiff must produce social media for the entire period for which she seeks damages.
  • Doe v. Carnival Corp., 2024 WL 4003709 (S.D. Fla. Feb. 22, 2024).  Plaintiff compelled to produce entire group chat following three insufficient partial productions.  Discovery reopened to accommodate the ordered full production.
  • Treminio v. Crowley Maritime Corp., 2024 WL 1075433 (M.D. Fla. March 12, 2024).  As a sanction for plaintiff’s unexplained deletion of relevant emails from her cellphone, defendant is entitled to a forensic examination of all of plaintiff’s devices paid for by plaintiff.  Additional discovery is also ordered.
  • Gorman v. Douglas County Sheriffs’ Office, 2024 WL 1211798 (D. Or. March 21, 2024).  Plaintiff delayed producing texts and social media from his cellphone and then spoliated his entire cloud backup.  Digital extraction was not unreasonable, given the suspiciously timed damage to the cellphone.  The loss of text messages and other ESI threatened to distort the resolution of the case.  Since summary judgment has been entered on the merits, an appropriate sanction is payment of the costs and attorney fees incurred in obtaining the digital extraction.
  • Windish v. 3M Co., 2024 WL 1604012 (E.D. Pa. April 12, 2024), aff’d, 2025 WL 572386 (3d Cir. Feb. 21, 2025).  Plaintiff repeatedly and deliberately violated orders to produce social media discovery.  She lied about her extent of use and about discussions with others employed by defendant.  Relevant social media discovery was plainly covered by the court’s order and within plaintiff’s control.  Even now, significant discovery remains undone.  Plaintiff’s action is dismissed with prejudice.
  • Ramsey v. Snorkel International, Inc., 2024 WL 1834365 (Mag. D. Kan. April 26, 2024).  In light of prior inadequate productions, plaintiff is ordered to conduct a diligent search of all social media and email accounts, supervised by his counsel.  Counsel is ordered to serve a signed certification as to his supervision.  If dissatisfied, defendant can pay for a forensic search of these accounts, with which plaintiff must cooperate, with sanctions possible.
  • Vorhees v. Esurance Insurance Services, Inc., 2024 WL 1972899 (W.D. Wash. May 3, 2024).  Motion to compel granted.  Defendant’s request for plaintiff’s social media posts from the date of the accident through the present is relevant and proportional.  Social media information revealing that the plaintiff is lying or exaggerating the claimed injuries should not be protected from disclosure.
  • Schall v. Nodak Insurance Co., 2024 WL 2355714 (Mag. D. Neb. May 23, 2024), objections overruled, 2025 WL 50144 (D. Neb. Jan. 8, 2025).  Plaintiff compelled to produce social media posts, pictures, videos as relevant to his emotional distress claim.
  • Saunders v. Signature Flight Support, LLC, 2024 WL 5671955 (Mag. M.D. Fla. June 4, 2024), adopted, 2024 WL 5671946 (M.D. Fla. Sept. 12, 2024).  Dismissal with prejudice ordered for extended failure to produce cellphone text messages, including making numerous false statements in court filings and at hearings and producing data in a manifestly inadequate form of a video of a scrolled computer screen.
  • Vancza v. Marist College, 2024 WL 3026683 (Mag. N.D.N.Y. June 17, 2024).  Plaintiff ordered to pay for a complete forensic examination of her cellphone due to spoliation of evidence and non-disclosure of her replacing the phone and failure to transfer relevant messages.  Plaintiff was consistently non-cooperative with ESI discovery.
  • M.A. v. Wyndham Hotels & Resorts, Inc., 2024 WL 3029215 (S.D. Ohio June 17, 2024).  Plaintiff’s deposition was reopened as a sanction for extended refusal to produce critically relevant social media activity.  For years, declined to identify any friends or family with whom she interacted during the relevant period.
  • Kellar v. Union Pacific Railroad Co., 2024 WL 3818535 (Mag. E.D. La. July 26, 2024), adopted, 2024 WL 4649244 (E.D. La. Oct. 17, 2024).  Plaintiff’s failure to provide the ordered complete extraction of cellphone data warranted adverse inference and monetary sanctions.  Plaintiff’s counsel failed to ensure preservation.  Instead it turned out that the phone had been factory reset, causing all the relevant data to be irrevocably lost.  Evidence indicated intentional spoliation.
  • Hernandez v. Thomas, 2024 WL 3511640 (Mag. S.D. Ga. July 23, 2024).  Defendant is entitled to unfettered forensic access to plaintiff’s cellphone and to any separate cloud backup.  Newly produced extraction data included numerous text messages, photos, and videos that were not included in the initial extraction.  Plaintiff’s explanations for late and incomplete production of social media and text messages has been inconsistent and possibly perjured.  There is also evidence of spoliation.
  • Michaels v. Embry-Riddle Aeronautical University Inc., 2024 WL 5484096 (M.D. Fla. Aug. 21, 2024).  Motion to compel granted for plaintiff’s social media and text messages.  Plaintiff is required to engage an ediscovery specialist to ensure she discharges her discovery obligations.
  • Pashaie v. H77LA, LLC, 2024 WL 4800698 (Mag. C.D. Cal. Sept. 9, 2024).  Motion to compel granted ordering plaintiff to obtain and pay for imaging of his cellphone so that all texts can be searched.  Counsel fees are also awarded.
  • James v. Professional Contract Services, Inc., 2024 WL 4858593 (Mag. S.D. Ga. Nov. 21, 2024).  Plaintiff must produce all phone records and text messages relevant to his claims in this lawsuit within 30 days.
  • Bailey v. Recreational Equipment, Inc., 2024 WL 4957279 (Mag. E.D.N.Y. Nov. 21, 2024).  Discovery of a party’s social media information provides relevant information about that person’s emotional or mental state, physical condition, level of activity, impact on employment, and the injuries claimed.  Defendant’s tailored discovery is appropriate and not invasive.  Plaintiff must produce responsive social media or a sworn affidavit that there are none and must also swear to the status of his former accounts and what efforts he made to comply with discovery of them.
  • Long v. Pratt (Target Container), Inc., 2025 WL 305881 (Mag. M.D. Fla. Jan. 27, 2025).  Plaintiff ordered to produce all text messages between her and two witnesses.  Her incomplete and disjointed voluntary production was insufficient.
  • Jones v. AssuredPartners NL, LLC, 2025 WL 373449 (W.D. Ky. Feb. 3, 2025).  Defendant is entitled to all electronic communications between the specified individual plaintiffs.  Forensic evidence is suggestive of spoliation.  The discovery is proportionate to the case.  Much of discovery is a fishing expedition, but with the courts determining the pond, the lures, and how long parties may keep their lines in the water.
  • Witham v. Hershey Co., 2025 WL 444399 (Mag. D. Minn. Feb. 10, 2025), adopted, 2025 WL 841024 (D. Minn. March 18, 2025).  Plaintiff’s production of social media was non-compliant and his use of search terms that created himself is hopelessly inadequate.  His counsel are responsible for ensuring that what is produced in discovery is both responsive and compliant.  Plaintiff must produce all responsive text messages and email communications, including the metadata and other accompanying information.  Plaintiff cannot skirt his responsibility to comply with his discovery obligations with vague allegations of undue burden or disproportionate cost.
  • Arnold v. Huntington Ingalls Inc., 2025 WL 2377664 (Mag. E.D. Va. May 30, 2025), adopted, 2025 WL 1879875 (E.D. Va. July 8, 2025).  Plaintiff violated an order to produce cellphone texts in a sequential, complete, and accurate manner.  Plaintiff’s haphazard compliance over an extended period shows bad faith.  Sanctions against pro se plaintiff to be determined.
  • Heym v. APG Housing, LLC, 2025 WL 1661414 (D. Md. June 11, 2025).  Plaintiffs ordered to produce responsive communications, including text messages and social media posts, concerning the house at issue and all injuries and losses.  The information is plainly relevant.
  • Pable v. Chicago Transit Authority, 145 F.4th 712 (7th Cir. July 28, 2025).  Monetary sanctions and ultimately dismissal of plaintiff’s suit with prejudice as a sanction for spoliation of ephemeral electronically stored information (Signal) affirmed.   Plaintiff’s explanation of the deletion “evolved over time,” justifying the trial court’s conclusion that the spoliation was intentional.  During discovery, plaintiff’s attorney attempted to hide the scope of the deletions.  In addition to his own sanctionable conduct, plaintiff was legally responsible for the conduct of the attorney he hired.
  • L.F. v. EF Educational Tours,  2025 WL 2777586 (M.D. Pa. Sept. 29, 2025).  Requests for social media information that supports, mentions, or contradicts a plaintiff’s allegations is relevant and discoverable.  Defendant is entitled to discovery of the minor plaintiff’s social media activity during the overseas trip where the alleged assault occurred.  Plaintiffs initially  misrepresented the existence of responsive electronically stored information.  Even after deposition testimony established regular texting, plaintiffs have not produced them.  Plaintiffs’ counsel refused to produce other ESI, and the results of his forensic extraction have proven to be incomplete.  An overseas trip with classmates and an alleged sexual assault, would usually entail an adolescent communicating with her peers and family.  Plaintiffs must produce all texts occurring during the trip and for a week before and after involving them or anyone involved with the trip.  Given past conduct, plaintiffs are further ordered to provide ISP authorizations for release of messages.
  • Koon v. Ricoh USA, Inc., 2025 WL 3022642 (Mag. D. Neb. Oct. 29, 2025).  Plaintiff’s actions cast doubt on his claim that he has no more unproduced text messages.  Text messages are routinely produced.  Either plaintiff can submit his phone to a forensic recovery vendor of his choosing, or the court will authorize the defendant to do so.  Plaintiff must also group text messages by person and conversation, with new consecutive bates numbers.  Defendant is entitled to redepose the plaintiff about newly produced text messages.
  • Oakley v. MSG Networks, Inc., 2025 WL 3041936 (Mag. S.D.N.Y. Oct. 31, 2025).  Defendant awarded over $600,000 in counsel fees and a spoliation inference against plaintiff for the unexplained deletion of all text messages from plaintiff’s phone for the relevant time period.
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As we’ve discussed before, Florida’s offer of judgment statute has real teeth. Under the Florida statute (Fla. Stat. § 768.79), a defendant can recover its costs and attorney’s fees if the other side rejects the offer and ultimately recovers 25% less than the amount of the offer.  The risk of paying the defendant’s attorney’s fees ought to be a meaningful deterrent to meritless claims.

In today’s decision, Jacob v. Mentor Worldwide LLP, 2025 WL 3134227 (M.D. Fla. Nov. 7, 2025) (rep. & rec.), the defendant made an offer of judgment under the Florida statute. But that didn’t deter the pro se plaintiff from pursuing her claim that a ruptured breast implant caused her to develop lupus-like symptoms.  As we blogged about here, following a lengthy and tumultuous procedural history, the defendant ultimately prevailed on summary judgment.  Prior to moving for summary judgment, the defendant made an offer of judgment of $3,500, which was the amount of its limited warranty for implant ruptures. After obtaining summary judgment, the defendant moved for its costs and attorney’s fees.    

Continue Reading Chomp Chomp – Taking a Bite with Florida’s Offer of Judgment Statute
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Back in April, we pondered whether the new judge in the Valsartan MDL would change things for the better.  In contrast to the Zantac MDL, which was established a year later and has proceeded on a very similar contamination theory, the first several years of the Valsartan MDL saw a bunch of bad rulings on preemption, class certification, state law predictions, and other issues.  The decision that prompted our musings involved the exclusion of the plaintiff’s economic expert in a third party payor bellwether case and showed how seriously the court took its gatekeeping responsibilities as emphasized in the 2023 revisions to Fed. R. Evid. 702.  We offered our hope that the court would reexamine preemption or, “[i]f that is a bridge too far, then other holes in plaintiffs’ case—at least while it is based on the mere assumption of dangerous contamination—should present real obstacles for the Valsartan MDL plaintiffs.”  Before we cause major soft tissue injury trying to pat ourselves on the back for our prescience, last week’s decision out of the Valsartan MDL that granted summary judgments to the defendants in “what was to be the first bellwether trial”—in a case selected by the parties—was not exactly as we forecast.  In re: Valsartan, Losartan & Irbesartan Prods. Liab. Litig., No. 19-2875, 2025 WL 3131002 (D.N.J. Nov. 10, 2025) (“Roberts”), excluded plaintiff’s sole specific causation expert based on her unreliable differential diagnosis (or, more accurately, differential etiology) because she lacked a reliable basis to rule in the medication use and rule out several other risk factors for plaintiff’s decedent’s liver cancer.  To plaintiff’s credit, he conceded that the exclusion of this expert would be fatal to his case; to the expert’s credit, she conceded that some of the steps in her causation analysis were “pure speculation.”  Id. at *2 & 21.  Still, this is a major win and affirmation that the proper Rule 702 standards should not yield to the needs of the plaintiffs in an MDL.

Decisions excluding specific causation opinions are often not as useful as decisions excluding a general causation opinion because the former involve a case-specific inquiry.  When the expert purports to form her specific causation opinion based on conducting a differential diagnosis, it can be even harder to extrapolate a decision excluding that opinion.  For us, the key part of Roberts is the ruling on the unreliability of the plaintiff’s expert’s ruling in of the prescription drug use as a substantial cause of the decedent’s liver cancer.  We will focus on that.  The court’s finding that the expert’s ruling out of the decedent’s various risk factors for liver cancer was unreliable is also worth reading and, as the court noted, would have been a sufficient reason to exclude her opinion.  Id. at *27 n.54.  Neither, at least according to the court, involved deciding general causation.  Id. at *3 n.5.  (The differences between general and specific causation blur when the focus is on issues such as the level of exposure needed to cause a disease or the specificity of the disease that the exposure can cause (e.g., cancer versus liver cancer versus hepatocellular carcinoma).)  The decedent in Roberts had such strong and established risk factors for the type of liver cancer he had that we can see why the defendants picked the case as a bellwether.  We speculate that the plaintiff lawyers assumed that Alabama’s law on causation would help them advance their argument that the prescription drug use was the final straw; they clearly liked that the Roberts decedent’s cancer diagnosis came soon after the product recall and that his remaining pills were apparently shown to have much higher levels of NDMA than FDA set as the maximum.  (The reliability of that testing, which is certainly not a foregone conclusion given the history of the litigation, was also not addressed.)  Regardless of how it got selected as a bellwether, Roberts teed up some classic causation issues that should impact other plaintiffs and experts in the MDL.

Roberts started with the affirmation that the 2023 amendment to Rule 702 “clarified that the preponderance standard applies to the three reliability-based requirements added in 2000—requirements that many courts have incorrectly determined to be governed by the more permissive Rule 104(b) standard.”  Id. at *6 n.11.  Placing the burden on plaintiff as the proponent of the expert evidence helped the Roberts court reject plaintiff’s arguments that his expert should get a pass based on the relatively few epidemiologic studies directly on-point, that the court should defer a ruling on admissibility until after the jury would have already heard the expert’s testimony, that the court was usurping the jury’s role, and implicitly that the evidence plaintiff needed to get to trial in an MDL bellwether case should not be excluded.  Throughout, the court cited cases over the thirty-two years since Daubert that have emphasized the gatekeeping role, the focus on methodology, and what reliable causation opinions need to be based on—in our view, the more convincing cases.  Fundamentally, plaintiff’s expert was unable to articulate how much NDMA from Valsartan is needed to cause the kind of cancer that plaintiff’s decedent had.  Id. at *25.  We do think this is fundamentally a general causation question, but it is also a key question for a reliable differential etiology—you cannot include a particular exposure on the list of potential causes unless the relevant level of exposure is known to be a cause.  This was essentially the issue in General Elec. Co. v. Joiner, 522 U.S. 136 (1997), which involved causation opinions about cancer and workplace exposure to alleged carcinogens.  Joiner did not expressly distinguish between general and specific causation or describe the plaintiff’s experts’ approach as differential diagnosis, but the issues analyzed in Roberts are very similar.  We see this return to Daubert and its early progeny, aided by the clear allocation of burden, as a good thing.

Roberts proceeded to analyze the three types of evidence that the expert claimed supported ruling in plaintiff’s decedent’s Valsartan use as a potential cause of his specific kind of liver cancer.  First were the studies that looked at human use of Valsartan and liver cancer, of which two reported a statistically significant increased risk.  One stated that “[c]ausation cannot be inferred” from its results and the other described its results as inconclusive.  Id. at *22.  The expert tried to jack up the very low relative risk calculations from these studies with a series of unfounded assumptions about exposure levels and dose-response relationships, which the court saw as unreliable.  When we say the relative risk calculations were low, we are reminded of an expert we saw at a number of trials a long time ago.  He liked to tell the jury about a simple attributable risk calculation he did to say what percentage of the injuries in an exposed population came from the exposure as opposed to other risk factors.  For these studies, using the same calculation, 86.2% and 89.3% of the exposed population in these studies did not get liver cancer from the exposure.  This is why Daubert II and Havner required epidemiologic studies with statistically significant relative risks greater than 2.0—i.e., greater than 50% on an attributable risk exposed calculation—to establish general causation.  That may be a little far afield, but the low risks in these studies could not be reinterpreted upwards.

The expert also tried to rely on an occupational exposure study, which the Zantac MDL judge had rejected as a basis for a reliable general causation opinion.  Roberts followed the reasoning in Zantac (discussed in detail here and taking in our nod for fourth best decision of 2022 here), which included that the study’s author said it “was not designed to assess NDMA exposure through an oral medication.”  2025 WL 3131002, *23.  The expert’s last hope was to blur the lines with animal studies on cancer with NDMA exposure.  She lacked a reliable basis to extrapolate from the animals to humans or to establish a dose-response relationship tying plaintiff’s decedent’s purported NDMA exposure to a level that was associated with liver cancer in the study animals.  Id. at *24-26.  We were pleased to see the old Soldo decision—which focused on the testimony of an expert whose deposition in the case was the first one we ever took—still being cited for how to evaluate medical causation opinions that are purportedly based on animal studies.  The Roberts expert’s opinions did not come close to the standards for a reliable causation opinion.  Plaintiff also pushed that the animal studies supported a rapid onset from NDMA exposure to the development of cancer, but that was both speculative and insufficient to make up for the big holes in the expert’s causation opinion.

As we noted above, the Roberts decision also includes detailed discussion of the expert’s methodologic failures in attempting to rule out alternative causes for the plaintiff’s decedent’s liver cancer.  There were many.  However, rather than recapping those, we return to the court’s rejection of plaintiff’s argument that the court should just let the expert testify and be subjected to “vigorous cross-examination,” before the court rules on admissibility:

This Court shall do no such thing. Given this Court’s serious concerns with Dr. Siddiqui’s testimony, this would amount to a total abdication of its gatekeeping responsibility. The entire purpose of Rule 702 is to keep unreliable expert testimony from ever reaching a jury. And for good reason. How could the Court ever “unring” the proverbial bell after the jury had listened to hours of unreliable expert testimony? The prejudice to Defendants would be insurmountable.

Id. at *12 (emphasis in original).  Any federal judge who still thinks that the Federal Rules of Evidence favor admissibility of expert testimony, that the proverbial tie goes to the runner, and/or that cross can cure any expert admissibility issues better have a good answer to the question posed in Roberts.

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Council for Responsible Nutrition v. James, 2025 WL 3165673 (2d Cir. Nov. 13, 2925), is a Second Circuit decision about a New York state restriction on the sale of certain dietary supplements to minors. This blog covers the case because the court’s decision includes a disturbing preemption holding.  This particular blogger covers the case because it addresses a recent matter of particular concern that has arisen in more and more cases — the extent to which the government can and should act as our food nanny. It also helps that the CRN case is a bit strange.

To begin with, the “James” named as a defendant is New York Attorney General Letitia James, who right now has at least one case that is probably causing her more worry than this one. CRN, the plaintiff, is a trade group representing the dietary supplement industry. CRN filed the lawsuit to enjoin enforcement of section 391-00 of the New York General Law, which prohibits selling dietary supplements to anyone under age 18 if the supplement is “labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building.”  CRN’s theory was that the statute violated the First Amendment’s free speech clause, was unconstitutionally vague, and was preempted by federal law.  The district court denied CRN’s motion for a preliminary injunction because CRN was unlikely to prevail on the merits, could not demonstrate irreparable harm, and showed no favorable balance of equities. The district court also dismissed CRN’s claims except for the First Amendment claim. The case went up to the Second Circuit. 

The Second Circuit affirmed the district court, holding that it had not abused its discretion in concluding that the plaintiff was unlikely to win on substance, there was no irreparable harm, and the public interest would not be served by an injunction. 

The free speech issue hinged on a commercial speech analysis under the Central Hudson test. The Second Circuit held that protection of minors’ health was a substantial government interest, that the statute directly advanced that interest because youth appeared to be misusing the supplements, and the statute was not overinclusive as it was reasonable for the Legislature to focus on the product’s marketing. The Second Circuit also held that requiring retailers to age-verify that purchasers were adults did not constitute compelled speech. In sum, the statute passed intermediate scrutiny for laws restricting commercial speech.  

The Second Circuit also held that CRN’s vagueness claim fell short of the burden of showing “that no set of circumstances exists” for which the law’s application would be unambiguous.  

Now we get to the preemption ruling.  We are not pleased. Why?  We are in the land of express food preemption in section 343-1(a) of the Food, Drug, and Cosmetic Act (FDCA), which provides that “no State or political subdivision of a State may directly or indirectly establish under any authority continue in effect as to any food in interstate commerce … (5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title.”  Section 343(r)(1), in turn, prohibits health-related claims regarding a product’s nutrients, while section 343(r)(6) makes certain exceptions for dietary supplements. That is pretty strong and clear preemption.  We might even call it “plain.” (Foreshadowing.)

As the Second Circuit saw it, the issue was whether the statute’s “age restriction, by being triggered by (among other things) a health claim made on a product label, is therefore a ‘requirement respecting’ such a health claim.”  The Second Circuit answered that question with a No, and how it got there is a little wobbly. Seemingly contrary to the Riegel  discussion of “requirement” always meaning the same thing in the FDCA (552 U.S. at 324, not even mentioned in the CRN opinion) the Second Circuit held that the meaning of “requirement” in the preemption clause of the food section of the FDCA is not “plain” and is therefore subject to narrowing under the presumption against preemption – notwithstanding the Supreme Court’s Franklin decision abolishing any presumption against preemption in express preemption cases.  According to the CRN decision, Franklin’s erasure of the presumption again preemption applies only if the statutory text is “plain.”  That seems to us to be sloppy, lazy reasoning. It is as if the Second Circuit was looking for an excuse to avoid the job of statutory interpretation. This approach seems to ignore, if not outright defy, Congressional  intent. 

Then, almost unbelievably, it gets worse.  The Second Circuit proceeds to lean on Bates (which is not even an FDCA case), to hold in CRN that incidental economic effects that “do[] not require a … maker to put anything in particular on a product label” do not count as “requirements.”  

After stumbling over the express preemption issue, the Second Circuit’s perfunctory treatment of the irreparable harm and public interest elements seems inevitable. Lost sales would not be irreparable harm and the industry pecuniary interests “pale in comparison to the State’s goal of protecting youth from products that unfettered access to dietary supplements present.”  It is hard to tell what is worse – the logic or the prose.  

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