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There are two main issues that make the eyes of your dutiful Drug and Device Law bloggers well up in frustration over In re Taxotere (Docetaxel) Eye Inj. Prods. Liab. Litig., No. 3023, 2025 U.S. Dist. LEXIS 233514, 2025 WL 3442731 (E.D. La. Dec. 1, 2025).

The first is a gut-level, “this is an example of something wrong with our civil justice system” point:

There have been thousands of lawsuits filed in two MDLs (MDL-2740 and MDL-3023) stretching back nearly a decade and involving the chemotherapy drug Taxotere—which is essential for the treatment of certain breast, lung (non-small cell), prostate, stomach (gastric), and head and neck cancers.  The newer MDL involves allegations that the Taxotere label did not provide full and detailed enough warnings about a potential risk that the drug might make patients cry; the earlier Taxotere MDL involved allegations that this chemotherapy drug caused hair loss. 

For the new MDL, the label warned of “excessive tearing which may be attributable to lacrimal duct obstruction,” but in the plaintiffs’ lawyers’ opinion, this warning also should have said that the “excessive tearing” was due to “stenosis” and patients should specifically consult “a lacrimal specialist at the first sign of excessive tearing.”

Got that? The drug label advised oncologists that their cancer patients might have “excessive tearing” due to tear “duct obstruction,” but because the label did not also say that the cause of the excessive tearing was “stenosis” and to immediately consult a “lacrimal specialist,” we have an MDL, thousands of lawsuits, and almost a decade of obscenely expensive litigation grinding on, with only the lawyers involved reaping anything other than minimal benefit.

Is it any wonder why we generally favor a high-regulation/low-litigation model?  (Or, at least we do when the regulators are actual scientists and doctors who follow the standards of those respective professions. Ahem.)

Which brings us to the second issue, preemption.

The Fifth Circuit already has had to correct the Taxotere MDL District Court once regarding preemption, in a case arising from the hair loss MDL, Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024). As Bexis explained about that decision, Taxotere came onto the market through the so-called “paper NDA” process, 21 U.S.C. §355(b)(2). In this earlier Taxotere decision, the Fifth Circuit rejected the District Court’s conclusion otherwise, and held that PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) applied just the same for paper NDA medications as for any other. Thus, because of federal preemption, plaintiffs cannot challenge the sufficiency of a drug’s label warning unless they can show that the manufacturer had “newly acquired” information that “reveal[ed] risks of a different type or greater severity or frequency than previously included in submissions to FDA” such that the manufacturer could have initiated a label change using the changes being effected (or “CBE”) regulation, 21 C.F.R. § 314.70(c)(6)(iii).

In fact, Hickey went further, and reviewed five items of medical literature that supposedly formed the “newly acquired information” that supposedly gave rise to a duty on the part of the Taxotere manufacturer to add the plaintiff-lawyer proposed language about hair loss.

According to the Fifth Circuit, four of the five items of medical literature identified by the plaintiffs could not constitute newly acquired information as a matter of law on the appellate record because they failed to meet the “different type or greater severity or frequency” requirement for the CBE regulation to apply, and because the overall degree of risk was essentially the same.

As to the fifth item of “medical literature”—an “abstract,” not even a full-fledged study—the Fifth Circuit left the door open by only the slimmest of cracks, remanding to the District Court to reconsider this evidence using the proper legal standard.

In this newest In re Taxotere preemption decision, from the excessive tearing MDL, the plaintiffs and District Court plowed through that narrow opening like the door wasn’t even there.

Once again, the manufacturer moved for summary judgment, arguing (similar to the argument in Hickey) that plaintiffs’ claims are preempted because it could not have invoked the CBE regulation—that no “newly acquired information” existed to justify a unilateral label change.

The District Court held that the manufacturer bears the ultimate burden of persuasion on preemption (but deferred whether the plaintiffs bear a limited burden of production to identify evidence of newly acquired information, because the plaintiffs here in fact did that).

The District Court also held that the question of whether information constitutes “newly acquired information” is a matter of law for the judge, not the jury and, as a result, expert testimony on that “ultimate issue” is inadmissible.

Because of this, the District Court’s entire decision—that the manufacturer did have newly acquired information of the necessary import to require a label change—is based entirely on its own assessment of the significance of one small study (the 2003 Esmaeli Cancer Study), without consideration of the affidavit by that study’s author, Dr. Bita Esmaeli, submitted by the manufacturer.

What makes all this troubling is that the District Court makes some pretty dramatic claims about the medical significance of the 2003 Esmaeli Cancer Study, even though that study was really small (it only involved 148 patients), and was duplicative of pre-label approval studies (the 2001 Esmaeli Article and the 2000 Kneuper Hall Abstract) that, as the District Court itself says, “reported on similar injuries and surgical interventions and penned similar warnings regarding the need for referral to an ophthalmologist and/or prompt intervention.”

There is a lot we can say about the significance, or lack thereof, of the conclusions of the 2003 Esmaeli Cancer Study, but the most notable thing the District Court seemed to miss is that, if anything, the study showed that the alleged condition (lacrimal duct obstruction due to stenosis) appears more common in use of Taxotere at a higher, off-label dosage (weekly instead of every three weeks)—in other words, how oncologists would use Taxotere for sicker cancer patients.

Thus, this single, small, repetitive study reflects, at most, new information reflecting a risk of a “different type or greater severity or frequency” regarding excessive tearing for the sickest cancer patients, and nothing about new information for most Taxotere patients receiving the usual treatment doses at the usual pace.  That matters because (at least, perhaps, until further review by the Fifth Circuit), the only Taxotere MDL plaintiffs who should have a non-preempted failure to warn claim are those that received the higher dosage.

And these plaintiffs will still have to prove warnings causation—that their treating oncologists would have declined to prescribe chemotherapy to them as cancer patients, had those oncologists only known about the incrementally different language of the plaintiffs’ lawyers proposed excessive tearing warning. Which, in a non-insane world, should be something very difficult to prove. How many physicians are going to testify, “Correct, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis, and that a lacrimal specialist consult should be considered.”

Which brings us back to our first point—does this litigation make any sense?

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If it’s Wednesday, it’s plainly time to talk about removal. Today’s case, In re Depo Provera Prods Liab. Litigation, 2025 WL 3252445 (N.D. Fla. Nov. 13, 2025), upholds one of the defense bar’s favorite procedural maneuvers,snap removal. The case was snapped in California, in the Ninth Circuit, and transferred to the Multidistrict Litigation in the Eleventh Circuit.  There was complete diversity (no party on one side of the v shared citizenship with anyone on the other side), and the case was removed before a forum defendant was served.  That should be, and was, a plain case of proper snap removal. 

Just as plain was the fact that the plaintiff did not help her case by never serving the forum defendant, even after removal to federal court.  The plaintiff moved to remand the case to state court, relying on the old chestnut that federal courts are courts of limited jurisdiction. But even with the principle that federal jurisdiction is narrowly construed, the relevant statute plainly allows snap removals, as three circuits (Second, Third, and Fifth) have held, and another (Sixth) had so indicated in a footnote.  Here, the court noted that other courts within the Eleventh Circuit had “come out both ways regarding the propriety of snap removal.”  At the same time, there was some language in an Eleventh Circuit case that “strongly suggests” that “absent gamesmanship on a removing defendant’s part, the Eleventh Circuit believes the statute means what it says.”  

We’re not sure what amount of “gamesmanship” could overcome the plain — there’s that word again — language of 28 U.S.C. section 1441(b)(2)). Snap removal is “at least rational,” and its result does not bump against the “absurdity bar.” In any event, no such gamesmanship was hinted at in this case. 

Accordingly, the court denied the remand motion. That is plainly the right result. 

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There’s a saying that “everyone is entitled to their day in court.” Fair enough. But, to have your day in court, you have to have standing. While the requirements for standing vary from jurisdiction to jurisdiction, all courts require a plaintiff to have suffered an injury in fact. Afterall, the entire idea of standing is to ensure courts handle real disputes—not speculative ones based on things that could, might, or possibly, if the stars align, go wrong. If plaintiffs without injuries can sue, then courts become astrologers, predicting future diseases like they are reading tea leaves. Standing exists because courts deal with facts, not probabilities that sound like they were calculated on a napkin.

In toxic-exposure cases, however, there is a category of plaintiffs who want to treat the courthouse like a medical clinic with a very generous insurance plan. These are individuals who seek medical monitoring because they were exposed to a chemical but experienced no actual physical injury. Not a rash, not a cough, not even an impressively dramatic fainting episode. Fortunately, in line with the growing trend, Colorado recently became the fifth state in a row where an appellate court expressly rejected no-injury medical monitoring claims.

Smith v. Terumo BCT, Inc., — P.3d –, 2025 WL 3029699 (Co. Ct. App. Oct. 30, 2025), is not a drug or device case, but it is adjacent. Defendants sterilize medical equipment using ethylene oxide (EtO), a known carcinogen. Plaintiff filed a purported class action on behalf of individuals who resided near defendants’ facilities alleging they had been injured by exposure to EtO emissions. The purported class explicitly excluded anyone who had been diagnosed with cancer due to EtO exposure, creating a class of individuals who were only alleging an increased risk of cancer or other illness in the future and seeking to be awarded the costs of diagnostic testing for early detection. Id. at *1.

The trial court dismissed the case for lack of standing. After which time, the procedural history gets a little complicated. But in short, plaintiff did not appeal the original order but instead filed a motion for leave to file an amended complaint. That motion went unruled on for three years. In which time we should note that, fortunately, plaintiff remained injury free. Finally, the court denied the request for several reasons, including that amendment would be futile because plaintiff did not cure the legal deficiencies that caused the court to dismiss the complaint in the first place—still no injury in fact, still no standing.  Id. at *2.

The appellate court’s reasoning and conclusion were simply stated:

One of the basic principles of law is that a party may not recover damages if he has not suffered an injury.  Consistent with this principle, a person cannot pursue a tort claim for future death, future physical injury, or future property damage. [An] allegation that EtO exposure increases [the] risk of cancer or other disease amounts to nothing more than a hypothetical claim of future physical injury. . . .

In recent years . . . courts throughout the country have repeatedly held that a toxic tort claim cannot proceed in the absence of a present physical injury. Because these cases are consistent with Colorado‘s longstanding rejection of tort claims based on the potential of future physical harm, the district court did not err by following them.

Id. at *6-7 (citations to other state appellate decisions rejecting medical monitoring claims) (emphasis original).

In other words: you can’t recover for harm you haven’t suffered. It’s the legal version of “no dessert until after dinner.” Plaintiffs asking for medical monitoring without an injury are basically saying, “I haven’t gotten sick, but I’d like to get paid just in case I might someday.” Future illness is speculative by definition and damages based on pure speculation don’t belong in the legal system.

The court addressed two additional arguments. First, plaintiff tried to get the court to adopt the Restatement (Second) of Torts definition of bodily harm which makes mention of a change to the structure of any part of the body even if that change causes no other harm. Restatement 2d, §15. So, plaintiff claimed that the EtO had been “absorbed” and “distributed” in his body constituting a “change in the structure of his body.” Id. at *7.  No Colorado court has ever adopted that definition of bodily harm, and the Smith court decided it need not tackle the question because plaintiff’s claims were conclusory. “[A]bsorption and metabolization do not necessarily lead to changes in the body’s structure or function.” Id. Because plaintiff had no specific allegations that he or any other named plaintiff was experiencing a “currently existing adverse event”, the court rejected the claims as conclusory.

Second, plaintiff argued that medical monitoring was an economic injury. But that argument “blurred the line between establishing injury and damages.” Id. A plaintiff has to demonstrate both a present physical injury and economic losses that result from that injury. You can’t just jump to damages and bypass injury.

At the end of the day, allowing no-injury medical monitoring claims would convert speculative fear into a legally compensable condition—and that’s a recipe for chaos. Let’s leave hypothetical harms where they belong–late-night WebMD spirals—not the courtroom.

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This post sort of got away from us.  We started with the proposition that our prescription medical product clients frequently move to dismiss cases, and thus seek to get courts to take judicial notice of FDA-related documents in product liability litigation involving their products.  Judicial notice in cases involving FDA regulated products can be of great assistance on pleadings-based motions (Rule 12(b)(6) and judgment on the pleadings) because judicial notice is an exception to the usual limitation of such motions to what plaintiffs plead – or, equally importantly, fail to plead – in their complaints.  Not only do judicially noticeable documents fill in facts that plaintiffs deliberately omit, but they can also defeat contrary factual allegations that the documents establish are untrue.  This is an important exception to the Rule 12 mantra that challenged allegations are to be taken as true.  Instead, allegations in a complaint are not credited where contradicted by judicially noticeable documents.  E.g., Fuqua v. Santa Fe County Sheriff’s Office, ___ F.4th ___, 2025 WL 3072794, at *4 (10th Cir. Nov. 4, 2025); Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001).  So judicial notice can overcome contrary pleadings.

Continue Reading Getting Noticed – Receiving FDA-Related Judicial Notice
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Removal-rama continues.  Art (if that is what you can call blogposting) mimics life. We have not just been blogging about removal cases lately, we’ve also been removing cases to federal court with startling frequency. And it’s been working. Twice, even with a removal basis that might be characterized as a jump ball, plaintiffs have not even bothered to file for remand to state court. That outcome almost certainly redounds to the benefit of our client. The lesson? Be brave.  It also helps to be right. 

But sometimes even being right might not be enough. In Brown v. Johnson & Johnson, 2025 U.S. Dist. LEXIS 231014, 2025 WL 3268408 (N.D. Cal. Nov. 24, 2025), the federal court incorrectly entered a remand order based on rejection of a “fraudulent joinder” argument. The plaintiff sued one of many related entities to defeat diversity and evidently picked the wrong one.  But the court was not sure it was the wrong entity, and, in any event, it looked like some other unsued entities might not be wrong. The plaintiff might be able to add those nondiverse parties, and somehow that concatenation of mights resulted in the case getting remanded. If that concatenation sounds a little sloppy, maybe even crazy, come sit right down beside us. 

The plaintiffs in Brown brought a lawsuit in a notoriously plaintiff-friendly jurisdiction, Alameda County, California, alleging that certain medications caused them to develop breast cancer.  The defendants included several drug maker defendants, all non-California citizens. To defeat diversity, the plaintiffs also sued Kaiser Permanente International. Kaiser is a California citizen, and its presence was the plaintiffs’ basis for avoiding federal court.  The defendants did not buy that basis, and removed the case to the Northern Disrict of California.  The defendants argued that Kaiser was solely a pharmacy, and relevant state law (California) seemed pretty clear that a pharmacy has a duty only to accurately fill prescriptions, and not to warn about the general risks of drugs.  Thus, Kaiser had been fraudulently joined, it should be dropped from the case, and the result would be complete diversity and federal jurisdiction. 

The plaintiffs disagreed. They filed a motion to remand the case to Alameda County. The plaintiffs argued that Kaiser insured them, treated them, and distributed the offending medications. Therefore, according to the plaintiffs, they had valid (or at least colorable) claims against Kaiser for strict liability failure to warn, general negligence, and negligent failure to warn. 

By now, we all know that the test for fraudulent joinder is tough, but that did not stop the Brown court from reminding us that “the question Is whether defendants have demonstrated that plaintiff could not possibly prevail on her claims against the allegedly fraudulently joined defendant.”  The burden is on the defense, and it is a heavy burden.

That being said, even if Kaiser is a large entity that does many things, it does not seem to have done the things that would make it liable for the claims alleged.  The plaintiffs seem to have been mistaken when they invited this partial Kaiser entity to the party. It is an understandable mistake, as there are several Kaiser entities. 

Did the Brown court decide that there might be a valid cause of action against the Kaiser entity that was actually sued?  Not really. The court did not even suggest that the failure to warn claims might apply to Kaiser.  But it hinted that a general negligence claim might stick. How?  Why?  We do not know. Instead, the court was won over by the plaintiffs’ that “even if” they cannot recover against that particular Kaiser entity, “they intend to amend their complaints to add other” similarly named entities.  Somehow, that possible amendment made the joinder of the Kaiser pharmacy non-fraudulent. Huh? Or to put things in rarefied legalese, so what? Isn’t the rule for removal purposes that the date of removal freezes the pleadings? That should mean that a promise or threat or idle speculation about filing an amended complaint in the future against some other defendant shouldn’t be enough to support remand.  Granted, the recent SCOTUS case of Royal Canin helped federal-fearing plaintiffs considerably by holding that post-removal amendments by plaintiffs could make diversity go away.  But at least in Royal Canin the plaintiff actually did the thing that obliterated diversity. In Brown, all we get is wish-casting. Mind you, we hate the holding in Royal Calin.  And now we hate the ruling in Brown. Even if plaintiffs are allowed to amend to defeat diversity in some circumstances, they had not done that in the Brown case.  It was the district court that did all the work — for bad reasons and in service of a bad result.  

(It’s almost as bad as a prosecutor getting an indictment by promising the grand jury that more and better evidence would be presented at trial. But that could never happen in our fair-minded republic — could it?)

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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.

Photo of Stephen McConnell

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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