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In case our title was too subtle, we think that a stack of purported inferences should neither state a claim for strict liability with a prescription medical device nor sidestep express preemption in the case of a Class III device.  We have long been dubious of the idea of a true parallel claim as articulated by Riegel and some of its misguided progeny.  Most of the state law duties that plaintiffs push in these cases are bogus.  Existing state law is rarely going to require what the FDCA requires of devices approved pursuant to a PMA.  These same plaintiffs almost always urge that their device was defective because it did not comply with FDA requirements.  Predicating claims on violations of the FDCA, including failing to submit required materials to FDA during or after the approval process, should run headlong into Buckman implied preemption.  When it comes to Class III devices, two of the three species of product liability, design defect and warnings (or informational) defect claims, are almost never going to be legitimate routes to avoid both express and implied preemption.  The third, manufacturing defect, has a shot.  The main problems with those claims, however, are that plaintiffs can rarely plead them with TwIqbal-compliant factual support and that they are properly limited to deviations from approved specifications, which are rarely provable and usually logically inconsistent with design defect theories.  Shortcutting manufacturing defect allegation requirements by making a res ipsa loquitur argument also should not work.

These dynamics played out in Purohit v. Abbott Labs., Inc., No. 2:25-cv-01026-JAD-EJY, 2025 WL 3527245 (D. Nev. Dec. 8, 2025), a case about an alleged manufacturing defect in a bioprosthetic heart valve, a Class III device that the manufacturer withdrew from the market in 2023.  Predictably, the plaintiff tried to avoid picking one of the types of defects recognized by Nevada law.  We previously reported on Schmidt v. C.R. Bard, Inc., a class II device product liability decision out of the same court.  In Schmidt, the plaintiff dropped his manufacturing defect claim before the court granted summary judgment on his warnings and design defect claims.  Probably because of the obvious preemption of warnings and design claims, the Purohit plaintiff advanced only a manufacturing defect claim when forced to articulate something more than a defect in the air claim.  His anti-preemption argument was that his valve being replaced nine years after implant meant that it had “deteriorated faster than expected,” which meant it had been defectively manufactured, which meant it violated FDA requirements, which meant that he had asserted a mythical parallel claim that dodged the FDCA’s express preemption of state law requirements that are “different from, or in addition to, any requirement” under the FDCA.  Plaintiff also offered an alternative insertion in between first and second “which” clauses above:  “which was similar to why the manufacturer withdrew the device from the market in 2023.”  Nice try, we guess.

In rejecting this daisy chain, the Purohit court had the advantage of the strong Ninth Circuit decision in Weber v. Allergan, which we discussed here.  Weber firmly rejected that an alleged misrepresentation about failure rate in the approved labeling for a Class III device was the same as a deviation from FDA requirements.  When it came time to articulate a particular deviation from FDA requirements, the Purohit plaintiff flailed.  He tried the circular argument that the purported failure of the prostheses in his case was itself proof of a violation of the specifications required by the PMA approval of the device.  2025 WL 3527245, *4.  Failure, without more, does not establish defect.  It certainly does not establish that a device was manufactured contrary to specs.  Plaintiff offered no factual allegations to support his reductionism.

Plaintiff next claimed that the voluntary withdrawal of the device in 2023—sometimes equated in Purohit to a recall—established that his device deviated from FDA requirements.  There is an extensive collection of cases that say the opposite, including a number from and within the Ninth Circuit.  See here and here for some of them.  You cannot infer a deviation from a recall or from an alleged malfunction.  You also cannot infer a defect from either.  Purohit followed this law and reasoning.  As it said, “The FDA approves products knowing that there is a possibility that a full compliance product can fail.  So the withdrawal of a product from the market does not automatically mean the product [did not] meet FDA requirements.”  Id.  (We also think that there was another problem with plaintiff’s recall argument.  His prostheses lasted nine years before its alleged failure.  The market withdrawal, from information on FDA’s website, was driven by the rate of particular structural failures within five years of implant.  Maybe nine years is not so bad for a tissue-based aortic valve.  After all, aortic valves are subject to quite a bit of pressure and stress; back when we did litigation relating to aortic valves, replacements with tissue, as opposed to artificial materials, typically lasted less than ten years before another surgery was indicated.  If a recall or withdrawal is ever going to be proof of a parallel claim, then it should be all fours with the case-specific allegations.)

Plaintiff also offered a Lance-like argument that the company should have withdrawn the product earlier, which was purportedly a state law obligation and somehow proof of a deviation from FDA requirements for his valve.  The Purohit court held this claim, to the extent it had been asserted at all, preempted.  Id.  “Purohit does[ not] point to any FDA requirement or any relevant statute or regulation that imposes such a requirement [and] such an allegation is irrelevant for a products-liability claim in which Purohit must allege that the manufacturing of the product deviated from a particular FDA requirement.”  Id.  Interestingly—at least to us—the court elected to rule on preemption and not whether the complaint stated a valid Nevada claim for failure to withdraw.  Id. at *4 n.56.  We do not think Nevada has such a claim, based on Lance or otherwise.  So, there was another reason why plaintiff’s complaint should have been dismissed, arguably before addressing preemption.  The court’s approach, though, probably helped it reach the next step that courts are often reluctant to take:  denying a request to amend the complaint.  An amendment would have been futile, largely because plaintiff’s request to amend did not identify what allegedly violated requirement would be addressed in a proposed amendment and the court was not going to allow plaintiff to shift to a new theory of liability.  Id. at *5.  Indeed, this may have been our favorite part of Purohit.  If parallel claims are unicorns and the plaintiff cannot plead one up front, then there should be some good basis offered before the plaintiff gets another chance to offer factual allegations supporting a myth.

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Today’s guest post is from Reed Smith‘s Matt Jacobson. His post is not (primarily) about British comedy, but rather about fraudulent joinder. The specific topic is most interesting if you practice in Wisconsin, but as to removal generally, it introduces a provision of the statute that many of our readers will be unfamiliar with, so you’ll probably learn something from this post. As always our guest posters deserve 100% of the credit (and any blame) for their writings.

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Mr. Bean is celebrating its 35th anniversary this year.  For those of you who have lived under a rock for the past 35 years—or do not have television—Mr. Bean is a British comedy that follows Mr. Bean, who often seems unaware of basic aspects of the way the world works.  The creator of the show described the title character as “a child in a grown man’s body,” as he solves various problems presented by everyday tasks and often causes disruption (and many laughs) in the process.

One of my favorite episodes from the animated series (which debuted seven years after the live-action series ended) involves Mr. Bean putting a fake pair of legs and wrench under his car to make it look like a mechanic was lying under the car to fix it.  He does this so he can avoid getting a parking ticket while parking on the street.  And it worked!  Avoidance was a key theme in many of Mr. Bean’s antics, whether he was actively trying to dodge a situation, task, person, or in this particular episode, a parking ticket.

Today’s post involves a case with a Ms. Bean, but as far as I can tell there is no relation.  In Bean v. Smith & Nephew, Case No. 25-C-184, 2025 WL 2945560 (E.D. Wis. Oct. 17, 2025), the Plaintiff originally filed her case in Wisconsin state court against the manufacturer of the device used in her knee replacement surgery, alleging a product defect.  She also named a fictional manufacturing company, fictional insurance companies, and her employer and its self-insured worker’s compensation carrier.  Like Mr. Bean used his fake legs to avoid a parking ticket, Ms. Bean was actively trying to avoid removal to federal court with her fake companies.  However, that plan would not work out as well as Mr. Bean’s and certainly is not as funny.

The non-fictitious medical device company removed the case to the Eastern District of Wisconsin under 28 U.S.C. § 1332 on the basis of fraudulent joinder.  Plaintiff moved for remand, arguing that her case was a non-removable worker’s compensation action under 28 U.S.C. § 1445(c) and that complete diversity did not exist, as her employer was properly joined as a defendant.  The court denied her motion and Plaintiff filed a motion requesting that the court certify the question of whether her claim arose under Wisconsin’s worker’s compensation law for immediate appeal and stay the case.

Plaintiff’s use of § 1445(c) was creative, if not comedic.  Bean is the Blog’s first occasion to mention it in its 19-year existence.  The court found that under 28 U.S.C. § 1445(c), a case cannot be removed to federal court that arises under a state’s worker’s compensation laws.  See 28 U.S.C. § 1445(c) (“A civil action in any State court arising under the workmen’s compensation laws of such State may not be removed to any district court of the United States.”)  The court said that it had denied Plaintiff’s motion for remand “because, contrary to her assertions, her claims do not arise under the State’s worker’s compensation laws . . . [W]hile she may have injured her knee while employed . . . her claims in this action are for damages arising out of the failure of a medical device used to replace her knee—claims that arise out of the common law of tort.”  Bean at *1.  Not only did the court deny her motion for remand, but it also realigned her employer and the worker’s compensation entity (to the extent it actually existed) as plaintiffs, since they would have subrogation rights.  Id.

The court’s reasoning went back to statutory interpretation from “what Congress would have understood the term ‘workmen’s compensation laws’ to mean in 1958, the year in which Congress enacted § 1445(c).”  Id. at *2.  Citing other decisions, the court found that “worker’s compensation laws at the time was ‘liability without fault (and with limited recovery) for injuries in the course of employment.’”  Id. (citations omitted).  Here, the Plaintiff alleged that she was implanted with a defective knee implant, which were routine product liability claims, not worker’s compensation claims, since they arose out of a claimed device failure.  Id.

The court analogized its reasoning to two other cases (neither of which involved a drug or device):  Houston v. Newark Boxboard Co., 597 F. Supp. 989 (E.D. Wis. 1984), and Hartford v. Schindler Elevator Corp., No. 09-CV-132, 2009 WL 3246670 (N.D. Ind. Oct. 6, 2009).  Both cases involved a plaintiff who was injured at work by an allegedly defective machine (laminating machine and elevator).  Bean at *3.  The plaintiffs sued the machine manufacturers, and the cases were properly removed to federal court, because the claims arose under tort law and not worker’s compensation laws.  Id.  As the court in Hartford found, “it is clear that while Plaintiff’s subrogation claim against a third-party tortfeasor for monies paid to an injured employee on behalf of its insured touches on Indiana worker’s compensation law, it does not arise under those laws for the purposes of applying 28 U.S.C. section 1445(c).”  Bean at *3 (citing Hartford, 2009 WL 3246670, at *3).  That same reasoning applied here.

The rest of the court’s opinion focused on Wisconsin-specific worker’s compensation law, which for this blog, is likely not as helpful.  For that reason,  I will not dive into it, but it was the reason why the court certified Plaintiff’s question for an interlocutory appeal.  

Just like Mr. Bean, Ms. Bean does not really understand how the world works.  Making up fictious companies and trying to make a straightforward product liability case fall under worker’s compensation laws just will not work.  And while it is not as funny as a Mr. Bean episode, understanding this section of the U.S. Code that deals with worker’s compensation cases is one more peculiarity that removing defendants should be aware of.  The end.

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There is a special kind of optimism—some might call it magical thinking—that animates the modern failure-to-warn claim against prescription drug manufacturers. It goes something like this: Yes, the FDA-approved label warned about the exact risk that happened to me, but the manufacturer still failed to warn.

Which is a pretty accurate summary of plaintiff’s argument in True v. AbbVie, Inc., 2025 WL 3560299 (N.D. Ga. Sep. 9, 2025). Let’s start with the inconvenient truth (sorry, True)–prescription drug labels are not written by vibes. They are the product of exhaustive clinical data, regulatory scrutiny, and FDA approval. When a label says, in plain English, that a drug carries a risk of X, and X is exactly what happened, it is difficult to argue—without blushing—that the manufacturer failed to warn. But that is exactly what plaintiff True did.

Plaintiff was prescribed an eyedrop to treat her presbyopia—not a disease so much as a rite of passage for anyone over forty or the time when your arms become mysteriously too short.  The active ingredient in the drug is pilocarpine hydrochloride, a member of a class of drugs called miotics. The label on the eyedrops plainly states that retinal detachment has been reported with the use of miotics.  Plaintiff used the drops as directed and within several weeks suffered retinal detachment. Her suit alleges claims for strict liability design defect, strict liability failure to warn, and negligence. Defendants moved to dismiss all claims.  

As the court explains in True, the approval of a New Drug Application (“NDA”), is an “onerous and lengthy” process, that includes the approval of the exact text of the approved label.  Id. at *4. Once approved, a drug manufacturer cannot unilaterally change a product’s label and warnings—with one narrow exception. The “changes being effected” (“CBE”) regulation allows a manufacturer to add or strengthen a warning without prior FDA approval where there is “newly acquired information about the evidence of a causal association between the drug and a risk of harm.” Id.  So, to avoid conflict preemption, a plaintiff must plausibly allege that there is a warning deficiency that the manufacturer could have corrected using the CBE process.

None of the information plaintiff cited to qualified as “newly acquired” information of a new or greater risk. She cited medical literature, case reports, and clinical studies. But none indicated that the risk of retinal detachment is any more severe or frequent than the risks already reviewed by the FDA and warned of in the labeling. Plaintiff also tried to rely on adverse event reports reported in the FDA reporting database (FAERS). But numerous courts, including True, hold that FAERS data is not newly acquired information that would support a CBE label change absent evidence of a causal association between the drug and the risk. Id. at *5. Even the FDA cautions that adverse event reports are not conclusions or admissions “that the drug caused or contributed to an adverse effect.” Id. (citing 21 CFR § 314.80(1).  

Without evidence of a causal link, the best plaintiff could do was put together a graph showing an uptick in adverse event reports. But the plaintiff provided no context, no time parameters, no explanation as to how the graphs demonstrated newly acquired information. Finally, plaintiff argued that defendant could have warned about the risk via its sales representatives and promotional materials, but the allegations of the complaint rest “solely on the inadequacy of the FDA-approved Label.” Id. at *6. Since the argument was “disconnected” from the allegations of the complaint, it could not save plaintiff’s failure to warn claim.

Failure-to-warn claims like this implicitly assume the manufacturer had a legal obligation to do the impossible: change an FDA-approved warning without legal authority to do so. Federal preemption exists precisely to prevent juries from deciding that drug manufacturers should have ignored federal law and rewritten labels on their own initiative.

The court also summarily dismissed plaintiff’s design defect and negligence claims. Plaintiff did not defend either cause of action. Plaintiff’s only design defect claim went to the drug’s formulation which the manufacturer cannot change without FDA approval. Therefore, like failure to warn, it was preempted. Id. To the extent plaintiff’s negligence claims were premised on the same design and warning allegations, they also failed. Id. at *7-8. Which left only negligent failure to research and test which Georgia law does not recognize as an independent cause of action. Id. at *8.   

Because plaintiff’s claims were either preempted or failed as a matter of law, the case was dismissed with prejudice.

And while we always celebrate a preemption win, we can’t overlook that in this case, the label warned of the risk; the risk occurred. End of story. Or at least it should be. The subtext of a claim like this is not that the warning was absent, but that the plaintiff wishes it had been more reassuring. The truth is that a warning can be adequate even if the risk materializes. Warnings are not guarantees. They are disclosures. And when a label discloses the very risk at issue, the failure-to-warn claim should collapse under the weight of its own contradiction.

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It’s been a been a while – some five years – since we discussed cross-jurisdictional class action tolling.  That’s mostly because, aside from the occasional result-oriented atrocity that occurred in the Valsartan MDL, class actions are no longer a top-shelf problem in prescription medical product liability litigation.  But it’s still nice to report on a major appellate decision from a large state giving that novel theory the boot.

That’s precisely what happened in on Halloween in Ackerman v. Arkema, Inc., 157 F.4th 715 (5th Cir. 2025).  Ackerman involved allegations of environmental pollution, not prescription medical product liability litigation.  Shortly after the event, some attorney purporting to represent residents filed a class action in federal court seeking both damages and injunctive relief less than a month after the explosions that allegedly caused the pollution.  Id. at 716.  The federal district court only certified the class for injunctive relief – hardly what the lawyers were primarily after – since monetary relief for different property damage claims isn’t the sort of common injury that supports a class action.  Id.

In 2024, some two years after the injunctive class settled, “800 members of [that] class filed individual actions in Texas state court seeking monetary damages.”  Id.  These claims were admittedly filed “almost six years after they had accrued,” long after the applicable two-year statute of limitations had expired.  Id.  But the plaintiffs claimed that the federal class action – which had never been certified as to property damage claims – somehow trumped the Texas statute and tolled Texas state-law claims brought in  state court.

That’s called “cross-jurisdictional class action tolling,” and Texas (like most states) had never permitted a class action filed in some other court system (here, a federal court) to toll its own statute of limitations in its own courts.  After these 800 claims were removed on diversity grounds to federal court, the trial court rejected their tolling arguments “because Texas law does not recognize cross-jurisdictional tolling of the statute of limitations.”  Id.

The Fifth Circuit has affirmed, rejecting the plaintiffs’ proposed reliance on “policy considerations” to justify their claimed federal procedural impingement on the Texas state statute of limitations.  As our cross-jurisdictional class action tolling scorecard indicates, while the issue has never reached the Texas Supreme Court, state and federal appellate courts have unanimously rejected such tolling.  See Bell v. Showa Denko K.K., 899 S.W.2d 749, 757-58 (Tex. App. 1995); Newby v. Enron Corp., 542 F.3d 463, 472 (5th Cir. 2008); Vaught v. Showa Denko K.K., 107 F.3d 1137, 1147 (5th Cir. 1997).  Adhering to this “binding precedent,” Ackerman, refused plaintiffs’ invitation to expand Texas law.  157 F.4th  at 717.  “state rules for tolling are based on state, not federal, law,” thus “Texas courts would not toll the state statute of limitations in light of a federal class action.”  Id. at 718 (citation and quotation marks omitted).

Plaintiffs “policy” claims were simply reprises of arguments that prior decisions had already considered and rejected:

Appellants’ arguments that there are exceptions to this bar on cross-jurisdictional tolling − such as when certain types of claims are at issue or when defendants have fair notice of the claims − are unavailing.  Newby considered and rejected such arguments, expressly abrogating district court cases holding that Texas courts would allow cross-jurisdictional tolling for property-related claims or where defendants had fair notice.  In the absence of any subsequent Texas decisions rendering our Erie guesses in Vaught and Newby clearly incorrect, we adhere to their holdings.

Id.  Nor was cross-jurisdictional class action tolling a “close question” that would warrant certification to the Texas Supreme Court where neither party sought such relief.  Id. at 718 n.2.

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We recently attended the ACI Drug & Medical Device Seminar in New York, where we always enjoy catching up with old friends, making new acquaintances, and hearing what’s new in our drug and device sandbox.  This year we spoke on the extensive and active litigation that is currently going on over the 340B drug pricing program.  We product liability litigators don’t often focus on drug pricing, but litigation over 340B discounts has become big enough that it has grabbed our attention, in a major way.  The stakes are substantial:  Spending under the 340B program was estimated at $66 billion in 2023, and it is expected to become the largest federal prescription drug program by 2028. 

Today we provide an update on litigation over the use of “contract pharmacies” to dispense prescription drugs purchased at steep 340B discounts.  We described the contours of that litigation here and here, and the latest development is from a lawsuit challenging Utah’s law mandating that manufacturers sell medicines at 340B discounts to unlimited numbers of pharmacies.  In Abbvie, Inc. v. Brown, No. 2:25-cv-00271, 2025 U.S. Dist. LEXIS 228160 (D. Utah No. 19, 2025), a federal court in Utah recently ruled that federal law preempts Utah’s contract pharmacy law and also that the Utah law enacted an unconstitutional taking. 

To recap, prescription drug manufacturers who want to participate in Medicare and Medicaid spending have to offer drugs under the 340B program at steep discounts to certain safety net healthcare providers—so-called “covered entities.”  Because not all covered entities have in-house pharmacies, they are allowed to contract with outside pharmacies to dispense medicines to their patients.  These “contract pharmacies” are thus eligible to purchase drugs at the 340B discounted prices.  For a variety of reasons, the use of contract pharmacies has exploded over the last 15 years, and many manufacturers have concluded, with substantial justification, that this exponential growth threatens the integrity of the program.  So, several of them have tried to apply the brakes by imposing reasonable limitations. 

Multiple states have struck back by passing laws mandating that manufacturers continue to sell 340B discounted drugs to unlimited numbers of pharmacies—including Utah.  In Brown, a group of prescription drug manufacturers sued to enjoin Utah’s law under which manufacturers are not allowed to limit delivery of discounted drugs to contract pharmacies, nor can manufacturers require the submission of claims data or other information as a condition of delivery.  2025 U.S. Dist. LEXIS 228160, at *12-*13. 

In challenging that law, the manufacturers argued (1) that federal law preempts the Utah law, (2) that the Utah law enacted an unconstitutional taking, and (3) that the Utah law violates Due Process and the Commerce Clause.  In denying the state’s motion to dismiss, the district court agreed with the manufacturers on preemption and the Takings Clause.  On preemption, the district court observed that the federal 340B statute did not necessarily occupy the entire field.  But regardless, the Utah statute conflicted with federal law because the Utah statute permits the transfer of drugs at 340B prices to entities that do not serve vulnerable populations.  As the court observed, “under [the Utah statute], entities that potentially do not dispense drugs to patients at all may acquire . . . drugs at 340B prices.”  Because that is “directly contrary” to the 340B program’s purpose, federal law preempts the state law.

On takings, the manufacturers argued that the Utah statute forced them to transfer property for the benefit of private parties “without serving any valid purpose,” including allowing diversion of drugs to ineligible providers.  The district court agreed.  Sure, the manufacturers’ participation in the 340B program is voluntary, but they did not voluntarily accede to the wider parameters imposed by Utah’s law.  In other words, Utah “may not broaden the bargain by riding the coattails of a federal benefit.”  Id. at *28.

The district court did, however, grant the state’s motion to dismiss the manufacturers’ claims based on the Due Process Clause and Commerce Clause.  On due process, the statute’s language—and particularly its use of the terms “interfere” and “pharmacy”—were not so vague as to make the law unconstitutional, and although the statute did not expressly include a scienter requirement, its penalties provision included one by referenced to another law.  Id. at *28-*33.

Finally, the manufacturers’ Commerce Clause failed because, even though Utah’s statute had extraterritorial effects, “[s]tates retain authority under their general police powers to regulate matters of legitimate local concern, even though interstate commerce may be affected.”  Id. at *33.  The Utah statute is limited in application to pharmacies in Utah, and the manufacturers did not allege facts demonstrating discrimination against other states. 

This is a good outcome for prescription drug manufacturers, but it is not the last word.  Stay tuned. 

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