Photo of Steven Boranian

No, your DDL bloggers are not offering a money-back guarantee—although we suppose offering one would not cost us anything, since reading the blog is free.  For enterprises that actually sell products though, the story is sometimes different, and many product sellers do guarantee satisfaction—or your money back.  Moreover, when those guarantees are unrestricted, we have a difficult time seeing how consumers could ever file lawsuits claiming they were overcharged.  All they had to do was ask for refunds, without the need for litigation or exorbitant claims for attorneys’ fees.  Case closed.

That is what happened a little while back in a short-but-smart order from a New York trial court.  In Scott v. Walmart, Inc., No. EF012051-2025, 2026 WL 2561736 (N.Y. Sup. Ct. July 28, 2026), the court dismissed a consumer class action brought by the purchaser of an over-the-counter sleep aid.  Because the seller offered a money-back guarantee, the purchaser/plaintiff had no standing to sue.  And, federal law preempted the claims to boot.

In Scott, the OTC product’s label said the product was “non-habit forming.”  The plaintiff alleged that statement was misleading because the product’s active ingredient allegedly could elevate the user’s mood, which could cause the user to want to use the product more.  Now mind you, this plaintiff did not allege that he actually experienced these sensations, or experienced any alleged injury at all.  He alleged instead that he paid more for the product because of the “misleading representations” and thus sought a partial refund for himself and his proposed class.

The court was having none of it.  First, the product seller offered an unrestricted money-back guarantee under which purchases could return the package for a full refund.  Sure, if there were strings attached, perhaps the purchaser could allege an injury in fact under New York’s consumer protection statutes.  But here the guarantee was unrestricted.  As a result, the court concluded that “Plaintiff herein would likewise be fully compensated by virtue of [the defendant’s] unrestricted money-back guarantee for the Product and therefore, having suffered no injury on fact, he lacks standing.”  Scott, at *4.

Second, even if the plaintiff had alleged a cognizable injury, federal law preempted his claims in any event.  As the court explained, Congress has created a national and uniform scheme to protect consumers from fraud or misrepresentations in the sale of food, drugs, and cosmetics.  Moreover, the FDCA contains an express preemption clause that bars states from establishing any requirement for OTC drugs that is “different from or in addition to, or that is otherwise not identical with” federal requirements.

Here, the FDA regulates the OTC product at issue through an FDA Monograph, which sets forth federal requirements for product labeling.  Because the plaintiff’s lawsuit would require the product seller to include different or additional information on a federally approved drug label, the plaintiff’s state-law claims were preempted.  In so holding, the court rejected precedent from our home district, the Northern District of California, which ruled that similar claims were not preempted because the Monograph did not explicitly address whether the “non-habit-forming” statement is misleading.  The New York court correctly saw it differently, and it held that if the FDA regulates a given subject matter—here, dependency on a certain active ingredient—then federal law “preempts all non-identical state laws within that subject matter.”  Scott, at *5.  Regulation of particular or specific statements within that subject matter is not required. 

The court closed with some choice words for the plaintiff’s counsel, who evidently favors exaggerated punctuation (lamely echoed in the title to this blogpost!!).  The court did not appreciate counsel’s attempt to denigrate defense counsel, nor counsel’s “specious attempt to cast aspersions on his adversary and to detract from the issues raised in the motion, especially in light of the disjointed and excessively punctuated submissions by Plaintiff’s counsel.”  Scott, at *5.  We will accept the court’s admonition on behalf of law bloggers everywhere.  Will our analysis be disjointed?  Usually not.  Will we excessively punctuate our pithy observations?  Never!!!!  Guaranteed, or your money back. 

Photo of Eric Alexander

A mere two weeks ago, we praised a California federal court for dismissing preempted claims against a prescription drug manufacturer and not giving the plaintiff a third chance to plead a non-preempted claim.  We noted that allowing three strikes seems to be the default rule on serial amendments in response to motions to dismiss or orders granting them, but that some courts have allowed a fourth complaint rather than dismiss all the claims with prejudice on the failed third try.  This week, we have a different California federal court dispensing a well-reasoned dismissal of all the claims in the third complaint against the manufacturer of a prescription blood glucose monitoring system, but the dismissal was somewhat sullied by the unexplained decision to give the plaintiffs a chance to file a fourth complaint.  The fourth strike, much like the fifth down that the Chiefs were afforded in the 2023 AFC Championship Game, is hard to justify, inviting speculation about possible undue bias or sympathy.  In Higginbottom v. Dexcom, Inc., No. 24-cv-0195-WQH-BLM, 2026 WL 2658079 (S.D. Cal. Sept. 9, 2026), the plaintiffs were the representatives and heirs of their deceased teenage son, so some sympathy is understandable.  In this case, however, another amendment seems patently futile and it is time for finality.  The case has been around for more than two and a half years without getting past pleadings; it has been more than two years since the claims against the manufacturer in the second complaint were dismissed without prejudice as expressly preempted and plaintiffs were permitted to file a third complaint. We discuss that dismissal here, along with other issues decided at the same time.  When the plaintiffs amended, the manufacturer moved to dismiss again.  After a stay and unsuccessful mediation, the manufacturer refiled its motion in October 2025 and the motion was ripe in early December 2025.  There are multiple cases around the country involving the device at issue that have not been consistent on preemption.  See here for a notable early preemption win with the same device.  Based on the two preemption decisions in Higginbottom it seems that the only way plaintiffs could plead around preemption would be to add completely new claims, which should not be happening at this stage.  The 2024 decision finding plaintiffs’ claims to be expressly preempted clearly put plaintiffs on notice of what their third complaint needed to accomplish but it fell short.  We would have expected that to be the end of the case.

Otherwise, Higginbottom is pretty good on the merits.  Plaintiffs’ minor son was diagnosed with type 1 diabetes and prescribed defendant’s glucose monitor and another company’s insulin pump.  After almost two years of successful control of his diabetes with the aid of these devices, the decedent changed a sensor in glucose monitor.  2026 WL 2658079, *3.  Within a day, it allegedly began to malfunction, registering high readings that led to the over-administration of insulin by the pump and decedent’s own hand.  He then drove himself on a rural road, allegedly experienced hypoglycemia from the excess insulin, passed out, and suffered a fatal automobile accident.  His estate initially sued both manufacturers, but ultimately settled with the pump manufacturer.  We infer that the allegations in the complaints shifted over time to focus on the alleged malfunction of the remaining defendant’s glucose monitor as being solely responsible for the hypoglycemia.  Although there were four counts in the third complaint, there was really a single theory that the defendant had failed to warn FDA of adverse events suggesting the monitor could lead to the over-administration of insulin.  It appears that plaintiffs must not have ever tried to articulate a potentially non-preempted warnings claim that the Instructions for Use failed to inform prescribing physicians of the device’s risk of contributing to hyperglycemia.  That was probably because they thought that the dubious judicial creation of a state law duty to warn FDA would carry the day.

As we have said before, ascertaining if the state law claims asserted actually exist and have been pleaded properly is a good starting point for deciding express and implied preemption.  Sometimes, that requires a choice of law analysis.  Plaintiffs wanted California law.  They sued there, presumably both because the glucose monitor’s manufacturer is based there and because California is one of the few states whose courts have made up a nonsensical state law duty to report adverse events to FDA.  The plaintiffs were from Wyoming, which is also where the prescription, use, and alleged malfunction of the device occurred and where their decedent’s fatal accident occurred.  Under California choice of law rules, Wyoming law was clearly the one to apply.  We will not dwell much on that analysis, but it did involve an Erie prediction as to whether Wyoming would adopt the same state law duty as California.  Although it did not cite Erie, Higginbottom cited cases that cited Erie and discussed the concept of Erie deference.  (Yes, we did mention Erie three times in one sentence.)  Citing an MDL’s survey of state law on the discussed here that found no support for Wyoming adopting the relatively novel duty, Higginbottom found no authority either and noted plaintiffs’ admission that Wyoming has made a “decision not to recognize a failure warn claim[ ] based on a failure to report adverse events.”  Id. at *8.  (Had the court looked to our surveys on the issue, it would have gotten the same absence of support in Wyoming.)  Thus, the court “decline[d] to recognize such a claim under Wyoming law at this stage of the proceedings.”  Id.  That established the conflict between California and Wyoming law, but it also mattered to the express preemption analysis.

As we discussed at length with the Dickson case that involved the same defendant’s glucose monitors, see here, here, and #6 in our list here, there is a middle ground between Lohr and Riegel that includes Class II devices cleared under de novo 510(k) applications that have special controls codified in a regulation.  Without diving into the issues with broadly applying Lohr to much more recently cleared Class II devices, it is obvious that the glucose monitor was not a “regular” Class II device.  Back in 2024, the first Higginbottom decision had relied heavily on Dickson in finding that the device’s specific regulatory history meant that express preemption applied to plaintiffs’ claims.  Id. at *13.  Plaintiffs urged a different result in 2026 based on the timing of the Final Rule (that is, the CFR section for this kind of device) in relation to the death of plaintiffs’ son.  However, the third complaint actually alleged that the same special controls applied when the device was cleared:

Unlike general requirements, which may be imposed through substantial-equivalence review, the SAC supports the inference that the FDA classified the G6 System subject to device-specific special controls for the purpose of assuring the safety of the medical device.  The allegations that the G6 System underwent subsequent § 510(k) reviews for various aspects of its system—including new interfaces for elements, such as its mobile application and an adhesive patch—do not indicate that the special controls reflected in its initial classification no longer applied.

Id. at *14.  That meant the FDCA’s express preemption provision applied. 

Because Wyoming does not have a state law claim for failure to warn the FDA, plaintiffs could not utilize the largely fictitious parallel claim under Stengel.  Id. at *15.  We have had too many posts on Stengel and parallel claims to link them here.  Many of those posts have talked about how claims that were held not to be expressly preempted could still be impliedly preempted under Buckman.  Higginbottom did not analyze implied preemption.  Maybe that will come up in the inevitable ruling on the motion to dismiss plaintiffs’ fourth complaint that tries to plead a single non-preempted claim.

Photo of Stephen McConnell

Our entering class of C.D. Cal. federal prosecutors back in 1992 was made up of an interesting cast of characters. Those Assistant United States Attorneys went on to become general counsels, judges, professors, and lowly bloggers. Most of the cohort came from BigLaw. Young lawyers were willing to halve their Skadden/Munger/Gibson/A&P etc. salaries so that they could acquire trial experience. But one of our classmates had taken a different route. He had labored for a while in the asset forfeiture division of the U.S. Attorney’s Office. That division was just across the plaza, but a million miles away in terms of the nature of the experience. What did we know about asset forfeiture cases in those salad days? Pretty much nothing. Our colleague regaled us with tales of successful forfeiture actions against drug kingpins, showering the U.S. Treasury with millions of dollars and lots of flashy cars. Who knew that the USAO could be a profit center? It seemed both righteous and cool.

Now that we mostly operate on the defense side of the v, we have developed skepticism about the government’s aggressive deployment of asset forfeiture actions. That brings us to today’s case, United States v. Ahmed, 2026 WL 2654883 (D. R.I. Sept. 9, 2026). Ahmed is an interesting Food Drug, and Cosmetic Act criminal ruling by a magistrate judge. The plaintiff had entered into a plea deal involving a misdemeanor drug misbranding charge. The government was attempting to enforce a $100,000 forfeiture provision in the plea agreement. Obviously, our ears perked up when we heard that drug misbranding might lead to asset forfeiture.

It turns out that the government can be mighty aggressive when it comes to asset forfeiture. Maybe too aggressive. The court in Ahmed held that forfeiture is not authorized against defendants like Ahmed who introduced misbranded drugs into interstate commerce in violation of 21 U.S.C. section 331(a). And even if forfeiture was authorized, the government had not established by a preponderance of the evidence that $100,000 was the true value of the property that was unavailable due to acts or omissions by the criminal defendant.

How did we get to those results? A statutory puzzle had to be pieced together, and then the government’s math appeared to be sloppy and inconsistent. Let’s start with the puzzle:

Fed. Crim. Pro. 32.2(b) requires the court to determine whether forfeiture is authorized in a particular case, if so, what property is subject to forfeiture, and the amount of money to be paid.  

21 U.S.C. section 334, is part of the FDCA, and is entitled “Seizure.” It provides that misbranded drugs may be ordered to be disposed of by destruction or sale.

28 U.S.C. section 2461(c) authorizes criminal forfeitures against defendants charged with crimes for which civil forfeiture of property is authorized.

21 U.S.C. section 853(p) authorizes forfeiture of substitute property when the actual property is unavailable as a result of any act or omission of the defendant.

The problem with the government’s argument is in that first step. It all depends on whether 21 U.S.C. section 334 is a civil forfeiture statute. Only if it is does 28 U.S.C. section 2461 swoop in to apply it in a criminal case, and then 21 U.S.C. section 853(p) allows substitution of property for forfeiture.  The Ahmed court was “unconvinced that 21 U.S.C. section 334 is a civil forfeiture statute.” The only federal court that had analyzed this issue was the Second Circuit in United States v. Fishman, 157 F.4th 143 (2d Cir. 2025). In Fishman, the court vacated a forfeiture order and held that “21 U.S.C. section 334 is not a civil forfeiture statute within the meaning of 28 U.S.C. section 2461(c).” The court reasoned that forfeiture statutes are typically intended to enable the “disgorgement of the fruits of illegal conduct” to penalize unlawful conduct and make it unprofitable and to compensate the government for investigation and enforcement expenditures, whereas the FDCA, by contrast, permits both the destruction of condemned goods and an owner’s retention of those goods after bringing them into regulatory compliance. The very different remedies took section 334 out of forfeiture land.

Now it is true that when the government comes calling, it can be hard to push back on their positions and requests. But if the government starts threatening asset forfeiture based on alleged FDCA violation, push back you must.

As for the government’s sloppy math, it seems like $100,000 was a nice, round, attention-getting number, but not one that was grounded in reality. It literally did not add up. The government asserted that the defendant had realized approximately $80,500 of sales of the misbranded drugs. To suggest that $80K is in the neighborhood of $100K really does illustrate the old saw of “close enough for government work.” But the court thought it was not close enough. Nor was the court impressed by the government’s position that $100,000 was the “negotiated amount” reached by the parties. A court will not order an asset forfeiture that lacks proof.

Accordingly,  the Ahmed court denied the government’s motion for an order of forfeiture.

Photo of Michelle Yeary

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

It’s a relatively new term (at least for us Gen Xers) – but we have all been ghosted. A second date that never gets confirmed. A contractor who quotes the job and then vanishes. A group text that just stops. It stings, but usually the only casualty is your ego. In Sarmiento-Tenecela v. Teva Pharmaceuticals USA, Inc., No. ESX-L-002653-20, slip op. (N.J. Super. Ct. Law Div. Aug. 31, 2026), the casualty was the entire case.

Plaintiff sued over a Paragard IUD that fractured on removal a decade after it was placed, and she planned to prove her claims with two experts — David Kessler, the former FDA Commissioner and go-to plaintiff’s expert in pharmaceutical mass torts, and Dr. Jimmy Mays, a polymer chemistry PhD who has done general causation work in the Paragard MDL on the device’s materials and design. These are not fly-by-night witnesses pulled off a for-hire circuit. They are the same experts other Paragard plaintiffs have relied on nationwide. Small problem — neither one ever sat for a deposition in this case. Defendants asked for dates. Plaintiff did not respond. The court ordered depositions to happen by a date certain and warned that noncompliance could mean preclusion of expert testimony or worse. Plaintiff still did not produce them. When the motion for sanctions finally landed, plaintiff’s excuse amounted to “we could not reach them” and “counsel had a family medical situation.” The court was sympathetic to the latter as a human matter and unmoved by it as a legal one. You cannot rely on an expert to beat summary judgment while simultaneously keeping that expert unreachable for the other side. That is not litigation, that is hide and seek.

Plaintiff’s defense was that Kessler and Mays are general experts in the Paragard MDL and that plaintiff’s counsel does not control their calendars. That much may be true. These experts likely are booked across dozens of cases and answer to MDL leadership, not to any one plaintiff’s firm, but it cuts against plaintiff, not for her. Nationally prominent, frequently deposed experts are not hard to find or schedule; they have existing deposition protocols, standing availability windows, and counsel who negotiate their calendars as a matter of routine. Plaintiff also cited counsel’s mother’s hospitalization for cardiac procedures as a reason the deadline slipped. The court did not dismiss those circumstances, but it also did not let them do the work plaintiff needed them to do. Personal hardship might explain a missed phone call. It does not explain months of silence on a court-ordered deposition schedule, and it certainly does not explain why they could not be produced even after the court compelled compliance.

Defendants asked for dismissal outright as a sanction. The court declined to go that far, noting that dismissal as a discovery sanction is reserved for cases where the misconduct goes to the very foundation of the claim or is deliberate and contumacious. Id. at 5. Instead, the court went with the lesser remedy of preclusion. Id. at 6-7. Kessler and Mays were barred from offering testimony at trial. But benching the experts turned out to be the ballgame anyway because plaintiff needed them to survive summary judgment.

To defeat preemption of a failure to warn claim, a plaintiff has to show the manufacturer could have made a unilateral label change under the FDA’s changes being effected regulation (“CBE”). Which requires plaintiff to produce evidence of “newly acquired information” that reveals risks of a “different type or greater severity or frequency” than what was available to the FDA at the time of approval.  Id. at 7.  In this case that meant, plaintiff needed to show defendant possessed qualifying newly acquired information before plaintiff’s IUD was implanted in April 2008. She did not. The adverse event reports she pointed to were already reflected in the FDA-approved label before her IUD was placed, and a study done in 2015 was simply seven years too late to support a CBE label change before 2008.  The court noted, tellingly, that it did not even know what Kessler would have said about newly acquired information as of 2008, because his MDL report never addressed the question. Funny how that works when you will not produce your expert for a deposition. The court found no genuine dispute of material fact and held the warning claims preempted. Id. at 18.

Plaintiff also argued the IUD’s breakage warning did not adequately cover fracture during routine removal without preexisting embedment. The court did not need to resolve that dispute because plaintiff’s only medical expert testified the device was in fact embedded at the time of removal. The precise risk plaintiff says the label failed to disclose is not the risk that happened to her. And having conceded she would not offer her case-specific medical expert on label adequacy at all, plaintiff was left with no warning expert whatsoever. Id. at 19.

The design defect claim fared no better. Plaintiff’s two design theories, the type of resin used and the barium sulfate concentration, required evidentiary support plaintiff simply did not have. She offered no evidence her own device used the disfavored resin, and no expert testimony that a different barium sulfate concentration would have prevented the fracture. Nor did she offer any expert evidence of a feasible alternative design.  Under New Jersey law, a design defect claim without an alternative design is not a design defect claim. Id. at 18.

This is a defense win on preemption, but our focus is on the preclusion ruling. Discovery gamesmanship around expert witnesses has consequences, even when a court is not willing to nuke the whole case as an outright sanction. A plaintiff who will not make her experts available for deposition simply does not get to use them, full stop, and courts should not need to hear the phrase “we could not reach them” more than once before losing patience.  Ghosting has consequences. In this case, plaintiff’s experts skipped the date, and the whole case got left standing at the altar.

Photo of Bexis

Last month we published a thought piece, Medical Monitoring and the Limits to Equity, pointing out how no-injury medical monitoring claims asserted in federal court could well fall outside the foundational limits on those courts’ equitable powers, given the holding in Grupo Mexicano de Desarrollo S.A. v. Alliance Bond Fund, Inc., 527 U.S. 308 (1999), limiting federal equity powers to the “the jurisdiction in equity exercised . . . in England at the time of the adoption of the Constitution and the enactment of the original Judiciary Act,” that being, of course, 1789.  Id. at 318.  We also concluded that the Judicial Act’s limits to federal equitable powers likely applied in diversity cases, given, Guaranty Trust Co. v. York, 326 U.S. 99, 104-06 (1945), and its progeny.

We cautioned, however, “that this argument seems never to have been tried before in the medical monitoring context,” given that we found no “opinion in any court citing to either Grupo Mexicano or Guaranty Trust that also included the phrase ‘medical monitoring.’”

That’s no longer true.

In Bio-Lab, Inc. v. Tartt, ___ S.E.2d ____, 2026 WL 2395789 (Ga. Aug. 18, 2026) – decided less than two weeks after our post – the Georgia Supreme Court came to the same result as the second part of our analysis – that the limits of equitable jurisdiction exercised by federal courts in diversity cases are federal in nature, given the Guaranty Trust line of cases.  Id. at *5-6.  Bio-Lab involved a medical monitoring claim, the state high court having accepted certified questions from a federal district court:

The Defendants moved to dismiss that request for equitable relief, arguing that, under Georgia law, the requested remedy is unavailable in the absence of allegations of present physical injury. . . .  [G]iven the dearth of Georgia case law on medical monitoring in connection with mass torts, [the federal court] was “left with considerable uncertainty as to whether Georgia law permits medical monitoring as a tort remedy absent a current physical injury.”

Discerning no clear answer to that question, the district court opted to seek our input and certified the following questions to this Court:

(1) Under Georgia law, can a plaintiff exposed to toxic substances which may cause future disease obtain equitable relief in the form of medical monitoring costs absent an allegation of present physical injury; and

(2) If so, what standard must the plaintiff meet to obtain such relief?

Id. at *2 (emphasis added).

The Georgia Supreme Court interpreted the first question “as implicating two broader legal issues with relevance beyond the specific facts,” the first being “under what circumstances is equitable relief available.”  Id. at *3.  That was a question governed by state law.  Id.  To be entitled to equitable relief, a plaintiff “must first identify some legally cognizable ‘wrong’ or ‘injury’ that needs to be remedied.”  Id. (citation and quotation marks omitted).  That is a “separate question whether that plaintiff is entitled to some form of relief.”  Id.

Bare fears of injury will not authorize equitable relief.  Rather, where a plaintiff seeks an equitable remedy for a threatened legal injury, that injury must be imminent, not remote, before equitable relief is authorized.

Id. at *4 (citations omitted).  Because “equity follows law,” equitable relief cannot be afforded “contrary to the law.”  Id. (citation and quotation marks omitted).

Given the pleadings-based status of the case, the Tartt court refused to go any further, and did not directly address medical monitoring.

[R]esolving the issue of whether equitable relief is available will first involve a thorough and intensive evaluation of whether the Plaintiffs’ complaint includes sufficient factual allegations to demonstrate both a legally cognizable injury and the necessity of equitable relief to remedy that injury.  But this Court, when answering questions certified to us by a federal court, does not reach the merits of the underlying case; instead, we answer the questions posed to us only in a general sense. . . .  Thus, we respectfully decline to answer the district court’s questions to the extent that it calls on us to decide the ultimate issues raised by the Defendants’ motion to dismiss.

Id. (citation and quotation marks omitted).

If the court had stopped there, Tartt would have been a non-event, since it did not reach the issue of whether no-injury medical monitoring was an available equitable remedy under Georgia law.

What made Tartt bloggable was the court’s treatment of the second question – “when equitable relief is available, what is the appropriate form and scope of that relief?”  Id. at *5.  That question, Tartt recognized, was “largely” a federal question under Guaranty Trust:

Unlike the question of entitlement to equitable relief (something we agree with the district court that state law governs), the form of equitable relief that a federal court sitting in diversity may grant may (we believe) be largely a question of federal law.  [citing Guaranty Trust and progeny decisions]  We acknowledge that this is a surprisingly thorny issue.  But we think the best reading of the relevant decisional law − which is not exactly a beacon of clarity − is that the appropriate form and scope of equitable relief must be determined as a matter of federal law.

Id. (other citations omitted) (emphasis added).  Why?  “[S]tate law clearly cannot commit the federal courts to grant equitable relief [in a diversity case] contrary to restraints imposed by the Constitution or an Act of Congress.”  Id. (Wright & Miller citation omitted).  “[C]rucially, some have interpreted Guaranty Trust to mean that state law does not govern the scope of the equity powers of the federal court, even when state law supplies the rule of decision.”  Id. at *6 (citation and quotation marks omitted) (emphasis original).

The referenced “some” cases include those that we had collected in the Guaranty Trust portion of our post not two weeks earlier.  Don’t worry, we’re not getting too full of ourselves – Tartt did not cite the same actual cases we did; ours were considerably more recent, so there’s no reason to believe that anybody involved in Tartt had ever read our post.

But, as to the second issue in our post, that federal law governed the scope of available equitable relief in diversity cases, Tartt reached the same conclusion we did:

So − as we understand the current state of the admittedly ambiguous law − a federal court, although limited by state jurisprudence on the question of whether the injunction remedy may be granted, is free to decide for itself what the scope and content of that injunction should be as befits the historically discretionary character of equity jurisprudence.  State law provides the basis for relief; it does not necessarily constrain the scope of that relief.  And that seems especially true where, as here, state law supplies no clear answer as to the availability of a specific form of injunctive relief.

2026 WL 2395789, at *6 (citation and quotation marks omitted).  Tartt thus “declined to opine” on the availability of any “specific form of equitable relief,” such as medical monitoring.  Id. at *7 (“We therefore respectfully decline to address whether Plaintiffs are entitled to a medical monitoring injunction.”).  Before that could happen, the federal court hearing the case would have to “determine[] that equitable relief is appropriate (or properly asserted).”  Id.

And that brings us back to the first, and most intriguing, point of our prior “Limits to Equity” blogpost – that “equitable” medical monitoring claims in federal court are subject to the United States Supreme Court’s Grupo Mexicano holding that federal equitable relief is limited to those powers recognized by the English courts of equity back in 1789.  We have no reason to believe that any English chancellor in equity during the reign of King George III (or before) had permitted uninjured persons to recover for medical testing expenses based on mere exposure to a purportedly toxic substance.  That’s something that we hope that the defendants in Tartt (and defendants in any medical monitoring litigation in federal court) will raise as a defense in the future.

Photo of Eric Hudson

About four years ago we posted about a decision in which the Wisconsin Court of Appeals reversed a trial court’s injunction requiring the administration of a certain medication to treat a patient suffering from COVID-19. In that decision, the party seeking the injunction relied on an unsworn declaration from a physician who stated that he was “generally considered the foremost authority” on the proposed treatment. Gahl v. Aurora Health Care, Inc., 403 Wis. 2d 539, 554-55 (Wis. Ct. App. 2022). That decision rejected the assertions in the declaration and noted that the declaration was “conspicuously devoid of any discussion of the patient in [the] case.” Id.  Today’s decision, Kory v. Waters, 2026 WL 2507087 (2d. Cir. Aug. 26, 2026), comes full circle—the physician who offered the declaration in Gahl supporting what might be considered unorthodox treatment was named as a defendant in a medical malpractice claim related to his treatment of a patient with COVID-19.  The dismissal of the malpractice claims underscores the broad scope of immunity under the Public Readiness and Emergency Preparedness Act (the PREP Act), 42 U.S.C. § 247d-6d.  Even if the treatment might be considered “counter-culture,” if the Act’s requirements are satisfied, it is subject to immunity from suit.

Continue Reading PREP Act Comes Full Circle for “Counter-Culture” Expert in COVID-19 Treatment
Photo of Lisa Baird

Today’s guest post comes from three Reed Smith colleagues and fellow European Union Product Liability Directive nerds, Jamie Lanphear, Greg Speier, and Wim Vandenberghe. As always, our guest posters get all the cheers for their work along with any jeers, though those are hardly likely.

**********

The Blog has been sounding the alarm on the EU’s new Product Liability Directive (“PLD”) for almost two years now—and with good reason.

For those just tuning in, the PLD is the most sweeping reform of EU product liability law in four decades—expanding the definition of “product,” introducing claimant-friendly presumptions of defect and causation, broadening disclosure obligations, and extending the categories of recoverable damage. The Directive requires all 27 EU Member States to transpose it into national law by December 9, 2026. It applies to products placed on the market or put into service after December 8, 2026 (a typo was recent corrected in the original text, which had stated December 9).

Over the past year and a half, the Blog has covered the Directive’s overhaul of EU product liability law (see, e.g., here, here, here, and here, ), including its implications for software and digital products (here), its expanded disclosure obligations and the risks they pose to privileged communications (here), and what the European Commission itself has said about its goals for the new regime (here).  

This post is about implementation—where each Member State stands with fewer than four months to go, and where meaningful national divergences are emerging that will shape litigation risk on day one. The short version: three Member States have completed transposition, twelve more have draft legislation in the pipeline, and the rest are somewhere between initial steps and radio silence.

Where Things Stand

Member State transposition efforts fall into four categories.

Completed Transposition: Hungary, Croatia, and Lithuania have completed transposition. Hungary was first, with its parliament adopting the implementing law on December 16, 2025. Croatia followed on July 7, 2026, amending its Civil Obligations Act and notifying the Commission. Lithuania’s Seimas adopted its bill on June 25, 2026, as Act XV-1080, with an entry-into-force date of December 9, 2026.

Well Underway: Twelve Member States have prepared draft legislation: Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Italy, the Netherlands, Poland, Slovakia, Slovenia, and Sweden. Germany, Slovakia, and the Netherlands are furthest along—each is in parliamentary process and tracking toward adoption this fall. Belgium, Italy, and Slovenia entered the pipeline more recently but are moving. The remainder have drafts in various stages of consultation and review.

Early Stages: Austria, Bulgaria, Estonia, France, the Republic of Ireland, Latvia, and Romania have taken initial steps toward transposition but have not yet published draft legislation. Austria expects to submit a draft to parliament this fall. Bulgaria is preparing draft legislation, with submission to the Council of Ministers expected in September. Estonia expects a government proposal to reach parliament in September 2026. France has confirmed an interministerial working group and stakeholder consultations, but no published text yet.

No Known Public Movement: Greece, Luxembourg, Malta, Portugal, and Spain have made no known public progress toward transposition.

Key Divergences to Watch

This is where it gets interesting. The PLD is a maximum-harmonization directive, meaning that Member States generally may not adopt more or less stringent rules than those set forth in the Directive. But the PLD expressly leaves room for national discretion in certain areas. In others, differences emerging in national implementing legislation raise questions about whether Member States have gone beyond the discretion the Directive allows.

Development Risk Defense: This defense—also known as the “state-of-the-art” defense—protects manufacturers from liability if the scientific and technical knowledge at the time the product was released was such that the defect could not have been discovered. Article 18 expressly permits Member States to depart from this defense. Most drafts retain it, but there are some exceptions: Finland will continue its longstanding exclusion of the defense. Hungary limits the defense for medicinal products used as instructed. Germany retains the defense, subject to its existing carve-out for genetic engineering products.

Non-Material Damages: The PLD expressly leaves aspects of damages to national law. Recital 23 provides that non-material losses—such as pain and suffering—are compensable to the extent permitted under national law. As a result, the availability and calculation of non-material damages will continue to vary across Member States, even under the PLD’s maximum-harmonization framework. That variable will likely shape forum-shopping decisions.

The “Excessive Difficulties” Threshold: This one is particularly concerning. Article 10(4)(a) allows courts to presume defectiveness and causation where a claimant faces “excessive difficulties” in proving those elements due to technical or scientific complexity. Finland and Sweden have removed the word “excessive” in their implementing proposals, arguably lowering the threshold for claimants to trigger the presumptions.

However, unlike the development risk defense and non-material damages, the PLD does not expressly authorize Member States to vary this threshold. Whether these divergences represent permissible implementation choices or conflict with the Directive’s maximum-harmonization requirement may ultimately require judicial resolution. But in the meantime, they create exactly the kind of patchwork that encourages forum shopping—claimants filing in the jurisdiction with the most favorable presumption standard.

Disclosure: As we discussed in a prior post, the PLD’s disclosure requirement is a significant development, particularly for jurisdictions that have historically had little or no pre-trial discovery. Member States are taking different approaches. Some are adopting new, PLD-specific disclosure provisions, while others are relying on existing procedural rules.

Regardless of approach, Article 9 requires courts to have authority to order that disclosed evidence be presented in an easily accessible and understandable manner. Belgium’s government has expressly acknowledged that the PLD disclosure requirement goes beyond existing document production under Article 877 of the Judicial Code. The Directive also contemplates that compliance may require compiling or classifying evidence into a comprehensible presentation—not simply producing documents as they exist. That is an obligation that will be new to many defendants.

Distributor Liability: Denmark proposes to keep its existing fault-based distributor liability rules within the PLD framework. Once the injured party proves defect, damage, and causal link, the burden shifts to the distributor to prove it did not make the product dangerous. Whether those rules fall entirely outside the PLD’s maximum-harmonization requirement may become an important issue as distributors defend claims under the new framework.

What This Means

The PLD’s transposition process is unfolding largely as expected: most Member States are hewing close to the Directive’s text, and late movers will likely copy-paste their way to compliance. But the divergences that are emerging—on defenses, the “excessive difficulties” threshold, and disclosure—are important to note. They will create different litigation environments across the EU, and they will shape where claimants choose to file.

For defense lawyers, the practical takeaway is straightforward: do not treat the PLD as a single, uniform regime. Map the differences. Monitor the late transposers. And prepare for the likelihood that the first wave of litigation under the new rules will be as much about testing the boundaries of national implementation as it is about the underlying claims.

December 9 is coming. The question is no longer whether the PLD will change the landscape. It is how—and where—the changes will land first.

Photo of Michelle Yeary

There is a certain kind of plaintiff’s theory that reads like it wandered in from a wellness blog rather than a products liability treatise. Today’s case is one of them. A plaintiff who eats vegan for medical reasons sues a device manufacturer because nobody warned her, personally, that the implant going into her shoulder had a bovine pedigree. No allegation that the warnings to her surgeon were wrong. No allegation that the device malfunctioned. Just a claim that the manufacturer owed her, the patient, a duty to check her diet. The court took one look at that theory and sent it back to the kitchen.

The case is Petty v. Schwartz, No. 71820/2025, slip op. at 1 (Sup. Ct. Westchester Cnty. Sept. 1, 2026), and it is a tidy little pleading-stage win worth flagging even though the underlying facts are, frankly, a little unusual. Plaintiff underwent arthroscopic shoulder surgery, during which her surgeon implanted a bovine-collagen device. Plaintiff alleges that she suffers from an autoimmune disease that causes her immune system to attack cartilage tissue, and that collagen products can trigger or worsen her symptoms — which is why, she alleges, she maintains a vegan diet and lifestyle. She claims the bovine-collagen implant triggered a permanent, severe, and debilitating reaction. Id. at 1-2.

The only claim against the device manufacturer was styled as a cause of action for lack of informed consent — a theory that plaintiff more or less conceded, in her own opposition brief, does not work against a manufacturer. Plaintiff and defendant relied on the same New York authority, which holds that a device manufacturer is not a medical practitioner and does not have a physician-patient relationship with the plaintiff. Id. at 3. Not to mention, the manufacturer’s duty to warn runs to the treating physician – the learned intermediary – not the patient directly. Id. at 4.

So instead of defending the pleaded claim, plaintiff tried to argue her allegations, properly construed, stated claims for failure to warn the physician and the wider medical community, negligent undertaking, and negligent marketing and promotion. The court was not interested in construing anything that generously. Under New York’s pleading standard, a court accepts the facts alleged as true and gives plaintiff the benefit of every favorable inference, but bare legal conclusions do not get that benefit. While the standard may forgive “imperfect labeling” of a claim, it does not supply missing allegations. Id.at 3 & 4.

On failure to warn, plaintiff never alleged that the implant’s labeling was inadequate, that contraindications were omitted, that screening information was deficient, or — critically — that any warning deficiency proximately caused her injury. A failure-to-warn claim needs a warning that was actually deficient and a causal link to the injury. Plaintiff supplied neither, just the conclusory assertion that the manufacturer should have told somebody, somewhere, about the bovine collagen. Id. at 4.

On negligent undertaking, the complaint did not allege that the manufacturer undertook to render any service, or that any act by its representatives — two employees present in the operating room — launched or increased plaintiff’s risk of harm. There were no allegations that those representatives gave advice, made recommendations, selected the device, participated in the surgery, or communicated with the surgeon about whether the implant was appropriate for this particular patient. Id. Simply having your people in the room when your product gets used is not, by itself, an undertaking that creates a duty of care to the patient.

On negligent marketing and promotion, plaintiff alleged that the manufacturer provided incentives or otherwise induced orthopedic surgeons generally, and this surgeon specifically, to use the implant. The court called this exactly what it is — conclusory and speculative. There was no allegation tying any marketing or promotional conduct to negligence, and no allegation linking that conduct to plaintiff’s injury. Id. Marketing a product, even enthusiastically, is not a tort, and “the manufacturer wanted its device used” is not a theory of liability.

With all three unpled theories rejected, and the only pleaded claim conceded to be non-viable, the claims against the manufacturer were dismissed in their entirety. Plaintiff also asked, in her opposition brief, for leave to amend if the court ruled against her. The court declined even to consider the request. There was no notice of motion or cross-motion seeking leave to amend, and no proposed amended pleading as required by local rules. A request for affirmative relief tucked into an opposition brief is not a motion, and courts are under no obligation to treat it as one. Which is a good procedural point for defense counsel to remember. If plaintiff wants a second bite, plaintiff has to actually ask for one the right way — a real motion, with a real proposed pleading attached, so the court and the defendant can evaluate exactly what is being proposed. A one-line request in a footnote-adjacent aside does not cut it, and this court was not shy about saying so.

Kudos to the court for not letting plaintiff dress up an admittedly non-viable informed consent claim as three different negligence theories she never actually pleaded. The learned intermediary rule exists precisely so that manufacturers can rely on communicating with the physician, not on independently vetting every patient’s dietary practices, religious beliefs, or lifestyle choices before a surgeon selects a device. Extending informed consent, or its negligence-flavored cousins, to manufacturers based on nothing more than a sales rep’s presence in the operating room would turn every device company into a second physician for consent purposes — a result no court should welcome, and this one correctly refused to create.

As for the vegan angle — we get it, dietary and religious restrictions on medical products are a real and serious issue, and patients are entitled to make informed choices about what goes into their bodies. But the obligation to have that conversation, and to obtain that consent, belongs to the treating physician, not the company that manufactured the device sitting on the shelf. The surgeon is the one who examines the patient, discusses the options, and decides what to implant. Try to put that obligation on the manufacturer instead, and you get a lawsuit that is dismissed as a matter of law — no meat required.

Photo of Bexis

The recent law review article by the always interesting and extremely prolific Lars Noah, “‘Market Shift Liability’ for Generic Drugs:  Market Share Theory’s Eccentric New Cousin,” 13 Tex. A&M L. Rev. 1415 (Spring 2026), warrants discussion.  We usually agree with Prof. Noah, but we don’t buy the central premise of the article:  that innovator liability – that the imposition of liability upon the original manufacturer to obtain FDA approval for a drug for injuries later caused by competing generic knock-offs – is similar to the now mostly passé market share liability theory from the 1980s.

The two theories have completely different origins, for one thing.  Market share liability was a causation dodge, created by various pro-plaintiff courts when plaintiffs were unable to meet the basic substantive product liability element of product identification in DES litigation.  DES was, in a sense the country’s first generic drug (no patent protection), with the result being the anybody with the necessary facilities could make it.  But back then (from the 1940s until 1971), people didn’t keep good records, and the alleged injuries skipped to the next generation and were thus very delayed.  So market share liability cut those plaintiffs a break by removing the but-for-causation requirement that they sue the actual manufacturer of the injurious product.

Innovator liability has nothing to do with causation, but-for, or proximate.  It’s a preemption dodge, pure and simple.  It didn’t gain any significant traction until after the Supreme Court, in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), preempted virtually all product liability claims against generic drug manufacturers.  So the theory wasn’t “a thing“ until after preemption required plaintiffs to look elsewhere for somebody to sue.  Indeed, innovator liability creates, rather than solves, causation problems as warning causation depends on prescribing doctors supposedly relying on the inadequate labels of drugs that they never actually prescribed, and that may have been substituted after-the-fact by the actions of independent pharmacies.  As we’ve discussed elsewhere, warning liability does not exist when the actor never read the allegedly defective warnings.

But while we find that aspect of “Market Shift Liability” a bit of a stretch, we wholeheartedly agree with Prof. Noah’s comprehensive critique of what we will continue to call “innovator liability” – since we are unapologetic defense hacks.  See 13 Tex. A&M L. Rev. at 1416 n.2 (quoting pro-plaintiff article that called “innovator liability” a “catchy name” created by “lawyers who represent drug companies”).  Cf. Id. at 1452 n.176 (we being the unnamed “bloggers” referred to in this footnote).

So, we’ll skip the article’s extended discussion (pp. 1421-52) of the development of both market share liability and innovator liability and go directly to that critique.  Note:  that’s not to say these origin stories aren’t interesting in their own right – Prof. Noah’s thorough and often wry exposition is quite readable – but it’s not what prompted us to find the article blogworthy.

So what does the esteemed Prof. Noah find objectionable about innovator liability?  Like us, just about everything.

  • “[V]iew[ing] the generic drug as a product of the brand-name manufacturer’s choices . . . seems only slightly less plausible than viewing NDA holders as pushers of prescription drugs sold by their competitors.”  13 Tex. A&M L. Rev. at 1453.
  • Pro-innovator liability articles “mak[e] a series of indefensible assumptions that create[] a caricature far removed from the messy reality surrounding these tort claims,” and “entirely ignor[e] the far more important role of learned intermediaries.”  Id. at 1454 (footnote omitted) & 1456 (footnote omitted).
  • Innovator liability will “accelerate” abandonment of the market by “brand-name manufacturers.”  Id. at 1458.  “If exit occurs prior to the approval of any ANDAs, the first to apply may have to file a petition to confirm that the NDA’s withdrawal did not occur because of concerns about safety or effectiveness.  Id. (footnote omitted).  This would create a “regulatory void . . . , leaving the FDA alone to drive future revisions to the labeling.” Id
  • To avoid potentially catastrophic “long tail” innovator liability, brand manufacturers could well seek to “persuade the FDA to withdraw the license in a way that would altogether prevent subsequent generic entry,” by engaging in liability reducing “product hopping.”  Id. at 1461.  What some view as “anticompetitive” behavior would gain the “legitimate business justification of “minimiz[ing] exposure to tort” liability.  Id. at 1462-63.
  • Treating drug labeling “as completely disembodied from the drug itself” is “visiting liability on purveyors of ideas and information that foreseeably might lead to physical injury,” which is recognized as having serious First Amendment implications.  Id. at  1465.
  • First Amendment implications “become[] more pointed . . . as misrepresentation claims threaten to penalize speech further removed from efforts to sell an allegedly injurious product.”  Id. at 1467 (footnote omitted).  There are “alarming free speech consequences of starting down this freewheeling path.”  Id. (footnote omitted).
  • Treating “the NDA sponsor as the ghost author for ANDA sponsors” might even (were it not for preemption) “allow plaintiffs injured by generic prescription drugs to assert design defect claims against brand-name manufacturers.”  Id. at 1470-71 (footnote omitted).
  • Innovator liability “seemingly would impose liability on the sponsor of an approved NDA that never came to market . . . because it could foresee that ANDA sponsors would mimic its never-used labeling.”  Id. at 1472-73 (footnote omitted).
  • “[P]redicating [innovator] liability on the supposed control exercised by the brand-name drug manufacturer hardly makes sense,” as “basing such claims instead on alleged misrepresentations arguably obviates any requirement of identity between the advertised product and the substitute product that caused an injury.”  Id. at  1474.  That could lead to liability based on warnings concerning “substitute product[s] posing somewhat different risks” such as “pharmacy-compounded versions.”  Id.

Thus, Prof. Noah concluded that innovator liability was “counterintuitive” and the rationales offered by courts and commentators to justify it were “muddle-head[ed].”

Even with its limited uptake to date, however, market shift liability threatens to cause far greater disruption of the pharmaceutical sector (as well as tort doctrine) than market share liability ever did.  For these and other reasons, innovative activity should not get singled out while imitative activity largely escapes any obligation to compensate patients injured because of alleged defects in prescription drugs. . . .  [C]ourts in other jurisdictions need to resist the temptation to produce lazy knock-offs of [California innovator liability].

13 Tex. A&M L. Rev. at 1476.

Defense counsel (and their amici curiae) confronted with plaintiffs advocating innovator liability should consult this article and consider relying upon not only the arguments it makes, but also on the copious material that the footnotes we’ve omitted provide.  In addition, feel free to utilize the Blog’s own material on innovator liability – our score card collecting all the cases that have addressed it in chronological order, and our 50-state survey.  We keep both of these current.

Photo of Steven Boranian

Federal officer jurisdiction is having a moment.  In November 2024, we called federal officer jurisdiction the quiet middle child of the federal jurisdiction family, but then earlier this year the Supreme Court decided Chevron USA Inc. v. Plaquemines Parish.  That opinion held that federal officer jurisdiction was broader than many previously thought, which we commented on here. 

The Supreme Court’s opinion got Bexis to start beating the federal officer jurisdiction drum (actually, in true Bexis form, he was restarting a riff that he took up way back in 2020).  We more recently posted on a case called Griffin v. Optum, Inc., where the Eighth Circuit approved federal officer jurisdiction over claims against pharmacy benefit managers (“PBMs”) in the long-running opioid litigation.  Because the defendant PBMs performed their functions under contracts with a federal agency, they successfully removed a lawsuit filed by a state attorney general to federal court, despite the AG’s efforts to “disclaim” recovery based on any federal-related activity. 

The Second Circuit has now joined the chorus, and it too has approved federal officer jurisdiction over opioid-related claims against PBMs.  In County of Westchester v. Express Scripts, Inc., No. 24-1639, 2026 WL 2589574 (8th Cir. Sept. 2, 2026), multiple New York counties sued PBMs over harms allegedly caused by the use and abuse of opioid pain medications.  We have seen this play before.  The counties alleged that PBMs contributed to the alleged harms through their benefit management function, such as managing drug formularies and rebates. 

The PBMs, however, performed formulary and rebate work in part under contracts with the Defense Department, the federal Office of Personnel Management, and the VA.  So they removed the cases to federal court under federal officer jurisdiction. 

This is where it gets interesting.  The counties cynically amended their complaints to add broad disclaimers purporting to abandon “any claims or recovery arising out of the Removing Defendants’ work on behalf of any federal entity,” and they moved to remand.  We have seen this play before too, and in the Eighth Circuit’s Griffin case, the “disclaimer” did not work.

It did not work in the Second Circuit either.  The central problem with the disclaimers is one of indivisibility.  As the court explained, the PBMs did not maintain separate federal and non-federal books of business.  Instead, they conducted singular negotiations with pharmaceutical manufacturers on behalf of all clients—federal plans and private plans alike.  In addition, the alleged community-wide harms were similarly indivisible, flowing from conduct that could not be neatly separated into federal and non-federal components.

The “disclaimers” therefore were ineffective.  In so holding, the Second Circuit followed opinions from multiple other circuits.  Relying for example on the First Circuit’s reasoning in Puerto Rico v. Express Scripts, Inc., the Second Circuit explained that a valid disclaimer must “clearly carve out certain factual bases, whether by time span or location,” so that no state court would ever need to evaluate whether the defendant acted under a federal officer.  By contrast, a disclaimer that requires the state court “to determine the nexus between the charged conduct and federal authority” is not valid because it is circular.  If permitted, such a disclaimer would require federal contractors to prove in state court that they were acting under federal contracts, which would negate their right to have a federal defense judged in federal court in the first place. 

The Second Circuit found that the plaintiffs’ disclaimers fell squarely into the circular category.  Whether in state or federal court, the plaintiffs were targeting rebate negotiations that were the same for federal and non-federal programs.  Federal defenses would likewise cover the whole of the alleged conduct.  In other words,

As a result, “Whether in state or federal court, Defendants will continue to press that the alleged conduct and resulting harm necessarily implicate their federal work and are subject to federal defenses.  More fundamentally, in deciding whether to enforce the disclaimers, either court will have to ascertain whether the harms from opioids distributed via federal and non-federal programs can be disaggregated at all.”  County of Westchester, at *8.  That determination belongs in federal court.

Having determined that the counties’ disclaimers were ineffective, the Second Circuit held that federal officer jurisdiction under 28 U.S.C. § 1442(a)(1) existed.  More specifically, the plaintiffs’ claims met the three-part test for federal officer removal under the Supreme Court’s Plaquemines Parish opinion. 

First, the PBMs were acting under a federal officer.  They administered formularies, processed claims, negotiated rebates, etc.—tasks that federal agencies would otherwise have had to perform themselves.  One PBM defendant operated under a detailed Statement of Work subject to weekly agency briefings and formal reviews.  Another had a similar deal with the VA, showing an “unusually close relationship involving detailed regulation, monitoring, or supervision” that satisfies the “acting under” prong. 

Second, the PBMs were sued for conduct “relating to any act under color of [federal] office.”  Under Plaquemines Parish, this requirement “sweeps broadly.”  The court found a clear relation between the plaintiffs’ allegations and the PBMs’ federal work because the rebate negotiations implicated federal clients, and they could not be bifurcated between federal and non-federal plans. Even the diffuse public-nuisance claims—targeting community-wide costs—necessarily encompass harms flowing from federally-administered prescription drug programs.

Third, the PBMs were asserting a colorable federal defense.  Namely, a government-contractor defense, a defense under a plan for military personnel, and federal preemption under the Federal Employees Health Benefits Act.  The court noted that these defenses need not be clearly sustainable—only colorable—and the plaintiffs’ sole counterargument was that they had disclaimed claims implicating those defenses, which the court had already rejected.

Federal officer jurisdiction is no longer the quiet middle child, if it ever was.  Following County of Westchester and other cases, including from the Supreme Court, we would say that federal officer jurisdiction is ready to shine. 

Drug & Device Resources

Bexis’ Book

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