Photo of Bexis

Recently, towards the end of a post about preemption and the FDA’s Current Good Manufacturing Practices (“cGMPs”) – also known as Quality Management System Regulations (“QMSRs”) − we noted a “significant change” last February.  “[T]he FDA issued a final rule” that replaced all existing cGMPs “by incorporating by reference an international standard specific for device quality management systems.”  The purpose of the FDA’s changeover was “harmonizing to align more closely with the international consensus standard for devices.  Id.

Thus, as of February, 2026, the cGMPs are no more.  They are now solely known as QMSRs, and the FDA no longer drafts them (and no longer has to bother with the niceties of the Administrative Procedure Act).  Instead, the Agency has incorporated by reference the set of model medical device quality standards created by the International Standards Organization, specifically ISO 13485:2016:

The QMSR incorporates by reference the international standard, ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes and clause 3 of ISO 9000:2015, Quality management systems – Fundamentals and vocabulary.  This allows U.S. medical device quality management system requirements to align with internationally recognized standards and reduce burden on regulated industry.

Incorporating by reference ISO 13485:2016 as the foundational quality management system framework for medical device manufacturers promotes consistency in design, production, and lifecycle controls across global markets and now specifically requires risk management.

Incorporating by reference the terms and definitions set forth in Clause 3 of ISO 9000:2015 supports a common understanding of quality management system fundamentals.  However, to the extent any clause of ISO 13485 conflicts with any provision of the FD&C Act and its implementing regulations, the FD&C Act and/or its implementing regulations will control.

FDA, Quality Management System Regulation (QMSR) (updated Feb. 2, 2026).  The FDA also has – but has yet to finalize – one of its infamous “draft guidances” concerning “Quality Management System Information for Certain Premarket Submission Reviews.”  Among other things, this draft guidance makes clear that the QMSRs apply to PMA approved devices, and thus will be relevant to preemption.  Id. at Introduction.

Ordinarily, a copy of ISO 13485:2016 would cost you it’s $250 a pop, payable in Swiss Francs, from the ISO’s website.  But as our prior post helpfully mentioned, read-only copies are available for free here through ANSI (but you would have to register).  We suspect (but aren’t sure) that the availability of free copies is required by the government’s incorporation by reference, since the same website also offers copies of other ISO standards that have been federally adopted.  Ordinarily we would link directly to the document itself, but this one contains a copyright notice.  While there may well be some law out there that forbids American citizens from being forced to pay for copies of the laws that they are supposed to follow, we aren’t going to be the guinea pigs, so you’ll have to download from the above link yourselves.

We did that and have reviewed the actual ISO standards, and have the following mostly preemption-oriented comments:

  • The FDA’s incorporated by reference “requirements” for PMA (and related) devices are extensive, “including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).”  The inclusion of “associated activities,” such as “technical support,” should bring many if not all of the activities of “authorized representatives” within the ambit of the MDA’s broad “different from or in addition to” preemption clause, thereby closing a loophole that plaintiffs have exploited.
  • The standard’s inclusion of “other” parties’ that supply “raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, [and] maintenance service” should reinforce Biomaterials Access Act preemption and perhaps expand preemption to new entities, depending on whether the ISO creates binding “requirements” as to them.
  • ISO 13485:2016 creates a “process approach” to device regulation, and “[a]ny activity that receives input and converts it to output can be considered as a process.”  Thus, the FDA’s blanket incorporation by reference of this standard would seem to create a very broad basis for preemption.
  • ISO 13485:2016 extends to a regulated entity’s “advisory notice” – “subsequent to delivery” – concerning the “use,” “modification,” “return,” or “destruction” of such devices.  Thus, its requirements extend to DHCP letters and recalls.
  • The definition of “labelling” (ISO 13485:2016 uses European spellings) is as broad as the FDA’s traditional definition:  “label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.”
  • We’re not sure what to make of the standard’s application in multi-component off-label use situations.  A “note” to the definition of “manufacturer” states:  “Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.”  But whatever it means, the incorporated requirements certainly extend to this situation, and thus should be preemptive.
  • The definitions of “medical device” and “product” both expressly include “software.”  We don’t know how that will influence, if at all, the common-law definition of “product,” but for preemption purposes, the incorporated requirements clearly extend to device software.
  • ISO 13485:2016 includes a definition of “service”:  “Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible.”  Services are not products for purposes of strict liability.  The standard includes examples, but they are unhelpful, since none of the examples relate to medical devices.
  • The standard’s “documentation” requirements are notably non-specific.  Take, for example, the “medical device file” (4.2.3).  That file is to include:  a “general description of the medical device, intended use/purpose, and labelling, including any instructions for use,” product “specifications,” “specifications or procedures for manufacturing, packaging, storage, handling and distribution,” “procedures for measuring and monitoring,” “as appropriate, requirements for installation,” and “as appropriate, procedures for servicing.”
  • The other ISO device requirements are just as generalized.  For instance, “design and development inputs (7.3.3)” consist of “functional, performance, usability and safety requirements, according to the intended use,” “applicable regulatory requirements and standards,” “applicable output(s) of risk management,” “as appropriate, information derived from previous similar designs,” and “other requirements essential for design and development of the product and processes.”  They are to “be reviewed for adequacy and approved.”
  • One last example, since it arises frequently in preemption cases, is reporting to the FDA.  Here is the sum total of the applicable ISO language (8.2.3):

If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the organization shall document procedures for providing notification to the appropriate regulatory authorities.  Records of reporting to regulatory authorities shall be maintained.

That’s it – “document” the “procedures.”

Actually, that’s not it.  What’s most important is what we mentioned in the prior post:  “[A]s part of the PMA process, the FDA actually examines the manufacturer’s proposed processes and then mandates (through premarket approval) what those processes must entail.”  That’s how these general device requirements become specific to each device.  The FDA reviews and approves exactly what and how each device manufacturer proposes to satisfy those general standards for each submitted device.  That approval is preemptive.

The FDA’s online statement and draft guidance both reference “harmonization” with international standards.  Whether that will have any impact on preemption, we don’t know, but it might create an additional argument for preemption of bizarre state-law duties that don’t harmonize with anything – such as the purported duty to innovate one’s products claimed in the pending Gilead litigation.  The draft guidance states:

If FDA finds there has not been a demonstration that the methods used in, and the facilities and controls used for, manufacturing, processing, and packing a device conform to the QMSR, including because there is insufficient information submitted in the PMA, FDA is required to deny approval of the application under the Act.

Id. at p.3 (footnote omitted).  This is further confirmation that the FDA reviews each of these things during pre-market approval, and thus that any divergent state-law requirements are preempted.

Like the former cGMPs, the QMSRs themselves do not specify the details of any of the processes that applicants for approval must use.  To the contrary, they are intentionally very broad and capacious, allowing applicants to decide what each new device needs.  For example, the guidance section on “design and development requirements” is four pages long and – like the ISO itself − does not contain a single specific requirement, leaving that choice to the applicant.  Id. at 10-13.  These contain requirements for “identification,” “description,” “traceability,” keeping “records,” “reviews,” and the like.  While the applicant must “describe” “Any test methods, protocols, acceptance criteria, and as appropriate, statistical techniques with sample descriptions/sizes and supporting rationale,” id. at 11, the guidance never dictates what any of these items must be.  That is reserved for individual PMAs.  Thus, to our way of thinking, any attempt by a plaintiff to dictate specifics would necessarily be “different from or in addition to” what the QMSRs require, and therefore preempted.  All of the other requirements listed in the FDA draft guidance are similarly general.

It will no doubt be a while before medical devices subject to the FDA’s new QMSR/ISO 13485:2016 regime start appearing in prescription medical product liability litigation, but it is never too early to start thinking about how these regulatory changes will affect our efforts to defend those devices when litigation inevitably reaches them.

Photo of Stephen McConnell

Our title comes from a famous scene in the movie, A Bronx Tale. Rowdy bikers tear up a bar in the Bronx. The proprietor, played by Chaz Palmientieri, proceeds to administer old school mob justice. Enjoy the fun here. 

When you live in a place with a climate as splendid as California’s, where do you go on vacation? We used to wonder about that, and then we moved there.  The answer was straightforward: explore the wonders of the Bear State, which are super abundant. Or maybe venture to Hawaii or Mexico. Or maybe maybe head up to Oregon.  Not once did we moon over Delaware as a potential destination.  Even tax-free shopping was not going to coax us from Disneyland to Wilmington.  But some people are built differently, we guess.

Paddock v. Novartis Pharms. Corp., 2026 U.S. Dist. LEXIS 130141 (D. Del. June 10, 2026), is an interesting transfer decision decided against obviously forum shopping California plaintiffs. Those plaintiffs originally sued in Delaware state court as a litigation aggregation tactic.  The plaintiffs alleged that the defendant pharmaceutical company wrongfully promoted the off-label used of an asthma drug to treat preterm labor in pregnant women. According to the plaintiffs, the result was that babies born to the women suffered from autism. The plaintiffs’ causes of action included negligence, negligent misrepresentation, intentional misrepresentation, and concealment. 

Without knowing much about the case (and when did that ever stop us?), we harbor deep skepticism about its merits. Decrying off-label promotion is usually a weak claim and a signal that the plaintiff lawyers are desperate. There also seems to be a strong felt need among some to blame all sorts of things for autism. And the blah misrepresentation, blah blah misrepresentation, and blah blah blah misrepresentation claims do not impress us. 

Anyway, the bad news began for the plaintiffs when the defendant removed the Delaware action to federal court on the basis of diversity of citizenship. The defendant fended off the inevitable remand motion and then, building success upon success, convinced the Delaware federal judge to sever the non-diverse plaintiffs and keep the rest in federal court.  As is so often the case, winning the procedural wrangling is at least as important as whatever happens with the substantive issues. Such wrangling is an example of smart litigation. It is not spending the other side into the ground (that is an old, overworn accusation against corporate defendants that is hardly ever true anymore); it is thinking the other side into the ground. 

At this point, the California plaintiffs belatedly decided that if they had to be in federal court, they would rather be in California. Whether this was animated by a preference for the Pacific Ocean over the Christina River, the Red Hot Chili Peppers over George Thorogood, the Dodgers over the Blue Rocks, sushi over scrapple, or left coast, corporate-hating jurors over more open-minded citizens of the First State, we simply do not know. The Californians moved to sever their claims under Federal Rule of Civil Procedure 22 and transfer them to our former home jurisdiction, the Central District of California, under 28 U.S.C. Section 1404(a). Another, similar action was pending there. 

Nope, held the Delaware  magistrate-judge. Mind you, the defendant did not oppose severance. But it did oppose transfer to C.D. Cal. Therefore, the court confined its analysis to the transfer issue under section 1404. 

Third Circuit law sets out six private interests and six public interests that should be taken into account when deciding a transfer request.  The six private interests are: (1) plaintiff forum choice “as manifested in their original choice,” (2) defendant preference, (3) where the claim arose, (4) convenience of the parties, (5) convenience of witnesses, and (6) locations of books and records.  The six public interests are: (1) enforceability of the judgment, (2) practical considerations making trial easier or harder, (3) relative court congestion between the possible jurisdictions, (4) a preference for deciding local interests, (5) public policies of the fora, and (6) familiarity of the trial judges with applicable law in diversity cases. 

Note that the first private interest, plaintiff forum choice, looks to the “original choice.”  Here, plaintiffs originally plumped for Delaware. But when a plaintiff subsequently  seeks to transfer a case, the plaintiff’s choice of forum no longer is of any weight. The plaintiff needs to show a change in circumstances since filing the original suit. But being in federal court was not the sort of change of circumstances that supports transfer. Nor was the severance of two plaintiffs from New Jersey, whose claims remained in Delaware state court as opposed to federal court. 

Claims of plaintiff inconvenience (making autistic California kids cross the country) rang hollow. First, it was plaintiffs who initially filed their lawsuits in Delaware.  Second, there were other plaintiffs from far away who were not seeking transfer. The other private interest factors were neutral on the issue of transfer. Except, of course, the defendant’s preferred forum weighed against transfer. 

The public factors did not help the plaintiffs’ transfer motion. Delaware’s interest in claims brought against a local defendant were as strong as California’s interest in vindicating the interests of its plaintiffs.  Meanwhile, a transfer of the Californians to their home state would not allow them to join the existing case without disrupting the discovery and trial schedule. 

Consequently, these California plaintiffs ended up with the worst of both worlds, now severed from all the other plaintiffs, and stuck in federal court in Delaware.  “Now youse can’t leave.” 

But there is a consolation prize for the misbegotten California tourists: try a Bobbie hoagie at Capriotti’s Sandwich Shop. It’s Thanksgiving tucked in bread.  It’s at least as good as a Phillipe’s French dip sandwich in downtown LA.

Meanwhile, congrats to the defense team at McCarter & English, many of whose members we count as good friends and esteemed colleagues. 

Photo of Michelle Yeary

Gadolinium is a heavy metal. Sounds ominous. But it is also the active component in contrast agents used in more than 100 million MRI procedures — and its accumulated safety record is, in the words of plaintiff’s own literature, “extraordinarily positive.” Combs v. Bayer AG, 2026 WL 1693470, at *11 n.19 (Okla. App. Ct. May 11, 2026). But that didn’t stop plaintiff from arguing that gadolinium retention causes a condition known as Gadolinium Deposition Disease (GDD) and that defendants failed to warn her of that risk. The Oklahoma appellate court’s affirmance of defendants’ summary judgment win is a welcome addition to the body of decisions finding those claims preempted. It also has some Oklahoma law bonuses worth noting.

Plaintiff received an injection of a gadolinium-based contrast agent (GBCA) manufactured by defendants in March 2016, as part of an MRI following a motor vehicle accident. After her injection, she experienced a wide range of symptoms she attributed to gadolinium retention in her body, including hives, migraines, muscle pain, swelling, and vision injury. She also eventually alleged she developed GDD. Id. at *1.

The crux of her case was that the FDA-approved warning for the GBCA addressed the risk of gadolinium retention only in patients with kidney disease — specifically, the risk of developing nephrogenic systemic fibrosis (NSF). Plaintiff had no kidney disease. The warning she wanted — one addressing the risk to patients with normal renal function — was not an FDA-approved warning. Id. at *2. So, plaintiff needed the CBE regulation to save her. It didn’t.

As regular readers of this blog know well, failure-to-warn claims brought against prescription drug manufacturers are preempted unless the manufacturer could have unilaterally changed its label under the Changes Being Effected (CBE) regulation. And the CBE has teeth: it requires newly acquired information showing reasonable evidence of a causal association between the drug and the alleged harm. Id. at *5.

What did plaintiff offer? First, she showed that the FDA was aware of gadolinium retention before her injection by pointing to adverse event reports. Adverse event reports alone do not establish a causal association. We have said this many times. And, as the court found, “[plaintiff] provided nothing to demonstrate that reasonable evidence of a causal association between [GBCAs] and these events existed before her injection.” Id. at *6.

Next, she argued that because gadolinium is “toxic” and is retained in the body, that was enough to trigger a CBE label change. But neither the toxicity nor the retention was newly acquired evidence and they certainly were not evidence of any causal association. Id. at *7.  Knowing a substance is retained in the body is not the same as knowing that retention causes clinical harm. That’s basic science. It is also the CBE standard.

Plaintiff also tried to undermine the FDA’s own conclusions. In 2017 and 2018, the FDA conducted a multi-year review of the literature on gadolinium retention. The agency found no direct link to adverse health effects in patients with normal kidney function. In 2018, the FDA approved a revised label stating precisely that: “clinical consequences of gadolinium retention have not been established in patients with normal renal function.” Id. at *7. Even though those events took place after plaintiff’s injection, they supported defendants’ argument that no newly acquired evidence existed in 2016 to allow a unilateral label change. Id. If it didn’t exist in 2018, it certainly didn’t exist in 2016. Rather than reckon with the FDA’s conclusions, plaintiff argued the FDA’s analysis was “tainted” by defendants’ influence. She provided no evidence of this. Id.  And — as courts have repeatedly recognized, and as we have pointed out in numerous posts — attacking FDA decision-making through state court litigation is exactly what Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), prohibits. Plaintiff offered no evidence of newly acquired information pre-2016 that would have allowed defendants to change the label, so the court affirmed summary judgment on the grounds of preemption. Id.

Preemption alone was sufficient to end this case, but the court also addressed two additional, independent grounds for summary judgment.

First, Oklahoma law provides a statutory rebuttable presumption that a manufacturer is not liable for harm caused by a product that complied with mandatory federal safety standards at the time of manufacture. 76 O.S. 2021, § 57.2(A). Defendants’ GBCA was FDA-approved, so the presumption was established. To rebut it, plaintiff needed to show either that the federal standards were inadequate or that defendants withheld information from or misrepresented information to the FDA. She argued neither on summary judgment. Those arguments were therefore waived. Id. at *8. But the court went further: even reaching the merits, what plaintiff offered was not evidence of fraud or inadequacy. It was, in the court’s pointed description, “hyperbolic speculation” about defendants’ motives. Id. at *11 n.7. That is not how you rebut a statutory presumption.

Plaintiff also tried a creative path around the presumption entirely. Section 57.2(D) of Oklahoma’s statute provides that the presumption does not apply when a product has been withdrawn from the market pursuant to an order or agreement with “any federal agency.” Id. at *9. Plaintiff pointed to the European Medicines Agency’s 2018 decision to suspend sale of the drug. The argument: if a “federal” agency — even a foreign one — takes action, the presumption evaporates. The court did not take long with this. “Federal agency” in the context of Oklahoma law means a federal agency of the United States of America. “We see nothing in the statute that signals an intent of the Oklahoma Legislature to defer to the judgment of the EU or its agencies.” Id. at *9. We see nothing either.

Plaintiff’s failure-to-warn claims also failed on causation under the learned intermediary doctrine. Plaintiff’s prescribing physician provided clear and consistent testimony in 2024: gadolinium retention from GBCAs does not cause clinical consequences in patients with normal renal function; GBCAs do not cause long-term negative symptoms in such patients; and — the pivotal question — knowing everything he knows today about the risks of retained gadolinium, he would not have changed his treatment. Id. at *10. That is exactly the kind of testimony that satisfies defendants’ burden on learned intermediary causation. The burden shifted to plaintiff to discredit her physician or show the undisclosed risk was sufficiently high that it would have altered his decision. She could not. The physician’s own answers said the opposite. Id.

Three grounds. All affirmed. Gadolinium may stay in the body. These claims should not.

Photo of Bexis

Some of us of a certain age were fans of Parliament/Funkadelic back in the day.  The group even released an album entitled “Medicaid Fraud Dogg.”  That was the most drug/device adjacent rock-and-roll since the Rolling Stones released “Mother’s Little Helper.”  One classic Parliament line was “make my funk the p-funk.”  Every time we think about PFAS litigation, our first response is “make my FAS the PFAS.”  That’s appropriate because that litigation is – as we’ve already observed – a whole lotta nuthin.

The FDA evidently thinks so, too.

Last year, in August, the agency issued a report on “PFAS in Medical Devices,” which detailed an “independent safety review” it conducted together with the patient safety organization ECRI.  The bottom line:  “The ECRI review found no conclusive evidence of patient health issues associated with PTFE as a material.”  Id.

Other significant points from the FDA safety review are:

  • “The PFAS materials used in medical devices (known as fluoropolymers) have a long history of use. The best-known of these materials is polytetrafluoroethylene (PTFE).”
  • “Many medical devices rely on plastic materials . . ., which are part of the PFAS family and have been safely used for decades.”
  • “Medical devices [that] . . . rely on the unique properties of PFAS . . . are necessary to save and sustain lives.”
  • “Currently, no other materials exist that can perform the critical roles of fluoropolymers in these devices.  The materials have unique properties that are essential for devices to function.”

Id.

The FDA conducted a second evaluation of PFAS in connection with its oversight of cosmetics.  In late 2025 the agency released its “Report on the Use of PFAS in Cosmetic Products & Associated Risks.”  PFAS are used in cosmetics “because they are water- and oil-resistant, and are long-lasting.”  Id. at 8.  In response to the same overblown allegations of purported health risks that we’ve seen in litigation, the FDA evaluated the safety of the 25 most commonly used PFAS compounds in cosmetics.  Id. at 9.  First, it concluded that, because:

There are currently no federal regulations that specifically address the use of PFAS in cosmetic products in the U.S.[,] PFAS that are intentionally added to cosmetic products as an ingredient are not currently prohibited and do not, based on presence alone, render the cosmetic product adulterated or misbranded,

Id. at 8 (footnote omitted).

As to the 25 particular PFAS compounds specifically evaluated, the FDA concluded, based on a “comprehensive search of PubMed, . . . [the] Web of Science, [and] existing official safety assessments from government agencies and scientific advisory groups,” id. at 9, that five of them had a “[l]ow safety concern based on available data,” 19 others had “insufficient data for safety conclusion,” and only one showed even a “potential safety concern based on available data at highest concentration of use.”  Id. at 9-10.  That’s a far cry from the hysterical bleatings of the plaintiffs’ bar and their hired gun “experts.”

Given the conclusions in these two 2025 FDA reports, any attempts to assert PFAS-related product liability claims in prescription medical product liability litigation should be both expressly and impliedly preempted.  To the extent products are governed by the MDA’s “different from or in addition to” express preemption clause in 21 U.S.C. §360k(a), the FDA has evaluated the PFAS used in medical devices and expressly concluded that no safety-based basis for either design changes or new warnings exists.  To the extent that implied preemption under Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), is involved, the FDA has expressly concluded that no available evidence suggests any basis for requiring different warnings.  So at least through the end of 2025, there is no basis to conclude that any “newly acquired information” exists that could support any warning-based claim.

In sum, we haven’t seen any product liability litigation in our drug/device sand box based on the presence of PFAS in prescription medical products.  These FDA evaluations establish that there is a good reason for the absence of such claims – they, too, would amount to a “nuthin.”

Photo of Steven Boranian

We reported a couple of months ago on important decisions in the Fourth Circuit that invalidated state laws in West Virginia and Maryland purporting to compel pharmaceutical manufacturers to deliver steeply discounted prescription medicines to unlimited numbers of pharmacies under the federal 340B drug discount program.  Because the opinions created a circuit split on a big money issue in which multiple stakeholders are intensely interested, we confidently predicted that the “next stop” would be the U.S. Supreme Court.  (See “Next Stop SCOTUS?”)

Well, we were wrong.  Sort of.  The Fourth Circuit has now agreed to rehear the appeals en banc, thus granting a motion for rehearing filed by the West Virgina AG.  The cases are Pharmaceutical Research and Manufacturers of America v. McCuskey, No. 25-1054, 2026 WL 898259 (4th Cir. Mar. 31, 2026) (to be published in F.4th), and Abbvie, Inc. v. Brown, No. 24-1939, 2026 U.S. App. LEXIS 10581 (4th Cir. Apr. 14, 2026). 

These cases may ultimately end up with SCOTUS, but not before the full Fourth Circuit first takes a crack at judging state laws that expressly and intentionally interfere with a drug discount program created by and governed by federal law.  We will not predict the outcome—after all, the Fifth Circuit and Eighth Circuit upheld similar laws passed in other states, and both Fourth Circuit opinions were over one judge’s dissent. 

We do know, however, that the stakes are high—manufacturers delivered $81.4 billion in covered outpatient drugs under the 340B program in 2024, and that figure continues to grow substantially year over year.  That is why we keep harping on 340B.  The state laws at issue prohibit manufacturers from controlling the numbers of pharmacies eligible to receive outpatient meds at the 340B discounts, and they also hamstring manufacturer efforts to gather information to verify eligibility.  You can read more about the 340B program and the potential for abuse in our prior posts (e.g, here, here, here, and here). 

It is important to understand that no pharmaceutical manufacturer has implemented rules refusing to offer outpatient drugs to eligible purchasers—typically facilities that serve rural or underserved communities, known as “covered entities.”  Manufacturers have, however, imposed limitations on the outside pharmacies (or “contract pharmacies”) that covered entities can designate to dispense meds purchased at the steeply discounted 340B prices, sometimes as low as a penny a dose.  Manufacturers have also asked for claims data to verify eligibility.  These efforts reflect the growing and demonstrable risk of error and abuse, namely that facilities will purchase drugs under duplicative discounts or that discounted outpatient medications will be diverted to ineligible patients.  Bear in mind that the law does not require covered entities to pass 340B discounts on to the patients, so when errors or abuses occur, the facilities and contract pharmacies benefit—not necessarily the patients. 

States like West Virginia enacted laws to stop manufacturers from placing controls on contract pharmacies.  In the opinion mainly at issue, the Fourth Circuit held that federal law preempted West Virginia’s contract pharmacy law because the state law specially targeted participants in the federal 340B program (drug manufacturers).  Moreover, in doing so, the state law altered the bargain that Congress struck with manufacturers when it created the program.  In other words, the state law targets a federal domain, and it “springs” additional obligations on pharmaceutical manufacturers.  These conditions are “uninvited” and thus disrupt the bargain.  That leads to federal preemption. 

For those who are monitoring these cases, we continue to believe that the key issue is this: While other courts have characterized state contract pharmacy laws as merely regulating delivery of medicines, which is purportedly outside the scope of the federal 340B statute, the Fourth Circuit recognized that West Virginia was really regulating price, which is what the federal 340B statute is all about.  As the manufacturers see it, the pharmacies are purchasing the medicines no matter what.  The only question is what price they will pay for them.  We will keep you posted. 

Photo of Eric Alexander

We rarely get riled up about a decision related to removals and remands.  A rejection of snap removal or a misapplication of Ruhrgas might quicken our nerdy pulses, but not engender our sense of outrage like many, many other things we have posted about through the years.  However, we read a decision where a veteran district judge in the Central District of California, a court notorious for its hostility to removal on fraudulent joinder, sua sponte remanded a case that had been removed based on diversity.  Not only did the plaintiffs not move to remand, but there was no indication from the decision or the docket that the court requested any briefing or evidentiary submissions.  Yet, the court remanded the case because the Notice of Removal—the only part of the record other than the complaint cited in the decision—did not include evidence establishing the jurisdictional minimum for the amount in controversy.

The case is Mehram v. ICU Med. Inc., No. 8:26-cv-01282-DOC-JDE, 2026 U.S. Dist. LEXIS 124084 (C.D. Cal. June 3, 2026), and it relates to product liability claims against a device manufacturer over the hypoxic brain injury and eventual death of a young child.  If your reaction is that this is just about the last case where anyone would question that more than $75,000 was at stake, then just wait.  A five year old British child with significant medical issues requiring constant ventilation using defendant’s tracheostomy tube suffered hypoxia and cardiac arrest allegedly due to a failure of the device and despite medical intervention.  After being hospitalized for twenty five days, she was declared clinically brain dead, her organs began to shut down, and she died.  More than four years later, her parents brought a product liability, wrongful death, and survival action against the manufacturer’s parent company in California state court.  The defendant filed a timely removal based on complete diversity—U.K. plaintiffs and a California defendant. That was all from the decision.  Id. at *2-3.  It does not say what damages the plaintiffs sought, so we dug a little.  From the docket and complaint, as well as the silence in the decision, we see that the plaintiff never moved to remand, the plaintiff never actually contested that the jurisdictional minimum was met, and the parties were never asked to brief or submit evidence relating to the jurisdictional minimum before the court issued its sua sponte order of remand within two weeks of the case being assigned.  We also see that the complaint contained a wide range of damages claims related to the decedent’s pain and suffering, her parents’ emotional distress, her parents’ loss of her love, services, and financial contributions over the course of her life, funeral and burial expenses, and all other expenses incurred, presumably including medical expenses.  (The care was all in Birmingham, England, so medical expenses are quite different than in the U.S., but U.K. governmental payors can still recover expenses from tortfeasors under mechanisms roughly akin to our lien system.)  It is true, though, that the complaint, like most U.S. product liability complaints, included specific dollar figures (and no pounds) only when discussing the defendant’s business.

Based on its review of the notice of removal and complaint and its interpretation of old caselaw, the Mehram court concluded that,

Defendant does not provide any concrete facts showing that Plaintiff’s alleged injuries might result in damages over $75,000. Defendant recites the extent of Plaintiff’s injuries, Not. at 4, but does not connect these alleged injuries to any specific amount of damages. While Plaintiff might have suffered injuries warranting an amount over $75,000, the record before the Court today does not support that.

Id. at *7.  This quote was followed by a citation to a 2003 Ninth Circuit case called Matheson.  The court also noted that the complaint does not “demand a specific amount of damages or otherwise indicate that Plaintiff is seeking more than $75,000.”  Id. at *6-7.  That is it for Mehram’s analysis, although the court did implore Congress to up the jurisdictional minimum from the $75,000 it has been since 1996.

The basic legal issue here is that Mehram applied the wrong legal standard because the cases on removal it cited stopped in 2010.  In 2014, the Supreme Court decided Dart Cherokee Basin Operating Co., LLC v. Owens, 574 U.S. 81 (2014).  The second paragraph of Judge Ginsburg’s concise opinion states:

To assert the amount in controversy adequately in the removal notice, does it suffice to allege the requisite amount plausibly, or must the defendant incorporate into the notice of removal evidence supporting the allegation? That is the single question argued here and below by the parties and the issue on which we granted review. The answer, we hold, is supplied by the removal statute itself. A statement “short and plain” need not contain evidentiary submissions.

Id. at 84.  So, the cases Mehram cited about the removing party’s evidentiary burden had been overruled more than a decade ago and its resulting analysis was wrong.  Dart also stated, “In sum, as specified in §1446(a), a defendant’s notice of removal need include only a plausible allegation that the amount in controversy exceeds the jurisdictional threshold. Evidence establishing the amount is required by §1446(c)(2)(B) only when the plaintiff contests, or the court questions, the defendant’s allegation.”  Id. at 89.  It even quoted text establishing Congress’s intent in adding language about evidence in §1446(c)(2)(B:  “Rather, defendants may simply allege or assert that the jurisdictional threshold has been met. Discovery may be taken with regard to that question. In case of a dispute, the district court must make findings of jurisdictional fact to which the preponderance standard applies.”  Id. at 88-89.  In Mehram, because the plaintiffs did not move to remand or otherwise claim that their case was worth less than $75,000, defendant never had to come forward with evidence on the issue.  It would have made no sense for the notice of removal to include such evidence, given that, as Dart noted, “Of course, a dispute about a defendant’s jurisdictional allegations cannot arise until after the defendant files a notice of removal containing those allegations.”  Id. at 89.

So, Mehram was really wrong and the court’s sua sponte treatment of remand deprived it of the chance to be told about the current law, receive evidence on the amount at issue, allow discovery to elucidate that issue, or even be told by plaintiffs that they did seek well over the jurisdictional amount.  However, what galls us even more is that the complaint makes it very clear that the parents of a deceased child who suffered “catastrophic” injuries and was hospitalized for close to a month before she died had filed a case that sought more than $75,000.  The law we see in removals around the country generally recognizes that personal injury claims alleging the expected types of economic and non-economic damages for “severe bodily injuries” are sufficient absent a clear statement in the complaint that damages above $75,000 are not being sought.  We have never seen a court require evidence that a claim that the defendant’s drug or device killed someone was worth more than $75,000.  As defense lawyers, we are sometimes accused of being heartless, lacking empathy, being unswayed by emotion, etc.  Yet, imagine how crass we would be accused of being if we loaded up a notice of removal in a case like Mehram with a exhibit-backed financial breakdown of what claims for catastrophic injury and wrongful death of a young child were worth.

Based on some internet searching and substituting general California numbers for Birmingham, England, where plaintiffs live or Orange County, where they sued, we pulled some numbers relevant to plaintiffs’ alleged damages.  The cost of a 26-day hospital stay in California in 2024 averaged between $80,000 and $132,000, depending on the type of hospital.  ICU stays typically cost twice that and, we assume, pediatric ICU stays cost even more.  Would that need to be included or would a common sense reading of the complaint have indicated that the medical expenses for the plaintiffs’ decedent exceeded the jurisdictional minimum?  A “traditional” funeral in California averages about $8000, whereas a “full” funeral is twice that.  Does that need to be included in the purportedly necessary tally in the notice of removal?  As a five year old female in 2023, U.S. government life tables indicate that plaintiffs’ decedent would have lived an average of another 76.55 years.  Should that be mentioned when discussing how the claims for the parents’ loss of the love and support of their daughter tallied up?  What about medical details on the pain and suffering associated with cardiac arrest and hypoxic brain injury?  If there were a trial, then all of these types of damages would be presented to the jury.  Before removal, should the defendant have filed a motion for more definite statement to make the complaint include dollar amounts whenever it discussed claimed damages?  Should the defendant have served a request for admission that the case sought more than $75,000 in damages?  We submit that it would be ludicrous, if not cruel, for any of this to be required to justify the jurisdictional minimum in a diversity removal as mandated by the misguided Mehram decision.  The Dart requirement that “a defendant’s notice of removal need include only a plausible allegation that the amount in controversy exceeds the jurisdictional threshold” makes way more sense.  It is a good thing that Dart is the law and Mehram is not.

Photo of Stephen McConnell

We’ve said before that plaintiff lawyers do a better job of putting together bench-bar conferences than the defense side does. It mirrors to a certain extent what goes on in the courtroom. The plaintiff side is better at showmanship. It is not just us saying that. Last week, we were at a bench-bar conference focused on Multidistrict Litigations (MDLs), and a state court judge told us the same thing. He had more fun at the plaintiff-run conferences. That judge was just one of many important judges (from state courts, including the Texas Business Court, as well as federal district and circuit courts) who came together to discuss the latest doings in MDLs, which have become the 64,000 pound gorilla of the American civil docket. Also in attendance were luminaries of the plaintiff bar, the usual suspects among defense hackery, and, increasingly important, tech vendors (more about artificial intelligence (AI) in a bit) and a banker (more about third party litigation funding (TPLF) in a bit.

The Chatham House Rule (note the singular – most people refer to the Chatham House Rules, but that plurality is a mistake) applied to the conference, which means that statements should not be attributed to any specific parties or affiliations. Therefore, anything we say about the conference will be like a plaintiff’s ultra-processed food complaint: broad, vague, and occasionally incoherent. 

We were on a panel moderated by an esteemed law professor. Also on the panel was a federal judge who had terrified us in a particular case. A long, long time ago, that judge had been a student of the professor’s, and it was interesting, surprising, and even a bit touching to see how the judge deferred to the professor. The panel was subjected to the Socratic method. We look forward to frequent anxiety dreams over the next couple of months. The main issue at hand was TPLF. There are draft bills in Congress on that topic, and there is a federal judiciary committee looking into it. As a card-carrying defense hack, it is obligatory for us to favor disclosure of TPLF, and a new Fed. R. Civ. P. modelled on Rule 26(a)(1)(A)(iv) — which mandates disclosure of a defendant’s insurance coverage — would suit us right down to the ground. The plaintiff lawyers were equally predictable in their opposition to such disclosure. Their argument was that such information is not relevant, it implicates work product concerns, and, anyway, there is no empirical evidence that such disclosure is needed. We waggled a finger at the professor. Unlike law school, where we were happy as a clam to, well, clam-up, we decided it was our duty to point out that absence of empirical evidence might be a function of absence of transparency. Moreover, some TPLF agreements have surfaced that, while cleverly disclaiming general control by the funder over the litigation, then go on to assert such control by dictating choice of lawyers, approval of settlements, and even client appearances. Some funding agreements require payments to the funders that include monetization of equitable relief. How does that work? As for more empirical evidence, what about Elizabeth Burch’s book, The Pain Brokers,  which documents a sleazy scheme that involved vaginal mesh litigation funding, unnecessary surgeries at inflated prices, and plaintiffs who emerged from the TPLF maw with scars and dissatisfaction?

At that point, a plaintiff lawyer who had worked on the vaginal mesh litigation expressed indignation that anyone would challenge the bona fides of that MDL. The illusion of harmony was dispelled for a moment. Not all was peaceable in the bench-bar kingdom. Should we respond? Galileo said “and yet it moves,” referring to the earth, after being criticized (an overly gentle way of putting it – Galileo was shown the implements of torture) for his heliocentric theory of the solar system. The scam afoot in The Pain Brokers might have been an aberration, but it happened. Sorry to veer from kumbaya. Go ahead, plaintiff bar, and defend the undefendable. And yet it reeks.

Maybe we should have reverted to law school form and just said “Pass.”

To be sure, we do not believe that the unhappy plaintiff lawyer or his firm had anything to do with anything inappropriate in the mesh litigation. But there are bad actors out there, and one reason that rules are necessary is to address the mischief wrought by such bad actors. That being said, the bad actors are not usually the folks who show up at bench-bar conferences. What puzzles us is why a good plaintiff lawyer would feel the need to protect the bottom-feeders. We do not mean to be unfair. There were several instances during the conference when plaintiff lawyers spoke in favor of early vetting of MDL cases. The good lawyers vet their own cases and make an effort at separating the wheat from the chaff before filing. We know who those lawyers are, and their inventories command much more respect from our clients.  Those lawyers actually embrace new Fed. R. Civ. P. 16.1, which lays out early vetting opportunities in MDLs. Rule 16.1 implements, at least in a hortatory tone, procedures that many MDL courts have improvised and deployed over recent years to, for example, require early showings of usage and injury. We heard from one judge who implemented state-of-the-art procedures to encourage early vetting. This was a judge who had learned from a prior MDL how messy things could get. It made us think of Irving Kristol’s quip that a neoconservative was “a liberal who had been mugged by reality.”

We heard from judges who were or had been on the Joint Panel for Multidistrict Litigation (JPML). Perhaps the best practice pointer of the conference came from one of those judges: when you are arguing for a particular location for an MDL, do not linger on the quality of the airport. The judges do not care about that infrastructure point very much, if at all. Much more crucial is what is the center of the litigation, in terms of witnesses, documents, etc.  In addition, before you launch into your one-two minute JPML argument, have in mind second and third choices for the transferee court. There might be reasons (e.g., a judge indicating no interest/availability in handling an MDL) why your first choice is a no-go.  

Too many MDL transferee courts assume from the jump that the affair must end in settlement.  That is bad enough. Still worse is when the transferee court designs everything in the MDL to drive the parties toward settlement. In the worst instances, that means bad rulings or, more typically, non-rulings. As is usual at these conferences, it was an in-house lawyer who had the temerity to challenge the initial, reflexive assumption that an MDL must pave a road to settlement. Sure, most of the MDLs do culminate in settlement one way or the other. But the process is not helped when one side sees the process as warped. Suspicion breeds resistance. In any event, settlement uber alles stinks. It needed to be said. It always does. 

There is a plaintiff lawyer out there (many of you know him) who is aggressive and effective at everything he does. We have personally been murdered by him in court during discovery squabbles. We saw him slice and dice one of our experts at trial. With all that mayhem, you might think we would get hives whenever we are in the same room with this plaintiff lawyer. But no, he is brilliant, funny, and fundamentally kind. That he clobbers us every once in a while is part of the deal. (Think Hyman Roth in Godfather 2 – this is the business we have chosen.) One thing about this particular plaintiff lawyer is that when he predicts that something is going to happen in this business, he is invariably right. Our ears perked up when he discussed medical devices approved through the de novo process – in between premarket approval (PMA) and 510(k). If there is no predicate device for 510(k) purposes — something that happens more and more as time goes on and new technology is invented – the device is probably destined for Class III/PMA treatment. But maybe the device is not implanted or the risks are moderate, so the manufacturer proposes it be treated as a Class II device. Through the de novo process, the manufacturer can submit an application with a ton of data – basically as much as a PMA –  about why the device is safe/effective and can be safely regulated without PMA.  If FDA agrees, it promulgates specific rules for that particular type of device.  The device that goes through the de novo process becomes the “predicate device” and then all future devices of that type can 510(k) off of that predicate. What does that de novo process mean with respect to preemption? The plaintiff lawyer opined that de novo devices were going to be more and more important and would raise interesting legal issues. Mark it down.  

Inevitably, AI was a featured player at the conference.  AI’s application in the legal field is already significant. That significance seems to be increasing exponentially just over the past couple of months. Anthropic’s Claude and other recently released products have supplied lawyers of all stripes with powerful tools. Judges also now have access to powerful tools, including some that enable them and their staff to identify hallucinated cases hiding in briefs. Be careful out there. The fact that judges are becoming more conversant with AI means that they will expect lawyers to do much more much faster. AI is making things much easier when it comes to analyzing medical records, comparing medical literature, drafting cross examinations, and- ta da!  – early case vetting. 

At the same time, AI lays traps for the unwary. What about deep fakes? Might we see fraudulent medical records? Might early vetting become a playground for AI mistakes – or worse? Did you know that it is possible to insert instructions into documents, via white ink and marginalia, that will force a reviewing AI program to veer away from its earlier instructions? Imagine the chaos that trick could cause. Anyone who would do such a thing would need to value their bar card cheaply, and the penalties for such abuse should be severe. But first it would need to be detected.  Finally, if you are suing a company that develops AI products, would responses to inquiries posed to that AI product constitute party admissions?

Our usual test for any bench-bar conference is whether we learned at least one worthwhile thing per day. By that measure, this MDL bench-bar conference gets a high grade. We learned a lot from important sources about things that are happening, or will happen, in our occupational neck of the woods. And then, of course, there is the hackneyed but true observation that the most important things are the people you encounter along the way. We encountered judges who have devoted enormous blocks of time to trying to improve our system of justice. (Let’s face it: the judiciary is the only part of our government that is doing its job with skill and honor.) We encountered a defense lawyer who is at the very top of her field, and has been for many years, and who now is absolutely heroic and inspiring. We encountered plaintiff lawyers who are brilliant, conscientious, and infuriatingly magical.  

We remember an episode of the sit-com Seinfeld in which one of the characters, Kramer, advises that one should get near a proctologist at parties because they tell the best stories.  Our advice for bench-bar conferences is to get near lawyers and judges from Louisiana. At conferences we like to plop down at tables with people we do not know, just to make new acquaintances. By chance, a couple of times we ended up sitting with judges, plaintiff lawyers, and consultants from Louisiana. Whether the topic was bizarre lawsuits (trading of alligator hides), lawyers (like the late Danny Becnel) who could have been characters in a Mark Twain story,  or what’ll you have to drink (one lawyer was gripping what had to have been a triple whiskey), people from the Pelican State are more colorful than their colleagues. Let the good times roll, indeed.

After the conference terminated, a group of us, both sides of the v as well as a couple of judges, headed for the hotel bar to watch game 2 of the NBA finals between the San Antonio Spurs and New York Knicks. None of us was from San Antonio and, for whatever reason, we were all rooting for the Knicks. (That came especially easy for us – the Drug and Device Law Son attended Villanova University, and the current iteration of the Knicks is essentially a Villanova squad that moved up the Jersey Turnpike to Madison Square Garden.) We cheered on the Knicks as they built a substantial lead, as they frittered away such lead, and as they ended up triumphing improbably in the last frantic seconds of the game. We swapped tall tales. We commiserated. During an hour or so of conviviality, we were all on the same side.

Photo of Michelle Yeary

A few weeks ago, we found ourselves underwhelmed by the court’s Rule 702 rulings in the Covidien Hernia Mesh MDL. Today, we can say much the same thing about its summary judgment decision. In In re: Covidien Hernia Mesh Products Liability Litigation No. II, 2026 WL 1555914 (D. Mass. June 2, 2026), the court largely denied summary judgment in a bellwether case governed by Alabama law. In fact, every claim survived except for design defect, on which the court reserved judgment pending a ruling on whether plaintiff may rely on a new alternative-design opinion offered only after his original expert opinions were excluded.

While we have concerns with several aspects of the decision, the court’s treatment of comment k is the most troubling.

Comment k to the Restatement recognizes that some products are “unavoidably unsafe” and therefore should not be subject to design defect liability. The Alabama Supreme Court has repeatedly applied comment k categorically to prescription drugs. The question presented here was whether the same rule applies to prescription medical devices.

The answer should not have been difficult. Alabama courts have never held that medical devices should be treated differently than prescription drugs under comment k. Indeed, the one Alabama federal court to squarely address the issue applied the same categorical approach to both. More broadly, our research has shown that states overwhelmingly apply the same comment k framework to prescription drugs and prescription medical devices, whether that framework is categorical or case-by-case.

But the Covidien Mesh MDL court charted a different course (an unfortunate recent MDL trend). Rather than follow Alabama precedent treating prescription products similarly, or the overwhelming authority from other jurisdictions that do the same, the court relied on what is essentially an outlier decision from Utah that distinguished between drugs and devices for comment k purposes. The result was a prediction that Alabama would apply comment k to medical devices on a case-by-case basis, even though no Alabama appellate court has ever done so. Id. at *6-7. 

That prediction is particularly difficult to square with the Erie doctrine. Federal courts sitting in diversity are not supposed to innovate or expand state law. Their task is to predict what the state’s highest court would do. Here, the court reasoned that because many states employ a case-by-case comment k analysis, Alabama would likely do the same for medical devices. Id. at *7. But that is not how Erie works. The relevant question is not what most states do. The question is what Alabama would do. And the best evidence of that answer is Alabama’s own precedent, which consistently applies comment k categorically to prescription drugs and has never suggested medical devices should be treated differently. If anything, applying a rule of “sameness” to medical devices would have been the more conservative prediction and the one less likely to expand state tort liability beyond existing precedent.

For now, the practical effect of the ruling remains uncertain. The court reserved final judgment on the design defect claim because plaintiff’s original alternative-design opinions were excluded under Rule 702. Plaintiff has since attempted to fill that gap with a new expert affidavit offering a different alternative design. Whether that late-breaking effort survives remains to be seen.

The rest of the decision is similarly generous to plaintiff.

Plaintiff’s failure-to-warn claim focused on the device’s collagen barrier, which is intended to reduce adhesions during the healing process. Plaintiff contended that defendant failed to warn that the barrier could degrade within seven days. The problem with that argument is that the Instructions for Use expressly warned about the very complications plaintiff allegedly suffered–adhesions, bowel obstruction, and hernia recurrence.  Id. at *8. The court nevertheless found a jury question because the warnings did not address the alleged “degree of danger.” Id. at *9. We are struggling to understand how a warning can be deemed inadequate when it warns physicians of the precise injuries that allegedly occurred. If a manufacturer identifies the relevant risks and the warned-of complications occur, one would think the warning accomplished exactly what it was supposed to do.

It also seems to support a finding that prescription medical devices, like prescription drugs, are unavoidably unsafe. There is no guarantee that every surgery will be 100% effective. So, manufacturers warn about the risks. Surgeons assess those risks, using their independent medical knowledge and their knowledge of the patient, and make treatment decisions.  When the risk that occurs is one that is warned about there can be neither design or warning defect liability.

The court’s causation analysis is equally difficult to follow. The implanting surgeon testified that he never read the IFU and would not have changed his decision to use the mesh. Id. at *10. Under Alabama’s learned intermediary doctrine, that testimony should ordinarily end the failure-to-warn claim because an unread warning cannot have affected the physician’s decision-making. Not here. The court concluded that causation could instead be established through alleged, but unidentified, statements by defendant’s sales representatives regarding the longevity of the collagen barrier. The evidentiary basis for this theory came from yet another late-filed declaration, this time from the implanting surgeon himself. Even then, the surgeon did not recall any representative actually making the alleged misstatement. Rather, the court held that a jury could infer the statements were made because sales representatives had been trained that the barrier could last up to thirty days. Id. at *10. 

That is a remarkable chain of inferences. Representatives were trained on a topic, therefore they must have communicated it to this surgeon, therefore the surgeon must have relied on it, despite not specifically recalling the communication. Yet those inferences were enough not only to preserve the failure-to-warn claim, but also plaintiff’s fraud and punitive damages claims. Id. at *11, *13.

Finally, the decision contains a cautionary tale about MDL case-management agreements. Alabama’s implied-warranty statute requires notice. Here, the court held that an email adding plaintiff to an MDL tolling agreement satisfied that statutory requirement. Id. at *12. Defendants often enter into MDL-wide agreements for practical reasons and to streamline litigation. This ruling serves as a reminder that such agreements can sometimes reappear later in entirely unexpected contexts.

Taken together, the opinion reflects a recurring theme. At multiple junctures, the court was willing to make Erie predictions that expanded state law, draw inferences unsupported by direct evidence, and overlook evidentiary shortcomings that ordinarily would doom a claim. Perhaps some of those rulings will ultimately prove academic if plaintiff cannot supply admissible evidence of a safer alternative design. But for now, this bellwether decision stands as another example of an MDL court finding a way to keep virtually every claim alive for another day.

Photo of Bexis

The Blog has always been interested in off-label use issues.  We hope our readers are as well.  Here are a couple of recent developments that have nothing in common except that they involve off-label issues.

The first is regulatory.  On May 12, 2023, the FDA actually did something smart, a relative rarity for the current regime.  Maybe Makary’s exit is already paying quick dividends.  It’s entitled “Drug Repurposing for Unmet Medical Needs; Request for Information,” and may be found at 91 Fed. Reg. 25897 (FDA May 12, 2026).  It doesn’t use the term “off-label use,” but that is what the “repurposing” is all about.

Drug repurposing refers to the identification of potential new uses of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.  Because drug repurposing takes into account existing knowledge of approved drugs (e.g., safety profiles) when considering the benefits and risks of potential new uses, it can be an important approach for identifying potential treatments for diseases, conditions, or populations that currently lack adequate approved therapies.

Id. at 25897.  “New uses of FDA-approved drugs” is off-label use.

Bexis’ off-label use article, “Off-Label Use in the Twenty-First Century:  Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021), addressed one of the most significant economic reasons for off-label use:

Economic realities can also keep uses off the label.  Because of the time and expense of obtaining FDA approval of new uses for an already approved drug, drug manufacturers frequently do not voluntarily request FDA approval for a new use unless the change in the labeling will pay for itself in increased profits.

Id. at 28 (footnote omitted).

Here’s a concrete example.  For over 20 years a drug, methotrexate, that has been around forever (i.e., it’s generic), has been recognized as the safest first-line treatment for juvenile dermatomyositis, a rare (and potentially crippling) autoimmune disease.

Here, we report use of MTX [methotrexate] as first-line therapy for DM, along with aggressively tapered corticosteroids, in an attempt to reduce treatment-related side effects.. . . .  

Conclusion: Use of MTX in conjunction with an aggressively tapered course of prednisone may be as effective as traditional long-term corticosteroid therapy for children with DM, while decreasing the cumulative dose of corticosteroids.

Ramanan, et al., “The Effectiveness of Treating Juvenile Dermatomyositis with Methotrexate & Aggressively Tapered Corticosteroids,” 52(11) Arth. & Rheum’y 3570-3578 (Nov. 2005) (at abstract).  That article (and others like it) was published more than 20 years ago, but this treatment still does not appear on the FDA-approved label for the drug.  Why?  Because, first the disease is rare (3 in 1 million children), and second it’s a generic drug, and generic manufacturers are not equipped to perform the sort of clinical testing that the FDA regulatory process demands for label changes.

But the FDA’s recent “information request” may be about to change all that.  It focuses “on FDA-approved drugs for which there appears to be no commercial interest in adding a new use through a supplement to a new drug application.”  91 Fed. Reg. at 25897.  The FDA is looking for “cases where there are compelling data but potentially no commercial interest in submitting a supplemental application.”  Id. at 25898.  Now, after spending decades trying to interfere with information about off-label use, the FDA wants to collect it and to “use other complementary approaches supported by existing legislation and regulatory pathways to encourage labeling updates with new uses for drugs.”  Id.

Take the methotrexate example.  The FDA request for information invokes 21 U.S.C. §353d – added after Bexis’ article – which allows the agency to “identify covered drugs for which labeling updates would provide a public health benefit,” covered drugs being generic drugs:

for which − there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling; . . . or there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and updating the approved labeling would benefit the public health.

Id. §353d(a)(1)(C) (further subheadings removed).  That sounds like it would cover methotrexate, but there’s more.

Aside from statutory powers, FDA has been quietly:

initiating systematic analyses of publicly available scientific literature, and upon determining that the information supports findings that could result in labeling changes, subsequently publishing Federal Register Notices to facilitate these changes by encouraging the filing of supplemental applications

91 Fed. Reg. at 25898.  In other words FDA has started proactively looking for accepted off-label uses that could be brought onto drug labels, and this request seeks to broaden that initiative.

We strongly encourage our readers who may have information about medically accepted off-label uses to provide that information to the FDA during the comment period, which is open through June 11, 2026.

Here are the “criteria” for what kinds of off-label uses the FDA is seeking to add to drug (but apparently not device) labels.

(1) There is compelling scientific evidence to support the effectiveness of the drug for the new use, (2) the dosage form(s) and route(s) of administration for the new use are the same as for an approved indication, and (3) there is a comparable safety profile for the patient populations for the new use and approved  indications.  FDA is also seeking input on potential candidates for drug repurposing that may not meet all of the above criteria but have preliminary promising data that might address an unmet need.

Id. at 25899.  These are the medical conditions that the FDA currently views as “priority areas”

metabolic diseases, neurodegenerative conditions, women’s health conditions (e.g., conditions related to menopause), men’s health conditions (e.g., testosterone deficiency), and substance use disorders, as well as rare diseases.

Id.  The FDA request also identifies three “scenarios” based on the amount of existing data that is available:

  • Candidates for which sufficient evidence may already exist to demonstrate their safety and effectiveness for a potential new use.
  • Candidates for which there are preliminary signals from clinical data, but sufficient evidence does not yet exist to demonstrate their safety and effectiveness for a new use.
  • Candidates for which there are preliminary signals from preclinical data, but no clinical evidence yet exists to demonstrate their safety and effectiveness for a new use.

Id. (emphasis added).

However, given our stance on truthful off-label speech, we would not mind seeing our readers publicize to the medical community the data that they are submitting to the FDA in response to the agency’s request for information.  We find it hard to see how that could possibly be “illegal,” but we’re not the FDA, and we don’t know how the FDA would view that.

And now for something off-label, but completely different.

Bexis’ law review article cited exactly one medical malpractice case, ever, that involved an allegation “premised on a physician’s failure to prescribe off-label.”  54 UIC J. Marshall L. Rev. at 30 n. 140.  Now there is even more bizarre case – a claim that it was malpractice not to treat the plaintiffs’ decedent with not just an off-label use, but with a drug that had no FDA approval at all.  Maybe we should call that an “off-off-label” use.

Last month, DeMizio v. Johns Hopkins Health System Corp., 2026 WL 1265362 (Md. Spec. App. May 8, 2026) (unpublished), affirmed a defense verdict in a case where the plaintiff’s, and her expert’s, theory was:

Regarding the drug . . ., over objections, [plaintiffs’ expert] said there were studies conducted . . . showing [its] effectiveness, and these studies were “known and available . . . in the United States.”  During that time period, the drug was approved in the European Union and Japan for the treatment of [the relevant condition].  Meaning that patients could travel abroad and receive treatment with [the drug] if they had the means.  The FDA did not approve the drug in the United States until 2019.  Even prior to the FDA’s approval, [plaintiff’s expert] said [the drug] was “known to be out there.”  To be prescribed [the drug] in the United States, there were . . . centers across the county where the drug could be prescribed off-label.

Id. at *3.

Not surprisingly this theory – that the medical standard of care in Maryland purportedly required treatment with a drug that the FDA had not yet approved for anything – failed miserably.  The expert “did not provide any peer reviewed or published literature to support his conclusion,” and the opinion was “an unjustified extrapolation where during the relevant treatment period the treatment with [that drug] was not FDA-approved for any purpose.”  Id. at *4.

On appeal, the plaintiffs lost again.

“Extrapolation” is one of the various factors relevant to Maryland’s quasi-Daubert-based approach to expert testimony.  The appellate court agreed that this “ipse dixit” opinion that use of a totally unapproved drug that was not available in the United States was somehow the “standard of care” flunked that test:

[W]hether there was an unjustified extrapolation from an accepted premise to an unfounded conclusion . . . is related to the concept of an “analytical gap”. . . .  An expert’s opinion has an analytical gap when the expert fails to bridge the gap between his or her opinion and the empirical foundation on which the opinion was derived.  A trial court is not required to admit an opinion that is connected to existing data only by the ipse dixit of the expert.  Here, [the expert’s] opinion that using [the drug] was the standard of care, when the drug was not yet FDA-approved for any purpose and [the expert] did not point to other evidence supporting his conclusion beyond his own testimony, had too wide of an analytical gap between the empirical foundation and the opinion. . . .  At the hearing, [the expert] failed to present sufficient evidence to support the reliability of his conclusion on [the drug].  Instead, [his] testimony on this issue was precisely the kind of ipse dixit opinion that Maryland courts have said is not sufficiently reliable for admission.

Id. at *9.

We think that DeMizio’s conclusion was absolutely correct.  That notion − that treatment with a totally unapproved drug (or device, for that matter) could nonetheless be the medical standard of care − is one of the most bizarre expert “opinions” we’ve ever come across in the context of prescription medical products.

Photo of Eric Hudson

Today’s post is not from the Reed Smith side of the blog.

We remember a time years ago when the phrase “Lone Pine order” was not widely understood. That has long since changed, and now it’s tough to imagine anyone who practices in mass torts not being familiar with it. Indeed, we’ve posted repeatedly about courts entering Lone Pine orders in certain litigation.  We also have a cheat sheet of favorable Lone Pine orders. But as we posted a year ago, the term “Lone Pine” carries a lot of baggage, and we suggested it might be time to stop using the name of a 1986 New Jersey case to refer to a case management procedure for requiring plaintiffs to establish the factual bases for their claims. Terms like “Threshold Evidence Orders” or “Case Vetting Orders” seem more appropriate, and dropping the Lone Pine description might generate less resistance from plaintiffs’ counsel and courts.   

Continue Reading Case Vetting Order in the Thalidomide Litigation

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