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Baby formula is not a prescription drug. No doctor hands you a slip of paper for it. The FDA does not regulate it that way. And yet — when a premature newborn receives cow-milk-based preterm formula through a tube in a neonatal intensive care unit, administered by hospital staff, ordered by neonatologists, selected after individualized review of the infant’s gestational age, birth weight, comorbidities, and the risks and benefits of every available feeding option — what is that if not a prescription? Watson v. Mead Johnson & Company, LLC, 2026 IL App (5th) 240936, 2026 WL 1706992 (Ill. App. Ct. June 12, 2026), answers that question. In what we believe is the first ruling by any appellate court on the issue, an Illinois intermediate appellate court reversed a multi-million-dollar verdict and held that the learned intermediary doctrine applies to infant formula used exclusively in a hospital setting under physician oversight. The formal absence of an FDA prescription requirement does not determine the analysis. The clinical context does.

Plaintiff’s son was born more than two months premature. He spent his entire 25-day life in neonatal intensive care. His physicians discussed the risks of prematurity with his mother, including necrotizing enterocolitis (NEC), a potentially fatal inflammatory intestinal disease, before and after birth. During his hospitalization, the baby’s neonatologists ordered his feedings be supplemented with defendant’s cow-milk-based formula for preterm infants. The child developed NEC and underwent three unsuccessful surgeries. Plaintiff sued the formula manufacturer for strict liability design defect, strict liability failure to warn, and negligence. The jury found for plaintiff on the failure-to-warn and negligence counts. Defendant’s posttrial motions were denied.  Id. at *1-3.

Before the appellate court could reach the learned intermediary question, it had to address plaintiff’s threshold procedural argument—the general verdict rule. The general verdict rule provides that when a jury returns a general verdict on multiple theories of liability, the verdict will be upheld if there was sufficient evidence to support any one of those theories—and a defendant who failed to request special interrogatories cannot complain on appeal. Id. at *17. Plaintiff argued that the learned intermediary doctrine applied only to her strict-liability failure-to-warn claim, not to her four theories of negligence, and that because the jury returned a general verdict encompassing negligence as well, defendant was foreclosed from raising the issue on appeal.

The court was not persuaded. It reviewed plaintiff’s four negligence theories: (a) defendant knew or should have known its formula significantly increased NEC risk; (b) it placed a harmful product into commerce; (c) it marketed the product for premature infants despite the risk; and (d) it failed to disclose NEC risks to parents and healthcare providers. The court dissected each in turn. Theory (a) mirrored the strict-liability failure-to-warn claim. Theory (b) was a reframing of the design-defect theory. Theory (c) was a restatement of the failure-to-warn claim—Illinois does not recognize negligent marketing as an independent cause of action. Theory (d) was “effectively identical” to the strict-liability failure-to-warn count. Id. at *19. In the court’s words, plaintiff’s “negligence theories materially overlap with, and in several instances merely restate, the same factual grounds underlying her strict liability design-defect and failure-to-warn claims.” Id. at *18. The negligence count did not set forth four distinct theories but rather “repeated iterations of the same operative facts framed under multiple labels.” Id. at *20. Where negligence is re-packaged strict liability, it is not treated as a separate basis for recovery, and the general verdict rule does not bar appellate review.

With that threshold cleared, the central question was to whom defendant’s duty to warn ran. Defendant said: to the physicians. Plaintiff said: to the mother.

Plaintiff’s position had surface appeal. Baby formula is not an FDA-regulated prescription drug. Parents can, in principle, purchase it online. The learned intermediary doctrine, the argument went, belongs to prescription drugs and prescription devices. Baby formula is a food.

The appellate court disagreed. It started with the rationale underlying the learned intermediary doctrine as articulated by the Illinois Supreme Court—prescription drugs are complex; the prescribing physician weighs a drug’s propensities against the patient’s susceptibilities; the choice the physician makes is an “informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.” Id. at *21. That rationale, the court observed, does not turn on whether the FDA has stamped “prescription only” on a label. It turns on whether individualized medical judgment was exercised in selecting and administering the product.

The undisputed evidence put the point beyond argument. The formula was obtained by the hospital directly from defendant. No infant in the NICU could receive it without a physician’s order. The neonatologists who ordered it for plaintiff’s son did so after evaluating his gestational age, birth weight, comorbidities, growth trajectory, the NEC risk associated with formula versus human milk, and the available alternatives. That is exactly “the individualized medical judgment of the type upon which the learned intermediary doctrine is based.” Id. at *22. The formal absence of a prescription requirement did not change what was actually happening in that NICU. The formula was, in the court’s words, “squarely within the class of products for which the learned intermediary doctrine applies.” Id.

Plaintiff pointed to the online availability of the product as evidence that the doctrine should not apply. The court dispatched that quickly. Plaintiff’s son never left the hospital. Plaintiff did not purchase the formula. “Considering the nature of [the formula] and the context in which the product was administered,” id., the court held that the learned intermediary doctrine applied as a matter of law. The duty ran to the physicians. We agree.

The trial court’s refusal to give the learned intermediary instruction was therefore reversible error. “By rejecting the doctrine, the trial court fundamentally skewed the legal lens through which jurors evaluated the evidence because the jury instruction misstated to whom [defendant’s] duty was owed.” Id. at *23. The error was not a technicality. It directed the jury to evaluate whether plaintiff was adequately warned when, as a matter of law, the duty ran to her son’s physicians. Illinois precedent is clear that when a case is tried under an erroneous theory of law, reversal and a new trial are required. Id.

The court also addressed one evidentiary issue it expected to recur on remand—the admission of extensive financial evidence regarding defendant’s revenues, profit margins, and executive compensation, despite the fact that plaintiff sought only compensatory damages and asserted no claim for punitives.

Plaintiff had argued the evidence was relevant to motive, knowledge, and corporate priorities. The trial court agreed and admitted it. The appellate court did not. Under Illinois law, when only compensatory damages are recoverable, a party’s financial condition is irrelevant and often prejudicial — it appeals to the jury’s sympathy and invites a verdict based on the defendant’s ability to pay rather than on evidence of liability. Id. at *24. The financial evidence here was anything but incidental. It was introduced before the first witness was called, highlighted repeatedly during trial, and emphasized in opening statements and closing argument. The jury heard about defendant’s revenues, its parent company’s billions in global sales, and executive compensation packages — none of which bore on whether the product was defective, whether the warnings were adequate, or what the compensatory damages should be. Motive, in any event, was not an element of plaintiff’s burden of proof. On remand, such evidence is inadmissible absent a punitive damages claim. Id.

The learned intermediary doctrine has never been a creature of FDA classifications. It is a doctrine built on clinical reality—a medical professional stands between the manufacturer and the patient, exercises independent expert judgment, and makes an individualized decision to use a product for a specific patient. When a preterm infant formula is ordered by a neonatologist in a NICU, administered through a tube, and selected through precisely that kind of individualized medical assessment, calling it “food” rather than a “prescription drug” does not change the analysis. The label on the can does not determine the law.

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We’ve posted twice recently about the potential jurisdictional benefits of the congressionally expanded “federal officer” basis for federal jurisdiction in tort litigation:  28 U.S.C. §1442 (a)(1).  Our first post cited in passing Griffin v. Optum, Inc., ___ F.4th ___, 2026 WL 1239289 (8th Cir. May 6, 2026), as an example of courts already applying Chevron USA Inc. v. Plaquemines Parish, 146 S.Ct. 1052 (2026), “to cases involving other industries.”

On second thought, though, the “other industry” in Griffin − pharmacy benefits managers (“PBMs”) – is sufficiently adjacent to our sandbox that it warrants a post of its own.  Indeed, Griffin is an opioid case, which makes it even more relevant, since plaintiffs make similar allegations against others in the chain of distribution of prescription drugs.  One other salient feature of Griffin is that the plaintiff here was a state attorney general, and opioid cases brought by states have been particularly difficult to remove.

So here’s Griffin.

The state sued four PBMs for supposedly “contributing to an opioid epidemic.  2026 WL 1239289, at *1.

Pharmacy benefit managers enter into service agreements with their clients − federal and non-federal sponsors of health insurance plans − to administer prescription drug programs.  As part of their services, the managers develop formularies, which are lists of prescription drugs covered by a health plan.

Id.  A “central” function of a PBM is negotiating rebates – “post-sale discounts calculated based on the number of consumers that fill a prescription for the manufacturer’s drug.”  PBMs get a cut of these rebates and pass “the remainder” to the various insurance plans that they service.  Id.  PBMs also “determine[ each] beneficiary’s coverage and copayment information.”  Id.  Critically, a couple of the PBM defendants performed these functions under a contract with a federal agency.  Id.

For that reason, they removed the entire state AG action to federal court on the basis that some of their challenged activities were taken under the supervision of a federal officer.  Id.  The state claimed that, by “disclaim[ing] all federal claims, including claims against ‘any federal officer or person acting under any office of the United States for or relating to any act under color of such office,’” in its complaint, it had immunized the suit from federal jurisdiction.  Id. at *2.  The district court fell for that ruse, but the court of appeals did not, and ordered the suit to remain in federal court.  Id.

Federal officer removal was “liberally construed” and “the typical presumption against removal does not apply.”  2026 WL 1239289, at *2 (citations and quotation marks omitted).  The PBMs were “persons” within the meaning of the statute, “acted under the direction of a federal officer,” in a way that had “sufficient connection between those acts and the[plaintiff’s] claims for relief,” and had “a colorable federal defense.”  Id. (citation omitted).

The key in Griffin was “acting under.”  That statutory phrase was “broad, and must be liberally construed.”  Id. (citations and quotation marks omitted).  It includes assisting the government in conducting “basic governmental tasks” such as “providing “the government with a product that it needed or performing a job that the government would otherwise have to perform.”  Id. (citation and quotation marks omitted) (emphasis added).

A PBM working for a government health program qualifies.

[The removing PBMs], at a minimum, acted under the direction of [a federal agency].  The [relevant federal statute] established a comprehensive program of health insurance for federal employees.  Congress [intended] to improve the position of the government with respect to private companies in recruiting the best talent [by] . . . establish[ing] a partnership between [that agency] and private carriers.  The [agency] contracts with private carriers and authorizes the carriers to subcontract with [PBMs] to provide coverage.  The [PBMs] negotiate with manufacturers to obtain discounts, often in the form of rebates, for the drugs that are ultimately included on the plan’s formulary.  When the [PBMs] negotiate with drug manufacturers, they play a key role in the [agency’] effort to carry out its duties . . . to provide prescription drug benefits.  Accordingly, the [PBMs] perform a basic governmental task by performing a task that the government itself would otherwise have to perform.

Id. at *3 (citations and quotation marks omitted).  The removing PBMs thus were subject to a variety of federal “regulations” and “guidelines” concerning “a variety of topics.”  Id. at *4.  These included mandatory contract terms providing federal “access to information at each claim and aggregate level” between the [PBMs] and pharmacies” so that the government could conduct audit “quarterly rebate guarantees, annual reconciliation and payments, actual billing and allocation of rebates, administrative fees, claim payments, fraud and abuse standards, performance guarantees, [and] pharmacy rebates.”  Id. at *4.

Since the state’s claims in Griffin broadly attacked the PBMs’ handling of various rebates, the claims obviously “sufficiently related” to the services the moving defendant was performing for the government.  Id. at *5.  “The State claims that the rebates and fees induced the alleged collusion” to promote opioid overprescription.  Id.  Indeed, the complaint went on and on about rebates.  Id.  So in that sense, the state was hoist on its own petard.

Nor could the state immunize itself from federal officer jurisdiction with boilerplate “disclaimers”:

[N]o disclaimer, however worded, can help the State avoid a causal nexus between [the removing PBMs’] conduct on behalf of the federal government and the State’s] claims.  [The removing PBMs] conduct[] rebate negotiations indivisibly for both plans under the [federal statute] and plans outside of [it].  [They] do[] not have separate rebate agreements with drug manufacturers for [federal] and non-[federal] plans, and none of the resulting discounts or rebates from the negotiations are exclusive to either [type of] plans.  If [the removing PBMs] were liable for negotiating rebates on behalf of private clients, [they] would necessarily also be liable for negotiating rebates on behalf of the federal government—because it is the same negotiation.”  Therefore, the State’s disclaimers do not, and could not, waive claims based on [the removing PBMs’] rebate negotiations undertaken on behalf of both the federal government and private clients.

Griffin, 2026 WL 1239289, at *5 (citations and quotation marks omitted) (emphasis added).  Thus, the remand order was reversed, and the case remains in federal court.

Governmental involvement in the nation’s health care system is ubiquitous.  Thus, we invite our clients and other readers to look for other examples where defendants sued in state court supply either products or services (see our first use of emphasis above) on the same terms and under the same overall regulatory scheme to both federal and non-federal purchasers.  Plaintiffs cannot attack defendants’ (and not just PBMs’) conduct with respect to non-federal purchasers without also implicating federal procurement as well – and disclaimers “do not and [can]not” separate the two for federal jurisdictional purposes.

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This post is off-topic – it has nothing to do with prescription medical product liability litigation, or even the law.  Bexis recently took a vacation on the island of Kauai, in Hawai’i, for the sixteenth time.  He hiked, for the tenth time, the first two miles of the Kalalau Trail, to Hanakapiai Beach.  That’s nice, but it’s not really an adventure.  The actual adventure begins at the beach itself.  Bexis is memorializing it here because he is getting old for this kind of thing, and he has not seen any description of this particular adventure in any travel book – even the Ultimate Kauai Guidebook − or online.

Bexis does not want his discovery to disappear without a trace, so he is detailing it here, on his blog.

To replicate Bexis’ adventure, first, do not bother with the difficult stream crossing where the trail meets the Hanakapiai Stream.  Instead make your way down the well-established, albeit unmarked, somewhat rough (big rounded rocks) path along the near (eastern) side of the stream.  You will pass some pleasant day lunch sites and freshwater pools.  Then you must clamber over the last of the large rocks to reach the sandy beach.

Note:  Hanakapiai Beach exists only in the summer months.  The ocean is far too rough and dangerous at any other time of the year to attempt this adventure.  It is also best pursued at low tide.

Facing the ocean (makai in Hawai’ian), adventurers should turn right (east) and follow the Hanakapiai Beach.  The cliffs gradually get closer to the ocean.  Some 50 yards to the east is a large, horizontal cave, perhaps what’s left of a million-year-old or more lava tube.  From the beach you will not see the back of this cave.  There may be a shelf of sand that you have to climb onto before entering the cave.  The amount of sand in the cave varies from visit to visit.

Once inside the cave, your eyes will adjust, and you can see the roof of the cave above.  Walk about 15 yards into the cave.  The ceiling in this part of the cave is quite high, and there is no need to stoop (yet).

After your vision is fully adjusted to the darkness of the cave, turn to the left (again, an easterly direction), facing away from the ocean (mauka in Hawai’ian).  In the distance you should see sunlight from the back entrance to the cave.  The sunlight will be quite distinctive against the cave’s darkness.  If there is no sunlight – abort the adventure.  That means the other end of the cave is filled with sand, and thus passage is impossible.

If, as Bexis did, you can see sunlight, move cautiously towards it.  Keep your hiking stick, or hand, in front of and above your head, because the roof of this part of the cave is much lower.  Bexis had to crawl on his stomach to get through the cave’s back entrance. (here’s a 2018- vintage video of the cave – but the sand was higher in 2026).

The back entrance of the cave leads to a small beach close to the ocean.  If the waves completely cover this beach, don’t go further, because the ocean at Hanakapiai is dangerous.

If this beach at the back of the cave is passable, the next part of the adventure is to climb up the rocks to the shelf that runs along the cliff face to the east of Hanakapiai Valley.  You will need a pair of water-resistant shoes for this next part.  The shelf is rough, but walkable, for about the next 300 yards or so.  Other than occasional spray, the waves should not be much of an issue, although it is never a good idea to turn your back entirely on the ocean.  Most of this part of the adventure involves walking and climbing across bare, sometimes jagged, lava rock.  The rest is residual patches of sand.  The winter storms prevent any plants from growing on the shelf.

Picking your way across this moonscape by the ocean will take 15-20 minutes.

The adventure reaches its destination when the shelf ends at a good-sized – but not nearly as large as Hanakapiai – beach.  The descent from the shelf to this beach is relatively easy, and the sand is every bit as soft as the sand on Hanakapiai Beach.  Here’s a picture:

Depending on the waves, and your inclination, you can spend an hour on this beach.  Bring snacks.  The near side of the beach features another good-sized sea cave (a bit of which is visible on the right side of the picture), which is home to numerous small sea birds, that will undoubtedly be annoyed by any human presence.  Beyond the cave, at the other end of the beach, is the waterfall that drops from the cliff above and cascades down the rocks.  The waterfall lands a pile of rocks rather than on the beach itself, so you can’t stand under it (probably a good idea, since that’s where the rocks came from) but as the picture shows the rocks are covered with lush inter-tidal vegetation.  That area is also home to numerous good-sized, but harmless, black crabs.  Except possibly in the early morning, the towering cliffs provide plenty of shade.

Repeat the process in reverse to return to Hanakapiai Beach.

That’s Bexis’ adventure.  A trip through a cave and then around a rocky, but quite passable point, to a deserted beach with its own cave and a lovely waterfall.  Bexis has successfully done this four times, with his family.  Bexis is now 70 years old, so if he can do it, so can any reasonably fit person who would like to experience a truly deserted beach in Hawai’i.

Hiking through caves and clambering over rocks to secluded beaches may or may not make me a better lawyer, but it’s fun.

Aloha.

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We’ve wondered if the widespread use of generative AI was going to produce an increase in the filing of pro se complaints and a marked change in their content. While the results are preliminary, at least one study shows a significant increase in pro se filings following the general availability of AI tools. And our own anecdotal experience suggests that, with the benefit of AI, pro se filings are moving from handwritten one-pagers to lengthy and more sophisticated complaints.

If AI is helping pro se plaintiffs prepare more sophisticated pleadings, we would hope that courts would become less deferential. After all, if generative AI helps pro se litigants bring their claims on a more level playing field, and if they’re bombarding courts with complaints, shouldn’t we see an end to the type of judicial indulgence in favor of pro se plaintiffs that leads to bizarrely pro plaintiff results? While we will continue to hold out hope, today’s case is an example of a court giving a pro se plaintiff the benefit of the doubt and, unfortunately, potentially expanding Texas product liability law into enterprise software.

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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.

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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. 

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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.

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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.”

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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. 

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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.

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