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On July 6, 2026 the FDA announced the results of a study it recently completed on tampons (which are medical devices) and their “Biocompatibility and Toxicology.”  The Agency’s conclusion was:

[T]esting conducted by FDA laboratories and a toxicological risk assessment related to metals found in tampons . . . found that, while trace metals are present in tampons, the amount released during use is too small to cause harm.  This study is consistent with findings from an independent systematic literature review previously commissioned by the FDA.

FDA, “Biocompatibility and Toxicology Program:  Research on Medical Devices, Biocompatibility, and Toxicology,” at Update dated July 6, 2026) (emphasis added).  Here’s a link to the study itself, which is Jin, et al., “Do metals in tampons pose a health risk? A toxicological risk assessment study,” 209(6) Toxic’l Scis. ??? (May 2026).  And here are excerpts from the study abstract (available at the link):

Recently concern has been raised over metal content in tampons and the possibility of toxicological risk to women. As a result, researchers at the United States Food and Drug Administration (FDA) investigated metals present in tampons and estimated the maximum exposure and toxicological risk associated with tampon use.  The levels of metals contained in, and released from 11 tampon products, which are legally marketed in the United States, were analyzed. . . .  19 metals were detected including . . . arsenic (As), cadmium (Cd), and lead (Pb) were found at trace levels.  Based on the in-depth [toxic risk assessment], all detected metals had margins of safety (MoS) indicating that there is negligible toxicological concern from the presence of metals in tampon materials.

(Emphasis added).  The study was written by FDA employees, so it is in the public domain.

Given these conclusions, there isn’t likely to be any “newly acquired information” that would allow a plaintiff to claim that state law demands a warning about any or all of these metals being present in tampons.  That’s important because of Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Tampons are considered Class II §510(k)-cleared medical devices, and until Lohr is overruled, as it should be, the only kind of preemption available to §510(k) devices is implied preemption.

Having said that, we should point out that this isn’t necessarily true for tampon warnings.  An FDA regulation, unique to tampons, 21 C.F.R. §801.430, specifies certain aspects of these products’ warnings – those concerning toxic shock syndrome (“TSS”).  Those FDA-specified warnings have been accorded preemptive effect as “device specific,” even under Lohr’s improper, atextual reading of the relevant “different from or in addition to” preemption clause (21 U.S.C. §360k(a)).  See Murphy v. Playtex Family Products Corp., 69 F. Appx. 140, 143 (4th Cir. 2003), aff’g, 176 F. Supp.2d 473, 487-88 (D. Md. 2001); Haddix v. Playtex Family Products Corp., 138 F.3d 681, 686 (7th Cir. 1998); Papike v. Tambrands, Inc., 107 F.3d 737, 741-42 (9th Cir. 1997); Choi v. Kimberly-Clark Worldwide, Inc., 2019 WL 4894120, at *7-8 (C.D. Cal. Aug. 28, 2019); Wichmann v. P&G Manufacturing Co., 2005 WL 2176922, at *2 (E.D. Mo. Sept. 8, 2005);

However, FDA-mandated tampon warnings under §801.430 are limited to TSS, and in Barton v. Kimberly-Clark Corp., 2025 WL 486316 (S.D. Cal. Feb. 13, 2025), the court rejected an express preemption argument.  The plaintiff’s “allegations d[id] not deal with TSS at all.” and “only target[ed] Defendant’s voluntary Representations” about its tampons.  Id. at *4-5.  Thus, Barton held:

The analysis turns on what “different from, or in addition to” actually means.  In 21 C.F.R. §808.1(d), the FDA interprets the preemption provision to mean that State and local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.  In other words, to consider a State or local requirement as being “in addition to” an FDA regulation, the State or local requirements must be, at a minimum, related to the specific regulation.

Id. at *5 (Papike citation omitted) (emphasis added).  The emphasis in the quotation is to underscore that Barton turned on the Chevron deference-driven limitation that the FDA imposed on §360k(a) – precisely what Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), held that administrative agencies can’t do, and that courts are now required to ignore.

Coming full circle, the plaintiff in Barton was suing over precisely what the FDA has now stated are bogus allegations.  The allegations were, first, that the defendant “failed to disclose, and materially omitted, that [tampons] contain lead – supposedly a violation of California consumer protection laws.  2025 WL 486316, at *1.  Second, plaintiff’s liability theory was based on the contention that “[t]here is no level of exposure to lead that is known to be without harmful effects.”  Id.  That’s exactly the opposite of what the FDA has just concluded – based on its own published scientific study.  Too bad that, according to PACER, Barton resolved last year.

However, plaintiff Barton is a serial litigator and has a second suit in which the preemption issue has yet to be decided.  See Barton v. Procter & Gamble Co., 766 F. Supp.3d 1045 (S.D. Cal. 2025) (deciding motion to dismiss that did not involve preemption).  The allegations about lead in tampons, and that there is purportedly no safe exposure level, are the same.  Id. at 1054.  On such allegations, there are now viable arguments on both express and implied preemption.

On express preemption, the argument would be grounded on the proper extent of the applicable preemption language, as stated in Monsanto Co. v. Durnell, 146 S. Ct. 2001 (2026).

The question, then, is whether the [state-law] failure-to-warn claim − which would require a . . . warning on the [product] label − would impose a labeling requirement that is “in addition to or different from” federal labeling requirements. . . .  The answer is yes. . . .  If a manufacturer does not use the [federally]-approved label, it may be subject to civil and criminal penalties. . . .  [A]bsent such an [agency]-approved or [agency]-required label change, the [regulated] manufacturers may − and indeed legally must − use the [product] label approved by [the agency] at registration.  In sum, federal law requires [defendant] to sell [its product] with the label that [the agency] approved . . . − that is, the label without [the plaintiff’s] warning.  [Plaintiff’s] state tort claim, by contrast, would require [defendant] to add a . . . warning to its labels.  That [state]-law requirement is “in addition to” and “different from” [defendant’s] federal-law labeling obligations.

Id. at 2010-11 (citations and footnote omitted).  A Durnell-based approach would, of course, require a long-overdue direct challenge to Lohr, since tampons are §510(k) devices.

Alternatively, an implied preemption argument is now available in light of the FDA’s recent actions.  While implied preemption has not been much utilized in medical device litigation, the Supreme Court has held, specifically in the medical device, context, that the two forms of preemption operate independently.  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”) (citation and quotation marks omitted).

The basis for implied preemption in the FDCA context is well settled – either:  (1) the plaintiff cannot establish the prerequisites of the FDA’s “changes being effected” regulations, in which case preemption exists because the defendant cannot change its labeling independently of FDA pre-approval (what we call the “Mensing independence principle”); or (2) the CBE rule is satisfied, in which case the defendant must come forward with “clear evidence” that the FDA would not agree to the label change that the plaintiff demanded.  See generally Bexis’ 2020 FDLI article on Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), here, at 12-15 (“Impact”).

Implied preemption under the first prong turns on whether “newly acquired information” – data that the FDA did not previously have available – exists, so that a unilateral CBE label change was possible.  The second prong must meet Albrecht’s test for “clear evidence.”  As for tampons and purported lead (or other metallic) “contamination,” the FDA’s July 6, 2026, announcement and the accompanying study published by FDA researchers, should satisfy both tests.  However, the “clear evidence” prong requires more in the way of regulatory technicalities.  But as for the first prong’s “newly acquired information” requirement, since the Agency has just stated that “while trace metals are present in tampons, the amount released during use is too small to cause harm,” we see no chance that any plaintiff could possibly meet applicable FDA standards for such information.  Hence, tampon-related warning claims should be preempted, Lohr or no Lohr, under this prong of FDCA-based implied preemption.

So, it looks like time to revisit preemption in at least some tampon product liability litigation.

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Today’s case, Schmidt v. Dexcom, Inc., 2026 WL 2244106 (E.D. Mich. Aug 2, 2026), involves a glucose monitoring device (the “G6”) and a pretty bad day for the plaintiff—both in terms of how he somehow managed to get a needle stuck in his arm when the device doesn’t go there and the shellacking he received in the opinion. The G6 device consists of an applicator, sensor and transmitter. The applicator deploys a needle and inserts the sensor under the skin, and the needle then retracts back into the applicator. Although the device is indicated for insertion in the abdomen, plaintiff claimed that the needle completely dislodged in his arm, requiring surgery and resulting in permanent scarring and disfigurement. The defense moved to dismiss, arguing that the plaintiff failed to establish personal jurisdiction, that the claim was preempted, and in the alternative to compel arbitration. Spoiler alert—plaintiff lost all three.

The court first addressed jurisdiction. Starting with general jurisdiction, the defendant was not incorporated in and did not maintain its principal place of business in Michigan, so there was nothing to indicate general jurisdiction would apply.  Plaintiff opposed the motion by arguing that the defendant’s business in Michigan was “continuous and systematic,” but that allegation wasn’t included in the complaint, and it wasn’t enough to show that the defendant’s activities in Michigan were so pervasive that it would effectively be “at home” in Michigan. Id. at *4.

Turning to specific jurisdiction, the complaint referenced the defendant’s action of placing the G6 device into the stream of commerce, but it went no further. It did not claim that the defendant purposely availed itself of the privilege of doing business in Michigan, and it did not allege that the injuries arose out of the defendant’s activities in Michigan.  Plaintiff argued in his opposition that the defendant “marketed, sold, and procured for use the G6 in Michigan,” but that information was not in the complaint and, “inexplicably,” plaintiff’s counsel did not request leave to amend the complaint or submit an affidavit in support of personal jurisdiction. Id. Given that, the court held that the plaintiff “did not allege facts to establish personal jurisdiction with reasonable particularity, and it is within the prerogative of this Court to dismiss this action for that failure.” Id.

You’re probably wondering whether the court granted plaintiff leave to amend. It didn’t. Why? Because the plaintiff “failed to meaningfully contest any of the Defendant’s other arguments in support of arbitration or [preemption].  Even if personal jurisdiction were proper, the Court would have compelled arbitration or dismissed the case anyway.” Id. at *5.

Arbitration was an issue because the G6 device was designed to work with a display device that showed the user’s glucose data. That display is typically the user’s smartphone, and to set that up the user has to create an account with the defendant and agree to certain terms of use that include an arbitration requirement. Plaintiff set up such an account, and in doing so accepted the defendant’s terms of use and arbitration clause. Defendant argued that, if the court found personal jurisdiction, it should compel arbitration because of the mandatory arbitration clause which covered all aspects of any dispute between the plaintiff and defendant—including tort claims. Plaintiff claimed he did not agree to the terms of use, but the court found that “plainly untrue.” Id. at *5. The defendant submitted affidavits showing that anyone accepting the terms of use accepted the arbitration clause and that the plaintiff himself accepted the terms. Plaintiff argued that there was no evidence of his signature on any agreement to arbitrate, but that is not required. Michigan requires only “some unequivocal act sufficient to demonstrate acceptance,” and “clicking a box” like the plaintiff did was sufficient. Id. at *6. As a result, the court held that, even if there was personal jurisdiction, it would compel arbitration. (If this gets you wondering about arbitration clauses in the medical device context, here’s a prior post on the topic).

As if that weren’t enough, the court also held that, if there was personal jurisdiction and the court declined to compel arbitration, it would still dismiss the case based on the defendant’s preemption arguments. Two years ago we posted about Dickson v. Dexcom, Inc., 2024 WL 3417392 (W.D. La. July 15, 2024), which was the first decision holding that 21 U.S.C. § 360k(a) preempts claims challenging the safety and effectiveness of a Class II medical device approved by the FDA through the “de novo classification” process. Dickson involved the same device here (the G6), and the defendant relied heavily on it and two later cases holding that claims involving the G6 device were preempted.  See Dickson v. Dexcom, Inc., 2024 WL 4291511 (W.D. La. Sept. 25, 2024) (dismissing failure to warn claims as preempted, which we blogged about here) and Higginbottom v. Dexcom, Inc., 744 F. Supp. 3d 1058 (S.D. Cal. 2024) (dismissing design, manufacturing and warning claims related to the G6 device based on preemption, and which we blogged about here).

Although the court did not provide much analysis on the question of preemption, it contrasted the defendant’s “meticulous” argument about preemption against plaintiff’s failure to “meaningfully contest” any of those arguments.  Given plaintiff’s failures, the court “would not allow Plaintiff a chance to amend his complaint to fix the deficiencies pertaining to personal jurisdiction due to his failure to meaningfully contest the other bases for relief that Defendant identified.”  Id. at *7.

Since the court held that the plaintiff failed to allege facts sufficient to establish personal jurisdiction, it dismissed the complaint without prejudice. But the court’s refusal to allow plaintiff an opportunity to amend, along with its “belt and suspenders” discussion of arbitration and preemption, should mean we won’t see this one again.

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Novo Nordisk A/S v. British Telecommunications Plc, 2026 WL 01791875 (Ch. Div. June 23, 2026), is the first judicial decision from the United Kingdom that we have featured on the Blog.  The high-tech solution that the court approved for combating proliferating fly-by-night websites that “in one way or another were involved in the sale of counterfeit and unlicensed” versions of the plaintiff’s “medicinal products” deserves consideration as a remedy in the United States for what is a world-wide problem.  [Sorry, but this UK decision has no internal pagination.]

The “applicant” (plaintiff) had gotten tired of Whac-A-Mole with multiple websites with “mirror domain names.”  It already had a “web blocking order” against four particular websites that it wanted to extend to seven new ones – all of which “were involved in the sale of counterfeit and unlicensed medicinal products to UK consumers.”  That alone would not have been notable, or blogworthy.

This time the applicants sought “a further variation” – a so-called “dynamic blocking” order:

The idea behind this is that the Applicants should not need to keep returning to Court as further potential Target Websites are identified.  Instead, they should be entitled to self-certify against a number of designated criteria, set out in a confidential schedule.  If the relevant criteria are met, then the Applicants will be able to notify the ISPs that the infringing websites are also proscribed as Target Websites, and thus require the ISPs to take steps to block them.  The ISPs – the direct Respondents to the proposed Order – have been consulted about the structure and do not oppose it, on the basis that their costs of compliance are met.

(Emphasis added).

The court recognized that illegal internet sales “is an area where creativity is needed in order to target wrongdoing effectively.”  “Applicants have become aware of over 130 other websites that promote counterfeit and unlicensed . . . products to UK consumers.”  Unfortunately, bad actors have the capability to create new fly-by-night websites faster than existing enforcement methods can shut them down.

The sale of unlicensed prescription-only medicinal products can result in serious harm.  Much of the activity has been linked to organised crime gangs, operating anonymously from abroad, typically using intermediary routing services but targeting UK consumers.  Their activities involve regulatory offences . . ., but in a manner which the relevant regulator . . . has in practice found very difficult to police.

The “legal framework” – “assimilated EU case law” (so much for Brexit) and various statutes − “makes it clear that the jurisdiction extends beyond the making of orders directed at bringing to an end existing infringements, and encompasses orders aimed at preventing future infringements.”  The record went well beyond the private wrong of infringements of the applicants’ patents, but included extensive criminal and regulatory wrongdoing:

(1) selling unauthorised medicinal products without any marketing authorisation;

(2) selling prescription-only medicines otherwise than in accordance with a prescription;

(3) selling prescription-only medicines without being authorised to dispense them; and

(4) advertising such products for sale without proper authorisation.

Further, “there is a wide jurisdiction to make orders against third parties who have become involved in facilitating wrongdoing by others in order to prevent continuation of that wrongdoing.”

The “proposed structure” of the dynamic blocking order was:

  • The Applicants themselves, as wronged victims, will be authorised to assess whether there are regulatory breaches involving criminal conduct.
  • The Applicants themselves will be able to notify the third-party ISPs who will be required to take steps to prevent it happening.
  • The Applicants will be able to self-certify whether the relevant blocking criteria are met by certifying that the targeted websites are infringing in violation of relevant  regulations.
  • The Applicants have the resources, skills, and incentive to be able to carry out the necessary Internet monitoring.
  • The relevant governmental enforcement welcome and support the use of private initiative aimed at safeguarding the online environment and preventing the illegal sale of medicines.
  • Safeguards, including a “sunset clause” and a requirement that operators of targeted websites be notified so that they can contest such orders, ensure that there is no real risk of “over blocking” and that potential interference with legitimate commercial activity is negligible.

The problem of illegal internet sales of many products, but particularly prescription drugs, is worldwide, not just confined to the United Kingdom.  We offer this description of the UK’s novel public/private enforcement mechanism in the hope that legitimate suppliers of the American market might be able to convince the courts and regulators to allow analogous methods of stopping illegal drug trafficking in the United States.

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2026 has been a festive year, marking the 250th anniversary of the Declaration of Independence, which was adopted in our home town of Philadelphia.  But did you know that the first formal call by any colony for independence from perfidious Albion was the Halifax Resolves, which was issued on April 12, 1776 in North Carolina? There is a lot to like about North Carolina. It has remarkable beauty, from the Outer Banks to the Smoky Mountains. The Biltmore Estate and Grove Park Inn are gorgeous. North Carolina, as its license plates will tell you, was First in Flight, seeing the Wright Brothers take off from Kitty Hawk in 1903. It has a curiously philosophical state motto: esse quam videri (“to be rather than to seem”). It has a governor, Josh Stein, whom we respect way more than most politicians. We worked on a matter that involved negotiations with state attorneys general from all over the country. Stein was North Carolina’s Attorney General back then (further proof that AG stands for aspiring governor) and he was one of maybe three AG’s who seemed both smart and ethical.  Otherwise, it was like stumbling into a nest of vipers. Maybe they were the top lawyers in their states, but  you would be nuts to trust most of them to research a relatively simple point of law – such as the statute of limitations. 

Why are we taking this moment to extol the virtues of North Carolina? Is it because it gave birth to Michael Jordan and Thomas Wolfe? Or because it is the improbable home of the current Stanley Cup champions? Or is it because North Carolina gave us the greatest donuts, both from NASCAR post victory celebrations and Krispy Kreme?

No, friends, we actually have a legal basis to laud North Carolina. 

A collective of crows is called a murder, and a collective of owls is called a parliament. What is a collective of defense lawyers? A disputation? A quarrel? Maybe it should be a whinge, because we are prone to complaining about rotten rulings and hellhole jurisdictions.  But being of a preternaturally sunny disposition, we like to flip the script toward the positive. If Los Angeles, Philly, Cook County, and a certain docket in South Carolina are hotbeds of anti-corporate animus where summary judgment motions are seldom granted (and maybe not even read), which jurisdictions offer more favorable playing fields?

We hereby nominate North Carolina. We have not had too many cases there, but every time we have, we have encountered fair minded judges and sound law. Maybe we were just lucky. Or maybe North Carolina really has a good legal environment. 

Page v. Elekta, Inc., 2026 WL 2217010 (E.D. N.C. July 31, 2026), is an example of rational tarheel law. To begin with, there is no strict liability in North Carolina, praise be. In Page, we learn that North Carolina has a favorable statute of limitations for personal injury (except for medical malpractice).  Instead of the usual mushy “accrual” language we see elsewhere, the statute begins to run when “bodily harm to the claimant … becomes apparent or ought reasonably to have become apparent to the claimant, whichever event first occurs.”  That language cuts out much of the “but I didn’t know ____” back and forth that typifies discovery rule litigation in other states. Indeed, too often we hear plaintiff lawyers argue that the discovery rule means that the statute of limitations does not get triggered until a plaintiff has learned that there is an airtight case against the particular defendant. Take this sophistry to its illogical conclusion and then the statute of limitations period does not start until the court denies summary judgment, or maybe not until the jury returns a verdict for the plaintiff, or maybe maybe not until the appellate court upholds said verdict. It can get pretty crazy. But not in North Carolina. 

In Page, the plaintiff alleged exposure to excessive radiation during treatment for her breast cancer. The radiation injuries — burns and other tissue damage — were readily apparent when they occurred.  The plaintiff sued her doctor but, at least initially, did not investigate the device itself.  More than three years after the injuries were apparent, she sued the device manufacturer, claiming to have learned of a software defect from discovery in the medical malpractice case.  

The statute of limitations in North Carolina for personal injury cases is three years. Thus, the product liability claim did not survive a motion to dismiss.   A plaintiff’s attribution of injuries to the particular defendant “is not material in assessing whether the discovery rule tolls the statute of limitations.”  All that matters is that the injury itself was apparent.  As the Page court explained, “it is the appearance of the ‘bodily harm’ — rather than plaintiff’s attribution of that harm’s cause — that starts the clock.” The plaintiff cited another case that interpreted the discovery rule more generously for plaintiffs, pausing the clock until the plaintiff discovers that she was injured as a result of the defendant’s wrongdoing, but that case involved a different statute – one governing medical malpractice claims. (Typically, the law regarding medical malpractice claims is more defense-friendly than product liability law. People, including legislators, like doctors. That is why most jurisdictions require plaintiffs to submit a certificate of merit to commence a med-mal case. We wish a similar certificate was required before launching a mass tort against medical products. Oh well. Anyway, North Carolina’s disparate starting guns for accrual of product and med-mal claims is unusual.) Because the plaintiff filed her claim more than three years after her radiation burns and other injuries were obvious to her, her negligence and breach of warranty claims were barred. 

Just in case another court goes, er, south on the statute of limitations issue, the Page court went on to explain why the plaintiff’s claim for breach of the implied warranty of merchantability failed. North Carolina warranty law requires privity, and no privity was pleaded in Page. Further, the plaintiff could not avail herself of the “buyer” exception, because she was not a buyer of the medical device at issue. A doctor is generally not a merchant or seller of goods under the Uniform Commercial Code. (The Page court relied on a pelvic mesh case for that holding. So even in the wretched pelvic mesh mass tort, in which dumb decisions dotted the landscape like kudzu, North Carolina stands out for judicial wisdom.) 

This decision turns the page on another glory of North Carolina law and will be published in F. Supp. Page offers yet another reason why plaintiff lawyers would prefer to litigate in Philly or South Carolina, and not so much in North Carolina, where the law does not just seem better, it is better. 

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Every good mystery needs a red herring. The suspicious houseguest. The gardener with the shaky alibi. The tanning lotion sitting quietly on the bathroom counter while the actual culprit — a chiropractor-prescribed anti-inflammatory cream applied minutes before the plaintiff’s collapse — walks right past the detectives without so much as a raised eyebrow. That is essentially the plot of today’s case, and unlike most mystery novels, the court had no trouble figuring out who did it.

The case is Mattox v. Product Innovations Research, LLC, 2026 WL 2071209 (E.D. Okla. Jul. 17, 2026). Plaintiff alleged she suffered a severe allergic reaction after using defendant’s tanning lotion (not sunscreen; no active SPF ingredients). Id. at *1-2. The complaint asserted claims for ordinary negligence, negligent training, negligent supervision, and strict products liability. But all four counts overlapped and boiled down to an allegation that defendant failed to sufficiently disclose an allergen plaintiffs believed was lurking in the formula. Id. at *4. Before we even get to causation, the court had to clear away a pile of duty theories that plaintiffs tried to stack on top of ordinary failure-to-warn law.

Plaintiffs argued that Oklahoma law imposes a broad, generalized duty on manufacturers “to avoid foreseeable harm” caused by mislabeling, failure to warn, failure to test, failure to adhere to industry standards, failure to comply with federal regulations, and negligent formulation. Id. at *5. That is a lot of duty to hang on the five cases plaintiffs cite, and the court was not having it. Going case by case, the court held that alleged deficiencies in labeling, testing, or formulation are “factual theories by which a plaintiff may attempt to show breach of [the] warnings-and-instructions duty; they are not independent duties” in their own right. Id. The court was similarly unimpressed by the argument that Oklahoma recognizes a separate duty to avoid misleading consumers. The court held that the case plaintiffs relied on presupposes existing strict-liability duties regarding design and warnings and does not recognize a separate negligence duty to avoid misleading consumers. Id. If plaintiffs want to complain about misleading labeling, that is a warning claim, full stop.

Next, plaintiffs cited a case to suggest that failure to comply with FDCA regulations can be a basis for a negligence per se claim. But plaintiffs did not bring such a claim.  Therefore, “plaintiffs’ references to federal regulations are properly treated, at most, as evidence bearing on ordinary negligence, not as an independent cause of action.” Id. at *14, n.5. Finally, as far as adhering to industry standards is concerned, Oklahoma law (a) provides that it can serve “as non-dispositive evidence bearing on breach of duties otherwise established” and (b) “limits the defensive use of industry-custom evidence” under the state’s strict-liability framework. Neither case cited by plaintiffs equates failure to adhere to industry standards as the broad breach of duty urged by plaintiffs. Id. at *6.

Plaintiffs also reached for res ipsa loquitur, arguing that a catastrophic allergic reaction just does not happen absent negligence. Id. The court’s response amounts to a well-deserved eye roll. “Res ipsa loquitur does not create a new duty, does not supply a product defect, and does not apply where the injury may reasonably occur in the absence of negligence.” Id. Allergic reactions, as any first-year torts student (or allergy sufferer) knows, are the textbook example of harm that can occur even when everyone did everything right. That is rather the point of an allergy — it is idiosyncratic to the person, not necessarily indicative of some derelict manufacturing process.

Next up was a spoliation argument. We will not dwell here, but it is worth a passing mention because it quietly foreshadows the causation problem to come. Defendants argued that plaintiffs’ failure to retain the actual bottle of lotion — a nonparty clinic employee tossed it before litigation even started — should sink the case on product identification and spoliation grounds. Id. at *8. The court declined to go that far, finding no evidence of a duty to preserve or culpable conduct sufficient to support sanctions, and holding that circumstantial evidence (photos, testimony, packaging) could get plaintiffs to a jury on product identification. Id. at *8-9. No spoliation defense here. But without the bottle, nobody could ever test what was actually in it. That gap in the record was consequential on causation.

Even assuming plaintiffs could get past duty and defect, they still needed evidence that the lotion — as opposed to literally anything else — caused the reaction. And their own evidence torpedoed them. Start with the timeline. The undisputed chronology showed days of uneventful use of defendant’s lotion, followed by a sudden, severe reaction that started right after application of a chiropractor-prescribed anti-inflammatory cream. Id. at *10. The history obtained by emergency personnel reflected that plaintiff began vomiting and experiencing shortness of breath after her husband applied the anti-inflammatory cream to her chest and back, and that she had a severe allergy to certain types of nuts and to ibuprofen. Id.

Plaintiffs relied on an allergist’s opinion that certain ingredients in the tanning lotion “may have contained” almond oil and that therefore, the lotion “likely” caused the reaction. Id. But plaintiffs’ expert’s own testing worked against them. Although plaintiff tested positive to almond on a tree nut skin-test panel, she tested negative when skin-tested with defendant’s tanning lotion itself. Id. That is about as clean a rebuttal as a defendant could ask for — the plaintiff is allergic to almonds, sure, but when you test her against the actual product she is suing over, nothing happens.

The court did not mince words about what this evidence amounted to. The court held that the expert’s causation opinion rested primarily on temporal association and the general allergenic potential of certain ingredient classes, rather than on testing that confirmed the presence and concentration of a particular allergen in the product as sold and applied. Id. at *11. Plaintiffs never established that a specific allergenic ingredient was actually present in the product they sued over. Remember, plaintiff tested negative for any allergic reaction to the tanning lotion generally and plaintiffs could not test the particular bottle she used because it was thrown away.  We told you the spoliation argument was foreshadowing. All plaintiffs had was a mere possibility that the product could have caused the injury. That is insufficient to establish defect or causation under Oklahoma law. Id.

Further, temporal association alone does not equal causation — particularly when there is a far more obvious, far better-timed alternative cause sitting right there in the medical chart. And in a footnote that is basically the judicial equivalent of a mic drop, the court noted that plaintiffs’ expert’s report did not address plaintiff’s intervening application of an anti-inflammatory cream, which undermined the temporal association on which his opinion relied. Id. at *14 n.9.

While plaintiffs tried to point to a lack of product testing, they identified no authority, state or federal, “imposing a duty on [the manufacturer] to conduct allergen testing or maintain post-market surveillance.” Id. at *10.  Combined with a causation case built entirely on speculation and bad timing, testing omissions, if any, do not themselves constitute a design or manufacturing defect. Id. The court held that plaintiffs had not identified a specific design or manufacturing defect that rendered defendant’s product unreasonably dangerous to ordinary consumers, and that the timing and circumstances of the reaction more closely aligned with the application of a different product, entitling defendants to judgment as a matter of law. Id. at *11.

With no viable underlying tort, punitive damages were dead on arrival — you cannot get exemplary damages on a claim that does not exist. Id. at *12. But the court went further and made a point worth bookmarking for future cases — alleged regulatory violations or deviation from industry-standard practices, without more, do not constitute clear and convincing evidence of reckless disregard or malice sufficient to support punitive damages under Oklahoma law. Id. Plaintiffs cannot dress up ordinary testing and labeling disagreements as the kind of conscious disregard that gets a jury an exemplary-damages instruction.

The court also did not need to reach plaintiff’s motion for summary judgment on defendant’s affirmative defenses of assumption of the risk and intervening cause, but it is a nice bit of belt-and-suspenders reasoning for the defense side of the ledger. The court found that the undisputed record — including plaintiff’s awareness of her severe nut and ibuprofen allergies, her repeated uneventful use of the lotion before the incident, and the onset of symptoms immediately after application of the anti-inflammatory cream — precluded the court from holding as a matter of law that no reasonable jury could find some degree of voluntary exposure to known risks or an independent, intervening cause Id. at *12-13.

Too many plaintiffs try to get from “I used a product and later got sick” to “the product made me sick” using nothing but sequence and suspicion. Post hoc ergo propter hoc is a logical fallacy, not a causation standard, and this court called it out for exactly that. When the plaintiff’s own medical history places the trigger event immediately after exposure to a different product, and the plaintiff’s own expert’s own testing comes back negative against the accused product, there is no jury question left to manufacture. The tanning lotion was the obvious suspect — sitting right there in the story, easy to blame, easy to sue. But the real cause of the reaction was somewhere else entirely, and the court, unlike plaintiffs’ counsel, actually followed the evidence to where it led. Case closed.

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Our initial inclination was not to blog about DiToto v. Nevro Corp., 2026 WL 1425041 (D. Md. May 21, 2026), given that it was an adverse, poorly reasoned trial court level decision.  But then we received an updated citation indicating that – for reasons that totally escape us – Thompson-Reuters/West had decided to publish it in F. Supp.  With that development, we’ve decided to write a critique after all.

Our waiting, however, has been serendipitous in one respect.  DiToto involved a FDA premarket approved (“PMA”) device, the kind that our readers know is supposed to be protected by broad preemption, given Riegel v. Medtronic, Inc., 552 U. S. 312 (2008).  As we recently discussed, the Supreme Court considered Riegel as the “dispositive” precedent in its new preemption decision, Monsanto Co. v. Durnell, 146 S. Ct. 2001 (

[W]e first address something that’s not found in the majority opinion at all – that is any reference to a “presumption,” or even an “assumption” against preemption.  That’s important because a 20+-year-old FIFRA opinion, Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), had relied on such a presumption, despite the statute’s express preemption clause.  Id. at 449-50.  In the interim (as the Blog has repeatedly discussed), the Court abolished any such presumption in express preemption cases.  Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016).  But in Durnell, despite what Bates had held about preemption presumptions, the majority opinion said not a word about it, even while discussing Bates itself.  Instead, the “textual conclusion” in Durnell gave force to the literal meaning of §136v(b)’s language[. Block quote omitted]

Hence the title of this post, that “‘different from’ and ’ in addition to’ mean what they say”. . . .  Durnell is further proof that, yes, the Supreme Court’s abolition of any presumption against express preemption applies to product liability litigation.

Contrast that with the first thing we wrote about DiToto when we added it to our Medical Device PMA Preemption Scorecard:  “Incorrectly applies a presumption against preemption that does not exist in express preemption.”

That’s right.  All of the dismal holdings in DiToto are based on this single basic false premise – that a presumption against preemption applied in what was a PMA express preemption case.  As part of its purported “preemption background,” DiToto asserts, “the Supreme Court has repeatedly recognized, including in the context of the Medical Device Amendments, that there is a presumption against preemption.”  DiToto, 2026 WL 1425041, at *6 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996), and the aforementioned Bates decision).  But that’s just plain wrong (or at minimum anachronistic; the judge in DiToto had senior status).  In Franklin Trust, the Court held:

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

579 U.S. at 125 (citations and quotation marks omitted).  As we’ve already mentioned, use of a presumption against preemption in Lohr and Bates has been superseded by Riegel and Durell, respectively – both of which considered such presumptions so irrelevant to express preemption that they did not even bother responding to dissents that asserted those purported presumptions.

Moreover, DiToto is a Maryland district court case, and Maryland is in the Fourth Circuit.  The Fourth Circuit has also followed Franklin Trust in express preemption cases:

We think the best course is simply to follow as faithfully as we can the wording of the express preemption provision, without applying a presumption one way or the other.  And in all events, we need not enter the great preemption presumption wars here because the text of the preemption provision . . . governs the disposition of this case.

Air Evac EMS, Inc. v. Cheatham, 910 F.3d 751, 762 n.1 (4th Cir. 2018) (citing Franklin).  See Maryland Building Industry Ass’n, Inc. v. McIlwain, 2026 WL 946235, at *7 (D. Md. April 2, 2026); CSX Transportation, Inc. v. Bonsal American, Inc., 2024 WL 4597224, at *12 (W.D.N.C. Oct. 28, 2024); Mikos v. Abbott Laboratories, 2021 WL 5416534, at *3 (D. Md. Nov. 18, 2021) (following Franklin in FDCA case); In re Smith & Nephew Birmingham Hip Resurfacing (BHR) & R3 Hip Implant Products Liability Litigation, 300 F. Supp.3d 732, 742 n.8 (D. Md. 2018) (same in a PMA preemption case).

That’s the number one reason why DiToto isn’t worth the paper it was printed on and has no business being published – it applied a non-existent, indeed abolished, legal presumption to reach multiple incorrect legal results.

But that’s not all.  Also, as part of its “preemption background,” DiToto states, “the Supreme Court in Riegel recognized that ‘§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case parallel, rather than add to, federal requirements.’”  2026 WL 1425041, at *6.

That mat makes DiToto 0-2.  As the Supreme Court recently reiterated in Durnell, Reigel did not “recognize” parallel claims at all – rather the plaintiff in Riegel waived them.

Riegel did not consider state-law claims that were parallel to an applicable federal requirement, apart from the FDA’s premarket approval process. . . .  It is true that Riegel did not assess whether the state-law claims at issue were “different from, or in addition to” the relevant federal-law requirements.

Durnell, 146 S. Ct. at 2015-16 n.9 (emphasis added).

Thus, DiToto’s “preemption background” was entirely bogus.  In that light, that DiToto would come to erroneous conclusions as to the particular claims that the plaintiff asserted is hardly surprising.

First up were “manufacturing” defects, which we have to concede, have historically been the category of claims with the highest potential to avoid preemption as so-called “parallel” claims.  But binding Fourth Circuit precedent, specifically Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012), rejects purportedly “parallel” manufacturing defect claims.  “[W]e agree . . . that an alleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations.”  Id. at 580 (citation and quotation marks omitted).  But DiToto did not cite Walker in its discussion of manufacturing defect claims – or, for that matter, Riegel.  2026 WL 1425041, at *6-7.  Instead DiToto relied on the notorious, and nonbinding, Bausch decision from the Seventh Circuit, and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which of course is superseded for PMA devices by Riegel.  The pro-plaintiff discussion of manufacturing defect ignores binding precedent as blatantly as we have ever seen (and some of us practice in Philadelphia).

And what was the supposed FDCA-violating “manufacturing defect” in DiToto anyway?

We don’t know.  This was all the plaintiff alleged:

The First Amended Complaint does not merely allege that [plaintiff’s] . . . device failed on a given date, however.  Instead, [plaintiff] alleges that the device was manufactured as defective, with the evidence of that defect being the fact that the device failed.

2026 WL 1425041, at *7.  DiToto recites that that this is enough “at the motion-to-dismiss stage” to be “plausible.”  Id.  But that’s simply wrong.  A purported malfunction isn’t enough to infer a FDCA violation.  Here is one of many decisions so holding:

There is no allegation that the manufacturing of [defendant’s device] deviated in any way from the process approved by the FDA, other than the conclusory allegation that [defendant] negligently failed “to manufacture a pacemaker that met FDA specifications . . . .”  Such an allegation is insufficient.  Plaintiffs cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.  The fact that the [device] allegedly failed does not itself establish a deviation from the FDA-approved standards.

Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *4 (D. Md. March 13, 2013).  For numerous other decisions for the same proposition, see our TwIqbal cheat sheet and search for “manufacturing.”  The allegation allowed to survive in DiToto – that the device “was manufactured such that it was defective when sold,” 2026 WL 1425041, at *7, says nothing at all.

Next, DiToto waves through “duty to warn” claims under the guise of “duty to report.”  The allegations were that the defendants “consistently” under-reported adverse events over a six-year period.  But that’s just repackaging a fraud on the FDA claim that is preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  That didn’t matter in DiToto, though.  DiToto cited, 2026 WL 1425041, at *8, one case, Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733, 742-43 (D. Md. 2015), that in turn cited no Maryland cases at all, for the proposition that, because Maryland generally “recognizes that a duty to warn can undergird a negligence case,” that this means Maryland would allow claims indirect warning claims involving governmental notification.  No Maryland court has ever allowed anything like that.  See Lamb v. Hopkins, 492 A.2d 1297, 1306 (Md. 1985) (probation officers’ statutory duty to report drunk driving offenses ran only to the government, no common-law duty owed to third persons); Lemon v. Stewart, 682 A.2d 1177, 1185 (Md. App.1996) (affirming dismissal of claim that health care providers could be liable for not reporting a patient’s HIV status to a local government agency); Sheridan v. United States, 969 F.2d 72, 73 (4th Cir. 1992) (military regulation requiring internal reporting of “infractions” by servicemen did not create any Maryland common-law duty to members of the general public).

Until DiToto, no Maryland law case in the last decade had allowed any FDCA-based failure to report claim to proceed.  See Merkle v. Medtronic, Inc., 2026 WL 1361491, at *7 (D. Md. May 15, 2026) (failure to report claims did not exist under Maryland law and are preempted under Buckman); Chiapello v. Corin USA Ltd., 2024 WL 3548726, at *5 (D. Md. July 23, 2024) (same); Mikos v. Abbott Laboratories, 2021 WL 5416534, at *8 (D. Md. Nov. 18, 2021) (failure to report claims preempted under Buckman).  None of these cases was mentioned, let alone distinguished, in DeToto).

After that, DiToto held that “failure to train” claims were not preempted, citing only Lohr and Bausch, neither of which even involved such claims.  Worse, DiToto did not even discuss whether the FDA imposed any training requirements on users of this device, which seems pretty basic, given the applicable “different from or in addition to” preemption clause.  DiToto viewed such claims as “allegations that . . . Defendants failed to use reasonable care in the sale of their [device].” Id. at *9.  That’s squarely preempted under Riegel, which extended preemption to “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the [device].  552 U.S. at 321 (emphasis added).  See also Walker, 670 F.3d at 580-81 (“common law tort claims based on the failure of devices that were designed, manufactured, and sold in accordance with the terms of their premarket approval [are] preempted under Riegel”) (emphasis added).

DiToto’s parade of errors continues with rulings about fraud, consumer fraud, and negligent misrepresentation.  DiToto lumped all these informationally-based claims together and held them not preempted “because each addresses the manner in which . . . Defendants allegedly marketed and sold the [device].”  That reasoning is bogus for the same reason that the duty to train claim should have been preempted.  Riegel − which DiToto again fails to mention – expressly held that all claims attacking a PMA device’s “design, testing, inspection, distribution, labeling, marketing, and sale” were preempted.  552 U.S. at 321 (emphasis added).  Moreover, the recent Durnell decision doubled down on Riegel holding that the same preemptive language (“in addition to”/”different from”) expressly preempted attacks on the information that the defendant provided with the product.  “Riegel is dispositive here.  If FDA’s premarket approval of medical devices preempted additional state-law requirements, so too must EPA’s registration of pesticides and approval of pesticide labels.”  2026 WL 1425041, at *9.

Continuing with DiToto’s pro-plaintiff hit parade, the plaintiff’s express warranty claim also survived preemption.  To us, this is the only plausible piece of the opinion, because significant precedent, including a Maryland appellate decision, considers voluntary statements beyond anything that the FDA approved not to be subject to preemption.  See DiToto, 2026 WL 1425041, at *10 (citing McCormick v. Medtronic, Inc., 101 A.3d 467, 492 (Md. App. 2014)).  Since Riegel, a lot of purported “express warranty” have been dismissed for a variety of reasons (from preemption to pleading to disclaimer), but the peculiar sales-representative-based statements apparently alleged in DiToto could fall through the cracks.

Last, and probably least, DiToto allowed what looks like an FDCA-based negligence per se claim to survive, again citing only Lohr and Bausch as preemption decisions.  “It is not preempted by §360k.”  2026 WL 1425041, at *11.  The only basis for a negligence per se claim offered in DiToto is the allegation that the device “deviated from the FDA’s premarket approval when it was manufactured.”  Id.  That’s wrong for all the reasons that we discussed above in connection with the manufacturing defect claim (barred by Riegel and Walker; malfunction insufficient to support a violation claim; no facts supporting any particular violation).  But not only that, the negligence per se claim is barred both by implied preemption (which DiToto apparently did not consider) as a private attempt to enforce the FDCA under Buckman, and under Maryland law since negligence per se will not lie where contrary to the intent of the underlying statute.  See Latz v. Parr, 254 A.3d 509, 519 (Md. App. 2021) (“in light of the ‘stated intent,’ we are not persuaded that the legislation was intended to change the common law” in the way that plaintiff’s negligence per se claim would).  In the FDCA, of course, Congress expressly barred private enforcement.  Buckman, 531 U.S. at 352 (“we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government”) (citing 21 U.S.C. §337(a)).  So even if an FDCA-based negligence per se could survive express preemption as a purported “parallel” claim, it neither exists in the first instance under Maryland law, and it would be impliedly preempted under Buckman.

In sum, DiToto relied exclusively on Lohr, which has been entirely superseded in the PMA preemption context by Riegel (and now Durnell), and on Bausch, which is incompatible with the controlling Fourth Circuit Walker decision.  The result is an erroneous mess, which unfortunately now has been amplified by an ill-considered decision to publish DiToto.  Rather than published, DiToto should be reconsidered and vacated under binding preemption precedent.

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Here’s a pop quiz. You’re a nurse. You’ve just used an insulin pen on Patient A. Do you: (a) use the same pen on Patient B or (b) grab Patient B’s own pen? If you picked (a), please put down the syringe, because you have apparently never heard of a little thing called the germ theory of disease, which has been settled science since roughly the era of gas lamps and top hats. And yet, in Griffin Health Services Corp. v. Novo Nordisk Inc., 2026 WL 2140889 (D. Conn. Jul. 24, 2026), the court ruled that a jury needs to debate whether this risk was actually obvious to a hospital and its nursing staff. Spoiler: there was nothing left to debate. The CDC saw it. The FDA saw it. The Institute for Safe Medication Practices saw it. At least one of the hospital’s nurses literally asked the question out loud and got the right answer. Everybody saw it. The only place where this obvious risk somehow became a genuine jury question is in this opinion.

First, the facts. The manufacturer designed and sold prefilled insulin pen products used at the plaintiff hospital’s facility. The hospital’s own competency checklist, that nurses had to master before using the pens, included an instruction to return the pen to the patient’s individual medication drawer — which, if followed, would have prevented sharing altogether. Id. at *1. The manufacturer’s representatives ran five training sessions for the hospital’s nurses, but those sessions were voluntary, not mandatory, and did not reach all nurses. Id. The hospital’s own CEO testified that “strict” adherence to medication administration policy is “not possible” — a stunning admission for an institution now trying to blame someone else for its nurses sharing needles. Id. at *4. And it gets better (worse). When a nurse specifically asked a manufacturer trainer whether the pen could be used on more than one patient — she was told no, they cannot be shared due to the risk of cross-contamination. Id. at *2. So a nurse asked the question. Got the right answer. And some nurses at this hospital shared pens anyway. The hospital’s response to this fact pattern was to sue the pen maker.

Let’s talk about what the plaintiff hospital’s theory actually requires you to believe. It requires you to believe that the manufacturer had a duty to tell trained medical professionals that you should not stick a needle-adjacent device into one patient and then jab it into another. This isn’t esoteric medical knowledge. It’s Infection Control 101. Reusing anything that has touched a patient’s bloodstream on another patient is a bad idea for the same reason double-dipping your chip is rude — except with double-dipping, nobody ends up exposed to hepatitis.

The Centers for Disease Control and Prevention have been sounding this alarm for years in blunt, unambiguous language: “Never use insulin pens for more than one person,” because “blood may be present in the pen after use,” even when the needle is changed between patients. Ctrs. for Disease Control & Prevention, Considerations for Blood Glucose Monitoring and Insulin Administration. The Institute for Safe Medication Practices flagged the exact same cross-contamination risk from insulin pens back in March 2008 — and the court’s own recitation of the record notes that a 1998 study in the journal Diabetes Care had already identified the risk of biological material becoming trapped in insulin pen delivery systems, and the FDA and CDC both issued their own alerts on the subject in 2009 and 2012, respectively. Griffin, 2026 WL 2140889, at *2. In other words, this was published and republished information in the same professional literature that hospitals are supposed to be monitoring as part of, you know, being a hospital.

Despite the obviousness of the risk, the Griffin decision denied summary judgment on nearly everything. On design defect, the court found the insulin pen, like any prescription medical device, is “inherently unsafe,” meaning the manufacturer’s duty is to properly warn of dangers, and held that “a reasonable jury could find that [the hospital] was unaware of any risk, and that [the manufacturer] failed to warn or train users on the dangers of contamination.” Id. at *5-6. Read that again. A hospital. Unaware. Of the risk of cross-infection from reused injection equipment. After the CDC, the FDA, and the Institute for Safe Medication Practices all told anyone paying attention exactly what would happen.

On failure to warn, the court applied Connecticut’s learned intermediary doctrine — sort of. It first found that a genuine dispute existed over whether the manufacturer provided any warnings at all, then hedged by adding that even if the doctrine did apply, plaintiff’s claims were based on failure to warn the hospital itself, in the person of its doctors and nurses, who function as the learned intermediaries. That’s curious given that the evidence was that the manufacturer’s representatives affirmatively told trainees not to share the pens, explained the cross-contamination risk from backflow, and handed out package inserts containing the same warnings. Id. at *6. The court brushed this aside finding there was conflicting record evidence on the point. But that doesn’t change the fact that the underlying legal theory — that manufacturers must anticipate and spell out an infection-control risk this fundamental — should never have survived on the “obviousness” ground alone.

That’s what really bothers us about the design defect and failure-to-warn rulings — the court never squarely grapples with the obvious-risk line of learned intermediary cases that should have controlled this outcome. That line of authority doesn’t just say a warning can be less detailed when a risk is well known — it says there is no duty to warn of a risk at all once it is within the knowledge of, or obvious to, the average learned intermediary. This brings us to the second, equally basic principle the court seems to have simply skipped past. Prescription medical product manufacturers do not have a duty to instruct healthcare professionals on how to practice medicine. We’ve discussed both issues many times, and the caselaw on them is not close. Courts applying the learned intermediary doctrine have rejected, over and over, the argument that a warning must explain to trained professionals things they already know from their training.  Sharing an injection device between patients is precisely the kind of “obvious risk” that this line of cases says a manufacturer has no duty to spell out, because it is “within the knowledge of or obvious to the average learned intermediary.” Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 266-68 (5th Cir. 2002) (see more authority here).

This is not a situation where the manufacturer is asking a court to assume some obscure clinical inference on the physician’s part. The specific, exact risk — cross-contamination and bloodborne pathogen transmission from reusing an injection device on more than one patient — had already been described in the peer-reviewed literature, flagged by multiple healthcare authorities, all before and during the years these pens were in use at the hospital. That is about as close to “universally known in the medical profession” as it gets. If the risk is universally known, the absence of a more explicit warning cannot be the legal cause of the resulting harm — a causation problem the Griffin court does not meaningfully address before sending the design defect and failure-to-warn claims to a jury.

Instead of confronting that body of law head-on, the court treated the “obviousness” of the risk as just another disputed fact for the jury, rather than as the threshold legal question — whether the risk was, as a matter of law, already within the knowledge of the average learned intermediary. A court that takes the obvious-risk doctrine seriously does not need a jury to tell it whether a nurse should already know not to reuse a blood-contaminated injection device on a second patient. That is precisely the kind of case this doctrine exists to take away from the jury, and it is the doctrinal gap that, in our view, is the real defect in this decision — not any close call on the summary judgment record, but the court’s failure to ask the right legal question in the first place.

Then there’s the “wrongful conduct” doctrine — what we usually call in pari delicto — which the manufacturer tried to invoke on the theory that the hospital was profiting from its own violation of drug-sharing statutes. No dice, said the court, because the doctrine only bars recovery for a plaintiff’s knowing participation in a criminal act, and none of the statutes the manufacturer cited actually covered insulin, since insulin is not a controlled substance. Griffin, at *4-5. Fair enough as a matter of statutory construction. But it’s still remarkable that a hospital’s institution-wide failure to enforce its own infection-control basics, gets no legal consequence at all, while the manufacturer that affirmatively told people not to share the pens gets dragged to trial.

If you thought it couldn’t get more galling, the court also let punitive damages go to the jury, reasoning that the manufacturer knew of similar issues at other hospitals. But punitive damages are supposed to punish conduct meaningfully worse than ordinary negligence, and it’s hard to square that with the facts here. Comparative fault isn’t a defense to strict liability, but a jury weighing “reckless disregard” ought to be allowed to reckon honestly with which party actually controlled whether its nurses shared needles day to day. That party wasn’t the manufacturer.

For dessert, the hospital lost roughly 150 completed nurse interview forms from its own internal investigation into the pen-sharing incidents — documents that presumably would have shed considerable light on how widespread and how known the risk was among its own staff. The court declined to draw an adverse inference because there was no evidence the documents were destroyed or altered rather than simply misplaced. Id. at *11-12.  Losing 150 witness statements documenting your own staff’s compliance failures, and then asking the manufacturer to eat the evidentiary consequences of your own paperwork problem is a lot to ask a reasonable jury to swallow.

We opened with a pop quiz, so let’s close with the answer key. Anyone who picks “reuse the pen” flunks basic infection control, whether they’re a first-year nursing student or a hospital defending a summary judgment motion. The germ theory of disease is not proprietary information belonging to medical device manufacturers; it is the shared inheritance of every trained healthcare provider since Pasteur. And a manufacturer that told trainees, in person, not to share its product, does not have an additional obligation to hold the hospital’s hand and make sure the hospital enforces its own policies. There really was nothing to see here, except apparently to the court, which decided a jury still needs to argue about it. Griffin kicks to a jury a question that shouldn’t have needed one— whether a hospital’s failure to train, monitor, and supervise its own nurses on a century-old, thoroughly-alerted infection risk can be laid at a manufacturer’s feet. We would love to see a “reasonable” jury actually buy that. We’re not holding our breath.

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Long ago, it seemed that large-scale drug or device litigation was usually spurred on by a recall, market withdrawal, or major labeling change describing a new risk or limiting the scope of product use.  The plaintiff lawyers these days seem to be more willing to put their energy into attacking currently marketed products without triggering events along these lines.  However, back when the rules on implied preemption for claims about prescription drugs were less settled—generally before the implications of Bartlett and Mensing for branded drugs had been recognized—some courts struggled with how a subsequent voluntary withdrawal from the market affected preemption and, more generally, product liability.  We detailed some of this in a long post about the Yates decision from the Sixth Circuit on the preemption of design defect claims as to a branded prescription drug.  Regardless of any recall, the temporal focus for whether failure to warn and design defect claims are preempted is not at some point in time after plaintiff stopped using the prescription drug.  Yet, there has been a tendency for some courts to get squeamish about the idea that a manufacturer can be “immune to” or “insulated from” liability if the drug is off the market by the time the motions are being decided.

Cosey v. Global Blood Therapeutics, Inc., No. 1:25-CV-09400, 2026 WL 2150348 (N.D. Ill. July 27, 2026), is a case where the court did the right thing on preemption despite a short time between plaintiff’s alleged injury from the drug and the decision by the manufacturer to withdraw it from the market.  The drug at issue in Cosey was, at the time of the use, one of the few approved medications (including gene therapy) available to treat sickle cell disease, a serious and potentially fatal genetic disorder.  One of the known significant complications of the disease is a vaso-occlusive crisis (“VOCs”) where deformed hemoglobin molecules in red blood cells lead to a blockage of blood flow in small vessels.  Plaintiff’s minor was first prescribed defendant’s medication for her sickle cell disease in January 2022, not very long after the medication was approved and had its indication expanded to cover use by younger children.  Id. at *1-2.  After more than two years of apparently safe and effective use, plaintiff’s minor allegedly suffered a VOC.  Within four months, on September 25, 2024, the manufacturer voluntarily withdrew the drug based on a possible increased risk of VOCs.  The Cosey decision identifies the basis of this decision as “the totality of the clinical data that indicated the overall benefit of [the drug] did not outweigh the risk in the approved sickle cell patient population [and the] data suggested occurrence of VOCs and fatal events that required further assessment.”  Id. at *1.  FDA’s website from which the court’s language appears to have been drawn adds that an increased risk of VOCs had been reported in postmarketing clinical trials.  Despite her VOC, plaintiff’s minor apparently kept taking the medication until the market withdrawal.  Relying in part on the tight timing, plaintiff sued the manufacturer and another entity and asserted the predictable product liability claims.  Predictably, the defendants moved to dismiss based on implied preemption and TwIqbal.

On the design defect claim, plaintiff argued that the manufacturer could have come up with a hypothetical safer drug and tried to get it approved instead of the drug it actually developed and got approved.  Citing only Bartlett, Cosey found this claim impliedly preempted.  Whether pre-approval or post-approval, “altering its composition” would not have resulted in a marketable drug without FDA approving the new drug.  So, there was no unilateral action that the defendants could take to sell a non-defective drug.  Id. at *3.  As far as we can tell, plaintiff did not argue explicitly that the recall negated preemption of the design defect claim, but the design defect allegations were not much more than the manufacturer’s statements in connection with the withdrawal.  Either way, this claim was dismissed with prejudice.

On failure to warn, which the court addressed along with express and implied warranty, Cosey took a deeper dive, citing the CBE regulations, Albrecht, Dolin, and some other decisions explaining that plaintiff has to do more than just say “CBE” to avoid implied preemption (as Levine misunderstood).  The complaint did not identify “‘newly acquired information’ that would have permitted unilateral modification to [the drug’s] label under the CBE regulation.”  Id. at *5.  The court was not fooled by plaintiff’s citation of the evidence the manufacturer said was new a few months after plaintiff’s alleged injury when it decided to withdraw the drug.  Nor were general allegations that there must have been something earlier sufficient. 

Plaintiff’s conclusory allegations that Defendants possessed “newly acquired information” about risks of [the drug], without identifying what that “newly acquired information” was or how it demonstrated a risk of a different type or greater severity than what the FDA already considered, does not suffice to undermine preemption. Since Plaintiff failed to identify any newly acquired information that shows Defendants were aware of an increased VOC risk, with sufficient time to initiate a label change before they withdrew the product, Plaintiff’s failure-to-warn claims fail.

Id. (emphasis added).  We pause on the italicized language to flag an issue that matters more in individual cases than in litigation-wide preemption motions.  Even where a CBE actually can be used to make a label change unilaterally, albeit temporarily, it still takes time.  We have seen cases where the allegedly newly acquired information that a plaintiff says should have led to a new warning was acquired a day or two before the last pre-injury prescription of the medication.  Under Cosey’s reasoning, the plaintiff would have to show the labeling change could have been effectuated in time for the prescribing physician to see it while it still could have affected the outcome alleged in the case. 

Plaintiff also included the sort of generalized negligence claim that is common in product liability cases, but typically does not implicate recognized duties to do more than design, manufacture, and warn about the product.  It appears that plaintiff did not actually contend there was some manufacturing issue specific to the pills that his minor took.  Instead, this was just a rehash of design and warnings claims the court already addressed.  Citing the Seventh Circuit’s Wagner decision we discussed here and here, the court found these repackaged claims preempted for the same reasons.

“For purposes of completeness,” Cosey also addressed what it called defendants’ argument that the warnings claims “are also preempted based on the learned intermediary doctrine.”  Id.  This, of course, is not a thing.  In Illinois, as in almost all states, the learned intermediary doctrine defines the duty to warn for the manufacturer of a prescription medical product.  The court’s conclusion that “Plaintiff cannot argue that, if properly warned, her physician would have altered her prescription, where her allegations make no mention of her physician at all” describes a failure to plead the elements of a state law claim consistent with TwIqbal.  Id. at *6.  In that context, it makes a bit more sense to give plaintiff another chance to plead a cognizable, non-preempted warnings claim.  Even if plaintiff uses the extra time the court gave him to amend to mention the prescribing physician by name, we doubt he can come up with factual allegations of newly acquired evidence from the right time period to avoid preemption of his warnings claims.

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Franco v. Chobani, LLC, 2026 WL 2150193 (7th Cir. July 27, 2026), is a food case, not a drug or device case, but it is vital reading for anyone who litigates over products regulated by the Food and Drug Administration (FDA).  In litigation involving regulated products, the fact of such regulation is usually a component of the defense. We defense hacks invoke regulatory compliance as both bona fides and bodyguards. We (and our clients) rely on what regulations say, and what regulators say about those regulations. 

Sometimes such reliance is misplaced.

Preemption is the apotheosis of a regulatory defense.  The recent SCOTUS opinion in the Roundup litigation (Durnell) explained the fundamental policy bases of regulatory preemption: consistency and uniformity. Companies making products that improve and extend our lives simply cannot carry on their business if they must conform to different, perhaps contradictory, rules set within different jurisdictions, and maybe even set by different juries within the same jurisdiction.  Moreover, whereas rule by regulation is driven by data, science, and experts, rule by litigation is driven by trial lawyer storytelling, cynicism, and faux morality tales of corporations elevating “dollars over lives.” Regulation balances risks and benefits; jury trials are crazy-quilt lotteries. Regulation imposes order; litigation exploits chaos. 

But what if the regulation succumbs to chaos? Franco is a festival of disillusionment.  This adverse decision by the Seventh Circuit in a food preemption case is more proof, if any was needed, that with the FDA under the control of a plaintiffs’ lawyer, the FDA is about as reliable as the Phillies bullpen.  The plaintiffs brought consumer deception claims on behalf of themselves and a putative class against Chobani over its “Zero Sugar” yogurt.  The plaintiffs alleged that they purchased the product advertised as “sugar free,” though it contained four grams per serving of allulose, a monosaccharide sweetener. The plaintiffs sought relief under various state consumer protection statutes. The district court dismissed the complaint under Rule 12(b)(6), deferring to FDA enforcement guidance and holding that the claims were preempted.

The plaintiffs appealed the ruling to the Seventh Circuit. The central issue was whether allulose is a “sugar” under 21 C.F.R. § 101.9(c)(6)(ii), which defines “total sugars” as “the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose).” Allulose is a “novel” sugar that differs from the not-so-novel sugars in terms of how it is metabolized and how it affects dental caries. Somewhere along the way, the FDA realized that its regulatory definition of “total sugar” (issued more than 30 years ago) had become outdated, given advances in materials science.  The FDA had in 2016 anticipated “future rulemaking” (that never occurred) to remove allulose from the definition of “total sugar” because it did not have the adverse physiological effects associated with ordinary sugars.  Rather than commence that rulemaking, in response to a citizen’s petition, in 2020 the FDA issued an allulose “guidance” that it would exercise “enforcement discretion” against prosecuting omission of this specific sugar from the declared quantities of total sugars.  That guidance was relied upon by the manufacturer in drafting the Nutrition Facts panel. It was also relied upon by the district court when it granted the motion to dismiss the Franco case.

During appellate oral argument, “both parties agreed that seeking the FDA’s perspective in this case would be helpful.” Given the regulatory history, especially the allulose guidance, one could see why the defendant would expect some help from the FDA in this case. But then the FDA filed an amicus brief and took the position that section 101.9(c)(6)(ii) was unambiguous and that total sugars as defined in that regulation included all monosaccharides, such as allulose. Talk about a reversal of fortunes! The district court had read section 101.9 to be ambiguous, and then deferred under Auer to the FDA’s Allulose 2020 guidance. (Chevron deference to an agency’s interpretation of statutes might be dead, but Auer deference to an agency’s definition of its regulations is not dead – yet.) But the FDA’s reversal of position led to the Seventh Circuit’s reversal of the district court. Relying on the regulation’s text and finding the FDA’s position in its amicus brief persuasive under Skidmore, the Seventh Circuit court concluded the sugar definition unambiguously includes all monosaccharides, and thus allulose is a sugar. Because foods labeled “sugar free” must contain less than 0.5 grams of sugars as defined by § 101.9(c)(6)(ii), the plaintiffs’ state-law claims, which mirror federal requirements, were not preempted. The court rejected the district court’s Auer deference to the FDA’s 2020 allulose guidance, characterizing it as enforcement discretion rather than a binding interpretation.

That last point is particularly disturbing. So much for settled expectations. The FDA took the position that its 2020 allulose guidance did not have the force of law, and therefore could not be considered preemptive.  The Seventh Circuit agreed.  Under the preemption requirements imposed by the Supreme Court in Albrecht, that may well be legally correct, but the independent preemptive effect of FDA enforcement discretion is nowhere mentioned.  For our purposes, the broader take away is that the RFK, Jr FDA can no longer be trusted to stand up for its actions when those actions would have supplied the bona fides and bodyguards referred to above.  According to the Seventh Circuit, the FDA allulose guidance was not a regulatory interpretation but merely “an announcement of the agency’s enforcement position.” The guidance was of no weight because it was not an agency “official position.” 

What about the defendant’s reliance interest?  The Seventh Circuit essentially said, tough. FDA regulated manufacturers are “sophisticated actors” that understand how mere FDA enforcement decisions “would not immunize the company” from product liability litigation.  To quote from another rotten ending, “Forget it Jake, it’s Chinatown.” Thus, regulated parties can no longer be content with ad hoc, FDA half-measures to resolve disputes, and should press for actual, legally binding regulatory changes.  Non-binding “guidance” is not enough, when the FDA can cut and run when called upon to give its views in litigation.  The less we say about the current FDA’s muddle-headedness’ and malevolent motives, the better.

Beyond that, the Seventh Circuit was content to allow a parenthetical – the “(such as glucose, fructose, lactose, and sucrose)” — in the original regulation to become a “redundancy” in light of the FDA’s position.  For the second week in a row, we consider a case involving the interpretation canon of noscitur a sociis. The notion of that canon is that a word is known by the company it keeps. Allulose is different in important ways from the sugars specified in the regulation. But the Seventh Circuit thought the defendant was making the “such as” do too much work.   

Our disappointment and indignation cannot surpass what was eloquently expressed in a recent article by Cory Andrews at the Washington Legal Foundation, “Guidance for Thee, But Not for Me: The FDA’s Bait-and-Switch in Franco v. Chobani.” (Link here.) Here is the conclusion of that article: “Franco tells every regulated business in the Seventh Circuit that FDA guidance is not a shield but a trap, and that the only safe course is to demand formal rulemaking the agency rarely and begrudgingly delivers. That is bad administrative law and bad policy.” At least one can always rely on WLF to get things right. Consistency and logic go a long way.

Addressing the defendant’s alternative Rule 12(b)(6) argument, the Seventh Circuit held that the complaint plausibly alleged consumer deception. The labels allegedly promised “sugar free” despite four grams per serving of allulose, and the court found it plausible that reasonable consumers could be misled by the absolute “sugar free” claim. Forget about whether allulose would not implicate any of the physiological effects that make consumers fret about the other sugars. The court held that “how reasonable consumers perceive Chobani’s labels and make decisions about its products are questions of fact that cannot be answered now.” Hello, discovery.

The only good thing about the decision is that the defendant gets to try again on different preemption grounds, based on the effect of FDA labeling approval after Durnell.   

The result in Franco is certainly bitter, not sweet. We remember when one could rely on the Seventh Circuit. (Okay, forget about Bausch for the moment. Let us momentarily wallow in our University of Chicago nostalgia over Posner, Easterbrook, and Wood.) We also remember when one could rely on the FDA.

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The California Supreme Court handed down its long-awaited decision in Gilead Tenofovir Cases yesterday, and as we hoped, the Court held that a drug manufacturer owes no duty of care when deciding whether and when to develop an allegedly safer alternative drug to replace an admittedly non-defective product.  The decision is a significant win for the pharmaceutical industry, and it puts an end to the novel “duty to innovate” theory of negligence liability that had been percolating in the lower courts.

And, yes, we can all agree now that prescription medications are not the same as chicken enchiladas, but put a pin in that.  We will come back to it later. 

We have been covering this litigation in California (here, here, here, and here) and elsewhere (e.g., here) for many years, and to provide the briefest of recaps, the plaintiffs in these cases allege injuries from taking TDF-based HIV antiretroviral medications.  They concede, however, that their TDF meds are not defective.  They allege instead that the manufacturer unreasonably delayed developing an alternative that plaintiffs allege was safer—TAF-based medications.  According to these plaintiffs, the manufacturer owed a duty to bring a different, allegedly safer medicine to market soon than it actually did.

The Court of Appeal bought it and created a newly minted tort—negligence based on a duty to innovate—in an opinion that we roundly criticized and named the worst drug and medical device opinion of 2024.  And deservedly so.  No court had ever recognized a tort duty to develop an alternative medicine faster, and imposing that duty would both impair innovation and punish a company for selling a non-defective product that saved thousands of lives.

The Supreme Court has now reversed, and its majority opinion acknowledges fully that the Court of Appeal’s new duty departed from existing California law in multiple ways and that the new duty was entirely unworkable.  Gilead Tenofovir Cases, No. S283862, 2026 WL 2223748 (Cal. Aug. 3, 2026) (slip op.) (to be published).

The Supreme Court first cast substantial doubt on whether a plaintiff can ever prevail in a product liability lawsuit (negligence or strict liability) without proving a product defect.  Generally speaking, the answer should be “no.”  The plaintiffs here argued that everyone is subject to a duty to avoid unreasonably causing harm to others.  But the Supreme Court explained that in the product liability context, the scope of any duty is limited to selling non-defective products:

In the products liability context, our decisions have generally defined a manufacturer’s duty under [California law] as the duty to design, manufacture, and market products that are free from defects.  Recognizing a broader duty under which liability may arise even absent a defect in the injury-producing product would create substantial tension with that body of law.

Id. at p.14-15.  That tension is because product liability law provides specific tests to determine whether a product is defective, and those standards both define potential liability and provide meaningful constraints.  The plaintiffs’ theory runs against this settled law: 

Plaintiffs’ theory risks circumventing these settled principles.  If manufacturers owed a broader duty to act reasonably to avoid all product-related injuries, plaintiffs could seek recovery for harms caused by concededly nondefective products merely by alleging the manufacturer acted unreasonably.  Questions currently governed by established defect tests would instead be left to a fact finder’s generalized assessment of reasonableness.

This problem is especially acute in the context of prescription drug development. 

Id. at p.15.  Echoing the defendant and multiple amici, the Supreme Court explained that an unconstrained negligence standard would invite juries to second-guess complex research and development decisions made decades ago under conditions of scientific uncertainty and incomplete information.  The contrast with established product liability principles was sharp.  “[P]roduct defect claims . . . are evaluated based on contemporaneous and relatively complete scientific evidence available at the time of the product’s distribution.”  The claims these plaintiffs asserted, by contrast, “would require retrospective assessment of inherently provisional judgments based on evolving scientific data.”  Id. at p.16.  In other words, products must be defective at the time of sale, not at some uncertain earlier time when their risks and benefits are still being researched.

The Court of Appeal’s attempt to deal with these factors resulted in an ineffective and unworkable standard.  The Court of Appeal pegged its new duty to whether an alternate product had already been “invented or developed,” but those terms were “ambiguous and, for that reason, are unlikely to act as meaningful constraints in practice.”  Id.  The Supreme Court was particularly critical of the Court of Appeal’s requirement that the manufacturer “know” the alternate medicine to be safer and equally as effective because

that conclusion rests on a flawed premise: namely, that a drug can be sufficiently developed, and its safety and efficacy sufficiently known, before completion of phase III clinical trials and FDA approval.  . . . It also underscores the difficulty of imposing negligence liability based on preliminary and evolving safety assessments of an alternative drug still under development, rather than on a defect in the drug currently being sold.

Id. at p.17.  The Court of Appeal’s “knowledge requirement” was essentially unattainable.  Moreover, in a passage that was particularly satisfying for us, the Supreme Court faulted the Court of Appeal for comparing life-saving medications to a chicken enchilada with a stray chicken bone.  (See title of our post on the Court of Appeal’s opinion.)  As the Supreme Court held, “That context is far removed from prescription-drug development.”  Id. at p.20.  We agree. 

Here is the quote you will want to come back to:

For these reasons, we have substantial doubt that California law recognizes a general negligence duty requiring drug manufacturers to act reasonably in making drug development and commercialization decisions apart from their established duty to design, manufacture, and market products free from defects.  Products liability law has long tied a manufacturer’s duty of care to defects in the product placed into the stream of commerce, and plaintiffs identify no clear limiting principle for imposing liability absent proof of a product defect.

Id. at p. 20.  Expressing “substantial doubt” may not be a definitive holding, but this is the California Supreme Court.  Lower courts and federal courts making Erie predictions should pay heed.

In the end, the Supreme Court held that regardless of whether manufacturers could owe some duty beyond selling non-defective products, California tort law did not support creating the Court of Appeal’s duty to innovate in any event.  That the product was an FDA-approved prescription medicine was key.  Applying the factors enumerated in Rowland v. Christian, 69 Cal.2d 108 (1968), the Supreme Court held that the defendant owed no duty to develop and commercialize the alternate products—TAF-based medications—earlier than it actually did. 

In Rowland, the Supreme Court identified considerations governing duties of care—grouped into foreseeability factors and public policy factors.  The foreseeability factors weighed heavily against the plaintiffs’ proposed duty.  Almost any harm can be described as “foreseeable” in hindsight.  The question is whether the harm was reasonably foreseeable to the manufacturer at the time it was developing the alternate product.  As the Court already explained, the nature of drug development and the regulatory process make it difficult to establish what a manufacturer “knew,” let alone what it foresaw or should have foreseen:

Because a manufacturer cannot truly know of a drug’s safety and efficacy before phase III testing and FDA approval, it cannot reasonably foresee early in the development process that any delay in commercializing an alternative drug will harm users of an existing one.

Gilead, slip op. at p.26.  The Supreme Court also found that any connection between the alleged delay and the alleged injuries was “highly attenuated.”  Any such injury would depend on speculation regarding multiple independent third parties, including healthcare providers and regulators.  The connection would also depend on medical causation and uncertain outcomes of additional clinical trials.

The public policy factors likewise weighed against creating the new duty.  Here, we will emphasize two points.  First, while the Court of Appeal was quick to find the defendant “morally blameworthy” for allegedly delaying development of TAF-based drugs in order to increase profits, the Supreme Court took a more balanced view.  In deciding whether to continue developing an alternative medicine, a pharma manufacturer might consider profits, but that may be only one of several factors.  Plus, equating profit motive to moral blameworthiness would apply to “virtually every negligence action brought against a business,” which is not California law.  Id. at p.35. 

Second, the Court of Appeal’s duty to innovate would not prevent future harm, and might even contribute to harm by discouraging innovation.  As the Supreme Court explained:

Perhaps more importantly, such a duty risks creating perverse incentives that may undermine, rather than advance the goal of preventing future harm.  Decisions regarding whether to continue developing a promising drug, how quickly to advance it through clinical trials, and how to allocate finite research and development resources are inherently complex.  . . . [A] duty to develop and commercialize, without undue delay, a potentially safer alternative to a nondefective drug could distort those decisions . . . .

Id. at p.37-38.  A manufacturer could conclude, for example, that investing in development of alternative drugs is necessary to reduce litigation risk, while research into entirely new therapies carries no comparable incentive.  Early clinical studies could be curtailed for fear that study results could create a new class of tort plaintiffs.  The Supreme Court previously held in Brown v. Superior Court that tort law should encourage research into potentially beneficial medications, not discourage it.  The plaintiffs argued that these concerns are overblown and that juries can figure out whether these kinds of development decisions are reasonable or not.  But “[n]either the plaintiffs nor the dissent have identified a single case wherein a fact finder has been tasked with making such determinations.”  Id. at p.40-41. 

Much of the debate leading up to oral argument was around whether the Court of Appeal’s new duty would adversely impact innovation.  The Supreme Court recognized that risk, and not necessarily only in the pharmaceutical industry.  As the Court held,

For the reasons explained above, the duty threatens to skew innovation priorities in a manner that does not advance—and may ultimately undermine—public health and safety.  [¶]  Moreover, plaintiffs provide no legal basis for confining their theory of liability to the pharmaceutical industry.

Id. at p.44.  The Supreme Court reversed the Court of Appeal and remanded for entry of summary judgment for the defendant on all causes of action.

The Supreme Court’s opinion effectively shuts the door on the “duty to innovate” theory in California, and that is the correct outcome.  There was a dissenting opinion, from the one justice who clearly signaled alignment with plaintiffs during oral argument.  That justice broadly accused the Court of providing “sweeping immunity” for pharmaceutical manufacturers, but nothing could be further from the truth.  As we have said all along, the Court of Appeal’s new duty was completely gratuitous.  Patients taking TDF-based medicines have tort remedies against the product manufacturer—provided they can prove the elements of a product liability claim under California law, including the presence of a product defect. 

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