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New York’s consumer protection statute (N.Y. Gen. Business Law §§349-50) has a “consumer orientation” element that has largely prevented that enactment from being abused by P-side purveyors of prescription medical product class actions.  We’re looking at how that works today.

The New York Court of Appeals held that, “as a threshold matter, plaintiffs claiming the benefit of section 349 . . . must charge conduct of the defendant that is consumer-oriented.”  Oswego Laborers’ Local 214 Pension Fund, 647 N.E.2d 741, 744 (N.Y. 1995).  The “standard of recovery” for §350, limited to “false advertising,” “is otherwise identical” to §349.  Goshen v. Mutual Life Insurance Co., 774 N.E.2d 1190, 1195 n.1 (N.Y. 2002).  Thus, “[t]o successfully assert a claim under . . . §349(h) or §350, a plaintiff must allege that a defendant has engaged in . . . consumer-oriented conduct.”  Koch v. Acker, Merrall & Condit Co., 967 N.E.2d 675, 675 (N.Y. 2012) (citation and quotation marks omitted) (per curiam).  To be considered “consumer-oriented” for purposes of the statute, conduct must “have a broad impact on consumers at large.” New York University v. Continental Insurance Co., 662 N.E.2d 763, 770 (N.Y. 1995).  Thus, purely “[p]rivate . . . disputes, unique to the parties, for example, [do] not fall within the ambit of the statute.”  Id. (quoting Oswego Laborers’, supra).

This “consumer oriented” requirement has significant consequences in prescription medical product liability litigation.  An appellate New York decision, Wholey v. Amgen, Inc., 86 N.Y.S.3d 16 (N.Y. App. Div. 2018), construed that element in prescription medical product-related litigation, declaring that “the generally alleged deceptive practice of failing to provide adequate warnings by concealing information is, as a matter of law, not a practice directed at consumers.”  Id. at 17-18.

Wholey referenced the discussion in Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 173-74 (W.D.N.Y. 2014), a “useful” decision that we originally blogged about here.  After quoting the Oswego Laborers’ holding, Amos recognized that consumer protection claims against a prescription drug fail as a matter of law, since under New York’s learned intermediary rule, purportedly inadequate drug information was directed solely to physicians.  That’s important because patients are the statute’s “consumers,” whereas the learned intermediary rule directs warnings to physicians – who are not “consumers”:

[P]laintiff alleges that the defendants deceived consumers by concealing information about the dangers of taking [the drug], and that [the decedent] died as a result of the defendants deceptive practices.  I find, however, that because a drug manufacturer’s duty to warn of a drug’s side effects runs to the doctor prescribing the drug, and not to the user of the drug, the issuance of drug warnings, for purposes of Section 349, is not an act directed at consumers, and therefore any alleged deceptive act related to the issuance of those warnings is not a “consumer oriented” act actionable under Section 349.

Amos, 28 F. Supp.3d at 173 (emphasis added).  New York’s consumer fraud statute requires “conduct of the defendant that is “consumer-oriented.”  Id. (quoting Oswego Laborers’).  But under the learned intermediary rule, “a manufacturer’s duty to warn extends to a patient’s doctor” and “not to the patient himself.”  Id. (citation omitted).

Accordingly, because the defendants’ alleged deceptive practice of failing to provide adequate warnings by concealing information is not, as a matter of law, a practice directed at consumers, plaintiff has failed to allege a consumer-oriented practice cognizable under Section 349.

Id. at 173-74.  Thus, the New York consumer plaintiff in Amos could pursue product liability, but not consumer protection, claims.  Id. at 174.

This requirement of New York’s consumer protection statute has precluded numerous claims by product liability plaintiffs.  The learned intermediary rule precluded any “consumer-oriented” conduct from existing in Zottola v. Eisai, Inc., 564 F. Supp.3d 302 (S.D.N.Y. 2021).  Plaintiffs alleged no more than  “deceptive, unfair, and misleading acts and practices” through misrepresentations to physicians about the safety of a drug.  Id. at 311.

But under the “informed intermediary” doctrine, it was the duty of doctors − not Defendants − to disclose the Medications’ cancer risks to patients, i.e., consumers.  Accordingly, and as a matter of law, Defendants’ alleged deception by failing to disclose the Medications’ . . . risks was not “consumer-oriented” conduct.

Id. (citations omitted).  Plaintiff’s attempt to avoid the learned intermediary rule failed in Zottola:

Plaintiff counters that it is “wrong” to apply the “informed intermediary” doctrine here, because [defendant’s drug] was not a “life-saving medication,” and instead, was “more akin to a consumer product.”  But Plaintiff’s purported exception to the “informed intermediary” doctrine for non-lifesaving medications fails for two reasons. . . .  Second, the nature of the drug is irrelevant to the Court’s analysis, because what matters is whether Defendants’ conduct was consumer-oriented − not whether the Medications themselves were.  As the “informed intermediary” doctrine makes clear, Defendants’ alleged conduct here, i.e., “[t]he generally alleged deceptive practice of failing to provide adequate warnings [for a prescription drug] by concealing information is, as a matter of law, not a practice directed at consumers.”  Accordingly, Plaintiff fails to plausibly allege that Defendants’ conduct was “consumer-oriented.”

Id. at 311-12 (quoting Wholey, supra).  See Buoniello v. Ethicon Women’s Health & Urology, 2022 WL 17784995, at *14 (E.D.N.Y. Aug. 18, 2022) (“materials [that] are intended to be used by the physician . . . are in no way directed at the consumer”); Dupere v. Ethicon, Inc., 2022 WL 523604, at *8 (S.D.N.Y. Feb. 22, 2022) (failing to allege any “misleading consumer-facing statement regarding [the device]” precluded consumer protection claim); Frei v. Taro Pharmaceuticals U.S.A., Inc., 443 F. Supp.3d 456, 470 (S.D.N.Y. 2020) (quoting and following Amos), aff’d, 844 F. Appx. 444 (2d Cir. 2021); Green v. Covidien LP, 2019 WL 4142480, at *9 (S.D.N.Y. Aug. 30, 2019) (dismissing allegations that did “not quote or attach any consumer-oriented marketing material” concerning prescription-only device); Richards v. Johnson & Johnson, Inc., 2018 WL 2976002, at *9 (N.D.N.Y. June 12, 2018) (action dismissed where plaintiff “has not identified a specific advertisement” that was “directed and available to the public at large”); Aston v. Johnson & Johnson, 248 F. Supp.3d 43, 57 (D.D.C. 2017) (following Amos) (applying New York law); In re Rezulin Products Liability Litigation, 392 F. Supp.2d 597, 613 (S.D.N.Y. 2005) (third-party payors could not recover for alleged safety misrepresentations because “the nature of this marketing effort − communication from one sophisticated business to another − was quite different from that of any promotion aimed directly at . . . patients”).

Poulin v. Boston Scientific Corp., 2022 WL 18215865 (Mag. W.D.N.Y. Dec. 9, 2022), adopted, 2023 WL 146069 (W.D.N.Y. Jan. 9, 2023), applied a slightly different reasoning to reach the same result.  The Poulin plaintiff’s  run-of-the-mill product liability claims could not support a New York consumer protection claims because, to be “consumer-oriented,” the allegations must assert “injury . . . to the public generally as distinguished from the plaintiff alone.”  Id. at *10 (citation and quotation marks omitted).

In the instant case, the allegations in the Amended Complaint fall short of alleging Defendant’s marketing of the [device] engaged in consumer-oriented conduct because there are no allegations, even broadly construed, showing Defendant engaged in any conduct having a broader impact on consumers at large.

Id. (citation omitted).  Similarly, the personal injury plaintiff in Scism v. Ethicon, Inc., 2020 WL 1245349 (N.D.N.Y. March 16, 2020), was “not a consumer in the sense that New York contemplates” because “[t]he physician ultimately makes the call as to which products he or she uses,” and plaintiff “did not make those choices.  Id. at *8.  Thus, “a medical warning is not an act directed at consumers, but is instead directed at the prescribing physician” (quoting Amos, supra). See Pfizer, Inc. v. Stryker Corp., 2003 WL 21660339, at *4 (S.D.N.Y. Jul.15, 2003) (“Although consumers eventually stood to be affected by any defects in the product at issue, the questions whether [seller] told [buyer] the truth when it represented that the business was in compliance with law . . . are essentially private matters.”).

Also outside the scope of “consumer-oriented” conduct are allegations “that Defendants concealed information or deceived the FDA.”  Dains v. Bayer HealthCare LLC, 2022 WL 16572021, at *9 (N.D.N.Y. Nov. 1, 2022); accord Gale v. Smith & Nephew, Inc., 989 F. Supp.2d 243, 250 (S.D.N.Y. 2013) (“Plaintiff alleges [defendant] deceived the FDA, but he does not explain how this allegedly improper conduct was ‘consumer-oriented.’”) (citation omitted).

Finally, in Vitolo v. Mentor H/S, Inc., 426 F. Supp. 2d 28, 34 (E.D.N.Y. 2006), aff’d, 213 F. Appx. 16 (2d Cir. 2007), a physician’s action against a medical device manufacturer for alleged reputational and other damages caused by his use of that purportedly defective product was held not “consumer-oriented” as a matter of law.  Id. at 33-34.

What kind of information is within the scope of the statute’s “consumer orientation” element?  We don’t do the other side’s research for them, but the kind of product-related information that could be “consumer-oriented” (but held to be non-causal) would be like the “brochure” and “website” “assumed” to meet that standard in Tears v. Boston Scientific Corp., 344 F. Supp.3d 500, 516 (S.D.N.Y. 2018).

Thus, the New York statute’s well-recognized consumer-orientation element renders it generally inapplicable to prescription-only medical products.  Most information about such products is designed for physicians, not end-user consumer/patients, as per the learned intermediary rule.  Unless plaintiffs are asserting something along the lines of DTC advertising, and can plead plaintiff-specific causation from such advertising, the New York statute should not be an available cause of action.

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Today’s decision is not from a drug or device case but raises an interesting MDL procedural issue we see from time to time:  Plaintiffs trying to jump the queue and avoid the MDL process. In re Paraquat Prods. Liab. Litig., No. 3:23-pq-02887, 2025 U.S. Dist. LEXIS 12392 (S.D. Ill. Jan. 23, 2025).

Continue Reading No Jumping the Queue in Paraquat MDL
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Like the radio stations of yore did with songs, we offer up two related posts back-to-back instead of the usual one.  We cannot offer a “favorite artist” as the source of consecutive songs, we offer two posts that relate to the legal implications of some of the typical things that FDA does and has been doing for quite some time.  As we and others have noted, the possibility of a decidedly atypical Secretary of HHS raised a specter that it may not be business as usual at FDA much longer.  For those of us whose legal practice focuses on cases related to FDA-regulated products, we cannot help but consider the impacts on litigation, both in terms of the kind of cases that get brought and how courts treat them.  (Our unwieldy double title above also makes us think about episode titles for the old Rocky & Bullwinkle show.)

First up is a little ditty called “Express Preemption Based on an OTC Drug Monograph.”  Over the years, we have written many posts on over-the-counter drugs and the express preemption provisions of 21 U.S.C. § 379r.  As a brief recap, that portion of the FDCA has an even stronger express preemption provision than others because it also covers state requirements that are “otherwise not identical with” federal requirements, but it does not apply to product liability claims.  The reality, though, is that plaintiff lawyers do not always push product liability claims in litigation they manufacture over these products largely because product liability claims almost always require physical, not merely subclinical or economic, injuries and class actions for physical injuries tend not to get certified.  (Product liability class actions for “no injuries” also tend not to get certified and many consumer protection statutes do not cover physical injuries from products.)  That means the preferred vehicle for plaintiff lawyers to bring cases against the manufacturers of OTC drugs is a proposed class action for economic damages based on a range of non-product liability theories, which they try to frame to avoid express preemption.  Also, consistent with a relatively recent trend we have seen for prescription drugs and devices, the assertions often seem to focus on risks allegedly posed by some contaminant, additive, or trace degradation product even though those risks did not lead to any physician injuries for which compensation is sought.  That is quite a tricky little dance based on scare tactics.

Many of the commonly used OTC products that are regulated as drugs based on their active ingredients are not products that many consumers may view as drugs, such as sunscreen and toothpaste.  Therapeutic or medicated shampoos, by contrast, sound more like OTC drugs, which they are depending on the active ingredient.  Eisman v. Johnson & Johnson Consumer, Inc., No. 2:24-cv-01982-ODW (AJRx), 2025 U.S. Dist. LEXIS 9493 (C.D. Cal. Jan. 17, 2025), addresses a motion to dismiss on preemption as to a proposed class of uninjured purchasers of two particular therapeutic shampoos with Coal Tar as the active ingredient.  The alleged issue was the presence of benzene in the Coal Tar, which was not disclosed in labeling that complied with the FDA’s monograph on therapeutic shampoos containing Coal Tar.  Alleged contamination by benzene has popped up in a number of the OTC cases we have seen recently, like in acne medications here and sunscreen here, but Eisman is a little different in that Coal Tar naturally has thousands of chemical compounds in it and benzene has been known for more than four decades (based on the decision itself) to be one of those.  So, it seemed likely that Eisman would join the list of proposed OTC class actions dismissed early on based on express preemption.  See here, here, here, and here, among many more.  Even though it was brought under California law and decided by a California federal court, Eisman did not disappoint.

After starting with a recap about the breadth of express preemption under § 379r, Eisman looked at the many requirements for active ingredients, labeling, etc., under the monograph for the control of dandruff, seborrheic dermatitis, and psoriasis under 21 C.F.R. §358.701 et seq.  2025 U.S. Dist. LEXIS 9493, *5-8.  Plaintiff’s broad allegations fit generally into the categories of 1) alleged omissions about benzene from product labeling and 2) alleged adulteration or misbranding based on the undisclosed presence of benzene in the products.  Any liability imposed under any of plaintiff’s theories would have imposed a requirement that was “different from or in addition to, or that is otherwise not identical with” the FDA requirements, which clearly did not require any disclosures about what makes up Coal Tar.  Id. at *9-10.  In this context, benzene was not an ingredient that should have been on the labeling, because it was not a “purposefully added component of the drug.”  Id. at *11.  Plaintiff’s allegations that the products needed to have benzene removed so that they were not considered adulterated was “fundamentally as odds with the FDA’s monograph.”  Id. at *12 (citing Howard v. Alchemee, LLC, No. 2:24-cv-01834-SB (BFMc), 2024 U.S. Dist. LEXIS 169359 (C.D. Cal. Sept. 19, 2024), which we discussed here).  Because the monograph was approved, FDA was clearly aware of the presence of small amounts of benzene in the Coal Tar and still “approved OTC Coal Tar drug products as generally safe and effective, and not adulterated, with the understanding that they would contain some level of benzene.” Id. at *13.  That meant all of plaintiff’s claims were expressly preempted.  The court also wisely denied leave to amend because it would have been futile.

That was all pretty straightforward and, from our perspective, correct.  The going-forward concern is that challenges to FDA decisions on the safety and efficacy of a product or category of products, including decisions that have remained unchanged for decades, will not be viewed as a hard stop should those decisions start getting reversed based on, shall we say, re-thinking of established science.  Even though the focus in a proper preemption analysis will be on what the manufacturer could have done in the past—in Eisman, the plaintiff bought the monograph-compliant shampoo back in February 2021—it is not hard to imagine how regulatory changes in the future could affect liability for alleged failures in the past.  Among other things, when a manufacturer elects to discontinue the sale of a product in response to regulatory actions, that decision almost always affects the analysis of liability related to the sale and use of the product several years earlier.  We will be watching how this all develops.

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Our second shot is called “The Delaney Clause and Personal Injury Litigation— FDA Delists Color Additive Red No. 3, but Will It Be Enough to Attract Even Dyed-in-the-Wool Plaintiffs Lawyers?” and it is a guest post from Justin Kadoura, a Holland & Knight litigation associate and Blog devotee.  As always, all credit and blame for a guest post—even one embedded within a two-fer—goes to the guest poster.  Despite very different regulatory schemes, the issues discussed below clearly fit with those discussed above.  Both fit with the sort of scare tactics about trace or theoretical exposures that plaintiffs like to feature.

On January 15, 2025, FDA granted a citizen petition submitted by the Center for Science in the Public Interest and others to repeal the approval of color additive Red No. 3 in foods based on the Delaney Clause of the 1958 Color Additive Amendments to the Food, Drug & Cosmetics Act.  The Delaney Clause prohibits approval, and requires the delisting, of food and color additives that have been shown to cause cancer in humans or animals.  The Red No. 3 petition cited to “multiple regulatory conclusions that FD&C Red No. 3 is carcinogenic in male rats, which are based on some in vivo studies”—studies which had not prompted any action in the thirty-seven years since they were published in 1987.  The FDA stated in its decision that although “Red No. 3 has been found to ‘induce cancer when ingested by . . . animals,’” and is thus subject to the Delaney Clause, “Red No. 3-induced thyroid tumors in male rats are of limited relevance to humans.”  “FD&C Red No. 3 is likely not genotoxic” and “appears to induce thyroid tumors in male rats through a key event—an increase in circulating TSH—and rodents show much higher sensitivity to such perturbations compared to humans.” 

Often, when FDA or another agency revokes approval for a substance used by consumers based on safety concerns, personal injury litigation follows.  Consequently, apart from having to reformulate (or discontinue) their Red No. 3-containing products, companies may fear that they face a risk of litigation from consumers who ingested those products and developed cancer.  Historically, however, FDA’s use of the Delaney Clause to delist a product has not resulted in significant tort litigation.  For example, FDA used the Delaney Clause to delist Red Nos. 2 and 4 in 1976.  Although that ban resulted in some patent litigation due to the potentially increased value of Red No. 40, see Warner-Jenkinson Co. v. Allied Chemical Corp., 567 F.2d 184, 185 (2d Cir. 1997), and even a seizure of adulterated roe by the government, see United States v. An Article of Food Consisting of 12 Barrels, More of Less, Labeled in Part: (Barrel) Lumpfish Roe 100 Kg Net Colored Black, 477 F. Supp. 1185 (S.D.N.Y. 1979), it did not initially result in significant tort litigation.  But see De Coursey v. Murad, LLC, 673 F. Supp. 3d 194 (N.D.N.Y. 2023) (alleging that manufacturer’s cosmetics contained color additives, including Red No. 4, long after they were delisted by the FDA); Morales v. Kraft Foods Grp., Inc., No. 14-cv-4387, 2014 WL 12597034, at *1 (C.D. Cal. Oct. 23, 2014) (alleging that manufacturer’s advertising that cheese was “natural” was deceptive because it contained food additives, including Red. No. 2).  In 2018, FDA delisted several synthetic flavor additives in response to a petition.  Although those additives have been subject to some environmental tort litigation, that litigation often does not reference (and in some instances predates) FDA’s 2018 action.

The history and purpose of the Delaney Clause shed some light on why substances banned under the Delaney Clause have not frequently been the subject of tort litigation.

The Delaney Clause was passed in 1958 as part of the Food Additives Amendment in response to the explosion of new techniques in food processing, including the introduction of hundreds of new preservatives and flavorings.  Before the Delaney Clause was passed, FDA had limited ability to prevent the use of potentially harmful additives before they were marketed to consumers.  Under the FDCA, substances that are already generally recognized as safe for their intended use are not considered “food additives.”  21 U.S.C. § 321(s).  Novel ingredients, however, generally require premarket approval from FDA, which in turn requires showing “reasonable certainty in the minds of competent scientists that the substance is not harmful under conditions of its intended use.” 21 C.F.R. § 170.3(i).  The Delaney Clause provides that both food additives are automatically “unsafe” and cannot be approved “if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.”  21 U.S.C. § 348(c)(3)(A).  Although “color additives,” such as Red No. 3, are exempted from the definition of “food additives,” the Color Additives Amendment of 1960 nonetheless subjects color additives to the premarket approval process, including their own Delaney Clause.  21 U.S.C. § 379e(a), (b)(5)(B); 21 CFR 70.3(i). 

The test set out in the Delaney Clause is not dose-dependent, does not require human cohort or epidemiology studies before an additive is banned, and does not allow FDA to consider other factors in determining an additive’s safety profile.  This strict prohibition is premised on Congress’s belief at the time that no additive that posed a risk of cancer could be determined to be safe, particularly given the less-advanced scientific understanding of cancerous substances in the 1950s.  Indeed, despite FDA’s initial attempts to limit the use of the Delaney Clause in situations where the risk of cancer was de minimis, courts held “that the Delaney Clause of the Color Additive Amendments does not contain an implicit de minimis exception for carcinogenic dyes with trivial risks to humans” and “that Congress adopted an ‘extraordinarily rigid’ position, denying the FDA authority to list a dye once it found it to ‘induce cancer in . . . animals’ in the conventional sense of the term.”  Public Citizen v. Young, 831 F.2d 1108, 1122 (D.C. Cir. 1987); see also Lee v. Reilly, 968 F.2d 985, 988 (9th Cir. 1992).  But see Scott v. FDA, 728 F.2d 322, 325 (6th Cir. 1984).

In light of the de minimis showing required to delist a substance under the Delaney Clause, it is unsurprising that such delisting to not often result in wide-spread tort litigation.  Successful tort claims typically require evidence of dose dependence and human studies that are not required under the Delaney Clause.

Moreover, the fact that the Delaney Clause can be used to deny approval to an additive before it reaches the market limits the pool of potential plaintiffs with any injuries.  And, despite the D.C. Circuit’s holding in Public Citizen, FDA continues to use the Delaney Clause to delist additives that are already on the market only sparingly—giving plaintiffs’ lawyers very few additives to target, especially over the last few decades when toxic tort litigation has expanded rapidly.

Even when FDA delists an additive under the Delaney Clause, it sometimes does so with reservations.  Indeed, FDA has other, more nuanced tools to evaluate and delist additives that have bad safety profiles without relying on the blunt instrument of the Delaney Clause.  In 1981, the U.S. General Accounting Office (“GOA”) issued a report to Congress evaluating the public and scientific opinions of the Delaney Clause, stating that it “is a source of controversy, an emotional issue, and a target for change.”  Among the GOA’s proposed alternatives was to repeal the Delaney Clause and allow FDA to regulate allegedly cancer-causing additives under the general safety provisions of the FDCA.  Accordingly, when FDA used the Delaney Clause to delist certain synthetic flavor additives in 2018, FDA stated that “[a]lthough we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use.  The synthetic flavoring substances that are the subject of this petition are typically used in foods available in the U.S. marketplace in very small amounts and their use results in very low levels of exposures and low risk,” but “the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses.”  These types of reserved statements would make it difficult for plaintiffs’ lawyers to effectively use FDA’s regulatory action as a sword in litigation.  Cf. Wilson v. ColourPop Cosmetics, LLC, No. 22-cv-5198, 2023 WL 6787986 (N.D. Cal. Sept. 7, 2023) (holding that plaintiff lacked standing to bring claim arising from purchase of cosmetics that contained unreasonably dangerous ingredients, including Red No. 4, because, among other things, the “claims ultimately depend on the existence of violations of federal law—the Court can’t make a decision the FDA itself did not make” and “the FDA has not made a scientific determination that the additives that are not ‘specifically’ approved for the eyes are likely to cause injuries”).

Nonetheless, the night is young, and substances that are initially delisted based solely on the Delaney Clause could later be revealed, through further testing, to pose actual risks of cancer.  Given the wide publicity given to FDA’s recent action taken on Red No. 3, manufacturers and distributors could be subject to litigation a few years down the road if the science becomes more developed. 

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When we first read what the claims were in Cohen v. Saraya  USA Inc., (E.D.N.Y. Jan. 20, 2025), we thought of the old Catskills joke about the elderly couple at dinner:  

Wife: “The food here has really gotten terrible.” 

Husband: “Yes. And such small portions.”  

The plaintiff in Cohen filed a class action complaining that the defendant deceptively marketed sugar substitutes. The allegedly deceptive representations were about “the serving size, health impact, and nutrient content levels of the Products.”   

Obviously, Cohen is a food case.  So why is the Drug and Device Law blog spilling ink on it?  Well, Cohen ends up being a nice defense preemption win under the Food, Drug and Cosmetics Act. The plaintiff argued that the defendant lied about its products and listed incorrect servings sizes on the product label in violation of Food and Drug Administration (FDA) regulations. We usually talk about the D in the FDA, but the F is at least as big a part of the FDA’s wheelhouse (maybe bigger?  The F, after all, does come first).  A rising FDCA preemption tide lifts all boats piloted by defense hacks.  There might be some ideas in food preemption worth stealing by drug defense lawyers. Or maybe a good food preemption case such as Cohen will merely inspire jealousy. Why can’t drug preemption be as vigorous?  Either way, the magistrate judge’s food preemption analysis in Cohen gives us something to chew on as we dream our preemption dreams. 

The class action complaint alleged violations of New York’s consumer protection statute (New York General Business Law sections 349 et seq). It also included a claim for unjust enrichment.  Among the items of relief sought was an injunction against the allegedly false advertising.  The plaintiff lawyers had also brought similar claims under California law in S.D. Cal., and the defendant in Cohen asked EDNY to stay the Cohen case pending resolution of the S.D. Cal. case. But the Cohen defendant got something better — complete dismissal. 

The Cohen plaintiff alleged that certain unspecified “testing” showed that the defendant’s food labeling misstated the number of calories per serving for the defendant’s artificial sweetener.  The complaint alleges that for some period of time the product label listed a serving size that was too small. You’ve probably heard of similar claims before. Back in the bad old days a small potato chip bag (clearly the kind that an average American would knock back in one sitting if not one swallow) might have promised low caloric or fat amounts, but got to those low numbers by assuming consumption of only a quarter of the bag.   It was silly.  Then again, it was so silly that it was hard to believe anyone was fooled. 

The NY consumer protection claims in Cohen were dismissed with prejudice, partially on TwIqbal and partially on preemption.  The court held that the complaint failed to allege that the defendant engaged in “materially misleading” conduct. The standard is an objective one. It “requires a probability that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.”  But here there was not even an adequate allegation of falsity. “[B]are, unsubstantiated allegations that separate studies, independent tests, and data results” contradict the products’ labeling “are insufficient to state a claim.”  That language has equal applicability to all testing allegations against any sort of product.  Such allegations must have factual substantiation.  This part of the opinion is where a drug and device lawyer might feel pangs of jealousy. There are too many drug or device cases where vague allegations of falsity or bad test results can get a plaintiff past the motion to dismiss stage. The more searching analysis of the Cohen court is deliciously appropriate.  Seconds, please.  To make things even more appetizing, the Cohen court supplies a nice collection of similar cases.  

Further, any potential misleading ambiguity caused by the front label regarding the amount of carbohydrates and caloric contents was “readily clarified by the back panel” of the label, which, per FDA regulations, listed the amount of carbohydrates and calories in each product.  Given that application of a sort of rule of completion, no reasonable consumer could be misled. 

The plaintiff tried to save her claim by invoking various FDA regulations, but under New York law challenged acts “cannot be recharacterized as ‘deceptive’ simply on the grounds that they violate another statute which does not allow for private enforcement.”  Violation of an FDA regulation — even assuming it is, indeed, a violation — does not make something inherently deceptive. 

Now we get to federal preemption. Importantly, the Cohen court quickly dispenses with any presumption against preemption.  Congressional intent to displace local, inconsistent food regulation is clear.  One of the plaintiff’s main beefs with the defendant’s labeling was the calculation of “net carbs.”  But because  the plaintiff could not explain how the defendant’s net carbs claim violated the federal scheme, “federal law preempts Plaintiff’s state law claims challenging Defendant’s net carbs claims.”  Similarly, the plaintiff’s attack on the defendant’s “zero calorie” claim failed.  FDA regulations permitted caloric calculations under any of five different methods.  Those regulations also offer a safe harbor permitting 20% leeway.  The plaintiff did not plead that she had tested the product under all five methods, or that every one of the test results exceeded the calorie value on the label by more than 20%.   

The unjust enrichment claim in Cohen, as in most cases alleging deceptive marketing, looked to be pure make-weight (somewhat ironic, given the claims alleged).  It rested on precisely the same allegations as the New York consumer protection claims. It was wholly duplicative and, for that reason, the magistrate judge recommended dismissal. 

Finally, the court recommended dismissal of the injunctive count for lack of standing. An injunctive claim does not arise much in personal injury cases, but does, for example, in OTC class actions.  Although past injuries may provide a basis for standing to seek money damages, they do not confer standing to seek injunctive relief unless the plantiff can demonstrate that she is likely to be harmed again in the future in a similar way.  Absent an intent to purchase the offending product in the future, a plaintiff lacks standing to seek injunctive relief.  Here, the plaintiff alleged that had she known the correct caloric and carbohydrate content of the products, she would not have purchased the products, or she would have paid less. That’s not good enough for standing. The plaintiff’s typical common injunctive “conditional promise” phraseology (e.g., I’d buy the products if their nutrient statements were accurate) was held insufficient.  

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Do kids still do connect-the-dots?  Back before tablets, smart phones, laptops, and even computers, when you went on a long car trip you passed the time playing license plate bingo, punch buggy, annoying your parents, and maybe you had an “activity book.”  An actual paperback book filled with coloring pages, mazes, word scrambles, seek-a-word, and — connect-the-dots.  The great thing about connect-the-dots puzzles was watching the image get revealed as you moved your crayon from one number to the next.  Voila! If you did it right, you ended up with a recognizable picture.  Like a hot air balloon or a rabbit in the woods.  If you missed some numbers or left some blank, you got something that maybe, almost, kind of, could be either a rabbit or a hot air balloon.  That’s fine for a kid to use his imagination and guess what the picture was supposed to be.  That’s not fine when plaintiffs ask the court to do the same.

Which is what the court told plaintiff in United States v. Siemens Medical Solutions USA, Inc., 2025 U.S. Dist. LEXIS 9511 (E.D.N.Y. Jan 17, 2025).  The case was brought by a plaintiff-relator alleging defendant, the manufacturer of laboratory tests, violated the False Claims Act (“FCA”) by not shipping those tests in containers that would ensure they maintained FDA-mandated temperature ranges during transport.  Id. at *6.-7.  Plaintiff alleged defendant was aware its products were being shipped inappropriately and that, therefore, its labeling regarding shelf-life and product stability were inaccurate.  Id.  This in turn, claimed plaintiff, caused other to submit false clams to the government “which did not disclose . . . the compromised reliability, safety, and efficacy” of the devices.  Id. at *8. 

Putting aside the sprawling nature of a transportation-based FCA claim and the myriad of issues it would raise, here the court only needed to analyze plaintiff’s claims under Federal Rule of Civil Procedure 9(b).  FCA claims are fraud-based, and therefore, subject to Rule 9’s heightened pleading requirements.  Id. at *16.  Plaintiff must allege the who, what, when, where, and how of the alleged fraud.  In the context of an FCA claim brought on “information and belief” that false claims were presented, plaintiff must

(1) make plausible allegations that the bills or invoices actually submitted to the government were uniquely within [the defendant’s] knowledge and control, and (2) adduce specific facts supporting a strong inference of fraud.

Id. at *17 (citations omitted).  Plaintiff here failed on both counts.

First, plaintiff merely pointed to adverse event reports found on the FDA’s MAUDE database to demonstrate that defendant’s devices malfunctioned.  But that is as far as the allegation went.  Nowhere did plaintiff allege any facts about what caused the malfunctions.  Rather it asked the court “to presume” the adverse events were caused by the devices’ storage or shipping conditions.  Id. at *18.  Some devices were reported as malfunctioning during the same period of time plaintiff alleges defendant was not adhering to proper shipping conditions.  And??  Rule 9 is not satisfied by setting out a set of circumstances and asking the court to connect to the dots. 

Second, the FCA’s “focus remains on those who present or directly induce the submission of false or fraudulent claims.”  Id. at *15.  Yet plaintiff failed to allege that defendant’s shipping practices compromised any tests for which claims were actually submitted to the federal government.  Id. at *20.  That alone was enough to dismiss the complaint.

The court is giving plaintiff another stab at connecting the dots, but plaintiff has had years to fill in the gaps and complete the picture.  We doubt a little more time is going to get the job done.

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Little more than a year ago, in our “Texas Mess” post, we critiqued what we called a “bizarre complaint” recently filed by the Texas attorney general (“TAG”) against a major COVID-19 vaccine manufacturer.  We described that complaint as a mélange of “various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media.”  On the merits, we predicted that the whole kit and kaboodle would be precluded by the PREP Act because:  (1) that statute “contains one of the most thoroughgoing express preemption clauses known to the law,” and (2) “pandemic countermeasures – specifically vaccines – are at the heart of” the act’s protections.”

And that’s precisely what happened at the end of 2024.  The entire complaint was dismissed for failure to state a claim due to PREP Act preemption.  “More specifically, the Court finds that as a matter of law under the circumstances of this case, the Defendant is entitled to immunity under the Public Readiness and Emergency Act (‘PREP Act’).”  State of Texas v. Pfizer, Inc., C.A. No. 5:23-CV-3l2-C, slip op. at 1 (N.D. Tex. Dec. 30, 2024).  Further, “both the PREP Act and the Food, Drug, and Cosmetic Act (“FDCA”) preempt Plaintiffs claims.”  Id. at 1-2.  Finally, adding insult to injury, the decision held that the TAG failed to apply the state’s consumer protection statute correctly.  Id. at 2 (“the alleged statements by Defendant were not connected to any ‘trade or commerce’ or any ‘consumer transaction’”).  Therefore, the complaint (called a “petition” in Texas parlance) was “DISMISSED for essentially the reasons argued in the Motion and Reply.”  Id. (online links added).

That’s it.  In only two pages, the entire TAG conspiratorial fantasy bit the dust.

The opinion was sufficiently terse that both Lexis and Westlaw missed it – and we didn’t find out about it for nearly a month.

To learn more about the why, how and wherefore of this dismissal, we followed the decision’s reference and took a look at the defendant’s brief and reply brief in support of the motion to dismiss.

The principal brief bluntly state that TAG “has no legal right to insert itself between FDA and the American people.”  Brief at 2.  Why?

 Congress has tasked FDA, not state officials, with deciding whether [defendant’s] vaccine is sufficiently safe and effective, and federal law presents several insurmountable barriers to this lawsuit. Not only does [defendant] have statutory immunity under the PREP Act, but TAG’s claims are preempted twice over.

Id.

Addressing the PREP Act, the principal defense brief pointed out that even TAG “acknowledged [that], federal law provides [defendant] with broad immunity from claims related to the COVID-19 vaccine” – first and foremost the PREP Act.  Id. at 10.  The first Trump Administration “identified COVID-19 vaccine manufactures as ‘covered persons’ and their vaccines as ‘covered countermeasures’” under the statute.  Id.  TAG’s allegations also involved a PREP Act “claim for loss,” since the act “defines ‘loss’ broadly, stating ‘the term ‘loss’ means any type of loss.’”  Id. at 11.

Under this expansive definition, the statute provides immunity from claims for “any type of loss” related to the administration or use of [defendant’s] vaccine.  The claims here fall squarely within this broad definition of “loss.” According to [TAG]’s own complaint, [defendant’s] alleged “unlawful acts or practices” “caused injury, loss, and damage to [the State], as well as caused adverse effects to the lawful conduct of trade and commerce, thereby directly or indirectly affecting the people of this State.”  The complaint further requests damages and restitution, which are only recoverable when the State or its citizens have suffered a “loss.”

Id. (citations omitted).  Adding up covered persons and countermeasures, as well as covered losses, the brief concluded, as to the PREP Act immunity:

The complaint in this case asserts state-law claims for “losses” “caused by, arising out of, relating to, or resulting from the administration to and use by” individuals of [defendant’s] vaccine, a covered countermeasure.  Accordingly, the PREP Act immunizes [defendant] against this lawsuit.

Id. at 12.

Moving from immunity to preemption, the defense principal brief next argued:

Congress enacted the PREP Act to incentivize private companies to assist the federal government in providing potentially lifesaving countermeasures during a public health emergency without fear of later being sued for actions taken in a time of crisis.  In offering immunity to the manufacturers of COVID-19 vaccines, HHS emphasized the serious public health emergency caused by the pandemic and the need for “a sustained, coordinated proactive response by the [g]overnment in order to contain and mitigate the spread” of the virus.  [Defendant] answered the federal government’s call.  Despite this, [TAG] seeks to hold the company liable under state law for actions “relating to,” among other things, the “design,” “development,” “clinical testing,” and “safety and efficacy” of the COVID-19 vaccine.  This lawsuit, which is in direct conflict with important federal prerogatives, is tailor made for dismissal under the PREP Act.

Brief at 14 (citations omitted).

The defense brief goes on to argue, persuasively, that the TAG complaint is also preempted directly by the FDCA.  Id. at 14-18.  But since the court’s decision rests on the PREP Act without mentioning the FDCA, we’ll skip this aspect of the defense preemption argument.

Moving to Texas Deceptive Trade Practices Act (“DTPA”), the defense principal brief points out a rather basic flaw in TAG’s allegations – the state had nothing to do with the transactions at issue.

[T]he federal government was the sole U.S. purchaser of the vaccine during 2020 and 2021 − when [defendant] allegedly overstated the vaccine’s benefits − and until very recently the federal government made the vaccine available, free of charge, to all people living in the United States.

Id. at 19 (citation omitted).  Thus, the allegations did not concern any “trade or commerce” subject to state regulation.  The feds bought the vaccine, and gave it away free to the public.  On one end, Texas can’t regulate the federal government, and on the other, the DTPA is “concerned with ‘business,’ not gratuitous transactions.”  Id. at 20 (citation omitted).  “Trade,” as used in a deceptive practices statute, “means ‘[t]he business of buying and selling or bartering goods or services.’”  Id. at 21 (citation omitted).

[R]ead as an integrated whole, . . . the DTPA applies to private business transactions, not charitable endeavors or large-scale government programs to advance the public health. . . .  [Defendant] Pfizer did not make [any] statements in connection with the sale of the vaccine.  As previously discussed, the statements in question, which Pfizer allegedly made in 2020 . . ., took place long after [defendant] contracted to provide hundreds of millions of doses to the federal government; the vaccine was not for sale to individual Texans.  Because [defendant’s] so-called “misrepresentations” in this case were disseminated to the general public − which received the vaccine for free − and not the federal officials who actually authorized and purchased the product, the alleged misstatements did not occur “in the conduct of any trade or commerce” and the complaint fails to state a DTPA claim.

Id. at 22 (citations omitted).

The defense reply brief, also mentioned in the opinion, mostly reiterated these same points.  TAG, the defendant argued, “argues for a narrower reading,” but only by “cherry pick[ing] words from the statute while ignoring the complete statutory language.”  That flaw “permeated” TAG’s papers, “which misleadingly cite[d] not just the language of the PREP Act, but also the DTPA and the relevant case law.”  Reply br. at 2-3.  TAG “violate[d bedrock] canons of construction at every turn.”  Id. at 3.  First, the PREP Act’s protections are hardly limited to “personal injury.”

Under the PREP Act, “the term ‘loss’ means any type of loss.”  This broad language is not limited to personal injuries.  In fact, the statute provides “any type of loss” also includes, but is not necessarily limited to, “loss of or damage to property, including business interruption loss.” Read as an integrated whole, the PREP Act’s immunity provision extends far beyond “physical or mental loss.”

Id. at 4 (citations omitted).

Next, TAG argued that the DTPA did not require the state to prove a loss – but that ignored TAG’s own complaint, which repeatedly alleged various losses.  Id.  The PREP Act further “prohibits claims far beyond those stemming ‘from the administration of’ a covered countermeasure.”  Id.  The PREP Act’s “broad grant of immunity” reached any allegations that “arise out of” or “relate to” administration of the COVID-19 vaccine, and the “very first page” of TAG’s complaint alleged that the purported “misleading” claims caused “hundreds of millions of Americans” to receive the defendant’s vaccine.  Id. at 5 (citations and quotation marks omitted).  The reply pointed out that “Courts have rejected as ‘nonsensical’ the argument that consumer protection claims lack a sufficient nexus to the ‘administration’ of a covered countermeasure.”  Id. (citation omitted).

Further, while states had no power to enforce vaccine-related claims, the PREP Act included an “explicit carve-out for federal enforcement actions.”  Id. at 6 (citation omitted).  TAG’s “absurd” argument that a manufacturer “could claim with impunity that the vaccine cures cancer, entirely misse[d] the point.”  Id.  Cancer was not a within the “the category or categories of diseases” within the government’s PREP Act declarations.  Id. (citations and quotation marks omitted).

TAG’s arguments against PREP Act preemption were equally unavailing:

[TAG]’s claims are in direct conflict with [the statute].  The complaint’s entire premise is that [defendant’s] statements about the vaccine misled individuals, thus “harm[ing] Texas and its citizens.”  Even [TAG] agrees that such claims, if brought by individuals, would be barred. . . .  [TAG] asserts, however, that the state may bring the same claim “on behalf of the public interest of its citizens” acting as “parens patriae.”  This cannot be correct; the preemption clause would be meaningless if states could bring the very claims the statute bars individuals from bringing.  At a minimum, [TAG]’s interpretation would read the word “enforce” out of the preemption clause entirely.  That is something courts must never do.

Id. at 7 (citations omitted).  Nor did the inane “mirror” federal requirements argument matter.  The PREP Act, as opposed to the FDCA, cannot be misread in this fashion, because the PREP Act does not rely on the FDCA at all.  Id.

Nor, as the defense reply pointed out repeatedly, did TAG offer any precedent supporting its position that federal distribution of free vaccines somehow came within the purview of the DTPA.  Id. at 8-10.  Other than nitpicking the precedent cited in the defendant’s brief, TAG “d[id] not meaningfully address the DTPA’s statutory text.”  Id. at 9.  Sure, the state did not itself have to be a “consumer,” but it had to be suing over “consumer” transactions, which free federal distribution was not.  Id.  “[T]he Texas Legislature was concerned with ‘business,’ not gratuitous transactions.”  Id. at 10 (citation and quotation marks omitted).

We understand that TAG is taking an appeal.  We don’t think that even the Fifth Circuit will find that appeal very appealing.

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For any of our loyal readers looking to start the New Year with a healthy helping of CLE credit, a friendly reminder that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – recently presented a free 90-minute CLE webinar on “The Good, the Bad and the Ugly: The best and worst drug/medical device decisions of 2024.” For those unable to attend live, and who would like the free CLE, a recording of the Webinar is now available online to view on-demand.

To view the webinar on-demand, please click here to register for, and then watch, the recording.

The webinar provides further insight and analysis on the cases featured in our annual posts on the worst decisions and best prescription drug and medical device decisions of the past year.

CLE Information for On-Demand Viewers: In order to receive CLE credit, you will need to notify Learning & Development CLE Attendance once you have viewed the program on-demand.

**Please note – CLE credit for on-demand viewing is only available in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Credit availability expires two years from the date of the live program.

CLE Questions? Contact Learning & Development CLE Attendance.

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When a defendant removes a case to federal court on the basis that the case presents federal questions, what happens if the plaintiff amends the complaint to remove all references to federal law, leaving only state-law claims?  The U.S. Supreme Court has ruled that once the plaintiff amends to delete all federal claims, a federal district court has no discretion to exercise jurisdiction over the remain state claims.  Remand is required. 

The case is Royal Canin U.S.A., Inc. v. Wullschleger, No. 23-677, 2025 WL 96212 (U.S. Jan. 15, 2025), a matter that we flagged as flying under the radar just a few months ago.  The opinion is now in, and the Supreme Court has squarely and unanimously established plaintiffs as “masters” of their complaints, including their chosen venue.  The Court has also upended the expectations of generations of lawyers brought up with the rule that federal jurisdiction is determined at the “time of filing.” 

The plaintiff in Royal Canin filed her complaint in Missouri state court and alleged violations of Missouri statutes and also violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”).  So the defendant removed the case to federal court.  The plaintiff, however, didn’t like that, so she amended her complaint to “delete its every mention of the FDCA” and moved to remand the case back to state court.  Id. at *4.  Having freely alleged violations of federal law—with the predictable consequence that the defendant would remove the case to federal court—can a plaintiff just call a “do over” and escape federal court merely by redlining federal law out of her complaint? 

The answer is yes, and it comes down to the limits of supplemental jurisdiction under 28 U.S.C. § 1367.  When a federal court has original jurisdiction over a case (for example, under federal question jurisdiction), section 1367 confers authority on the court to decide other claims involving only state law, so long as the state claims are “so related to” the federal claims as to form “part of the same case.”  This is supplemental jurisdiction, and it typically involves federal claims and state claims that arise from the same operative facts.  Royal Canin, at *5. 

Because supplemental jurisdiction begins with the federal court having original jurisdiction in the first place, the Supreme Court ruled that supplemental jurisdiction cannot survive once original jurisdiction goes away.  Or, as the Supreme Court bluntly stated, “Once the plaintiff has ditched all claims involving federal questions, the leftover state claims are supplemental to nothing—and § 1367(a) does not authorize a federal court to resolve them.”  Id. at *6.

The most important point for the Court—cited repeatedly in the opinion—was that section 1367 does not distinguish between cases removed to federal court and cases originally filed there.  That is critical because the Court has already held that when a plaintiff files a complaint in federal court and then voluntarily amends the complaint, courts look to the amended complaint to determine federal jurisdiction.  And, if an amended complaint in an originally filed case withdraws the federal claims, that filing divests the federal court of jurisdiction.  Id. (citing Rockwell Int’l Corp. v. United States, 549 U.S. 457, 473–474 (2007)). 

The Supreme Court held that the same rule should apply to cases removed from state court, noting that if Congress had intended to grant district courts discretion to decline jurisdiction under these circumstances, it would have said so.  The Court further reasoned that this result is consistent with how Congress typically views how amended pleadings can impact federal jurisdiction.  An amended complaint can create federal jurisdiction where there was none before, and section 1367 itself contemplates that when a plaintiff files an amended complaint, jurisdiction is “reviewed anew.”  If federal claims are removed, then “the state-law claims are just state-law claims, outside §1367(a)’s purview.”  Id. at *7.

Again, the court circled back to the theme that it should make no difference whether a case was removed to federal court or filed in federal court to start.  Here is the quote that you will probably most often see:

The appropriateness of federal jurisdiction—of the lack thereof—does not depend on whether the plaintiff first filed suit in federal or state court.  Rather, it depends, in either event, on the substance of the suit—the legal basis of the claims (federal or state?) and the citizenship of the parties (diverse or not?).  (That focus on substance is indeed why original jurisdiction and removal jurisdiction generally mirror each other in scope.) 

Id. at * 9.  In so holding, the Court dismissed some legitimate points.  First, what about the rule that federal jurisdiction is determined at the “time of filing”?  Well, that rule concerns only the actual “state of things” relevant to jurisdiction.  The facts on the ground.  A New York plaintiff who sues a California defendant cannot destroy diversity by moving to California.  By contrast, the claims and the parties can change, and when they do, they can impact jurisdiction.  Id. at *7 n.5.

Second, the Court distinguished its own prior authorities supporting the removing defendant’s position.  Most notably, the Court had itself articulated the rule that the defendant urged in a footnote in the Rockwell opinion: “[W]hen a defendant removes a case to federal court based on the presence of a federal claim, . . . an amendment eliminating the original basis for federal jurisdiction generally does not defeat jurisdiction.”  Id. at *10.  That sounds pretty on-point to us, especially coming from the Supreme Court itself.  The Court, however, called it “barely reasoned” dicta because Rockwell was an original federal case, not a removed one.  It was thus “beside the point.”  Id.  (As an aside, in declining to follow its own precedent, the Supreme Court noted that district courts and the Court of Appeal do not have the same prerogative: “It is of course a much different thing for this Court to reach that conclusion than for a lower court to do so.”  Id. at *10 n.10). 

Third, the Court did not share any concern over forum manipulation.  Plaintiffs can usually forum shop without resort to any amendments, including by dismissing their cases entirely and refiling somewhere else (provided there is no time bar).  In any event, the supplemental jurisdiction statute is what it is:  Jurisdiction follows the amended pleading, and section 1367 “offers no basis for treating original and removed cases differently.”  Id. at *10 n.9. 

In the end, because the plaintiff “reconfigured” her lawsuit to make it only about state law, it became a matter for a state court.  Remanded. 

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In this, the Year of Our Lord 2025, that title could apply to so, so, so many things.  Soooooo many things.

But this is the Drug and Device Law Blog, product liability is our niche, and what we are referring to is the new, 2024 European Union Product Liability Directive (the “PLD”), also known as Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Nov. 18, 2024).

We have spoken and written about the issue before.  And now we are starting to jump up and down to get attention on this.

Why the cause for alarm?  Look at the litigation funding industry.  Rumor has it that they are so excited about the new PLD, they already have set up camp in Amsterdam and London in anticipation of the disputes to come.

You may be thinking to yourself, I’ve defended mass torts in some of the most plaintiff-friendly jurisdictions in the U.S., how bad can it be?

How about not actually requiring proof of defect, particularly because the product at issue is a life-saving medical device:

Some products, such as life-sustaining medical devices, entail an especially high risk of causing damage to people and therefore give rise to particularly high safety expectations. In order to take such expectations into account, it should be possible for a court to find that a product is defective without establishing its actual defectiveness, where it belongs to the same production series as a product already proven to be defective.

PLD, at 19 (emphasis added). 

How about holding subsequent remedial measures against manufacturers?  The silver lining (?) is that subsequent remedial measure “should not in itself lead to the conclusion that a product is defective.”  PLD, at 22, id. at 60. 

How about a rebuttable presumption of defectiveness where a defendant has failed to comply with an “obligation to disclose information.”  PLD, at 31, id. at 67 (“relevant evidence”). 

How about a rebuttable presumption of defectiveness “in a case of obvious malfunction… since it is unnecessarily burdensome to require a claimant to prove defectiveness when the circumstances are such that its existence is undisputed”  PLD, at 31, id.at 67.  Obvious to whom?  Undisputed by whom?   

How about a rebuttable presumption of causation “[w]here it has been established that a product is defective” (maybe through one of the defectiveness presumptions above) “and the kind of damage that occurred is, based primarily on similar cases, typically caused by the defectiveness in question” because “the claimant should not be required to prove the causal link and its existence should be presumed.”  PLD, at 32, 68.  Should we call this the “you win one, you win them all rule” for plaintiffs?

Perhaps worst of all is the rebuttable presumption of both defectiveness and causation, which will arises just because the issues are hard:

National courts should presume the defectiveness of a product or the causal link between the damage and the defectiveness, or both, where, notwithstanding the defendant’s disclosure of information, it would be excessively difficult for the claimant, in particular due to the technical or scientific complexity of the case, to prove the defectiveness or the causal link, or both…. While a claimant should provide arguments to demonstrate excessive difficulties, proof of such difficulties should not be required.

PLD, at 33 (emphasis added); see also PLD, at 68. 

And again, our clients’ essential products are called out as deserving of punishment through this evidentiary shortcut designed to lead straight to a liability finding:

Technical or scientific complexity should be determined by national courts on a case-by-case basis, taking into account various factors. Those factors should include the complex nature of the product, such as an innovative medical device.

PLD, at 33 (emphasis added). 

Also mind-boggling are the rationales given for the new PLD.  For example:

Liability without fault on the part of economic operators remains the sole means of adequately addressing the problem of fair apportionment of risk inherent in modern technological production. 

PLD, at 2 (emphasis added).  Really?  How about the regulatory systems in place in the E.U. already?  They work quite well for the pharmaceutical and medical device sectors.  How about national health care programs that provide medical care to all without risk of personal bankruptcy or the inefficiency of litigation, and the already-existing possibility of recovery from pharmaceutical manufacturers, when necessary and if appropriate, by those national health care programs?

One very modest (very modest) beneficial (or at least not openly harmful) provision that we see in the new PLD is a sort-of regulatory compliance defense: 

An economic operator . . .  shall not be liable for damage caused by a defective product if that economic operator proves . . . that the defectiveness that caused the damage is due to compliance of the product with legal requirements.

PLD, at 69. 

Another is the “state of the art” defense:

An economic operator . . .  shall not be liable for damage caused by a defective product if that economic operator proves . . . the objective state of scientific and technical knowledge at the time the product was placed on the market or put into service or during the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered.

PLD, at 70.  But don’t get too excited:  individual E.U. nations can opt out of this one.  PLD, at 79-80. 

There is a lot more about the new PLD that warrants discussion. 

For example, it isn’t only pharmaceutical and medical device manufacturers who are in the cross-hairs.  If there is a nuclear accident, or you make free and open-source software, you are in the clear.  PLD, at 4, 47.  But other software, AI, digital manufacturing files (as for 3D printers), electricity, and raw materials are products falling within the PLD.  See PLD, at 8, 49-50.  And the new PLD applies to goods and related services.  See PLD, at 11.    

The new PLD was published in the Official Journal of the European Union on November 18, 2024.
EU Member States now have two years to “transpose” it into their national laws, i.e. by December 9, 2026, and the new PLD will apply to products put on the market in the EU after December 9, 2026.

In the coming months, we will continue to pick apart the new PLD—and continue to sound the alarm.

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

When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science. 

Materials science is the interdisciplinary study and analysis of product composition with application to the design, development and manufacturing of real products.  It is something we have found weirdly interesting, ever since an amazing materials scientist explained that a favorite blazer with a nubbly texture never wrinkled because it had “predetermined collapse points.”  Because of those predetermined collapse points, the garment never took on additional collapse points (aka wrinkles), no matter how badly it was squished in a suitcase.

3D printing/additive manufacturing is another area of interest to the blog, and another area where materials science matters quite significantly.  In talking with another great materials scientist, Ming Tang, we learned that the simple act of changing the orientation of how an object is 3D printed may change its properties in pretty significant ways.  Ming and his colleague Larry Eiselstein were even kind enough to send us an article, 3D-Printed Metallic Medical Devices: Increasing Interest from Medical Device Manufacturers, Opportunities, and Challenges, in which they explained this and other materials science issues related to 3D printing in the medical device space.  Even to a lay person, it is a quick and understandable read, not to mention eye-opening and interesting.

With that short detour over , turn with us now to Hill v. Medical Device Bus. Srvcs., Inc., No. 3:21-cv-0440, 2024 U.S. Dist. LEXIS 140272, 2024 WL 3696481 (M.D. Tenn Aug. 7, 2024), a case in which the plaintiff’s materials science expert was challenged and excluded, for good reason.

The plaintiff in Hill had two hip replacement surgeries.  A 2014 surgery was for the initial implant of his total hip replacement system, and a 2015 surgery was to replace certain components, although one component, the femoral stem, was left unchanged.  Five years later, the femoral stem component fractured, and the entire hip implant construct was explanted and replaced. 

According to the court, the parties seemingly agreed that the femoral stem component broke due to a small flaw in its metal, “but they disagree[d] as to how that flaw came to exist”:

Defendant’s experts assert that a flaw was introduced to the product during surgery from the use of electrocautery… [whereas] Plaintiffs assert that a flaw was introduced to the product during the manufacturing process.

Hill, 2024 U.S. Dist. LEXIS 140272 at *4.

As our readers know, expert testimony is measured against the standard in the updated Federal Rule of Evidence 702, which emphasizes the importance of the gatekeeping function of our courts:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.

To its credit, the Hill court recognized the changes to Rule 702 were meant to give it more teeth, and that courts “can exclude a conclusion if it is based on methods that are unreliable (and thus do not serve to reliably substantiate the conclusion[)]”.

The Hill court also realized that Sixth Circuit cases applying the pre-amendment version of Rule 702 might be amongst the “misguided cases” that led to rules Advisory Committee to update Rule 702.  But—in the only really confounding part of the opinion, footnote 9—the court believed that it had to follow Sixth Circuit authorities interpreting the previous version of Rule 702 even though Rule 702 itself has changed.  See here for contrary Supreme Court precedent recognizing that rules changes, like statutory changes, overturn prior judicial precedent.

The good news is, the court did not need to resolve any finer points of the pre- versus post-Rule 702 amendment test to conclude that the plaintiffs’ materials science experts’ opinions were inadmissible.

Plaintiffs’ first expert was a well-credentialed materials scientist who opined that the critical flaw in the implant’s femoral stem was introduced during manufacturing, and that she had ruled out all other potential causes for the flaw.  But, as the court recognized, she did not actually have any evidentiary basis for ruling out those other potential causes: 

For example, she ruled out that the failure was caused by the Implant being placed at the improper angle during surgery, but [Plaintiffs fail] to explain how she can give that opinion when (as Plaintiffs do not dispute) she does not know the proper angle at which the Implant should have been placed.  If she does not know what angle is improper, then she lacks a basis for saying that an improper angle did not cause the break.  Similarly, she lacks a basis to rule out “trauma and blunt force” during surgery . . . because she did not know anything about how the surgery was conducted.

Hill, 2024 U.S. Dist. LEXIS 140272 at *21.

Moreover, although this expert testified it was possible for the flaw to have been introduced during manufacturing, the expert did not examine whether the defendant had appropriate measures in place to control the size of flaws during manufacture of its metal implants.  Thus, she couldn’t actually tie the flaw in the plaintiff’s implant to the manufacturing process or to the reason the plaintiff’s implant broke.

With the plaintiffs’ first expert out, the second expert also had to be excluded:  part of his opinion merely parroted the first expert and thus was unreliable, and the rest of his opinion was predicated on statements that the first expert never expressed.

With both of plaintiffs’ experts out, the Court concluded (quite rightly) that the burden of proof meant it did not need to consider challenges to the defendant’s experts and instead could just move on to the defendant’s motion for summary judgment.  

Without experts to establish causation, summary judgment should have been—and was—a relatively easy grant.  But plaintiffs tried one last gambit, the res ipsa loquitur-like malfunction theory:  that the factfinder can infer defectiveness merely from the existence of an alleged malfunction and a negation of other causes. 

We don’t buy the malfunction theory, just as we look askance at other variations of res ipsa loquitur.  When the malfunction theory is accepted, it is supposed to be fairly rigorous:  If the plaintiff can show that the product malfunctioned, and if the plaintiff also can negate all other causes for the malfunction other than a product defect, then the malfunction theory is applicable and an inference of a product defect is permissible.

But we find it often is trotted out just because the plaintiffs’ counsel or experts haven’t done their homework and are missing key pieces of evidence.  The device must have had a defect, they will argue, because devices don’t just fail. 

But the reality is that medical devices, particularly implanted medical devices, do fail for unknown reasons—and plaintiff’s second expert admitted as much here.  And when the plaintiff has not actually negated all other causes of malfunction, then the malfunction theory just doesn’t apply:

[W]hen a device is known to fail for unknown reasons, it is pure speculation that a failure is attributable to a manufacturing defect and not some other unknown cause without evidence supporting one cause over another.

Hill, 2024 U.S. Dist. LEXIS 140272 at *49.

The plaintiff in Hill certainly did not negate all other potential causes of malfunction, and so the court came to the right conclusion:  The defense wins.

An appeal has been filed, so we shall see if the Sixth Circuit agrees.

Our thanks to Robyn Maguire and Sarah Jin of Barnes & Thornburg for sending the case and a congratulations as well for the nice win!