Photo of Bexis

The Ohio Supreme Court’s decision in In re National Prescription Opiate Litigation, ___ N.E.3d ___, 2024 WL 5049302, 2024 Ohio Lexis 2785 (Ohio Dec. 10, 2024), which was our third best case of that year, was primarily a statutory interpretation case involving the Ohio Product Liability Act (“OPLA”), and specifically Ohio Rev. Code §2307.71(b), stating the legislature’s “inten[t] . . . to abrogate all common law product liability claims or causes of action,” and the subsequent amendment to §2307.71(a)(13), clarifying that OPLA “also includes” “any public nuisance claim” involving “the design, manufacture, supply, marketing, distribution, promotion, advertising, labeling, or sale of a product.”

Plaintiffs attempted to limit the scope of OPLA’s abrogation of the common law to claims that alleged what the plaintiffs contended was “one of the enumerated product defects” in subsection (a)(13).  2024 Ohio Lexis 2785, at *12.  Plaintiffs then argued that public nuisance claims did not involve product defects, so they escaped abrogation – despite their express inclusion by the subsequent amendment.  Id.  Not surprisingly, the defendants disagreed, and contended that the legislature’s specific addition of “public nuisance” to the statute’s was separate from, and not limited by, the other parts of the definition of “product liability action” in the same subsection.  Id. at *12-13.  You can read all about how that dispute was resolved in our original post on Opiate, here.

Our latest Ohio idea (as for our first Ohio idea; it didn’t seem to go anywhere) has nothing to do with public nuisance, or opioids, but rather with the overall approach that the Ohio Supreme Court took towards OPLA in Opiate.  The Court more broadly rejected the plaintiff’s view that the three “statutory analogues” to common-law defects limited OPLA’s reach, thereby creating their “defect” limitation even though the relevant OPLA sections didn’t use the term “defect” at all.  Id. at *18.  After rejecting that argument specifically because it “contravenes [OPLA’s] plain text,” the Court held that OPLA as a whole simply didn’t work that way:

What’s more, the OPLA’s limitation on product-liability theories to those involving a defect by no means demands the conclusion that the definition of “product liability claim” is equally limited.  Another possibility is that “product liability claim” is defined broadly enough to eliminate all product-based common-law claims while the rest of the OPLA is narrowly tailored to resurrect only some of the common-law theories into statutory form.  Such an understanding of the OPLA is consistent with the plain text of R.C. 2307.71.

Opiate, at *18 (emphasis added).  That view of OPLA not only was a better fit with the statute’s “plain text,” but accorded with an uncodified section of the relevant OPLA amendment that “expresses the General Assembly’s intent to abrogate ‘all common law product liability causes of action . . ., regardless of how the claim is described.’”  Id. at *21.

It is now unfortunately common for plaintiffs to overplead wildly in their product liability complaints.  To take but one of many examples, a standard pelvic mesh complaint of the sort filed in Ohio included no fewer than eighteen different “counts,” all purporting to be separate causes of action.  E.g., Sylvester v. Ethicon, Inc., 2020 U.S. Dist. Lexis 47467 (N.D. Ohio March 19, 2020), listing:

(I) Negligence; (II) Strict Liability − Manufacturing Defect; (III) Strict Liability − Failure to Warn; (IV) Strict Liability − Defective Product; (V) Strict Liability − Design Defect; (VI) Common Law Fraud; (VII) Fraudulent Concealment; (VIII) Constructive Fraud; (IX) Negligent Misrepresentation; (X) Negligent Infliction of Emotional Distress; (XI) Breach of Express Warranty; (XII) Breach of Implied Warranty; (XII) Violation of Consumer Protection Laws; (XIV) Gross Negligence; (XV) Unjust Enrichment; (XVI) Loss of Consortium; (XVII) Punitive Damages; and (XVIII) Discovery Rule and Tolling

Id. at *2.  See also Burris v. Ethicon Inc., 2021 U.S. Dist. Lexis 260147, at *3 (N.D. Ohio Jan. 6, 2021); Simpson v. Johnson & Johnson, 2020 U.S. Dist. Lexis 172542, at *1 (N.D. Ohio Sept. 21, 2020); Heide v. Ethicon, Inc., 2020 U.S. Dist. Lexis 48402, at *14 (N.D. Ohio March 20, 2020) (other Ohio mesh cases with similarly long lists of “counts”).

Under the analysis of OPLA adopted in Opiate, that shouldn’t be allowed, because what the statute, and its various amendments, did was to broadly abolish all this plethora of common-law claims and only resurrect a limited number and type of allowed “statutory” actions for product liability  – what the plaintiffs in Opiate referred to as “defect actions.”  Thus, according to Opiate, the OPLA abolished all common law “product liability actions” – such as various forms of fraud, various forms of negligence, unjust enrichment, etc. − and only resurrected the specified OPLA statutory claims in §§2307.74-2307.77.  The only exceptions are those specifically exempted in OPLA itself, such as the economic loss and environmental claims referenced in Ohio Rev. Code §2307.72.

For example, some federal courts have held that fraud claims escape OPLA’s abrogation of all common-law product liability claims on the rather lame excuse that they involve a “more general” duty than OPLA addressed:

The complaint also generally alleges that [defendant] actively misrepresented the truth about [the drug’s] safety.  The claims of active misrepresentation are not necessarily abrogated by the OPLA because they may implicate the more general duty not to deceive, rather than the duty to warn.

Stratford v. SmithKline Beecham Corp., 2008 U.S. Dist. Lexis 84826, at *24 (S.D. Ohio June 17, 2008).  Stratford cited one Sixth Circuit case, Glassner v. R. J. Reynolds Tobacco Co., 223 F.3d 343 (6th Cir. 2000), for that description, but Glassner involved preemption, and had nothing to do with OPLA.  Stratford also cited a few OPLA cases that predated the amendment clarifying that OPLA was expressly intended to abrogate all product liability-related common law:  Chamberlain v. American Tobacco Co., 1999 U.S. Dist. Lexis 22636, at *18 (N.D. Ohio Nov. 19, 1999); Hollar v. Philip Morris Inc., 43 F. Supp. 2d 794, 808 (N.D. Ohio 1998).

Nonetheless, the proposition that fraud claims involving product-related injuries escape OPLA’s abolition of Ohio common law has persisted, because courts have rotely applied that earlier rationale in the absence of definitive state appellate authority.  See, e.g., Kelley v. Insys Therapeutics, Inc., 2019 U.S. Dist. Lexis 12507, at *12-13 (N.D. Ohio Jan. 25, 2019); Z.H. v. Abbott Laboratories, Inc., 2016 U.S. Dist. Lexis 135792, at *36-37 (N.D. Ohio Sept. 30, 2016); Hogue v. Pfizer, Inc., 893 F. Supp.2d 914, 918 (S.D. Ohio 2012); Musgrave v. Breg., 2011 U.S. Dist. Lexis 99491, at *28 (S.D. Ohio Sept. 2, 2011); CCB Ohio LLC v. Chemque, Inc., 649 F. Supp.2d 757, 763-64 (S.D. Ohio 2009).

After Opiate, defendants in cases subject to OPLA no longer have to bother with distinguishing these fraud-related precedents on the basis of omissions versus active deception.  Rather, they should argue that, under Opiate’s now controlling view of how OPLA works, all product-related fraud claims are abrogated, regardless of the earlier federal-court blather about some “broader duty to deceive.”  Opiate demonstrates that all of those expansive Erie predictions of Ohio law were wrong.  Even assuming such a duty, it falls within OPLA’s complete abrogation of prior product-related common law, and was not resurrected by any of the four permissible statutory causes of action.

Further, fraud is just an example.  The same rationale should bar claims raising any of the other theories mentioned, above, in the mesh cases.

The blog would like to thank Ohio attorneys, Dr. Frank Woodside and Greg Matthews, for providing an in-state sanity check for our Ohio idea.

Photo of Steven Boranian

The federal government and the Fourth Circuit have ruled that a charitable patient assistant program conceived to increase access to cancer drugs for needy patients violated the federal Anti-Kickback Statute.  In an opinion long on canons of statutory interpretation and short on compassion for sick and dying patients, the Fourth Circuit upheld an HHS advisory opinion ruling that the program funded by a coalition of pharmaceutical manufacturers illegally offered remuneration to induce individuals to purchase federally reimbursable drugs. Unfortunately, this isn’t the first time that HHS has callously blocked such a program.

The case is Pharmaceutical Coalition for Patient Access v. United States, No. 24-1230, 2025 U.S. App. 1465 (4th Cir. Jan. 23, 2025), and it arises from the Coalition’s effort to help financially needy Medicare Part D beneficiaries afford cancer drugs, which can be very expensive to patients because of the way Part D structures co-payments.  The Coalition is a charitable organization led by an independent board of patient advocates and health experts, and any manufacturer of cancer drugs was welcome to join.  However, to prevent free riders, the Coalition would support only those patients using drugs made and sold by Coalition members. 

In forming this charitable Coalition, the founders were not writing on a clean slate.  The Anti-Kickback Statute is a criminal law that prohibits the knowing and willing payment of “remuneration” to “induce” the purchase of federally reimbursable healthcare products or services.  The classic example is physician referrals, where pharmacies, imaging labs, or other providers pay physicians for referring their patients.  Under circumstances on which others in our firm are experts (but not us), those kinds of fees can be impermissible kickbacks, punishable as federal crimes. 

The rub here is that HHS issued an advisory bulletin on patient assistance programs in 2005, in which it informed pharmaceutical manufacturers that they could reduce the risk of Anti-Kickback exposure by designing their programs to avoid incentivizing beneficiaries to choose one drug over another.  The bulletin also encouraged a “coalition” model, under which large groups of manufacturers could agree to support patients using all their drugs covered under Part D.  This “all for one and one for all” approach would defeat the inference that any particular manufacturer was trying to steer patients to its own drugs through financial support. 

The Pharmaceutical Coalition for Patient Access followed the recommended approach, and it took the additional step of requesting an advisory opinion from the HHS Office of Inspector General (“OIG”).  In response, OIG issued an opinion holding that patient assistance under the program was “highly suspect” and would run afoul of the Anti-Kickback Statute “if the required mens rea were present.”  Id. at *5.  The program, according to OIG, was an attempt to “sidestep” the Anti-Kickback Statute. 

A program to help financially challenged cancer patients gain access to essential drugs and that followed the government’s own recommended approach was “highly suspect”?  Pharma manufacturers who funded the program and affirmatively submitted it for government review were “sidestepping” the law?  In our biased view, this seems harsh. 

Regardless, and unfortunately for this charitable Coalition and the needy cancer patients it was conceived to assist, a district judge in Virginia agreed with OIG, and the Fourth Circuit affirmed.  First, the Fourth Circuit rejected the argument that the word “induce” had a criminal meaning and thus required corrupt intent.  Under a plain meaning of “induce,” the program would have the effect of inducing patients to purchase drugs made and sold by the Coalition members.  No corruption was required.  The term “remuneration” carried no connotation of corruption, either.  The statute prohibited “any remuneration (including any kickback, bribe, or rebate).”  Id. at *24-*25.  Sure, kickbacks and bribes implied corrupt intent, but rebates not so much.  The Fourth Circuit concluded that any remuneration means any remuneration.  Again, an intent to corrupt the medical decision making process was not required. 

Second, the Fourth Circuit held that the program constituted a prohibited quid pro quo, i.e., patients receiving support were expected/required to use the Coalition members’ products.  The Coalition argued that there was no quid pro quo because the program collectively supported patients using all their Part D products and thus was “agnostic” on which manufacturers’ drugs were prescribed.  In other words, “the subsidies are not contingent on the purchase of specific, individual drugs.”  Id. at *28-*29.  This argument is eminently logical and makes compelling sense.  But recall that not all cancer drug manufacturers joined the Coalition.  This was dispositive for the Fourth Circuit, which reasoned that the patient subsidies (quid) were limited to the Coalition members’ products (quo), leaving other manufacturers and drugs out of the mix. 

Third, the Fourth Circuit rejected the Coalition’s argument that HHS was impermissibly dispensing disparate treatment because it had pledged to forego enforcement of the Anti-Kickback Statute with regard to other patient assistant programs, but not this one.  The Fourth Circuit agreed with the district court that it had no subject matter jurisdiction because the Coalition was seeking to review an agency enforcement decision.  Such decisions are “committed to the agency’s discretion when no judicially manageable standards are available.”  Id. at *33.  Thus, the Coalition’s disparate treatment challenge “is directed purely against how the Inspector General employs its enforcement discretion.  It therefore must fail as unreviewable.”  Id. at *36-*37.  Although not discussed in this part of the opinion, we cannot help but think that HHS’s 2005 advisory bulletin looms large here.  Did other patient assistance programs follow that guidance and get a pass, while the Coalition’s program did not?  We don’t know, but we can see how disparate treatment would seem really disparate if that were the case. 

The Anti-Kickback Statute is a compelling law aimed at address compelling concerns in the healthcare marketplace.  This particular program seems like an unlikely and unworthy enforcement target. 

Photo of Bexis

Today’s guest post comes from Reed Smith partner, Matt Jacobson. He discusses a new medical device case that puts the “Tw” in TwIqball – as in twisting a screw. The result is a total defense win, albeit with the “twist” that the plaintiff can try again, if he can. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.

*********

Have you ever heard that old idiom “having a screw loose” and wondered where it came from?  My guess is most of you have heard the saying, but never thought twice about its origin (well maybe Bexis has).  But since I have your attention, here is a small history lesson.  During the industrial revolution, if a screw from a machine came loose it meant that the machine was not behaving normally.  Since these machines were built for mass production, having a screw come loose would cause the entire machine to shut down, halting the process.  At least one person claims that Eli Whitney, famed for inventing the cotton gin, was the person to say this phrase first.  But I cannot verify that fact no matter how many internet searches I ran, so that will remain a mystery.   

Continue Reading Guest Post – Twlqbal in the E.D. Cal.- No Screws Loose There
Photo of Stephen McConnell

Did it seem to you in law school that sometimes the hardest part of reading cases was not deciphering some obscure legal principle — say, the difference between larceny by trick and taking under false pretenses, or the Rule in Shelley’s Case, or pretty much anything in Article 9 of the Uniform Commercial Code — but just figuring out what happened?  For every case with a clear, memorable fact pattern, there was another that would be completely opaque.  Behold poor Mrs. Palsgraf getting kabonged on the noggin by a falling roof tile. But also behold the poor first year law student trying to unravel the story of Pennoyer v. Neff. Both resulted in headaches. Is it that life is sometimes muddled, or legal cases are sometimes complicated, or that judges are sometimes bad writers, or that law school textbooks are sometimes badly edited?  Is “sometimes” really the right word?

Be grateful that we perused today’s case, Phillips v. Ethicon Endo-Surgery, Inc., 2025 U.S. Dist. LEXIS 16811 (W.D. Tex. Jan. 29, 20250, so that you do not have to.  Phillips is a procedural mess.  But at least we know why the background of the Phillips case is harder to follow than Finnegan’s Wake or A Brief History of Time:  the plaintiffs created what the court called “a complicated procedural history.” The plaintiffs did so both through clumsiness and calculation.  Fittingly, it was the plaintiffs who paid the price for constructing such chaos.

The one thing clear about Phillips is that the underlying facts add up to a sad story.  A man underwent an operation to repair his colon.   The surgery appeared to be successful.  The man was discharged and sent home.  But an anatomical staple failed, resulting in sepsis, resulting in death. The man’s estate brought a lawsuit.  The claim was that a bum staple caused the death.

And then tragedy turned into farce.  

The plaintiffs’ various missteps came back to haunt them.  First, the plaintiffs sued the wrong manufacturer.  At least the plaintiffs acknowledged the error and filed a stipulation of dismissal. Then the plaintiffs sued different defendants, alleging breach of the implied warranty of fitness for a particular purpose, breach of the implied warranty of merchantability, and design defect. The defendants moved to dismiss this complaint in its entirety.  Before the court could rule on this motion, the plaintiffs amended their complaint, dropping all of the defendants save one, and dropping the design defect claim. The sole remaining complaint again moved to dismiss.  When the magistrate judge recommended dismissal of the amended complaint as inadequately pleaded, instead of giving a reason to support an amendment, the plaintiffs filed another action in Texas state court.  This state court complaint added new defendants that were allegedly manufacturers of the staple.  Then the plaintiffs amended their state court complaint to add yet another defendant.  

Got all that?

The plaintiffs then opposed entry of judgment against them in the federal case — sort of.  The plaintiffs conceded that their claim for breach of warranty of fitness for a particular purpose should be dismissed with prejudice.  The plaintiffs also agreed that their claim for breach of warranty of merchantability should be dismissed without prejudice, while offering “an explanation as to the complicated [there’s that word again] history of this litigation and Plaintiffs’ continued argument as to why pre-suit notice should not bar their lawsuit.”  Ultimately – well, maybe that is the wrong word, since there’s more tale to tell – the district court dismissed both warranty claims with prejudice.  The plaintiffs “had never — in any of their briefing — given any ‘indication of how they would amend their complaint to present a viable, non-futile claim for breach of the warranty of merchantability,’ despite having multiple opportunities to do so.” 

Meanwhile, the defendants in the state court action (Phillips II) removed the case to federal court.  The defendants then moved to dismiss Phillips II case as being barred by the doctrines of res judicata and collateral estoppel.  After all, Phillips I and Phillips II were based on the same facts, same legal theories, and the “same parties (or parties in privity).” Once again, the plaintiffs sought to forestall an adverse decision via and amended complaint in Phillips II that dropped some defendants. Inevitably, the remaining defendants moved again to dismiss the claims based on res judicata and collateral estoppel.

And now let’s put Phillips II aside, leaving the motion to dismiss pending in limbo. But we will return to it.  (That probably sounds more like a threat than a promise, doesn’t it?)

We must hasten back to Phillips I.  As if to pile weirdness upon weirdness, the plaintiffs belatedly sought reconsideration of the dismissal of Phillips I.  It is the denial of that motion for reconsideration that is the subject of the opinion with the citation above. It has been said with respect to government regulation that complexity ends up being a form of taxation. In Phillips (be it I or II or whatever might come next), complexity seems to have taxed judicial patience.  The plaintiffs had by now squandered all credibility.  They characterized their motion for reconsideration as traveling under Fed. R. Civ. P. 59(e) and 60(b)(2), but, due to timing issues, only Rule 59(e) applied.  Then the plaintiffs attempted to support their motion for reconsideration in Phillips I by attaching a draft Second Amended Complaint filed in Phillips II. That maneuver did not work.  Indeed, it probably reinforced the court’s impression that the plaintiffs were playing games.  The key problem for the plaintiffs was that they lacked any excuse for not filing a timely amendment in Phillips I.  The plaintiffs argued that they had held off on amending their complaint in Phillips I “so as not to jeopardize the chance of settlement” in an impending mediation.  

The court in Phillips I cut through the craziness by following the criteria in Rule 59(e).  First, the plaintiffs identified no “manifest error in law or in fact” in the court’s prior dismissal.  They had not shown the court any non-futile amendment.  Second, the plaintiffs showed no “newly discovered evidence” that undercut the dismissal with prejudice.  The plaintiffs alluded to potential testimony and other facts that they asserted might have helped them, but none of it related to a key reason for dismissal — the plaintiffs’ failure to furnish pre-suit notice.  Further, nothing prevented the plaintiffs from seeking all of that discovery prior to dismissal.  The third and last criterion under Rule 59(e) was whether failure to reconsider would result in “manifest injustice.” The court in Phillips I saw no danger of manifest injustice because the plaintiffs’ failures to move for leave to amend the complaint or provide the court with detail as to what an amendment would include were the result of the plaintiffs’ “strategic choice that did not play out as they hoped.”  The plaintiffs’ delays, duplications, and inglorious muteness did them no favors. Bad strategic choices, whether or not they could be laid at the feet of counsel, are not the stuff of manifest injustice.  The PhillipsI court applied Rule 59(e), denied the plaintiffs’ motion for reconsideration, and struck a blow for fairness, rationality, and finality.  

Photo of Michelle Yeary

Yes, we are the Drug and Device Law Blog.  Yes, we at times stray into other areas when we think a decision has application to our DDL world.  Yes, today’s case is about a “drug” product.  No, today’s case is not about a drug for humans.  In fact, it really isn’t about a drug at all, but in the veterinary product world, “drug” actually carries different meanings. The upshot is Vanzant v. Hill’s Pet Nutrition, 2025 WL 296062 (N.D. Ill. Jan. 24, 20025), is a favorable FDCA preemption ruling that we thought was worth mentioning even if it presents in the unusual context of pet food.

Plaintiffs, in a previously certified class, allege that defendants unfairly marketed their “prescription diet” pet food as such in violation of the Illinois Consumer Fraud and Deceptive Practices Act (“ICFA”).  The pet food is available to consumers through veterinarians and retail pet stores, but only with a veterinarian’s prescription.  Id. at *1-2. 

Plaintiffs’ unfair practices claim evolved over time.  Originally, the complaint contained allegations that defendant used its “prescription” branding to charge above-market prices.  Id. at *5.  However, plaintiffs abandoned that theory at the class certification stage in favor of pursuing only a claim that the pet food was marketed for the treatment or prevention of disease bringing it within the definition of “drug” under the FDCA, and without FDA approval the “drug” was adulterated.  Id. at *5-6.  Not surprisingly, when faced with Buckman preemption at summary judgment, plaintiffs tried to resurrect their earlier theory, but the court rejected that dodge.  Since plaintiffs did not advance those claims at the class certification stage, they did not undergo the “rigorous analysis” required to be certified for class treatment. 

That left as the only active claim that the product was “statutorily unsafe, adulterated and misbranded” which plaintiffs premised exclusively on the product’s claimed status as an unapproved animal drug.  Because that claim would not exist in the absence of the FDCA, it was preempted.  Plaintiffs were attempting to bring a disguised FDCA enforcement claim. 

Plaintiffs put forth no argument or evidence that the . . .products are unsafe, adulterated, or misbranded outside the confines of the FDCA—in other words, there is no allegation or evidence that a pet was physically injured, fell ill, or was otherwise harmed because of the . . . products, or that the . . . products did not provide the advertised therapeutic benefits.

. . . .

To be sure, Plaintiffs allege that Defendants’ conduct . . . is unfair under ICFA. But why is it alleged to be unfair? Not because any pet was harmed or because the product does not work as promised, but solely because it falls within the FDCA’s statutory definition of unsafe, adulterated, and misbranded products.

Id. at *6, *7. 

Distinguishing products liability cases from economic loss cases, the court concluded “plantiffs’ claim was unmistakably one for direct enforcement of the FDCA, for which no private right of action exists.”  Id. at *8. 

Less on point for DDL Blog purposes, but notable, was plaintiffs’ second claim that consumers were misled to believe that the product legally required a prescription, when the prescription requirement was only imposed by the seller.  To prevail on such a claim under the ICFA, plaintiffs need to establish that the misrepresentation was “material” to reasonable consumers and that it caused actual damages.  Plaintiffs failed to proffer evidence on either materiality or injury.  In fact, the evidence showed that it made no material difference to consumers whether the “prescription” requirement was imposed by law or by the seller.  Most consumers bought the pet food because their veterinarians directed them to.  Without evidence that consumers were deceived on this point, or injured, the court granted summary judgment.  Id. at *12-13. 

Finally, one of the named plaintiffs had her claims dismissed for lack of causation based on evidence that she continued to purchase defendants’ pet food after filing suit. Id. at *13-14.  Hard to argue she was deceived. 

All that is left of this class action lawsuit is one part of plaintiff’s individual claim – making it a paws-itively delightful defense win.    

Photo of Bexis

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.

Photo of Susanna Moldoveanu

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
Photo of Eric Alexander

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.

* * * * * * *

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. 

Photo of Stephen McConnell

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.  

Photo of Michelle Yeary

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.

Drug & Device Resources

Bexis’ Book

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