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Late last year, when we were putting together our massive post that collected and categorized every case that had ever judicially noticed an FDA document, we ran across the intriguing proposition that in deciding Rule 12 pleading-based motions, “allegations in a complaint are not credited where contradicted by judicially noticeable documents.”  We cited several appellate decisions for that principle.  The most recent one, Fuqua v. Santa Fe County Sheriff’s Office, 157 F.4th 1288 (10th Cir. 2025), stated:

The general rule prohibiting courts from considering evidence outside the complaint on a motion to dismiss has an[] exception:  matters of which a court may take judicial notice.  Judicial notice allows the court to accept a matter as proved without requiring the party to offer evidence of it.  And taking judicial notice precludes a party from introducing contrary evidence and, in effect, directs a verdict against him as to the fact noticed.

Id. at 1298 (citations and quotation marks omitted).  Fuqua cited a Supreme Court case for this point, Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007).  The Supreme Court held in that case, that in adjudicating Rule 12(b)(6) motions, “courts must consider the complaint in its entirety, as well as other sources courts ordinarily examine” such as “matters of which a court may take judicial notice.”  Id. at 322.

Other cases for this proposition include Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir. 2001), affirming that in the 12(b)(6) context, courts “need not . . . accept as true allegations that contradict matters properly subject to judicial notice” or that “are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.”  Id. at 988 (citations omitted).  The Sprewell decision has been particularly influential and has been followed by several other Ninth Circuit decisions.  Readers of this post will notice a disproportionately high percentage of the cases discussed below are from Ninth Circuit district courts.

For additional appellate authority supporting the general proposition that judicial notice trumps contrary pleadings, see Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024) (affirming dismissal when considering“ all matters of proper judicial notice”) (citation and quotation marks omitted); Secured Mail Solutions LLC v. Universal Wilde, Inc., 873 F.3d 905, 913 (Fed. Cir. 2017) (“[i]n ruling on a 12(b)(6) motion, a court need not accept as true allegations that contradict matters properly subject to judicial notice”) (citation and quotation marks omitted); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021) (“this court may take judicial notice of public records, and we are not required to accept as true factual allegations that are contradicted by those records”) (citation omitted); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014) (courts “need not accept allegations that contradict matters properly subject to judicial notice”) (citation and quotation marks omitted); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004) (“Nor must we accept as true the complaint’s factual allegations insofar as they contradict . . . matters subject to judicial notice”) (citation omitted); Gupta v. Wipro Ltd., 749 F. Appx. 94, 97 (3d Cir. 2018) (“Although we generally must accept as true the complaint’s factual allegations, this requirement does not apply when the allegations are contradicted by . . . matters subject to judicial notice.”) (citation and quotation marks omitted).

We decided to look for cases that apply the general proposition that courts need not accept as true allegations refuted by matters subject to judicial notice in the specific context of prescription medical product liability litigation.  One such case is Plumlee v. Pfizer, Inc., 2014 WL 4275519 (N.D. Cal. Aug. 29, 2014), where the court took judicial notice of a drug’s FDA-approved labeling and certain changes to that labeling that also went through proper FDA regulatory channels.  Id. at *4 & n.2.  The court also took judicial notice of the existence of “dozens of exhibits submitted by Defendant” that “directly contradict Plaintiff’s claim.”  Id. at 8.  Those exhibits established that, contrary to the plaintiff’s allegations, she could not, as a “reasonable consumer,” have been “ignorant” of the issue she belatedly sought to litigate after the expiration of the statute of limitations.  Id. at *8.

On appeal, the Ninth Circuit affirmed.

[T]he district court took judicial notice of an extensive record of documents − all publicly available during the relevant limitations periods − which discussed [the efficacy issues raised by plaintiff’s complaint]. The district court did not err in taking judicial notice of these documents.  The judicially noticed documents either identified [the drug] specifically or referred to antidepressants generally. . . . Therefore, the district court properly rejected [plaintiff’s] allegation that no information questioning [the drug’s] efficacy existed within the three- and four-year limitations periods. . . to which a reasonably diligent consumer would have been exposed.

Plumlee v. Pfizer, Inc., 664 F. Appx. 651, 653-54 (9th Cir. 2016).

Chapman v. Abbott Laboratories, 930 F. Supp.2d 1321 (M.D. Fla. 2013), reached a similar result.  In Chapman the plaintiff’s allegations about the drug’s warnings were directly contradicted by its FDA-approved labeling, which was subject to judicial notice.

[Plaintiff’s] claim is squarely contradicted by the . . . judicially-noticed drug label that does contain warnings. . . .  This conflict renders implausible the failure to warn theory as currently pled in [plaintiff’s] strict liability and negligence counts. . . .  [It is] clear that the overarching theme of [plaintiff’s] case is failure to warn, as evidenced by [plaintiff’s] counsel’s summary of the action in his response to the motion to dismiss. . . .   Accordingly, the Court will grant the motion to dismiss insofar as it seeks dismissal of the strict liability and negligence counts.

Id. at 1323-24 (citation omitted).

Another example is De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. 2016).  Relying on judicially noticed FDA enforcement materials (Forms 483) the court dismissed the plaintiff’s manufacturing defect claims because they misconstrued the contents of those documents:

[T]o escape implied preemption [plaintiff] must allege that the irregularities documented in the Form 483s resulted in a manufacturing defect that caused her injuries. . . .  [Plaintiff] has failed to allege such a manufacturing defect.

The complaint offers no description of the “non-conforming material” used in manufacturing the device, or how the use of that material caused a defect in the product itself.  In fact, the Form 483 indicated that [defendant’s] contract manufacturer used the “non-conforming material” in a validation protocol, not in the actual manufacture of the product.  Moreover, the report indicated that the manufacturer had erred by failing to adequately document the disposition of that material, not by using the material itself.  [Plaintiff] has provided no basis for concluding that the failure to document the disposition of non-conforming material in a validation protocol caused a manufacturing defect in any . . . device.

Id. at 1094-95 (citations omitted).  See also Id. at 1096, 1098 (additional dismissals of failure to train and express warranty claims due to contradiction with judicially noticed FDA documents).

Likewise, in Trisvan v. Heyman, 305 F. Supp.3d 381 (E.D.N.Y. 2018), the plaintiff alleged – falsely – “that there were no warnings about the relevant side-effects” with the defendant’s drug.  Id. at 399 (emphasis original).  Since the defendant’s judicially noticed warnings (and the Physician’s Desk Reference) belied that allegation, it was ignored and the aspect of the plaintiff’s complaint was dismissed:

In contrast to most other failure to warn cases, the adequacy of the warning in this action turns on its mere existence.  Defendants, however, have offered FDA-approved labels as evidence of warnings provided to physicians contemporaneous with or predating Plaintiff’s use. . . .  At the very least, these FDA labels list [specific warnings omitted].  Accordingly, Plaintiff’s failure to warn claims based on a lack of any warnings are dismissed with prejudice.

Id. at 400 (citations omitted).  Accord Trisvan v. Heyman, 2018 WL 6573434, at *4-5 (E.D.N.Y. Dec. 13, 2018) (second dismissal for “allegations in a complaint that contradict or are inconsistent with judicially-noticed facts”) (footnote omitted).

In Carter v. Amgen, Inc., 2015 WL 13388039 (C.D. Cal. July 16, 2015), aff’d, 682 F. Appx. 620 (9th Cir. 2017), plaintiff repeatedly alleged, in conclusory function, that the relevant use of a drug was “contraindicated.  Id. at 6.  “[J]udicially noticed FDA labels” established that these allegations were untrue, and the claim was dismissed:

[T]he contraindicated allegation is directly contradicted by the FDA-approved labels that the Court has judicially noticed. . . .  The labels each contain a section entitled “Contraindications”. . . .  [discussion of labeled contraindications omitted]  Thus, the Court need not accept as true the allegation that [the drug] was “contraindicated” for [decedent’s] use of the drug because the judicially noticed labels demonstrate that the allegation blatantly false.

Id. (citations and quotation marks omitted).

The same result occurred in Becker v. Cephalon, Inc., 2015 WL 5472311 (S.D.N.Y. Sept. 15, 2015).  Plaintiff’s warning-related allegations were “squarely contradicted” by the drug’s judicially noticed labeling, requiring their dismissal:

While a court must generally accept a plaintiff’s factual allegations as true in evaluating a motion to dismiss, it need not accept as true allegations in a complaint that contradict or are inconsistent with judicially-noticed facts.  Plaintiff’s allegations that [defendant] failed to warn of the risk [at issue] when taking [the drug] . . . are squarely contradicted by the [drug’s] label. . . .  Because all of the alleged side effects described by Plaintiff are specifically indicated as potential side effects in the drug’s package insert, . . . Plaintiff’s strict liability and negligence products liability claims based on a failure to warn theory are foreclosed and must be dismissed.

Id. at *5-6 (citations and quotation marks omitted).

Those decisions are hardly all the examples we found of contradictions with judicially noticed material resulting in Rule 12 dismissal.  Here are a bunch of other cases where FDA materials or other unimpeachable documents concerning FDA regulated products were judicially noticed and resulted in dismissal of claims, despite contrary pleaded allegations.  Govea v. Medtronic, Inc., 2025 WL 3467214, at *13 (C.D. Cal. Nov. 26, 2025) (judicially noticed FDA device approval establishes its intended uses; plaintiff’s claim of off-label promotion is dismissed because it concerned a labeled use); Brock v. City of Bellingham, 2025 WL 254725, at *5 (W.D. Wash. Jan. 21, 2025) (judicially noticing FDA COVID vaccine emergency use approvals; “[g]iven the judicially noticeable facts . . ., the Court concludes that the . . . vaccine available to Plaintiffs was not an ‘investigational drug’ at any time relevant to Plaintiffs’ claims”); Argueta v. Walgreens Co., 760 F. Supp.3d 1028, 1038 (E.D. Cal. 2024) (complaint dismissed where court took judicial notice that the defendant’s product “is indeed a drug approved for the treatment” of the relevant condition); Curtis v. PeaceHealth, 2024 WL 248719, at *2 (W.D. Wash. Jan. 23, 2024) (same as prior Curtis holding), aff’d, 154 F.4th 678 (9th Cir. 2025); Curtis v. Inslee, 709 F. Supp.3d 1257, 1265 (W.D. Wash. 2023) (The COVID vaccine’s status “is accurately and readily determined from the FDA’s approval and CDC’s explanation,” which “are sources whose accuracy cannot be reasonably questioned”), aff’d, 154 F.4th 678 (9th Cir. 2025); Leake v. Raytheon Technologies Corp., 2023 WL 2242857, at *1 n.2 (D. Ariz. Feb. 27, 2023) (judicially noticed FDA information established that allegation of a product recall was “demonstrably false”), aff’d, 2024 WL 1854287 (9th Cir. April 29, 2024); Morris v. Sun Pharma Global, Inc., 2021 WL 3913191, at *3 (C.D. Cal. May 13, 2021) (allegation that defendant was a drug “manufacturer” contradicted by judicially noticed FDA document listing defendant as a “distributor”; “[a]ll of Plaintiff’s allegations based on negligence relate to the manufacturing, not the distribution, of [the drug]”, so “Plaintiff fails to state a negligence claim”); Gioia v. Janssen Pharmaceuticals, 2021 WL 602683, at *4 (E.D.N.Y. Feb. 16, 2021) (judicial notice taken of drug labeling; “plaintiff’s conclusory allegations coupled with plaintiff’s allegations of suffering from the very side effects of which defendant warns, require dismissal of plaintiff’s claim”); Dye v. Covidien LP, 470 F. Supp.3d 1329, 1341 (S.D. Fla. 2020) (judicial notice taken of FDA-approved device instructions for use; “[c]learly, the IFU contradicts all of Plaintiff’s allegations”); Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1163 & n.5 (E.D. Cal. 2019) (warning claims dismissed as inconsistent with judicially noticed drug label); Lifeway Foods, Inc. v. Millenium Products, Inc., 2016 WL 7336721, at *2 (C.D. Cal. Dec. 14, 2016) (non-prescription medical product case; judicially noticed FDA letters; “this Court . . . will not blindly accept allegations which are directly contradicted by evidence subject to judicial notice”); Porter v. Wetzel, 2012 WL 4442792, at *5 (Mag. W.D. Pa. Aug. 24, 2012) (judicial notice of FDA approval established that, contrary to the complaint, plaintiff received appropriate medical care), adopted, 2012 WL 4378116 (W.D. Pa. Sept. 25, 2012); In re Bayer Corp. Combination Aspirin Products Marketing & Sales Practices Litigation, 701 F. Supp.2d 356, 367-68 (E.D.N.Y. 2010) (allegations contrary to judicially noticed FDA documents disregarded; “[a]lthough . . . a motion to dismiss . . . tak[es] all the allegations as true . . ., the court is not required to reason in a vacuum”).

As our earlier post demonstrated, many types of FDA materials have properly been the subject of judicial notice.  To the extent that a complaint makes factually false allegations that defense counsel can refute by judicially noticeable FDA documents, these allegations can be disregarded for purposes of otherwise pleadings-based motions under Rule 12.  Successfully doing so can be of great value to our clients, which are thereby spared the expense and bother of discovery that waiting for summary judgment would otherwise require.

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Today’s guest post is by Kevin Hara, of Reed Smith, who is pinch-hitting for Steve Boranian. His post today discusses the Texas Supreme Court’s procedural reversal of a lower court’s refusal to hear an interlocutory appeal concerning application of a Texas distributor immunity statute arising in the context of an FDA-regulated drug. The distributor’s motion to dismiss had been denied by the lower court’s creation of a “product liability” limitation on the statute that was contrary to the statute’s express terms. As always, our guest posters should receive all the credit (and any blame) for their writings.

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It is an honor to pinch-hit for a great friend and mentor, one of the regular contributors to this esteemed blog who is enjoying a much-deserved respite.  As readers of this blog are aware, Plaintiffs and their attorneys are relentlessly seek to circumvent limitations on defendants’ liability, whether through creative pleading, trying to categorize the learned intermediary rule as an affirmative defense (it is not), pleading around defenses like the statute of limitations and preemption, blatant forum shopping—a plaintiffs’ playbook favorite—or in today’s case, seeking to evade the plain language of a Texas statute that limits the liability of non-manufacturing sellers. See Tex. Civ. Prac. & Rem. Code § 82.003. (“Section 82.003”).

The Texas Supreme Court recently issued an important procedural decision granting interlocutory review for a “substantial ground for difference of opinion” as to the interpretation of Section 82.003 that will potentially eliminate liability for the distributor in this featured action and other non-manufacturing sellers in the future.  That is good news, because Texas has often been problematic for product liability defendants, as the jurisdiction that invented the heeding presumption (which Texas thankfully no longer applies to prescription medical products), and a very late (if relatively enthusiastic) adopter of the learned intermediary rule.

In McKesson Medical-Surgical Inc. v. Cleveland, No. 26-0005, 2026 Tex. LEXIS 654, at *1-2 (Tex. June 26, 2026), the plaintiff died after visiting a medical spa, allegedly as a result of an infusion containing Total Parenteral Nutrition (“TPN”) electrolytes, an FDA-regulated drug that is administered intravenously to persons with impaired digestive systems due to medical conditions that inhibit their ability to process food and absorb nutrients.

The decedent’s relatives filed suit in Texas state court against the spa and the distributor of the TPN electrolytes; the latter moved to dismiss under Section 82.003.  This statute provides that “[a] seller that did not manufacture a product is not liable for harm caused to the claimant by that product unless the claimant proves” one of seven possible exceptions, including the types of involvement—inter alia, product design, warnings, alterations, express warranties, or knowledge of pre-existing product defects—that are not typical of distributors that act as conduits for supplying pharmaceuticals and medical devices in their original form.  See Section 82.003(a)(1)-(7).  Many states have similar “sealed package” statutes designed to insulate non-manufacturing sellers from liability.  This is sound policy because distributors (often named to defeat diversity) generally have no input or control over the design, manufacture, or warnings pertaining to such products.  Nor would they have knowledge of any alleged defects.  Therefore, statutes analogous to Section 82.003(a) are an important part of the arsenal in defending product liability actions as Bexis detailed here.

The plain language of the statute precludes liability against the distributor of the TPN electrolytes unless the plaintiffs establish one of the enumerated exceptions, and one would think that would be the end of the story.  If only things were that easy.  Unfortunately, that unambiguous language was not enough—at least for now.  Plaintiffs argued that the statute “applie[d] only to product liability actions,” not to their claim, simply because they chose not to allege that the “TPN electrolytes were defective.”  Rather, they contended that the distributor negligently created “an online portal” allowing an unlicensed purchaser to order TPN electrolytes for shipment to the spa.  Cleveland, 2026 Tex. LEXIS 654, at *2-3.  Notably, the statute contains no product liability limitation, nor is the “negligence” argument one of the seven exceptions to Section 82.003(a).

However, this atextual limitation was enough for the trial court to deny the distributor’s motion to dismiss, agreeing that Section 82.003(a) “[did] not apply to sellers, . . ., in cases that are not ‘product liability actions,’” while citing no appellate authority supporting its conclusion.  The trial court acknowledged that the only on-point case, Lopez v. Huron, 490 S.W.3d 517 (Tex. App. 2016), was “potentially doubtful” because the statutory language did not limit its application to product liability actions. Cleveland, 2026 Tex. LEXIS 654, at *3.  That doubt led the trial court to grant the distributor’s request to appeal, framing the legal question: “whether [Section] 82.003(a) . . . applies to sellers in cases that are not product liability actions or whether it applies only to sellers in ‘products liability actions’ or cases where damages are allegedly caused by defective products.”  Id. (quotations omitted.)

That led to more obstruction.  The intermediate appellate court denied the petition, ruling that the distributor failed to show “‘a substantial ground for difference of opinion’ regarding the controlling legal question.”  Id. at *4.  That court also concluded that the absence of authority contrary to Lopez weighed against allowing the appeal.  Id.  Fortunately, the Texas Supreme Court disagreed—finding that while the existence of conflicting authority “strongly suggests a substantial ground for difference of opinion,” . . . “an actual conflict” is unnecessary “when the statute is subject to competing reasonable interpretations.”  Id.  The Texas high court cited the “express acknowledgment” in Lopez that its conclusion was at odds with Section 82.003(a)’s text as enough to establish “that reasonable jurists could disagree with Lopez regarding Section 82.003(a)’s scope.”  Id.  Conversely, the trial court acknowledged Section 82.003(a) has more than one plausible interpretation and that the Texas Supreme Court had yet to render a definitive decision on the issue.  Accordingly, there was “a substantial ground” for differing opinions under Tex. Civ. Prac. & Rem. Code § 51.014(d)(1) (providing the usual “controlling question” and “substantial grounds” test for interlocutory appeals by permission).  The Texas Supreme Court specifically stated that the “substantial ground for difference of opinion” standard is broad, rather than restrictive, designed to permit appeals of “genuinely disputed legal questions in varied contexts.”  Cleveland, 2026 Tex. LEXIS 654, at *5 n.1.

Further, while not deciding whether principles of statutory construction—discussed in the appellate court opinion—merited following Lopez, the Texas Supreme Court highlighted that the “potential clash with Section 82.003(a)’s plain text substantiates that an interlocutory appeal is appropriate.”  Id. at *5.  The court rejected the court of appeal’s reliance on “passing comments” in another case that stated only “that non-manufacturing sellers are not liable for product defects,” finding that action “indisputably involved alleged product defects.”  Id., citing Amazon.com, Inc. v. McMillan, 625 S.W.3d 101, 109 (Tex. 2021).

Against that backdrop, the Texas Supreme Court ruled that the appellate court erred in concluding that the distributor failed to satisfy the criteria for Section 51.014(d)(1) and never addressed the statute’s second requirement—whether “an immediate appeal . . . may materially advance the ultimate termination of the litigation.” Id., citing Section 51.014(d)(2).  In contrast, the trial court ruled an immediate appeal would “resolve a dispositive legal question prior to trial . . . because a ruling in [the distributor’s] favor” on Section 82.003(a) would “eliminate all potential claims.”  Id. at *5-6.  The court favorably cited prior appeals that obviated discovery burdens, “eliminate[d] the need for further litigation,” or would be dispositive of at least some of the claims against the defendants.  Id. at *6.

Plaintiffs argued an immediate appeal would “neither streamline the litigation nor dispose of all claims,” and that resolution of the applicability of the enumerated exceptions in Section 82.003(a) would not result in the distributor’s dismissal.  Id.  That was a straw man, as plaintiffs never alleged they met Section 82.003(a)’s exceptions, and therefore, if the statute applied, it would dispose of all the claims against the distributor—sufficient to satisfy Section 51.014(d)(2).  Id. at *6-7.  The Supreme Court emphasized that this was “precisely the kind of case in which an immediate appeal would allow for the efficient correction of error instead of risking the waste of judicial and party resources.”  Id. at *7 (emphasis added).

Thus, the “court of appeals erred in concluding that there was no substantial ground for difference of opinion” and should have granted the request for an appeal because “(1) the statutory construction question has not been decided by this Court and has more than one plausible answer and (2) resolution of the question may materially advance the litigation’s termination.”  Id.  Thankfully, the court granted the petition for review and ordered the appellate court to accept the appeal.  Id.  The Texas Supreme Court’s decision is one step in the right direction and gives the distributor and other sellers hope for the future.  This case still bears watching for a Texas two-step: a successful appeal and dismissal of the distributor under Section 82.003(a).

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This post comes from the non-RS and non-Dechert side of the Blog.

The great post-modern existentialist philosopher John Madden once said, “If you have two quarterbacks, you actually have no quarterback.”  This was not the result of a fanciful math equation where you (impermissibly) divide by zero.  In American football, except on rare trick plays, only one quarterback will be on the field at the same time (even though up to six players on offense are eligible to throw the ball forward in a given play).  Splitting the practice and game snaps nearly evenly between two different quarterbacks tends to be a bad idea.  The saying does not really translate to the other football, except perhaps if you swap in “goalkeeper” for “quarterback.”  What about product liability claims?  Can two separate products cause the plaintiff’s claimed injury?  In most jurisdictions, depending on timing, yes.  What about 179 separate products to which the plaintiff was allegedly exposed on a regular basis for more than a decade leading up to the diagnosis of his claimed injuries?  No way.  We doubt that any complaint with that basic fact pattern could even make sufficient factual assertions to get past a motion to dismiss in federal court.

The plaintiff in Martinez v. Kraft Heinz Co., No. 2:25-cv-00377, 2026 WL 1878602 (E.D. Pa. June 30, 2026), sure could not do it in two tries and was not given a third chance.  The Martinez plaintiff claimed to have developed type 2 diabetes and steatohepatitis (fatty liver) by the time he was sixteen.  He blamed this on his collective use of 179 different food and beverage products that he had been voluntarily consuming on a regular basis since he was 3 years old.  His lawyers lumped these together as “Ultra Processed Foods” and threw together a very long and obviously templated complaint to detail the purported risks of these products, their ingredients, and aspects of their manufacturing.  Presumably, the core of these allegations could be used to try to support a general link between a bunch of different products and a range of diseases/conditions.  Perhaps, the individual products and their manufacturers were selected by the lawyers to be addressed in any complaint rather than coming from the actual list of what foods this plaintiff had been consuming regularly over that thirteen year period.  In any event, plaintiff’s first complaint failed to meet TwIqbal standards for causation, which was required for each of his asserted claims.  The “shotgun approach” did not “identify any specific products consumed by Martinez, when or how they were consumed, or how that consumption relates to Martinez’s diagnoses,” leaving it uncertain “who is responsible for what.”  Id. at *3.  Defendants had wisely removed this case from the Philadelphia Court of Common Pleas, where the pleading standards would surely have been more lenient. 

The amended complaint, presumably intended to correct the failures the court had previously identified, is what we are discussing here.  Perhaps because he knew he could not offer the required defendant- and product-specific allegations he needed, plaintiff also tried to get the court to bite on inapplicable theories of liability.  As it was, plaintiff’s second complaint attempted more misdirection and fearmongering rather than offering factual assertions that might have established legal causation.  “[A]llegations of increased risk, biological plausibility, and association do not show that any particular product—and particular Defendant’s product—actually caused Martinez’s diagnoses.”  Id. at *6.  None of the non-Pennsylvania law that plaintiff cited supported that his collective causation assertions could suffice for specific causation.  For us, there was a good source of the applicable law not discussed in Martinez that further supports the ruling.  Pennsylvania has Suggested Standard Jury Instructions, including one on “factual cause” that would have applied to plaintiff’s claims had they proceeded to trial.  The unaltered text of the current SSJI (Civ) § 13.20 is as follows:

In order for [name of plaintiff] to recover in this case, [name of defendant]’ s [negligent] [grossly negligent] [reckless] conduct must have been a factual cause in bringing about harm. Conduct is a factual cause of harm when the harm would not have occurred absent the conduct. To be a factual cause, the conduct must have been an actual, real factor in causing the harm, even if the result is unusual or unexpected. A factual cause cannot be an imaginary or fanciful factor having no connection or only an insignificant connection with the harm.

To be a factual cause, [name of defendant]’s conduct need not be the only factual cause. The fact that some other causes concur with [name of defendant]’ s negligence in producing an injury does not relieve [name of defendant] from liability as long as [his] [her] [their] own negligence is a factual cause of the injury.

The Subcommittee’s notes also cite a number of Pennsylvania cases explaining the specific causation standards, including in cases with multiple defendants, although none of them were cited in Martinez.  Taking even what seems to be plaintiff’s allegedly most-often consumed product, a particular brand of cheese slice, its contribution to plaintiff’s alleged injuries would undoubtedly be an “imaginary or fanciful factor having no connection or only an insignificant connection with” his alleged injuries when lumped together with 178 other allegedly harmful food items that plaintiff also regularly consumed.  Even if the complaint had been pared down to omit mention of most of the other allegedly harmful food items that plaintiff regularly consumed, it is hard to imagine a plausible allegation that the consumption of these cheese slices was “an actual, real factor” in him developing diabetes in light of his overall diet, to say nothing of his genetics, activity level, and other risk factors.  Without much more, it is even more implausible that the same 179 products were factual causes of both of plaintiff’s diagnoses.

Of course, plaintiff and his lawyers made the decision to target 179 different products sold by eleven different companies, which made it much harder to offer factual allegations sufficient to establish plausible specific causation under TwIqbal.  Were we deciding the adequacy of plaintiff’s complaints, we might have said plaintiff bit off more than he could chew or had eyes bigger than his stomach, but the Martinez court was overtly sympathetic to plaintiff.  It noted that the causation pleading requirement “creates a unique challenge for plaintiffs, like Martinez, who consume a large number of products over a lengthy period of time.”  Id. at *4.  Frankly, we draw the opposite conclusion from the court’s observation that “Martinez casts a wide net in seeking to hold numerous food producers liable for illnesses resulting from his consumption of nearly two hundred different products over the court of multiple years.”  Id.  It is not a failing of the law that plaintiff did not have a plausible causation story to assert.  It is not unfair that a defendant gets to insist that a liability be based on proof that its conduct caused plaintiff’s injury.  Plaintiff’s burden does not diminish because he sues ten other defendants and claims that 150 or so of their products also caused his injuries.  The court’s sympathy, though, led it to consider and reject plaintiff’s attempts to get special rules for cases like his.

Plaintiff dragged out Summers v. Tice and the Pennsylvania equivalent, Snoparsky v. Baer, 266 A.2d 707 (Pa. 1970), to suggest that he should get a lessened causation burden under an alternative joint liability theory.  Id. at *6-7.  Summers is the famous hunting accident case and Snoparsky involved a child’s injury from getting hit by a rock thrown by one of a group of rock-throwing children.  “[T]his doctrine exists to redress harms caused by one defendant from within a comprehensive, but otherwise limited, pool of potential harm-doers, only when determining fault is otherwise impossible.”  Id. at *7.  Plaintiff’s attempt to impose simultaneous liability on eleven manufacturers for making 179 products that were not alleged to be the only contributors to his alleged injuries was not remotely like the limited cases that had accepted this unusual theory.  The old DES case in the Philadelphia Court of Common Pleas that permitted alternative joint liability involved identical products made by multiple manufacturers that controlled substantially all the market but the plaintiff could not determine whose DES her mother took long ago.  Id. at *7-8 (discussing Erlich v. Abbott Labs., 5 Phila. 249 (Phila. Ct. Com. Pls. 1981)).  By contrast, the Martinez plaintiff’s suit sought to impose liability against eleven defendants that made many different products he claimed to have consumed.  The Eastern District of Pennsylvania had previously rejected the theory in another case seeking to impose liability for a physical injury on eleven defendants that made different products to which plaintiff claimed exposure over time.  Id. at *7 (discussing Klein v. Council of Chem. Assocs., 587 F. Supp. 213 (E.D. Pa. 1984)).  “[G]iven Pennsylvania’s hesitance to expand the alternative liability doctrine beyond those involving identical products,” the court could not take the “significant logical leap” to apply it to this case.  Id. at *8.  Had Martinez acknowledged the need for Erie restraint, the required leap would have been even harder.

Martinez also entertained the market share liability theory that had originated in the notorious California Sindell DES case.  It noted that the Southern District of New York had predicted, despite an acknowledgement of Erie restraint, that the Pennsylvania Supreme Court would likely adopt market share liability in a groundwater contamination case involving fungible products made by multiple manufacturers.  Id. at *8 (discussing In re Methyl Tertiary Butyl Ether (MTBE) Prods. Liab. Litig., 379 F. Supp. 2d 348 (S.D.N.Y. 2005)). The allegations in Martinez, however, were not close to that fact pattern, including because its defendants sold different products with different alleged problems.  If Martinez had checked the Blog, it would have seen a number of cases rejecting market share liability under Pennsylvania law in situations that were much closer to basic facts in Martinez, but a deeper dive was not needed to reject market share liability.  Nor did the court suffer the failing of many courts to give plaintiff a third bite at the proverbial apple:

The FAC fails to establish but-for causation because it lacks sufficient facts showing each Defendant or product individually caused or contributed to his harm.  Removing one Defendant or one product illustrates the deficiencies—the outcome would not change.  Alternative liability and market share liability cannot save Martinez’s claims because Defendants’ products and the dangerous chemicals contained therein are not the same.  For these reasons, leave to amend must be denied.

We note that Martinez did not go further and address whether plaintiff’s liability allegations were sufficient.  We have our doubts.  Plaintiff had alleged that all of the products were designed and marketed to “promot[e] subconscious overconsumption.”  In other words, the plaintiff lawyers were following the social media playbook that demonized the edible version of infinite scrolling and minimized personal responsibility.  The reptilian appeal of the typical plaintiff tactics may or may not translate to sweeping attacks on food and beverages, whether lumped together under the label of ultra-processed, genetically-modified, shelf-stable, or something else.  After all, ascribing negative mental health impacts to the plaintiff’s use of a specific application, website, or chat bot is a far cry from ascribing the plaintiff’s development of diseases that occur in the general population collectively to his consumption of a number of different foods and beverages over the course of many years.  As oversimplified, if not unscientific, as many discussions of public health have become, it would be particularly simplistic to make the precise source of the roughly 12 million calories that the plaintiff in Martinez would have consumed from when he started consuming the defendants’ 179 different products until he was diagnosed with type 2 diabetes and steatohepatitis the sole focus.  Designing or marketing a food so that people continue to buy and consume it does not sound tortious.  It sounds pretty normal.  By contrast, how a company’s particular food products fit into larger public health issues like increasing rates diabetes diagnoses among teens is very complex.

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Lately, weirdly, sadly, some people have suggested that the Enlightenment was a mistake. They contend that an overemphasis on rationality robbed humanity of feeling, faith, etc. What drivel. Every day of the week, we’ll take Voltaire over any pretend-King, data over dogma, and science over stupidity. 

Thus, we are pleased with Miller v. McDonald, 2026 WL 1871521 (2d Cir. June 30, 2026), another appellate win for mandatory school vaccination requirements.  

The opinion begins with a recitation of New York’s history of regulating immunization in schools. In 1860, New York empowered school officials to deny admission of unvaccinated students. There were exemptions for students who could not be vaccinated for medical reasons or those whose parents held religious objections. Much more recently, in 2018-19, New York became the epicenter of a measles outbreak. Following that outbreak, the legislature repealed the religious belief exemption but not the medical exemption. Various Amish community schools and their officials brought this lawsuit under 42 USC section 1983, alleging that the immunization law infringed their free exercise rights under the First and Fourteenth Amendments. The plaintiffs also argued that the law impaired the right of parents to control the religious upbringing of their kids. 

The plaintiffs relied on Wisconsin v. Yoder, 406 U.S. 205 (1972), a case studied by pretty much everyone who attended law school over the last 50 years. In Yoder, the Supreme Court held that the First Amendment free exercise right of Amish parents outweighed the state’s interest in compelling school attendance beyond eighth grade. That precedent might not be precisely on point, but it is pretty helpful for the plaintiffs. But it was not helpful enough.  

The district court in Miller granted the state’s motion to dismiss and the Second Circuit affirmed. But then the United States Supreme Court granted certiorari, vacated the judgment, and sent the case back for reconsideration in light of Mahmoud v. Taylor, 606 U.S. 522 (2025). In Mahmoud, the Supreme Court overturned a school board’s refusal to allow parents to opt their young children out of classroom instruction using storybooks that conveyed messages contrary to the parents’ religious briefs.  

Thus, the Miller plaintiffs got a do-over. But after going through an analysis of the free exercise claims and the interplay of Mahmoud with Yoder, the Second Circuit decided it had been right all along and, again, affirmed dismissal of the case. Again, the Second Circuit held that New York did not act unconstitutionally when it repealed its religious exception to mandatory vaccination following a measles outbreak.  

The Second Circuit began its analysis with the observation that generally applicable vaccination requirements do not unconstitutionally burden the free exercise of religion. For the umpteenth time, we are treated to a citation to the Jacobson (1905) case in which the Supreme Court upheld a Massachusetts law requiring vaccination against smallpox. A neutral vaccination mandate need pass only rational basis review.  By contrast, a vaccination law animated by hostility to a particular religious sect would face fatal-in-fact strict scrutiny. As in Jacobson, the New York vaccination mandate was religiously neutral, and addressed a legitimate governmental interest in preventing communicable disease. It was an easy rational basis case. “Government is generally free to place incidental burdens on religious exercise so long as it does so pursuant to a neutral policy that is generally applicable.”  Repealing a religious exemption does not transmute an otherwise neutral law into one that targets religious belief.  The legislative history, read as a whole, does not show religious bias. (There might have been some isolated bits supporting the plaintiffs’ suspicion of bias, but they were isolated and unrepresentative, and serve as reminders of why Justice Scalia was deeply skeptical of legislative history.) Providing medical exemptions does not require providing religious ones.  The two are not comparable.  The medical exemption is the same as other vaccination exemptions that are constitutionally permissible.  

Further, mandatory vaccination does not unconstitutionally burden parental rights.  It is a general health requirement that does not seek to change any child’s religious belief. The burden of mandatory vacination “is not remotely of the same character as those imposed in Yoder and Mahmoud. The law is a public health measure, not an instrument of ideological indoctrination. It does not expose children to values or beliefs that might be hostile to their parents’ religious beliefs.”

Score one for public health. And while we’re at it, score one for leading figures of the Enlightenment, such as Montesquieu, Adam Smith, and, yes, John Adams and Thomas Jefferson. 

Post-script: On June 29, the Supreme Court denied certiorari in another vaccine-related appeal, Doe v. Hochul, from another Second Circuit/NY decision, that made similar religiously based attacks on mandatory vaccination, in that case, employment-related.  Doe had been hanging around all term, with more than the average amount of activity,  https://www.scotusblog.com/cases/does-1-2-v-hochul/.

The day after the denial, the Second Circuit handed down Miller.  Maybe a coincidence, maybe not.

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We have written before about the Taxotere eye injury MDL — and we wish we could say things were getting better. They are not.

Last December, we noted the fundamental absurdity at the heart of this litigation. Cancer patients — many of them breast cancer patients — were given Taxotere, a chemotherapy drug. The label warned that excessive tearing “may be attributable to lacrimal duct obstruction.” Plaintiffs’ lawyers, never ones to let adequate warnings stand in the way of a good MDL, decided that was not good enough. They wanted the label to say the tearing may be caused by “stenosis of the nasolacrimal drainage system.” And so we have, as we put it before, thousands of lawsuits, nearly a decade of litigation, and only the lawyers reaping anything other than minimal benefit.

Now the same MDL court has denied the defendant’s motion for summary judgment on warning adequacy. In re Taxotere (Docetaxel) Eye Injury Products Liability Litigation, 2026 WL 1839097 (E.D. La. June 25, 2026). The court managed to find genuine disputes of material fact lurking in what is, at bottom, a series of complaints that could be described as the medical terminology equivalent of arguing about whether a “hot dog” is a “sandwich.” The court did not even bother to apply the law of any particular state, applying instead a kind of generalized, multi-jurisdictional soup of failure-to-warn principles. The result is a roadmap for how to nitpick a warning to death.

Let us count the ways plaintiffs were permitted to pick apart an otherwise adequate warning.

Number 1. The label warned of “lacrimal duct obstruction.” Plaintiffs argued it should have said “nasolacrimal drainage system.” The defendant’s regulatory expert opined there was no material distinction between the two — that “nasolacrimal” and “lacrimal” do not “inherently change the characterization of the condition or impart additional or more useful information for the prescriber.” Id. at *5. On the other side, one of plaintiffs’ experts opined that “lacrimal duct obstruction is not terminology he uses in his practice.” Id. He didn’t say he didn’t understand the term, just that he personally does not use it. The court found a jury question. We find an eye roll.

Number 2. The defendant pointed to Stedman’s Medical Dictionary, which defines “obstruction” as a “blockage or clogging, e.g., by occlusion or stenosis.” Id. at *4. Stenosis, in other words, is one of the things that causes obstruction. Obstruction is the thing the label warned about. So the label warned about the thing caused by the thing plaintiffs say should have been mentioned. Plaintiffs countered with a different edition of the same dictionary that defines stenosis as a “narrowing” and cautions not to confuse it with “occlusion.” Id. The court found a jury question. We find it hard to keep a straight face.

Number 3. The label did not specifically say the condition could become permanent. Plaintiffs say it should have. To compound matters, the label noted that certain visual disturbances were “reversible upon discontinuation of infusion.” Defendant argued, correctly, that this referred to the immediately preceding sentence about transient visual disturbances during infusion — not to lacrimal duct obstruction, which appeared several sentences earlier. The court disagreed. Viewing everything in the light most favorable to plaintiffs, the court found a jury could conclude the label misleadingly implied the tearing risk was also reversible. Id. at *6.

Number 4. Plaintiffs’ expert opined the label should have warned physicians to promptly refer patients to an ophthalmologist upon signs of excessive tearing and mentioned the potential need for surgical intervention. This, as we have noted before, is the pharmaceutical equivalent of requiring a car manufacturer to tell drivers how to parallel park. Labels are not required to instruct physicians on how to practice medicine. The court acknowledged that manufacturers generally need not instruct physicians how to manage disclosed side effects, but found this wasn’t necessarily a “management instruction” and again found a jury question. Id. at *6.

And number 5. On top of all of that, plaintiffs’ expert opined the warning should have appeared in the “Warnings and Precautions” section rather than in the “Adverse Reactions” section. The court let that theory survive too. Id. at *7. This, again, is a theory we have seen before and continue to find unpersuasive — especially for a risk that is, let’s remember, associated with a chemotherapy drug being given to cancer patients.

Before getting to the merits of the warning claims, the court noted something worth flagging: it wasn’t going to apply the law of any particular state. Plaintiffs didn’t argue for an individualized choice-of-law analysis, and the court was apparently content to proceed under a generalized “common principles” approach. Id. at *4.

In an MDL involving thousands of plaintiffs from dozens of states, that is a curious thing. The whole point of Erie is that federal courts sitting in diversity apply state law — not a blended smoothie of principles that happen to be shared by most states. Different states have different standards for warning adequacy. Some apply the learned intermediary doctrine more rigorously; some have statutory presumptions; some are more forgiving of general warnings; some require specific causal language. A ruling that deliberately declines to engage with any of that is a ruling built on a foundation that can shift at any moment — which is bad for everyone, including plaintiffs, though they may not see it that way right now.

Even setting aside all of the above, we are compelled to return to the point we made in December, because it has not gotten any less true: these plaintiffs still have to prove warnings causation.

Under the learned intermediary doctrine — which the court acknowledges applies here — adequacy is measured by whether the prescribing physician would have reasonably understood the risk. Id. at *3. And even if the jury somehow finds the warning inadequate, each plaintiff must then show that a different warning would have changed her oncologist’s prescribing decision.

So. How many oncologists are going to take the stand and testify: “Yes, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis of the nasolacrimal drainage system, and that I should refer to an ophthalmologist promptly”?

In a non-insane world, this should be something very difficult to prove. Oncologists treat cancer. They weigh the risks of chemotherapy — real risks, like neutropenia, neuropathy, and secondary malignancies — against the risk of dying from cancer. The suggestion that the difference between “lacrimal duct obstruction” and “stenosis of the nasolacrimal drainage system” would have led any oncologist to withhold chemotherapy from a cancer patient strains credulity past the breaking point.

But here we are. Thousands of cases. Nearly a decade. And counting.

If beauty is in the eye of the beholder, this MDL court seems to see beauty in every alleged gap in a warning label — no matter how fine the distinction, no matter how unlikely it would have changed anything, and no matter what state’s law is supposed to govern.

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We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation.  The reason is simple − our clients (and target audience) can be found on either side of the “v.”  So, it’s best that we leave the offering of opinions on patent/IP issues to others.

That certainly wasn’t a problem with the recent Hikma “skinny label” patent decision, Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391 (U.S. 2026).  Hikma touched off a torrent of patent-related commentary – see, e.g., here, here, here, here, here, here, here, here, and here.  We wouldn’t have been able to match that, since we’re product liability, not patent, lawyers.

But we do think that Hikma has implications for product liability litigation as well.  For one thing, it has off-label use issues throughout, even though that phrase is not directly mentioned (the decision uses “off-patent” as the equivalent).  Hikma involved the drug Vascepa, manufactured by the plaintiff/respondent Amarin Pharma.  That’s a tip off right there.  The same drug, and the same manufacturer, produced the landmark off-label use decision, Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), that we named our sixth best case of 2015.  Amarin beat the FDA on First Amendment grounds after the agency threatened to take enforcement action against the company for truthful off-label speech:

Plaintiff  . . . Amarin[] manufactures . . . Vascepa.  The FDA has approved Vascepa for one use, but doctors have widely, and lawfully, prescribed it for another.  Amarin wishes to make truthful statements to doctors relating to Vascepa’s off-label use. . . .  [that] the FDA largely but not wholly concedes . . . are truthful and non-misleading.  However, the FDA, recognizing that Amarin’s purpose . . . would be to promote an unapproved use of Vascepa, has threatened to bring misbranding charges against Amarin (and, presumably, its employees) if it does so.

119 F. Supp.3d at 198.  The initial, limited, FDA approval for Vascepa – that also made off-label use possible − occurred in 2012.  Id. at 209.

Fast forward ten years.  As Hikma discussed, “[i]n 2019, . . . the FDA approved Vascepa for a second, much more common use.”  146 S. Ct. at 1398.  The use approved in 2019 was the same use that was off-label in 2015 and was the subject of Amarin’s win over the FDA.  The more limited Vascepa use originally approved in 2012 was the same one allowed by the “skinny label” for the generic competitor in Hikma, since Amarin’s original patent for that use − but not for the more lucrative use ultimately approved in 2019 – had expired.  Id. (“Hikma [the generic defendant] now sought approval of a skinny label that included only the [more limited use that was] no longer protected by [the relevant] patent”).

Thus, the same off-label use issue existed between the parties in Hikma that had been litigated between the FDA and Amarin in 2015 – only the interested parties were different.  The FDA had been defanged and took no action against any off-label generic promotion of the same, broader use.  Instead, Amarin, the branded manufacturer, sued the generic (Hikma) on a patent-based theory that paralleled the FDA’s threatened enforcement action from 2015:

Soon after [the generic defendant] began marketing its generic drug, Amarin filed suit . . ., alleging that [defendant] had actively induced others to infringe Amarin’s patent for the [more lucrative] method of use.  Amarin alleged that the totality of [defendant’s] statements across several documents encouraged infringing uses.

Id.  Since, as Buckman has taught us, private parties cannot enforce the FDCA, the patent claim in Hikma was phrased differently – as “induced infringement” – but functionally it involves “encouragement” via speech, which is closely parallel to the FDA’s concept of “off-label promotion.”  Indeed, given the “skinny label,” the use that the generic defendant allegedly sought to induce was necessarily also off-label, since the omission of “the carved-out use” is what made the generic defendant’s label “skinny” in the first place.  Id. at 1401.

Which leads us to what the Supreme Court found lacking about the induced infringement that was pleaded in Himka.  It is not enough under Rules 8 and 12 simply to “allege a plausible chain of events through which statements made by [the defendant] could lead a healthcare provider to prescribe or dispense [defendant’s] drug” for an off-label/off-patent use.  146 S. Ct. at 1400 (quotation marks omitted).  Instead:

  • A defendant must take “affirmative steps to encourage infringement.”  Id. at 1401.
  • Statements that “comply[] with the law or with standard industry practice” are insufficient to create inducement liability.  “[A]dherence to the law and industry standards” are not “building blocks for illegal conduct.”  Id.
  • Plaintiffs “may not rely on mere omissions, inactions, or nonfeasance” to allege active inducement.”  Id. at 1402 (citation and quotation marks omitted).
  • “[W]e look for affirmative statements or actions . . . to avoid trenching on regular commerce based on such a contingent chain of events.  Otherwise, ordinary merchants could become liable for any misuse of their goods and services [by their customers], no matter how attenuated their relationship with the wrongdoer.”  Id.
  • “[V]ague statements combined with speculation about how medical providers may act in response to those statements” “come[] up short” as pleadings.  Id. (citation and quotation marks omitted).
  • Since the relevant statute “requires active not passive, inducement . . ., the question is not merely whether the statements could be plausibly understood to induce infringement, but whether they plausibly constitute affirmative steps to bring about the desired result of infringement.”  Id. (citation and quotation marks omitted).
  • Statements such as “a warning and a disclaimer” cannot be “active inducement of infringement” because they “are implausibly roundabout ways to induce medical providers to infringe” by engaging in off-label use.  Id.

The FDA’s intended use regulations, 21 C.F.R. §§201.128 (drugs), 801.4 (medical devices), as amended in 2021 (see our post here) contain similar language.  They rely on “objective” intent as “shown by labeling claims, advertising matter, or oral or written statements.”  Id.  Specifically, “intent” cannot exist “based solely on [a regulated entity’s] knowledge that such drug [or device] was being prescribed or used by health care providers for such use.”  Id.  Thus, we think that the pleading requirements for induced infringement” through encouragement of off-label use that the Court imposed in Hikma should be equally applicable to allegations that off-label speech affects a product’s “intended use” under these regulations.  It’s the same speech, subject to an equivalent affirmative intent legal element, concerning identical conduct – alleged encouragement of physician off-label use.

In addition, we think that the requirement of “active” inducement enforced in Hikma means that the latest ridiculously pro-plaintiff law review article that we’ve read, D. Simon, “Off-Label Inducement,” 111 Iowa L. Rev. 1181 (2026), is dead on arrival.  The entire premise of that article is application of “intellectual property” inducement concepts to tort law in order to create “a new theory of liability” − off-label inducement − that would hold a manufacturer liable if its speech “induces a provider to negligently prescribe, administer, or use its drug or device off-label.”  Id. (at abstract).  The article would allow liability on “evidence of a general awareness of a role in an improper activity.”  Id. at 1196.  Its “negligence” standard would not require “that the manufacturer actually knew that the promoted use was malpractice” – only that it was “foreseeable . . . regardless of the manufacturer’s intent.”  Id. at 1198.  Specifically relying on cases (including the decision reversed in Hikma), the article proposes:

[P]romotional activities can be a legal cause of the underlying tort, even if the promotion is not explicit about what it wants the infringer to do. . . .  [W]hat is problematic is the underlying behavior the speech encourages, rather than the speech itself[ such as] truthful commercial speech [that] accurately described the generic as “therapeutically equivalent to the brand product.”  But . . . in so doing, it implied that physicians should prescribe it for all uses, including the patented ones.  Even though it was truthful, the advertising could be prohibited because it encouraged tortious behavior.

Id. at 1208-09 (footnotes omitted).  But that is exactly what Hikma held was insufficient – right down to “therapeutically equivalent” claim.  See Hikma, 146 S. Ct. at 1401 (“it is normal industry practice to truthfully describe a generic drug as ‘equivalent’ to the brand-name comparator.”) (citation omitted).

Initially, we thought the “Off-Label Inducement” article was so far off the wall we weren’t going to bother with it – until Hikma obliterated the article’s core proposition less than three months after the article was published.  That’s a mercifully quick interment of a bizarre and unprecedented theory of liability.

*          *          *          *

However, there is a second, and broader way that we think Hikma is important to our sandbox.  It’s a Supreme Court application of TwIqbal’s “well-established federal pleading standard” specifically in the pharmaceutical context.  146 S. Ct. at 1399.  

[TwIqbal’s] plausibility standard asks for more than a sheer possibility that a defendant has acted unlawfully.  If the complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.  Instead, to nudge a claim across the line from conceivable to plausible, a plaintiff must plead facts that, if true, allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged, and to rule out obvious alternative explanations for the defendant’s conduct.

This case requires us to apply these familiar pleading standards to the third element of an induced-infringement claim: that the inducer took active steps to encourage direct infringement.

Id. (numerous TwIqbal citations and accompanying quotation marks omitted).  So, maybe “TwIqbal” should become “Twiqbalma.”

Nah.

But this standard does apply to all pleadings.  Hikma should mean, for example, that for any liability theory premised on “affirmative, as opposed to passive, steps,” Rules 8 and 12 cannot be satisfied by allegations of “mere omissions, inactions, or nonfeasance.”  146 S. Ct. 1400, 1402.  Hikma should apply to the pleading of any claim (such as providing information or aiding and abetting) that seeks to impose liability on a defendant for conduct that purportedly encourages others to engage in supposedly tortious conduct.  For one thing, the pleading standards listed above should apply to motions to dismiss allegations involving sales representatives, which are a common preemption dodge in prescription medical product liability litigation.

Thus, for all these reasons, we think that Hikma should have significant impact on litigation not involving patents or intellectual property – and its toughened pleading standards are particularly applicable to prescription medical product liability litigation.

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If you are a regular blog reader, you may have seen some of our prior posts about the new Product Liability Directive adopted by the European Union and going into force this December.  

Two weeks ago, we had the pleasure of Co-Chairing the inaugural forum on Life Sciences Product Liability Europe in Brussels, and it was everything you want in a conference:  informative, interesting, great presentations, great informal interactions.  We left having been better for attending and with more ideas to think about—and advise clients about.

The European Union Product Liability Directive: A Quick Backgrounder

The formal name of what we call the “EU PLD” is 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).  Here is a high level overview:

  • The 27 EU member countries must transpose (adopt) the EU PLD into their national law by December 9, 2026 and it will apply to any “products” sold or put into service in the EU as of December 10, 2026.
  • “Products” means tangible goods plus commercial software, AI, electricity, raw materials, digital manufacturing files, and digital services that a product needs to function.
  • The EU PLD is designed to ensure there always is an EU-based defendant (“economic operator”) to sue.  If not the manufacturer, the importer, an authorized representative, or a fulfillment service provider.  Even distributors and some online platforms can get tagged if they don’t identify an upstream economic operator.  Substantial modifiers of a product also may be liable.
  • A product is defective when it doesn’t provide “the safety that a person is entitled to expect” or that is required by some other regulation or law.
  • A product is defective if there was an “obvious malfunction” in ordinary or foreseeable use.
  • Defects also include post-sale problematic software updates and failures to patch cybersecurity vulnerabilities.
  • Causation is presumed when defect is established and the damage is “of a kind typically consistent with the defect in question”.
  • Both defect and/or causation must be presumed where the claimant faces excessive difficulties—in particular due to technical or scientific complexity (as with AI and pharmaceutical “black boxes”)—in proving the elements of defect and/or causation, and those elements are “likely”.  (What is likely?)  
  • Damages caps are gone, and medically recognized psychological harm is recoverable.  Data loss and corruption are now compensable damages.
  • New disclosure obligations: Even if a given EU country never previously provided for discovery, the EU PLD will now require defendants to disclose documents and information. Supposedly the disclosure will just be what is “necessary and appropriate”.  
  • In addition, the defendant can be ordered to produce documents and information in a manner reasonably understandable to the claimant.  (What does that mean?  Unclear.).  
  • Also, a presumption of defect arises if a defendant fails to disclose evidence it was obliged to.
  • Longer limitations period (3 years) and statute of repose/long-stop period for latent injuries (25 years).
  • Works alongside the newer EU collective-redress/representative-action mechanism.

Take-Aways From The Inaugural Life Sciences Product Liability Europe Conference

One of the presenters we looked most forward to hearing from was Katrin Saaremӓel of the European Commission, who is working on implementation of the EU PLD and provides support to the EU countries working on transposing the Directive into national law.  

During her presentation, Ms. Saaremӓel indicated that the European Commission’s intent in proposing the new EU PLD was four-fold:

  1. To adapt to the digital age.

The EU PLD wound up written as it is in part because of how it was developed—initially in conjunction with a potential AI Directive.  Eventually the AI Directive project was dropped and software and AI concerns worked their way into the EU PLD.  As a result, the EU PLD is intended to impose liability after products are placed on the market if there are problems with software updates or upgrades, or if there is some failure to address cybersecurity risks.

  • To adapt to the circular economy.

To the extent products are increasingly going to be reused and recycled, the drafters concluded that those who make substantial modifications should be liable for introducing new defects.

  • To adapt to global value chains and “level the playing field” between EU and non-EU manufacturers.

The European Commission wanted to make sure that if they were increasing liability, that it would not only apply to EU manufacturers.  Many of the provisions were incorporated to make sure there always will be someone in the chain of distribution in the EU who could be tagged for litigation.

  • To make it easier for injured people to prove liability and get full compensation.

It was interesting to hear that an expressly-stated goal of the new EU PLD is to “make it easier for injured people to prove liability and get full compensation”.  There are so many assumptions and policy judgments embedded in that statement.  

But this goal, of increasing product liability and verdicts, is directly reflected in the EU PLD:  The new disclosure obligations, all the presumptions of defect and/or causation, the extension of the long-stop period for latent injuries to 25 years, and the removal of financial ceilings.   

The European Commission plans programs to train judges in the courts of the EU nations, and to prepare materials to be distributed about the EU PLD.  Query what the emphasis of that training will be and whether it will address the issues we have and the EU business community may well have as well.

The European Commission also intends a campaign to raise the general public’s awareness of the PLD, including creating a website about the European Commission with a FAQ page.

One key revelation:  The European Commission has set up an email box for comments on the EU PLD.  It was mentioned for the purpose of collecting information about Member States’ efforts to transpose the EU PLD into national law (and whether there were any errors made in the transposition process).  But this email address is apparently operational, so we suggest considering submission of other comments and questions also.  The address:

GROW-EU-PRODUCT-LIABILITY@ec.europa.eu

EU Product Liability Opinions

Ms. Saaremӓel noted that one hurdle the European Commission had in studying the prior EU PLD was that until now, product liability opinions from throughout the EU are hard to find.  What opinions are available apparently reside with Professor Duncan Fairgrieve (a keynote speaker at the conference) who has collected about 650 cases from 1985 to present into a database.

The new EU PLD seeks to make all EU product liability opinions more readily available going forward.  Each EU member nation will be required to publish any final appellate its own opinions touching on the EU PLD. From there, the European Commission will collect those into an easily accessible and publicly available database.

Having those decisions more readily available should be helpful for defense lawyers looking to help propagating good rulings across the EU.  But it just as easily could help spread the bad ones, so there is work to do.

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If preemption were an independent basis for federal subject matter jurisdiction, almost all of our drug, device, and vaccine product liability litigation would be in federal court.  We’ve long been resigned that preemption is a defense, not grounds for jurisdiction.   E.g., Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 811 (1986).  A recent decision, United States v. California, ___ F. Supp.3d ___, 2026 WL 784514 (C.D. Cal. March 18, 2026), confirmed that distinction in a rather unusual manner.  It’s worth paying attention to.  If the result in US v. CA had been different, it could have been a very big deal.

In US v. CA the United States, that is to say the current federal regime, was the plaintiff.  It sued the state of California, that is to say a current state regime, over state legislation “prohibit[ing] the sale of eggs from hens confined under certain ‘cruel’ conditions.”  Id. at *1.  The constitutionality of this type of statute was recently affirmed by the United States Supreme Court in National Pork Producers Council v. Ross, 598 U.S. 356, 376 (2023), holding that the “dormant commerce clause” doesn’t “question . . . the ability of a State to project its power extraterritorially” so long as they don’t discriminate.

So, the federal government took another approach in US v. CA.  The feds claimed that the state egg statute was preempted by a federal statute, the Egg Products Inspection Act.  This preemption claim, the government argued, created a basis for it to sue California – even though the government itself was not damaged in the slightest by the California law.  That would have  been a big change.  Imagine our clients being able to bring a federal claim – or a counterclaim (in a public nuisance suit) – based solely on federal preemption.

However, the lack of any particularized injury caused dismissal of US v. CA for lack of standing.  “Under Article III of the Constitution, a plaintiff needs a ‘personal stake’ in the case.”  2026 WL 784514, at *2 (citation and quotation marks omitted).  That includes the federal government as a plaintiff.

This principle extends to the federal government at large, which similarly must establish its standing to bring a civil suit in federal court.  Because the United States is not the target of the challenged government action, as it does not allege it is a participant in the . . . marketplace to which the subject [state] laws and regulations apply, the federal government’s ability to bring suit is substantially more difficult to establish.

Id.  There is no such thing as governmental standing by reason of “injury to its sovereignty.”  Id. at *3.  “[T]he mere existence of a preempted state law” has never “create[d] a sovereign injury to the federal government.”  Id. (footnote omitted) (emphasis original).  The government did not argue that “enforcement” of the state statute actually “impeded” its “operations or functions” – only that the statute was preempted.  Id.

Instead, preemption can be pursued as a defense to enforcement by persons harmed by the statute in question.

[P]reemption provisions . . . should be read to confer on private entities a federal right to engage in certain conduct subject only to certain (federal) constraints.  This is because preemption principles derived from the Supremacy Clause provide a rule of decision, not an independent grant of legislative power to Congress.

Id. at *4 (citations and quotation marks omitted).  A preemption clause “is neither directed to nor violable by any State, and the Supremacy Clause does not itself conjure a substantive right that Congress or the United States may vindicate through suit.”  Id. (citation omitted).

Moreover, the jurisprudential ramifications of converting preemption into an affirmative cause of action were significant.  The government could involve itself as a party in any private litigation (such as prescription medical product liability litigation) where preemption is at issue.  Id.  Worse – and probably the actual motivation of this particular suit – “[t]he potential for abuse of the federal courts for political purposes is manifest.”  Id.

[S]uppose the executive or the decisionmakers at the Department of Justice simply do not like a state law because it is in tension with their policies.  Without requiring the United States to show some redressable injury, the federal government might initiate a campaign of preemption suits under the aegis of its sovereignty to bring state laws in line with its own political agenda.

Id.

We don’t know whether there are other similar federal attempts out there seeking to convert preemption into an affirmative basis for jurisdiction.  If we find any, we’ll of course let our readers know.  Because anything that the federal government may succeed in asserting regarding preemption certainly bears analysis to see if our clients could make the same, or analogous arguments.

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June 25, 2026 was a very good day for preemption. While one hand of the judiciary was busy with the Supreme Court handing down its 7-2 ruling in Monsanto Co. v. Durnell — establishing that FIFRA expressly preempts Roundup state-law failure-to-warn claims, the other hand was quietly doing the same thing with toothpaste. Specifically, the Southern District of New York issued Brower v. Colgate-Palmolive Co., 2026 WL 1831253 (S.D.N.Y. June 25, 2026), a partial dismissal of an OTC economic loss class action that drew a clean line between preempted omission claims and surviving affirmative misrepresentation claims under the FDCA.

Plaintiffs — a geographically scattered group of consumers from New York, Minnesota, Illinois, New Jersey, Arizona, and California — sued Colgate-Palmolive on behalf of a putative nationwide class, alleging that Colgate’s toothpastes contained heavy metals, specifically lead and mercury, that Colgate knew about but chose not to disclose to consumers. Id. at *1. The complaint ran to thirteen claims: eleven state consumer protection counts, a common law fraud by omission claim, and unjust enrichment. Defendant moved to dismiss on four grounds: (1) express preemption under the FDCA; (2) lack of standing; (3) failure to state a claim; and (4) statute of limitations. The court granted the motion in part, and the preemption analysis is where the real action is.

Before diving in, we have to acknowledge the timing — and its significance. As we discussed in our post on Durnell, the Supreme Court’s ruling established that FIFRA’s express preemption clause — which the Court described as “materially identical” to the FDCA’s device preemption provision at 21 U.S.C. § 360k(a) — bars state-law claims that would impose requirements “in addition to or different from” what federal law demands. The Brower court wasted no time citing Durnell in its preemption analysis of the FDCA’s OTC drug preemption clause, 21 U.S.C. § 379r(a). That is no coincidence. As we noted in our Durnell post, § 379r(a), appears on the Supreme Court’s own list of FDCA provisions with preemption language “similar or identical” to FIFRA’s. See Durnell, 2026 WL 1825691, at *8.

The upshot: the Supreme Court’s interpretation of what “in addition to or different from” means in the FIFRA context — that it means exactly what it says — applies with equal force to the FDCA’s express preemption clauses. Brower v. Colgate is, in part, a same-day proof of concept.

Plaintiffs alleged that defendant’s voluntary safety-related statements — including that its products promote “Whole Mouth Health,” “Protect teeth, tongue, cheeks [and] gums,” and are “Responsibly Made” — were false and misleading because the products actually contained lead and other heavy metals. Id. at *3. The court held these claims were not preempted. The FDCA itself prohibits false or misleading labeling under 21 U.S.C. § 352(a)(1), and plaintiffs’ state-law claims ran parallel to that federal prohibition rather than imposing requirements different from or in addition to it. Because the challenged statements were voluntary marketing claims not addressed by the FDA’s monograph, they were fair game for challenge under state consumer protection law. Id. at *4.

The key piece of the court’s analysis is that the existence of the monograph does not give manufacturers blanket immunity over every statement that appears on their label. Here, the monograph authorizes specific decay-prevention claims and prescribes labeling requirements for the anti-cavity drug component. It does not, as the court put it, “broadly immunize all advertising or labeling statements made by manufacturers.” Id.

The story is different for omission claims. Plaintiffs also argued that defendants should have disclosed the presence of heavy metals on its labeling. The court held those claims expressly preempted under § 379r(a). Id. at *5. The reasoning is straightforward. Because the FDCA imposes no obligation to disclose the presence of heavy metal contaminants anywhere on a toothpaste label, any state-law claim premised on that omission creates requirements “in addition to” what federal law demands. And that is precisely what § 379r(a) forbids.

Central to this conclusion was the court’s characterization of the FDA monograph as “comprehensive and granular.” The monograph prescribes, with considerable specificity, the required active ingredient disclosures, warning language, directions for use, indications, and format requirements for anti-cavity drug products. This level of regulatory detail, the court found, reflects a considered exercise of the FDA’s comprehensive authority over OTC drug labeling. When the FDA has constructed an elaborate labeling framework and heavy metal disclosures appear nowhere in that framework, the inference that the agency made a deliberate judgment about label content is “substantially stronger” than in cases where the regulatory scheme only lightly touches the relevant product category. Id. As the court memorably put it:

To allow state omission claims to supplement this comprehensive scheme would be to substitute judicial judgment for agency judgment in precisely the domain Congress assigned to the FDA.

Id. In other words, when the FDA has spoken comprehensively about what belongs on a label, a state court cannot supplement that judgment by compelling additional disclosures the agency never required.

The court also took care to distinguish (and politely part ways with) the District of Connecticut’s analysis in Clinger v. Edgewell Personal Care Brands, 2023 WL 2477499 (D. Conn. Mar. 13, 2023), which had addressed omission claims in a similar OTC drug context. The Clinger court acknowledged the full text of § 379r(a) — with its “different from” and “in addition to” prongs — but then analyzed only the former in applying the standard. By asking only whether federal law prohibited the omitted disclosure (rather than whether it required it), Clinger effectively collapsed the two prongs into one, treating the absence of a federal prohibition as sufficient to defeat express preemption. Brower, 2026 WL 1831253, at *5. That, the court explained, drains the “in addition to” language of its independent force. The two prongs are distinct, and the Brower court rightly gave both their due.

This is good ammunition for future preemption arguments. The “in addition to” prong — which asks whether a state requirement exceeds the federal floor rather than whether it conflicts with federal law — is an independent basis for preemption that plaintiffs’ counsel has too often been allowed to paper over.

Having preempted the omission claims, the court turned to standing and trimmed the plaintiff roster further. The problems were predictable, but instructive for those fighting contamination class actions. Several plaintiffs were dismissed for failure to meaningfully link their testing allegations to the products they personally purchased. Plaintiffs relied on two sources of testing data. Both were found wanting for deficiencies like failing to state the number of samples tested, the geographic proximity of testing to plaintiffs’ purchases, the date of testing, or who performed it. Id. Without those details, the court could not infer that heavy metals were systematically present in the products each plaintiff actually bought. “Some study found lead in something” does not establish that your tube of toothpaste had lead in it.

One additional standing point that deserves emphasis: the court rejected plaintiffs’ argument that one named plaintiff’s standing confers standing on other named plaintiffs. Id. Each plaintiff in a class action must establish their own Article III standing. That principle is sometimes honored more in the breach, and it was good to see it applied here with rigor.

So as to provide a complete picture of the decision, here are also the key points on the other issues addressed by the court:

  • Failure to state a claim. On the surviving affirmative misrepresentation claims, plaintiffs sufficiently alleged that the challenged statements were false or misleading and that there was a material safety risk from the trace amounts of heavy metals at issue. Whether statements like “Whole Mouth Health” and “Responsibly Made” are misleading to a reasonable consumer is a question of fact for the jury, and the court declined to resolve it on a 12(b)(6) motion. Id. at *9. The court similarly refused to look behind plaintiffs’ “any exposure to heavy metals is harmful” theory of injury; whether those trace amounts actually pose a health risk is reserved for summary judgment.
  • Consumer fraud elements by state. The New York GBL §§ 349 and 350 claims survived, as did the California CLRA and UCL claims, for the same reasons. Id. at *9-10. On the Minnesota claims: the MFSAA and MCFA survived (the public benefit requirement was satisfied given the breadth of the alleged marketplace deception), but the MDTPA claim was dismissed because plaintiff Brower — the only Minnesota named plaintiff — failed to adequately allege irreparable injury or a genuine threat of future harm necessary for injunctive relief under that statute. Id. at *11.
  • Unjust enrichment. Dismissed as duplicative. The unjust enrichment claim rested on the exact same facts and sought the exact same relief as the remaining statutory claims, without identifying any independent quasi-contractual basis for recovery. Id. at *12.
  • Statute of limitations. Defendant argued that New York’s three-year statute of limitations for consumer protection claims bars any recovery for purchases predating 2022. The court declined to dismiss on that basis because the complaint did not plead facts sufficient to determine when particular purchases were made. The issue is preserved, so it’s a fight for another day. Id. at *13.

Two decisions on the same day (one by the Supreme Court) reinforcing the same concept: “in addition to” and “different from” mean exactly what they say, and courts should not let plaintiffs collapse those two prongs into one. And, while this is not a complete preemption win, for defendants it ultimately leaves a manageable battlefield — the surviving affirmative misrepresentation claims are limited to specific voluntary marketing puffery, not the full universe of possible labeling challenges. A good day indeed.

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New Jersey law requires that trial courts conduct a “rigorous gatekeeping” analysis when assessing the admissibility of expert opinions.  That’s the Accutane standard, named for the New Jersey Supreme Court’s opinion in In re Accutane, 234 N.J. 340 (2018).  To the extent there was any ambiguity on whether Accutane applies to all civil cases, the New Jersey Supreme Court has now revolved it  Accutane applies in every civil case.  Moreover, the “rigorous analysis” requirement applies to all purported methodologies, including differential diagnoses.

The case is Beavan v. Allergan U.S.A., Inc., 355 A.3d 1201 (N.J. 2026), which involved an FDA-approved steroid pellet used to treat certain eye conditions. In 2018, the manufacturer advised the FDA that during assembly a tiny silicone particulate could detach from the needle’s sleeve and be ejected with the pellet.  This issue ultimately led to a recall covering twenty-two lots in which sample testing showed that two of ninety units—2.2 percent—contained a silicone particulate.

The plaintiff was treated with an injection from a recalled lot and alleged that she lost vision in one eye as a result.  To prove this, she relied on two experts, whose opinions were based on . . . well, not much.  Both reasoned that because the plaintiff had received prior injections without complications, the recalled unit must have been defective and most likely caused the injury.  But notably, neither could cite evidence that a silicone particulate was actually generated or injected during the plaintiff’s procedure.  As one expert (the treating physician) acknowledged, “the only thing we were going by” was that “it was a recalled lot.”  Beavan, 355 A.3d at 1210. 

The trial court found these opinions sufficiently reliable to raise triable issues of fact, but did so without conducting the Accutane gatekeeping inquiry.  The Appellate Division reversed and ordered entry of summary judgment for the defendant, in an opinion that we reported on here. 

The New Jersey Supreme Court took a different tack and remanded for the trial court to conduct the proper “rigorous gatekeeping” under Accutane.  According to the Supreme Court any dispute about the reliability of expert testimony in a civil case must be resolved by the trial court acting as gatekeeper, applying the Accutane framework.  Here is the quote you will want to use:

Our view of proper gatekeeping in a methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies . . . scientifically recognized methodology in the way that others in the field practice the methodology. When a proponent does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable.

Beavan, 355 A.3d at 1216 (quoting Accutane).  There are no exceptions.  Nor is Accutane’s mandate confined to the mass tort context, which the Supreme Court made clear:

The procedural framework adopted in Accutane is not limited to the specific setting in which that case arose; it applies to all civil cases in which the parties dispute the reliability of expert testimony under N.J.R.E. 702 and 703.

Id. (emphasis added). 

Accutane likewise carved out no exception for differential diagnosis. To the contrary, when an expert uses a differential diagnosis to opine on the cause of an injury, the gatekeeping inquiry must be applied to both steps of the analysis: the “rule in” step, in which the expert compiles plausible causes, and the “rule out” step, where the expert eliminates factors to reach a conclusion as the most likely cause. The trial court must scrutinize each component of the opinion to confirm it rests on a methodology satisfying Accutane.

Applying these principles, the Supreme Court held that the trial court erred by admitting the testimony without “rigorous gatekeeping,” and the Appellate Division got it wrong too by directing entry of summary judgment.  The proper outcome, in the Supreme Court’s view, was to remand for the trial court to properly assess the admissibility of plaintiffs’ experts.

So the plaintiff gets a do over.  The Supreme Court encouraged the trial court to hold an evidentiary hearing, and it also held that the plaintiff’s retained expert’s opinion was not a “net opinion,” which is a New Jersey thing.  A “net opinion” is one that is unsupported by facts or data, but the retained expert here adequately explained the “why and wherefore” of his opinions in his report.  That does not, however, mean that the retained expert’s opinions will be admissible after scrutiny under Accutane, which is a separate inquiry. 

Finally, the Court also flagged that a treating physician designated to offer expert causation testimony must, like a retained expert, serve a written report when an adversary requests one through interrogatories. The treating physician here did not prepare a report.  On remand, the trial court will determine whether the plaintiff will be allowed to serve one. 

The New Jersey Supreme Court vacated a good outcome for the defendant in the Appellate Division, but the good news is that it solidified the trial court’s gatekeeping role and closed off any uncertainty on whether and how broadly Accutane applies.  Rigorous gatekeeping is required, in all civil cases. 

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