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Prescription drug warnings require FDA approval which dictates what the manufacturer can say in the product’s labeling.  An exception to the FDA-approval rule is the Changes Being Effected (CBE) regulation which allows a manufacturer to unilaterally change a drug’s warnings “to reflect newly acquired information” and where the revision would “add or strengthen a contraindication, warning, precaution, or adverse reaction for which evidence of a causal association satisfies the standard for inclusion in the labeling under [21 C.F.R. § 201.57(c).”  21 C.F. R. § 314.70(c)(6)(iii)(A).  The CBE regulation is not an easy hoop to jump through and it shouldn’t be.  FDA oversight of drug warnings and labeling serves several important objectives, including preventing over-warning that could lead to people not receiving appropriate care.  So, when courts are faced with failure to warn claims in the prescription drug context, they should carefully consider what evidence plaintiff relies on to suggest a CBE labeling change was a viable option.  The type of analysis seen in Warner v. Amgen Inc., 2025 U.S. Dist. LEXIS 26141 (D. Mass. Feb. 13, 2025).

The facts of Warner are tragic.  Plaintiff’s son suffered from an arteriovenous malformation which caused him to experience frequent headaches throughout his life.  Defendant manufacturers a drug approved for the treatment of migraine headaches.  It operates by blocking calcitonin gene-related peptide (“CGRP”) receptors.  Increased levels of CGRP are associated with migraines.  One month after the drug was approved, plaintiff’s son received an injection of the drug.  He suffered a massive seizure which led to brain damage and eventually to his death. 

Plaintiff’s failure to warn claim was entirely premised on her allegation that defendant’s warnings should have included that individuals with a history of seizures and cerebrovascular disease or surgery, like her son, were excluded from the clinical testing done to obtain FDA approval.  Plaintiff claimed that her claim was not preempted because defendant could have included such a warning pre-approval in its new drug application or defendant could have changed the warning post-approval under the CBE regulations.  On defendant’s motion to dismiss, the court found both claims were preempted. 

On plaintiff’s pre-approval warnings claim, she only had precedent outside the First Circuit to rely on.  But as the court pointed out,

the First Circuit held that the FDA is “the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing states to reach contrary conclusions when new information not considered by the FDA develops.” 

Id. at *21 (quoting In re Celexa and Lexapro Mktg. & Sales Pracs. Litig., 779 F.3d 34, 41 (1st Cir. 2015).  So, in the First Circuit, the question is not whether a manufacturer could have proposed a different warning during the approval process, but “whether the FDA considered the safety and efficacy information giving rise to the need for that warning.”  Id. In this case, it was clear that the FDA was aware of the exclusion criteria used in the clinical trials before it approved the drug and did not require defendant to include the full list on the drug’s label.  Id. at *23.  Therefore, plaintiff’s pre-approval failure to warn claim was preempted.

Plaintiff’s post-approval failure to warn claim completely hinged on whether defendant could have strengthened the label warnings through the CBE process.  But remember, plaintiff’s son received his injection just one month after the drug was approved. So, the window for newly acquired information is quite small. 

Plaintiff’s complaint did not allege any newly acquired information and therefore could not survive a preemption defense.  But plaintiff moved to amend her complaint to add allegations related to nine articles which she contended constituted “newly acquired information of the cerebral risks presented by CGRP-blocking drugs, like [defendant’s].”  Id. at *27.  They did not.

None of the articles link the drug to any adverse event.  They were about CGRP generally.  So they could not show the “causal association” needed for a CBE labeling change.  Nor were they “newly acquired information.”  Three pre-date FDA-approval and the court found in implausible that FDA was not aware of these studies considered it “reviewed the world’s literature” before preparing its report on the risks of CGRP antagonism.  Id. at *31.  Of the six articles that post-dated approval, none discussed seizures as a risk.  The court found all of the studies too attenuated to meet the rigors of the CBE regulations.  For example, plaintiff could not show that an animal study about CGRP deficiency could be generalized to CGRP antagonist drugs.  As both the pre- and post-approval failure to warn claims were preempted, the complaint was dismissed with prejudice and leave to amend was denied.

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We read a brief from the other side recently that claimed that Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), abolished implied preemption altogether.  We kid you not.  Under the heading, “Implied preemption is an unconstitutional intrusion into the dual sovereignty of the States,” plaintiffs made the following pitch:

The Supreme Court elucidated the contours of judicial deference and statutory construction in Loper Bright v. Raimondo, 144 S. Ct. 2244 (2024).  A reading of Wyeth[ v. Levine, 555 U.S. 555 (2009)], in the framework of Loper Bright, together with deference to the police powers of the States recognized in both Wyeth and Dobbs v. Jackson Women’s Health Organization, affirms [plaintiff’s] position: if Congress wants to make a law, or to displace a State law, it must explicitly say so.

In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, PLC’S Response to Partial Motion to Dismiss for Failure to State a Claim (ECF No. 126), Br. at pp. 41-51 (filed Aug. 23, 2024).

In our latest Loper Bright post, back in November, we predicted p-side “attempts to use Loper Bright for nefarious purposes,” but we expected something more nuanced than this sort of meat-axe approach.  But that kind of extreme position only makes our job easier.

Implied preemption stems directly from the Constitution’s Supremacy Clause, which holds that “the Laws of the United States” and other federal enactments “shall be the supreme Law of the Land, and the Judges in every State shall be bound thereby” regardless of “any Thing in the Constitution or Laws of any State.”  U.S. Const, Art, IV.  Implied preemption – that federal enactments overturn conflicting state law without any express language to that effect − has been recognized for over 200 years, since McCulloch v. Maryland, 17 U.S. 316 (1819).  In McColloch, as any first-year law student should have learned, a federal statute establishing a national bank with a Maryland branch impliedly preempted due to conflict – “repugnant,” id. at 425 – a state law seeking to tax that federal institution.  Preemption by conflict stemmed directly from the Supremacy Clause, without the need for any statutory clause to that effect:

This great principle is, that the constitution and the laws made in pursuance thereof are supreme; that they control the constitution and laws of the respective States, and cannot be controlled by them.  From this, which may be almost termed an axiom, other propositions are deduced as corollaries. . . .  These are, first that a power to create implies a power to preserve.  Second.  That a power to destroy, if wielded by a different hand, is hostile to, and incompatible with these powers to create and to preserve.  Third.  That where this repugnancy exists, that authority which is supreme must control, not yield to that over which it is supreme.

McColloch, 17 U.S. at 426 (emphasis added).  Thus, the Supremacy Clause alone can be sufficient for preemption in a case of “repugnancy” (the modern term being “conflict”) between federal and state law. McColloch made no mention of any preemptive language in the relevant federal statute.  To the extent, as plaintiffs argued in Suboxone (Br. at 48) that Dobbs stands for the general proposition that “courts must ground decisions in ‘text, history, or precedent,’” 597 U.S. at 270, McColloch, and its two centuries of extensive, preemptive progeny, demonstrate that implied preemption is on firm ground, and that plaintiffs’ arguments are not.

Taking the timeline in the other direction, Loper Bright was only decided last June, at the end of the Supreme Court term, so there haven’t been many Supreme Court preemption (or any) decisions since then.  But in Moyle v. United States, 603 U.S. 324 (2024), three justices concurring in the dismissal of a petition as improvidently granted also invoked implied preemption principles, “[a federal statute] requires hospitals to provide abortions that [state] law prohibits.  When that is so, [state] law is preempted.”  Id. at 328.  Just as in McColloch, over 200 years before, there was no mention in Moyle of any preemptive language in the federal statute.

The notion that Loper Bright, either alone or together with the other two (Levine and Dobbs) of the other side’s suddenly favorite Supreme Court cases, somehow sub silentio overruled 200+ years of implied preemption precedent is, as our title indicates, absurd.  Loper Bright was about one thing – statutory interpretation – and the only mention of preemption in Loper Bright was a fleeting reference in a concurring opinion.  Even that reference specifically contrasted “traditional canon[s] of construction” with the Chevron doctrine, specifically because those traditional propositions were “centuries old[].”  603 U.S. at 435 n.5.  “Centuries old” describes McColloch to a T.

Plaintiff’s anti-preemption argument also contends, citing nothing, that “[u]nder the Tenth Amendment, Congressional silence cannot serve as a basis to invalidate State laws under the Supremacy Clause.”  Br. at 41.  First, neither Loper Bright, nor Levine − nor even Dobbs − relies at any point, or even cites to, the Tenth Amendment.  Second, the Tenth Amendment is a residuary clause, dealing with rights and powers not mentioned elsewhere in the Constitution:

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

U.S. Const. Amdt. 10 (emphasis added).  The Supremacy Clause specifically provides that federal statutes (and other enactments) are “supreme” and that “Judges in every State shall be bound thereby.”  Since supremacy is a power specifically delegated to federal law elsewhere in the constitution itself, the Tenth Amendment facially does not apply to preemption, express or implied.

Indeed, the only appellate decision that we’re aware of (at least during the 17 years that this Blog has existed) that ever purported to interpose the Tenth Amendment against federal preemption, is Gustafson v. Springfield, Inc., 2020 Pa. Super. Lexis 843 (Pa. Super. Sept. 28, 2020) (discussed here), which no longer exists.  Reconsideration in Gustafson was granted and the original opinion withdrawn.  When reconsidered by the full en banc court, a majority of the nine judges expressly rejected the kooky Tenth Amendment argument embraced by the prior panel.  Gustafson v. Springfield, Inc., 282 A.3d 739, 763, 772-74, 783 Pa. Super. 2022), appeal pending, 296 A.3d 560 (Pa. 2023).

Plaintiff’s Loper Bright argument went off the rails almost immediately, when it attempted to go beyond that decision’s focus on statutory interpretation.  It describes Loper Bright as “signal[ing] a full embrace of the Framers’ understanding of the judicial function: to interpret acts of Congress to ascertain the parties’ rights.”  Br. at 44.

Umm. . . .  No.  That is way overbroad.  Loper Bright is a significant decision, but not about preemption.  Rather, Loper Bright relied on the Administrative Procedures Act, 5 U.S.C. §701, et seq. (“APA”), to reject the proposition that administrative agencies were better positioned to interpret their organic statutes than the courts.

[The APA] specifies that courts, not agencies, will decide “all relevant questions of law” . . . − even those involving ambiguous laws − and set aside any such action inconsistent with the law as they interpret it.  And it prescribes no deferential standard for courts to employ in answering those legal questions.  That omission is telling, because [APA] Section 706 does mandate that judicial review of agency policymaking and factfinding be deferential.

603 U.S. at 392.  That involved an “unremarkable . . . proposition,” that “courts decide legal questions by applying their own judgment,” id. − not the overturning of 200+ years of preemption precedent.   Moreover, as we discussed, in a prior post, that “deferential” review of agency actions that Loper Bright contrasted with pure statutory interpretation has unanimously been applied to FDA requirements imposed via that agency’s approvals of prescription medical products.

Another reason Loper Bright cited for overruling the Chevron doctrine was that it had become encrusted with many exceptions.  Discussing the many twists and turns that had been encrusted on the Chevron decision that Loper Bright was overruling, the majority referenced the so-called “major questions” doctrine:

Chevron does not apply if the question at issue is one of “deep ‘economic and political significance.’  We have instead expected Congress to delegate such authority “expressly” if at all, for “[e]xtraordinary grants of regulatory authority are rarely accomplished through ‘modest words,’ ‘vague terms,’ or ‘subtle device[s].’”

603 U.S. at 405 (citing King v. Burwell, 576 U. S. 473, 486 (2015), and West Virginia v. EPA, 597 U. S. 697, 723 (2022)).  Plaintiffs’ argument puts the rabbit in the hat by applying this “expressly if at all” language to preemption, Br. at 45-46, which neither Loper Bright nor any Supreme Court preemption decision ever has.  That sought to turn the “major questions” doctrine fully on its head, as plaintiffs tried to find an elephant − abolition of implied preemption – in the mousehole of Loper Bright’s application of the APA to a case about fishing.

Having utterly miscited Loper Bright, the plaintiffs’ argument followed with the remarkable claim that “[i]f Congress has not provided an express preemption clause in a statute, that must be the end of the matter.”  Br. 46.  That statement was remarkable because it is contrary to multiple, directly on point, Supreme Court decisions – which, of course, plaintiffs never acknowledged, let alone addressed, in their brief.  Our favorite of those decisions is Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), which held:

[Plaintiff] also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision. . . .  To the extent [plaintiff] posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion . . . that neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles.’

Id. at 353.

Buckman cited Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000), which held:

We now conclude that the saving clause (like the express pre-emption provision) does not bar the ordinary working of conflict pre-emption principles.  Nothing in the language of the saving clause suggests an intent to save state-law tort actions that conflict with federal regulations.

Id. at 869.  Geier also explained why plaintiffs’ no-implied-preemption argument makes no sense under our federal system of government:

Why, in any event, would Congress not have wanted ordinary pre-emption principles to apply where an actual conflict with a federal objective is at stake?  Some such principle is needed.  In its absence, state law could impose legal duties that would conflict directly with federal regulatory mandates. . . .  Insofar as [plaintiffs’] argument would permit common-law actions that “actually conflict” with federal regulations, it would take from those who would enforce a federal law the very ability to achieve the law’s congressionally mandated objectives that the Constitution, through the operation of ordinary pre-emption principles, seeks to protect.

Id. at 871-72 (citation omitted).

Geier relied in part on a third decision, Freightliner Corp. v. Myrick, 514 U.S. 280 (1995).  Myrick rejected outright the same sort of “implied preemption cannot exist” argument on facts stronger for plaintiffs than mere silence – a statute having an express preemption clause that did not cover the case in question.  Myrick held instead:

The fact that an express definition of the pre-emptive reach of a statute “implies” − i.e., supports a reasonable inference − that Congress did not intend to pre-empt other matters does not mean that the express clause entirely forecloses any possibility of implied pre-emption. . . .  At best, [there is] an inference that an express pre-emption clause forecloses implied pre-emption; it does not establish a rule.

Id. at 288-89 (citations omitted).  Implied preemption failed in Myrick because there was no conflict, not because of the statute’s preemption language (or lack of it).  Id. at 289.  See also, e.g., Williamson v. Mazda Motor, Inc., 562 U.S. 323, 329 (2011) (“neither can the statute’s saving clause foreclose or limit the operation of ordinary conflict pre-emption principles”); Altria Group, Inc. v. Good, 555 U.S. 70, 67-77 (2008) (the existence of an “express pre-emption clause . . . does not immediately end the inquiry because . . . [p]re-emptive intent may also be inferred . . . if there is an actual conflict between state and  federal law”).

Indeed, that is all that plaintiffs’ long-time favorite case Wyeth v. Levine, 555 U.S. 555 (2009), did.  Levine nowhere held that the absence of an express preemption clause in the prescription drug provisions of the FDCA precluded the operation of implied preemption.  Levine simply applied the sort of “inference” discussed in Myrick.  Levine “recognize[d] that some state-law claims might well frustrate the achievement of congressional objectives,” and thus would be “impliedly preempted by virtue of that conflict,” but Levine was “not such a case.”  555 U.S. at 518.  Rather, according to Levine, implied preemption required “clear evidence that the FDA would not have approved a change to [a drug’s] label” that the plaintiff in a particular case was demanding.  Id. at 571.

In all three of its prescription drug preemption decisions since Levine, the Court has rejected the sort of absolutist positions that plaintiffs advocated in the Suboxone brief.  Indeed, the Court found implied preemption in two of them.  See PLIVA, Inc. v. Mensing, 564 U.S. 604, 621 (2011) (implied impossibility preemption exists where the defendant cannot “independently do under federal law what state law requires of it”; rejecting the plaintiffs’ “argument [that] would render conflict pre-emption largely meaningless”); Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 488-89 (2013) (claim that defendant could avoid liability by stopping the sale of its FDA-approved drug was “incompatible with our pre-emption jurisprudence” because, it would mean that “the vast majority − if not all − of the cases in which the Court has found impossibility pre-emption, were wrongly decided”); Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299, 316 (2019) (preemption, including implied preemption, is a legal question for courts to decide; implied preemption exists in cases of “actual conflict between state and federal law”).

Plaintiff’s Suboxone argument against implied preemption as a constitutional concept is simply old wine in a new, Loper Bright/Dobbs bottle.  The same argument has already been made, and rejected, in Albrecht, Bartlett, Mensing, Levine, Buckman, Geier, and Myrick (and probably in more cases if we looked further).  Not surprisingly, that argument received the back of the judicial hand in In re Suboxone Buprenorphine/Naloxone Film Products Liability Litigation, 2024 U.S. Dist. Lexis 234771 (N.D. Ohio Dec. 31, 2024):

Plaintiff argues that the Court should consider the constitutionality of preemption doctrine, particularly based on the Supreme Court’s recent decision in Loper Bright. . . .  That case says little, if anything, about preemption doctrine.  Instead, Loper Bright involves questions of deference to agency interpretations of ambiguous statutes, and preemption involves determining the intent of Congress, not an agency. . . .  Therefore, preemption of State-law claims requiring the marketing of a product following agency approval flows from the congressional intent expressed in the statute.  In any event, Supreme Court and Sixth Circuit precedent compel application of preemption doctrine unless and until one or both courts say otherwise.

Id. at *43 (citation omitted).

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Happy Valentine’s Day. Today’s decision is about a rather un-romantic topic—holding companies.  But that got us thinking about a lesser-known band out of San Francisco called Big Brother and the Holding Company. One of America’s most iconic vocalists got her start with the band. Big Brother and the Holding Company’s second album, Cheap Thrills, reached number one on the Billboard charts in 1968 (we won’t go into the full name of the album – which was considered too controversial back then). More importantly, it was Janis Joplin’s break-out album and launched her successful but short-lived solo career. And, although a little edgy, the song “Piece of My Heart” from the album would certainly qualify as appropriate for Valentine’s Day.  Even if not your cup of romantic tea, it’s certainly a great example of Joplin’s powerful and heart wrenching vocals (the album also contains a nice version of Summertime—popularized by Ella Fitzgerald and Louis Armstrong, who are some real romantic crooners).  So, Valentine’s Day and holding companies? You bet. Now on to today’s decision.

We’ve all handled litigation in which complaints name incorrect corporate defendants. Usually that involves the inclusion of parent or subsidiary companies that have no involvement with the case. Often this can be addressed through conversations and agreements with plaintiffs’ counsel. But sometimes plaintiffs won’t agree to dismiss an improperly named defendant.  Today’s decision from Delaware – traditionally the jurisdiction of choice for corporate law and the state in which many of our clients are incorporated – is a helpful reminder that parent holding companies are almost always improper defendants.  While not a product liability case, NuVasive, Inc. v. Miles, 2025 Del. Ch. LEXIS 25 (Del. Ch. Jan. 31, 2025) is helpful for defense lawyers trying to extricate these sorts of entities from litigation.

The case followed the typical fact pattern for breach of employment agreement claims. A high-level employee left one company, joined a competitor, and the competitor started purloining the  former employer’s sales network.  Both of the companies focused on the development of technologies to treat spinal disease. The twist is that the plaintiff sued the former employee, the operating company and a parent holding company.  The operating entity did not conduct business in Delaware, so the case proceeded only against the former employee and the holding company (there was a separate, similar lawsuit in California that proceeded against the operating entity without the holding company).  The holding company moved to dismiss, contending that it did not conduct any business activities that could render it liable for plaintiff’s claims. The court denied the motion, and the case ultimately proceeded to a bench trial on plaintiff’s tortious interference and unfair business practices claims (in a separate opinion the court found for the former employee on the plaintiff’s breach of fiduciary claim. NuVasive, Inc. v. Miles, 2024 Del. Ch. LEXIS 294 (Del. Ch. Aug. 16, 2024)).  The holding company filed a post-trial motion raising the same defenses it raised in its motion to dismiss.

The court first provided a summary of the facts shown at trial.  After leaving employment with the plaintiff, the former employee became the president and CEO of the competing operating entity and its holding company. The plaintiff alleged that the now-CEO then recruited and hired its exclusive sales representatives and distributors in at least four states. Those distributors stopped carrying the plaintiff’s devices and began selling and distributing the operating entity’s devices. The court found that all of these activities were undertaken by the operating entity rather than the holding company.

The court did recognize some sloppiness in the activities of the holding company, as its former 10-Ks noted employment agreements showing that it directly employed the sales representatives and distributors who committed the alleged tortious activities. However, there was credible trial testimony that (1) the employment agreements were mistakenly drafted under the holding company’s name, and (2) to the extent individuals employed by the holding company recruited the sales representatives and distributors, those actions were taken on behalf of the operating entity – as it was the entity with commercial operations and marketed products.

The court concluded that the holding company was a passive entity that did nothing more than own and hold subsidiaries, including the operating entity that employed the plaintiff’s former employee.  The court recited some core precepts of Delaware corporation law, which is “largely built on the idea that the existence of separate legal entities should be respected.” NuVasive, 2025 Del. Ch. LEXIS 25, * 7.  “[C]ontrol and even total ownership of one corporation by another is not sufficient to warrant the disregard of a separate corporate entity.” Id.  In other words, the court was going to respect the form and separateness of the holding company, and unless there was evidence that the holding company was separately liable for the plaintiff’s claims, it could not be liable for the actions of the operating entity.

Plaintiff also argued that the operating entity and holding company acted in concert, as they conducted joint board meetings, and executives did not formally distinguish between the two entities.  The court found that these sorts of facts would be of much greater relevance if the plaintiff was attempting to pierce the corporate veil between the operating entity and holding company.  But the plaintiff did not include any claims of veil piercing, and the court found no basis to hold that the holding company was a sham entity or that it used its corporate form to defraud the plaintiff. The court held that the holding company did not make or sell medical devices, did not engage in the spine medical device business, and that it did not conduct any business operations whatsoever. The court accordingly ruled in favor of the holding company on all claims.

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Four weeks ago, we posted concerning an MDL judge’s decision not to sanction a plaintiff lawyer for false representations concerning diversity jurisdiction.  We disputed that acting in the client’s “best interest” was a good excuse and questioned whether MDL courts cut plaintiff lawyers more slack than they should.  We also had a bit of a tie-in to the then-on-ongoing NFL playoffs.  Those playoffs ended on Sunday with the crowning of the Philadelphia franchise that routinely and effectively utilized a version of the quarterback sneak known by a play on the city’s moniker.  Quite coincidentally, our post today relates to a Philly federal judge’s sanctioning of a local plaintiff lawyer for some ineffective sneakiness of his own.

We would not normally post about a case about an automobile accident without product liability claims or some relevant constitutional issue (such as personal jurisdiction in Ford v. Montana), but Shelton v. Chaudry, No. 24-5657, 2025 U.S. Dist. LEXIS 13415 (E.D. Pa. Jan. 27, 2025), caught our eye.  While we do not tend to mention judges or plaintiff lawyers by name, we note at the outset that the judge was a plaintiff lawyer before taking the bench and the plaintiff lawyer in this case will be called by the generic “PL” in this post.  The case was actually the second one filed by PL about the same accident.  The first had been dismissed for lack of subject matter jurisdiction, but not before the judge noticed contradictory assertions in the complaint concerning diversity jurisdiction and issued a show cause order asking PL to “explain why he should not be sanctioned under Rule 11 for asserting diversity while pleading facts that explicitly demonstrated the absence of diversity jurisdiction, requiring the Court to devote time and attention to addressing a frivolous pleading.”  Id. at *3.  (Our continuing summary of the decision omits some details, not because we are eschewing our own non-existent duty of diligence in blogging, but because we do not want our readers to devote too much time and attention to a post about a judge’s frustration in addressing frivolous pleadings.)  PL’s response basically blamed “his team” at the firm he founded and managed.  The court considered these errors “egregious,” but imposed no sanctions yet at that point.  Id. at *5.  Then PL filed another case in the same court over the same accident, omitting the prior non-diverse defendants.  It ended up with the same judge, who noticed the second complaint contradicted the first and itself on the location of the accident in relation to venue, among other issues.  “Dismayed by [PL’s] continued factual and legal misrepresentations to the Court,” the judge issued another show cause order.  Id. at *6.  PL basically said “oops,” disclaimed bad intent, and agreed the case should be transferred to the district with proper venue.  The judge was not letting the case go without first giving PL a not-so-brotherly shove on his way out.

As you read our ensuing recitation of the Shelton court’s analysis supporting imposing sanctions against PL, we suggest asking how the same considerations would apply to fairly routine plaintiff lawyer conduct in MDLs, coordinated proceedings, and mass torts.  “As officers of the court, lawyers must not mislead courts.  So before they state facts, they must investigate reasonably.”  Id. at *9 (quoting Wharton v. Superintendent Graterford SCL, 95 F.4th 140, 151 (3d Cir. 2024)).  That means “negligence” by the lawyer is enough to impose sanctions under Rule 11.  As for PL, he was not just negligent, but “duplicitous in his representations to the Court.”  Id.  However, the absence of bad faith would not be an excuse anyway, as “Rule 11 does not have a ‘pure heart and empty head defense.’”  Id. at *13 (citation omitted).  There is also no defense of no harm, no foul as PL tried to assert by agreeing to transfer the second case.  Unfounded contentions in each complaint forced the court and Defendants to spend their resources, which justified “weighty sanctions.”  Id. at *16-17.   By contrast, “[i]mposing sanctions for these completely unfounded contentions will hardly deter valid litigation.”  Id. at *17.  PL’s request for leniency by pointing to his position in his firms and the local plaintiffs’ bar—on the Board for the Philadelphia Trial Lawyers and the Pennsylvania Association for Justice—only made the gaffes worse in the court’s view.  The claim of acting in his client’s interest, such as worked in the decision in our prior post, also did not work here.  The idea that PL helped his client “get the best medical care for his injuries” was easily rebuffed as a litigation tactic for which PL was reimbursed, and which resulted in no actual care for the plaintiff.  Id. at *20-21.

The actual sanctions imposed—a formal reprimand, $7500, and a directive that every attorney at PL’s firm get the decision—may not seem like much, but we think they could have deterrent value.  For one thing, by the rules of most courts we know, the formal reprimand for “[f]ailing to comply with the duties of an attorney by filing pleadings containing false representations and legally unsupportable contentions” would have to be reported in connection with any application for admission, pro hac vice or otherwise.  Id. at *21.  In addition, the justification for circulating the decision could have ripples:  “[B]ased on the many [PL’s firm] cases that have come before me and my colleagues, I am persuaded that the facially obvious errors found in this case reflect a cultural norm at [PL’s firm] to prioritize volume at the expense of accuracy.”  Id. at *26.  The reference to the judge’s colleagues on the bench of this fairly prominent district is not too subtle.  Nor is how similar reasoning about the problem with “prioritiz[ing] volume at the expense of accuracy” would apply to the drug and device cases we see.

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In the litigation strategy class we teach at Penn Law, we always set aside a few minutes to go over the Aristotelian rhetoric trilogy of logos, pathos. and ethos.  As you probably already know, logos is the persuasive value of an argument’s logic, pathos is the power of sympathy, and ethos refers to one’s character in terms of credibility from authority and overall excellence.  We think (hope?) that this blog’s breakdowns of case outcomes are heavy on logos. Pathos is more typically an issue of jury appeal. But what of ethos?  When does that come into play? 

To be sure, we have seen lawyers squander credibility in front of a judge or jury.  Bad ethos. After enough instances of dishonesty or stupidity, an attorney’s arguments go unheard or unbelieved.  And we’ve seen litigants who manage to give jurors the creeps. But we have not seen many parties whose character and conduct drove a judge to decide dispositive motions against them. 

Today’s case, Hunt v. Medtronic USA, Inc., 2025 U.S. Dist. LEXIS 17966 (W.D.Wash. Jan. 31, 2025), might offer an example where a party’s conduct was sufficiently repellent so as to push the court toward ruling against that party. The plaintiff in Hunt complained of pain from an implanted spinal cord stimulator (SCS). But the plaintiff seemed to be a constant pain in another part of the anatomy. In the end, it was the plaintiff who suffered the pain of defeat. 

The plaintiff alleged that a medical device company had induced him into choosing a particular SCS device because the sales representative who demonstrated the product to the plaintiff used a tablet controller that included 28 settings. All those settings impressed the plaintiff. He wanted them. He claimed that the sales representative promised the plaintiff all 28 settings. But the SCS implanted in the plaintiff came with only three settings.  Disappointing ensued.  And then things got worse. The plaintiff claimed that the SCS performed unsatisfactorily and ended up delivering more pain than relief.  He filed a complaint containing causes of action for breach of contract, violation of Washington’s consumer protection statute, and negligence. The breach of contract action disappeared early on, and what was before the court was the defendant’s motion for summary judgment on the consumer protection and negligence counts. 

What was it about this plaintiff that made this case so … dispensable?  Right from the start, the plaintiff spewed out complaints in all directions. According to the plaintiff, his doctors and the device company lied to him and refused to help him. The plaintiff ended his relationship with his doctors because they wanted him to “taper off pain medications or find a new pain management doctor.”  

Hmmm.  What does that tell you?

The plaintiff later got into a car accident and claimed that his SCS gave him an “jolt.”  He then got the SCS reprogrammed but it was still no good.  He “requested various accommodations” including “access to the tablet, daily calibrations, shutting down the device, and removal of the device.”  The plaintiff claimed that various doctors and company representatives failed him.  Around the time of an ER visit, the plaintiff “‘made an incision to cut out the SCS himself, then after the ER visit, he hit the battery pack with a mallet until it stopped working.”  

That is taking self-help a bit far, isn’t it?

At this point, our thoughts drifted away from Aristotle and toward the Justified television show.  For those of you who never saw the show (and if you are in that category, you should remedy that situation sooner rather than later), the protagonist is U.S. Marshall Raylan Givens.  Givens is a good shot, and he gets many chances to prove that because he is quick to throw bullets.  That is, he shoots a lot of people.  But these shootings are invariably – wait for it – justified. In one episode, Givens says something like this: If in the course of your day you run into an a-hole, well, you had the misfortune of running into an a-hole.  But if all day long you find yourself constantly running into a-holes, guess what?  Maybe you’re the a-hole.

The Hunt plaintiff’s unique and persistent truculence was a big reason why his claims were dismissed. The court dismissed both the consumer protection and negligent misrepresentation claims.  The court dismissed the consumer fraud claim because one of the statutory requirements was that the alleged deception impacted the public. But Hunt was purely a private personal injury case without the required public impact element.  The case involved only peculiar, plaintiff-specific facts.  The plaintiff came up with no evidence “that any person other than himself suffered the same deceit” or that the device company was “likely to make the same misrepresentations to someone else.”  The plaintiff asserted that the company’s representatives were trained to make the alleged misrepresentations and regularly did so, but he had no evidence in support. 

On the alleged deception regarding the number of controller settings, the defendant provided unrebutted evidence that it had “never allowed patients to own or use the tablet alone, and that FDA restrictions would not permit it to do so.”  The court shrewdly observed that if the device company in fact regularly promised patients they would get the 28 level tablet and then reneged, the plaintiff in Hunt “would likely have company as a plaintiff.”  The court dismissed the consumer protection claim with prejudice. 

The negligence claim travelled under two theories.  The first was that the defendant’s agents misled the plaintiff about the device controller’s features. The second theory was that the company breached its “duty to service the malfunctioning SCS, ultimately prompting him to cut the device out of his body in desperation to stop the unbearable unprompted shocks.”  

The Hunt court decided that the negligence claim lacked the necessary expert testimony on scope of duty, standard of care, and causation. “Because expert testimony is necessary to explain how the SCS works, expert testimony is necessary to sustain a claim for negligent marketing and certainly for negligent servicing of the SCS.” The plaintiff had no expert testimony to support his claim that the company had improperly marketed and inadequately serviced the device.  Moreover, whether the device malfunctioned so as to injure the plaintiff likewise required expert testimony. On this point. The plaintiff did not merely lack expert testimony; his experts actually undercut his position by blaming the car crash for causing the leads in the SCS to migrate and thereby causing the plaintiff’s pain. 

The Hunt complaint was replete with – well – complaints. But the plaintiff had precious little evidence to support such complaints.  The court’s dismissal of the complaint was hardly shocking. 

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We hope we have some 1980s cartoon fans out there who will remember that G.I. Joe ended each of his cartoons with a PSA – “Now you know. And knowing is half the battle . . .”  The PSA was usually about something dangerous kids did unintentionally—like running out into traffic.  The idea was that once kids knew about a risk, they would take the necessary steps to avoid it.  Turns out the same thing applies to learned intermediaries.  It is not enough that they are aware of the risks of a medical device, but knowledge of those risks must spur them to take a different course of action.  Otherwise, as the plaintiff in In re Biozorb Device Products Liability Litigation, learned—there is no failure to warn causation.  2025 U.S. Dist. LEXIS 18654 (D. Mass. Feb. 3, 2025).

Plaintiffs in this litigation have brought failure to warn, design defect, breach of implied warranty, and negligence claims against the manufacturer of an implantable medical device used as a marker for procedures such as radiation treatment.  The product is designed to dissolve or reabsorb over time, leaving just clips that allow for radiographic targeting.  The device’s Instructions for Use state that the reabsorption could take one or more years.  Id. at *9-10.  Plaintiffs allege that the extend reabsorption time led to complications, including pain, a palpable mass, and the need for explant surgery.    

Plaintiff who is the subject of this decision was one of four bellwether plaintiffs whose case was proceeding through phased discovery.  Phase one was discovery related to failure to warn and the learned intermediary doctrine.  Following the deposition of plaintiff’s implanting physician, defendant moved for summary judgment.  That testimony included that the surgeon had been using the device for 3-5 years at the time of plaintiff’s surgery and he was aware the reabsorption process could be prolonged.  Id. at *11-12.  He was also asked about an FDA Safety Communication that came out in 2024, six years after plaintiff’s surgery.  He testified that most of the risks identified in 2024 were risks common to any kind of surgery with any kind of implantable device, such as infection and seroma.  Id. at *13-14.  Finally, the surgeon was asked whether he still would have implanted the device in plaintiff in 2018 had he known about the risks described in the FDA Safety Communication.  He testified that he would and that he still does.  Id. at *14-15. 

Against that factual background, the court was compelled to award summary judgment to defendant on plaintiff’s failure to warn claim.  Plaintiff was a resident of Michigan, where she also had her surgery and sustained her alleged injuries.  So, the court applied Michigan learned intermediary law.  Under which

[t]o establish the element of proximate causation, a plaintiff must show that an adequate warning would have prevented the plaintiff’s injury by altering the prescribing doctor’s conduct or that the doctor might have heeded the warning.

Id. at *18.

Because the implanting surgeon testified that additional warnings would not have changed his conduct, plaintiff tried to argue that a material dispute existed regarding the surgeon’s actual knowledge of the risks at the time he prescribed the device.  But the doctor’s awareness, or even lack thereof, “says nothing about the critical question on the issue of causation: that is, what [the doctor] would have done had he known of those risks.”  Id. at *20 (emphasis in original).  Plaintiff cited no Michigan law for the proposition that a lack of knowledge alone is sufficient to defeat summary judgment.  It does not.

After G.I Joe gave his lesson, the cartoon kids crowded around and yelled Now we know!  Learned intermediaries may shout the same.  But knowing or not knowing isn’t enough.  Action based on knowledge is what is required–both by kids learning not to play in traffic and surgeons acting as learned intermediaries.

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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.

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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. 

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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.

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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
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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.  

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