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This is from the Holland & Knight side of the Blog only.

Quite a few phrases from sports have entered our collective lexicon.  (Not Lexecon, which is a whole other thing entirely.)  We hit home runs in many contexts divorced from a baseball or softball field.  We can be deked out when not on a hockey rink or a lacrosse field.  People are dunked on in any manner of ways not associated with a basketball hoop.  One may be said to have outkicked his coverage in dating someone who is way better than he is.  Perhaps that resulted from throwing a Hail Mary as the clock ticked down on their first date or encounter.  We will not attempt a rope-a-dope by purporting to offer a complete list of such terms, metaphors, and phrases.  They certainly are rife in the legal world, as well.  Opening and closing statements, for instance, may describe the burden of proof in terms of yard lines on a football field or describe the prevalence of a risk by the number of people in a stadium.  There is also a tactic seen in some complaints where it is hoped that there are so many disparate allegations and claims that a motion to dismiss could not possibly cover them all well enough to convince a judge to get rid of the entire case.  From football plays that send multiple eligible receivers to one part of the field—such as a flat route, an out route, and a corner route to the right—we call this “flooding the zone.”  The term has been bandied about (another sports term) in the press over the last few months in different contexts, but we will stick with civil litigation here.

Flooding the zone worked for opioid plaintiffs for several years.  Cases often targeted dozens of defendants, asserting many different legal theories of recovery in massive complaints.  It could be easy to get lost in all the allegations to test the basics of a 12(b)(6) motion in terms of whether any particular claim asserted by a particular plaintiff against a particular defendant was supported by sufficient factual allegations for each element of a legally cognizable cause of action.  This was particularly so where the alleged conduct of some defendants sounded bad, and the societal harms of widespread drug abuse were so grave.  As we saw last year with the Ohio Supreme Court’s rejection of public nuisance seven years after the creation of an MDL in Ohio that put Ohio public nuisance claims front and center, it can take some time to work through all the fluff to get to the determinative issue.  Up in Maine, which has a reputation for a slow pace, it took a mere forty-one months from the filing of an opioid case against more than a dozen defendants until the Supreme Judicial Court affirmed its dismissal.  In 2021, several Maine hospitals sued a series of drug manufacturers, distributors, and retail pharmacies in a 509-page complaint with 1847 numbered paragraphs and six different theories of recovery.  Eastern Maine Med. Ctr. v. Walgreen Co., No. BCD-23-73, 2025 ME 10, 2025 Me. LEXIS 11 (Me. Feb. 6, 2025) (“Eastern Maine”).  The trial court eventually dismissed all the counts without leave to amend.  On appeal, the obvious attempt to flood the zone actually hurt plaintiffs’ chances.

One of the bases for dismissal below was Maine Rule of Civil Procedure 8(a), which matches Fed. R. Civ. P. 8(a)(2) in requiring that a complaint include “a short and plain statement of the claim showing that the pleader is entitled to relief.”  Unless the subject is Russian literature, 509 pages is not short; the rambling and repetitive complaint was also not plain.  2025 Me. LEXIS 11, *9. Maine also requires, unlike the Federal Rules, that “[e]ach averment . . . be simple, concise, and direct.”  The complaint’s length also did not hide its shortcomings:  “The complaint describes in eye-watering detail the evidence the Hospitals presumably intend to rely upon to prove their claims, but fails to link the cited evidence in a clear fashion to the elements of the claims pleaded in the complaint.”  Id. at *10.  (Practice pointer:  you do not want a court or jury to describe anything you do as “eye-watering.”)  Thus, in a relative rarity outside of the Pine Tree State, the dismissal was justified by the “sheer length of the complaint.”  Id. at *11.

On the merits, which presumably also tied to the trial court’s refusal to permit an amendment, we are going to mix up the order to address public nuisance first because that has been the theory driving civil litigation concerning opioids.  Unlike in Ohio (where the decision earned our third best spot last year), this was not an issue of abrogation.  Maine has public nuisance (also called common nuisance) under its common law and a statute that authorizes damages.  However, for a private plaintiff—like hospitals—to bring public nuisance claims under Maine law, it “must show an infringement of private rights resulting in special legal injury different in kind as well as degree from that suffered by others.”  Id. at *22 (internal citation and quotation omitted).  By alleging that the defendants “increase[d] the incidence of opioid misuse” and damaged the public health in Maine and elsewhere, the Eastern Maine plaintiffs described a public injury, but not a special private one.  That was game over.  The claim that the hospitals lost money because opioid misuse led to the hospitals providing care that was not fully reimbursed paled in comparison to what the complaint described for others:

But there is ultimately no difference in kind between the injury to the Hospitals and the injury to the public—we all have suffered the devastating human, social, and economic effects that result from an increase in opioid misuse.  The alleged injuries to the Hospital are not sufficiently particular to the Hospitals to support a public nuisance claim; they are instead part of the broad public injury resulting from increased opioid misuse and therefore may not be addressed in a private cause of action.

Id. at *23-24 (citation omitted).  On the other hand, an individual who suffered direct special damages because of her own misuse of opioids might encounter insurmountable causation issues, including those related to intervening criminal acts by the plaintiff or someone else.  In addition, Eastern Maine relied upon the Third Restatement’s express rejection of public nuisance claims involving product-related injuries.  Id. at *26 & n.6.

The other claims in Eastern Maine suffered similar problems.  The negligence claims fell flat because the defendants did not owe a duty to the hospital plaintiffs to minimize their provision of unreimbursed care.  “We have never held . . . that a hospital that treats a victim injured by a negligent act can assert its own negligence claim for the cost of treatment directly against the person who caused the injury.”  Id. at *15.  One could argue that hospitals exist to provide care to patients, regardless of who might have injured them, and actually make money by providing that care.

The various versions of fraud plaintiffs asserted were based on a range of allegations about what was allegedly concealed from “accrediting bodies, governmental agencies, prescribers, and consumers,” but the complaint lacked allegations that the hospital plaintiffs relied on anything said or concealed by the defendants when the hospitals provided “treatment to patients with opioid use disorders.”  Id. at *16-17.  It certainly did not allege reliance with specificity.  Similarly, the unjust enrichment claims fell, even with a generous recasting as “equitable subrogation,” because they were not tied to allegations about individual patients who abused opioids and required medical care at the plaintiff hospitals.  The appellate court could not “make the categorical assumption of law that the claim requires.”  Id. at *18.  The civil conspiracy also struck out because it required “the actual commission of some independently recognized tort.”  Id. at *29 (citation omitted).

Surely, someone could argue that the Ohio Supreme Court and Supreme Judicial Court of Maine decisions should not be lumped together or viewed as indictments of the broader opioid litigation, but they were two months apart and both were decisive rejections of opioid plaintiffs’ claims before the two courts.  Combined with the Oklahoma Supreme Court decision from 2023, which also followed the Third Restatement in rejecting public nuisance in opioid litigation, we seem to have something of a streak.

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Bergdoll v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 38300 (W.D. Mo. March 4, 2025), is a good Class III medical device preemption decision. The device was a Filshie clip, which is used to perform tubal ligations.  The claim in Bergdoll is the typical one that the clip migrated and caused adverse symptoms. Bergdoll is also typical of the trend of defendants in Filshie clip litigation doing better on premarket approval (PMA) preemption on summary judgment than on a motion to dismiss.  

The plaintiffs (wife and husband) brought claims for design defect, manufacturing defect, failure to warn, “strict liability negligence” (whatever that is), violation of consumer protection laws, gross negligence, and punitive damages. The plaintiffs’ main beef with the defendants seems to be a failure to report adverse events to the Food and Drug Administration (FDA), resulting in an alleged understatement of the rate of migration. 

Both sides filed summary judgment motions.  The plaintiffs lost and the defendants won. The court’s opinion makes clear why that had to be the result. 

It was undisputed that the FDA reviewed and audited the defendants’ complaint-handling procedures and never found noncompliance.  The plaintiffs claimed that “the FDA does not know about the vast numbers of ‘scientific articles’ and ‘hundreds of adverse event reports’ that Defendants have deemed not reportable.  In essence, Plaintiffs contend Defendants are failing to report information to the FDA and if the FDA had this information Defendants would not be found in compliance.”

The plaintiffs were obviously endeavoring to evade preemption, but they failed. PMA device express preemption is triggered when the federal government established requirements – which, of course, it did for the Filshie clips – and the plaintiffs’ claims would impose requirements “that are different from, or in addition to the federal ones, and that relate to safety and effectiveness.”  Check, check, and check. 

It is a wonder that the plaintiffs even bothered to file a design defect claim.  With a class III device, preemption of such claims is iron clad.  

The Bergdoll decision might be most helpful on preemption of the manufacturing defect claim. That is a cause of action where plaintiffs tend to raise the most dust (and by “dust” we mean confusion) over the scope of preemption.  The Bergdoll court held that to escape preemption of a manufacturing defect claim on summary judgment, the plaintiff must prove that the medical device “was manufactured in a way that violated the PMA requirements.”  Compliance with the manufacturing process matters. Malfunction by itself does not establish deviation from specs.  

Naturally, the plaintiffs attempted to avail themselves of the dreaded Riegel parallel claim exception, but, again, the plaintiffs offered no claims of design or manufacturing deviations from FDA requirements. 

The failure to warn claims were a goner because the defendants’ FDA-approved warnings stated the rate of symptomatic migration.  

Bergdoll appears to be a situation in which plaintiff lawyer advertising dredged up old cases like this one, where the insertion was at least 15 years before suit.  Here, the plaintiffs attempted to assert a warning defect by way of failure to report.  That failed.  The warning language was what the FDA approved.  Anything else would be “different from or in addition to.”  

The Bergdoll court delivered a one-two preemption punch to the plaintiffs’ case, because it also held that the failure to report claims amounted to private FDCA enforcement and were thus impliedly preempted under Buckman.  

Further, to the extent the plaintiffs’ theory would require device manufacturers to inform end users about a higher migration rate, that would counter or supplement the FDA requirement to send adverse event reports to the FDA only.  The variance that the plaintiffs identified between the lower reported migration rate and what plaintiffs assert is the actual, higher migration rate seems to be that asymptomatic migration claims are not reportable adverse events.  Fine. That variance is not the stuff of a product liability claim, no matter the cause of action. But it is the stuff of preemption of every cause of action. 

Various other claims, based on negligence and consumer fraud were based on the same facts and were similarly preempted.  

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Sometime last year, one of our esteemed bloggers wrote: “The qui tam provision of the FCA, which permits private plaintiffs – sorry, relators – to steer FCA claims presents marvelous opportunities for mischief.” We couldn’t have said it any better, so we won’t try.  Moreover, mischief makes us think of the Marauder’s Map (Harry Potter) – created by complex magic, it allowed its user to track the movements of everyone within the walls of Hogwarts. The map’s contents, however, only revealed themselves to those who knew the activating phrase:  I solemnly swear I am up to no good.  We think relators are acutely familiar with this phrase. 

A few months before that astute mischief observation, we also posted that the Eastern District of Texas had dismissed a similar FCA claim involving the off-label use of Botox to treat pediatric migraines.  The court granted the relator an opportunity to amend his off-label claims, which he apparently did. So, here we are nearly a year later, but this time on a summary judgment motion.  Little else appears to have changed.

To prove an FCA claim, the relator needs evidence that the defendant made “(1) a false statement; (2) with the requisite scienter; (3) that was material; and (4) caused the government to pay out money or to forfeit moneys due.”  United States ex rel. Hearrell v. Allergan, Inc., 2025 U.S. Dist. LEXIS 37033, at *2 (E.D. Tex. Mar. 3, 2025).  The relator in Hearrell advanced two FCA theories.  One, that defendant violated the FCA by violating the Anti-Kickback Statute (AKS).  Two, that defendant violated the FCA by promoting Botox for an off-label purpose, in this case the treatment of chronic migraines in minors. 

On the AKS theory, plaintiff would have needed to establish that the defendant “knowing and willfully” paid a doctor to induce him/her to prescribe Botox, a claim for which was then submitted to Medicaid for federal reimbursement.  The only evidence relator offered was that the defendant retained Key Opinion Leaders (“KOLs”), a common practice in the pharmaceutical industry.  KOLs provide consulting and advisory services for drug manufacturers and can be paid for speaking engagements. That is completely legal and not evidence of a kickback.  The relator alleged that the payments were for KOLs to make “referrals to pediatric specialists.”  Id. *3.  But at oral argument, relator had to concede he had no evidence to support that allegation.  Not that further discovery would have turned up any such evidence, but relator did not depose or obtain written/document discovery from any KOL.  Id. at *4.  Another indication that relator was really up to no good here.

As for his off-label promotion theory, it failed at step one—no proof of a false statement.  That’s because the Medicaid claims at issue “explicitly disclose” that the treatments were for off-label pediatric use.  Further, Medicaid “routinely reimburses” for such off-label use and the prescribing physician “obtained prior authorization” for each prescription. Id. at *4-5.  Relator’s only counter to this overwhelming evidence was that defendant misrepresented Botox as “safe and effective” for pediatric migraine treatment.  The court found the argument unpersuasive.  “If the government knows the particulars of a claim and approves it, that claim cannot be fraudulent.” Id. at *5.

Finding no material disputed fact on either theory, the court granted summary judgment for defendant. 

Mischief managed.

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We were promised “radical transparency” by the incoming Secretary of HHS.  We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.”  Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself.  For one thing, as we mentioned most recently here, the FDA takes notice and comment on guidance documents, such as those it issues that concern off-label speech.  As we’ve pointed out many times, guidance documents are not regulations with force of law.

Continue Reading “Radical” but Not “Transparent”
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We reported a few months ago on a California court that largely gutted a pharma-related privacy class action centered on the alleged disclosure of personal information through the use of computer pixels.  Today we bring you another pixel case, but with a different outcome.  In Jancik v. WebMD LLC, No. 1:22-cv-644, 2025 U.S. Dist. LEXIS 30054 (N.D. Ga. Feb. 20, 2025), a federal court in Georgia certified a class of individuals who allegedly viewed videos on a health information website, only to have their video viewing history allegedly disclosed to a third party via pixels. 

You might ask, what’s wrong with that?  Well, according to the plaintiffs, disclosure of video viewing violated the Video Privacy Protection Act, a federal law enacted in 1988 to regulate when video rental shops could tell other people what videotapes you were renting.  Some readers might recall the hubbub in the 1980s when a too-clever reporter obtained and published a list of videotapes that Supreme Court nominee Robert Bork rented from his local video store.  Judge Bork did not succeed in being appointed to the Supreme Court in 1987, but Congress successfully (and very quickly) passed a law the next year to avoid comparable leaks.  We do not recall anything remotely controversial in Judge Bork’s video rentals, but still, we see the point.

Fast forward to the Internet age, and the issue in Jancik was pixels, which are small pieces of code that websites can deploy to gather information on website visitors—what they searched for, which links they clicked on, etc.  As we surmised in our prior post, when you make travel plans online and then start receiving ads from airlines and hotels in Facebook or on Instagram, that might be the work of tracking pixels.  The Jancik plaintiffs alleged that the defendant’s health information website used pixels to track their video viewing (called “Event Data”) and then shared that information with a third party.  They sought certification of a class of individuals who used the same email addresses in connection with the website and the third party and whose “Event Data” was in the third party’s possession.

We have no idea whether this defendant violated the Video Privacy Protection Act.  We do not know, for example, whether its terms of use covered this scenario, whether certain user settings were relevant, whether website visitors gave consent, or whether other circumstances would place the defendant within one of the Act’s exceptions or outside the Act’s purview altogether.  This defendant, after all, was not Blockbuster Video.  Regardless, the district court ruled that the lawsuit presented sufficient common issues and otherwise met Rule 23’s requirements for a class action. 

First, the court ruled that the class was ascertainable, even though neither the plaintiffs nor the defendant has possession of information sufficient to know who would be in the class.  For that, the plaintiffs asserted that they would obtain information from the third party, which then could be compared to other information, which then would generate a list of putative class members.  But a software engineer from the third party testified that “he suspected” that analysis would be “possible” and that he “believe[d] you could probably do that.”  Id. at *12-*13.  Not exactly a vote of confidence, or an opinion to a “reasonable degree” of certainty.  The court nevertheless found it sufficient and noted that the defendant (who did not have any burden of proof or production under Rule 23) had “not offered testimony to the contrary.”  Id. at *13.  Put a pin in that. 

Second, the court found the proposed class met the other requirements of Rule 23(a).  It found the class to be numerous, citing “common sense.”  Given that numerosity is easily demonstrated and rarely contested, we won’t dwell on this.  The court also found commonality and typicality, which we will dwell on.  The defendants argued that the putative class members’ claims presented individual issues because myriad factors would affect whether and how tracking pixels would operate, including privacy setting, usage of different devices, and sharing of accounts by different individuals.  The court ruled, however, that the plaintiffs had “circumvented” these concerns by defining the class to include individuals whose Event Data was already in the third party’s possession.  The court similarly rejected more technical arguments offered by the defendant “without diving too far into the specifics” and found that the defendant (there’s that burden of proof problem again) had not shown why other differences between class members were significant.  Having found the class representative’s claims were typical of the class, the court found the class representative adequate, too.  Id. at *22-*27. 

Third, the court ruled that common issues predominated over individual issues and that a class action would be superior to other forms of resolution under Rule 23(b)(3).  Common issues included whether website subscribers were “consumers,” whether the defendant was a “video tape service provider,” whether the type of data allegedly transmitted was personally identifiable information, and whether the defendant obtained consent.  Id. at *28-*29.  We cannot help but think, however, that it is not quite so simple.  The defendant urged that each class member would need to prove individually that his or her private information was shared with the third party, and even the court acknowledged that just ascertaining the class would have to “account[ ] for device, browser, and other settings.”  Some of those “other settings” might be game changers.  We can’t tell.  The court also banked on a “class action administrator” performing “quality assurance checks” to exclude class members whose claims are without merit.  We have seen this play before, and when a certified class includes class members without valid claims, it is little solace to hear that a class administrator will sort it all out after the fact. 

Finally, the court certified an injunctive relief class under Rule 23(b)(3), although it seems the relief sought was only vaguely described as “protect the interests” of the class and comply with the law. 

The result is a relatively rare certification of a privacy class action in the healthcare space.  We observe in closing that this court seems to have given the moving party the benefit of the doubt—for example, by finding ascertainability based on equivocal evidence, while chiding the defendant for not offering contrary testimony.  Another example is the court’s note that the defendant had not shown why differences among the putative class members were significant.  The plaintiff bore the burden on this motion. 

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Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so.  Our post about the Ninth Circuit’s decision is here. 

The short version is that the Davidson plaintiffs filed a putative class action claiming Sprouts mislabeled the nutritional content of certain baby foods, such as the number of grams of protein or fiber.  The plaintiffs contended this was a violation of the Sherman Act, a “mini-FDCA” law that parallels the federal FDCA, and thus established the “unlawful” prong for their California Unfair Competition Law (UCL) claim. 

Now, however, we write about the cert petition pending in the United States Supreme Court in Sprout Foods, Inc. v. Davidson.  Respondent has until March 14, 2025 to respond to the cert petition, so the case is not yet up for conference.

The issue in Sprout Foods is one of our bread-and-butter preemption issues:  The FDCA, and in particular 21 U.S.C. § 337(a) as construed in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), states that, with minor exceptions, actions to enforce the FDCA have to be brought by the federal government, because they “shall be by and in the name of the United States.”  21 U.S.C. § 337(a) (emphasis added).

As the Supreme Court recognized in Buckman, this statutory language “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the [FDCA’s] provisions.” Buckman, 531 U.S. at 349 n.4.

Because of this “no private right of action” provision, if a product liability tort claim seeks to enforce duties that “exist solely by virtue of the FDCA,” it is impliedly preempted.

On the other hand, claims that are founded “on traditional state tort law which … predate[s]” the FDCA are not impliedly preempted. Buckman, 531 U.S. at 352–53.  (But of course if the claim involves a PMA medical device and imposes state law requirements that are different from, or in addition to, those imposed by federal law, then the express preemption clause of the Medical Device Amendments to the FDCA (21 U.S.C. §360(k)(a)) kicks in, and the claim is expressly preempted.  But we digress.). 

So where does an alleged violation of food labeling provisions adopted through a mini-FDCA like the Sherman Act fit into this picture regarding “exclusive federal enforcement” versus “claims founded on traditional state tort law” that predates the FDCA?

Well, a mini-FDCA like the Sherman Act does not predate the FDCA, because by definition a mini-FDCA was enacted to incorporate FDCA requirements, so that can’t apply.

Aha, you think:  Then the FDCA’s exclusive federal remedy provision supplies the answer, and requires preemption of private litigants’ claims.

According to the Ninth Circuit, however, there was no preemption and no problem.  As our prior post explained:

Despite acknowledging that the food-labeling requirements imposed by California’s Sherman Law are, by definition, the requirements established by the FDCA, the Davidson majority held that § 337(a) does not preempt private suits to enforce those requirements because, it said, “plaintiffs are claiming violations of California law, the Sherman Law, not the federal FDCA.” [Davidson,] 2024 WL 3213277, at *6 [(9th Cir. 2024)]. According to the majority, § 337(a) has no bearing on private actions to enforce California’s Sherman Law because it “addresses only enforcement of the federal law.” Id. at *7.

In the eyes of the Davidson majority, it would make no sense to hold private Sherman Law claims impliedly preempted when a provision of the FDCA—namely, the express-preemption clause of the Nutrition Labeling and Education Act (NLEA)—allows states to adopt food-labeling requirements “identical” to those adopted under the NLEA. 21 U.S.C. § 343-1(a). There is, the majority said, “no reason … why Congress would permit states to enact particular legislation and then deny enforcement by their citizens.” Davidson, 2024 WL 3213277, at *6.

But as the prior post also explained, the Ninth Circuit’s analysis ignores important issues raised by the Ninth Circuit dissenter.  And, as we noted at the outset, Sprout Foods has now filed its cert petition, which drew very helpful amicus support from the Atlantic Legal Foundation. 

While the Davidson majority concluded that private enforcement of the FDCA’s food labeling provisions must have been intended by Congress, they never explain why Congress did not enact a private right of action to expressly authorize this.  And in the absence of an express private right of action, allowing states to adopt federal food, drug, and cosmetic provisions wholesale must be read within the context of the general FDCA provision about rights of enforcement: 21 U.S.C. § 337. 

Not only does § 337(a) prohibit private rights of action and generally make federal enforcement the exclusive remedy, § 337(b) allows state enforcement—but only under strict parameters, including pre-suit notice to the FDA and an opportunity for the FDA to intervene. 

Thus, the answer to the conundrum that the Ninth Circuit majority saw—why “permit states to enact particular legislation and then deny enforcement by their citizens”?—is answered by the statute itself: Congress permitted states to enact particular legislation, and then granted the states themselves (not their citizens) the power to enforce them, with certain procedural limitations and requirements.

Thus, the Sprout Food cert petition raises interesting issues of statutory interpretation that hopefully will garner enough attention at the Supreme Court to result in a grant.  The Ninth Circuit’s view is not widely accepted, and a split on the issues in the Circuits certainly justifies the high court’s attention and (hopefully) its ultimate reversal.

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The Butler Snow contingent on the DDL blogging team had nothing to do with this post. 

New York law is surprisingly good for defendants.  Or maybe we’re jaded by bad experiences in other jurisdictions, and New York law manages to seem fair only by comparison.  Certainly, we’d rather be in a courtroom in New York than in California, Illinois, or Pennsylvania. 

Silverstein v. Coolsculpting – Zeltiq Aesthetics, Inc., 2025 N.Y. App. Div. LEXIS 1118, 2025 NY Slip Op. 01183 (N.Y. App. Div. Feb. 27, 2025), is an example of a New York decision that treats a medical device defendant reasonably well. To begin with, in New York, defendants are permitted to appeal denials of summary judgment as of right. Silverstein is a New York Appellate Division decision unanimously reversing denial of summary judgment. That makes it the very best form of authority.  A defense hack can cite Silverstein and tell a judge that it means that a denial of summary judgment will be reversed. (In the hierarchy of case law authority, one ascends from good language in a case that came out the wrong way, nice dicta, a case that came out the right way, an appellate case affirming a case that came out the right way, and an appellate court reversing a case that came out the wrong way.  Silverstein sits at the top of this hierarchy.)

In Silverstein, the plaintiff sustained second and third degree burns from ice packs applied to her skin after treatment by the medical device at issue. She alleged that the manufacturer of the medical device had a duty to warn of “synergistic” risks caused by the use of another product it did not make (the ice pack) in conjunction with a procedure using the device it did make.  The best piece of evidence the plaintiff had was a slide the manufacturer provided to clinics with recommendations for mitigating pain. The slide listed icing, among other methods, as a way of possibly reducing the severity of side effects. But that is not the same thing as the ice packs being necessary to use the medical device. In fact, the ice packs were not necessary.  The device functioned without ice packs and ice packs were not included among the supplies accompanying the device.  The user manual did not recommend using ice packs. Rather, the manual merely listed ice packs as something that might be “considered for use only after the treatment was completed.”

Thus, the narrow exception involving products that required some other product in order to function properly (think bare metal/asbestos cases) was not applicable.  Otherwise, there is no duty to warn about the risks of someone else’s product.  

Further, the learned intermediary rule applied and the claimed warning was “obvious” to pretty much anyone and was well-known to this prescriber. He testified that “through his education and training, he was aware of and knew the dangers of placing ice on bare skin, and that those dangers were basic medical knowledge.”  Thus, in addition to there being no duty, there was no warning causation either.  

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And patience is a virtue…all great achievements require time…trust the process.  All easier said than done.  Waiting can be a breeding ground for discouragement or frustration—like in litigation where, unfortunately for defendants that waiting usually comes at the significant cost of having to defend against and conduct discovery.  Especially when the result after all that discovery feels like it could have come much earlier.  Which may be what the defendants in Arnold v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 34520 (S.D. Ohio Feb. 26, 2025) are feeling.

A year and a half ago we brought you the decision in Arnold on defendants’ motions to dismiss.  The court dismissed all of plaintiff’s claims as preempted except for failure to warn—finding plaintiff’s warning theory to be “not well defined” but good enough to survive the pleadings stage and for the case to proceed to discovery.  Id. at *12-13.  It came as no surprise to us that discovery didn’t fix plaintiff’s problems.

The product at issue is a Filshie Clip, a medical device used in tubal ligations.  The device was pre-market approved by the FDA in 1996 and has been sold throughout the United States ever since.  In plaintiff’s case, she underwent her tubal ligation in 2003 and nearly 20 years later, an x-ray of her pelvis after a fall on the ice revealed that a clip had migrated in her abdomen.  Id. at *7-8.

Medical devices that undergo pre-market approval, PMA devices, are subject to FDA requirements imposed as part of their approval.  Therefore, any state law requirement that is “different from, or in addition to” the FDA’s PMA requirements is expressly preempted.  21 U.S.C. § 360k(a).   Further, some claims that are not expressly preempted can still be impliedly preempted because the Supreme Court has held that the FDA is the “exclusive enforcing body of the FDCA.”  Id. at *18.  Thus, a plaintiff cannot sue a defendant for violating the FDCA.   Each of plaintiff’s failure to warn claims ran afoul of either express or implied preemption.

Plaintiff’s first theory was that defendants failed to adequately warn about the risk of migration both at the time of her surgery and thereafter.  Specifically, plaintiff wanted defendant to warn that the clips had a 25% migration rate—a warning that the FDA never requested or required.  Id. at *19-20.  Therefore, plaintiff is asking the court to impose a warning requirement that is beyond what was required by the FDA.  Such a claim is expressly preempted.  Id. at *20.  Plaintiff’s post-sale failure to warn claim suffered the same fate.  As part of the PMA process, the FDA requires continuous updates, in part so that it can assess the need for new warnings.  The undisputed evidence in the case is that defendants complied with the FDA post-PMA reporting requirements and the FDA never required the clip’s warning to include the 25% migration rate.  Because the FDA’s requirements extend to post-sale warnings, this claim was also expressly preempted.  Id. at *21-24.

Plaintiff’s second failure to warn theory was actually a failure to report claim.  She argued that defendant should be liable for not reporting adverse events to the FDA and/or to her and her surgeon directly.  Failure to report to the FDA is just another way of saying fraud-on-the-FDA which is impliedly preempted under Buckman. Id. at *25-26.  Further, plaintiff could not identify any state law duty to report adverse events to the FDA.  In other words, plaintiff claim is entirely based on an allegation that defendant violated the reporting requirements of the FDCA.  Another reason her failure to report claim was impliedly preempted.

As far as direct reporting of adverse events to patients and doctors—again there is no state duty requiring such reporting.  For good reason.  “Adverse event reports are not warnings.”  Id. at *27.    Far from it. They merely report that an event occurred, not that the device caused or contributed to the event.  Moreover, the FDCA does not require that manufacturers report adverse events to patients or doctors, so any state law requirement to that effect would be different from or in addition to federal requirements and therefore preempted.  And the court acknowledged that this conclusion comports with decisions by courts across the country on the same claims. 

While defendants may have been vexed that they did not obtain this result at the dismissal stage, they can take solace in a summary judgment win that is better late than never.  Or all’s well that ends well…a smooth sea never made a skilled sailor…there’s light at end of the tunnel…….

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Rieger v. Medtronic Minimed, Inc., 2025 Cal. Super. Lexis 14 (Cal. Super. L.A. Cnty. Jan. 28, 2025), is an excellent PMA preemption decision from, of all places, Los Angeles County Superior Court, in California – home of the notorious “the Bank” courthouse.  We have no idea whether Rieger was adjudicated in LA’s Central Civil West Courthouse, but that is the first thing we defense hacks think of when we see a “Cal. Super. L.A. Cnty.” citation.

But a few more like Rieger, and maybe we won’t any longer.

Continue Reading Taking Preemption to the Bank
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The word of the day is targeted.  Targeted discovery on a targeting device and a district court laser-focused on the failure to warn causation target.  The end result is a decisive defense win on failure to warn.  See In re Biozorb Device Prods. Liab. Litig., 1:23-cv-10599-ADB, No. 1:22-CV-11895-ADB, 2025 WL 509834 (D. Mass. Feb. 14, 2025).

The BioZorb is a Class II medical device indicated for situations where an excision site needs to be marked for future medical procedures, like radiation treatment.  The device consists of a spiral-shaped spacer that dissolves into the body, leaving behind titanium clips that allow radiographic targeting.

The court’s case management order, agreed to by the parties, is a unique one.  See In re Biozorb Device Prods. Liab. Litig., 1:23-cv-10599-ADB, Dkt. 11 (D. Mass. Apr. 25, 2023).  The first phase is focused on the learned intermediary rule, allowing a core set of document discovery, depositions of the plaintiffs and the implanting physicians, and summary judgment motions on the learned intermediary rule.  Waves of cases were selected to proceed through this process.  This case was one of the first four bellwether trial plaintiffs, with Colorado supplying the applicable substantive law. We have reported on other cases in the group here and here.

In the case at bar, the implanting physician testified that she stands by her decision to use the BioZorb for the plaintiff (she also did not believe that the Plaintiff’s alleged injuries of pain and fibrosis were related to the BioZorb).  This type of testimony should, of course, result in summary judgment on failure to warn.

To try to avoid summary judgment, Plaintiff deployed a couple of tactics that sometimes lead courts astray. This court stayed on target. 

First, Plaintiff failed to ask the correct causation questions. Whether they did it deliberately we can’t say, but certainly plaintiffs’ counsel sometimes do.  The correct failure to warn causation inquiry is “whether a stronger warning would have changed [the implanter’s] decision to use the BioZorb.” 2025 WL 509834 at *4.  But Plaintiff’s counsel asked no such thing.  Instead, Plaintiff’s counsel “elicited testimony that Dr. Pomerenke was unaware of a variety of potential risks associated with the BioZorb.”  Id.  “Aha! Failure to warn causation!” says Plaintiff.  Not so fast.  Testimony that the doctor did not know certain alleged risks “cannot carry her burden at summary judgment, as it says nothing about the critical question on the issue of causation: that is, what Dr. Pomerenke would have done if she had known of those risks.”  Id. (emphasis the court’s). 

Second, lacking evidence of causation, Plaintiff trotted out the heeding presumption.  But Colorado does not recognize any such presumption. Rather, plaintiffs “must produce evidence that [the implanting physician] would not have used the BioZorb had the manufacturer provided adequate warnings.”  Id. at *3.

Under the staged discovery order, the other claims will be decided later, so this is only partial summary judgment on failure to warn.  But so far, this decision hits the mark.

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