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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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From its start, the Blog has railed against certain expansions of traditional product liability that could have negative impacts on scientific progress and the availability of good medical products.  Innovator liability, first described in Conte back in 2008, is a good example of a bad idea.  Its offspring, the so-called duty to innovate, is such a bad idea that we might liken it to Fenrir, the mythological wolf-son of Loki who was fated to swallow the earth.  Not quite so overly dramatic are the variety of alleged liabilities of clinical trial sponsors for doing the various things described in informed consent documents, such as assigning the participant to a placebo arm of the trial or ending free treatment with a study drug once the trial ends.  Perhaps a little lower down the list is the subject of publisher liability, both as to journals and to investigators and institutions that conduct research that might help get an allegedly harmful medical product on the market.  See here, here, and here.  It is not hard to see how creating liability, or even the threat of costly litigation, that runs from someone who conducts research to someone who was allegedly harmed by the product at issue in the research (but was not part of the study itself) could have a chilling effect on research.  We do not think we are going out on a limb by saying sound public policy favors encouraging quality scientific and medical research that might lead to new medical products and other advances in public health.

But what about dreck?  Some research is of low quality, not just because it has poor design, poor funding, and/or poor investigators, but because the investigators have an agenda.  We know that plaintiff lawyers like to portray all industry-sponsored research and research done by researchers with even tangential ties to industry as being inherently biased.  However, there is research that really can be labeled as “litigation-driven.”  This genus has a species where experts write up their take on patients they were retained to help in litigation.  If you lump enough of these takes together, especially if you throw in some non-litigation cases, then you have something that can dressed up for publication as a case series or a case study (the deceptively dressed case series).  If published in a peer reviewed journal, such a litigation-driven case series can be accorded a check on each side of Daubert ledger.  There is also a species with legitimate, protocol-driven research to address an issue raised in litigation or to respond to a publication from the other side offering a hypothesis that goes against the established mainstream scientific view but helps one side in litigation.  Of course, there is also the species where laboratories with partially obscured ties to the plaintiff bar purport to detect potentially dangerous levels of some unexpected chemical in an everyday item, with the intent to further litigation before the lack of reproducibility can have its own impact.

Most of the attention on these pages to litigation-driven research has related to admissibility of expert opinions based in whole or in part on them.  Dressed up ipse dixit is still ipse dixit.  “My proof of general causation is that I have a specific causation opinion in this case in which I am retained as an expert for the plaintiff” is not too different than “My proof of general causation is that I have had specific causation opinions in multiple cases where I was retained as an expert for the plaintiff and I was able to publish a case series about them.”  We have seen a few cases recently where defendants have gone after data from the research frequent flyer plaintiff experts claims supports their recurring positions.  Results have been mixed, like here, here, and here.  In LLT Management, LLC v. Emory, No. 4:24-cv-75, 2025 WL 438100 (E.D. Va. Feb. 7, 2025), a subsidiary of a well-known talc manufacturer took a different approach.  It sued three plaintiff experts who published an article that it claims created liability for business harms under three different theories.  The experts-turned-defendants moved to dismiss and knocked out two of the three claims.  However, surviving the motion to dismiss means the manufacturer will be able to seek discovery from the experts that we expect will be broader than could have been obtained through a more traditional route.  Plus, the experts have to defend and risk liability in the case as it proceeds through the E.D. Va. “rocket docket.”

Negative consequences for an expert who provides testimony that is less than factual are generally limited.  We have never heard of a prosecution for perjury of a testifying expert.  Sanctions are rare.  Reputational damage is hard to measure, and the skeptical defense lawyer in us might proffer that being good at stretching the truth might help a plaintiff expert get work in serial product liability litigation.  While a few states have a cause of action against a party that brings frivolous litigation, liability for an expert for slander from the stand is not really a thing.  If the false statement appears in writing in an article that is available to the public, however, then the expert/author has at least theoretically exposed herself to liability, particularly if the statement is viewed as being tied to the author’s own business ventures.  That distinction was key in the Emory decision.

The allegations in the Emory complaint were that the three frequent flyer experts in asbestos litigation published a case series in March 2020 that purported to describe 75 patients who were separate from 33 patients in an earlier case series, each of whom purportedly had mesothelioma despite no known exposure to asbestos except through cosmetic talc, of which plaintiff’s parent was a major manufacturer.  However, the authors allegedly knew of overlap between the two case series and that at least six of the patients had other known exposures to asbestos; they allegedly knew this because they had been retained experts for those patients when they sued the manufacturer.  They also allegedly published the case report as part of a symbiotic relationship with plaintiff lawyers to generate negative attention about the manufacturer, encourage more lawsuits against it, and provide more opportunities where they could be hired as experts.  These allegations were offered in support of New Jersey common law claims for “Injurious Falsehood/Product Disparagement” and fraud and a Lanham Act claim for false advertising.  Defendants moved to dismiss on statute of limitations, laches, standing, and failure to state a claim.

We will focus our discussion on the issues that are more likely applicable to future cases like this.  In terms of statute of limitations and laches, the main issues were 1) that the clock started with the publication given the manufacturer’s knowledge from prior litigation and 2) that the experts failed to articulate prejudice from any delay in bringing the Lanham Act claim approximately four years after the publication.  The fraud count fell based on the application of Virginia’s two-year statute of limitations.

As to standing, the manufacturer claimed harms from the article in terms of lost sales volume and profits and the increased expense of defending litigation.  Each was sufficient to create standing for the surviving common law claim.  The allegation that there was a connection between the publication of the case series and the manufacturer’s discontinuation of certain products two months later may prove to be unsupported, but it was enough of an allegation for Article III standing.  So too for allegations that more lawsuits were brought because of the article and that defending cases became more costly when opposing experts relied on the article.  Standing under the Lanham Act requires, among other things, that the defendant’s advertising or promotion be made “for the purpose of influencing customers to buy goods or services.”  Because the experts were not selling or encouraging the purchase of any goods, the only promoted services that could lead to standing would be for plaintiff lawyers to hire them as experts.  That meant the Lanham Act claim had to be somewhat circumscribed.  (We also find it interesting that one of the arguments the experts made in challenging Lanham Act standing was that “the potential link between cosmetic talc and cancer has long been known to consumers,” which seems contrary to the positions taken by consumers as product liability plaintiffs against cosmetic talc manufacturers.  Plaintiffs tend not to want their experts to support an assumption of the risk defense.)

The limitation on the Lanham Act claim meant that it did not state a claim.  If the alleged false advertising related to the experts’ “litigation services,” then the alleged statements by the experts in the article did not constitute false advertising.  They accurately promised to testify consistent with the article, regardless of whether the article contained misrepresentations about the cases it discussed.  That left the claim for “Injurious Falsehood/Product Disparagement” under New Jersey law.  Somewhat surprisingly, the authors did not challenge that the element of malice has been properly pleaded.  Instead, they argued that the article contained opinions instead of verifiable facts.  Whether there were cases that appeared in both of the case series and whether there were “known” exposures to asbestos beyond cosmetic talc were matters of fact, not opinion.  New Jersey law does not have a blanket protection for what is in a peer-reviewed journal, but sets the test as whether “the facts are adduced through a scientific method, or whether they exist independent of the scientific process.”  Information the authors had from being experts in litigation before the article was published is the latter.  The other challenges also failed.  In a bit of a reverse nod to market share liability, the statements in the article were reasonably inferred to relate to the manufacturer’s products, because they had a majority of the market and name recognition.  The damages allegations discussed above were also sufficient, at the motion to dismiss stage, to establish the requirement that the product disparagement is alleged to cause special damages.

That brings us back to where we started.  The expert-turned-authors-turned-defendants will be subjected to discovery on their work, their relationship with plaintiff lawyers, and presumably other sensitive subjects.  It remains to be seen whether the underlying facts of Emory are too unusual to make this sort of collateral litigation a standard option and whether there will be a chilling effect on legitimate scientific scholarship about products that are or will become the subject of major product liability litigation.  We doubt either will come to pass, but, having crossed many experts whose allegedly independent scientific publications overlap with their decidedly biased litigation work, we cannot help but be intrigued by the implications of Emory.

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