Photo of Stephen McConnell

Federal preemption of tort claims involving medical devices receiving premarket approval (PMA) is a powerful defense. But for some reason, there are plaintiff lawyers who think it does not apply, or barely applies, to claims for manufacturing defect. That is bad enough.  When courts buy into that misconception, it is even worse. It takes clear thinking (and clear writing and clear oral argument) to explain how PMA preemption of manufacturing defect claims works. Sometimes it also takes persistence. 

Today’s court opinion, Jacob v. Mentor Worldwide LLC, 2025 WL 2114888 (M.D. Fla. July 28, 2025), is short, but represents the culmination (maybe) of a long (six years) saga with many ups and downs — most of which should be familiar to readers of this blog.  The plaintiff is a pro se former neurologist who claimed she lost her husband, her job, and her health after she got breast implants in 2007.

The plaintiff filed the lawsuit in 2019. The district court dismissed the complaint on preemption and other grounds (Rule 8 and 10). Jacob v. Mentor, 389 F.Supp.3d 1024 (M.D. Fla. 2019).  The Blog covered this decision here: M.D. Fla. Holds Breast Implant Claims Preempted | Drug & Device Law

The plaintiff amended her complaint, and the district court again dismissed. Jacob v. Mentor, 2019 WL 6766574 (M.D. Fla. Dec. 10, 2019).  The Blog covered this decision here:  Breast Implant Preemption (the Sequel) | Drug & Device Law

So far, so good. 

The plaintiff appealed. And then Covid-19 entered the picture. Delay ensued. The appeal languished in the Eleventh Circuit for years as the plaintiff sought and received more than ten extensions of time.  Eventually, the court assigned the plaintiff an appointed appellate counsel.  That appointed counsel must have done something right, or the Eleventh Circuit must have done something wrong, as the result was a reversal of the dismissal on appeal. Jacob v. Mentor, 40 F.4th 1329 (11th Cir. 2022).  The Blog covered this decision here: Who Needs a Lawyer in the Eleventh Circuit? | Drug & Device Law

By “covered,” we mean derided. Indeed, the DDL Blog ranked this as one of the ten worst prescription drug/medical device decisions of 2022, coming in at #7: The Agony of Defeat -The Ten Worst Prescription Drug/Medical Device Decisions of 2022 | Drug & Device Law

The Eleventh Circuit remanded the case to the district court. The parties entered the maw of the great American discovery machine.  When it became evident that the plaintiff’s pro se limitations were going to make discovery nearly impossible, the parties (i.e., at the defendant’s urging) agreed to bifurcate the issues, dealing with manufacturing defect first, and medical causation (which was extremely complicated given the plaintiff’s extensive medical problems and dozens of treating physicians) second.  Smart move. Front-ending issues that have a good chance of terminating a case serves judicial economy. In fact, though plaintiff lawyers will deny it, such front-ending serves everyone’s economy. 

After a brief period of discovery involving production of the defendant’s PMA manufacturing specifications and the plaintiff’s implants’ manufacturing records and a deposition of the plaintiff’s manufacturing defect expert (an inveterate breast implant critic), the defendant  moved for summary judgment.  The defendant argued that the plaintiff had no evidence that her implants deviated from their PMA specifications. The plaintiff’s expert did not compare the plaintiff’s implants against the PMA specifications.  In fact, the plaintiff expert did not even review the PMA specifications.  

By contrast, the defendant submitted a declaration from an engineer who reviewed the PMA specifications and the manufacturing records for the plaintiff’s implants and concluded they were manufactured in compliance with PMA specifications.  

The defendant also moved to exclude each of the plaintiff’s three “experts” on amended Rule 702 grounds and for exclusion of the main expert’s opinions due to his spoliation. He had thrown out the implants while the case was on appeal without notice to the plaintiff or the defendant (which is why the defendant had to rely on manufacturing records instead of the actual implants).

We say this not because we are highly biased defense hacks (though we are), but because we are sentient beings: these defense motions were stone cold winners. Are we right about that?  Well, yes and no. 

Hunter S. Thompson said that when the going gets tough, the tough get weird.  Things in the Jacob case got weird (or maybe the right word is “weirder”).  At this point, we should mention that this is now two weeks in a row where we find ourselves blogging about strange legal doings in Florida.  Last week we mentioned the now overused trope of Florida Man.  We certainly do not mean to be sexist.  Florida Woman can also bring the crazy. 

The district court denied all of the defendant’s motions. Jacob v. Mentor, 2024 WL 1118811 (M.D. Fla. Mar. 14, 2024).  The court even denied the motion on spoliation, holding that it was the defendant’s fault that the plaintiff’s expert disposed of the implants,even though the defendant had never possessed the implants and the plaintiff’s expert threw the implants out during the appeal process before discovery ever commenced in the district court.  

When that sort of setback happens to us, we reconsider our  career choice.  Remember when that Heroes for Zeroes class taught by Professor Nagy made us think about getting a Ph.D in philology?  Remember when the prospect of being a ranger at a national park seemed so alluring?  Why-oh-why did we go to law school and set in motion 40 years of indignities?

But the defense lawyers in the Jacob case were made of stronger stuff than we are. There is psychological research suggesting that lawyers are less resilient than the general population.  But the defense lawyers in the Jacob case countered that canard. They showed what resilience is.  When a court gives you lemons, make lemon/reconsideration-ade. In this uncommon case, the defendant did something truly uncommon – it filed a motion for reconsideration and a request for oral argument.  

In opposition, the plaintiff unleashed a blizzard of exasperation.  It was as if the three letters P, M, and A operated as some sort of trigger.  The plaintiff told the court (twice) that she had never accused the defendant of not following PMA specifications. 

Hmmm.  

Cue the flipping calendar pages. Time passed. For a long while, the defendant heard nothing on the motion for reconsideration.

The parties proceeded down the delightful path of discovery on medical causation and damages (for the next eight months), conducting depositions of many of the plaintiff’s physicians, none of whom thought her breast implants were responsible for her medical issues.  Rather, they all believed her multiple issues stemmed from her pre-existing uncontrolled diabetes and lupus.  

With certain deadlines approaching, and the parties needing additional time to conduct discovery, the parties jointly sought an extension of the case management order deadlines in January 2025.  

Then, like a Floridian bolt from the blue,  the court denied the motion for an extension of time and stayed the case pending a ruling on the long-pending motion for reconsideration. After some delays, the court granted the defendant’s motion for reconsideration as to the issue of preemption of the plaintiff’s manufacturing defect claim only.  Jacob v. Mentor, 2025 WL 2114887 (Mar. 11, 2025).  After more delays, the court held a hearing and then zeroed in on the key issue on which the defendant had originally moved for summary judgment (nearly two years prior) — that the plaintiff had no evidence that her breast implants deviated from their PMA specifications, which is a required element of a manufacturing defect claim against a Class III, PMA device in Florida.  ’”Parallel’ state duties survive so long as they claim a violation of state tort law that aligns with a federal requirement. In contrast, a claim that a device violated state tort law notwithstanding compliance with the relevant federal requirements would clearly be preempted.”Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1326 (11th Cir. 2017) (citation and quotation marks omitted). See also Marmol v. St. Jude Med. Ctr., 132 F.Supp.3d 1359, 1365 (M.D. Fla. 2015) (required element is proof “[t]he defect resulted from a violation of a particular PMA requirement.”).

The Jacob court observed that the plaintiff’s sole expert on manufacturing defect had not even reviewed the defendant’s PMA specifications and had no opinions on whether they complied with or deviated from those specifications.  The court also observed that because the plaintiff’s expert had disposed of the implants, neither he nor any expert could ever perform the required analysis of whether the implants were in compliance with their PMA specifications.  The court reversed itself and granted the defendant summary judgment from the bench and dismissed the plaintiff’s case. The written opinion, short as it is, includes this: “Specifically, Plaintiff had failed to offer any competent expert testimony establishing that the alleged manufacturing defect resulted from a violation of a particular PMA requirement. Without such evidence, Plaintiff cannot proceed with a state-law based manufacturing defect claim that overcomes preemption.”

There is truth to the saying that justice delayed is justice denied, but a delayed win can still be a nice piece of vindication. 

Big time kudos to the defense team: Dustin Rawlin and Monee Hanna of Nelson Mullins, and local counsel David Walz of Carlton Fields. Persistence paid off in this case. We’d like to think the case is over.  But you know what Yogi Berra said. 

 
 

Photo of Michelle Yeary

Plaintiffs bring product liability suits against medical device manufacturers when outcomes fall short of expectations. Such as when a bone plate—a device surgically implanted to stabilize broken bones and enable proper healing—breaks. Now indulge us for a moment because Bexis and Yeary learned a lot about bone screws and orthopedic devices back in the day. And we know that bone plates are designed to stabilize fractured bones, not to permanently carry all the mechanical load that a bone normally bears. They are temporary supports meant to hold bone fragments in place long enough to allow natural healing to occur. If the bone never heals or is delayed in healing, the plate is stuck doing all the work indefinitely. That’s like asking a scaffold to permanently hold up a collapsed building, it’s going to fail eventually.  When a bone plate breaks in the absence of bone healing, the root cause is almost always biomechanical overload due to biological failure. These devices are robust, but not magic. They rely on the body’s cooperation, and that cooperation often fails when the patient doesn’t follow basic medical advice—especially the cardinal instruction to stop smoking.

Afterall, the success of any medical device implant hinges, not insignificantly, on the patient’s compliance with post-operative care. Among the most critical instructions given to patients with bone injuries is to abstain from smoking. This isn’t arbitrary advice; it’s grounded in decades of clinical evidence showing that nicotine constricts blood vessels, reduces oxygenation of tissue, and impairs bone healing. In short, continuing to smoke after surgery is like trying to extinguish a fire with gasoline—it fundamentally undermines the healing process the device is meant to support. If a plaintiff disregards this medical guidance, the argument that the bone plate “didn’t work” begins to look a lot like blaming the parachute for not opening—after jumping without pulling the cord.

So the plaintiff found out in Smith v. DePuy Synthes, Inc., 2025 WL 2145819 (E.D. La. Jul. 29, 2025). After falling and breaking her left leg, plaintiff’s surgeon implanted a bone plate and screws manufactured by defendant to realign plaintiff’s tibia.  Plaintiff admitted to smoking just under a pack of cigarettes a day, which her surgeon advised her to stop as smoking can impair healing and can increase the risk of a nonunion or delayed union of the bone by 30%.  Plaintiff never stopped smoking.  Id. at *1. 

Approximately six months after surgery, an x-ray revealed that the implanted plate had broken due to fatigue, but that the bone closest to plaintiff’s knee joint had healed. A second surgery was performed where the broken device was removed, and a nail and screws were used to repair unhealed bone in the lower part of the leg. That hardware was eventually removed as well, but by then x-rays showed a “well-healed fracture.”

Plaintiff brought all available claims under the Louisiana Products Liability Act (LPLA)–design defect, manufacturing defect, failure to warn, and breach of express warranty—as well as claims for breach of implied warranty and redhibition.  Defendant moved for summary judgment.  Because Louisiana has not included implied warranty claims in the LPLA, that claim is not cognizable under Louisiana law and was dismissed.  Id. at *8. A Louisiana redhibition claim allows plaintiff to recover the value of the product or other economic loss, but only if plaintiff proves the product is “useless for its intended purposes.” Id. As described above, and further below, the bone plates were far from useless because they allowed plaintiff’s bone to reman intact long enough for the uppermost part of her leg to heal.  Therefore, that claim was also dismissed.

Plaintiff’s LPLA claims did not fare any better. Plaintiff alleged that the bone plate’s design was defective because it had multiple screw holes along the shaft of the plate. The purpose was to allow the surgeon to customize the fit to the patient. Plaintiff argued the holes made the device weaker and that defendant should either have reduced the number of holes or provided the surgeon with fillers for the unused holes. What plaintiff did not do was present evidence of a reasonable alternative design. Plaintiff’s hired metallurgic expert offered no opinion as to a safer alternative design. Plaintiff’s surgeon offered testimony directly contradicting plaintiff’s suggested design. Namely, the screw holes are a necessary part of the design, there is no other bone plate product that offers “fillers,” there were no studies or scientific evidence showing fillers would actually work, and “it would be impossible to entirely eliminate the risk of stress [fractures].” Id. at *4. Under Louisiana law, failure to establish a reasonable alternative design is fatal to a design defect claim.

Plaintiff’s failure to warn claim failed both because defendant warned of the very risk that occurred and because any different warning would not have made a difference.  The possibility of device fracture is stated multiple times on the device’s package insert. Moreover, her surgeon described the risk as “common knowledge.” Id.at *5. Further, even if you drill down to a specific warning about weakness at the screw holes, plaintiff’s surgeon was also aware that is where plates break because it is the weaker part of the plate. Defendants need not warn the learned intermediary of risks he is already aware of.  Finally, plaintiff’s surgeon also testified that he could not recall ever reading the device’s package insert. Therefore, even a modified warning would not have made a difference because plaintiff’s surgeon would not have seen it.  Id.

Plaintiff’s manufacturing defect claim quickly went away because plaintiff’s expert did not review any manufacturing specifications for the bone plate, any testing of the plate, any engineering drawings, or any design documents.  Id. at *6. Therefore, plaintiff could offer no expert testimony of a manufacturing defect. Instead, plaintiff argued that there may have been a problem with the sterilization of the screws used in her surgery that led to her getting an infection. Putting aside the question of how that relates to the fracture of the bone plate and her injury, it also was not a defect because the screws were sold as “non-sterilized.” Any issue with sterilization was not the fault of defendant. Selling non-sterilized screws was not a defect, but rather an intentional product offering.

Finally, defendant was entitled to summary judgment on plaintiff’s express warranty claim because plaintiff failed to identify any express warranty made by defendant. “When the plaintiff cannot specify the express warranty made by the defendant, and make only general allegations that a product failed to conform to an express warranty, the defendant is entitled to summary judgment.” Id. at *7.

Plaintiff tried one last Hail Mary arguing that defendant should not be granted summary judgment because submitting an adverse event report about this incident to the FDA was an admission that the product may have caused or contributed to plaintiff’s injury. Plaintiff cited no authority to support this absurd contention, nor could the court find any. Which doesn’t surprise us. We direct you to the abundance of case law excluding adverse event reports and finding they are not evidence of causation.  

Product liability law was never designed to be a catch-all safety net for bad outcomes regardless of cause. It’s about fairly assigning responsibility, even when that responsibility lies with the one in the mirror. We expect people to wear seatbelts before suing over an airbag; we should expect them to lay down the cigarettes before suing over a fractured bone plate.

Photo of Bexis

Bexis is updating (probably for the last time) the preemption chapter of his drug and device product liability treatise, so expect blogposts like this on preemption-related topics.

Briefly, preemption in the prescription drug context is limited to implied preemption because, unlike medical devices, the FDCA lacks any preemption language applicable to those products.  The foundation for prescription drug preemption is what the Blog calls the “Mensing independence principle:  “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  PLIVA v. Mensing, 564 U.S. 604, 623-24 (2011).

Plaintiffs’ primary way around this principle is what the FDA calls its “changes being effected” (“CBE”) regulations – which are essentially the same for both drugs and biologics (and devices, but they benefit from express preemption, so the device regulation is rarely invoked).  These regulations allow unilateral, that is, “independent,” changes to “strengthen” warnings if certain conditions are met.  The chief condition is for the change to be based on “newly acquired information.”  E.g., 21 C.F.R. §314.70(c)(6)(iii).

Every jot and tittle of this regulation (and other regulations that the CBE regulation references) have been litigated since the Supreme Court first went this route in Wyeth v. Levine, 555 U.S. 555 (2009).  The aspect we’re considering today is who can create “newly acquired information.”

Plaintiffs, of course, would dearly love to be able to create newly acquired information themselves, using their own experts to gin up something “new” in every preemption case.  But no, they can’t.  Litigation usually (but see, medical monitoring) follows injury, and a CBE label change cannot be based on information that doesn’t yet exist.  The In re Zofran (Ondansetron) Products Liability Litigation, 57 F.4th 327, 340 (1st Cir. 2023), decision roundly rejected ex post facto expert opinions when advanced as “newly acquired information.”  First, as we mentioned recently, Zofran rejected expert opinions on preemption issues – preemption being a question of law – as “likely inadmissible.”  Id. at 340.  Second, a litigation-driven expert reinterpretation of earlier data could not be “newly acquired” within the meaning of the CBE regulation, because the defendant cannot submit something that didn’t exist:

[The] expert report was not prepared, and thus not available to or possessed by [the defendant], until [well after the plaintiff’s injury].  Thus, it cannot serve as newly acquired information that would have triggered an obligation by [defendant] to unilaterally amend [the drug’s] label prior to [that time].

Id. (the bracketed time happening to be 2018).

MDL plaintiffs had previously tried the same gambit in In re Incretin-Based Therapies Products Liability Litigation, 524 F. Supp.3d 1007 (S.D. Cal. 2021), aff’d, 2022 WL 898595 (9th Cir. March 28, 2022), having their expert conduct a “re-analysis of the slide images” underlying a published study and claiming that was newly acquired information.  Id. at 1024.  “The Court disagree[d].”

This expert report was generated in preparation for litigation and is not supported by published research. The Court therefore finds that one unpublished and litigation-driven animal study does not make a risk apparent or otherwise constitute reasonable evidence of association.

Id. at 1024-25 (citations and quotation marks omitted).

In reliance on both Zofran and Incretin, similar bought-and-paid-for expert testimony was excluded in Bueno v. Merck & Co., 746 F. Supp.3d 853 (S.D. Cal. 2024), and Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024), two substantively identical opinions.  Unable to find anything that could pass as newly acquired information, these plaintiffs turned to their experts to make something up.  Didn’t work.  The expert took a study that the defendant had published, and “recalculated” it.  Bueno, 746 F. Supp.3d at 877.  Predictably, the expert found the published analysis “flawed” and massaged the data to reach the desired contrary conclusion that the drug was actually “significantly associated” with the condition the plaintiff claimed to have.  Id.

Bueno found that approach not very bueno as a preemption dodge.

The Court rejects Plaintiff’s argument.  While “new analyses of previously submitted data” can constitute “newly acquired information” in certain circumstances, 21 C.F.R. § 314.3(b), new analyses do not comprise newly acquired information when conducted by an expert in preparation for litigation with the benefit of hindsight.

Id. at 878 (citation and quotation marks omitted); see Parker, 2024 WL 3974764, at *13 (identical analysis).

In re Gardasil Products Liability Litigation, 770 F. Supp.3d 893, 916 (W.D.N.C. 2025), likewise gave the back of the judicial hand to the plaintiffs’ attempt at self-help through creating after-the-fact “newly acquired information.”

[T]he governing regulations do not permit a plaintiff to present an expert report created for litigation – here well more than a decade after the plaintiff claims a warning should have been given – that in essence says that the manufacturer and the FDA got it wrong and then have that opinion be sufficient to avoid preemption.  Preemption must be judged on the information actually available to the manufacturer at the relevant time which was “not submitted” to the FDA.

Id. at 916 (citation omitted).

There are also some unreported decisions that reach the same result.  R.S.B. v. Merck & Co., 2022 WL 3927868, at *4 (E.D. Wis. Aug. 31, 2022 (plaintiffs’ expert’s “conclusions are litigation-driven and unsupported by any published research, and therefore do not constitute newly acquired information”); R.S.B. v. Merck & Co., 2021 WL 6128161 at *4 (E.D. Wis. Dec. 28, 2021):

But “new analyses of previously submitted data” does not mean an analysis conducted by an expert in preparation for litigation with the benefit of hindsight. . . .  In other words, Plaintiffs are not entitled to create their own “newly acquired information” through the use of experts; rather, they must point to the existence of newly acquired information that [defendant] possessed during the relevant time period.

(Emphasis original); In re Byetta Cases, 2021 WL 2462800, at *16 (Cal. Super. April 6, 2021) (reaching the same conclusion as Incretin, above, about the same litigation-driven slide reanalysis); Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, at *19 (Conn. Super. Sept. 11, 2019) (“the court is unaware of any authority for the proposition that expert testimony at trial, unsupported by any published research, can constitute newly acquired information”).

Having failed with do-it-yourself “newly acquired information,” plaintiffs also have a fallback position – that defendants had some sort of “testing” duty that obligated them to create newly acquired information that never existed at the time of the relevant submissions to the FDA.  That claim hasn’t received much judicial love either.  As one of our scorecards demonstrates, most states don’t recognize any independent testing duty in any circumstance.  Nor have newly acquired information-related arguments fared any better.  We’ll start with Bueno/Parker, which “additionally” addressed, and rejected, this argument.  “[A]sserting that a manufacturer could or should have done more studies − i.e., that a manufacturer should have created the ‘newly acquired information’ − is insufficient to avoid preemption under the CBE regulation.”  Bueno, 746 F. Supp.3d at 878 (citation and quotation marks omitted); see Parker, 2024 WL 3974764, at *13 (identical analysis).  Bueno/Parker quoted Holley v. Gilead Sciences, Inc., 2023 WL 6390598, at *8 (N.D. Cal. Sept. 28, 2023).

Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), aff’d, 847 F. App’x 79 (2d Cir. 2021), was emphatic in rejecting such an unprecedented extension of the already discredited duty to test to preemption:

Plaintiffs also argue that [defendant] could have analyzed the adverse event reports and that [its] alleged failure to do that amounts to “newly acquired evidence”. . . .  This argument is also unavailing.  To shift the burden to [defendant], Plaintiffs must demonstrate the existence of “newly acquired information.”  Plaintiffs’ attempt to shift the burden to [defendant] upends the framework [for considering such evidence].  Under Plaintiffs’ theory, any litigant could circumvent [preemption] by merely alleging that a manufacturer should have created the “newly acquired information.”

Id. at 88.  For additional precedent for rejecting any affirmative duty to test in the preemption context, see:  Dickson v. Dexcom, Inc., 2024 WL 4291511, at *4 (W.D. La. Sept. 25, 2024) (“Likewise, it is insufficient to assert that a manufacturer ‘could have or should have done more studies’ to create such ‘newly acquired information.’”); R.S.B., 2022 WL 3927868, at *4 (E.D. Wis. Aug. 31, 2022) (“Plaintiffs attempt to shift the burden to [defendant]by arguing that it could have undertaken the same analysis that [their expert] did, . . . [b]ut this burden-shifting argument ‘upends’ the preemption framework laid out by the various Courts of Appeal and would allow litigants to circumvent it”).

These decisions make good sense.  There’s a reason why the FDA’s CBE regulations exist – to provide an avenue to address different and emergent risks ASAP.  This purpose is not served by after-the-fact, litigation-inspired junk science, or by demanding “more studies” in the absence any known reason for conducting them.

Photo of Eric Hudson

Sometimes opinions go entirely in favor of the defense, analyzing numerous, independent bases for the dismissal of a complaint.  Today’s decision, Doyle v. Bayer Corp., 2025 WL 1666261 (W.D. Wash. June 12, 2025), is definitely one of those. It is a perfect example of what should happen when a plaintiff files a generic, bare-bones complaint in a prescription medical product case.

Plaintiff had an intrauterine device (IUD) implanted, and after about two years was informed that the IUD had likely been expelled from her body.  More than ten years after that, plaintiff obtained an x-ray for a persistent cough.  Doctors suspected that a shadow shown on the x-ray in the plaintiff’s abdomen was the IUD.  Plaintiff subsequently had surgery to remove the IUD, and she and her husband then filed suit against the manufacturer. Plaintiffs asserted five common law product liability claims and a sixth for unfair business practices.

Continue Reading Belt and Suspenders – Dismissal in the Western District of Washington
Photo of Eric Alexander

This is from the non-Butler Snow side of the Blog.

Readers of the Blog know that we believe in strictly applying the requirements of Federal Rules of Evidence 702 and 703.  Long before the 2023 amendments to Rule 702 were a twinkle in the advisory committee’s collective eye, we were pounding the proverbial drum that federal courts should consider the burden on the proponent of the expert opinion testimony and get over the old saw that the Federal Rules favor admissibility.  Drums and saws aside, the Supreme Court’s decision in Daubert and the subsequent amendments to Rule 702 should have obviated the need for our blogospheric advocacy.  The proponent of evidence always bears the burden of establishing its admissibility, and there is no default that a jury should be confronted with junk science and unreliable drivel just because a party—usually the plaintiff, in our experience—paid an expert witness to offer it.  Predictably, we followed closely the steps of what became the 2023 amendments to Rule 702.  We have also followed closely the impact of those amendments, as well as fighting off arguments from the plaintiff lawyers in our own cases that nothing had changed.

So, we were surprised to see a recent decision from an experienced judge that seemed to be mired in exactly the sort of mindset that the 2023 amendments tried to correct.  The case is Thacker v. Ethicon, Inc., No. 5:20cv-50-KKC, 2025 WL 2028082 (E.D. Ky. July 21, 2025), a pelvic mesh remand case, and the defendants made a few challenges to the admissibility of the opinions of plaintiff’s expert, who defendants conceded was a qualified biomedical engineer.  The result is not as noteworthy to us as how the court got there.  For instance, the word “burden” is not found in the opinion.  Nor are any form of the words “demonstrate” or “establish.”  The 2023 amendments are not mentioned.  The cases and secondary authorities cited all pre-date their effective date.  The current Rule 702 is quoted in part, but the omitted portion is mischaracterized in a meaningful way.  The Thacker court started its analysis with:

Under Federal Rules of Evidence 702, an expert witness may testify if

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; (d) the expert has reliably applied the principles and methods to the facts of the case.

Id. at *1.  With omitted language italicized and sometimes bolded, here is the actual language of Rule 702:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.

We can give the court a pass for shortening “a witness who is qualified as an expert by knowledge, skill, experience, training or education” to “expert witness” in a case where expertise was not challenged.  We can also let slide saying “testify” without adding “in the form of an opinion or otherwise.”  The rest is problematic.

Consistent with writing the proponent’s “burden” out of the rule, the Thacker court’s analysis of the challenges to the expert’s opinions did not always appear to apply the right standards.  (We will omit discussion of the exclusion of medical opinions and allowance of opinions on the device’s Instructions of Use, given that the 2023 amendments did not change the standards for evaluating the scope of qualifications.) 

The first challenge was to the plaintiff’s expert’s criticism of the defendants’ design control and risk management systems without performing an audit of defendants’ systems.  In rejecting this challenge, the court did use the right standards of the opinion being based on “sufficient facts” and “reliable principles and methods.”  Id.  However, the 2008 case it cited in this section offers an outdated, lower standard:  “[W]here the opinion has a factual basis, it should not be excluded [because] it is up to opposing counsel to inquire into the expert’s factual basis.”  Id. (citation omitted).  The proponent has to establish a “sufficient” factual basis for the expert’s opinions as one of four requirements, not including the expert’s qualifications.  This difference was highlighted in the notes for the 2023 amendment:

First, the rule has been amended to clarify and emphasize that expert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in the rule. See Rule 104(a). This is the preponderance of the evidence standard that applies to most of the admissibility requirements set forth in the evidence rules. See Bourjaily v. United States, 483 U.S. 171, 175 (1987) (“The preponderance standard ensures that before admitting evidence, the court will have found it more likely than not that the technical issues and policy concerns addressed by the Federal Rules of Evidence have been afforded due consideration.”); Huddleston v. United States, 485 U.S. 681, 687 n.5 (1988) (“preliminary factual findings under Rule 104(a) are subject to the preponderance-of-the evidence standard”). But many courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility. These rulings are an incorrect application of Rules 702 and 104(a).

The Thacker court’s rejection of the second challenge—that the expert measured the defendants’ systems against standards in ISOs from the International Organization of Standards instead of regulations from the United States FDA—had similar issues.  The court did not measure whether plaintiff carried her burden to establish reliability, but whether defendants proved the opposite, noting “the Defendants [sic] failure to offer any evidence or authority stating that ISOs are irrelevant to medical device manufacturers in the United States.”  Id. at *2.  Notwithstanding Joiner’s ruling that “nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert,” Thacker credited the expert’s ipse dixit that her opinions connected:  “[The expert] plainly opines that ISOs were ‘[t]he primary standards applicable’ to Ethicon’s quality and risk management systems.”  The court also noted that the defendants could cross the expert on the basis for her opinions.  Again, the 2023 notes addressed this dynamic:

Rule 702(d) has also been amended to emphasize that each expert opinion must stay within the bounds of what can be concluded from a reliable application of the expert’s basis and methodology. Judicial gatekeeping is essential because just as jurors may be unable, due to lack of specialized knowledge, to evaluate meaningfully the reliability of scientific and other methods underlying expert opinion, jurors may also lack the specialized knowledge to determine whether the conclusions of an expert go beyond what the expert’s basis and methodology may reliably support.

Thacker did place two useful qualifiers on admitting the expert’s opinions based on ISOs instead of FDA regulations.  First, notwithstanding Cisson and its questionable progeny, defendants would be permitted to cross the expert “on the subject of FDA regulation compliance.”  Id.  Presumably, defendants would also get to offer other responsive evidence on FDA compliance once plaintiff opens the door.  Second, the expert’s “testimony shall not equate compliance or non-compliance [to her own view of the ISOs] with satisfaction or dereliction of the duty of care.”  Id. at *3.  We could question how the testimony would “help the trier of fact to understand the evidence or to determine a fact in issue,” and can see significant Rule 403 confusion concerns looming.  That reminds us—and perhaps only us—of an older advisory committee note for Rule 704:

The abolition of the ultimate issue rule does not lower the bars so as to admit all opinions. Under Rules 701 and 702 , opinions must be helpful to the trier of fact, and Rule 403 provides for exclusion of evidence which wastes time. These provisions afford ample assurances against the admission of opinions which would merely tell the jury what result to reach, somewhat in the manner of the oath-helpers of an earlier day. They also stand ready to exclude opinions phrased in terms of inadequately explored legal criteria.

Thacker also rejected a challenge that the expert’s opinions were unreliable because she failed to consider a number of risk analyses the defendants performed.  The 2023 notes address this too:

Some challenges to expert testimony will raise matters of weight rather than admissibility even under the Rule 104(a) standard. For example, if the court finds it more likely than not that an expert has a sufficient basis to support an opinion, the fact that the expert has not read every single study that exists will raise a question of weight and not admissibility. But this does not mean, as certain courts have held, that arguments about the sufficiency of an expert’s basis always go to weight and not admissibility. Rather it means that once the court has found it more likely than not that the admissibility requirement has been met, any attack by the opponent will go only to the weight of the evidence.

Thacker found attacks on the breadth of the expert’s review to go to weight and it had already found her methodology had a sufficient basis.  However, the proponent is typically—and, we think, properly—required to justify why cherry-picking what data to consider is consistent with a reliable methodology.  From our perspective, this is part of why it is important to start off with the correct understanding of what it means for the burden to be on the proponent of the expert opinion testimony.

Photo of Stephen McConnell

Surely, you’ve heard the definition of insanity as repeating the same conduct but expecting different results. You might also have heard that Einstein said it, though that might not be right – not even relatively right. 

It is definitely not right for plaintiffs to keep filing meritless actions even after they keep receiving benchslaps.  Maybe insane is too strong a word, but it is certainly unjust, tedious, and expensive.  In other words, filing patently meritless actions is wholly counter to Fed. R. Civ. P. 1. (If you cannot recite that rule by heart, consider committing it to memory. We can hardly think of an argument in federal court that did not implicate Rule 1.) 

You have probably also heard of the rule of three. Maybe it started when Julius Caesar began his account of the Gallic Wars by observing that all of Gaul is divided into three parts. Our college foreign policy professor, the great Stanley Hoffman, always divided his lectures into three parts. Rule 1, referenced above, provides that the federal rules should serve the three goals of making litigation just, speedy, and inexpensive. There were three wise men, three deathly hallows, three blind mice, and Three Dog Night.  And, of course, three strikes and you’re out.

Last year, we featured a federal decision that rejected an attempt by the notorious MSP Recovery to cut discovery corners by employing a Florida-peculiar “bill of discovery.”  (We do not like that procedure one bit.  But we practice in Pennsylvania, which has similar crazy litigation short-cuts, so we are throwing no stones.) 

MSP stands for Medicare Secondary Payer, and its business, at least to our highly biased defense-hack eyes, looks very much like litigation leechery.  MSP likes to invoke the Florida pure bill of discovery (Fla. Stat. section 26.01(2)) in aid of its actions under the Medicare Secondary Payer Act, 42 U.S.C. Section 1395y, et seq. That S might stand for secondary, but here it should be a T for tertiary – as in three time loser. We have that federal MSP loss, a state court loss, then this case, which we are enjoying today. In the prior federal case that we blogged about, the N.D. Georgia federal court held that there was no personal jurisdiction over the device manufacturer. Florida requires a closer nexus between the state and the activity in question than is required by the federal Due Process clause. Such nexus was absent in that case.  Adios. (Our blogpost on that case recited other potential bases for dismissal. It also recounted the sad saga surrounding litigation strategies of MSP recovery entities.) 

Did that federal decision put an end to MSP’s efforts to fish for discovery from foreign corporations? Of course not.  Did MSP’s earlier, similar loss in Florida state court against another device manufacturer dissuade it?  Nope. By the way, each state court case involved how many tries by MSP?  That’s right: three.

Today’s case, Coloplast Corp. v. MSP Recovery Claims, Series, LLC, 2025 WL 2055769 (Fla. 3d Dist. Ct. App. July 23, 2025), is short, weird, and satisfying. Of course.  It is, after all, from Florida. (Okay, so we are growing a couple, or maybe three, pebbles.) MSP’s filing was the equivalent of Florida Man heaving an alligator through a fast food drive-thru window. Three times. 

The trial court refused to dismiss, but on appeal the Third (!!!) Florida district court of appeals reversed in a short-but-published decision.  

As we said, this is an instance of repeated repetition. The Florida Third DCA in “an almost identical case” had ruled that MSP had not established personal jurisdiction over a foreign company – the selfsame defendant in this case – and there was no basis to distinguish the cases. 

MSP tried to distinguish based on including more verbiage, but more was not better.  MSP asserted personal jurisdiction “under the business venture prong.” Nope. This decision finds no basis for personal jurisdiction over the non-Florida manufacturer under the Florida long arm statute.  After three complaints, enough was enough and out MSP went again.  A non-resident manufacturer is not subject to a bill of discovery simply because a Florida plaintiff files one.  There must be a “substantive connection” to the foreign device manufacturer’s activities in the Sunshine State, and there was no such connection. 

Accordingly, the appellate court reversed the trial court and concluded as follows: “Because MSP is not able to amend the complaint to show the claim’s required causal connection to Florida, we remand the case and instruct the trial court to dismiss with prejudice.”  

Will this decision stop the insanity? Somehow, we doubt it. As the appellate court pointed out, MSP was on notice of its pleading deficiency. 

Next time – strike four – the meritless assertion of personal jurisdiction should be greeted with sanctions. 

Photo of Michelle Yeary

The term “kitchen sink complaint” is not meant as a compliment. And the court did not use it as one in describing the proposed amended complaint in Ehlers v. Abiomed, Inc., — F. Supp. 3d –, 2025 WL 2029662, *9 (E.D. Mo. Jul. 21, 2025). The term refers to the tendency of some attorneys to cram every conceivable legal theory, tangential grievance, and hypothetical harm into one massive, often incoherent document. Rather than focusing on the specific facts and legal merits of a claim, these complaints drown the court in allegations, regardless of relevance or plausibility. That is not advocacy. It’s legal bloat. Or strategic spaghetti throwing—hurl enough theories at the court and see what sticks. Sheer tenacity aside, length is not a substitute for substance. So, when a complaint is packed with more filler than a gas station hot dog, we know the game: overwhelm the defendant, survive a motion to dismiss by burying the court in verbiage, and keep the case alive long enough to force a settlement. Fortunately, plaintiff’s kitchen sink approach in Ehlers accomplished none of those objectives.

Ehlers involved a Class III, Pre-Market Approved medical device used during plaintiff’s mother’s surgery to replace her mitral valve. Plaintiff alleges that the lead on the device did not release after surgery causing her mother to experience intravascular hemolysis which led to her death. Id. at *1. Defendant argued that all of plaintiff’s claims were preempted. The decision contains a nice summary of PMA preemption law generally and how it has developed in the Eighth Circuit. Id. at *4-7.

The original complaint in Ehlers was two-and-a-half pages long and contained two causes of action. While defendant’s motion to dismiss that complaint was pending, plaintiff filed a motion for leave to amend attaching a 50-page proposed amended complaint with over two hundred allegations and four causes of action (negligence, strict liability, breach of express warranty, and breach of implied warranty). Id. *1-2. In turn demonstrating perhaps the most damning feature of a kitchen sink complaint—that they are a cover for weak cases. When a lawyer has a strong, clear claim it doesn’t require 200 paragraphs to explain. But when the facts are thin, and causation is murky, that’s when you see the kitchen sink come out. It’s not “a short and plain statement of the claim.” It’s camouflage. But don’t take our word for it. Here’s how the court described the kitchen sink complaint in Ehlers:

[M]any of the exceptionally technical allegations in the complaint bear no relevance to [plaintiff]’s claims or theories for relief—they instead look more like an attempt to obfuscate the issues, paint [defendant] in an unsympathetic light by pointing to red herrings, and proffer as many legal theories as possible, likely in the hope that at least one claim would survive the pleading stage.

Id. at *9.

Going back to the original complaint, it suffered the opposite problem. There was no “there” anywhere.  The complaint alleged a manufacturing defect claim but only stated that the lead did not release. It did not allege either how the device was defective or how the alleged manufacturing defect violated the FDA’s PMA requirements. Plaintiff failed to include any allegations of how her state law claim paralleled federal requirements so as to avoid PMA preemption. Plaintiff tried to fix that problem in her response brief by including a list of alleged violations. But as that list was not in the complaint, nor did the complaint contain any factual allegations to support the alleged violations, the court held plaintiff’s conclusory arguments were “at best nothing more than an attempt to amend her complaint by brief.” Id. at *8. Which the court rejected. Plaintiff’s only other claim, breach of implied warranty, would require her to convince the jury that the device was not safe and effective, “a finding that would be contrary to the FDA’s approval,” and therefore preempted.  Id.

After granting defendant’s motion to dismiss, the court turned its attention to plaintiff’s motion to amend and defendant’s argument that the proposed amendment would be futile. Because the complaint was so “broad” and “disorganized,” and because “it is the alleged factual matter that make or breaks a complaint at the pleadings stage,” the court’s analysis went allegation-by-allegation to determine whether it stated any non-preempted claim. Spoiler alert—it didn’t. We’ll spare you the allegation-by-allegation re-play and hit the highlights instead.

Every time the allegations focused on an alleged failure to warn, plaintiff failed to include any allegations about hemolysis, the actual injury at issue. Moreover, because the allegedly missing warnings went beyond those that were FDA-approved, any claim premised on them was preempted.  Id. at *10.  Also, the only “example” of misleading information the plaintiff included was a link to the defendant’s website for the medical device. The court took this as an invitation to visit the website, where it found an explicit warning of the very adverse event plaintiff’s mother allegedly suffered, as well as numerous other warnings. Id. at *14-15.

While plaintiff spent dozens of paragraphs explaining how the medical device can cause hemolysis, nowhere in the over 200 paragraphs did plaintiff alleged that the medical device caused plaintiff’s mother’s hemolysis “because of any defect in the device.” Id. at *11. At best, the complaint raises concerns about an inherent risk of the device—making it an “attack[] on the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device,” which is expressly preempted. Id.

The opinion goes on like this cataloging all the flaws in the hundreds of allegations in the amended complaint, including many about risks and procedures completely unrelated to the surgery or alleged injury at issue.  All of which led the court to conclude that even with the addition of 48 new pages, plaintiff’s claims would not survive a renewed motion to dismiss.  Id. at *15.      

Complaints like this turn judges are not garbage sorters, tasked with parsing through a landfill of vague and unsupported allegations to find a pearl of plausibility, or not. Ehlers is proof that the kitchen sink complaint is a crutch for weak lawyering. If a plaintiff’s case has merit, it can stand on its own. If it doesn’t, no amount of padding will save it.

Congratulations to Bart Sullivan of Fox Smith and  J.T. Larson & Erin Pauley of Barnes & Thornburg for the win and thanks for bringing it to our attention.

Photo of Steven Boranian

We don’t venture into politics here at the DDL Blog, but sometimes we have to call them like we see them.  A divided panel of the Fourth Circuit filed an opinion last week upholding a state law that essentially prohibits the sale and use of an FDA-approved drug within that state for its FDA-approved intended use.  We have seen this play before, but with a different ending.  More than 10 years ago, we wrote about a state law banning the sale and use of an FDA-approved pain medicine, i.e., state law purporting to ban behavior that federal law expressly authorized.  The results there were orders enjoining the state law because federal law regulating the sale and use of prescription drugs impliedly preempted them. 

Implied preemption, the bread and butter of the blog.  So why then are we citing politics?  Well, the prescription drug involved here was mifepristone, which the FDA has approved for use in medically induced abortions.  In GenBioPro, Inc. v. Raynes, No. 23-2194, 2025 WL 1932936 (4th Cir. July 15, 2025) (to be published), the Fourth Circuit upheld a West Virginia law prohibiting abortion in most circumstances and with few exceptions.  The plaintiff generic mifepristone manufacturer claimed that federal law regulating both the sale and use of mifepristone for its FDA-approved use preempted the state law. 

The manufacturer was on solid footing.  The FDA has not only approved mifepristone for use in medically induced abortions, but has also mandated a Risk Evaluation and Medication Strategy (or “REMS”) program under which only specially certified providers can prescribe and dispense the drug under specific protocols regarding treatment, handling, and recordkeeping.  Id. at *1-*2.  These are federal requirements, and under these circumstances, the manufacturer argued with substantial justification that federal law impliedly preempted West Virginia’s law prohibiting abortions and essentially banning the sale and use of an FDA-approved drug for its approved indication. 

The district court upheld the West Virginia law, and the Fourth Circuit affirmed.  It all started with Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022).  And we don’t mean figuratively.  The opinion cites Dobbs literally in the first sentence, setting our expectations and the tone of the opinion from the get go.  In the view of this two-judge majority, Dobbs restored the states’ right to regulate abortion and allowing federal law to preempt such efforts would be “one small step short of defiance.”  Id. at *1.  More on this later. 

How did this court get from the FDA’s well-established authority to regulate prescription drugs to an opinion that denigrates federal law as a “maze of provisions” enacted by a “distant sovereign,” which has to give way to a state’s “sovereign right to protect . . . health and safety”?  Id.  We know that implied preemption is grounded in the Supremacy Clause, which mandates that federal law is “the supreme law of the land.  However, according to the Fourth Circuit, our version of federalism assumes that federal law will not supplant state law unless Congress clearly and manifestly intended that result.  Id. at *5.

You can see where this is going:  The presumption against preemption.  (Regular readers of the blog can hear Bexis groaning).  The Fourth Circuit invoked the presumption against preemption (and other unrelated presumptions) to erect a protective barrier around state regulation of health and safety, including laws enacted “for the express purpose of ‘protecting unborn lives.’”  Id.  (We assume the West Virginia legislature and the Fourth Circuit have equal concern for the health and wellbeing of pregnant women, but that concern is not mentioned in this opinion.)  The court acknowledged that the presumption against preemption does not apply when a state regulates in an area where there has been “a history of significant federal presence.”  Id. at *6.  But here, the court reasoned that states have long regulated abortion under their traditional authority over health and safety and that federal regulation of prescription drugs is merely “incidental” and “tangential.”  Id. 

The court thus rejected both implied field preemption and implied conflict preemption.  On field preemption, the court found that the laws operated in different fields:  The state regulates abortion, including whether an abortion can be performed and under what circumstances.  Federal law, on the other hand, regulates how mifepristone can be prescribed and dispensed.  And even if the laws regulated the same field, it is not one that Congress has occupied. 

On conflict preemption, the manufacturer argued that federal law has authorized the sale and use of mifepristone while state law has banned it.  The Fourth Circuit, however, found this reasoning “flawed” because Congress did not intend to guarantee nationwide access to mifepristone through the FDA and REMS programs.  Federal law merely established minimum safety rules in the event the drug is legally prescribed.  Again, the Fourth Circuit faults the manufacturer for urging “a significant intrusion into a state’s traditional authority to protect the health and welfare of its citizens.”  Id. at *8-*9.  This is the first time ever, we believe, that a state ban against the use of an FDA-approved drug for its FDA-approved intended use has ever survived preemption.

We have several thoughts on this opinion, some of them covered in the dissenting opinion and others not.  First and foremost, the Fourth Circuit emphasizes Dobbs and the rule of law, but what about Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013)?  The Supreme Court held in Bartlett that the FDA’s regulation of prescription drugs impliedly preempted state-law design defect claims.  More to the point, the Supreme Court also held that it is no answer to say that a manufacturer can comply with both state and federal law by simply not selling the drug.  The West Virginia law places manufacturers in the same position—they can comply with the law by not selling the drug in West Virginia at all.  Oddly, neither the majority opinion nor the dissent even mentions Bartlett. 

Second, and as explained thoroughly in the dissenting opinion, the majority has not faithfully acknowledged the FDA’s role in regulating mifepristone and does not adequately explain away implied preemption.  Federal law provides a comprehensive framework for accessing and using this product, yet West Virginia’s law criminalizes behavior that complies with federal requirements.  That is neither “tangential” nor “incidental.”  Contrary to the court’s conclusion, there is a history of “significant federal presence” in the regulation of prescription drugs.  Moreover, when the majority finds that regulation of abortion and regulation of mifepristone occupy different fields, it is fair to ask whether the court is slicing the onion a bit too thin. 

Third, the majority opinion (and the dissent) both trumpet that Dobbs returned the issue of abortion to the states.  That is not what Dobbs held.  The Supreme Court held in Dobbs that the constitution does not prohibit states from regulating abortion, subject to rational basis review, and that “authority to regulate abortion is returned to the people and their elected representatives.”  Dobbs, at 259.  So yes, the Supreme Court placed abortion in the hands of elected officials, but nowhere did it ordain that states would hold an exclusive position over federal lawmakers. 

Fourth, and relatedly, the Fourth Circuit’s opinion rests squarely on states’ prerogative over health and safety, which is fine as far as it goes.  But states’ authority over public health does not insulate them from federal requirements.  It just so happens that the federal government has substantial authority over public health too, including and especially in connection with the sale and use of prescription drugs.  Simply put, there is no “health” exception to the Supremacy Clause. 

Finally, we cannot help but note the triumphant, even celebratory tone of this opinion.  The author of the opinion is a true conservative, appointed by Ronald Reagan, and he has long expressed the view that Roe v. Wade was a judicial overreach and that issues such as abortion and gay marriage should not be constitutionalized.  To make a point, he once wrote a concurring opinion describing abortion in graphic terms.  He also is a respected jurist who just months ago published a resounding and expertly crafted rebuke of our current administration and its stunning disrespect for the judicial process.  Hear, hear!  All that being said, we formed the distinct impression in reading the opinion that these judges were taking a victory lap for “states’ rights.”  Review the opinion for yourself, and see what you think. 

Photo of Bexis

Every week Bexis circulates an email with new, bloggable cases, but sometimes there are more new decisions than blogging days, and cases get passed over.

Here are three (relatively) recent examples

Gonzalez v. International Medical Devices, Inc., ___ F. Supp.3d ___, 2025 WL 2054361 (W.D. Tex. June 20, 2025), arose from the plaintiff’s apparent off-label use of a penile implant for “cosmetic enhancement” rather than its intended therapeutic purpose.  Id. at *6.  Needless to say, since Gonzalez is a product liability action, there were complications.  The first significant issue in Gonzalez was personal jurisdiction over the out-of-state alleged inventor of the device and his corporation.  Plaintiff succeeded on specific personal jurisdiction based on allegations that, beyond maintaining a website, which wasn’t enough, id. at *5, he “purposefully” targeted the jurisdiction (Texas) by providing device-related training to in-state surgeons and “licensing” them to use his invention.  Id. at *5-6.  That’s a point that is important for inventors and smaller companies to realize.  Licensing and training physicians in use of a product has the potential to support specific personal jurisdiction in the forum where the physicians who were so instructed practice.

A Texas consumer fraud claim also survived (for the time being) in Gonzalez.  The allegation was that the defendants’ website affirmatively misrepresented that the device was “FDA-cleared” for a particular intended use when the actual clearance was for something else.  Id. at *6.  Potential allegations that defendants have some sort of heightened duty to disclose FDA intended uses in off-label use cases always catches our eye because we reject that FDA regulatory status – as opposed to medical risks and benefits – are relevant to anything plaintiffs must be told in such litigation.  However, Gonzalez appears to be different, alleging an actual misrepresentation, as opposed to some unmet duty to disclose.  Id.  Moreover, the Gonzalez allegations are probably factually incorrect and thus unlikely to survive once the pleadings are pierced.  Id. (refusing, on the pleadings, to entertain an argument that the plaintiff’s allegation was simply “wrong” as to “which iteration” of the device had been implanted).

Finally, Gonzalez held that causation under the Texas learned intermediary rule was adequately pleaded, given allegations that the implanter “opined the older model of the . . . Device was defective and that he no longer provides [that kind of] implant surgery due to his patients’ dissatisfaction.”  Id. at *8.  Ouch.  Again, these are pleadings, the veracity of which is questionable, but to us they demonstrate what TwIqbal really requires for learned intermediary causation.  We don’t see this sort of specific and detailed allegation often, if at all, from plaintiffs.

Case #2 is Morrison v. Family Dollar Stores, LLC, 2025 WL 1368839 (Mag. S.D. Fla. May 5, 2025), which dismissed another of these all-too-common OTC drug economic loss class actions.  Plaintiffs alleged they “purchased numerous different over-the-counter (“OTC”) drugs and medical devices” from the defendant’s “stores in twenty states” and mentioned several recalls for improper storage in their complaint.  Id. at *1.  They alleged “adulteration,” attempting to take advantage of precedent that gave such claims a free pass on alleging injury-in-fact.  Id. at *4-5.

Not enough – not nearly.  Their other allegations made clear that “adulteration” could not be decided across the board:

[T]his case is not about whether a product contains an ingredient that renders it (every single unit of it) adulterated at the outset.  Rather, Plaintiffs allege that the products they purchased became adulterated because they were stored outside of labeled temperature requirements.  And while it is plausible, based on Plaintiffs’ allegations, that some [of these] products were stored outside of labeled temperature requirements, Plaintiffs’ allegations that they themselves purchased such products are speculative, not plausible.

Morrison, 2025 WL 1368839, at *6 (footnote omitted).  Plaintiffs alleged no facts that products they purchased had the claimed storage problems.  Their broad-brush allegations that everything was “adulterated” were “a conclusory label that is not entitled to the assumption of truth.”  Id. (citations omitted).  The complaint “beg[ged] the question of how one could conclude that the products Plaintiffs purchased were ‘Adulterated Products.’”  Id.

Transportation and storage-related conditions are inherently individualized (which should also eventually kill class certification, if Morrison ever got that far).  The various recalls couldn’t provide the essential inference.  Id. at *7.  For this proposition, Morrison cited what we called the “silver lining” in the otherwise adverse Huertas v. Bayer US LLC, 120 F.4th 1169 (3d Cir. 2024), decision:  “The mere fact that a product was recalled would not nudge Plaintiffs’ claims across the line from conceivable to plausible.”  Morrison, 2025 WL 1368839, at *7 (quoting Huertas, 120 F.4th at 1178).  Nor are recalls any sort of “admission” that every unit of every recalled product necessarily had the recalled attribute.  Id. (that was “not a reasonable inference”).

Further, plaintiffs did not allege any facts to establish that they actually bought recalled products:

Plaintiffs merely allege that they purchased those products during the Class Period, without alleging facts showing that they purchased the products during the relevant recall period, much less from the affected stores or in the affected states.  But the Class Period exceeds 28 months.  And for more than 19 of those 28 months, no recalls were in effect.

Id.  The complaint established only the “possibility” that plaintiffs could have bought recalled products, not that they actually did.  Id.  Nor could potential testimony from a “handful of former employees” suffice to create some overarching presumption that every product everywhere was “adulterated.”  Id. at *9.  Again, the Huertas silver lining came to the defendant’s rescue, since the recalls “had no relevance to the plaintiffs who did not allege they purchased spray products with the lot numbers in the recall,” and these plaintiffs pleaded no facts supporting any purchase of recalled products.  Id. at *11.  In sum:

Plaintiffs have failed to plausibly allege that any of the drugs or devices they purchased from [defendant] were adulterated.  Nor have they plausibly alleged such widespread adulteration to the degree that every single OTC drug and device sold . . . at any store in the United States during the 28-plus month Class Period (including Plaintiffs’ products) was adulterated.

Id.  Case dismissed for lack of standing.  Even with an “adulteration” free pass on injury-in-fact, the Morrison  plaintiffs could not get to first base under TwIqbal.

The third and final case, In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Products Liability Litigation, 2025 WL 1334619 (D.N.J. May 7, 2025), involved talc (obviously), rather than prescription medical products.  The proposition it established, however – that mere unenacted FDA “proposals” are not admissible in product liability litigation – is more likely to recur in our sandbox than anywhere else.

This ruling is short and sweet.  In Talcum, plaintiffs sought either to “supplement the record” or have “judicial notice” taken of a pending – not final − FDA proposed rule concerning testing of talc-containing products generally.  Id. at *1.  Both requests were denied because “the FDA has not completed its formal rulemaking process.”  Id.  Plainly the proposal was “not final,” so it could not possibly “represent final agency action.”  Id.  “Because current regulations govern until the Proposed Rule becomes final, the Court ‘decline[s] to take cognizance of the proposed regulation.’”  Id. (quoting Depenbrock v. Cigna Corp., 389 F.3d 78, 85 (3d Cir. 2004)).  The FDA proposal was not yet in effect (in contrast to non-binding, but current, FDA guidance) and thus could not have any retroactive relevance to the litigation.

Given the current management of the FDA, we have no idea what unusual (or worse) proposals may be coming down the pike.  This Talcum order will be directly on point, should plaintiffs try to influence judges or juries with some off-the-wall future FDA proposal.

Photo of Bexis

Today we have a guest post on some recent developments on whether strict liability applies to software, apps, artificial intelligence, and other forms of electronic data, which depends, as this 50-state survey addresses, on whether such intangible items meet the common-law definition of “product.” It is by Reed Smith attorneys (and repeat guest posters) Mildred Segura and Jamie Lanphear. As always, our guest posters should receive 100% of the credit (and any blame) for what they have written.

**********

Those of us who grew up watching The Jetsons remember fantasizing about a future filled with flying cars and robot housekeepers like Rosey (later spelled Rosie), who handled everything from vacuuming to snarky commentary. While the flying cars haven’t arrived—yet—our present-day product liability defense attorney selves are equally captivated by the proliferation of AI, particularly in the life sciences sector.

AI’s expanding role across diagnostics, epidemiology, drug discovery, clinical trial management, personalized medicine, and healthcare operations has established it as a critical tool for advancing patient care, accelerating research, and optimizing business processes within the life sciences sector. But with innovation comes risk—and the legal landscape is evolving to address these new advancements. One of the trickiest challenges is that AI doesn’t fit neatly into existing legal frameworks. Product liability law, for example, has traditionally dealt with physical products. For decades, the prevailing view has been that software is not a “product.” With the proliferation of mobile apps, social media, and AI-enabled tools, however, that consensus is shifting.

Courts Are Redrawing the Line

Recent decisions show that courts are increasingly willing to entertain product liability claims against software-based systems—either in whole or in part—under a few different theories. Here are three (non-exclusive) approaches we’re seeing:

  1. Function-by-Function: The “Defect-Specific” Approach

The Northern District of California was the first to articulate the “defect-specific” approach in the In re Social Media Adolescent Addiction Personal Injury/Products Liability Litigation MDL. Plaintiffs—primarily parents suing on behalf of minors—allege that several social media platforms were intentionally designed to be addictive, leading to harms such as mental health issues and the sexual exploitation of minors. A key legal battle was whether these platforms should be considered “products” under traditional product liability law. Historically, courts have treated software as a service, not a product, shielding developers from product liability claims. And that was the argument made by the defendants in their motion to dismiss. The court, however, rejected this “all or nothing” approach. 702 F. Supp. 3d 809 (N.D. Cal. 2023). Instead, the court examined the specific functions alleged to be defective, evaluating whether each could be analogized to tangible personal property. For every single function it analyzed, the court concluded that there was some tangible property analogous to it and allowed the plaintiffs’ design defect claims to proceed. We have previously reported on this decision here and here.

The “defect-specific” approach has since influenced other rulings. In In re Uber Technologies, for example, the court applied a similar framework to evaluate safety features in a rideshare app, finding some sufficiently “product-like” to allow strict liability claims to proceed. 745 F. Supp. 3d 869 (N.D. Cal. 2024). In more recent cases—like AF v. Character Techs. and Doe v. Roblox—plaintiffs appear to be borrowing this playbook by focusing their product liability claims on the design and operation of specific software features, rather than the platform as a whole.

  • App-as-Product: The Platform-as-a-Whole View

Some courts have taken a broader view, evaluating whether the app or platform as a whole is analogous to tangible personal property. In T.V. v. Grindr, the Middle District of Florida took this position to conclude at the motion to dismiss stage that a dating app was a product subject to strict liability. 2024 U.S. Dist. LEXIS 143777 (M.D. Fla. Aug. 13, 2024). The court considered how the app was designed, mass-marketed, and monetized, emphasizing that while the Restatement (Third) of Torts generally defines “product” as tangible personal property, the definition also includes intangibles when their distribution and use are sufficiently analogous to the distribution and use of tangible goods. The court highlighted the need for common law to keep pace with technological change and underscored the policy behind strict liability: placing the cost of injury on the party best able to prevent it. Mass-marketing and distributing the app for profit was enough, in the court’s view, to make it a product under tort law.

  • Drawing a Line Between Design and Content

A third approach—often invoked in response to arguments under Section 230 of the Communications Decency Act (CDA)—distinguishes between content and the medium through which content is delivered. In Garcia v. Character Technologies, a case involving claims against a generative AI chatbot, the court differentiated between the chatbot’s expressive outputs (not actionable under product liability) and its designfeatures, such as inadequate age verification, which were actionable. Claims based on “content” were dismissed; claims based on “design” were not. This ruling reinforced a critical and increasingly litigated boundary: product liability applies to how a digital tool is built—not what it says.

Continuing the Trend: Nazario v. ByteDance Ltd. as the Most Recent Example

The latest example comes from New York. In Nazario v. ByteDance Ltd. (June 2025), the court declined to dismiss product liability and negligence claims against several social media platforms. The plaintiff alleged that algorithms had targeted a minor with harmful content. In its analysis, the court drew a clear distinction between passive content delivery—which is often protected by Section 230—and the use of targeted recommendation engines that leverage demographic and behavioral data.

That distinction proved significant. The court determined that, if proven, the platform’s targeting practices could constitute a design defect in a product, rather than mere editorial judgment. As a result, Section 230 did not categorically bar these claims, since they were framed around the design and function of the algorithms, not their content. This decision reinforces the growing trend of courts treating software and AI as products—at least at the motion to dismiss stage. Courts have yet to address the issue at the summary judgment stage, so it remains to be seen how they will rule once they have the benefit of a full factual record developed through discovery.

A New Wrinkle from Ohio: Deditch v. Uber Technologies, Inc.

A recent development in an Ohio case, Deditch v. Uber Technologies, Inc., 2025 WL 1928937 (N.D. Ohio July 14, 2025), adds a new wrinkle to this evolving area. There, a ride-sharing company moved to dismiss a negligence claim involving its app by arguing that the Ohio Product Liability Act (OPLA) abrogates all common law product liability claims—including those based on the alleged negligent design of its app. What’s curious about this strategy is that the defendant simultaneously agreed “that its app is not a product” under OPLA’s definition. Id. at *2. That raised a novel issue of whether OPLA’s broad abrogation of common-law product liability extended to litigation not involving statutory “products.” Id. at *3. The court thus certified the question of whether claims involving digital apps fall within the Act’s scope to the Ohio Supreme Court. This case is one to watch, as the Ohio Supreme Court’s answer could set an important precedent for how software is treated under state product liability statutes. 

Meanwhile, in the EU…

Across the Atlantic, lawmakers in countries without the Anglo-American common law tradition are not waiting for the courts. The EU recently adopted a new Product Liability Directive that explicitly defines software and AI as “products”—even when delivered as a service. While that shift does not bind U.S. courts, it does add international momentum to an already-evolving concept. For global companies, the implications are hard to ignore.

So, Is Software Now a Product?

Not always. Not everywhere. But it’s getting harder to say no. Courts are showing a growing willingness to interrogate how software works—and, in some cases, to treat it like the very things tort law was designed to address: products.

As software increasingly serves as the bridge between human decision-making and tangible, real-world outcomes, the traditional distinction between a service and a product may be breaking down.

We are witnessing this boundary shift in real time. Software, step by step, may be moving from one side of the line to the other.

Drug & Device Resources

Bexis’ Book

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