Photo of Lisa Baird

Taking pot shots at “Big Pharma” is easy.  Crack a joke about Big Pharma and you are sure to get a laugh.  Amirite? 

That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country. 

But what never makes sense to us is the idea that our clients deliver products with little to no value.  Direct-acting antiviral medicines can cure more than 95 % of hepatitis C infections.  Incredible advances can help prevent HIV infection and have made HIV infection more treatable.  In 2000, measles was declared effectively eliminated in United States (although outbreaks of the disease are back on the rise because vaccination rates have dropped off). 

The list of amazing progress in medicine goes on and on, and is part of the reason we take umbrage at the “get a name, file a claim” mass tort litigation that proliferates against pharmaceutical and medical device manufacturers.  Using sheer force of numbers to bring litigation based on shoddy science does nothing to help patients who need innovative medical treatments, and carries a very real prospect of driving good medical treatments off the market due to out-of-whack litigation risks.

The Gardasil MDL is a prime example.  This Human Papillomavirus (HPV) vaccine has an incredibly high efficacy rate (close to 100%) for prevention of persistent infection, cervical intraepithelial neoplasia (CIN) 2/3, and adenocarcinoma in situ (you know, cancer) in clinical trials.  Following Gardasil’s introduction to the market, HPV infections that cause most HPV cancers and genital warts in teen girls have dropped 88%, and HPV-linked cervical cancers have dropped 40% in vaccinated women.  So of course the manufacturer is being punished with a federal MDL.

Although the Gardasil MDL should not exist because of the Vaccine Act’s separate compensation system for alleged vaccine injuries, earlier Gardasil MDL opinions have been helpful.  One dismissed claims as untimely and kept the MDL plaintiffs from collaterally attacking Vaccine Court findings.  Another recognized disguised design defect claims as preempted under the Vaccine Act/Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228-30 (2011), dismissed manufacturing defect claims (it is not a manufacturing defect if the criticized aspect of the product is in every single unit), and found direct-to-consumer failure to warn and fraud claims barred by the Vaccine Act.  Another turned aside a constitutional challenge to the Vaccine Act itself. 

And now we have another good decision on implied preemption, one dismissing the remaining claims for all the Gardasil bellwether cases (and other MDL plaintiffs pursuant to MDL procedural orders):  In re Gardasil Prods. Liab. Litig., MDL No. 3036, 2025 U.S. Dist. LEXIS 44376 (W.D.N.C. Mar. 10, 2025). 

The Gardasil MDL plaintiffs  contend they have “postural orthostatic tachycardia syndrome” (“POTS”), which is characterized by dizziness and occasional fainting when standing up, or “primary ovarian insufficiency” (“POI”), which involves lower estrogen or irregular egg release in women under 40.  The MDL plaintiffs’ remaining theory was that the vaccine’s manufacturer violated state law by failing to warn medical providers about the alleged risk of POTS and POI. 

Federal law, however, quite strictly regulates vaccine labeling.  So the issue in the latest Gardasil opinion was one of implied conflict preemption of the impossibility variety:  Was it impossible for the manufacturer to comply with both the federal vaccine labeling requirements, and a state law duty to add warnings about POTS and POI?

Although impossibility preemption is a “demanding defense,” it isn’t as demanding as the plaintiffs suggested.  The MDL plaintiffs wanted the manufacturer to establish “clear evidence” that it was entitled to preemption (relying on language from Wyeth v. Levine, 555 U.S. 555 (2009)).  But the MDL judge recognized that Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019) had clarified (we’d say superseded, or maybe abrogated) that Levine language.  Post-Albrecht, Levine’s “clear evidence” language is “not to be interpreted as an evidentiary standard.”  In re Gardasil Prods. Liab. Litig., 2025 U.S. Dist. LEXIS 44376, at *36 n. 7.  It’s more of a “rhetorical flourish”. 

Moreover, because preemption is a question of law, the MDL court recognized that it, not a jury, had to decide the preemption issue—and that doing so before trial served the interests of the litigants and judicial economy.   Id. at 29 (citing Albrecht, 587 U.S. at 303).

Framing the exact inquiry, plaintiffs’ claims would be preempted if it was impossible for the manufacturer to comply with both federal and state law, either because the manufacturer:

(1) “did not have the authority to make changes to the label” that the plaintiff demanded; or

(2) established “that the FDA would not have approved the changes to the label that the plaintiffs contend should have been made.”

Id. at *36-37.

Starting with the first question, the court asked whether the manufacturer

was permitted under federal law to add [the plaintiffs’ proposed] warnings to the vaccine’s label without prior approval from the Food and Drug Administration (“FDA”) (which is typically required for any changes to a vaccine’s prescribing information).

Id. at *27. 

The answer was no, of course not.  As with new drugs, the FDA controls the warning labels on biologics like vaccines, and it is not a question of “more is better” when it comes to warnings. 

In formulating a vaccine’s label, FDA regulations seek to provide what may be best described as the “Goldilocks” amount of information; that is, ‘just right’ – not too little and not too much.  In addition to seeking to include all necessary information, the FDA tries to ‘prevent overwarning, which may deter appropriate use of medical products, or overshadow more important warnings.” 

Id. at *37-38. 

As to the “changes being effected” (“CBE”) exception to prior FDA approval, federal law (21 C.F.R § 601.12(f)(2)(i)) potentially does allow a manufacturer to change its warnings, but only in very limited circumstances:  If the manufacturer receives sufficient “newly acquired information” not previously submitted to the FDA, and the proposed change is based on “reasonable evidence,” it can roll out the new warnings as it seeks approval.  But again, the information has to be new, and there has to be reasonable evidence—evidence “on the basis of which experts qualified by scientific training and experience can reasonably conclude that the hazard is associated with the use of the drug.”  See 44 Fed. Reg. 2848, 2851 (allowing a CBE amendment only for “known hazards and not theoretical possibility”).

Relying on the CBE regulation, the MDL plaintiffs contended the Gardasil manufacturer should have unilaterally added warnings about POTS by 2011 and POI by 2013.  The burden thus fell to plaintiffs to identify the “newly acquired information” that supposedly would have allowed these unilateral label changes.  In re Gardasil Prods. Liab. Litig., 2025 U.S. Dist. LEXIS 44376, at *41.

Yet, as the Court noted, the evidence back then just did not support a causal connection, and was already known to the FDA anyway:

[By 2013], there had been only one published, verified case of POTS and four published case reports of POI. (In addition, there were scattered unverified reports of the illnesses, still totaling only a relatively miniscule handful). To the extent there were any broader studies or analyses before the relevant dates, they did not establish causal associations. Simply put, no scientist could reasonably conclude there is a causal association between POTS and POI and Gardasil based on this paucity of evidence, even putting aside the fact that the FDA was made aware of all these cases and studies (which raises a question whether they can even qualify as “newly acquired information”).

Id. at *28.

Having resolved the impossibility preemption issue by concluding that the Gardasil manufacturer could not do what plaintiffs said that state law required, plaintiffs’ claims were preempted. 

Sensing what was coming, plaintiffs had tried a few dodges.

During oral argument and in supplemental briefing, they argued that if POTS and POI warnings weren’t required in 2011 or 2013, the court could find they were required on some other date over the following decade or so, based on a rough “totality of the evidence” standard.  The MDL judge was having none of it (in judge-speak, it “declined this invitation to error”).

It is plainly impractical for the Court to separately rule on preemption for each day, month or even year between 2011 and January 2021 (the date of the last vaccination of a Bellwether Plaintiff). In fact, it is at least theoretically possible that [a manufacturer] could have had reasonable evidence of a causal association based on the “totality of the record” on a given date and then later not have such evidence if the record evolved in favor of [its] position.

Id. at *57.

The MDL judge also had a few thoughts about whether the FDA would have rejected “the changes to the label that the plaintiffs contend should have been made” if it had been asked:

[T]here is substantial evidence that the FDA does not agree with Plaintiffs’ allegations that there is a causal association between taking Gardasil and becoming sick with POTS and POI. The FDA has approved numerous Gardasil labels without any POTS or POI warnings from 2006 to the present; the department of Health and Human Services (“HHS”) (FDA’s parent agency) has consistently opposed allegations of a causal connection in the “Vaccine Court”; and HHS / FDA has publicly stated its view that Gardasil does not cause POTS or POI in general communications and the federal register.

Id. at *28 n. 2. 

The court’s discussion of the scientific evidence about whether Gardasil can cause POTS or POI is a good read.  While a few pages shorter, it is reminiscent of the In re Zantac MDL judge’s dismantling of the scientific evidence in that litigation.  A few notable nuggets: 

  • Temporal coincidence is insufficient for causation. 
  • Isolated case reports are insufficient for causation. 
  • Where the total number of possible adverse events in the time period is less than the overall background occurrence of the condition, the evidence is insufficient for causation. 
  • The FDA’s supposed lack of resources does not allow plaintiffs to ignore FDA standards. 
  • Supposed evidence about one issue (“autoimmunity”) does not help prove causation for a different issue (POTS).
  • Experts who rely on a handful of adverse events will be called out when they turn around and nitpick powerful studies involving thousands of patients as being “too small”. 
  • Preemption does not allow paid litigation experts to opine, well after the fact, that the FDA got the warnings wrong. 

At this point, there should not be much, if anything, of the Gardasil MDL left—and we just may have a good candidate for our “best of” list at the end of 2025. 

Photo of Bexis

As anyone who has read more than a paragraph of what we’ve written knows, this is a forthrightly pro-defense Blog.  It is not our practice to criticize the strategy or tactics of defendants or their counsel.  It’s not that what defendants do is always right, but to us its almost always understandable.

We were all set to make an exception to this rule, however, due to our disappointment in several decisions recently handed down in a Filshie Clip case in Texas:  Those decisions are:  Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 35222 (Mag. S.D. Tex. Feb. 27, 2025) (“Bulox I”); Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 34275 (Mag. S.D. Tex. Feb. 26, 2025) (“Bulox II”); and Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 34274 (Mag. S.D. Tex. Feb. 26, 2025) (“Bulox III”).  It’s not that the results were bad – the Bulox defendants won all three motions – but the reasoning is atrocious.  The Magistrate Judge completely ignored the 2023 amendment to Fed. R. Evid. 702 in denying the plaintiffs’ motions in these three orders.

Instead we were treated to statements such as:

  • “[A]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility.”  Bulox I, 2025 U.S. Dist. Lexis 35222, at *5 (quoting pre-amendments decision); Bulox II, 2025 U.S. Dist. Lexis 34275, at *5 (same);  Bulox III, 2025 U.S. Dist. Lexis 34274, at *4-5 (same).

That “bases and sources” merely go to the “weight” under Rule 702 is one of the “incorrect” statements that the 2023 amendments were enacted to stop.  That is a quote originating in a pre-Daubert case, Viterbo v. Dow Chemical Co., 826 F.2d 420, 422 (5th Cir. 1987) – one that the 2023 amendments to Rule 702 consider “incorrect.”  For further discussion of this, and other, points we make in this post, see our prior blogposts, here, here, and here, as well as M. Behrens & A. Trask, “Federal Rule of Evidence 702: A History & Guide to the 2023 Amendments Governing Expert Evidence,” 12 Texas A&M L. Rev. 43 (2024); and E. Lasker & J. Leader, “New Federal Rule of Evidence Rule 702:  A Circuit-by-Circuit Guide to Overruled ‘Wayward Caselaw,’” Def. Counsel J. (Summer 2024) (particularly the Fifth Circuit section). 

  • “While the district court must act as a gatekeeper to exclude all irrelevant and unreliable expert testimony, ‘the rejection of expert testimony is the exception rather than the rule.’”  Bulox I, 2025 U.S. Dist. Lexis 35222, at *5 (quoting pre-amendments decision); Bulox II, 2025 U.S. Dist. Lexis 34275, at *5-6 (same); Bulox III, 2025 U.S. Dist. Lexis 34274, at *5 (same).

That is another canard that the 2023 amendments were specifically intended to reject.  The “rule” is that the proponent of expert testimony must prove all elements of admissibility by a preponderance of the evidence.  If not, then the testimony is inadmissible; if so, then it can be heard.  One is not an exception to the other – they are two sides of the same coin.

  • “Furthermore, ‘[a]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility and should be left for the jury’s consideration.”’  Bulox I, 2025 U.S. Dist. Lexis 35222, at *11 (quoting pre-amendments decisions); Bulox II, 2025 U.S. Dist. Lexis 34275, at *11-12 (same).

There it is again.  The same outdated and incorrect statement from Viterbo, recycled through a different set of pre-amendments caselaw.

  • Movants’ “arguments largely relate to the bases of [the expert’s] review decisions, not the underlying methodology, and are therefore more suitable for cross examination.  Bulox I, 2025 U.S. Dist. Lexis 35222, at *11 (citations omitted); Bulox III, 2025 U.S. Dist. Lexis 34274, at *11.

This statement effectively reads recently amended Fed. R. Evid. 702(d) out of the Rule altogether.  The reliability of a would-be expert’s “principles and methods” is addressed by Rule 702(c).  That portion of the Rule was not amended.  Rule 702(d), however, was amended to clarify that the gatekeeping function (and the burden of proof) extend to “the expert’s opinion reflect[ing] a reliable application of the principles and methods to the facts of the case” (emphasis added).  So, no – putative experts do not get a free pass on applying “underlying methodology” to case-specific facts.  That statement is brazenly bogus.

  • Movants’ “arguments regarding [the expert’s] document review in reaching his opinion go to the bases and sources of his opinion and therefore, impact the weight, not the admissibility of his testimony. . . .  If these bases and sources are incorrect or incomplete, then Plaintiffs can effectively address those issues on cross-examination.  Bulox II, 2025 U.S. Dist. Lexis 34275, at *12.

That is the same erroneous Viterboesque statement using slightly different phrasing.  “Bases and sources” is just another way of saying “the facts of the case.”  This is yet another way that the Bulox trilogy simply ignores Rule 702(d), which was the one element of the Rule that the 2023 amendments specifically strengthened.

So here we were with three decisions denying all the Bulox plaintiffs’ largely perfunctory Rule 702 challenges to the three defense experts (yay!); but doing so by unnecessarily relying on anachronistic precedent contrary to the 2023 amendments to the Rule (boo, hiss!).  We were all set to write a rare blogpost criticizing defense counsel for jeopardizing the amendments merely to win denial of some motions that were poorly supported in the first place.  See Bulox II, 2025 U.S. Dist. Lexis 34275, at *7-8; Bulox III, 2025 U.S. Dist. Lexis 34274, at *9 (both finding waiver by reason of “inadequate briefing”).

But before we did such a thing, we wanted to be sure.  We have a PACER account and we know how to use it.  So we checked the defense opposition to the three motions in Bulox.  Those were the documents located at docket numbers 142, 144, and 145.  It turns out that the defense briefing in Bulox did not contain any of the incorrect statements about post-amendments Rule 702, nor did it cite to any of the anachronistic decisions cited in the three opinions.  Neither, however, did they emphasize the 2023 amendments and the changes they made.  Thus, it turns out that, while we remain appalled by terrible way that these three decisions reached correct results, we simply cannot blame it on either the defendants or their counsel.  They did not include any improper citations or make any penny-wise-but-pound-foolish arguments in their brief.

Instead, we blame a judicial system that places a low priority on updating outmoded template orders such as the Rule 702 forms that are obviously still being used in that chambers.  But be forewarned − if we do find instances of defense counsel making bad Rule 702 law by relying on bad pre-2023-amendments precedents, we will let you know.  Yes, it is that important.  Remember – “Don’t Say Daubert.”

Photo of Michelle Yeary

Certainly not us.  We had never heard of the UJNFLA before today and would likely have thought it was a reference to United Joggers of Northern Florida as much as to a Uniform Act promulgated in 1936 which, based on some quick research, was adopted by at least twenty-eight states, including Indiana where it is still on the books.  The status of the UJNFLA in the other twenty-seven states would need to be the subject of further investigation.  For example, we learned that in New Jersey it was once codified at N.J.S.A. § 2A:82-33 et seq., but was superseded by N.J. Rule of Evidence 201(a), which does not contain all of the same provisions.  Notably missing from that rule of evidence but present in the UJNFLA is a requirement that before any party can offer evidence of another state’s laws or ask for judicial notice of same, “reasonable notice shall be given to the adverse parties, either in the pleadings or otherwise.”  Ind. Code § 34-38-4-4.  What does that mean?  In Indiana it means that if a plaintiff, for example, wants to try to avoid that state’s statute of repose by arguing his home state’s law should apply – he better make that argument before summary judgment briefing. So said the Indiana Court of Appeals in Shaling v. Biomet, Inc., 2025 Ind. App. LEXIS 68 (Mar. 11, 2025).

Plaintiff, a resident of Alabama, underwent hip replacement surgery in 2001 with a medical device manufactured by defendant, a resident of Indiana.  Approximately fourteen years later, in early 2015, testing revealed elevated metal ion levels in plaintiff’s blood.  After additional testing, the metal hip implant was explanted in 2017.  Plaintiff filed suit in Indiana in 2019—eighteen years after the device was implanted.  The case progressed and was set for trial in June 2024.  In October 2023, defendant moved for summary judgment arguing that plaintiff’s claims were barred by Indiana’s ten-year statute of repose.  In opposition, plaintiff argued for the first time that the court should apply Alabama law which does not have an applicable statute of repose.  The trial court, relying on the UJNFLA, concluded that plaintiff failed to provide sufficient notice of his request to apply Alabama law and granted defendant summary judgment.

On appeal, the trial court’s application of the UJNFLA was reviewed for an abuse of discretion.  The Indiana Supreme Court has previously held that the “purpose of the notice requirement is to allow the other party time to prepare by studying the applicable law.”  Sword v. NKC Hospitals, Inc., 714 N.E.2d 142, 147 (Ind. 1999).  In that case, like in Shaling, plaintiffs waited until summary judgment to argue that Kentucky law should apply and claimed that reasonable notice was given because a sister action was pending in Kentucky state court.  The Indiana Supreme Court rejected that argument, finding that just because an injury occurred in another state is not “reasonable notice that a party will seek to use the other state’s laws.  Id. at 146.  Further, raising the issue at the summary judgment stage was not reasonable because “plaintiffs asserted a potentially strategy-altering issues without allowing [the defense] any opportunity to prepare.”  Id. at 147. 

Shaling is the same.  Plaintiff did not raise his choice of Alabama law until four years after the complaint had been filed, after defendant filed its summary judgement motion, and six months before trial—all after defendant had conducted discovery and developed its trial strategy based on Indiana law.  The appellate court found no abuse of discretion in the trial court’s application of the UJNFLA.

Since plaintiff was stuck with Indiana law, he tried to argue that he should be exempt from the statute of repose because his injuries are the result of a “protracted exposure to an inherently dangerous foreign substance” – like asbestos.  Shaling, 2025 Ind. App. LEXIS 68, at *12.  But the Indiana Product Liability Act is clear, a product liability action must be commenced with ten years after the delivery of the product to the consumer. I.C. § 34-20-3-1.  There is only one judicially created exception—for allegations of latent harm from asbestos exposure.  But there is no case law to support plaintiff’s theory that Indiana has adopted a “general latent disease exception.”  Id. at *15.  Any such exception has to be enacted by the legislature, not the courts.  Plaintiff’s claims, filed eighteen years after the device was implanted, were barred by the stature of repose.  Summary judgment was affirmed.

Wonder what we’ll learn tomorrow?   

Photo of Bexis

In the last few months, we have discussed two decisions rejecting claims made by plaintiffs in prescription medical product liability litigation that medical device manufacturers somehow had a duty to warn about claimed risks that occurred when their products were used (by physicians, of course) in conjunction with some other product.  In Silverstein v. Coolsculpting – Zeltiq Aesthetics, Inc., 2025 N.Y. App. Div. Lexis 1118 (N.Y. App. Div. Feb. 27, 2025), discussed here, a plaintiff claimed unsuccessfully that a device manufacturer had a duty to warn about the risks of a different product (ice packs) that physicians may, or may not, choose to use during the patient’s recovery period.

[U]nder New York law, the manufacturer of a product has a duty to warn of the danger arising from the known and reasonably foreseeable use of its product in combination with a third-party product which, as a matter of design, mechanics or economic necessity, is necessary to enable the manufacturer’s product to function as intended.  . . . [T]he ice packs were not necessary in any way for the . . . device to function as intended.  Indeed, the device functioned without incorporating ice packs, and the ice packs were not included as supplies with the . . . device.

Id. at *2-3 (citations and quotation marks omitted).

A little earlier, in Lin v. Solta Medical, Inc., ___ F. Supp.3d ___, 2021 U.S. Dist. Lexis 228901 (N.D. Cal. Dec. 18, 2024), discussed here, a plaintiff lost an argument that a medical device manufacturer had to warn about “enhanced” risks that only arose when the defendant’s device was used in conjunction with a second device made by someone else.  However, a defendant “cannot be liable for a product it did not manufacture, control, or create.”  Id. at *7.

[T]here is no warning specifically about greater risk when a different medical device [is also used].  Plaintiff argues that failing to specifically warn that another medical device . . . enhances the risk of injury constituted a failure to adequately warn. . . .  But plaintiff asks too much by proposing that defendant must warn with specificity about every conceivable element that might enhance the [risk of injury].

Id. at *24  (emphasis original).

These two cases demonstrate that plaintiffs regularly attempt (fortunately, without much success) to impose on prescription medical product manufacturers expansive duties to warn about the products of other manufacturers that, presumably, are judgment proof or otherwise difficult to sue.  Similar attempts, with similar motivations, are reflected in the economically absurd, and largely rejected, “innovator liability” theory that would require branded drug manufacturers to warn about risks of competing generic products (immunized by preemption).  See, e.g., our Innovator Liability Scorecard.  An earlier example, that thankfully seems to have largely run its course, is “market share liability,” which would create industry-wide warning liability in situations where plaintiffs couldn’t prove which manufacturers’ drug they took.  A 50-state survey of ours from 2010 hasn’t changed much, except for Wisconsin having since abolished the theory through legislation.  See Wis. Code §895.046(3-4) (added in 2011).

To counter the continuing threat of non-manufacturer warning liability, we offer the following discussion of the law.

We start in our sandbox, with prescription medical product liability litigation.  As our scorecard demonstrates, courts overwhelmingly reject attempts to create the “innovator liability” form non-manufacturer prescription drug warning liability.  In Huck v. Wyeth, Inc., the Iowa Supreme Court cautioned:

It may well be foreseeable that competitors will mimic a product design or label. But, we decline [plaintiff’s] invitation to step onto the slippery slope of imposing … liability on manufacturers for harm caused by a competitor’s product. Where would such liability stop?

850 N.W.2d 353, 380 (Iowa 2014) (citation omitted).  Similarly, McNair v. Johnson & Johnson, 818 S.E.2d 852 (W. Va. 2018), held:

[W]hile our law states that manufacturers are subject to the duty to warn about the risks of their products, the generic drug in this case is not a product of the brand manufacturer. Consequently, brand manufacturers cannot be held strictly liable for failure to warn of another manufacturer’s product.

Id. at 861.  Liability for other manufacturers’ products “stretches foreseeability too far.” McNair, 818 S.E.2d at 862.  For convenience, here is a current list of all other appellate authority rejecting innovator liability (see the Scorecard for trial level decisions).  Forest Laboratories, LLC v. Feheley, 296 So.3d 302, 315 (Ala. 2019) (a “manufacturer cannot be held liable for injury caused by a product it did not manufacture”); Rafferty v. Merck & Co., 92 N.E.3d 1205, 1213 (Mass. 2018) (“a manufacturer may be found liable for a failure to warn only where the product that caused the injury was made by that manufacturer”); Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-15 (5th Cir. 2014) (applying Louisiana law); In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 938, 941-54  (6th Cir. 2014) (applying the laws of 22 states); Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 681 (5th Cir. 2014) (applying Texas law); Lashley v. Pfizer, Inc., 750 F.3d 470, 476-78 (5th Cir. 2014) (applying Mississippi & Texas law); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1284 (10th Cir. 2013) (applying Oklahoma law); Fullington v. PLIVA, Inc., 720 F.3d 739, 744 (8th Cir. 2013) (applying Arkansas law); Guarino v. Wyeth, 719 F.3d 1245, 1251-53 (11th Cir. 2013) (applying Florida law); Smith v. Wyeth, Inc., 657 F.3d 420, 423-24 (6th Cir. 2011) (applying Kentucky law); Foster v. American Home Products Corp., 29 F.3d 165, 168-71 (4th Cir. 1994) (applying Maryland law); Moretti v. Wyeth, Inc., 579 F. Appx. 563, 564-65 (9th Cir. 2014) (applying Nevada law); PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015); Franzman v. Wyeth, Inc., 451 S.W.3d 676, 689-92 (Mo. App. 2014) (applying Kentucky law); Stanley v. Wyeth, Inc., 991 So.2d 31, 34-35 (La. App. 2008); Flynn v. American Home Products Corp., 627 N.W.2d 342, 350 (Minn. App. 2001).  Only California has allowed innovator liability on anything less than intentional conduct. See T.H. v. Novartis Pharmaceuticals. Corp., 407 P.3d 18, 27- 40 (Cal. 2017).

Other prescription medical product cases have rejected non-manufacturer warning liability in the context of comparative warning claims.  Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying New York law), held that drug manufacturers’ warning duties did not extend to allegedly lower risks of competing drugs.  Warning duties existed only about a product’s own risks, “not to different drugs treating the same ailment.”  Id. at 291-92.  Earlier, Pluto v. Searle Laboratories, 690 N.E.2d 619 (Ill. App. 1997), rejected the same argument, finding no duty to warn about the comparative risks of “competing products”:

[Defendant] is under no duty to provide information on other products in the marketplace. Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies. This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product.

Id. at 621.  Accord Nelson v. C.R. Bard, Inc., 553 F. Supp.3d 343, 355 (S.D. Miss. 2021) (refusing to take the “slippery slope” of requiring warnings “of danger compared with other products”), aff’d, 44 F.4th 277 (5th Cir. 2022).  See Ackley v. Wyeth Laboratories, 919 F.2d 397, 405 (6th Cir. 1990) (manufacturer “not obligated to provide a comparison of its drug with others”) (applying Ohio law); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 314 (D. Conn. 2016) (defendant owed no duty to warn “about a product that it did not make or sell”); Adamson v. Ortho-McNeil Pharms., Inc., 463 F. Supp.2d 496, 504 (D.N.J. 2006) (“courts have routinely held that competitors have no duty to advertise or sell a competitor’s products”); Smith v. Wyeth Laboratories, Inc., 1986 U.S. Dist. Lexis 21331, at *28 (S.D.W. Va. Aug. 21, 1986) (“no authority for [plaintiffs’] argument that a drug manufacturer may be required to represent that other drugs with similar effects are safer”).

Additional medical product decisions rejecting non-manufacturer warning claims in other situations are: Johnson v. American Cyanamid Co., 718 P.2d 1318, 1326 (Kan. 1986) (rejecting claim that defendant “did not provide information on alternate vaccines”); Martinez v. Medical Depot, Inc., 434 F. Supp. 3d 537, 547 (S.D. Tex. 2020) (“no duty to warn or instruct about another manufacturer’s products, though those products might be used in connection with the manufacturer’s own products”) (citation and quotation marks omitted); Kapps v. Biosense Webster, Inc., 813 F. Supp.2d 1128, 1158 (D. Minn. 2011) (defendant “does not reprocess its own” devices; therefore no duty to warn of risks of third-party reprocessing); Doe v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp.2d 614, 626-27 (M.D.N.C. 2004) (knowledge “that other manufacturers were copying [defendant’s] expired patent” did not create duty to warn).

Going outside our sandbox, we continue with the seemingly perpetual plague of asbestos litigation, which has turned to non-manufacturer warning liability as the funds of actual asbestos manufacturers were depleted by endless litigation and liability.  In Air & Liquid Systems Corp. v. DeVries, 586 U.S. 446 (2019), the not-so-business-friendly Supreme Court allowed limited non-manufacturer warning liability in a maritime law case, while invoking “[m]aritime law’s longstanding solicitude for sailors.”  Id. at 456.  The limited duty in DeVries exists only “when: (i) a manufacturer directs that the part be incorporated; (ii) a manufacturer itself makes the product with a part that the manufacturer knows will require replacement with a similar part; or (iii) a product would be useless without the part.” Id. at 457 (internal citations omitted) (emphasis added).  As exemplified by Silverstein, supra, that is not the type of situation likely to exist in prescription medical product liability litigation – but perhaps it could.

DeVries, however, was a maritime law case, and after it, most states have declined p-side invitations even to adopt its narrow form of non-manufacturer warning liability.  The most prominent such decision is Coffman v. Armstrong International, Inc., 615 S.W.3d 888, 899 (Tenn. 2021), which held that, under Tennessee’s product liability statute, “manufacturers have no duty to warn with respect to products manufactured and sold by others.” Id. at 899.

[T]he best reading of the TPLA does not create a duty or liability for defendants for the post-sale incorporation of [other] products … after it left their control…. The TPLA specifically provides that a defendant shall not be liable under the TPLA unless the product is defective or unreasonably dangerous at the time it left the defendant’s control.

Id. at 895 (citation omitted).

Georgia has a similar product liability statute, also requiring the claimed product defect to have existed at the time the product was sold. Ga. Code §51-1-11(b)(1).  Davis v. John Crane, Inc., 836 S.E.2d 577, 584 (Ga. App. 2019), thus concluded, like Coffman, that “foreseeability” of the product later being used with another manufacturer’s dangerous product was insufficient to create a warning duty:

Appellant seeks to expand the traditional duty to warn so as to require a manufacturer to warn of the hazards in another manufacturer’s product. This has never been the law in Georgia, and we decline to expand our case law in this respect.

Id. at 251 (emphasis original).  For other appellate asbestos since our 2015 post on the so-called “bare metal” defense, see Beverage v. Alcoa, Inc., 975 N.W.2d 670, 688 (Iowa 2022) (“limit[ing] products liability claims against manufacturers or sellers to exposures from their own products” and barring “products liability claims premised on products or component parts made or sold by others”); Gillenwater v. Honeywell International, Inc., 996 N.E.2d 1179, 1200 (Ill. App. 2013) (“to impose liability [here] would violate a fundamental tenet of products-liability law:  a manufacturer is responsible only for the defects in the products it manufactured”).

Significantly, quite a few other states have statutes containing the same defect-at-sale element as Tennessee and Georgia or otherwise explicitly defining “product liability” actions to confine liability to those who manufactured, distributed or were otherwise involved with the product that caused injury.  See Ala. Code §6-5-530(a), Ariz. Rev. Stat. §12-681(5); Ark. Code §16-116-101; Colo. Rev. Stat. §13-21-401(2); Conn. Gen. Stat. §52-572n(a); Idaho Code §6-1402(1); Ind. Code §34- 20-1-1; Kan. Stat. §60-3302(a-c); La. Stat. §9:2800.52; Me. Rev. Stat. tit. 14, §221; Miss. Code §11-1-63; Mont. Code §27-1-719; N.C. Gen. Stat. §99B-1; N.D. Cent. Code §28-01.3-01; N.J. Stat. §2A:58C-2; Ohio Rev. Code §2307.71(13); Or. Rev. Stat. §30.900; S.C. Code §15-73-10 (codifying Restatement §402A); Tex. Civ. Prac. & Rem. Code §82.001(2); Utah Code §78B-6-703(1); Wash. Rev. Code §7.72.030(1); Wis. Stat. §895.046(3).  Since, by definition, a product cannot be used in conjunction with some other product until after it has been sold, these statutes should also preclude non-manufacturer warning liability.

Numerous non-manufacturer liability claims have also been brought, and rejected, in litigation involving vehicle parts – cars, trucks, and assorted other self-propelled products.  Decisions involving motorized vehicles have broadly rejected warning claims that ignore who made what.  New York’s high court “decline[d]” to extend warning duties to tire manufacturers merely because they “produce[d] a sound product which is compatible for use with a defective product” made by someone else.  Rastelli v. Goodyear Tire & Rubber Co., 591 N.E.2d 222, 225-26 (N.Y. 1992).  Such liability for other products was inappropriate where the defendant “did not contribute to the alleged defect in [the other] product, had no control over it, and did not produce it.”  Id. at 226 (citations omitted).

[Defendant] had no control over the production of the [other product], had no role in placing that [product] in the stream of commerce, and derived no benefit from its sale. [Defendant’s product] did not create the alleged defect in the [other product] that caused the [accident].

Id. Accord Hansen v. Honda Motor Co., 480 N.Y.S. 2d 244, 246 (N.Y. App. Div. 1984) (defect-at-sale requirement meant manufacturer had no duty to warn about subsequent modifications “however foreseeable such modifications may have been”).

Acoba v. General Tire, Inc., 986 P.2d 288, 304-05 (Haw. 1999), agreed with Rastelli that “a manufacturer owes a duty to warn regarding its own product, not regarding products it did not produce, sell, or control”) (emphasis original).  Baughman v. Gen. Motors Corp., 780 F.2d 1131 (4th Cir. 1986) (applying South Carolina law), likewise found no “rationale for imposing liability” where “the defendant manufacturer did not incorporate the defective component part into its finished product and did not place the defective component into the stream of commerce.”  Id. at 1132-33.

[Plaintiff’s] position would require a manufacturer to test all possible replacement parts made by any manufacturer to determine their safety and to warn against the use of certain replacement parts.  If the law were to impose such a duty, the burden upon a manufacturer would be excessive.

Id. at 1133.

The Texas Supreme Court reached the same result in Firestone Steel Products Co. v. Barajas, 927 S.W.2d 608, 614 (Tex. 1996), holding that a manufacturer had no duty to warn regarding the product of another manufacturer that modified the defendant’s design.  “A manufacturer generally does not have a duty to warn or instruct about another manufacturer’s products, even though a third party might use those products in connection with the manufacturer’s own product.” Id. at 614.

An earlier Texas decision, Walton v. Harnischfeger, 796 S.W.2d 225 (Tex. App. 1990), applied the same logic to a crane, holding “that a manufacturer does not have a duty to warn or instruct about another manufacturer’s products, even though those products might be used in connection with the manufacturer’s own product.”  Id. at 226. “To require [a crane] manufacturer to warn of all . . . dangers would be unfair and unrealistic.”  Id.  That defendant “had no duty to warn or instruct users of its crane about [items] it did not manufacture, incorporate into its crane, or place into the stream of commerce.”  Id. at 227.

Most recently, in Tennessee, an appellate court, guided by Coffman, supra, held that an auto parts manufacturer “did not have the legal duty . . . to warn about the misuse that arose from the combination of its product with the products of other manufacturers.”  Woodruff v. Ford Motor Co., 2024 Tenn. App. Lexis 222, at *29 (Tenn. App. May 20, 2024), appeal pending.

Plaintiff claims that [defendant] had a duty to warn about the combined use of its [product] with another manufacturer’s product, . . . as opposed to a duty to warn about some intrinsic feature of the actual [product].  We find that Coffman’s explicit holding that “under the [Tennessee statute], manufacturers have no duty to warn with respect to products manufactured and sold by others” applies to the facts of this action.

Id. at *27.  Accord Woodruff v. Ford Motor Co., 2024 Tenn. App. Lexis 229, at *23-24 (Tenn. App. May 28, 2024) (identical ruling with as to other manufacturer’s product).

Likewise, a vehicle manufacturer was not liable in Louisiana for injuries from a replacement part because the part “was not the one manufactured by [defendant].  It was a completely foreign device.”  Landry v. E.A. Caldwell, Inc., 280 So. 2d 231, 235 (La. App. 1973).  Accord Cousineau v. Ford Motor Co., 363 N.W.2d 721, 728 (Mich. App. 1985) (“Failure of a component not supplied by the manufacturer does not give rise to liability on the manufacturer’s part.”) (citation omitted).

Finally, non-manufacturer warning claims concerning a wide variety of other products  products have failed.  The law’s refusal to impose duties to warn about risks of other entities’ products extends broadly.  Chemical manufacturers are not obligated to warn about any conceivable combination with other chemicals that might create injurious reactions.

[T]he manufacturer’s duty is restricted to warnings based on the characteristics of the manufacturer’s own product. Understandably, the law does not require a manufacturer to study and analyze the products of others and to warn users of risks of those products.

Powell v. Standard Brands Paint Co., 212 Cal. Rptr. 395, 398 (Cal. App. 1985) (citations omitted).  A chemical manufacturer in Blackwell v. Phelps Dodge Corp., 203 Cal. Rptr. 706, 710 (Cal. App. 1984), likewise had no duty to warn about risks created by storage containers it did not make. “The product alleged to have been dangerous, and hence defective, for lack of warnings and instructions was not the [chemical] supplied by defendant, but the tank car in which the [chemical] was shipped.” Id. at 710.

A paint manufacturer in Johnson v. Jones-Blair Paint Co., 607 S.W.2d 305 (Tex. App. 1980), had no duty to warn about the flammability of third-party products used to clean spilled paint, although spills and spatters are inevitable occurrences.

[T]he product (paint) is not unreasonably dangerous in the absence of the warning urged by plaintiffs. The dried paint spots did not explode. The explosion resulted from the use of a product (gasoline) supplied by a seller other than [defendant].

Id. at 306. Accord Drake-Willock International, Ltd., 530 N.W.2d 510, 515 (Mich. App. 1995) (“recommend[ing]” a cleaning method created no duty to warn, since “manufacturers d[o] not have a duty to provide warnings for dangerous conditions present in other products”).

Nor must a glass bottle maker warn about a product (the bottle cap) that it did not produce.  The defendant in Andry v. Canada Dry Corp., 355 So.2d 639, 641 (La. App. 1978), was “responsible for only one component” − the bottle − and the plaintiff offered “no evidence that the bottle involved in this case, which was the only component manufactured by the defendant . . ., malfunctioned in any way.” Id. at 641.

Rejection of non-manufacturer warning duties is also preclusive in scaffolding cases.  “We have never held a manufacturer liable … for failure to warn of risks created solely in the use or misuse of the product of another manufacturer.”  Mitchell v. Sky Climber, Inc., 487 N.E.2d 1374, 1376 (Mass. 1986).  A scaffold manufacturer had no “foreseeability”-based duty to warn about flooring planks made by others.  “[W]e emphasize [defendant] did not supply the ‘defective’ product.” “Pennsylvania law does not permit” liability for not “warn[ing] of dangers inherent in [a product] that it did not supply.” Toth v. Economy Forms Corp., 571 A.2d 420, 422-23 (Pa. Super. 1990).

In Baker v. Poolservice Co., 636 S.E.2d 360, 365 (Va. 2006), the duty to warn “ha[d] no application . . . because [defendant] was not the manufacturer of the [hot tub] or any of its component parts.” A manufacturer of an “off-the-shelf” product “ha[s] no duty to warn [plaintiff] of possible dangers … that might depend on the operation of components other than” its product. Sanders v. Ingram Equipment, Inc., 531 So.2d 879, 880 (Ala. 1988). “[A]n ancillary component manufacturer has no duty to warn regarding the dangers associated with a separate manufacturer’s defective products.”  Schreiner v. Wieser Concrete Prods., Inc., 720 N.W.2d 525, 530 (Wis. App. 2006).

Thus, when it comes to claims that a prescription medical product manufacturer could be liable for failure to warn about the risks of some other product, whether competing or compatible, such a targeted defendant can take advantage of a broad body of product liability precedent rejecting that sort of claim.  Our clients are not alone.  Numerous state statutes, and precedent concerning products ranging from asbestos to autos to scaffolds and soda bottles has limited the duty to warn to the risks of defendant manufacturers’ own products.

Photo of Eric Hudson

We blogged a lot about the Taxotere MDL.  From Lone Pine orders to denials of motions to amend in remand cases, we reported on some pretty good decisions.  The MDL court also dismissed a number of plaintiffs who failed to make timely service on the defendants, which we blogged about here and here. Today’s decision addresses a plaintiff who appealed her dismissal for failing to make timely service. Reeder v. Hospira, Inc. (In re Taxotere Docetaxel Prods. Liab. Litig.), 2025 U.S. App. LEXIS 4735 (5th Cir. Mar. 6, 2025).

Continue Reading Fifth Circuit Affirms Taxotere Dismissal for Failure to Serve
Photo of Eric Alexander

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

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

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

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

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

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

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

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

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

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

Photo of Stephen McConnell

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.  

Photo of Michelle Yeary

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.

Photo of Bexis

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”
Photo of Steven Boranian

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. 

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