Clip, Clip Hooray – LexBlog

A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation.  The end results weren’t horrible (p-side motions were denied), but th0se Rule 702 opinions completely ignored the changes wrought by the 2023 amendments to that Rule.  It was so striking that we went on PACER to see whether defense counsel was to blame for any of that – they weren’t.

Well, today we’re cheering the latest decision(s) in the same litigation.  Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2005) (“Bulox I”), adopted, 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025) (“Bulox II”), is as good a PMA medical device preemption decision as a defendant has a right to expect.  This Bulox decision should go a long way towards defeating the other side’s latest campaign to deprive women of contraceptive choice.

The product, Filshie clips, being FDA pre-market approved medical devices, were covered by the extensive express preemption recognized by the Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Bulox I, 2025 U.S. Dist. Lexis 56370, at *2-3.  In addition to express preemption, preemption dodges masquerading as “parallel” claims were subject to implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), to the (large) extent that they are private attempts to enforce the FDCA.  Bulox I, 2025 U.S. Dist. Lexis 56370, at *4.

The plaintiffs’ primary contention in Filshie clip cases appears to be that the “adverse events” section of this device’s FDA approved labeling states a “migration rate of 0.13%, whereas plaintiffs claim the migration rate is closer to 25%.  There’s a perfectly good reason for that, because adverse events have to be “adverse” and the great majority of migrations are asymptomatic or minor, as we discussed here.

Plaintiffs, however, frequently attempt to use that discrepancy to claim that the defendant manufacturer failed to report adverse events, and they tried the same ploy in Bulox.  It backfired, big time.  Bulox I recognized that these weren’t what the FDA considered adverse events at all:

[Defendant] reviewed the complaints but determined that the reporting threshold was not met as to any of them.  In its 2019 PMA annual report, [it] reported its expert determined that, over the last 10 years, “[n]one of the Filshie clip migrations were life-threatening or caused permanent impairment of a body function.”

2025 U.S. Dist. Lexis 56370, at *5 (citation omitted).

Not only was the failure-to-report claim factually unsupported, but it was legally meritless as well.  “[T]he Court finds that preemption bars all Plaintiffs’ claims.”  Id. at *6.

Design defect claims – Plaintiffs unsuccessfully attempted to import their reporting-based garbage into their design-related arguments.  Id. at *8 (“[t]he design was approved by the FDA without the benefit of the knowledge that Filshie Clips had a greater than .13% risk of migration”).  That, of course, is precisely the same fraud-on-the-FDA allegation made in Buckman.  None of that helped because the plaintiffs did “not plead that the Filshie Clips . . . were designed in a manner other than as the FDA approved.”  Bulox I, 2025 U.S. Dist. Lexis 56370, at *8.  “Because Plaintiffs have not alleged that the product in question was designed in violation of federal standards, they have failed to plausibly state a claim for design defect that would avoid preemption under the MDA.”  Id. at *9 (citations omitted).  As in Buckman, plaintiffs’ attempt to “connect” the design claim “to the adverse event reporting requirement” was impliedly preempted.

[A]lthough embedded in state-law terms, any such claims would exist solely by virtue of federal law.  Accordingly, this Court finds that, to the extent [Plaintiffs’] claims are not expressly preempted . . . they are impliedly preempted.

Bulox I, 2025 U.S. Dist. Lexis 56370, at *10 (citations and quotation marks omitted).

And just to be sure, the design claim failed on state-law grounds as well.  Plaintiffs’ purported “alternative designs” (required under Texas law) weren’t a design at all, but rather other forms of surgery that didn’t involve any clips.  Id.  As we discussed at length here, different surgeries are not alternative product designs.

Here, the proposed alternatives are surgeries or methods different from the Filshie Clip ligation, but under Texas law, Plaintiffs must propose a safer and feasible alternative design to the alleged defective designs, not different procedures or strategies entirely.

Id. at *11 (citations and quotation marks omitted).

One down.

Warning defect claims −  Plaintiffs warning claim was also preempted.  It was, as usual, the bogus migration rate allegation.  Id.  To the extent that plaintiffs claimed that the FDA-approved rate for adverse migration-related events was wrong, that was “different from” the FDA-approved warning and expressly preempted.  “Federal law squarely preempts any claim for failure to provide adequate warnings or instructions that would question the sufficiency of the FDA-approved labeling, warnings, and instructions.”  Id. at *12.  Since plaintiffs did not claim that the FDA-approved labeling was not on the device, they had no warning claim.  Id. at *13.

Plaintiffs also attempted to morph their warning allegations into a “later-acquired knowledge theory” – that information the defendants learned after the FDA approved the warning required them to change the warning.  Id.  That reporting-based claim was expressly preempted (no parallel claim), impliedly preempted (purely private FDCA enforcement), and failed to state a state-law claim in the first place:

[While, u]nder federal law, device manufacturers must report any incident to the FDA where their device may have caused or contributed to a death or serious injury . . ., Texas law provides no such parallel duty.  Indeed, under Texas law, manufacturers owe a duty to warn consumers, not the FDA, of potential dangers.

Id. at *14-15 (citations and quotation marks omitted) (emphasis original).

Nor could the FDA qualify as a state-law “learned intermediary.”

Plaintiffs have not produced any Texas authority that this [warning] duty can be discharged by informing the FDA, which means that Texas failure-to-warn claims impose a different requirement from federal law:  warning consumers or prescribing physicians instead of warning the FDA.  As a result, this claim is preempted.

Id. at *15-16 (footnote omitted).  The footnote is worth a read, too, since it distinguishes Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), as “based . . . on now defunct Mississippi products liability law.”  Bulox I, 2025 U.S. Dist. Lexis 56370, at *16 n.7.

We also love the point that “Texas courts generally reject arguments that reporting statutes give rise to common-law causes of action under Texas law.”  Id. at *16 (citations and footnote omitted).  That’s why we’ve collected all the non-FDCA-related failure-to-report decisions we could find (for all 50 states) in our 50-state survey.  Since there was no equivalent state-law claim, plaintiffs’ failure-to-report claims were simply preempted attempts to enforce the FDCA privately:

Accordingly, because there is no “parallel” state requirement under Texas law, Plaintiffs’ contention that Defendants’ failure to warn via failure to report adverse event complaints is simply an attempt by private parties to enforce FDA reporting requirements, which is foreclosed under §337(a), as construed in Buckman.

Id. (citation and quotation marks omitted).

Thus, the plaintiffs’ failure-to-report claim was dismissed in Bulox I three times over – as expressly preempted, impliedly preempted, and for failing to state a claim under Texas law.

That’s two – plaintiffs  no longer asserted any manufacturing defect claim.

Predictably, plaintiffs appealed the magistrate’s decision to the district court.  Not so predictably, the district court wrote a substantive opinion adopting the magistrate’s opinion in full.  That opinion held:

• Plaintiffs design defect claim was preempted because there was no allegation that the product was “designed in violation of federal standards.”
• Plaintiffs failure-to-report allegations did not create any “parallel” design claim.
• “[E]ntirely different procedures” are not alternative designs.
• “[N]o parallel duty exists under Texas law to report adverse events to the FDA.”
• Failure-to-report claims are “simply an attempt by private parties to enforce FDA reporting requirements, which is foreclosed under 21 U.S.C. §337(a).”
• “[T]he Court agrees with [the] analysis of the Fifth Circuit’s opinion in Hughes.”
• “Plaintiffs have not identified an independent and parallel source of liability in Texas law for violating federal reporting requirements.”

Bulox II, 2025 U.S. Dist. Lexis 54755, at *3-9 (various citations and quotation marks omitted).

Overall, we think this is the best decision yet out of the Filshie clip liltigation.