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Note: There is a table in this post that may be easier to view on a phone than on a computer.

Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”). 

These devices are a very small subset of FDA-regulated medical devices – around 1% — and they are, by definition, cutting-edge.  They preserve health or protect life, but because they are so complex and novel and because medicine is still part art, they inherently involve risks.  Congress recognized that such devices thus required some protection from litigation—lest the burdens of litigation stifle innovation and drive essential devices off market.

In fact, Congress did not just intend to protect these devices from litigation judgments, they hoped to protect against even from the costs of discovery which alone can impose a considerable burden.  Preemption arguments are often appropriately upheld on motion to dismiss.

But not always.  Often enough to be frustrating, we encounter judges who reflexively deny motions to dismiss on preemption grounds.  Sometimes, the same judges eventually see the preemption light on summary judgment, and that is better than the defendant having to wait to get the problem fixed on appeal.  But we really wish courts would take preemption authorities to heart at the outset of a case, as Congress intended.

Today’s decision involves just that sort of scenario.  Last year, the Middle District of Alabama denied the defendants’ motions to dismiss raising federal preemption in Mack v CooperSurgical, Inc., 2023 U.S. Dist. LEXIS 51402, 2023 WL 2653365 (M.D. Ala. March 27, 2023) (Mack I).  Earlier this month, the same judge granted defendants’ motions for summary judgment on the same ground in Mack v. CooperSurgical, Inc., 2024 U.S. Dist. LEXIS 181699 (M.D. Ala. Oct. 4, 2024) (Mack II).  In the intervening 15 months, we are sure the parties spent tons and tons of unnecessary money on discovery, experts, and additional motions.

The Mack case involves an implanted contraceptive medical device known as Filshie Clips.  Blog readers know that contraceptive products are a litigation magnet, so you won’t be surprised to learn that we have discussed Filshie Clips before here, here, and here.

Filshie Clips are silicone-lined titanium medical devices used in tubal ligation procedures, to permanently block the fallopian tubes.  The FDA granted PMA for Filshie Clips in 1996, and has never suspended or withdrawn that approval.  As the Mack court noted, premarket approval includes FDA approval of device warnings and precautions which, for Filshie Clips, included a potential risk of clip migration of 0.13%.

The Mack plaintiff alleged that she experienced Filshie Clip migration-related symptoms soon after her 2017 implant procedure, with migration confirmed in 2020 when the Clips were explanted and a fallopian tube was removed, eventually followed by a complete hysterectomy.

Her complaint alleged that migration was occurring much more frequently than the FDA-approved warnings specified, “in over 25% of patients.”  The complaint alleged that defendants were aware of the higher rate of migration through adverse event reports that they allegedly failed to report to the FDA, and that they failed to update their “marketing materials” to advise physicians and patients about the higher rate.

The plaintiffs’ theories of liability did not change between the motion to dismiss phase and summary judgment, and to be frank, it also does not look like there is much difference between the well-pleaded facts assumed to be true on motion to dismiss and the undisputed evidence before the court on summary judgment.

So we put the relevant portions from the two opinions side-by-side to see if we could determine what was the inflection point for this judge, and nothing super-obvious jumps out at us.  The court makes the obligatory “on summary judgment plaintiff needs evidence” decree, employs some different language between the two opinions, and emphasizes some different authorities.  But we don’t see anything that should have precluded a preemption-based dismissal at the pleading stage while allowing it on summary judgment. 

What we do see are errors in Mack I more-or-less corrected in Mack II, without much discussion of why. Take a look:

Order Denying MTD/Mack IOrder Granting MSJ/Mack IIOur Commentary
Statement of Law re Express
Preemption
“The express preemption provision bars any claim based on a state law requirement ‘which is different from, or in addition to, any requirement’ under the MDA that ‘relates to the safety or effectiveness of the device’ or any other MDA requirement.”  [Godelia v. Doe 1, 881 F.3d 1309, 1317 (11th Cir. 2018)] (quoting 21 U.S.C. § 360k(a)). “State requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law.” [Riegel v. Medtronic, Inc., 552 U.S. 312, 330  (2008)] (quoting 21 U.S.C. § 360k(a)). The MDA does not expressly preempt state law claims based upon “state duties [that] . . . ‘parallel,’ rather than add to, federal requirements.” Id. (citation omitted).The express preemption provision “does not allow a state to impose a requirement on a [medical device that has gone through the premarket approval process] that is ‘different from, or in addition to’ any federal requirement on the device.” Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1325 (11th Cir. 2017) (quoting 21 U.S.C. § 360k(a)). However, a “plaintiff’s state common law claims . . . [are] not preempted to the extent their claims parallel[] federal requirements.” Id. at 1326.Other than adopting the parallel claim rubric, this is a fair statement of what 21 U.S.C. § 360k(a), as interpreted by Riegel, means.
Application of Express PreemptionThe Macks’ state law claims are … not expressly preempted. This Court finds the district court’s decision in Blevins-Ellington v. Coopersurgical, Inc., No. 1:22-CV-00197-LMM, 2023 U.S. Dist. LEXIS 28936, 2023 WL 2111346, at *13 (N.D. Ga. Jan. 17, 2023), which reaches a similar conclusion as to Defendants’ liability under state law for injuries caused by Filshie Clips, persuasive and instructive on this point. Alabama law permits negligence and strict liability claims against product manufacturers and distributors that rest on common law duties owed to individuals…. Like the plaintiffs in Mink and Blevins-Ellington, the Macks have alleged violations of these state common law duties owed to them. … Among others, the Macks assert that the Defendants owed them a duty to prevent manufacturing and design defects, to warn of the risk of harm, and to exercise ordinary care, each of which the Macks connect to parallel federal requirements—for example, the requirement that the Defendants “obtain[] approval for changes in the design, manufacture, and warnings/marketing approved by the FDA.”The Macks do not argue and have not provided any evidence that the Defendants ever deviated from the FDA-approved warnings and instructions concerning Filshie Clips. In fact, their experts are quick to acknowledge that. . . . [T]he Macks consent to summary judgment on their manufacturing defect [claim]. . . . As to the Macks’ design defect theories of liability, the Macks do not provide evidence of any failure by the Defendants to adhere to the FDA-approved design of Filshie Clips. Their experts ([Dr. James] Wheeler, [Dr. Bruce] Rosenzweig and [Dr. Lisa] Harris) acknowledge as much.  Mack I seems to get side-tracked by the wrongly-decided Blevins-Ellington.  It blurs express and implied preemption concepts.  And the idea that needing federal approval for design or warning changes constitutes a parallel claim?  We don’t even understand what Mack I was trying to suggest with that. By contrast, Mack II gets it – did the defendant violate federal warning or design requirements in a way material to plaintiff’s theory of liability?  If not, the claim is expressly preempted.  Short and sweet.
Implied
Preemption Law
[Implied preemption] bars claims “that merely attempt to enforce duties owed to the FDA, so-called ‘fraud-on-the-FDA claims.'” Godelia, 881 F.3d at 1317 (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001))). The MDA “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Buckman, 531 U.S. at 349 n.4; 21 U.S.C. § 337(a). Causes of action not arising from “traditional state tort law which . . . predated the federal enactments in question[]” are preempted. See Buckman, 531 U.S. at 353. Specifically, actions arising “solely from the violation of [MDA] requirements,” are impliedly preempted because “Congress intended that the MDA be enforced exclusively by the Federal Government.” Id. at 352.  The implied preemption provision states, in relevant part: “[A]ll such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.” 21 U.S.C. § 337(a). This provision has been applied to so-called “fraud-on-the-FDA claims”—where the manufacturer makes misrepresentations or non-disclosures to the FDA. Mink, 860 F.3d at 1327 (quoting Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001) (holding fraud-on-the-FDA claims are impliedly preempted because they “exist solely by virtue of the [Food, Drug, and Cosmetic Act’s] disclosure requirements”))). In sum, “traditional state-law tort claims survive implied preemption so long as they don’t seek to privately enforce a duty owed to the FDA.” Id.; see also Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329, 1336 (11th Cir. 2022) (“Put another way: a plaintiff cannot seek to privately enforce a duty that is owed to the FDA.”). “So, even if a plaintiff’s claim is not expressly preempted, it is impliedly preempted if it is cognizable only because of duties owed to the FDA.” Jacob, 40 F.4th at 1336.  Both Mack I and Mack II discuss “MDA” (or “Medical Device Amendments”) implied preemption, which isn’t quite correct.  21 U.S.C. § 337(a) – which is the Food, Drug and Cosmetics Act’s “no private right of action” provision, is not located in the Medical Device Amendments, and thus isn’t limited to the medical device context.  Similarly, implied preemption principles are not limited to the medical device context. Otherwise, the statement of implied preemption law is a better organized in Mack II, perhaps suggesting a deeper understanding of the issue over time.
“Narrow Gap”As the Eleventh Circuit has recognized, “[t]aken together, these two types of preemption leave a ‘narrow gap’ through which plaintiffs making medical device claims must proceed.” Godelia, 881 F.3d at 1317 (citation omitted). “To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).” Mink, 860 F.3d at 1327.These express and implied preemption provisions, operating in tandem, have created what some federal courts have described as a “narrow gap.” [Jacob, 40 F.4th at 1336] (quoting Mink, 860 F.3d at 1327 (11th Cir. 2017)). To make it through, “a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption) but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).” Id. (quoting Mink, 860 F.3d at 1327)).  These statements about the “narrow gap” are similar enough, but neither Mack I nor Mack II really discuss or attempt to apply it to the case.
Failure
to Warn and “Fraud on the FDA”
[T]he Macks “acknowledged the risk of preemption and explicitly limited their pleadings to parallel violations of federal law.” See Blevins-Ellington, 2023 U.S. Dist. LEXIS 28936, 2023 WL 2111346, at *13; Mink, 860 F.3d at 1329. … [T]he Macks’ failure to warn claim is based on their contention that the Defendants had a continuing duty to warn the Macks regarding the Filshie Clips’ “unreasonable risk of migration” but failed to do so. … The Macks thus rely on “traditional state tort law which had predated the federal enactments,” see Buckman, 531 U.S. at 353, and their claims do not “implicate a duty owed to the FDA,” see Mink, 860 F.3d at 1330 (reaching a similar conclusion about Florida state law claims).While they do not affirmatively claim in their Complaint that the Defendants should have used more or different language in their FDA-approved warnings and instructions than those previously approved by the FDA, in their summary judgment briefing, they do seem to suggest that the Defendants should have.  For example, in arguing for application of fraudulent concealment and equitable tolling in opposing the Defendants’ statute of limitations assertions, the Macks repeatedly emphasize the Defendants’ alleged suppression of information (for example, that labeling should reflect a reported 25% migration rate and not a 0.13% rate) from physicians and the general public in the Instructions for Use that accompanied their Filshie Clip product in 2017. … This argument demonstrates that the Macks are indeed making state law claims based on a fraud-on-the-FDA theory and that Defendants’ warnings and labeling should have been different, i.e., reflecting different migration statistics and complications. Such claims clearly are preempted.The Court’s discussions of the complaint in the two opinions make it clear that if plaintiffs had been required to articulate the specifics of the alleged failure to warn at the pleading stage, or if the Court had looked at the complaint with a more rigorous eye, the complaint would have been held preempted on motion to dismiss.  Both opinions recognize that the plaintiffs’ contention was that the FDA-approved warning about a .13% risk of clip migration was too low, and any claim requiring a different warning is a squarely preempted claim.
“Failure to Report to FDA”[Defendants] insist that because the Macks allege in nearly every count that the Defendants failed to report adverse events about the Filshie Clips to the FDA, the Macks’ claims are impermissible “fraud-on-the-FDA” claims and therefore impliedly preempted. The Court is not persuaded. [Defendants’] focus on the allegations regarding the failure to report to the FDA ignores the other allegations that do not implicate a duty owed only to the FDA: that the Defendants owed common law duties to the Macks to not negligently design, manufacture, or fail to warn the Macks about the alleged dangers of the Filshie Clips. Reading the Complaint as a whole and construing it in the light most favorable to the Macks, the allegations regarding the failure to report to the FDA do not render the Macks’ claims impliedly preempted at this stage.The Macks further claim that the Defendants failed to report to the FDA, the Macks, and the medical community “the hundreds of adverse events reports they received from patients and medical professionals of instances where the migrating Filshie Clips …. [But Plaintiffs] point to no Alabama law that parallels the federal requirement to report adverse events to the FDA nor to any federal law that requires reporting of adverse events to the Macks or the medical community. Therefore, such an assertion here under the Macks’ state law theories would impose requirements on the Defendants that are different from or in addition to the requirements imposed by the FDA. . . . This “failure to report” theory of liability recently was addressed by the Eleventh Circuit in Mink. … The Eleventh Circuit held that this theory was impliedly preempted, stating: “Because this theory of liability is based on a duty to file a report with the FDA, it is very much like the ‘fraud-on-the FDA’ claim the Supreme Court held was impliedly preempted in Buckman.” . . . The Macks do not attempt to distinguish Mink, other than to say that [Mack I] previously refused to dismiss their claims under Mink at the motion to dismiss stage. … Like they did in their opposition to the Defendants’ motion to dismiss, they argue that their Complaint was “carefully drafted” to stay within the bounds of the MDA. … Despite how they couch it, their claims are now subject to an evidentiary standard, not self-described careful drafting. As such, the Macks must actually present evidence that their failure to warn claims consist of more than a failure to report adverse events to the FDA. Here, they have failed to do so.Mack I cannot be reconciled with Mack II in its treatment of an alleged failure to report to the FDA claim.  As Mack II recognized, that is a federal law duty, and there is no Alabama law equivalent. Mack II got it right, but its discussion of pleadings-versus-evidence doesn’t explain the different outcome, nor does its discussion of the “recent” Mink decision, which (as a 2017 opinion) predated Mack I as well. The right result, but too long in coming.
Design and Manufacturing Defect[T]he Macks’ design defect and manufacturing defect claims are based on their contentions that (1) the Filshie Clips used in Mrs. Mack were “defective in design” because their “risk of harm exceed[s] their claimed benefits,” specifically as it relates to the device’s alleged migration from the implantation site, … and (2) the Filshie Clips were “unreasonably dangerous” and “failed to perform as safely as the ordinary consumer would expect, causing injury[.”] …   The Macks thus rely on “traditional state tort law which had predated the federal enactments,” see Buckman, 531 U.S. at 353, and their claims do not “implicate a duty owed to the FDA,” see Mink, 860 F.3d at 1330.[I]t appears that the Macks’ design defect claims are premised upon the theory that the Defendants failed to make adequate disclosures to the FDA of adverse event reports about migration and complications. These claims focus on the Defendants’ alleged failure to disclose adverse events to the FDA both before and after premarketapproval.  And again, this is the type of fraud-on-the-FDA claim that the Supreme Court determined was preempted in Buckman, 531 U.S. at 343-44 (footnote omitted).As above, Mack II got it right, eventually.  But it doesn’t square with Mack I, and putting the defendants through the expense of litigating to summary judgment contravenes the intent Congress had in limiting liability involving medical devices.  

So there you have it.  A good outcome in Mack II, and unanswered questions about why it took so long.

Before we close out our discussion of the Mack saga, there are two side items worth mentioning.

First, the Court also granted summary judgment for Defendants on statute of limitations grounds.  We don’t talk about statutes of limitations often because they are fact-specific, but there is a legal angle to file away in your noggin:  Under Alabama law, a cause of action accrues when the first legal injury, and the discovery rule does not apply unless there was fraudulent concealment by the defendant, or a basis for equitable estoppel.  Those of us who practice in states where plaintiffs get the benefit of the discovery rule with any vague suggestion the plaintiff didn’t know of the injury or its cause may find Alabama’s standard refreshingly more rigorous.   “[P]laintiff’s ignorance of the tort or injury, at least if there is no fraudulent concealment by defendant, [does not] postpone the running of the statute until the tort or injury is discovered.”

And second, Alabama requires proof of a feasible alternative design for a design defect claim—but the alternative has to be an alternative device, not an alternative surgical procedure.  While acknowledging that they must show a safer, practical, alternative design was available to the Defendants at the time they manufactured Filshie Clips …, the Macks fail to proffer one. Instead, they only offer alternative methods of tubal ligation. … That is not the type of evidence needed to show that a safer, practical, alternative design was available to the Defendants.