Preemption and Recalls | Drug & Device Law

We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space.The complaints filed by such attorneys often are written as if federal preemption doesn’t exist, so our motions to dismiss start by explaining the basics of express medical device preemption, 21 U.S.C. § 360k(a) as interpreted by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and implied preemption, generally in the vein of Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  Then we detail how the plaintiffs’ causes of action seek to impose liability based on state tort law standards which are different from, or in addition to” the federal requirements imposed by the FDA through its premarket approval of the device.

The opposition briefs we receive in response tend to miss the mark.  They also generally fall into a couple of regular buckets.  The “tangent about Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)” bucket.  The “presumption against preemption” bucket.  The “but plaintiff needs discovery” bucket.

Today, we are going to talk about the “but the device was recalled” bucket.

The theme in these plaintiffs’ briefs is that preemption cannot possibly apply, because the medical device at issue was one that was recalled.  (For the less-discerning plaintiff lawyers, heck, it doesn’t even have to be the same device that was recalled.  If the company had a recall of a different model, in a different year, involving an entirely different device issue, close enough!)

Sometimes, the analysis is no deeper than “recall = plaintiff wins”.

Sometimes, the opposition suggests that because there was a recall, there must have been a violation of federal PMA requirements, and that means they have asserted one of the mythical “parallel claims” that thread the Scylla and Charybdis of express and implied preemption.

Regardless, the defense position is that the fact that a recall occurred does not necessarily change things.  If the plaintiff wants to argue their tort claim involves state law duties that are not “different from, or in addition to” federal requirements imposed through the PMA process, then they must “identify some pertinent federal regulation, a violation of that specific regulation, and sufficient facts to substantiate the allegation, including a causal link to the alleged injury.”  Womack v. Nevro Corp., 2019 U.S. Dist. LEXIS 103864, at *6 (M.D. Fla. June 21, 2019) (emphasis added).  Evidence of a defect, without evidence that the defect was the result of a violation of a federal requirement for the device, is insufficient to defeat preemption. Weber v. Allergan, Inc., 940 F.3d 1106, 1114 (9th Cir. 2019) (“district court properly granted summary judgment because [plaintiff] failed to raise a genuine dispute of material fact that [defendant] violated a federal ‘requirement’ for [its medical device]”).  Stated differently, a plaintiff cannot “rely on res ipsa loquitur” “to survive MDA preemption.”  Id. at 1109; see also Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011).

Before we go further into the preemption recall discussion, however, a few digressions.

First, remember (ha!) that the term “recall” has a specific meaning in this context that generally differs from what most lay people expect the term “recall” to mean.

To the FDA, a “recall” is any “removal or correction”—including any “repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location”—but the term “does not include a market withdrawal or a stock recovery.”  21 CFR § 7.3(g), (h).  In other words, within the medical device space, a recall might mean the manufacturer sent an “Important Medical Advice Advisory” to physicians with updated patient management information.  It certainly does not mean that the manufacturer has demanded all implanted devices be immediately explanted from patients and returned to the company.

Also remember that, from a regulatory perspective, the existence of a recall does not mean that the FDA has withdrawn its premarket approval of the device.  Withdrawing premarket approval for a device requires specific procedures and findings.  See 21 CFR § 814.46 (specifying procedure required for FDA to withdraw a PMA).  Without those, the FDA’s premarket approval remains in place.  See In re Medtronic, Inc., 592 F. Supp. 2d 1147 (D. Minn. 2009) (rejecting plaintiff’s argument that recall “invalidated” the device’s premarket approval).

Another point to remember:  Even when a device allegedly malfunctions or allegedly causes injury, that does not automatically mean that the device has a defect.  “Medical devices, even [or especially] Class III medical devices receiving rigorous premarket approval, inherently carry risks and the potential for harm to consumers.”  Gross v. Stryker Corp., 858 F. Supp. 2d 466, 499-500 (W.D. Pa. 2012).

Class III medical devices are “complex” and “can fail for a variety of reasons, including medical complications, body rejection phenomena, allergic reaction, and surgical techniques, all of which occur without someone acting in a negligent manner.”  Clark v. Medtronic, Inc., 572 F. Supp. 2d 1090, 1094-95 (D. Minn. 2008).  Indeed,

the “safety and reliability” of an implanted device “cannot be guaranteed indefinitely in the ‘extremely hostile environment of the human body,’ where myriad other factors external to the device are brought to bear.”

Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012).

Like mere evidence of malfunction or injury, evidence that a recall occurred does not amount to evidence of a defect without more.  See Christian v. Altaire Pharms., 2020 U.S. Dist. LEXIS 189231, at *13 (E.D. Ky. Oct. 13, 2020) (“Standing alone, a voluntary recall notice which fails to identify a specific contamination issue and expressly states that no product has been identified as out-of-specification does not constitute a plausible allegation of a product defect”); Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 171021, at *-9 (E.D.N.Y. July 12, 2013) (“the fact that the [device] loosened and was recalled for the same issue is merely consistent with [defendant’s] liability and stops short of the line between possibility and plausibility of entitlement to relief”) (internal citations omitted).

Now, getting back to preemption, the existence of a recall does not mean a device deviated from federal requirements.  “Many courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.”  Erickson v. Bos. Sci. Corp., 846 F. Supp. 2d 1085, 1093 (C.D. Cal. 2011). There are some good recent cases on this:

In Wilhite v. Medtronic, Inc., 2024 U.S. Dist. LEXIS 39248, *5 (N.D. Ala. Mar. 6, 2024), despite a recall of the PMA defibrillator due to a potential risk of premature battery depletion, the plaintiff’s claims were held to be expressly preempted.  In fact, the court concluded that plaintiff did not allege a parallel claim because an “oblique suggestion” of a violation of an FDA requirement is not enough.

Likewise, in Tripolskiy v. Boston Scientific Corp., 2023 U.S. Dist. LEXIS 146689, *14 (C.D. Cal. Aug. 18, 2023), that court also held that claims regarding a premarket-approved implantable cardioverter defibrillator (“ICD”) recalled due to the potential risk of premature battery depletion were expressly preempted.  This court agreed the plaintiff did not allege a parallel claim; specifically noting that a conclusory allegation that the device “did not meet federal standards, based solely on the [product]’s failure and product recalls . . . is insufficient.” Tripolskiy, 2023 U.S. Dist. LEXIS at *14 (citing Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011)).

And there are some older, also good cases on this:

• Engle v. Medtronic, Inc., 2021 WL 1318322, at *14 (W.D. Ky. April 8, 2021) (“[T]he FDA’s recall of a PMA Class-III medical device does not give rise to a claim capable of surviving federal preemption.”);
• ASEA/AFSCME Local 52 Health Benefits Tr. v. St. Jude Med., LLC, 362 F. Supp. 3d 642, 645, 650 (D. Minn. 2019) (dismissing state law claims as preempted in case involving recalled device);
• McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193, 1201 (M.D. Fla. 2013) (granting preemption motion to dismiss in case involving recalled device);

• Simmons v. Bos. Sci. Corp., 2013 U.S. Dist. LEXIS 45852, at *15-16 (C.D. Cal. Mar. 25, 2013) (preemption motion granted where device was the subject of a corrective action classified by FDA as a recall);
• Franklin v. Medtronic, Inc., 2010 U.S. Dist. LEXIS 71069, at *31 (D. Colo. May 12, 2010), report and recommendation adopted, 2010 U.S. Dist. LEXIS 61889 (D. Colo. June 22, 2010) (claim that defendant failed to warn physicians and patients of purported defect with device that was later recalled was insufficient to constitute parallel claim); and

• Gow v. Medtronic, Inc., 2010 Ky. Cir. LEXIS 4, *18-19 (Ky. Cir. Aug. 26, 2010) (a recall does not affect PMA approval; all state law claims preempted in case involving Class III device).

Claims that a manufacturer should have recalled a device sooner also are preempted by 21 U.S.C. § 360k(a).  See In re Medtronic, Inc., 592 F. Supp. 2d 1147, 1159 (D. Minn. 2009) (“claims alleging that [manufacturer] should have recalled the [device] leads sooner than it did are similarly preempted”).  They also seem to us to be a version “stop selling” claims that are subject to implied preemption.

Finally, don’t forget that recall-based theories may be improper for other reasons. “Failure to recall” claims do not exist at common law.  And evidence of a recall can be a subsequent remedial measure inadmissible pursuant to Federal Rule of Evidence 407, unless offered for another purpose like impeachment or notice