When You Don’t Have a Preemption Defense, What Then? Pick a Path or Your Poison

Favorable developments in the last two decades have made the legal doctrine of preemption a leading defense in pharmaceutical and medical device litigation involving products that have been approved by the Food and Drug Administration (FDA). See, e.g., Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019); Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). There is, however, a large category of medical devices that comes to market under the 510(k) premarket notification process whereby the FDA clears the device after finding it is as safe and effective as—i.e., substantially equivalent to—a legally marketed device. See 21 U.S.C. § 360c(i). The availability of “510(k) preemption” continues to be uncertain, although some conceptual legal inroads to establish impossibility preemption of state law tort claims based on 510(k) clearance have been made. Compare Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), with Sikkelee v. Precision Airmotive Corp., 822 F.3d 680 (3d Cir. 2016) (applying impossibility preemption recognized in Mensing and Bartlett to design defect claims in aircraft governed by Federal Aviation Act regulations), and Kelsey v. Alcon Labs., Inc., 2019 WL 1884225 (Utah Dist. Ct. Apr. 22, 2019) (finding state law manufacturing and design claims against 510(k)-cleared contact lens solution preempted). But even in the absence of a preemption defense, medical device manufacturers can attempt to take advantage of their compliance with federal regulations to defend against product liability claims.

Statutory Bases for Rebuttable Presumptions

More than a dozen states (Arizona, Arkansas, Colorado, Florida, Indiana, Kansas, Michigan, New Jersey, North Carolina, North Dakota, Tennessee, Texas, Utah, and Wisconsin) have enacted statutes stating that evidence of compliance with regulations or government rules creates a rebuttable presumption that the product is not defective or the manufacturer is not negligent. Some of these statutes also recognize a rebuttable presumption against an award of punitive damages in products liability cases—the logic being that reasonable compliance with regulatory requirements defeats the wantonness or willfulness required for a punitive damages finding. See, e.g., N.J. Stat. Ann. § 2A:58C-5; McDarby v. Merck & Co., 949 A.2d 223 (N.J. Super. Ct. App. Div. 2011). Others create a rebuttal presumption against any liability. For example, according to Florida’s “government rules defense,” there is a rebuttable presumption that the product is not defective and the manufacturer is not liable if (1) the defendant demonstrates that the aspect of the product that allegedly caused the harm complied with federal or state regulations relevant to the event causing the injury; (2) the regulations are designed to prevent the injury that allegedly occurred, i.e., for safety; and (3) compliance is required to market the product. See Fla. Stat. Ann. § 768.1256(1). The Florida statute also creates the converse rebuttable presumption—that the product is defective and the manufacturer liable—if the product does not comply with applicable regulations relevant to the event causing injury. Fla. Stat. Ann. § 768.1256(2).

510(k) Clearance and Rebuttable Presumptions

Some courts have recognized that FDA 510(k) clearance is the type of government rules compliance that should create the rebuttable presumption. See, e.g., Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *2–3 (N.D. Tex. Mar. 23, 2015) (finding that 510(k) clearance gave rise to rebuttable presumption under Tex. Civ. Prac. & Rem. Code § 82.008). Recently, more courts—largely linked to the pelvic mesh litigation—have found otherwise. These decisions follow the misinterpreted language of Medtronic, Inc. v. Lohr, 518 U.S. 470 (1998), that the 510(k) process is less rigorous in terms of safety than the premarket approval process. First, the Supreme Court drew that distinction for the purpose of analyzing express preemption. The Supreme Court did not hold that the 510(k) process has no bearing on a device’s safety and effectiveness. Rather, the Lohr Court recognized that “the FDA may examine § 510(k) applications . . . with a concern for the safety and effectiveness of the device. . . .” Id. at 493. Lest there be any doubt, the Court clarified in Buckman “the FDA simultaneously maintains the exhaustive PMA [premarket approval] and the more limited § 510(k) processes in order to ensure . . . that medical devices are reasonably safe and effective. . . .” Buckman, 531 U.S. at 349–50.

It appears that some courts have become hung up on whether 510(k) clearance is conclusive as to the issue of safety and involves the same level of scrutiny as premarket approval, with its corresponding preemptive effect. While the 510(k) process is admittedly not as detailed as premarket approval, the FDA itself believes that the 510(k) premarket notification process does involve an examination of the safety of the device. See Ctr. for Devices & Radiologic Health, CDRH Preliminary Internal Evaluations—Volume I: 510(k) Working Group Preliminary Report and Recommendations 34 (Aug. 2010) (explaining that the “multifaceted premarket review process . . . is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness”); U.S. Dep’t of Health & Human Servs. et al., Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], at 6 (2014) (explaining that “the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review”). As one court observed, the “[Safe Medical Devices Act of 1990] did introduce safety and effectiveness considerations into 510(k) review,” even if the standard for those considerations is only comparative. In re Bard IVC Filters Prods. Liab. Litig., 2017 WL 5625547, at *7 (D. Ariz. Nov. 22, 2017).

But some courts have used Lohr’s language to hold that the 510(k) process does not relate to safety at all and therefore cannot serve as the predicate for a rebuttable presumption of non-defectiveness. For instance, in Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 757 (S.D. W. Va. 2014), the pelvic mesh MDL court relied heavily on the Supreme Court’s statement in Lohr that “the 510(k) process is focused on equivalence, not safety[,]” in excluding evidence of 510(k) clearance and rejecting the defendant’s attempt to rely on the Texas government rules defense. Other courts have followed that MDL court’s logic. See, e.g., Ohall v. Boston Sci. Corp., 2020 WL 5513341, at *2 (M.D. Fla. Sept. 14, 2020) (denying summary judgment and holding 510(k) clearance does not give rise to rebuttable presumption under Florida law); Kaiser v. Johnson & Johnson, 2018 WL 1358407, at *2–3 (N.D. Ind. Mar. 16, 2018) (excluding evidence of 510(k) clearance for purposes of rebuttable presumption under Indiana law); Eghnayem v. Boston Sci. Corp., 873 F.3d 1304 (11th Cir. 2017) (same under Florida law); Tingey v. Radionics, 193 F. App’x 747, 755 (10th Cir. 2006) (same under Utah law); Adams v. Boston Sci. Corp., 177 F. Supp. 3d 959 (S.D. W. Va. 2016) (same under Texas law); Williams v. Boston Sci. Corp., 2016 WL 1448860, at *3 (S.D. W. Va. Apr. 12, 2016) (same under Wisconsin law); Winebarger v. Boston Sci. Corp., 2015 WL 5567578, at *5–7 (W.D.N.C. Sept. 22, 2015) (same under North Carolina law).

Admissibility of 510(k) Clearance

Other courts have gone even further, extending that rationale to hold that the fact of 510(k) clearance is not even admissible at trial, including to rebut evidence of willfulness justifying punitive damages. See, e.g., Cisson v. C.R. Bard, Inc., 810 F.3d 913, 919–23 (affirming trial court’s exclusion of evidence of 510(k) clearance at trial as more prejudicial than probative). Other courts correctly go the other way. See, e.g., Keen v. C.R. Bard, Inc., 2020 WL 4818801 (E.D. Pa. Aug. 19, 2020); In re Cook Med., Inc. IVC Filters Mktg., Sales Practices & Prod. Liab. Litig., 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018); In re Bard IVC Filters Prods. Liab. Litig., 289 F. Supp. 3d 1045 (D. Ariz. 2018); James M. Beck, “FDA Device Clearance—Clearly Relevant,” Drug & Device Law (July 5, 2013). And at least one MDL court has ruled inconsistently on the issue multiple times: “One of the recurring issues in this multi-district litigation that has perplexed the Court is whether evidence that Mentor’s product was approved by the FDA during the 510(k) clearance process should be admitted. The issue has apparently been so perplexing that the Court’s resolution of it has been inconsistent.” In re Mentor Corp. ObTape Transobturator Sling Prod. Liab. Litig., 2015 WL 7863032, at *5–6 (M.D. Ga. Dec. 3, 2015) (noting that the court excluded evidence of 510(k) clearance in the first bellwether trial, admitted it with a limiting instruction in the second, and then excluded it again in third trial—not surprisingly, with varying verdicts).

The tension “perplexing” the courts appears to arise somewhat depending on how the defendant frames the 510(k) clearance issue—as a regulatory process proving safety or as merely some evidence of the manufacturer’s reasonable conduct and state of mind. Courts excluding evidence of 510(k) clearance have balked at the concept of substantial equivalence being misrepresented as a conclusive finding of safety by the FDA. See Lewis, 991 F. Supp. 2d at 754 (“Evidence regarding the 510(k) process poses a substantial risk of misleading the jury and confusing the issue. . . . Admission of any evidence regarding the 510(k) process runs the risk of misleading the jury to believe that FDA 510(k) clearance might be dispositive of the plaintiffs’ state law claims.”). Courts allowing it seem to have been comfortable with it being introduced along with other non-dispositive evidence of a defendant’s use of ordinary care in designing, manufacturing, and marketing a product. See, e.g., Musgrave v. Breg, Inc., 2011 WL 4620767, at *3 (S.D. Ohio Oct. 3, 2011) (“Plaintiffs may argue about what [the 510(k) process] means, but they cannot keep the jury from hearing the fact that the FDA cleared [the product], and that Breg understood” what clearance meant); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012) (finding that defendant’s compliance with FDA regulations is relevant to negligence claim); Hegna v. E.I. du Pont de Nemours & Co., 806 F. Supp. 822, 830 (D. Minn. 1992) (“FDA regulation and compliance” for Class II implantable device is “evidence, although not conclusive, of the reasonableness of a party’s actions”).

Carefully Picking Your Path

In cases involving Class II or Class III devices cleared under section 510(k), defendants should carefully weigh how best to use such evidence. Go for the home run by arguing that 510(k) clearance demonstrates the device’s safety? Or consider whether admissibility of 510(k) clearance at trial, even with a limiting instruction, is the better path.

With respect to the states that have enacted rebuttable presumption statutes, courts have used the sometimes vague wording of the statutes to wiggle out of accepting 510(k) clearance as satisfying the statutes’ requirements. For example, Texas Civil Practice and Remedies Code section 82.008(a) refers to “mandatory safety standards or regulations.” Section 82.008(c), however, refers to “pre-market licensing or approval” “after full consideration of the product’s risks and benefits.” The Lewis court rationalized that 510(k) clearance did not relate to safety and was not a full consideration of the product’s risks and benefits, which would be more akin to the premarket approval process. Lewis, 991 F. Supp. 2d at 761–62. If these states’ legislatures intend for 510(k) clearance to trigger the rebuttable presumption, using clear language that premarket notification or “clearance” is sufficient may give manufacturers more refuge from skittish courts.