Ruberti v. Ethicon, Inc.
| Decision Date | 22 December 2022 |
| Docket Number | 2:20-CV-874-WKW [WO] |
| Parties | DEBRA RUBERTI, Plaintiff, v. ETHICON, INC. and JOHNSON & JOHNSON, Defendants. |
| Court | U.S. District Court — Middle District of Alabama |
Before the court are Plaintiff's motions in limine (Doc. # 162)[1] and Defendants' responses (Doc. # 170).[2] For the reasons discussed below Plaintiffs motions are GRANTED in part, DENIED in part, and DEFERRED in part.[3]
In her first motion in limine, “Plaintiff seeks to preclude Defendants from offering argument, testimony, or evidence of any type relating to the activities of the” U.S. Food and Drug Administration (FDA) “as it pertains to the” Gynemesh Tension-free Vaginal Tape - Obturator (TVT-O). (Doc. # 162 at 2.) Specifically, Plaintiff seeks to preclude any evidence regarding “the FDA's 510(k) ‘clearance process'” because evidence of this process is irrelevant (Fed. R. Evid. 401, 402) and unduly prejudicial (Fed. R. Evid. 403). (Doc. # 162 at 2.)
First, Plaintiff asserts that evidence of the 510(k) process is “not relevant to tort law.” (Doc. # 162 at 2 (emphasis omitted).) Plaintiff argues that FDA's 510(k) process allows products “to be marketed based solely on a finding of ‘substantial equivalence' to a product on the market prior to 1976, rather than a determination of the product's safety or efficacy.” (Doc. # 162 at 3.) “The issues in this case involve the defectiveness of design and/or the adequacy of the warnings of Defendants '” TVT-O “device and whether that product was a cause of Plaintiff's injuries.” (Doc. # 162 at 2-3.) As a result, the FDA's 510(k) clearance process is not relevant. (Doc. # 162 at 3.)
Plaintiff relies on the determinations of other courts, primarily the Multi-District Litigation (MDL) court-the United States District Court for the Southern District of West Virginia-to support her argument. The MDL court excluded “all evidence related to the FDA's 510(k) process and enforcement.” In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., No. 2:10-CV-01224, 2013 WL 3282926, at *2 (S.D. W.Va. June 27, 2013), on reconsideration in part sub nom. In re C.R. Bard, Inc., No. 2:10-CV-01224, 2013 WL 11089794 (S.D. W.Va. July 1, 2013), and aff'd in part, rev'd in part sub nom. In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prod. Liab. Litig., 810 F.3d 913 (4th Cir. 2016). In its order addressing defendant's “Motion for Clarification and Reconsideration,” the MDL court reaffirmed its exclusion of “all of the evidence related to the 510(k) process and enforcement” because, in part, such evidence was “irrelevant” under Federal Rule of Evidence 402. In re C.R. Bard, Inc., 2013 WL 11089794, at *1-2. The court found that such evidence was irrelevant because, “[u]nder United States Supreme Court precedent the FDA 510(k) process does not go to whether the product is safe and effective.” Id. at 2.
Before discussing what the cases say, an overview of the statutory scheme is required. Before an entity can introduce “into interstate commerce for commercial distribution . . . a device intended for human use,” it must submit a report to the FDA. 21 U.S.C. § 360(k). This reporting process is called the “510(k) process . . . after the number of the section in the original Act.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 478 (1996). In the report, the entity must state, in part, “the class in which the device is classified.” 21 U.S.C. § 360(k)(1). There are three classes of devices: class I, class II, and class III. 21 U.S.C. § 360c.
Class I devices are those with the lowest level of accompanying risk that can be effectively regulated by “general controls.” 21 U.S.C. § 360(a)(1)(A). Class II devices are those that “cannot be classified as class I [devices] because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device[s]” and are those that have “sufficient information to establish special controls . . . to provide such assurance.” 21 U.S.C. § 360c(a)(1)(B). Class III devices are those that do not fit into either of the first two categories and (1) are “purported or represented to be for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health” or (2) “present[] a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C).
After the entity has submitted its report, the FDA reviews the report and decides what the initial classification of the device will be. 21 U.S.C. § 360(n)(1). Any device that is introduced after May 28, 1976 “is classified in class III unless” it is (1) a device introduced before May 28, 1976 or (2) it is a device introduced after May 28, 1976, and “has been classified in class I or class II” and is “ substantially equivalent[4] to another device within such type.” 21 U.S.C. § 360c(f)(1)(A) (emphasis added). If the device is classified within class III, it must receive “premarket approval” (PMA). 21 U.S.C. §§ 360c(a)(1)(C), 360(e).[5] The TVT-O was cleared for marketing via the 510(k) process. (Doc. # 170-5.)
The Supreme Court has stated that the 510(k) process “imposes a limited form of review on every manufacturer intending to market a new device.” Lohr, 518 U.S. at 478. But in Lohr, the Court noted that the FDA had said, in relation to the device at issue, that a determination of “substantially equivalent” “should not be construed as an endorsement of the [device's] safety.” Id. at 480. Indeed, “the 510(k) process is focused on equivalence, not safety.” Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008) (quoting Lohr, 518 U.S. at 493). “[D]evices that enter the market through § 510(k) have ‘never been formally reviewed . . . for safety or efficacy.'” Riegel, 552 U.S. at 323 (quoting Lohr, 518 U.S. at 493); Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304, 1317 (11th Cir. 2017) (citations omitted) (quoting Riegel, 552 U.S. at 323); see also Huskey v. Ethicon, Inc., 848 F.3d 151, 160 (4th Cir. 2017) (citation omitted) (“[T]he 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only ‘ tangentially' examines the safety of the product going through the process.”); Brooks v. Howmedica, Inc., 273 F.3d 785, 794 (8th Cir. 2001) ().
As a result, the MDL court was correct that “the 510(k) process does not go to whether the product is safe and effective.” In re C.R. Bard, Inc., 2013 WL 11089794, at *2. But this does not automatically mean that all evidence of the 510(k) process ought to be excluded as irrelevant. The MDL court was applying Georgia law which allowed the jury to “consider compliance with federal regulations.” Id. The relevant Georgia law said that a jury could “consider proof of the manufacturer's compliance with federal or state safety standards” when determining the reasonableness of the defendant's actions. Id. at *1-2 (quoting Georgia Pattern Jury Instructions 62.670). Because a jury was allowed to consider safety regulations or statutes, the MDL court reasoned that the 510(k) process, which does not “go to whether . . . products are safe and effective,” was inapplicable and irrelevant. Id. at *2.
Here, Plaintiff seeks to exclude evidence of the 510(k) process based on the MDL court's reasoning. (Doc. # 162 at 3.) But that will not work because Alabama tort law-not Georgia tort law-governs Plaintiff's claims against Defendants. Defendants mention that the Alabama statutes implicated by this case would make evidence of the 510(k) process relevant. (Doc. # 170 at 1-3.) That may be so. But it may be true that the Alabama statutory provisions at issue are like what the MDL court applied: the jury may consider safety regulations and statutes, but the 510(k) process does not address safety and so is irrelevant. Plaintiff has provided no argument as to how or why the relevant Alabama statutes would make this evidence irrelevant. Because of this uncertainty, it is premature to decide whether this evidence is relevant.
Second, Plaintiff argues that, even if evidence of the 510(k) process was relevant, “any probative value that might be garnered through presenting this evidence would be substantially outweighed by the danger of unfair prejudice and the risk of confusing the jury” and so should be excluded under Federal Rule of Evidence 403. (Doc # 162 at 3-4.) Once again, Plaintiff heavily relies on prior determinations of the MDL court. The MDL court has repeatedly said, essentially, the following:
[E]vidence as to the FDA's 510(k) process and lack of enforcement action should be excluded under Federal Rule of Evidence 403 because of the danger of misleading the jury, confusing the issues, and unfair prejudice. . . . [I]t is abundantly clear that there would be a substantial mini-trial on the 510(k) process and enforcement should it be allowed. In short, this evidence poses a substantial risk of misleading the jury to believe that FDA 510(k) clearance might be dispositive of the plaintiffs' state law claims, and if such evidence comes in via expert testimony, the expert would effectively be offering a legal conclusion.
Bellew v. Ethicon, Inc., No. 2:13-CV-22473, 2014 WL 6680356, at *10 (S.D. W.Va. Nov. 25, 2014) (quoting In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., 2013 WL 3282926, at *2); see also Lewis v. Johnson & Johnson, 991 F.Supp.2d 748, 754 (S.D. W.Va. 2014).
The Eleventh Circuit has found that a district court did not abuse its discretion when it precluded evidence of the 510(k...
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