Lewis v. Johnson

• Decision Date: 15 January 2014
• Docket Number: Civil Action No. 2:12–cv–04301.
• Citation: 991 F.Supp.2d 748
• Court: U.S. District Court — Southern District of West Virginia
• Parties: Carolyn LEWIS, et al., Plaintiffs, v. JOHNSON & JOHNSON, et al., Defendants.

991 F.Supp.2d 748

Carolyn LEWIS, et al., Plaintiffs,

v.JOHNSON & JOHNSON, et al., Defendants.

Civil Action No. 2:12–cv–04301.

United States District Court, S.D. West Virginia.

Jan. 15, 2014.

David P. Matthews, Julie L. Rhoades, Matthews & Associates, Houston, TX, D. Renee Baggett, Bryan F. Aylstock, Aylstock Witkin Kreis & Overholtz, Pensacola, FL, Calle Mendenhall, Richard Arthur Freese, Freese & Goss, Birmingham, AL, Kevin L. Edwards, Peter De La Cerda, Edwards & De La Cerda, John P. Harloe, Tim K. Goss, Tamara L. Banno, Freese & Goss, Dallas, TX, Jeffrey M. Kuntz, Thomas P. Cartmell, Wagstaff & Cartmell, Kansas City, MO, for Plaintiffs.

David B. Thomas, Philip J. Combs, Susan M. Robinson, Thomas Combs & Spann, Charleston, WV, Kari L. Sutherland, Butler Snow, Oxford, MS, Christy D. Jones, Anita Modak–Truran, Laura H. Dixon, William M. Gage, Butler Snow, Ridgeland, MS, Erik W. Legg, Michael J. Farrell, Farrell White & Legg, Huntington, WV, Tracy G. Weiss, Reed Smith, Philadelphia, PA, for Defendants.

MEMORANDUM OPINION AND ORDER

(Motion in Limine No. 1, Summary Judgment Motions on 510(k) Issue)

JOSEPH R. GOODWIN, District Judge.

Pending are Plaintiffs' Motion in Limine No. 1—510(k) Clearance of the Ethicon Mesh Products by the United State Food and Drug Administration (“FDA”), or Lack of FDA Enforcement Action [Docket 124], Defendants' Motion for Partial Summary Judgment Based on Preemption of Certain Claims [Docket 128], and Plaintiffs' Motion for Partial Summary Judgment [Docket 150]. The motions are ripe for review. For the reasons set forth below, Plaintiffs' Motion in Limine No. 1 [Docket 124] is GRANTED, Defendants' Motion for Partial Summary Judgment Based on Preemption of Certain Claims [Docket 128] is DENIED, and Plaintiffs' Motion for Partial Summary Judgment [Docket 150] is GRANTED.

I. Background

A. Factual and Procedural History

This multidistrict litigation involves surgical mesh products manufactured and sold by the defendants, Ethicon, Inc. and Johnson & Johnson, Inc. (collectively “Ethicon”) to treat pelvic organ prolapse and stress urinary incontinence. One of the devices produced by Ethicon is the Gynecare TVT (“TVT”), which was implanted in the plaintiff, Ms. Lewis. The instant case is the first bellwether trial scheduled in this MDL, and trial is set to begin on February 10, 2014.

There are three motions currently before the court. The first is Plaintiffs' Motion in Limine No. 1—510(k) Clearance of the Ethicon Mesh Products by the United State Food and Drug Administration, or Lack of FDA Enforcement Action [Docket 124]. In it, the plaintiffs argue that evidence related to FDA clearance and regulation of the TVT should be excluded under Federal Rules of Evidence 402 and 403. The plaintiffs contend that because the FDA's 510(k) clearance process is not related to safety and efficacy, evidence of the clearance is irrelevant and misleading to the jury. The defendants respond that compliance with FDA regulations is relevant and admissible, that the TVT's clearance is relevant to its safety and effectiveness, and that post-clearance FDA regulation also relates to safety and effectiveness.

The second motion is Defendants' Motion for Partial Summary Judgment Based on Preemption of Certain Claims (“Defs.' Mot. for Summ. J.”) [Docket 128]. The defendants primarily argue that because the TVT is made with the same material that is in another device approved through the FDA's premarket approval process, state law tort claims related to the TVT are preempted. The plaintiffs contend that Ethicon's discussion of the premarket approval of other medical devices is irrelevant to the TVT and the case at hand.

The third motion is Plaintiffs' Motion for Partial Summary Judgment [Docket 150]. In it, the plaintiffs argue that three affirmative defenses provided for by Texas law do not apply to Ethicon. The plaintiffs state that two of the defenses fail because they speak only to products that have been approved by the FDA, and the TVT was not approved by the FDA. They also argue that a third affirmative defense does not apply because it relates only to mandatory safety regulations, and no such regulations exist in this case.

B. The FDA 510(k) Approval Process

The TVT is a Class II medical device regulated by the FDA. In order to market and sell the TVT, Ethicon went through the FDA's 510(k) clearance process. See21 C.F.R. § 807.87, 807.92, 807.93 (2012) (describing the requirements for 510(k) clearance). The 510(k) clearance process “imposes a limited form of review” on manufacturers of qualifying devices. Medtronic, Inc. v. Lohr, 518 U.S. 470, 478, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). “If the FDA concludes on the basis of the § 510(k) notification that the device is ‘substantially equivalent’ to a pre-existing device, it can be marketed without further regulatory analysis [.]” Id. This is an easier bar to pass than the FDA's rigorous premarket approval process, under which “[m]anufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission.” Id. at 477, 116 S.Ct. 2240; see also id. at 478–79, 116 S.Ct. 2240 (“The § 510(k) notification process is by no means comparable to the [premarket approval] process; in contrast to the 1,200 hours necessary to complete a [premarket approval] review, the § 510(k) review is completed in an average of only 20 hours. As one commentator noted: ‘The attraction of substantial equivalence to manufacturers is clear. Section 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed very quickly.’ ”) (internal citations omitted); Horn v. Thoratec Corp., 376 F.3d 163, 167 (3d Cir.2004) (“A manufacturer can obtain an FDA finding of ‘substantial equivalence’ by submitting a pre-market notification to the agency in accordance with Section 510(k) of the [Federal Food, Drug and Cosmetic] Act. A device found to be ‘substantially equivalent’ to a predicate device is said to be ‘cleared’ by FDA (as opposed to ‘approved’ by the agency under a [premarket approval] ). A pre-market notification submitted under Section 510(k) is thus entirely different from a [premarket approval], which must include data sufficient to demonstrate to FDA that the device is safe and effective.”) (quoting Amicus Curiae Letter Brief to the Court, filed by the FDA) (internal citations omitted) (emphasis in original).

The Supreme Court has determined that the 510(k) process is focused on equivalence with a preexisting device rather than safety, while the premarket approval process is focused on safety and efficacy. Riegel v. Medtronic, Inc., 552 U.S. 312, 323, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); Lohr, 518 U.S. at 478–79, 493, 116 S.Ct. 2240. Because of the differences in these processes, tort claims regarding medical devices cleared through the 510(k) process are not preempted by federal law, while tort claims regarding medical devices approved through the premarket approval process generally are preempted. Riegel, 552 U.S. at 321–23, 128 S.Ct. 999; Lohr, 518 U.S. at 501–02, 116 S.Ct. 2240.¹

II. Legal Standards

A. Choice of Law

Under 28 U.S.C. § 1407, this court has authority to rule on pre-trial motions. In multidistrict litigation cases such as this, the choice-of-law for these pre-trial motions depends on whether they involve federal or state law. “When analyzing questions of federal law, the transferee court should apply the law of the circuit in which it is located.” In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig., 97 F.3d 1050, 1055 (8th Cir.1996) (internal citations omitted); see also15 Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 3866 (3d ed. 2009). This is in accordance with the law in this circuit. See Bradley v. United States, 161 F.3d 777, 782 n. 4 (4th Cir.1998) (“[T]his court cannot and does not apply the law of another circuit simply because the case was transferred from the other circuit.”).

The Honorable Shira A. Scheindlin has made a similar observation that the law of the transferee circuit applies:

[C]ourts have held that the law of the transferee circuit controls pretrial issues such as whether the court has subject matter or personal jurisdiction over the action, or whether the cases should be remanded to state court because the cases were not properly removed.In re Methyl Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., 241 F.R.D. 435, 439 (S.D.N.Y.2007) (footnote omitted). Judge Scheindlin's observation, as noted in her opinion, reflects the general approach. See, e.g., In re Linerboard Antitrust Litig., No. 04 Civ. 4001, MDL 1261, 2005 WL 1625040, at *4 (E.D.Pa. July 11, 2005) (applying the law of the Third Circuit on a motion to dismiss for lack of subject matter jurisdiction); In re Bridgestone/Firestone, Inc., Tires Prods. Liab. Litig., 256 F.Supp.2d 884, 888 (S.D.Ind.2003) (applying the law of the Seventh Circuit on a motion for remand to state court). Pursuant to this doctrine and this court's Order on summary judgment motions, Texas substantive law will apply to the plaintiffs' tort claims, New Jersey law will apply to the plaintiffs' punitive damages claims, and the law of the Fourth Circuit will apply to issues of federal law.

B. Summary Judgment

To obtain summary judgment, the moving party must show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a). In considering a motion for summary judgment, the court will not “weigh the evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Instead, the court will draw any permissible inference from the underlying facts in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S....