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Freed v. St. Jude Medical, Inc.

United States District Court, D. Delaware

October 11, 2019

KATHLEEN M. FREED and RICHARD FREED, Plaintiffs,
v.
ST. JUDE MEDICAL, INC., ST. JUDE MEDICAL S.C., INC., and ADVANCED NEUROMODULATION SYSTEMS, INC., d/b/a ST. JUDE MEDICAL NEUROMODULATION DIVISION, Defendants.

          David G. Culley, TYBOUT, REDFEARN & PELL, Wilmington, DE, Attorney for Plaintiffs.

          Brian M. Rostocki and Benjamin P. Chappie, REED SMITH LLP, Wilmington, DE; J. David Bickham, REED SMITH LLP, San Francisco, CA; Lisa M. Baird, REED SMITH LLP, Miami, FL; Michael K. Brown, REED SMITH LLP, Los Angeles, CA, Attorneys for Defendants.

          MEMORANDUM OPINION

          BURKE, UNITED STATES MAGISTRATE JUDGE.

         Plaintiffs Kathleen M. Freed and Richard Freed ("Plaintiffs" or "the Freeds") bring this products liability action against Defendants St. Jude Medical, Inc., St. Jude Medical S.C., Inc., Abbott Laboratories, Inc. and Advanced Neuromodulation Systems, Inc., d/b/a St. Jude Medical Neuromodulation Division (collectively, "St. Jude" or "Defendants"). Presently before the Court is St. Jude's "Motion to Dismiss Plaintiffs' Second Amended Complaint[, ]" filed pursuant to Federal Rule of Civil Procedure 12(b)(6) (the "Motion"). (D.I. 42) For the reasons that follow, the Court DENIES St. Jude's Motion.

         I. BACKGROUND AND STANDARD OF REVIEW

         The Court here writes primarily for the parties, who are well familiar with the issues in this case. The Court has previously provided an overview of the relevant background regarding this matter in its February 1, 2019 Memorandum Opinion (hereinafter, "Freed IF), and incorporates that summary herein by reference. (D.I. 34 at 2-5) The Court will only set out additional background facts as needed, in light of the current case posture.

         After the Court granted-in-part and denied-in-part St. Jude's Motion to Dismiss the First Amended Complaint ("FAC") in Freed II, [1] Plaintiffs filed their Second Amended Complaint ("SAC") on April 9, 2019. (D.I. 39)[2] In lieu of filing an Answer, on May 9, 2019, St. Jude filed the instant Motion. (D.I. 42) The Motion was fully briefed on June 18, 2019, (D.I. 48), and the Court heard oral argument on the Motion on October 8, 2019.

         The Court additionally incorporates by reference the legal principles regarding motions to dismiss filed pursuant to Federal Rule of Civil Procedure 12(b)(6), and those regarding the legal doctrine of preemption, all of which were also set out in Freed II. (D.I. 34 at 5-12)

         II. DISCUSSION

         The Court will address St. Jude's arguments with respect to Plaintiffs' negligent manufacturing claim and failure to warn claim in turn.

         A. Negligent Manufacturing

         With respect to their negligent manufacturing claim, Plaintiffs allege in the SAC that, inter alia: (1) St. Jude manufactured and/or sold a variety of spinal cord stimulator devices ("SCS device(s)") with components including batteries that were defective and that caused injury to patients like Mrs. Freed, (D.I. 39 at ¶ 83); (2) St. Jude has conducted recall campaigns in the past for various such devices and their components, including batteries, (id, at ¶¶ 27, 84); and (3) St. Jude manufactured and/or sold to Mrs. Freed an SCS device that was adulterated or that was otherwise nonconforming with certain identified good manufacturing practices ("GMPs") required by the FDA, (id. at ¶¶ 81 (citing 21 U.S.C. § 351), 85; see also id, at ¶ 35 (citing 21 C.F.R. §§ 820.90(a), 820.100(a)(3)). Importantly, Plaintiffs made these same allegations in their FAC. (See, e.g., D.I. 19 at ¶¶ 12, 16, 48, 50-52) Indeed, at oral argument, St. Jude's counsel acknowledged that in substance, Plaintiffs' negligent manufacturing claim in their SAC is the same as it was in their FAC.

         Nevertheless, in the instant Motion, St. Jude asserts that Plaintiffs' negligent manufacturing claim should now be dismissed with prejudice for two reasons. First, St. Jude argues that the recalls that Plaintiffs rely upon cannot support a viable claim for negligent manufacturing, sufficient to survive the affirmative defense of preemption, because those recalls relate to prior devices (i.e., the Genesis and Eon family of neurostimulator devices) with different FDA Premarket Approvals ("PMAs") that predate the March 2014 PMA for the Protege, the device at issue. (D.I. 43 at 9-11; D.I. 48 at 2-3) Second, St. Jude argues that Plaintiffs' reliance on GMP regulations cannot serve as the basis for a federal violation sufficient to survive preemption, because such GMPs are vague and open-ended, and thus create standards that are different from, or in addition to, those required by federal requirements. (D.I. 43 at 15-16; D.I. 48 at 6-9) St. Jude did not raise either of these arguments in its prior Motion to Dismiss the FAC. (See D.I. 34 at 33 n.20; D.I. 43 at 15 n.5; D.I. 48 at 9-10)

         Plaintiffs respond that these two arguments "should have been raised in [Defendants'] Motion to Dismiss the FAC" but were not, and therefore "have been waived by Defendants" at this Rule 12(b)(6) stage. (D.I. 45 at ...


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