MEMORANDUM OPINION
CHRISTOPHER J. BURKE, 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 II"), 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 Protégé, 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 3; see also id. at 11-12, 17) The Court agrees.
Federal Rule of Civil Procedure 12(g)(2) states that: "[e]xcept as provided in Rule 12(h)(2) or (3), a party that makes a motion under this rule must not make another motion under this rule raising a defense or objection that was available to the party but omitted from its earlier motion." Fed. R. Civ. P. 12(g)(2). When St. Jude filed its previous motion to dismiss the FAC, it could have made these same two arguments for dismissal (regarding a claim that was the same in substance in that complaint), as even its counsel acknowledged during oral argument here. But it did not. Thus, pursuant to Rule 12(g)(2), St. Jude should not be allowed to raise these previously-available arguments in a subsequent Rule 12(b)(6) motion. See Leyse v. Bank of Am. Nat'l Ass'n, 804 F.3d 316, 320-22 & n.5 (3d Cir. 2015) (finding that when defendant filed a second Rule 12(b)(6) motion to dismiss asserting that the plaintiff lacked statutory standing, but where defendant could have and did not raise such a defense in its prior Rule 12(b)(6) motion, the district court committed "error" in nevertheless considering that statutory standing argument); Sunoco Partners Mktg. & Terminals L.P. v. Powder Springs Logistics, LLC, Civil Action No. 17-1390-LPS-CJB, (D.I. 322 at 5-7) (D. Del. Aug. 7, 2019) (finding a motion to dismiss waived as to certain claims because the original complaint contained those claims, but defendant's prior motion to dismiss that original complaint did not seek to dismiss those claims) (citing cases).3 Therefore, St. Jude's Motion with respect to Plaintiffs' negligent manufacturing claim is denied.
B. Failure to Warn
As noted above, in Freed II, the Court found Plaintiffs' failure to warn claim to be insufficiently pleaded because "Plaintiffs did not adequately plead a causal nexus between St. Jude's alleged failure to report adverse events (on the one hand) and Mrs. Freed's injuries (on the other." (D.I. 34 at 27) To that end, the FAC did not "allege that had St. Jude reported certain adverse events to the FDA, this information would have reached Mrs. Freed's physicians (and ultimately her) and would have impacted Mrs. Freed's decision to have the SCS device implanted in her body[,]" nor did it "explain how the reporting of such adverse events to the FDA would have prompted the FDA to take an action that would have made the information available to Mrs. Freed and her physician." (Id.) In their SAC, Plaintiffs added the following new allegations relevant to causation:
34. Upon information and belief the FDA publishes reports of adverse events and [reports made pursuant to Medical Device Reporting requirements] in a searchable database for use by the general public including physicians and patients. This reporting serves to notify the public of a potential problem with a device so the informed person can avoid the hazard or develop a solution to address it....
76. In the event that St. Jude had properly informed or notified the FDA of the SCS devices' hazards/risks/defects Mrs. Freed and/or her physicians would have learned about them and either chosen to implant a different neurostimulation system or taken steps to avoid the use of the SCS device in a specific manner or environment that created the risk of harm.
(D.I. 39 at ¶¶ 34, 76 (emphasis omitted))4
Notwithstanding these additional allegations, St. Jude argues that Plaintiffs still fail to adequately plead sufficient facts relating to the causation element for the SAC's failure to warn claim, and that the claim should therefore be dismissed with prejudice. (D.I. 43 at 12-15; D.I. 48 at 4-6) During oral argument, St. Jude's counsel primarily argued that Plaintiffs' causation allegations remain deficient because the adverse events that Plaintiffs allege St. Jude had a duty to report pursuant to federal requirements (i.e., the various past recalls involving the Genesis and Eon family of neurostimulator devices) do not involve the Protégé, and instead were related to other previous products (i.e., the Eon Mini neurostimulation device). Indeed, St. Jude's counsel acknowledged that if this was a case relating to an Eon device, Plaintiffs' allegations with respect to causation would be at least "closer" to nudging over the line of plausibility.
However, this argument—that the allegations regarding causation are insufficient because they relate to the wrong products—was not clearly and explicitly raised in St. Jude's briefing on the Motion. (D.I. 43 at 12-15; D.I. 48 at 4-6) Therefore, St. Jude has waived this argument for purposes of this Motion. See, e.g., In re La Paloma Generating Co. LLC, Civ. No. 17-1697-LPS, Civ. No. 19-17-LPS, 2019 WL 4674865, at *11 (D. Del. Sept. 24, 2019); Horatio Washington Depot Techs. LLC v. TOLMAR, Inc., Civil Action No. 17-1086-LPS, 2018 WL 5669168, at *7 n.4 (D. Del. Nov. 1, 2018).
Nevertheless, even were the Court to consider the merits of that argument here (along with the other arguments as to lack of causation made in St. Jude's briefing) the Court would still conclude that Plaintiffs have set out just enough facts to establish a plausible claim for relief. That is, Plaintiffs' allegations are sufficient to plausibly allege a causal nexus between St. Jude's alleged failure to report adverse events and Mrs. Freed's injuries. In this regard, the SAC alleges that:
(1) The FDA publishes reports of adverse events in a searchable database for use by the general public, including physicians and patients, and this database serves to notify the public of potential problems with a device, (D.I. 39 at ¶ 34);
(2) Plaintiffs did internet research regarding the Protégé and other devices before deciding to proceed with permanent implantation of the Protégé device, (id. at ¶ 37); and
(3) If St. Jude had properly informed the FDA of the hazards, risks and defects associated with the device (i.e., those associated with the recalls of certain St. Jude products), Mrs. Freed and/or her physicians would have learned about them and taken appropriate steps to avoid the risk of harm associated with the device, (id. at ¶ 76).
And while it is true that Plaintiffs' allegations with respect to the recall history relate to the Eon Mini device, (id. at ¶ 27), Plaintiffs further allege that on March 21, 2014, the FDA approved a St. Jude PMA supplement, the effect of which was to simply change the name of the "Eon Mini" device to the "Protégé" device, and to implement certain software modifications related to this name change, (id. at ¶ 23; D.I. 45 at 9 n.9).5 Taking all of this into account: (1) if adverse event reports regarding the allegedly defective components of the Eon Mini device at issue had been inputted into the FDA's database prior to Mrs. Freed's initial implantation procedure in 2014;6 and (2) if it is true (as Plaintiffs assert) that the Eon Mini device and the Protégé device were mechanically identical (and that the March 2014 FDA supplemental PMA action was focused on simply approving a name change to the product); then (3) it seems plausible that Mrs. Freed (whom we know was doing internet research on the Protégé device prior to her 2014 operation) and/or her physicians might have seen indication of such adverse events online in 2014, might have connected them to the Protégé device, and might thus have declined to go forward with implantation of the Protégé device in that year or thereafter.
It certainly would have been better for Plaintiffs had their new allegations in the SAC relating to causation been more robust. But nevertheless, construing Plaintiffs' allegations in the light most favorable to them (as the Court must at this nascent stage of the case), it is plausible that St. Jude's alleged failure to warn the FDA (and therefore Mrs. Freed) about alleged hazards, risks and defects relating to the device at issue could have caused Mrs. Freed's injuries.7 Therefore, St. Jude's Motion with respect to Plaintiffs' failure to warn claim is denied.
III. CONCLUSION
For the reasons set out above, the Court DENIES the Motion.
An appropriate Order follows.
