Sharp v. St. Jude Med., S.C., Inc.
| Decision Date | 14 August 2019 |
| Docket Number | CIVIL ACTION FILE NO. 1:17-CV-3181-SCJ |
| Citation | 396 F.Supp.3d 1250 |
| Parties | Wendy SHARP, Individually, and as Administrator of the Estate of Milton Sharp, Plaintiff, v. ST. JUDE MEDICAL, S.C., INC., St. Jude Medical, Inc., Pacesetter, Inc., d/b/a St. Jude Medical Cardiac Rhythm Management Division, St. Jude Medical LLC and Abbot Laboratories, Inc. Defendants. |
| Court | U.S. District Court — Northern District of Georgia |
Alexandra Cole, Darren W. Penn, William L. Ballard, Penn Law, LLC, Atlanta, GA, for Plaintiff.
Andrew E. Tauber, Pro Hac Vice, Mayer Brown LLP-DC, Washington, DC, Daniel L. Ring, Pro Hac Vice, Mayer Brown LLP-IL, Chicago, IL, Lucas Allen Westby, Shaniqua L. Singleton, Stephen Mann Brooks, Nelson Mullins Riley & Scarborough, LLP-ATL, Atlanta, GA, for Defendant.
This matter appears before the Court on Defendants' Motion to Dismiss Plaintiff's Second Amended Complaint (Doc. No. [31] ).1
This product liability lawsuit follows the August 23, 2015 death of Milton Sharp, who was at high risk for cardiac arrest
and who relied upon a device manufactured by Defendants to treat his serious heart condition. Doc. No. [28], ¶¶ 1, 9, and 26. The device is an implantable cardiac defibrillator ("ICD") and the wire that connects the ICD2 to the heart, known as a "lead." Id. ¶ 1.3
Mr. Sharp's wife, Wendy Sharp, as Plaintiff, brings this civil action for wrongful death, individually and in her capacity as administrator of Mr. Sharp's estate. Id. ¶¶ 14–16. Plaintiff states that on August 23, 2015, Mr. Sharp suffered a cardiac arrest
as he was driving, causing him to veer off the road. Id. ¶ 48. Plaintiff further states that the [d]evice (previously implanted in Mr. Sharp) did not work and failed to deliver the life-saving electrical shock Mr. Sharp's heart needed. Doc. No. [28], ¶ 51. Plaintiff further states that "[t]he ICD failed ... because friction between the external insulation on the Riata lead and the ICD exposed the wires inside the lead, causing the ICD to malfunction when it attempted to administer the shock." Id. ¶ 10.
Plaintiff states that her claims "arise out of the Defendants' violation of [Federal Food and Drug Administration (FDA) ] regulations, policies and procedures applicable to the testing, evaluation, manufacture, sale, recall and warnings related to this [d]evice." Id. ¶ 12. Plaintiff states that the device at issue is a Class III medical device, requiring pre-market approval (PMA) by the FDA. Id. ¶¶ 57, 64. The PMA for Defendants' device was approved in May of 1996 and March of 2002 and supplements to the PMA were also subsequently approved. Id. ¶¶ 65, 74, 76, and 77. Plaintiff asserts that representations and commitments made by Defendants during the PMA process were not true and accurate and ultimately led to the recall of the device and Mr. Sharp's death. Id. ¶¶ 51, 78.
Plaintiff's Complaint, as amended , alleges the following counts against Defendants: Strict Liability-Manufacturing Defect (Count I), Negligence-Manufacturing Defect (Count II), Strict Liability–Failure to Warn (Count III), Negligent Failure to Warn (Count IV), and Negligence Per Se (Count V), Loss of Consortium (Count VI) and Punitive Damages (Count VII). Doc. No. [28].
On October 9, 2018, Defendants4 filed a Motion to Dismiss the Second Amended Complaint, asserting that Plaintiff's claims are preempted by federal law and fail to state a claim under state law. Doc. No. [31]. The motion has been fully briefed and is now ripe for review.5
Federal Rule of Civil Procedure 8(a) requires a complaint to contain a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Pleadings do not require any particular technical form. Fed. R. Civ. P. (8)(d)(1). However, labels, conclusions, and formulaic recitations of the elements of the case of action "will not do." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007).
Pursuant to Federal Rule of Civil Procedure 12(b)(6), a defendant may move to dismiss a complaint for failure to state a claim upon which relief may be granted. Fed. R. Civ. P. 12(b)(6).
"To decide whether a complaint survives a motion to dismiss, [courts] use a two-step framework." McCullough v. Finley, 907 F.3d 1324, 1333 (11th Cir. 2018). First, the court identifies "the allegations that are ‘no more than conclusions," [as] [c]onclusory allegations are not entitled to the assumption of truth. Id. (citations omitted). "Second, after disregarding conclusory allegations, [the Court] assume[s] any remaining factual allegations are true, [identifies the elements that the plaintiffs must plead to state a claim] and determine[s] whether those factual allegations ‘plausibly give rise to an entitlement to relief.’ " Id.; see also Ashcroft v. Iqbal, 556 U.S. 662, 675, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) () and Speaker v. U.S. Dep't. of Health & Human Servs. Ctrs. for Disease Control & Prevention, 623 F.3d 1371, 1379 (11th Cir. 2010) () and Fed. R. Civ. P. 8(e) ().
A complaint will be dismissed for failure to state a claim only if the facts as pled do not state a claim that is plausible on its face. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 ; Twombly, 550 U.S. at 555–56, 127 S.Ct. 1955. In order to state a plausible claim, a plaintiff need only plead "factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. "Asking for plausible grounds ... does not impose a probability requirement at the pleading stage; it simply calls for enough fact to raise a reasonable expectation that discovery will reveal evidence of [the claim]." Twombly, 550 U.S. at 556, 127 S.Ct. 1955.
"[W]hile notice pleading may not require that the pleader allege a specific fact to cover every element or allege with precision each element of a claim, it is still necessary that a complaint contain either direct or inferential allegations respecting all the material elements necessary to sustain a recovery under some viable legal theory." Fin. Sec. Assur., Inc. v. Stephens, Inc., 500 F.3d 1276, 1282–83 (11th Cir. 2007) (quotations omitted).
As stated above, in their motion to dismiss, Defendants assert that Plaintiff's claims are expressly and impliedly preempted by federal law and fail to state a claim under state law. Doc. No. [31].6 In accordance with Eleventh Circuit authority, the Court will first evaluate whether each claim was properly pled under Georgia law. Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327–28 (11th Cir. 2017). Then, the Court will Mink, 860 F.3d at 1328 ().
Express preemption and implied preemption, "operating in tandem, have created what some federal courts have described as a ‘narrow gap’ for pleadings." Mink, 860 F.3d at 1327 (citing In re Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010) (quotation omitted)). "To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption)." Mink, 860 F.3d at 1327. "Putting these ideas into practice, the Seventh Circuit says a plaintiff may proceed on her claim so long as she claims the ‘breach of a well-recognized duty owed to her under state law’ and so ‘long as she can show that she was harmed by a violation of applicable federal law.’ " Id. (citing Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010) ).
The Court's analysis is divided into three parts. First, the Court considers whether Plaintiff's Complaint, as amended , states a claim under Rule 12(b)(6). Second, the Court considers Defendants' express preemption arguments and third, the Court considers Defendants' implied preemption arguments.
As stated above, Plaintiff's Complaint, as amended , alleges various counts of manufacturing defects (Counts I and II), failure to warn (Counts II, III, and IV), and negligence per se (Count V) for which Defendants have raised failure to state a claim arguments.
In their Motion to Dismiss, Defendants assert that Plaintiff has failed to adequately plead a defect in the product and a causal link between the manufacturing defect and her injury. More specifically, Defendants assert that "[a]bsent facts plausibly suggesting that ‘the particular [lead] that was implanted in [Mr. Sharp] was defective’ and as a result failed in a manner that caused his death, the Complaint does ‘not come close to alleging facts sufficient to ‘raise a right to relief above the speculative level.’ " Doc. No. [31-1], p. 29.
"The sine qua non of a products liability claim, regardless of whether the plaintiff proceeds under a theory of strict liability or negligence, is a defect in the product." Boswell v. OHD Corp., 292 Ga. App. 234, 235, 664 S.E.2d 262, 263 (2008) (citations...
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