Opinion
CIVIL ACTION FILE NO. 1:17-CV-3181-SCJ
2019-08-14
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.
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.
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.
ORDER
HONORABLE STEVE C. JONES, UNITED STATES DISTRICT JUDGE This matter appears before the Court on Defendants' Motion to Dismiss Plaintiff's Second Amended Complaint (Doc. No. [31] ).
The Complaint, as amended , names the following entities as defendants and refers to them collectively (as "Defendants") in the pleadings: St. Jude Medical, Inc., St. Jude Medical S.C., Inc., Pacesetter, Inc. d/b/a St. Jude Medical Cardiac Rhythm Management Division and St. Jude Medical, LLC. The Court has done likewise in this Order.
I. BACKGROUND
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 ICD to the heart, known as a "lead." Id. ¶ 1.
"ICDs are used in patients who have potentially fatal heart rhythms such as ventricular fibrillation (rapid, ineffective contraction of the ventricles of the heart) and ventricular tachycardia (excessively rapid heartbeat) that are not adequately controlled with medication." Doc. No. [28], ¶ 2.
The Complaint states that the Riata and Riata ST leads are at issue in this case. Doc. No. [28], ¶¶ 19, 29. The Complaint also states that Mr. Sharp was implanted with a Riata Active Fixation Lead and a St. Jude Fortify DR ICD. Id. ¶¶ 35–36.
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, Defendants 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.
While Defendant Abbott Laboratories, Inc., is not named in the motion, the CM/ECF docket text indicates that the motion applies to said defendant as well.
The motion also contains a request for oral argument, which is DENIED in light of the comprehensiveness of the briefing and the grant of Defendants' request to file excess pages. Doc. No. [38].
II. LEGAL STANDARD
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) (beginning the 12(b)(6) analysis "by taking note of the elements a plaintiff must plead to state a claim ....") and Speaker v. U.S. Dep't. of Health & Human Servs. Ctrs. for Disease Control & Prevention, 623 F.3d 1371, 1379 (11th Cir. 2010) ("In ruling on a 12(b)(6) motion, the Court accepts the factual allegations in the complaint as true and construes them in the light most favorable to the plaintiff.") and Fed. R. Civ. P. 8(e) ("Pleadings must be construed so as to do justice.").
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]. 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 "examine whether federal law preempts the claim, either by express or implied preemption. Because preemption is a principle derived from the Supremacy Clause, U.S. Const. Art. VI, cl. 2, [the Court] must first analyze whether each claim can stand under state law, and only then decide the preemption questions where necessary." Mink, 860 F.3d at 1328 (citing Slack v. McDaniel, 529 U.S. 473, 485, 120 S.Ct. 1595, 146 L.Ed.2d 542 (2000) (explaining courts should "not pass upon a constitutional question although properly presented by the record, if there is also present some other ground upon which the case may be disposed of") (quotation omitted)).
The Court recognizes that preemption is an affirmative defense and the Eleventh Circuit has stated that "[g]enerally, the existence of an affirmative defense will not support a motion to dismiss" unless the defense appears on the face of the complaint. Quiller v. Barclays Am./Credit, Inc., 727 F.2d 1067, 1069 (11th Cir. 1984), on reh'g , 764 F.2d 1400 (11th Cir. 1985) ("Generally, the existence of an affirmative defense will not support a motion to dismiss. Nevertheless, a complaint may be dismissed under Rule 12(b)(6) when its own allegations indicate the existence of an affirmative defense, so long as the defense clearly appears on the face of the complaint."). Defendants assert that preemption is apparent on the face of the complaint (Doc. No. [31-1], p. 7) and the Court agrees.
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) ).
III. ANALYSIS
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.
A. Rule 12(b)(6)
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.
1. Manufacturing defect claims (Counts I and II)
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 omitted). "A manufacturing defect is an unintended flaw or abnormal condition that occurs during the production of the product that makes the product more dangerous than it would have been had the product been manufactured properly." Haynes v. Cyberonics, Inc., No. 1:09-CV-2700-JEC, 2011 WL 3903238, at *5 (N.D. Ga. Sept. 6, 2011) (citing Georgia pattern jury instructions). There must also be plausible allegations that show a "causal connection between the alleged ... manufacturing defect and [the] injury." Id.
In opposition to Defendants' arguments, Plaintiff asserts that "it is enough to allege that the device did not conform to PMA requirements, and that this nonconformity was the cause of the plaintiff's injury." Doc. No. [32], pp. 10, 11. Plaintiff also states that PMAs are confidential documents by which discovery is necessary to ascertain the exact provisions contain therein. Id. (citing Bausch v. Stryker Corp., 630 F.3d 546, 556 (7th Cir. 2010) ). Plaintiff further asserts that post-mortem interrogation of the device at issue revealed that "the RV to CAN arc damaged two high voltage output transistors on the electronic circuit board" and as a result, subsequent VF episodes "were aborted due to detection of possible HV circuit damage." Doc. No. [32], p. 11 (citing Doc. No. [28], ¶ 51).
The meaning of the acronyms HV, VF, RV, and CAN are not defined in the Complaint, though it appears to the Court that "HV" means "high-voltage."
Plaintiff also cites the case of Williams v. St. Jude et al., 2017 WL 11113322, 1:16-cv-04437-ELR (N.D. Ga. Oct. 19, 2017) ; however, that case is distinguishable on its facts because that case involved a different lead (a Durata lead) and there was also a published case report of the cause of the decedent's death — i.e., a specific medical finding as to the cause of death being the Durata lead. While the Complaint in the case sub judice , describes post-mortem testing, there are no allegations, as in Williams, of the medical finding as to the cause of death attributable to a manufacturing defect in the lead, only Plaintiff's conclusion as to the results of the post-mortem testing, which is not sufficient to state a claim. See e.g., Doc. No. [28], ¶¶ 52–54.
After review of the Complaint, the Court upholds Defendants' arguments and citations of authority and concludes that Plaintiff's Complaint, as amended , fails to allege facts that state a plausible claim that Mr. Sharp's lead suffered from a manufacturing defect (or that the device suffered from premature battery depletion) that caused Mr. Sharp's death—as opposed to merely alleging facts that show that the device at issue malfunctioned. The Court is unable to uphold Plaintiff's arguments and citation of non-binding authority to the contrary, as it has been recognized that "the circuits have disagreed on the degree of specificity required to establish a plausible claim." White v. Stryker Corp., 818 F. Supp. 2d 1032, 1039 (W.D. Ky. 2011). The Court also recognizes Plaintiff's arguments regarding a need for discovery; however, the Seventh Circuit case that Plaintiff relies on was published prior to the Eleventh Circuit's ruling in Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011), in which the Court indicated that "[t]o properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated." (quotations and citations omitted). In light of this authority, the Court must hold Plaintiff to a requirement of alleging facts that point to specific PMA requirement that have been violated and not wait for discovery on such matters.
Furthermore, without more, Plaintiff's argument is insufficient, because as correctly stated by Defendants, "Plaintiff offers no explanation of how she can simultaneously assert the existence of requirements purportedly found in the Riata PMA and contend that the PMA's confidentiality prevents her from ascertaining its contents." Doc. No. [37], p. 16, n.4.
2. Failure to warn claims
In their motion to dismiss, Defendants assert that Plaintiff's failure-to-warn claims fail because Georgia has adopted the learned intermediary and sophisticated-user doctrines. Doc. No. [31-1], p. 30. Defendants reference the Complaint (Doc. No. [28], ¶ 119), which cites to a 2012 published article/study of deaths associated with the Riata leads, derived from search and analysis of the FDA's Manufacturer and User Facility Device Experience ("MAUDE") database—a database that physicians use to obtain safety data on medical devices. Doc. No. [28], p. 37, ¶ 119. The article was written by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation (MHI) and is entitled "Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. " Doc. No. [28], ¶ 119. Defendants also cite to the allegations in the Complaint that show that Mr. Sharp's physician interrogated his Riata leads multiple times and discovered that there were patient safety alerts. Doc. No. [31-1], p. 30; see also id. ¶¶ 41–47. The Complaint also states that "it was known that Mr. Sharp had a recalled Riata Lead." Doc. No. [28], ¶ 47.
As stated in the Complaint, "Physicians monitor ICD devices to ensure that they are functioning correctly using a non-invasive process known as ‘interrogation.’ During an interrogation, the device is connected to a device programmer using a special wand placed on the skin over the ICD. The data is transmitted from the device to the programmer and evaluated." Doc. No. [28], p. 13, ¶ 37.
Georgia law has been summarized as follows:
Under Georgia law, "the manufacturer of a product which, to its actual or constructive knowledge, involves danger to users, has a duty to give warning of such danger." Battersby v. Boyer, 241 Ga. App. 115, 117, 526 S.E.2d 159, 162 (1999) (quoting Chrysler Corp. v. Batten, 264 Ga. 723, 724, 450 S.E.2d 208 (1994) ). "Georgia law insists that a plaintiff show that the defendant had a duty to warn, that the defendant breached that duty, and that the breach proximately caused the plaintiff's injury." Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir.2010) (quoting Wheat v. Sofamor, S.N.C., 46 F.Supp.2d 1351, 1362 (N.D. Ga. 1999) ).
An exception arises, however, in products liability cases involving a ... medical device. Dietz, 598 F.3d at 815. In those cases, Georgia courts apply the learned intermediary doctrine. Id. (quoting
McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253, 587 S.E.2d 594, 595 (2003) ). The learned intermediary doctrine provides that the manufacturer ... "does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the manufacturer." McCombs, 277 Ga. at 253, 587 S.E.2d at 595. To state a claim under Georgia law, Plaintiff must plausibly allege that Defendants failed to provide Plaintiff's physician an adequate warning of foreseeable harms associated with [the medical device]. Dietz, 598 F.3d at 815.
Henderson v. Sun Pharm. Indus., Ltd., No. 4:11-CV-0060-HLM, 2011 WL 4024656, at *4 (N.D. Ga. June 9, 2011).
In addition, under the sophisticated user doctrine, "[w]here the product is vended to a particular group or profession, the manufacturer is not required to warn against risks generally known to such group or profession." Parker v. Schmiede Mach. & Tool Corp., 445 F. App'x 231, 235 (11th Cir. 2011) (citations omitted).
The Court finds, contrary to Plaintiff's opposition arguments, that the learned intermediary and sophisticated-user doctrines are applicable to this case at the present procedural stage of the case, as demonstrated by Defendants' citation of authority. See Doc. No. [37], p. 33 (citing Rounds v. Genzyme Corp., 440 F. App'x 753, 757 (11th Cir. 2011) ; Connolly v. Sandoz Pharm. Corp., No. 2:14-CV-152-WCO, 2014 WL 12480025, at *5 (N.D. Ga. 2014) ; Presto v. Sandoz Pharm. Corp., 226 Ga. App. 547, 547, 487 S.E.2d 70, 72 (1997). Accordingly, after applying the above-stated doctrines, the Court concludes that Plaintiff has failed to state a plausible claim.
The Court recognizes Plaintiff's argument that Defendant "did not tell ... physicians that it was dangerous to leave the defective leads ... inside patients." Doc. No. [28], p. 57, ¶ 168. However, as correctly stated by Defendant under the sophisticated user doctrine, "[t]here was no need for St. Jude to warn physicians of the alleged risks of the Riata leads where those risks were well known in light of the publicly available information alleged in the Second Amended Complaint." Doc. No. [37], p. 34 (citing Doc. No. [28], ¶¶ 40–46, 101–15, 119–21, 124–42, 155–80, 182).
3. Negligence per se
In their motion to dismiss, Defendants argue that Plaintiff cannot assert a negligence per se claim based on violations of the Federal Food, Drug, and Cosmetic Act (FDCA) or the FDA's implementing regulations. Doc. No. [31-1], p. 31 (citations and quotations omitted). Defendants also assert that while Plaintiff's Complaint lists a "bevy of federal regulations to which St. Jude was purportedly subject, it fails to specify which regulations St. Jude is alleged to have violated and how it supposedly violated them with respect to Mr. Sharp's lead." Doc. No. [31-1], p. 31. Defendant further asserts that the Complaint "alleges no facts plausibly suggesting that St. Jude violated any of the regulations listed, much less facts plausibly suggesting that a violation caused Plaintiff's alleged injury." Id.
After review, the Court agrees that Plaintiff's negligence per se claim is subject to dismissal for failure to state a claim for the reasons asserted by Defendants.
The Court's failure to state a claim conclusion is determinative of this case; nevertheless, in the interest of caution, the Court considers Defendants' preemption arguments.
"Express preemption will bar state-law claims that impose on the medical device a requirement different from or additional to federal requirements." Mink, 860 F.3d at 1327.
The parallel claim principle applies here, which has been described as follows:
In order for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under [21 U.S.C.] § 360k(a), the plaintiff must show that the requirements are "genuinely equivalent." State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law.
Wolicki-Gables, 634 F.3d at 1300. "The Supreme Court established a two-pronged test ... for deciding whether state claims are preempted. First, a court must ‘determine whether the Federal Government has established requirements applicable [to the device].’ If so, ‘[the court] must then determine whether the [plaintiff's] common-law claims are based upon [state law] requirements with respect to the device that are ‘different from, or in addition to’ the federal ones, and that relate to safety and effectiveness.’ " Id. at pp. 1300–01 (citations omitted).
In their Motion to Dismiss, Defendants argue that Plaintiff's "Second Amended Complaint ... fails to do what it must to state a claim that survives express preemption: plead facts plausibly suggesting that Defendants ... violated a federal requirement in a way that both caused Mr. Sharp's death and gives rise to liability under Georgia state law." Doc. No. [31-1], p. 8.
1. Manufacturing defect claims
As stated above in Counts I and II of the Complaint, Plaintiff asserts claims for strict liability-manufacturing defect and negligence-manufacturing defect. Doc. No. [28], p. 65. Defendants assert that "[t]he purported federal requirements upon which Plaintiff bases her claims are inadequately alleged and do not exist." Doc. No. [31-1], p. 15. In support of their argument, Defendants rely on the case of Pinsonneault v. St. Jude Med., Inc., No. 12-CV-1717 PJS/JSM, 2014 WL 2879754, at *1 (D. Minn. June 24, 2014), in which at the summary judgment stage, the district court found no evidence to support similar federal requirements as Plaintiff alleges in the case sub judice. Despite Defendants' arguments to the contrary, the Court is reluctant to rely on a summary judgment case to render its ruling at the motion to dismiss stage of the case.
Defendants further argue that even if Plaintiff did plausibly suggest a PMA violation, the Complaint fails to adequately allege that any such violation caused Mr. Sharp's death. As stated above, the Court agrees that causation has been inadequately pled in this case and that the Complaint is subject to dismissal on this ground.
As for Plaintiff's allegations concerning the Mr. Sharp's ICD, Defendants recognize that Plaintiff claims that the ICD battery was subject to premature depletion, but states that Plaintiff failed to allege that the ICD battery caused Mr. Sharp's injuries, as in the causation paragraph of the Complaint (Doc. No. [28] ¶ 10), Plaintiff alleged that the "ICD failed ... because friction between the external insulation on the Riata lead and the ICD exposed wires inside the lead, causing the ICD to malfunction." Doc. No. [31-1], p. 20; Doc. No. [28], ¶ 10. Defendants also assert that it is conclusory, to state as Plaintiff did in the Complaint that the rapid battery depletion was "in violation of the PMA," without specifically stating the PMA requirements violated. Doc. No. [31-1], p. 21. Defendants also point to two places in the Complaint by which the problems with the battery indicate a "design" defect, which is preempted, as opposed to a manufacturing defect. Id. (citing Doc. No. [28], ¶¶ 181, 184).
Plaintiff also asserts that "the specific ‘design validation procedures’ set forth in 21 CFR § 820.30(g) also supports a parallel violation claim." Doc. No. [32], p. 19. However, as correctly noted by Defendants, the Complaint does not allege a violation of § 820.30(g) and the Court was unable to locate a citation to subsection (g) in the Complaint. Doc. No. [37], p. 20, n.5.
After review, the Court upholds Defendants' preemption arguments and declines to uphold Plaintiff's arguments to the contrary. The Court concludes that Plaintiff has not set forth well-pleaded factual allegations in her Complaint that establish a causal connection between any purported PMA violation and the Plaintiff's theory of the cause of Mr. Sharp's death (in the Complaint at Doc. No. [28], ¶ 10). Wolicki-Gables, 634 F.3d at 1301–02 ("These allegations do not ‘set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.’ Because the [plaintiffs] have failed to allege facts in their complaint demonstrating the presence of the elements of a parallel claim, we are persuaded that the [d]istrict [c]ourt did not err in concluding that their state common law claims were preempted."). Plaintiff has also failed to plead factual allegations that plausibly suggest that that "the particular lead Mr. Sharp received had ‘[a PMA violation of] inconsistent insulation diameters’ or that any such inconsistency, if it existed, caused" Mr. Sharp's death. Doc. No. [37], p. 24.
2. Failure to warn claims
Defendants argue that Plaintiff's claim that Defendants should have provided additional or different warnings is preempted, no matter how the arguments are construed. Doc. No. [31-1], p. 22. In support of their argument, Defendants cite the United States Supreme Court case of Riegel v. Medtronic, Inc., 552 U.S. 312, 329, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), in which the Court stated, "[s]urely this means that [federal law] would pre-empt a jury determination that the FDA-approved labeling for a pacemaker violated a state common-law requirement for additional warnings." See also Leonard v. Medtronic, Inc., No. 1:10-CV-03787-JEC, 2011 WL 3652311, at *8 (N.D. Ga. Aug. 19, 2011) ("[p]laintiffs' claim would thus impose different requirements under state law than those required under federal law. Consequently, it is preempted under [federal law, 21 U.S.C. § 360k ].").
The Court upholds Defendants' arguments and citations of authority. A review of the Complaint shows that, like the complaint in Mink, Plaintiff's "theory of liability is based on a duty to file a report with the FDA," which is "very much like" a "fraud-on-the FDA" claim and is preempted. Mink, 860 F.3d at 1330 ; see also Doc. No. [28], ¶¶ 227, 231, and 237. Contrary to Plaintiff's arguments (Doc. No. [32], p. 21), the fact that the device at issue was subject to a recall does not change the Court's conclusion. See In re Medtronic, Inc., 623 F.3d at 1205 n.4 (rejecting plaintiff's argument that defendant lost its federal preemption defense when the leads were recalled).
3. Failure to report adverse events claims
Defendants assert that "[i]f Plaintiff's theory is that St. Jude had a duty to provide [adverse events] reports directly to patients and physicians ... , the claim is expressly preempted because it ‘seeks to impose a duty to warn onto defendants that is broader and in addition to those required by federal law.’ " Doc. No. [31-1], p. 23 (citing Martin v. Medtronic, Inc., No. 115CV00994DADMJS, 2017 WL 825410, at *7 (E.D. Cal. Feb. 24, 2017) and Stengel v. Medtronic Inc., 704 F. 3d 1224, 1234 (9th Cir. 2013) (Watford, J., concurring) ("any attempt to predicate the ... claim on an alleged state law duty to warn doctors directly would [be] expressly preempted")). The Court agrees that Defendants have satisfied the two-part test for establishing preemption. See Wolicki-Gables, 634 F.3d at 1300–01 ("The Supreme Court established a two-pronged test in Riegel for deciding whether state claims are preempted. First, a court must ‘determine whether the Federal Government has established requirements applicable [to the device].’ If so, ‘[the court] must then determine whether the [plaintiff's] common-law claims are based upon [state law] requirements with respect to the device that are ‘different from, or in addition to’ the federal ones, and that relate to safety and effectiveness.’ ") (citations omitted).
C. Implied Preemption
"[I]mplied preemption prohibits state-law claims that seek to privately enforce duties owed to the FDA." Mink, 860 F.3d at 1327. To avoid express preemption, a plaintiff cannot sue only because the conduct at issue violated a federal requirement. Id. (emphasis added).
Defendants assert that Plaintiff's negligence per se claim is impliedly preempted, as Plaintiff ultimately uses Defendants' alleged violation of federal law to substantiate the existence of a state tort claim in her negligence per se cause of action. Doc. No. [31-1], pp. 26–27 (citing Markland v. Insys Therapeutics, Inc., 270 F. Supp. 3d 1318, 1331 (M.D. Fla. 2017), aff'd , 758 F. App'x 777 (11th Cir. 2018) (dismissing a plaintiff's complaint on preemption grounds after finding that plaintiff was using a violation of federal law to substantiate the existence of a state tort claim).
The Court upholds Defendants' arguments and citations of authority.
D. Derivative Claims
Because Plaintiff's loss of consortium and punitive damages claims are derivative to her other claims, the inability of Plaintiff to recover on the other claims means that these two claims fail as well. See Wheeler v. Novartis Pharm. Corp., 944 F. Supp. 2d 1344, 1354 (S.D. Ga. 2013) and Haynes v. Cyberonics, Inc., No. 1:09-CV-2700-JEC, 2011 WL 3903238, at *9 (N.D. Ga. Sept. 6, 2011).
IV. CONCLUSION
Defendants' Motion to Dismiss Plaintiff's Second Amended Complaint (Doc. No. [31] ) is hereby GRANTED .
Nothing further remaining for this Court's review, the Clerk is DIRECTED to close this case.
IT IS SO ORDERED this 14th day of August, 2019.