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Freed v. St. Jude Medical, Inc.

United States District Court, D. Delaware

February 1, 2019


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

          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, Attorneys for Defendants.



         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' Amended Complaint[, ]" filed pursuant to Federal Rule of Civil Procedure 12(b)(6) (the "Motion"). (D.I. 20) For the reasons that follow, the Court GRANTS-IN-PART St. Jude's Motion.

         I. BACKGROUND

         A. Factual Background

         St. Jude manufacturers a variety of medical devices, including the Protege 16-Channel IPG Spinal Cord Stimulator Catalogue Number 3789, Lot Number 4699346 (hereinafter, "the SCS device"). (D.I. 19 (hereinafter, "First Amended Complaint" or "FAC") at ¶ 7) The SCS device is implanted in patients suffering from chronic lower back and lower extremity pain. (Id.)

         In 2001, following the submission of a premarket approval ("PMA") application and review, the United States Food and Drug Administration ("FDA") issued an approval for the commercial distribution of the Genesis and Eon Family of Neurostimulation (IPG) Systems, manufactured by St. Jude. (Id. at ¶ 8)[1] In March 2014, the FDA issued an approval to change the name of a device in this family, the Eon Mini IPG, to the Protege Model 3789 (i.e., the SCS device). (Id. at¶ll)

         Mrs. Freed has suffered from chronic lower back and left lower extremity pain since before October 17, 2014. (Id. at ¶ 17) She has received various surgical and non-surgical treatments providing only modest overall relief of her pain. (Id.) On or about July 14, 2014, Mrs. Freed underwent a trial placement of an SCS device. (Id. at ¶ 18) A St. Jude representative was present during the procedure, and this representative told Mrs. Freed that she would be "very happy" with the SCS device. (Id.) Mrs. Freed's physician subsequently recommended that Mrs. Freed undergo surgery to have an SCS device permanently implanted for management of her chronic pain. (Id.) After conducting internet research (including on St. Jude's website) regarding the SCS device and alternative devices, Plaintiffs decided that Mrs. Freed would proceed with permanent implantation of the SCS device in her body. (Id.)

         On October 17, 2014, Mrs. Freed underwent the implantation procedure at Christiana Hospital in Newark, Delaware. (Id. at ¶ 19) Dr. Kennedy Yalamanchili surgically implanted the neurostimulator and battery components of the SCS device in the soft tissues of Mrs. Freed's left buttocks. (Id.) A St. Jude representative was present at Christiana Hospital during the procedure. (Id.) Thereafter, Mrs. Freed met regularly with representative(s) of St. Jude and her physician(s) regarding the SCS device's performance. (Id. at ¶ 20)

         On or about June 12, 2015, Mrs. Freed underwent further exploratory and fusion surgery on her lumbar spine by Dr. Yalamanchili at Christiana Hospital. (Id. at ¶ 21) Shortly thereafter, Dr. Yalamanchili prescribed the use of a bone growth stimulator to assist the healing process. (Id.)

         When Mrs. Freed began using the bone stimulator, she experienced discomfort in her left buttocks where the neurostimulator and battery components of the SCS device had been implanted. (Id. at ¶ 22) The discomfort progressed such that the SCS device began giving off severely painful electrical shocks and a burning sensation throughout her left buttocks. (Id.) Mrs. Freed stopped using the SCS device. (Id.) On August 5, 2015 she went to the Emergency Department at the Easton Hospital in Easton, Maryland due to persistent severe burning pain in her left buttocks. (Id.) Mrs. Freed spoke to a St. Jude representative present at the Emergency Department. (Id.)

         Mrs. Freed then consulted with Dr. Yalamanchili and a St. Jude representative, and a medical decision was made to surgically remove the SCS device. (Id. at ¶ 23) On August 17, 2015, Dr. Yalamanchili performed the surgery at the Upper Bay Surgery Center in Elkton, Maryland. (Id.) A representative of St. Jude was present, and took possession of the neurostimulator and battery components that had been removed. (Id.) Plaintiffs allege that Mrs. Freed has experienced and will continue to experience severe pain and suffering and emotional distress due to the implementation of the SCS device into her body. (See, e.g., Id. at ¶ 37)

         B. Procedural History

         Plaintiffs filed a Complaint in the Superior Court of the State of Delaware that was removed to this Court on August 11, 2017; that Complaint asserted state law claims for injuries allegedly sustained as a result of the implementation of the SCS device. (D.I. 1) With the case now in this Court, St. Jude moved to dismiss Plaintiffs' Complaint, arguing that, inter alia, Plaintiffs' state law claims are preempted by federal law. (D.I. 4; D.I. 5) On September 15, 2017, United States District Judge Mark A. Kearney[2] granted St. Jude's motion without prejudice to Plaintiffs' ability to file an amended complaint. Freed v. St. Jude Medical, Inc., CIVIL ACTION NO. 17-1128, 2017 WL 4102583 (D. Del. Sept. 15, 2017) (hereinafter, 'Treed i").[3] On that same date, the parties jointly consented to the Court's authority to conduct all proceedings in this case, including trial, the entry of final judgment, and all post-trial proceedings. (D.I. 18)

         On October 2, 2017, Plaintiffs filed the currently operative First Amended Complaint ("FAC"). (D.I. 19) In the FAC, Plaintiffs have asserted claims under Delaware law for breach of express warranty (Count I), breach of implied warranties of merchantability and fitness for a particular purpose (Counts II and III, respectively), the manufacture and/or sale of a dangerous chattel (Count IV), and loss of consortium (Count V). (Id.) In lieu of filing an Answer, on October 16, 2017, St. Jude filed the instant Motion, (D.I. 20), arguing that: (1) Plaintiffs' claims remain preempted by federal law; and (2) as to all of their claims, Plaintiffs have not otherwise stated a plausible claim for relief pursuant to Federal Rule of Civil Procedure 12(b)(6), (D.I. 21). The Motion was fully briefed on November 6, 2017. (D.I. 26)


         The sufficiency of pleadings for non-fraud cases is governed by Federal Rule of Civil Procedure 8, which requires "a short and plain statement of the claim showing that the pleader is entitled to relief[.]" Fed.R.Civ.P. 8(a)(2). When presented with a Rule 12(b)(6) motion to dismiss for failure to state a claim, a court conducts a two-part analysis. Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). First, the court separates the factual and legal elements of a claim, accepting "all of the complaint's well-pleaded facts as true, but [disregarding] any legal conclusions." Id. at 210-11. Second, the court determines "whether the facts alleged in the complaint are sufficient to show that the plaintiff has a 'plausible claim for relief.'" Id. at 211 (quoting Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009)). A plausible claim does more than merely allege entitlement to relief; it must also demonstrate the basis for that "entitlement with its facts." Id. Thus, a claimant's "obligation to provide the 'grounds' of his' entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do[.]" Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). In assessing the plausibility of a claim, the court must '"construe the complaint in the light most favorable to the plaintiff, and determine whether, under any reasonable reading of the complaint, the plaintiff may be entitled to relief.'" Fowler, 578 F.3d at 210 (quoting Phillips v. Cty. of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).[4]


         In Freed I, as noted above, Judge Kearney granted St. Jude's motion to dismiss the original Complaint without prejudice to file an amended complaint. In doing so, he found that the original Complaint did "not plausibly allege the facts necessary to avoid federal preemption[.]" Freed I, 2017 WL 41025 83, at * 1. In the instant motion, St. Jude asserts that while the Freed I decision "outlined the defects in the initial Complaint. . . Plaintiffs' [FAC] still has not cured the fundamental problems" and that preemption requires dismissal of Plaintiffs' claims with prejudice. (D.I. 21 at 1-2) Additionally, St. Jude asserts that Plaintiffs "still have not [otherwise] adequately stated any claim under [Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)] and [Ashcroft v. Iqbal, 556 U.S. 662 (2009)], and some of their causes of action must also be dismissed on state law grounds." (Id. at 2)

         The Court will first set out the relevant law regarding federal preemption as it relates to medical devices. Then, the Court will assess whether Plaintiffs' amended claims in the FAC warrant dismissal on the various grounds pressed by St. Jude.

         A. Preemption

         Preemption is a concept based on the Supremacy Clause of the United States Constitution. See Hillsborough Cty. v. Automated Med. Labs., 471 U.S. 707, 712 (1985); Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 242 (3d Cir. 2008). It provides that a conflicting state law will be trumped by its federal counterpart. Hillsborough, 471 U.S. at 712-13; Fellner, 539 F.3d at 242-43. Preemption may be express or implied. Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 95(1983).

         Enacted in 1976, the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA") established the federal regulatory regime for medical devices (an area that had previously been left to the states). Riegel v. Medtronic, Inc., 552 U.S. 312, 315-16 (2008). Pursuant to the MDA, medical devices are classified into three categories, depending on the risks that they present. Id. at 316-17. Class III devices, like those at issue in this case, receive the greatest amount of federal oversight; they are devices used '"in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, '" or that'"present[] a potential unreasonable risk of illness or injury.'" Id. at3l7 (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)).[5] The rigorous process of federal review that new Class III medical devices undergo for the evaluation of safety and effectiveness is known as "premarket approval" (or PMA). 21 U.S.C. § 360e; Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 766 (3d Cir. 2018).

         Once a Class III device has received premarket approval, the manufacturer is not permitted to change design specifications, manufacturing processes or labeling that would affect safety or effectiveness without permission from the FDA. Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 36Oe(d)(6)(A)(i)). A manufacturer seeking to make such changes must submit an application for supplemental premarket approval ("PMA Supplement") to the FDA; it must then await approval pursuant to the same rigorous standard of review that is applied during the initial PMA application process. Id.

         The MDA also imposes reporting requirements on manufacturers following the PMA process. Manufacturers are required to "inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of. .. and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred[.]" Id. (citing 21 C.F.R. §§ 803.50(a), 814.84(b)(2)).

         The MDA contains an express preemption provision. It provides that state laws "which relate[] to the safety or effectiveness of [a Class III medical] device" and are "different from, or in addition to" federal requirements under the MDA, are expressly preempted. 21 U.S.C. § 360k(a) ("Section 360k(a)" or "Section 360k"); see also Shuker, 885 F.3d at 767 ("The [MDA's] comprehensive and tiered approval procedures for medical devices leave only limited room for additional state regulation, especially considering the statute contains a broad express preemption provision."). Class III device manufacturers receive express preemption protections because the devices have undergone premarket approval, and thus such devices have been found to satisfy federal requirements applicable to the device. Shuker, 885 F.3d at 767; see also Riegel, 552 U.S. at 318 ("The FDA spends an average of 1, 200 hours reviewing each [Class III medical device application], and grants premarket approval only if it finds there is a 'reasonable assurance' of the device's 'safety and effectiveness[.]'") (quoting 21 U.S.C. § 36Oe(d)). In light of Section 36Ok(a), the Supreme Court of the United States has construed the MDA as protecting Class III device manufacturers from liability under state law tort claims if the manufacturer has complied with federal regulatory requirements. See Riegel, 552 U.S. at 323-24; see also, e.g., Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir. 2010) ("Generalized common law theories of liability ... are precisely the type of claims the MDA sought to preempt."); Millman v. Medtronic, Civil Action No. 14-cv-1465, 2015 WL 778779, at *5 (D.N.J. Feb. 24, 2015) ("As stated by one court, 'Riegel is loud and clear: if a manufacturer complies with the premarket approval, it gets a free pass on [products liability and implied breach of warranty] claims.'") (citation omitted).

         However, "state laws are not shut out entirely" when it comes to claims against Class III device manufacturers. Shuker, 885 F.3d at 768. The MDA's express preemption provision does not apply to "parallel" claims-that is, to claims premised on state requirements that merely incorporate federal requirements and therefore are not "different from, or in addition to," federal requirements. Id. (internal quotation marks and citations omitted); see also Riegel, 552 U.S. at 330 (noting that Section 360k "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements") (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)); Hart v. Medtronic, Inc., Civil Action No. 1:16-cv-05403 (JBS-AMD), 2017 WL 5951698, at *4 (D.N.J. Nov. 30, 2017) (explaining that Riegel recognized that "claims alleging that a manufacturer failed to adhere to the specifications imposed by a device's premarket approval are not preempted... . because they merely parallel federal requirements-that is, they do not add to or differ from federal requirements, which is the cornerstone of the MDA's medical device preemption).

         In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court established a two-step form of analysis for determining whether a claim is expressly preempted pursuant to the MDA. 552 U.S. at 321-22. First, the court must determine whether the FDA has established requirements applicable to the medical device at issue. Here, that step is not at issue, for it is undisputed that the SCS device is a Class III device, and the Supreme Court has held that any Class III device receiving PMA approval from the FDA will satisfy this first step in the analysis. Id. at 322 ("Premarket approval.. . imposes 'requirements' under the MDA[.]"); Hart, 2017 WL 5951698, at *3.[6] Second, the court must determine whether the plaintiffs' state law claims relate to safety and effectiveness and impose requirements that are "different from, or in addition to" those imposed by federal law. Riegel, 552 U.S. at 321-22 (internal quotation marks and citation omitted). If they do, those claims are expressly preempted. Mat 330.

         The parallel claim exception to preemption requires more than just the use of certain terminology; a plaintiff "cannot simply incant the magic words 'Defendant violated FDA regulations' in order to avoid preemption." Clements v. Sanofi-Aventis, U.S., Inc., 111 F.Supp.3d 586, 598 (D.N.J. 2015) (certain internal quotation marks, brackets and citations omitted); see also Smith v. Depuy Orthopaedics, Inc., Civil Action No. 11-4139 (JAP), 2013 WL 1108555, at *12 (D.N.J. Mar. 18, 2013) ("[B]road references to federal regulations in pleadings are insufficient [to properly plead a parallel claim].") (internal quotation marks and citations omitted). Rather, a plaintiff must plead "facts showing action or inaction in [the] defendants' efforts to take part in the PMA process or implement its results." Smith, 2013 WL 1108555, at * 12 (internal quotation marks, brackets and citation omitted). In sum, a "parallel claim," like any other claim, is subject to the pleading standards of Twombly and Iqbal. Hart, 2017 WL 5951698, at *5.

         Moreover, in addition to the MDA's express preemption clause, the MDA provides that all actions to enforce FDA requirements "shall be by and in the name of the United States." 21 U.S.C. § 337(a). In Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), the Supreme Court construed this provision as barring suits by private litigants "for noncompliance with the medical device provisions." 531 U.S. at 349 n.4. To avoid implied preemption under Buckman, a claim must assert violation of a state tort duty that also violates some FDA requirement. See Hughes v. Boston Sci. Corp., 631 F.3d 762, 775 (5th Cir. 2011). That is, the conduct on which the plaintiffs' claim is premised must be the type of conduct that would traditionally give rise to liability under state law, and that would give rise to liability under state law even if the FDCA had never been enacted. Yosowitz v. Covidien LP, 182 F.Supp.3d 683, 690 (S.D. Tex. 2016); see also, e.g., Bull v. St. Jude Med, Inc., CIVIL ACTION NO. 17-1141, 2018 WL 3397544, at *9 (E.D. Pa. July 12, 2018) ("State law claims that allege liability based on a common law tort theory and which parallel federal law claims ... are not impliedly preempted under Buckman"). If the defendant's conduct is not of this type, then (regardless of how the plaintiff has labeled the claim) the claim is impliedly preempted under Buckman because the plaintiff is effectively suing for a violation of the FDCA. Yosowitz, 182 F.Supp.3d at 690.

         B. Analysis of the FAC's Claims

          In Freed I, Judge Kearney concluded that Plaintiffs' state law claims, as alleged in the original Complaint, were all expressly preempted by federal law because they were all theories of liability relating to the safety or effectiveness of the SCS device and Plaintiffs failed to plead facts sufficient to show that the claims did not impose requirements that were "different from, or in addition to" those imposed by federal law. Plaintiffs had conceded that their original Complaint failed to reference specific federal regulations, but they had argued that "their claims are parallel to federal requirements, pointing [in their briefing] to federal regulations pertaining to labeling and compliance with good manufacturing practices post-approval[.]" Freed I, 2017 WL 4102583, at *6. But ultimately, Plaintiffs' "fail[ure] to plead the Device failed to comply with a federal regulation" doomed the claims of the original Complaint. Id.

         With the instant Motion, St. Jude contends that Plaintiffs' FAC is "hardly different" from their original Complaint. (D.I. 21 at 2) While St. Jude acknowledges that Plaintiffs' FAC now cites to federal regulations, (D.I. 26 at 2), it asserts that Plaintiffs "still have not 'plausibly allege[d] the facts necessary to avoid federal preemption[, ]'" (D.I. 21 at 2 (quoting Freed I, 2017 WL 4102583, at *1); see also D.I. 26 at 2-3). St. Jude also argues that Plaintiffs do not otherwise plead sufficient facts to make out plausible claims under the Twombly/lqbal pleading standard. For these reasons, according to St. Jude, the FAC must be dismissed with prejudice. (D.I. 21 at 1-2)

         Below, the Court will assess each of Plaintiffs' claims, in the order they are listed in the FAC.

         1. Breach of Express ...

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