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Mikesell v. St. Jude Medical, Inc.

United States District Court, N.D. Indiana, South Bend Division

February 2, 2017

RON MIKESELL, et al., Plaintiffs,
ST. JUDE MEDICAL, INC. et al., Defendants.



         On August 19, 2016, Defendants, St. Jude Medical, Inc. and Pacesetter, Inc. (collectively, “St Jude”), filed their Motion to Dismiss. On August 24, 2016, Plaintiffs, Ron and Beverly Mikesell, filed their response in opposition to St. Jude's motion. St. Jude's motion became ripe on September 6, 2016, when St. Jude filed a reply brief. On October 7, 2016, St. Jude's motion was referred to the undersigned for a report and recommendation pursuant to 28 U.S.C. § 636(b)(1)(B), Fed.R.Civ.P. 72(b), and N.D. Ind. L.R. 72-1(c). For the reasons stated below, the undersigned recommends that St. Jude's motion be GRANTED. [DE 10].

         I. Relevant Background

         On April 19, 2016, Plaintiffs filed their complaint raising four claims-strict liability- manufacturing defect (Count I), negligence in manufacturing (Count II), negligence per se (Count III), and loss of consortium (Count IV). Plaintiffs' claims are based on allegations that Mr. Mikesell was injured as the result of manufacturing defects in the St. Jude Riata and Riata ST Leads (“Riata Leads” or “Leads”) implanted in him in 2005 as part of an implantable cardiac defibrillator (“ICD”).[1] [DE 6 at 1, ¶ 1]. The Riata Leads, manufactured by St. Jude, are wires attached to ICDs “that deliver[] signals that allow an [ICD] to detect an abnormal heart rhythm and deliver a shock to help the heart return to an appropriate rhythm.” In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1203 (8th Cir. 2010).

         According to Plaintiffs' complaint, St. Jude introduced its Riata Leads, a Class III medical device, to the American market in about 2002 after securing approval for its design, manufacturing method, and labeling from the Food and Drug Administration (“FDA”). Class III medical devices “present a potential unreasonable risk of illness or injury and therefore incur the FDA's strictest regulation.” Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001) (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)(II)) (internal quotations omitted). Before they may enter the market, Class III medical devices must undergo the rigorous premarket approval process (“PMA”), designed to provide the consuming public with “reasonable assurance that such device is safe [and effective] under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” Id. (quoting 21 U.S.C. § 360e(d)(2)(A)-(B)).

         Plaintiffs allege in their complaint that from January 2003 through 2010, after securing initial approval of the Leads through the PMA process, St. Jude submitted multiple PMA Supplements through which it sought and received approval to manufacture additional models of Leads as well as to make modifications to the original Riata Leads. [DE 6 at 5-7, ¶¶ 16-32]. Plaintiffs more specifically allege that “St. Jude applied for over 27 manufacturing or process changes to the Riata Leads” between 2005 and 2010 and that “St. Jude failed to manufacture the Riata Leads consistent with these approved changes, thereby creating a defective product.” [Id. at 7, ¶ 32]. In the section of their complaint entitled “Manufacturing Defects with Regard to Riata Leads, ” Plaintiffs allege that the defects resulting from St. Jude's alleged failure to comply with the 27 manufacturing or process changes violated the PMA and included “inconsistent insulation diameters surrounding the electric conductors, ” [Id., ¶ 33], inconsistent application of “a lubricious interface between the inner and outer insulation, ” [Id. at 8, ¶ 36], “reduced tensile strength of the silicone insulation” as the result of “failure to comply with approved methods of curing and sterilization during the manufacture of the Leads, ” [Id., ¶ 37], and “insecure crimps over the length of the Lead” resulting from “failure to crimp with a controlled, uniform, degree of force” [Id., ¶ 38].

         Plaintiffs also allege that St. Jude sent two advisories, one in 2010 and one in 2011, to doctors regarding the Riata Leads. St. Jude acknowledges that on December 21, 2011, the FDA reclassified St. Jude's advisories as a Class I Recall as Plaintiffs alleged. [Id. at 10, ¶ 46; DE 11 at 9]. According to Plaintiffs, “the FDA indicated that the reason for the recall was that ‘failures associated with lead insulation abrasion on the St. Jude [Riata Leads] may cause the conductors to become externalized, ” which “may cause serious adverse health causes [sic][2], including death.” [DE 6 at 10, ¶ 48].

         Plaintiffs assert that Mr. Mikesell “first learned that his Riata [L]ead had been recalled on or about August 2014” and that “[o]n October 03, 2014, [he] underwent invasive surgery to remove and replace the defective Riata Lead of his pacemaker.” [Id. at 2, ¶ 6]. Plaintiffs further allege that “[a]s a result of the defect in his Riata lead, [Mr. Mikesell] is now 100 percent dependent upon his pacemaker when he formerly was only 40 percent dependent upon his pacemaker.” [Id., ¶ 7].

         Plaintiffs' strict liability-manufacturing defect claim (Count I) alleges that “the defendant [sic][3]” was injured “as a direct and proximate result of the manufacturing defect resulting “because the actual manufacture of the Riata Leads differs from the specifications set forth in the PMA and the conditions for approval.” [Id. at 12, ¶¶ 56-61]. Through their negligence in manufacturing claim (Count II), Plaintiffs allege that St. Jude breached its duty to manufacture the Riata Leads consistent with the PMA and conditions of approval and that St. Jude's breach directly and proximately caused Mr. Mikesell's injuries. [Id., ¶¶ 62-64]. Plaintiffs' negligence per se claim (Count III) is based on St. Jude's alleged failure to comply with twenty specific Federal Regulations and the Conditions of Approval for the Leads, which allegedly were the direct and proximate cause of Mr. Mikesell's injuries. [Id. at 13, ¶¶ 65-70]. And lastly in Count IV, Mrs. Mikesell alleges that she “suffered and will continue to suffer the loss of services and consortium of her husband” as a direct and proximate result of the St. Jude's negligence. [Id., ¶ 71].

         In the instant motion to dismiss, St. Jude argues that Plaintiffs have failed to state any claim. Specifically, St. Jude contends that (1) Counts I and II fail to satisfy the Rule 8 pleading requirements and are also expressly pre-empted under 21 U.S.C. § 360k(a) [DE 11 at 17-27]; (2) Count III is inadequately pleaded and is also impliedly pre-empted because there is no private right of action to enforce the FDCA [Id. at 27-31]; and (3) Count IV must be dismissed with the other claims because it is dependent upon them and cannot stand alone [Id. at 31-32].

         II. Analysis

         A. Manufacturing Defect Claims: Count I (Strict Liability) and Count II (Negligence in Manufacturing)

         1.Express Preemption

         Claims arising from Class III medical devices with premarket approval are limited under the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetics Act (“FDCA”). Specifically, 21 U.S.C. § 360k(a) prohibits states from

establish[ing] or continu[ing] in effect with respect to a device intended for human use any requirement-
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable ...

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