UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF INDIANA

SOUTH BEND DIVISION

RON MIKESELL, et al.,

Plaintiffs,

v.

ST. JUDE MEDICAL, INC. et al.,

Defendants.

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CAUSE NO. 3:16-CV-304-JD-MGG

REPORT AND RECOMMENDATION

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 
2

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.

 1 In their complaint, Plaintiffs refer to Mr. Mikesell as “the decedent” multiple times. [DE 6 at 1, ¶ 1; 2, ¶ 6; 12, 

¶ 60]. Because of other references in the Complaint [Id. at 2, ¶¶ 5, 7; 12, ¶ 64] combined with Plaintiffs’ failure to 

challenge St. Jude’s assumption that he is alive [DE 11 at 8 n.1], the undersigned also assumes that Mr. Mikesell is 

alive.
3

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].

 2 The Court assumes that Plaintiffs meant to use the word “consequences” instead of “causes.”
4

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

 3 The Court assumes that Plaintiffs meant to reference Mr. Mikesell specifically rather than “the defendant.”
5

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 to the device under this chapter.

In Riegel v. Medtronic, Inc., the United States Supreme Court established a two-step preemption 

analysis. 552 U.S. 312, 321–22 (2008). In determining whether a state law claim is expressly 

preempted under 21 U.S.C. § 360k, court must first ascertain “whether the Federal Government 

has established requirements applicable to” the specific medical device. Id. at 321. 

Requirements imposed on the manufacture of medical devices through the FDA’s premarket 

approval (“PMA”) process constitute such federal requirements. Id. at 322–23. With such 

federal requirements in place, the court must “then determine whether the [plantiff’s] commonlaw claims are based upon [state] 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 321–22 

(quoting 21 U.S.C. § 360k(a)).

Here, device-specific federal requirements have been imposed on the Riata Leads at issue 

in this case through the PMA process. See id. at 322–23. Therefore, the first step in the 

preemption analysis is satisfied and the second step is the key to determining whether Plaintiffs’ 

manufacturing defect claims are expressly preempted. In Riegel, “the Court found that the state 

requirements implicit in the [plaintiffs’] common law [tort] claims were different from or in 

addition to the federal requirements and were preempted under section 360k.” Bausch v. Stryker 
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Corp., 630 F.3d 546, 552 (7th Cir. 2010). Yet the Riegel Court “limit[ed] its holding to claims 

that the device at issue ‘violated state tort law notwithstanding compliance with the relevant 

federal requirements.’” Id. (quoting Riegel, 552 U.S. at 330 (emphasis added)). Accordingly, 

lower courts should “allow claims to proceed when they are based on claimed violations of 

federal law.” Id. “[Section] 360k does not prevent a State from providing a damages remedy for 

claims premised on a violation of FDA regulations.” Riegel, 552 U.S. at 330. “The presence of 

a damages remedy does not amount to the additional of different ‘requirement’ that is necessary 

under [Section 360k]; rather, it merely provides another reason for manufacturers to comply with 

identical existing ‘requirements’ under federal law.” Meditronic, Inc. v. Lohr, 518 U.S. 470, 495 

(1996). Thus, “section 360k protects a medical device manufacturer from liability to the extent 

that it has complied with federal law, but it does not extend protection from liability where the 

claim is based on a violation of federal law” or where “state law is parallel to federal law.” 

Bausch, 630 F.3d at 552.

State requirements are parallel to federal requirements when they are genuinely 

equivalent. McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (citing Bates v. Dow 

Agrosciences LLC, 544 U.S. 431, 454 (2005)). “To state a parallel claim and avoid preemption, 

[a plaintiff] must show that [state] law imposes a requirement or duty that is ‘genuinely 

equivalent’ to the federal reporting requirements that were allegedly violated.” McAfee v. 

Medtronic, Inc., No. 1:12-CV-417 RLM, 2016 WL 2588807, at *3 (N.D. Ind. May 5, 2016)

(citing Bates, 544 U.S. at 454; Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300–01 (11th 

Cir. 2011); McMullen, 421 F.3d at 489.) “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.” McMullen, 421 F.3d at 489.
7

In this case, Plaintiffs strict liability and negligence in manufacturing claims are

potentially parallel because they depend upon alleged violations of the federal PMA 

requirements and the Conditions of Approval for the Riata Leads. See DE 6 at 12, ¶¶ 57, 62–63. 

Specifically, Plaintiffs allege that the Riata Leads were manufactured in violation of PMA 

requirements for “[]consistent insulation diameters surrounding the electric conductors,” [Id. at 

7, ¶ 33]; consistent application of “a lubricious interface between the inner and outer insulation,” 

[Id. at 8, ¶ 36]; compliance “with the approved methods of curing and sterilization,” [Id., ¶ 37]; 

and “application of a controlled, uniform degree of force when applying the crimp” [Id., ¶ 38].

St. Jude argues, however, that Counts I and II cannot be parallel because at least four of 

the federal requirements Plaintiffs allege do not actually exist. Specifically, St. Jude contends 

that the PMA and PMA Supplements do not include requirements for consistent insulation 

diameters, a lubricious interface, a particular method of curing, or application of a uniform 

degree of force. In support of this contention, St. Jude cites Pinsonneault v. St. Jude Med., Inc., 

No. 12-CV-1717 PJS/JSM, 2014 WL 2879754, at *9–*11 (D. Minn. June 24, 2014). In 

Pinsonneault, the plaintiffs alleged—exactly as Plaintiffs in this case allege—that St. Jude 

manufactured defective Riata Leads by failing to comply with the PMA requirements for 

“uniform insulation thickness; . . . uniform degree of force when crimping the lead wires;” use of 

“approved methods and specifications for curing” and for sterilizing; and consistent application 

of a lubricious interface between the inner and outer insulation.” Id. at *4. The court ultimately 

granted summary judgment to St. Jude because the plaintiffs had failed to cite evidence of any 

such requirements. Id. at *9–*11. In addition, the Court found that St. Jude had presented 

“evidence that, standing alone, prove[d] by a preponderance of the evidence that there are no 

[such] federal requirements.” Id. at *8.
8

The Pinsonneault court appropriately considered the evidence before it at the summary 

judgment stage. Before this Court, however, is St. Jude’s motion to dismiss where evidence is 

not the focus of the analysis. Indeed, “much of the critical information” related to Class III 

medical devices such as Riata Leads, “is kept confidential as a matter of federal law.” Bausch, 

630 F.3d at 560. For instance, “[t]he specifications of the FDA’s premarket approval documents 

. . . are confidential, and there is not public access to complete versions of these documents.” Id. 

As a result, injured patients like Mr. Mikesell “cannot gain access to that information without 

discovery.” Id. (citations omitted). Just because the Pinsonneault plaintiffs did not meet their 

burden to show that these requirements exist does not mean that Plaintiffs here should be 

precluded from the opportunity afforded through discovery to determine whether evidence exists 

to show that such requirements exist.

With that said, St. Jude may still be able to present evidence—maybe even the same 

evidence considered in Pinsonneault—that tips the scales in favor of their preemption position. 

Such a finding on the instant motion to dismiss, however, would be premature. Based on the 

complaint alone, Plaintiffs’ Counts I and II present potentially parallel claims that might not be 

expressly preempted and should not be dismissed as a result.

However, parallel claims that survive preemption must still “allege facts . . . establishing 

a causal nexus between the alleged injury and the [alleged federal] violation.” Erickson v. 

Boston Sci. Corp., 846 F. Supp. 2d 1085, 1092 (C.D. Cal. 2011); accord McAfee, 2016 WL 

2588807, at *1 (citing Bates, 544 U.S. at 454; Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 

1296, 1300–01 (11th Cir. 2011); McMullen, 421 F.3d at 489.) Moreover, the plaintiff must meet 

the Rule 12(b)(6) pleading standard by alleging “facts sufficient to meet the new ‘plausibility’ 
9

standard applied in Iqbal and Twombly.” Bausch, 630 F.3d at 558. This is where Plaintiffs’ 

manufacturing defects claims in Counts I and II fail.

2. Pleading Parallel Claims

Under Fed. R. Civ. P. 12(b)(6), dismissal of a complaint is appropriate when the 

complaint fails to allege a cause of action for which relief can be granted. Federal law only 

requires a plaintiff to provide a short and plain statement of the claim that the pleader is entitled 

to relief. Fed. R. Civ. P. 8; see Bartholet v. Resihauer A.G. (Zurich), 953 F.2d 1073, 1078 (7th 

Cir. 1992). When considering a 12(b)(6) motion to dismiss, the court should “construe the 

complaint in the light most favorable to the plaintiff, accepting as true all well-pleaded facts 

alleged, and drawing all possible inferences in her favor.” Tamayo v. Blagojevich, 526 F.3d 

1074, 1081 (7th Cir. 2008). “However, [the court] need not ignore facts set forth in the 

complaint that undermine the plaintiff’s claim or give weight to unsupported conclusions of 

law.” Buchanan-Moore v. Cty. of Milwaukee, 570 F.3d 824, 827 (7th Cir. 2009); accord Bogie 

v. Rosenberg, 705 F.3d 603, 609 (7th Cir. 2013).

A complaint that states a plausible claim for relief survives a motion to dismiss. See 

Ashcroft v. Iqbal, 556 U.S. 662, 677–79 (2009); see also Bell Atlantic Corp. v. Twombly, 550 

U.S. 544, 556 (2007) (holding that the pleading stage does not impose a probability requirement 

but does require alleged facts to be plausible so as to entitle a person to relief even if recovery is 

remote and unlikely). Put another way, a complaint survives a motion to dismiss if it “contains

sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’”

Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). “[T]he plausibility standard [asks]

for more than a sheer possibility that a defendant has acted unlawfully.” United Food & 
10

Commercial Workers Unions & Emp’rs Midwest Health Benefits Fund v. Walgreen Co., 719 

F.3d 849, 853 (7th Cir. 2013) (internal quotations and citations omitted).

Consequently, “a court need not accept as true ‘legal conclusions[, or t]hreadbare recitals 

of the elements of a cause of action, supported by mere conclusory statements.’” Brooks v. Ross, 

578 F.3d 574, 581 (7th Cir. 2009) (quoting Iqbal, 556 U.S. at 678). Indeed, such conclusory 

statements are not entitled to the presumption of truth. McCauley v. City of Chicago, 671 F.3d 

611, 616 (7th Cir. 2011). With conclusory statements properly discounted, the court can then 

“determine whether the remaining factual allegations plausibly suggest an entitlement to relief.

Id. (internal quotations and citations omitted). A complaint fails if “it tenders ‘naked 

assertion[s]’ devoid of ‘further factual enhancement.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 

550 U.S. at 557).

In Bausch, the Seventh Circuit found that plaintiffs had sufficiently pleaded their parallel 

manufacturing defect claims. The Bausch complaint alleged that the medical device at issue was 

“unreasonably dangerous, causing plaintiff to suffer an unstable right hip, pain, suffering, 

disability, and what is euphemistically called ‘revision’ surgery.” 630 F.3d at 558. Plaintiffs 

here comparably allege that the manufacturing defect—allegedly arising from St. Jude’s 

manufacture of the Riata Leads using specifications different from those set forth through the 

PMA and its accompanying Conditions for Approval—“renders the Riata Lead unreasonably 

dangerous for its intended use and Plaintiff could not have anticipated the danger the defect in 

this product created.” [DE 6 at 12, ¶¶ 57–58]. However, the Bausch complaint went on to allege 

more facts, for which no counterpart exists in Plaintiffs’ complaint.

For instance, the Bausch plaintiffs alleged that “defendants knew, or at least should have 

known, before plaintiff’s original surgery that the [device] implanted . . . was defective.” 
11

Bausch, 630 F.3d at 559. The Bausch complaint also alleged that six days before the plaintiff’s 

surgery implanting the device at issue, the FDA had issued a letter to the defendants warning that 

the device was “adulterated due to manufacturing methods . . . not in conformity with industry 

and regulatory standards.” Id.

Plaintiffs here allege nothing as to St. Jude’s knowledge of defects or any recall of the 

Riata Lead before it was implanted into Mr. Mikesell in 2005. In fact, Plaintiffs’ allegations 

appear to be based on St. Jude’s failure to comply with modifications to the Riata Leads 

approved between 2005 and 2010, presumably after Mr. Mikesell’s Leads were implanted. 

Moreover, the 2010 and 2011 advisories had not been issued when Mr. Mikesell’s Leads were 

implanted bringing into question even the possibility that the specific Leads implanted in Mr. 

Miksell could have been affected by the violations of federal requirements Plaintiffs allege.

Furthermore, the Bausch complaint relied on additional specific factual allegations 

including that “[a] device bearing the same catalogue number as the device allegedly not in 

compliance with regulations, was then implanted in Bausch’s body the next week . . . failed. . . 

and was later recalled.” Id. Plaintiffs’ complaint here, however, alleges nothing as to the 

identification of the specific device implanted in Mr. Mikesell. Moreover, the Mikesell

complaint alleges that a manufacturing defect in the Riata Leads caused Mr. Mikesell’s injuries

without actually alleging that the specific device implanted in Mr. Mikesell failed or what 

symptoms he experienced as a result of the allegedly defective device implanted. The 

allegations in the complaint seem to do a good job of pleading that Riata Leads suffered from 

defects generally, but not that the specific Leads implanted in Mr. Mikesell were defective or 

that any defect in those Leads specifically actually increased Mr. Mikesell’s dependence on his 
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pacemaker by 60 percent—his alleged injuries. Without such detail, Plaintiffs’ manufacturing 

defect claims fail to meet the Iqbal/Twombly plausibility standard.

The Court acknowledges that discovery may be necessary to plead with specificity details 

about the PMA requirements or other matters kept confidential by St. Jude. See Bausch, 630 

F.3d at 560. However, “a plaintiff’s pleading burden should be commensurate with the amount 

of information available to them.” Id. at 561 (quoting and adopting the dissenting position in In 

re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1212 (8th Cir. 2010)

(Melloy, J., dissenting)). While the plaintiff in Bausch pled sufficiently based on the information 

to which she had access, Mr. and Mrs. Mikesell have not done so here.

Mr. Mikesell experienced life with the implanted and allegedly defective Riata Lead. He 

also alleged that the alleged defect could result in “Oversensing (leading to inhibition of pacing 

or inappropriate high voltage therapy); . . . Undersensing; . . . Loss of capture; . . . Changes in 

pacing and/or high voltage lead impedences; and . . . Inability to deliver high voltage therapy.4

 

[DE 6 at 9, ¶ 42]. Such symptoms of device failure should have been known to him either 

experientially or through reports from his doctor before, during, or after the October 2014 

replacement surgery. It seems obvious that a patient would recognize if the pacing of the device 

was inhibited or if the device was misapplying high voltage therapy. None of those specific 

failures of Mr. Mikesell’s device is alleged here.

Furthermore, facts that Plaintiffs have alleged bring into question whether the device 

actually failed at all. For instance, Plaintiffs allege that the Riata Leads were recalled in 2011, 

but that Mr. Mikesell first learned of the recall in August 2014. The complaint alleges nothing as 

to the sequence of events that led to the discovery of the recall. Moreover, had the device failed, 

 4 Notably, Plaintiffs’ complaint alleges nothing, even generally, about the potential for the alleged defects in the 

Riata Leads to cause increased dependence on a pacemaker, Mr. Mikesell’s only alleged injury.
13

Mr. Mikesell would likely have been discussing symptoms of the failure with his physician, 

which in turn would have probably led to an earlier discovery of the recall. In addition, the 

complaint alleges nothing besides the recall as the rationale for the replacement surgery in 

October 2014. The recall alone does not suggest that Mr. Mikesell’s Riata Leads specifically 

failed, just that they could fail.

Taken together, Plaintiffs’ pleadings in Counts I and II do not allege facts that even taken 

as true could establish a causal nexus between Mr. Mikesell’s increased dependence on his 

pacemaker and St. Jude’s alleged violations of the PMA requirements. See Erickson, 846 F. 

Supp. 2d at 1092. Therefore, the undersigned recommends granting St. Jude’s motion to dismiss 

as to Plaintiffs’ strict liability (Count I) and negligence in manufacturing (Count II) claims based 

on manufacturing defects.

B. Negligence Per Se Claim: Count III

1. Implied Preemption

Congress has declared that all actions to enforce the FDCA “shall be by and in the name 

of the United States.” 21 U.S.C. § 337(a). As a result, there is no private right of action to 

enforce the FDCA. Buckman, 531 U.S. at 349 n.4. As already alluded to above,

Riegel and Buckman create a narrow gap through which a plaintiff’s state-law 

claim must fit if it is to escape express or implied preemption. The plaintiff must 

be suing for conduct that violates the FDCA (or else his claim is expressly 

preempted by § 360k(a)), but the plaintiff must not be suing because the conduct 

violates the FDCA (such a claim would be impliedly preempted under Buckman ).

Medtronic Leads, 623 F.3d at 1204 (quoting Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 

(D.Minn.2009); accord Bausch, 630 F.3d at 557–58. As a result, any state-law claim that simply 

seeks to enforce a manufacturer’s duty to comply with federal regulations is subject to implied 

preemption.
14

For example, the United States Supreme Court held that a fraud on the FDA claim was 

impliedly preempted. Buckman, 531 U.S. at 353. The Buckman claim alleged that a regulatory 

consultant had made fraudulent representations to the FDA while obtaining approval for a 

medical device and that those misrepresentations were the “but for” cause of the plaintiff’s 

injuries from implantation of the device. Id. at 343. Despite St. Jude’s arguments to the 

contrary, Plaintiffs’ negligence per se claim here is distinguishable from the fraud claim in 

Buckman. See Bausch, 630 F.3d at 557. “[T]he federal statutory scheme amply empowers the 

FDA to punish and deter fraud against the Administration.” Buckman, 531 U.S. at 348. Here, 

Plaintiffs do not ask the Court to enforce the PMA requirements and federal regulations at issue. 

Instead, Plaintiffs simply seek compensation for damages resulting from alleged violations of the 

federal requirements and regulations—a proper role for state law tort law. See Riegel, 552 U.S. 

at 330 (holding that states are not prohibited from providing a damages remedy for claims 

premised on a violation of FDA regulations); see also Lohr, 518 U.S. at 495 (stating that a statelaw damages remedy is not preempted but “merely provides another reason for manufacturers to 

comply with identical existing ‘requirements’ under federal law.”).

Therefore, Plaintiffs’ negligence per se claim is not impliedly preempted. However, that 

does not end the inquiry because the negligence per se claim suffers the same pleading 

deficiencies that caused the undersigned to recommend that Counts I and II be dismissed.

2. Sufficiency of Pleadings

Even though Plaintiffs’ negligence per se claim may survive the implied preemption 

analysis, it must still meet the plausibility standard discussed above and articulated in Iqbal and 

Twombley. Plaintiffs allege that “St. Jude failed to comply with the Conditions of Approval and 

Federal Regulations.” [DE 6 at 13, ¶ 69]. Plaintiffs clearly identify twenty different regulations
15

that St. Jude allegedly violated. [Id., ¶ 67]. Yet Plaintiffs’ allegations based on these regulations 

are bare conclusions, bereft of any factual support that St. Jude actually could or did violate these 

regulations. In fact, St. Jude argues that many of the identified regulations are definitional such 

that they cannot be violated.

In addition, Plaintiffs’ complaint fails to plead sufficiently any causal connection—this 

time between St. Jude’s violations of these specific federal regulations and the Conditions of 

Approval for the Riata Leads and Mr. Mikesell’s increased dependence on his pacemaker. 

Without more, Plaintiffs’ negligence per se claim merely alleges the possibility, not the 

plausibility, that St. Jude violated federal law or caused Mr. Mikesell’s damages. As a result, the 

undersigned must also recommend that St. Jude’s motion to dismiss the negligence per se claim 

(Count III).

C. Loss of Consortium (Count IV)

The complaint alleges a loss of consortium claim only as to Mrs. Mikesell. [DE 6 at 14, 

¶ 71] (“As a direct and proximate result of the negligence of the Defendants, the Plaintiff has 

suffered and will continue to suffer the loss of services and consortium of her husband.”). “[A]

claim of loss of consortium is a derivative claim and absent actionable injury to one spouse, the 

other spouse cannot recover for loss of consortium.” Miller v. Cent. Ind. Cmty. Found., Inc., 11 

N.E.3d 944, 963 (Ind. Ct. App. 2014) (internal quotations and citations omitted). Plaintiffs do 

not dispute this statement of the law. In light of the recommendations discussed above 

dismissing all of Plaintiffs’ negligence claims, Mrs. Mikesell retains no loss of consortium claim 

because her spouse, Mr. Mikesell, lacks any actionable injury. Therefore, the undersigned also 

recommends dismissing Mrs. Mikesell’s loss of consortium claim (Count IV).
16

III. CONCLUSION

For the reasons stated above, Plaintiffs have failed to plead sufficiently claims for strict 

liability–manufacturing defect, negligence in manufacturing, and negligence per se against St. 

Jude. With no valid tort claims remaining, the predicate for Plaintiffs’ loss of consortium claim 

no longer exists. Therefore, the undersigned RECOMMENDS that St. Jude’s motion to dismiss 

be GRANTED as to all four counts in Plaintiffs’ complaint. [DE 10]. Should the Court 

GRANT St. Jude’s instant motion to dismiss as recommended, the undersigned also 

RECOMMENDS that Plaintiffs be GRANTED the opportunity to amend their complaint. See 

Bausch, 630 F.3d at 561–63.

NOTICE IS HEREBY GIVEN that within fourteen (14) days after being 

served with a copy of this recommended disposition a party may serve and 

file specific, written objections to the proposed findings and/or 

recommendations. Fed. R. Civ. P. 72(b). FAILURE TO FILE 

OBJECTIONS WITHIN THE SPECIFIED TIME WAIVES THE RIGHT 

TO APPEAL THE DISTRICT COURT’S ORDER.

SO ORDERED.

Dated this 2nd day of February 2017.

s/Michael G. Gotsch, Sr.

Michael G. Gotsch, Sr.

United States Magistrate Judge