UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF INDIANA

SOUTH BEND DIVISION

RON MIKESELL, et al., )

)

Plaintiffs, )

)

v. ) Case No. 3:16-CV-304 JD 

)

ST. JUDE MEDICAL, INC., et al., )

)

Defendants. )

ORDER

On April 19, 2016, Plaintiffs Ron and Beverly Mikesell filed a complaint in state court

alleging that Ron Mikesell was injured as the result of manufacturing defects in a St. Jude

cardiac defibulator component implanted in him in 2005. [DE 6]. The Defendants removed that

complaint to federal court, [DE 1], and then filed a motion to dismiss [DE 10] all four of the

Plaintiffs’ claims. They contend that the Plaintiffs’ three substantive claims are preempted by

federal law and fail to satisfy Rule 8 pleading requirements. Further, they say that the Plaintiffs’

loss of consortium claim cannot survive alone. The Plaintiffs responded in opposition, arguing

that their claims are not preempted and satisfy federal pleading requirements. [DE 12]. 

On October 7, 2016, the undersigned referred this motion to Magistrate Judge Michael G.

Gotsch for a report and recommendation, pursuant to 28 U.S.C. § 636(b)(1)(B), Federal Rule of

Civil Procedure 72(b) and Northern District of Indiana Local Rule 72.1(c). [DE 14]. On

February 2, 2017, Magistrate Judge Gotsch issued his Report and Recommendation [DE 15],

which recommends that the Court dismiss the Plaintiffs’ complaint in its entirety, though permit

the Plaintiffs an opportunity to file an amended complaint.

The Court’s review of a Magistrate Judge’s report and recommendation is governed by
28 U.S.C. § 636(b)(1), which provides in part:

A judge of the court shall make a de novo determination of those portions of the

report or specified proposed findings or recommendations to which objection is

made. A judge of the court may accept, reject, or modify, in whole or in part, the

findings or recommendations made by the magistrate judge. The judge may also

receive further evidence or recommit the matter to the magistrate judge with

instructions.

Under Fed. R. Civ. P. 72(b), however, the Court must only make a de novo determination

of those portions of the Magistrate Judge’s report and recommendation to which specific written

objection has been made. Johnson v. Zema Sys. Corp., 170 F.3d 734, 739 (7th Cir. 1999); Fed.

R. Civ. P. 72(b). If no objection or only a partial objection is made, the Court reviews those

unobjected portions for clear error. Id. In addition, failure to file objections with the district

court “waives the right to appeal all issues addressed in the recommendation, both factual and

legal.” Id. Under the clear error standard, the Court can only overturn a Magistrate Judge’s

ruling if the Court is left with “the definite and firm conviction that a mistake has been made.” 

Weeks v. Samsung Heavy Indus. Co., Ltd., 126 F.3d 926, 943 (7th Cir. 1997). 

Both 28 U.S.C. § 636(b)(1) and Fed. R. Civ. P. 72(b) require the parties to file objections

to a report and recommendation within fourteen days of being served with a copy of the same. 

See 28 U.S.C. § 636(b)(1); Fed. R. Civ. P. 72(b)(2). More than 14 days have passed since the

parties were served with Magistrate Judge Gotsch’s Report and Recommendation and no party

has filed an objection. Consequently, because the time period for objections has passed, the

Court considers there to be no objection to Magistrate Judge Gotsch’s Report and

Recommendation. 

Having reviewed that Report and Recommendation, the Court finds no clear error

therein. The Court concurs that, at the pleadings stage, it would be premature to conclude that

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Counts I (strict liability - manufacturing defect) and II (negligence in manufacturing) of the

complaint are expressly preempted by 21 U.S.C. § 360k(a). However, the Plaintiffs do not offer

sufficient factual allegations to substantiate those claims. In particular, they do not plausibly

allege that the specific leads implanted in Mikesell were defective, or that a defect in those leads

actually increased Mikesell’s dependence on his pacemaker. As to Count III (negligence per se),

the Magistrate Judge correctly concluded that this claim is distinguishable from the fraud claims

in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 344 (2001) and thus is not impliedly

preempted by federal regulations. Nevertheless, this claim too lacks the factual heft required by

Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 556 (2007). The Plaintiffs provide conclusory

allegations that St. Jude violated numerous federal regulations, though make no effort to explain

how it did so. That simply fails to “give the defendant fair notice of what the . . . claim is and the

grounds upon which it rests.” Brooks v. Ross, 578 F.3d 574, 581 (7th Cir. 2009). The Court thus

finds that the Magistrate Judge did not clearly err in concluding that the Plaintiffs failed to

sufficiently plead their first three claims. Since the remaining loss of consortium claim is not

independently actionable, it too must be dismissed. Miller v. Cent. Ind. Cmty. Found., Inc., 11

N.E.3d 944, 963 (Ind. Ct. App. 2014). 

As such, the Court ADOPTS Magistrate Judge Gotsch’s Report and Recommendation

[DE 15] in its entirety and incorporates that Report and Recommendation into this order. The

Court accordingly GRANTS the Defendants’ motion to dismiss and dismisses all four of the

Plaintiffs’ claims. The Plaintiffs may file an amended complaint no later than March 15, 2017. 

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SO ORDERED.

ENTERED: February 17, 2017

 /s/ JON E. DEGUILIO 

Judge

United States District Court

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