United States District Court, N.D. Indiana, South Bend Division
DEGUILIO JUDGE UNITED STATES DISTRICT COURT.
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].
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.
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.
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).
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.
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 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).
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