Tufts v. Medtronic Inc et al
ORDER AND OPINION granting 5 Motion to Dismiss With Prejudice. Signed by Honorable J Michelle Childs on 3/21/2017.(asni, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF SOUTH CAROLINA
Carol Ann Tufts,
Medtronic, Inc. and Medtronic USA, Inc., )
Civil Action No: 1:16-cv-00698-JMC
This matter is before the court on Defendants’ Rule 12(b)(6) Motion to Dismiss Plaintiff’s
Complaint, filed March 11, 2016. (ECF No. 5.) Plaintiff did not provide a response.
Plaintiff commenced this civil action by filing her Complaint in the Court of Common Pleas
of Aiken County, South Carolina on January 29, 2016. (ECF No. 1-1.) Defendants timely filed a
proper Notice of Removal, on March 4, 2016, requesting removal of this case to this court on the
basis of diversity jurisdiction, 28 U.S.C. § 1332. (ECF No. 1.) In this action, Plaintiff alleges claims
for negligence, strict liability, and breach of implied warranty of merchantability arising out of
Defendants’ manufacture, design and distribution of a Medtronic SynchroMed II Programmable
Pump that delivers medications over time to chronically ill patients. (ECF No. 1-1.) This device
was implanted in Plaintiff and allegedly malfunctioned and led to a “toxic overdose of medication”
into Plaintiff, causing her severe and permanent injuries. (ECF No. 1-1 at 8 ¶¶ 9-10 & 9 ¶ 14.) On
April 14, 2016, the parties filed a Stipulation to Stay Proceedings for one hundred and twenty (120)
days for the parties to address certain initial discovery issues. (ECF No. 8.) On December 16, 2016,
the court granted Plaintiff’s counsel’s Motion to Withdraw as Attorney (ECF No. 13), to which
Plaintiff consented (ECF No. 13-1), and offered Plaintiff ninety (90) days to secure new counsel.
(ECF No. 14.) Plaintiff failed to secure new counsel and now Defendants’ Motion is ripe for ruling.
In their Motion, Defendants argue that Plaintiff’s claims are preempted by federal law and
therefore should be dismissed. More specifically, Defendants assert that 1) Plaintiff has not “pled
facts suggesting that her purported injuries resulted from a violation of any federal requirement
applicable to her device”; 2) Plaintiff’s claims are not adequately pled; 3) Plaintiff’s strict liability
design defect claim is barred by comment k to Section 402A of the Restatement (Second of Torts);
and 4) Plaintiff’s claims that Defendants failed to provide appropriate warnings to her are barred by
the learned-intermediary doctrine. (ECF No. 5 at 2-3.)
The Federal Drug Administration strictly regulates the design, manufacture, and sale of Class
III medical devices pursuant to the Medical Device Amendments to the Food, Drug and Cosmetic
Act, 21 U.S.C. § 301 et seq. (“FDCA”). The Medical Device Amendments contain an express
preemption provision declaring that no state “may establish or continue in effect with respect to a
device . . . 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.” 21 U.S.C.
§ 360k(a). Thus, absent fitting into an exception, state law claims challenging the design,
manufacture, or labeling of a premarket approval medical device are expressly preempted. Riegel
v. Medtronic Inc., 552 U.S. 312 (2008). Furthermore, in this action, Plaintiff does not allege any
claim or defect that is premised on a violation or deviation from federal law. (See ECF No. 1-1.)
Thus, this court finds that the FDCA pre-empts Plaintiff’s common law claims for negligence, strict
liability, and breach of implied warranty of merchantability arising out of Defendants’ manufacture,
design and distribution of a Medtronic SynchroMed II Programmable Pump, and has held such in
a similar case, see, e.g., Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 WL
5644699, at *6-8 (D.S.C. Nov. 4, 2014) (holding that claims based on strict liability, negligence, and
breach of implied warranty were expressly preempted). Accordingly, for the reasons stated above,
the court GRANTS Defendants’ Motion to Dismiss (ECF No. 5) with prejudice.1
IT IS SO ORDERED.
United States District Judge
March 21, 2017
Columbia, South Carolina
Because the court has determined that Plaintiff’s common law claims are preempted, it need not
reach a decision on Defendants’ other arguments.
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