Spier v. Coloplast Corp.

121 F. Supp. 3d 809, 2015 U.S. Dist. LEXIS 108234, 2015 WL 4902742
CourtDistrict Court, E.D. Tennessee
DecidedAugust 17, 2015
DocketNo. 3:14-CV-550-TAV-HBG
StatusPublished
Cited by8 cases

This text of 121 F. Supp. 3d 809 (Spier v. Coloplast Corp.) is published on Counsel Stack Legal Research, covering District Court, E.D. Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Spier v. Coloplast Corp., 121 F. Supp. 3d 809, 2015 U.S. Dist. LEXIS 108234, 2015 WL 4902742 (E.D. Tenn. 2015).

Opinion

MEMORANDUM OPINION

THOMAS A. VARLAN, Chief Judge.

This civil action is before the Court on defendant Coloplast Corporation’s motion to dismiss plaintiffs complaint [Doc. 8]. The complaint asserts four state-law causes of action arising out of the manufacture and sale of the Titan Inflatable Penile Prosthesis (“the Titan Prosthesis”): design defect, failure to warn, and breach of express and implied warranties [Doc. 1-1 p. 3-6]. Defendant contends each of these claims is either expressly preempted by federal law or otherwise inadequately pleaded and must be dismissed pursuant to Federal Rule of Civil Procedure 12(b)(6) [Doc. 8 ¶¶ 3-4].

Plaintiff has failed to respond to defendant’s motion, despite being granted additional time to do so. See E.D. Tenn. L.R. 7.2 (“Failure to respond to a motion may be deemed a waiver of any opposition to the relief 'sought.”). The Court, nevertheless, has carefully considered the matter,1 and will dismiss plaintiffs design defect, failure-to-warn, and implied warranty claims with prejudice and his express warranty claim without prejudice.

I. Background

This case concerns several alleged failings of the Titan Prosthesis, which defen[811]*811dant manufactures and which plaintiff received via surgical implant [Doc. 1-1 ¶ 3],

A. FDA Approval of the Titan Prosthesis 2

The medical device now known as the Titan Prosthesis was originally owned and marketed by Mentor Corporation as the Mentor Alpha I Inflatable Penile Prosthesis [Doc. 10-1 p. 2]. Mentor intended the device for use by “male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis” [/&]. On February 7, 2000, Mentor submitted an application to the FDA for premarket approval (“PMA”) of its device, which the FDA approved on July 14, 2000, subject to certain terms and “Conditions of Approval” [Id. at 2-9],

These conditions required Mentor to, inter alia, only use certain pre-approved labeling, submit annual post-approval reports, and restrict advertising to approved uses of the device [Id. at 5-6], Mentor also was obligated to submit a PMA supplement application “[bjefore making any change affecting the safety or effectiveness of the device” [Id. at 5]; see also 21 C.F.R. § 814.39(a) (placing “the burden for determining whether a supplement is required ..'. primarily on the PMA holder”). The FDA issued a public Summary of Safety and Effectiveness Data for the Titan Prosthesis [Doc. 10-3], which disclosed the information upon which the FDA relied in granting it PMA status [Doc. 10-2].

In June 2006, defendant Coloplast Corporation informed the FDA that it had purchased the Titan Prosthesis from Mentor [See Doc. 10-8 p. 2 (indicating to defendant that “[a]ll previous regulatory requirements remain in effect and are now the responsibility of Coloplast”) ]. In addition, since the device first received PMA status in 2000, Mentor and defendant have collectively submitted multiple PMA supplements for the Titan Prosthesis, all of which the FDA approved [Docs. 10-5 through 10-7], On June 13, 2008, for example, defendant received permission to add “a new one-touch release pump,” along with other modifications, and to alter the device’s labeling accordingly [Doc. 10-7 p. 2].

B. Factual Allegations and Procedural History

According to the complaint, Brian Parker, M.D., implanted a Titan Prosthesis into plaintiff on September 18, 2013 [Doc. 1-1 ¶ 3]. After the surgery, the device was “left in a ‘mainly deflated state’ ” [Id. ¶ 3]. Plaintiff returned to Dr. Parker’s office a month later for instruction on the device’s use; however, once the Titan Prosthesis was inflated, none of the medical personnel present were able to deflate it [Id. ¶ 4]. During a follow-up visit the next day, the same malfunction occurred and the device again did not fully deflate [Id. ¶ 5]. Dr. Parker eventually concluded, on October 31, 2013, that the device was “‘nonfunc[812]*812tioning/poorly -functioning”’ [Id. ¶.6]. Plaintiff alleges these malfunctions caused him to suffer “injuries requiring] professional medical care” and “great pain of body and mind; said injuries being permanent in nature” [Id. ¶¶ 8-9],

Almost a year later, plaintiff brought suit against defendant in the Circuit Court for Knox County, Tennessee [Id. at 3, 5]. Defendant timely removed to federal court, asserting diversity of citizenship pursuant to 28 U.S.C.'§ 1332 as the basis for the Court’s subject'matter jurisdiction [Doc. 1 ¶¶ 11-12]. On Décember 19, 2014, defendant filed the present motion to dismiss [Doc. 8], supporting memorandum of law [Doc. 9], and supporting declaration with attached FDA records [Docs. 10,10-1 through 10-10]. After plaintiff failed to timely respond to the motion, defendant moved for either an order of dismissal or an order for plaintiff to show cause [Doc. 11 p. 2]. On June 3, 2015, the Court afforded plaintiff fourteen days to show cause why the action should not be dismissed [Doc. 12].'

Responding pro se on June 17, 2015, plaintiff explained that his counsel, Steven L. Williams, never received a copy of the motion to dismiss because he “is not currently licensed in [this Court] and as such is not part of the electronic filing system” [Doc. 13 ¶ 4].. Plaintiff supported his response with, an affidavit from Mr. Williams [Doc. 13-1] and requested thirty days to obtain substitute counsel and respond to defendant’s motion to dismiss [Doc. 13 ¶ 7]. The Court granted plaintiffs request and ordered that he - respond to defendant’s motion within thirty days [Doc. 14].

That deadline has now passed, see Fed. R.Civ.P. 6(a)(1), and the record contains no further response from plaintiff. Defendant subsequently filed a Motion for Entry of Order of Dismissal based on plaintiffs continued failure to respond and the merits of its motion to dismiss [Doc. 15].3

II. Standard of Review

Rule 8(a)(2) of the Federal Rules of Civil Procedure sets forth a liberal pleading standard. Smith v. City of Salem, 378 F.3d 566, 576 n. 1 (6th Cir.2004). It requires only “ - a short and plain statement of the claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant fair notice of what the ... claim is and the grounds upon which it rests.’ ” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (alteration in original) (quoting Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)).

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121 F. Supp. 3d 809, 2015 U.S. Dist. LEXIS 108234, 2015 WL 4902742, Counsel Stack Legal Research, https://law.counselstack.com/opinion/spier-v-coloplast-corp-tned-2015.