Spier v. Coloplast Corp.

• Decision Date: 17 August 2015
• Docket Number: No. 3:14–CV–550–TAV–HBG.,3:14–CV–550–TAV–HBG.
• Citation: 121 F.Supp.3d 809
• Parties: Stanley Roger SPIER, Plaintiff, v. COLOPLAST CORPORATION, Defendant.
• Court: U.S. District Court — Eastern District of Tennessee

121 F.Supp.3d 809

Stanley Roger SPIER, Plaintiff,

v.COLOPLAST CORPORATION, Defendant.

No. 3:14–CV–550–TAV–HBG.

United States District Court, E.D. Tennessee.

Filed Aug. 17, 2015.

Andre T. Hanson, Ronn B. Kreps, Sparrowleaf D. McGregor, Fulbright & Jaworski, LLP, Minneapolis, MN, W. Tyler Chastain, Bernstein, Stair & McAdams, LLP, Knoxville, TN, for Defendant.

MEMORANDUM OPINION

THOMAS A. VARLAN, Chief Judge.

This civil action is before the Court on defendant Coloplast Corporation's motion to dismiss plaintiff's 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 plaintiff's 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 defendant manufactures and which plaintiff received via surgical implant [Doc. 1–1 ¶ 3].

A. FDA Approval of the Titan Prosthesis²

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" [Id. ]. 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 "[b]efore 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 " ‘nonfunctioning /poorly functioning’ " [Id. ¶ 6]. Plaintiff alleges these malfunctions caused him to suffer "injuries ... requir [ing] 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 December 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 plaintiff's 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 plaintiff's 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) ). Detailed factual allegations are not required, but a party's "obligation to provide the ‘grounds' of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (alteration in original) (quoting Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986) ). "Nor does a complaint suffice if it tenders ‘naked assertion[s]’ devoid of ‘further factual enhancement.’ "

Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (alteration in original) (quoting Twombly, 550 U.S. at 557, 127 S.Ct. 1955 ).

In deciding a Rule 12(b)(6) motion to dismiss, the Court must determine whether the complaint contains "enough facts to state a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570, 127 S.Ct. 1955. In doing so, the Court "construe[s] the complaint in the light most favorable to the plaintiff, accept[s] its allegations as true, and draw[s] all reasonable inferences in favor of the plaintiff." Directv, Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir.2007) (citation omitted). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955 ).

"Determining whether a complaint states a plausible claim for relief will ... be a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. at 679, 129 S.Ct. 1937 (citation omitted). In addition, while the Court's analysis under Rule 12(b)(6)" ‘rests primarily upon the allegations of the complaint, matters of public record, orders, items appearing in the record of the case, and exhibits attached to the complaint also may be taken into account.’ " Henry v. Chesapeake Appalachia, L.L.C., 739 F.3d 909, 912 (6th Cir.2014) (quoting Barany–Snyder v. Weiner, 539 F.3d 327, 332 (6th Cir.2008) ); see also Malin v. JPMorgan, 860 F.Supp.2d 574, 578 (E.D.Tenn.2012) (citations omitted) (finding that taking judicial notice of matters of public record does not convert a Rule 12(b)(6) motion into a Rule 56 motion for summary judgment); Signature Combs, Inc. v. United States, 253 F.Supp.2d 1028, 1040 n. 5 (W.D.Tenn.2003) (same).

III. Analysis

Defendant argues that plaintiff's four state-law causes of action—design defect, failure to warn, and breach of express and implied warranties⁴ —either are expressly preempted by federal law or otherwise fail to meet the pleading standard of Federal Rule of Civil Procedure 8(a)(2), as interpreted by the Supreme Court in Twombly and Iqbal [Doc. 9 p. 5, 16, 20].⁵ For the reasons below, the Court agrees with defendant that all of plaintiff's claims fail as a matter of law and must be dismissed.

A. Legal Background

The Food, Drug, and Cosmetic Act of 1938 provided for FDA premarket approval of new prescription drugs, but "it did not authorize any control over the introduction of new medical devices." Medtronic, Inc. v. Lohr, 518 U.S. 470, 475, 116 S.Ct. 2240, 135...