Mink v. Smith & Nephew, Inc., Case No. 15–CIV–61210–BLOOM/Valle

• Decision Date: 18 November 2015
• Docket Number: Case No. 15–CIV–61210–BLOOM/Valle
• Citation: 145 F.Supp.3d 1208
• Court: U.S. District Court — Southern District of Florida
• Parties: Joseph T. Mink, Plaintiff, v. Smith & Nephew, Inc., a foreign corporation, Defendant.

145 F.Supp.3d 1208

Joseph T. Mink, Plaintiff,

v.Smith & Nephew, Inc., a foreign corporation, Defendant.

Case No. 15–CIV–61210–BLOOM/Valle

United States District Court, S.D. Florida.

Signed November 18, 2015

Entered November 19, 2015

Robert Edward O'Connell, Robert E. O'Connell, P.A., Pompano Beach, FL, for Plaintiff.

David J. Walz, Edward Walter Gerecke, Carlton Fields Jorden Burt, P.A., Tampa, FL, for Defendant.

ORDER

BETH BLOOM, UNITED STATES DISTRICT JUDGE

THIS CAUSE is before the Court upon Defendant's Motion to Dismiss, ECF No. [16] (“Motion”), Plaintiff's Amended Complaint, ECF No. [6] (“Am.Compl.”). The Court has reviewed the Motion, all supporting and opposing filings, including Plaintiff's Response, ECF No. [20] (“Pl.Resp.”), and Defendant's Reply, ECF No. [27], and the record in this case. Being fully advised, the Motion is GRANTED for the reasons set forth below.

I. Background

On June 6, 2011, Plaintiff Joseph Mink (“Plaintiff” or “Mink”) underwent a hip-replacement surgery. See Am. Compl. at ¶ 16. Shortly thereafter, Mink began experiencing elevated chromium and cobalt levels in his blood, metal ions which are toxic to the human body at certain levels. See id. ¶¶ 23–24. Mink suffered deleterious effects from the large content of metal ions in his bloodstream, id. ¶¶ 25–28, and now brings this action for damages related to the harm that he incurred.

Defendant Smith & Nephew, Inc. (“Defendant” or S & N”) develops and manufactures joint replacement systems, including a metal-on-metal hip resurfacing prosthesis comprised of a femoral head and hemispherical acetabular cup, known as the “Birmingham Hip Resurfacing System” (the “BHR,” “BHR System,” or “System”). Id. ¶¶ 7–8. Prior to its commercial distribution, the BHR underwent premarket approval (“PMA”) by the Food and Drug Administration (“FDA”). Id. ¶ 9. The BHR received conditional approval on May 9, 2006, which permitted S & N to distribute the BHR in accordance with certain conditions imposed by the FDA, including FDA approval of supplemental changes affecting the safety or effectiveness of the device, post-approval reporting requirements, and adverse reaction and device defect reporting. Id. ¶¶ 9–10; Exhibit “A” to Am. Compl., May 9, 2006, FDA Approval Letter, ECF No. [6–1] (“PMA Approval Letter”) at 1, 6–9.

After being diagnosed as requiring a hip replacement, Mink's orthopedic surgeon scheduled the surgery with a competing manufacturer's system. Am. Compl. ¶¶ 11–12. Upon learning of S & N's BHR System through advertisements, Mink met with Jason Weisstein, M.D. (“Dr.Weisstein”), an orthopedic surgeon purportedly acting as an agent and representative of S & N. Id. ¶¶ 12–13. Dr. Weisstein advised Mink of the BHR's FDA premarket approval and informed Mink that if he agreed to use the BHR, he would be included in S & N's 10–year post approval study, where he would be regularly monitored with follow-up visits and testing for 10 years at no personal cost (the “BHR Study” or “Study”). Id. ¶ 14. Based on these representations made by Dr. Weisstein, Mink agreed to undergo his hip replacement surgery using the BHR system and signed a form consenting to his involvement in the post-surgery study. Id. ¶ 15; Exhibit “B” to Am. Compl., Consent to Participate in a Clinical Research Study Entitled: A Prospective, Multi–Centered Study of the Birmingham Hip Resurfacing System, ECF No. [6–2] (“Consent to Participate Form”) at 2–10.

As noted above, Mink began encountering adverse effects of the BHR System shortly after it was installed. See Am. Compl. ¶¶ 23–24. He suffered from eye problems and an enlarged left inguinal lymph node near the operative site that had to be surgically removed. Id. at ¶ 25.

Additionally, Mink was no longer able to participate in the BHR Study. Id. ¶¶ 18–23. In August 2011, Dr. Weisstein advised Mink that he was relocating due to a job opportunity and that the BHR Study would not continue at his office. Id. ¶¶ 18–19; Exhibit “C” to Am. Compl., ECF No. [6–3] (“August 1st Weisstein Letter”) at 2. Stating that he was in communication with S & N regarding Mink's continued involvement in the BHR Study, Dr. Weisstein told Mink that he would arrange a convenient, local follow-up. Id. On August 18, 2011, Dr. Weisstein made good on his promise and informed Mink that S & N had arranged for him to continue as a participant in the BHR Study with Gregory Martin, M.D. (“Dr.Martin”). Am. Compl. ¶ 20; see also Exhibit “D” to Am. Compl., ECF No. [6–4] (“August 18th Weisstein Letter”) at 2. Assuming that the visit to Dr. Martin would be covered by the BHR Study, Mink was surprised when Dr. Martin knew nothing about him or his participation in the BHR Study. See Am. Compl. ¶ 21. Mink received a bill for his visit. Id. On May 14, 2012, S & N informed Mink that the BHR Study had been terminated with Mink's regional hospital and that S & N was unable to identify a clinical site to continue the follow-up study activities. See id. ¶ 22; Exhibit “E” to Am. Compl., ECF No. [6–5] (“Termination Letter”) at 2. Accordingly, S & N released Mink from the Study and explained to him that he would not be subject to any follow-up obligations. See Termination Letter at 2. Mink did not wish to be terminated from the BHR Study and, due to the ever-increasing toxicity of his blood, was obligated to monitor the situation at his own expense. See Am. Compl. ¶¶ 23–24. On November 17, 2014, Mink underwent a second, corrective surgery to remove the BHR that was allegedly poisoning him. Id. ¶ 30.

Due to the injurious effects of the BHR, Mink asserts that the System was defective “in that it did not meet the requirements of the FDA to comply with current good manufacturing practices to insure that the finished BHR [would] be safe and effective and otherwise in compliance with 21 U.S.C. Section 360(e).” Id. ¶ 27. Mink further alleges that the sole basis for termination of the Study, both with him individually and with his local hospital, was avoidance of reporting requirements. Id. ¶ 29.

Thus, Mink brings three claims predicated upon the alleged fact that S & N violated federal safety statutes and regulations.¹

Id. ¶¶ 37, 42. First, Mink brings a claim for negligence stemming from S & N's purported violations of a laundry list of related federal regulations, and asserts that S & N breached its duty to comply with the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360 et seq. (the “FDCA” or “Act”) (“Count I”). See id. ¶¶ 31–38. Second, Mink brings a claim for strict products liability, believing that the BHR System was “unreasonably dangerous” when it left S & N's control and entered the stream of commerce (“Count II”). See id. at ¶¶ 37–43.² Third, Mink alleges that S & N breached an express or implied warranty by (1) failing to honor the bargain that Mink would continue as a BHR Study participant, and (2) by expressly warranting that the BHR System was in full compliance with FDA PMA conditions (“Count V”). See id. ¶¶ 62–69.

Mink also brings claims for breach of contract (“Count III”) and negligent misrepresentation (“Count IV”). See generally id. ¶¶ 44–61. Under his theory of breach of contract, Mink contends that S & N failed to comply with the terms of the Consent to Participate Form by terminating him as a Study participant and declining to transfer Mink to another approved doctor to continue the Study. Id. ¶¶ 44–55. Mink's claim for negligent misrepresentation travels under a similar theory, namely, that S & N misrepresented to Mink that he would be a continuing BHR Study participant and would receive the benefits thereof for a minimum of 10 years at no out-of-pocket cost to him. See id. ¶¶ 55–61. He alleges that these misrepresentations induced him to abandon the competitor's product and, instead, sign up for implantation of the BHR. See id.

S & N now seeks dismissal, stating that the entirety of Mink's Amended Complaint is preempted under federal law and otherwise fails to allege parallel claims. See generally Motion.

II. Legal Standard

Rule 8 of the Federal Rules requires a pleading to contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). Although a complaint “does not need detailed factual allegations,” it must provide “more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ; see Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (explaining that Rule 8(a)(2)'s pleading standard “demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation”). In the same vein, a complaint may not rest on “ ‘naked assertion [s]’ devoid of ‘further factual enhancement.’ ” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 557, 127 S.Ct. 1955 (alteration in original)). These elements are required to survive a motion brought under Rule 12(b)(6) of the Federal Rules of Civil Procedure, which requests dismissal for “failure to state a claim upon which relief can be granted.”

When reviewing a motion under Rule 12(b)(6), a court, as a general rule, must accept the plaintiff's allegations as true and evaluate all plausible inferences derived from those facts in favor of the plaintiff. See Chaparro v. Carnival Corp., 693 F.3d 1333, 1337 (11th Cir.2012) ; Miccosukee Tribe of Indians of Fla. v. S. Everglades Restoration Alliance, 304 F.3d 1076, 1084 (11th Cir.2002) ; AXA Equitable Life Ins. Co. v. Infinity Fin. Grp., LLC, 608 F.Supp.2d 1349, 1353 (S.D.Fla.2009) (“On a motion to dismiss, the complaint is construed in the light most favorable to the non-moving party, and all facts alleged by the non-moving party are accepted as true.”). Accordingly, a court considering a Rule 12(b) motion is generally limited to the facts contained in the complaint and attached exhibits, including documents referred to in the complaint that are central to the claim. See ...