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

Decision Date11 March 2016
Docket NumberCase No. 15–CIV–61210–BLOOM/VALLE
CourtU.S. District Court — Southern District of Florida
Parties Joseph T. Mink, Plaintiff, v. Smith & Nephew, Inc., a foreign corporation, Defendant.

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.




This cause is before the Court upon Defendant Smith & Nephew, Inc's Motion to Dismiss Plaintiff's Second Amended Complaint (“Motion”), ECF No. [32]. The Court has considered the Motion, all supporting and opposing filings, including Plaintiff Joseph Mink's Response (Pl.Resp.), ECF No. [33], and Defendant's Reply (“Def.Reply”), ECF No. [36], and has reviewed Plaintiff's Second Amended Complaint (“SAC”), ECF No. [29], and the record in this case. Being fully advised, the Motion is GRANTED for the reasons set forth below.


The instant Motion raises issues identical to those raised with respect to Plaintiff Joseph Mink's Amended Complaint, which was dismissed with leave to amend on November 18, 2015. See Mink v. Smith & Nephew, Inc., 145 F.Supp.3d 1208, No. 15–CIV–61210, 2015 WL 7356285 (S.D.Fla. Nov. 18, 2015)

. Consequently, a recitation of the underlying facts is repetitive but necessary.

On June 6, 2011, Plaintiff Joseph Mink (Plaintiff or “Mink”) underwent a hip-replacement surgery. See SAC at ¶ 19. 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. at ¶¶ 28–29, 32. Mink suffered deleterious effects from the large content of metal ions in his bloodstream, including eye problems and an enlarged left inguinal lymph node near the operative site that had to be surgically removed. Id. at ¶¶ 28–32. Mink now brings this action for damages stemming from this harm.

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”). See id. at ¶¶ 6–8. Prior to its commercial distribution, the BHR underwent premarket approval (“PMA”) by the Food and Drug Administration (“FDA”). Id. at ¶ 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. at ¶¶ 9–10, 38–42; Exhibit “A” to SAC, May 9, 2006, FDA Approval Letter (“PMA Approval Letter”), ECF No. [29–1] 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. SAC at ¶¶ 11–12. Upon learning of S & N's BHR System through advertisements, Mink contacted S & N, and was directed by S & N to Jason Weisstein, M.D. (“Dr.Weisstein”), a local orthopedic surgeon purportedly acting as either the express or implied agent or representative of S & N. Id. at ¶¶ 12–13. Mink met with Dr. Weisstein, who 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. at ¶ 14. The Study included assessments of renal functions, as well as blood samples to monitor metal ions in the blood over the long term. Id. Based on these representations concerning the BHR Study, Mink believed that he would be more closely monitored than if he had the surgery performed elsewhere. See id. at ¶ 15. Accordingly, Mink agreed to undergo the hip replacement surgery using the BHR System and signed a form consenting to his involvement in the BHR Study. Id. at ¶ 16; Exhibit “B” to SAC, Consent to Participate in a Clinical Research Study Entitled: A Prospective, Multi–Centered Study of the Birmingham Hip Resurfacing System (“Consent to Participate Form”), ECF No. [29–2] at 2–10.

Approximately seven weeks after the surgery, on August 1, 2011, Dr. Weisstein advised Mink that he was relocating and that the follow-ups under the BHR Study at his office would be discontinued. Id. at ¶¶ 22; Exhibit “C” to SAC (“August 1st Weisstein Letter”), ECF No. [29–3] 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. August 1st Weisstein Letter at 2. 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”). SAC at ¶ 23; see also Exhibit “D” to SAC (“August 18th Weisstein Letter”), ECF No. [29–4] 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, and was even more surprised when he received a bill for his visit. See SAC at ¶ 25. On May 14, 2012, S & N informed Mink that it could not locate a clinical site to continue follow-up study activities and was, therefore, terminating him from the Study. See id. at ¶ 26; see also Exhibit “E” to SAC (“Termination Letter”), ECF No. [29–5] at 2 (noting that S & N was “releasing [Mink] of any/and all follow-up obligations per protocol”). At no point did Mink wish to be terminated from the Study, particularly in light of the ever-increasing chromium and cobalt levels in his blood. See id. at ¶ 28. Due to the rising toxicity in his blood, Mink was obligated to monitor the situation at his own expense. Id. at ¶ 29. On November 17, 2014, Mink underwent revision surgery to remove the BHR System. Id. at ¶ 37.

As noted, the injurious effects of the BHR prompted Mink to initiate this action, where he now asserts that the BHR System was defective because it failed to comport with FDA requirements and failed to follow the FDA's Current Good Manufacturing Practice provisions “to insure that the finished BHR will be in specific compliance with 21 U.S.C. § 360(e)

,” believing that a properly manufactured BHR System “would not cause immediate and toxic levels of chromium and cobalt in [his] blood.” See SAC at ¶ 33. Although Mink cannot presently identify how the BHR System is noncompliant with 21 U.S.C. § 360(e), he, nevertheless, believes that the installed System was not manufactured to the specifications required by 21 U.S.C. § 360(e) based on the immediacy of the metal poisoning.1

Id. at ¶ 34. Mink also insinuates that his termination from the Study was, in part, an attempt to avoid reporting requirements. Id. at ¶ 35 (noting that S & N would have been required to file an “Adverse Reaction and Device Defect Report” with the FDA).

Based on the foregoing, Mink brings four claims: (1) negligence; (2) strict products liability; (3) breach of contract; and (4) misrepresentation. See id. at ¶¶ 43–89.

Mink's common-law negligence claim (“Count I”) arises from S & N's purported breach of its duty to comply with and not deviate from the PMA requirements contained in the BHR System's FDA approval, as well as “other federal statutory and regulatory requirements that applied to the BHR System.” See id. at ¶¶ 43–45. Specifically, Mink discloses a slew of alleged violations of 21 C.F.R. §§ 814.82

, 814.84, 820.30, 820.80, 820.100, and 820.198, which are brought “only to the extent that they are parallel to and not different from or in addition to the requirements of federal law.” See

id. at ¶ 51. Mink's strict products liability claim (“Count II”) similarly relies on S & N's purported violation of 21 C.F.R. § 814.80 and other federal regulatory law by deviating from the manufacture specifications approved by the FDA in its PMA Approval Letter. Id. at ¶ 59. Based on these violations, Mink concludes that the BHR System was defective and unreasonably dangerous when it left S & N's possession. See

id. at ¶ 59.

Mink also brings claims for breach of contract (“Count III”) and negligent misrepresentation (“Count IV”). See generally id. at ¶¶ 66–89. 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. at ¶¶ 74–76. 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. at ¶¶ 81–88. He alleges that these misrepresentations induced him to abandon the competitor's product and, instead, sign up for implantation of the BHR. See id. Although the representations related to Counts III and IV were made by Dr. Weisstein, Mink contends that Dr. Weisstein was S & N's trained and approved doctor, who was acting as S & N's expressed and implied agent. Id. at ¶¶ 66–68, 70, 81. Alternatively, Mink claims that S & N ratified Dr. Weisstein's representations and commitments. See, e.g., id. at ¶ 67.

Once again, S & N seeks dismissal, arguing that the operative pleading is either expressly or impliedly preempted, or otherwise barred under Florida law. See Motion.

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...

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