Mink v. Smith & Nephew, Inc.
| Citation | 860 F.3d 1319 |
| Decision Date | 26 June 2017 |
| Docket Number | No. 16-11646,16-11646 |
| Court | United States Courts of Appeals. United States Court of Appeals (11th Circuit) |
| Parties | Joseph MINK, Plaintiff-Appellant, v. SMITH & NEPHEW, INC., Defendant-Appellee. |
Robert E. O'Connell, Robert E. O'Connell, PA, DEERFIELD BEACH, FL, Patrick Allen Luff, Luff Law Firm, PLLC, SAN ANTONIO, TX, Kip A. Petroff, Law Office of Kip A. Petroff, DALLAS, TX, for Plaintiff-Appellant.
Joseph H. Lang, Jr., Edward W. Gerecke, David J. Walz, Carlton Fields Jorden Burt, PA, TAMPA, FL, for Defendant-Appellee.
Before WILLIAM PRYOR, MARTIN, and BOGGS,* Circuit Judges.
Joseph Mink appeals the District Court's dismissal of his case against Smith & Nephew, Inc. ("S&N"), which brought four claims under Florida law. Mr. Mink's negligence, product liability, breach of contract, and misrepresentation claims stem from his decision to get S&N's metal-on-metal hip replacement system and the injuries he says it caused him. This system is a medical device regulated by the Food and Drug Administration ("FDA"). The District Court dismissed Mr. Mink's claims after finding they were not viable under Florida law and, in any event, were expressly and impliedly preempted by federal law. After careful consideration, and with the benefit of oral argument, we affirm the District Court's dismissal of Mr. Mink's negligence claim to the extent it relies on an improper training or failure to warn theory of liability. We also affirm the dismissal of Mr. Mink's breach of contract claim. We reverse the District Court's dismissal of Mr. Mink's negligence claim and strict product liability claims premised on manufacturing defect, as well as his misrepresentation claim.
S&N develops and manufactures joint replacement systems. One of its systems is the Birmingham Hip Resurfacing ("BHR") System, which is a metal-on-metal hip replacement system. As a Class III medical device, the BHR System requires premarket approval from the FDA before it can be made commercially available. The FDA gave this approval in May 2006, but set conditions. One condition was that S&N conduct a post-approval study to be sure of the device's safety and effectiveness over time. This study included assessments of renal function and monitoring of metal ion levels in a patient's blood.
Mr. Mink's doctor told him he needed a hip replacement. His doctor scheduled the surgery, planning to use a hip replacement system other than S&N's. However, before his surgery, Mr. Mink saw an advertisement for S&N's BHR system and contacted S&N about it. S&N referred Mr. Mink to Dr. Jason Weisstein, who was a local orthopedic surgeon and served as an S&N representative. Dr. Weisstein told Mr. Mink he could get the BHR System as a part of S&N's 10-year post-approval study. He also told Mr. Mink that as a study participant, Mr. Mink would be regularly monitored and tested for 10 years at no cost. Mr. Mink liked the sound of that. He agreed to use the BHR System as his hip replacement system and signed the consent form to enter the study. He believed he would get better monitoring and medical attention from S&N than he would get from a competitor's product that came with no study or related free benefits.
On June 6, 2011, Mr. Mink had the hip replacement surgery and got the BHR System. About seven weeks later, on August 1, 2011, Dr. Weisstein informed Mr. Mink that he was moving away and could no longer see Mr. Mink for the BHR study. But Dr. Weisstein assured Mr. Mink that he would find another local doctor so that Mr. Mink could continue to participate in the BHR study and receive its benefits. On August 18, 2011, Dr. Weisstein told Mr. Mink that S&N had arranged for his continued participation in the study with Dr. Gregory Martin. So Mr. Mink visited Dr. Martin. To his surprise, Dr. Martin had never heard about Mr. Mink or his participation in the BHR study. To add insult to Mr. Mink's injury, he also got a bill for his visit to Dr. Martin. On May 14, 2012, S&N told Mr. Mink it could not find a clinical site for him to continue participating in the BHR study. S&N terminated Mr. Mink from the study and told him so.
As time passed, Mr. Mink experienced higher-than-normal chromium and cobalt levels in his blood. In light of this, he had the metal-ion levels in his blood closely monitored even after he was terminated from the study—only now at his own expense. Unfortunately, Mr. Mink's problems with the BHR System only got worse. He began to experience eye problems, and his left inguinal lymph node, near the site of his hip replacement, became so enlarged it had to be surgically removed. Mr. Mink's blood toxicity from the chromium and cobalt leaching from the BHR System continued to worsen as well. Eventually, on November 17, 2014, Mr. Mink had to have the BHR System removed in what is called a "revision" surgery.
Mr. Mink brought four claims under Florida law against S&N. They are claims for (1) negligence; (2) strict product liability; (3) breach of contract; and (4) misrepresentation. His negligence claim is, in turn, premised on three possible theories: (1) a defect in the manufacturing process; (2) inadequate or improper training; and (3) failure to report adverse events. His strict product liability claim is also based on a manufacturing defect theory. The strict product liability claim alleged that S&N violated the FDA-required manufacturing specifications in the BHR System he got. His breach of contract claim alleges that S&N breached its agreement with him about the BHR study. And his misrepresentation claim is based on misrepresentations that Mr. Mink says S&N made about the free medical care he would receive as well as misrepresentations about the product having been proven safe in England. He says these misrepresentations induced him to get S&N's BHR system instead of a competitor's hip replacement product.
The District Court granted S&N's motion to dismiss. S&N argued that all four of Mr. Mink's claims failed to state a claim upon which relief could be granted because they were barred under Florida state law; expressly preempted by federal law; and impliedly preempted by federal law. The District Court found all claims due to be dismissed because: (1) the negligence claim was barred under Florida law, and alternatively, impliedly preempted by federal law; (2) the strict product liability claim was impliedly preempted by federal law; (3) the breach of contract claim failed under Florida law, and alternatively, was expressly preempted by federal law; and (4) the misrepresentation claim "succumb[ed] to the same legal theories which force[d] the dismissal of the previously-discussed claims." All of Mr. Mink's claims were dismissed with prejudice. This appeal followed.
We review de novo the District Court's dismissal of a complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). Hill v. White , 321 F.3d 1334, 1335 (11th Cir. 2003) (per curiam). A plaintiff's allegations are accepted as true and we construe his complaint in the light most favorable to him. Id. We also review de novo the District Court's interpretation of state law. Tampa Bay Water v. HDR Eng'g, Inc. , 731 F.3d 1171, 1177 (11th Cir. 2013). We may affirm the District Court on any ground supported by the record, regardless of whether the District Court relied on it. See Krutzig v. Pulte Home Corp. , 602 F.3d 1231, 1234 (11th Cir. 2010).
The Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. , were enacted to amend the FDA's enabling statute, the Food, Drug, and Cosmetic Act, id. § 301 et seq. The Medical Device Amendments gave the FDA regulatory authority over medical devices for human use. See § 360c et seq. Under that authority, the FDA classifies medical devices into three categories, depending on the level of risk presented. See Riegel v. Medtronic, Inc. , 552 U.S. 312, 316–17, 128 S.Ct. 999, 1003, 169 L.Ed.2d 892 (2008). All metal-on-metal hip replacements are considered "Class III" medical devices, which is the highest category of risk. See id. ; 21 U.S.C. § 360c(a)(1) ; 21 C.F.R. § 888. Any company wanting to sell a metal-on-metal hip replacement system is required to undergo the FDA's "premarket approval" process. 21 C.F.R. § 814.1.
Premarket approval is a rigorous process of federal review that evaluates a medical device's safety and effectiveness. See Riegel , 552 U.S. at 317–20, 128 S.Ct. at 1004–05 (describing this process). This process takes, on average, about 1,200 hours of review by the FDA. Id. at 318, 128 S.Ct. 999. For each device, the FDA compiles a large amount of data and carefully weighs the risks and benefits. See id. Even once approved, the FDA regularly attaches specific conditions to a device. See id. at 319, 128 S.Ct. 999 ; 21 U.S.C. § 360j(e)(1). And after the FDA approves a device, the manufacturer may not make any change to the device's specifications, or anything else that might affect its safety and effectiveness, unless it submits a supplemental application to the FDA. 21 U.S.C. § 360e(d)(5)(A)(i). The FDA must be informed of changes to the manufacturing process. Id. The manufacturer must report information to the FDA, including new studies about the device and any adverse events. Id. § 360i; 21 C.F.R. §§ 803.50(a), 814.84(b)(2).
The Medical Device Amendments contain, among other things, two provisions that are central to this appeal. They are 21 U.S.C. § 360k(a), the "express preemption" provision, and 21 U.S.C. § 337(a), the "implied preemption" provision. S&N argues that these two provisions preempt all of Mr. Mink's state law claims.
Section 360k(a) applies to Class III medical devices and says:
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