The Federal Medical Device Amendments Do Not Preempt All State-Law Claims

The Eleventh Circuit applied Florida law and the preemption provisions of the federal Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq., to reverse the district court’s dismissal of some, but not all, of a plaintiff’s claims against the manufacturer of a hip-replacement device. Mink v. Smith & Nephew, Inc., 2017 WL 2723913 (11th Cir. June 26, 2017).

The device at issue—a “metal-on-metal” hip replacement system—was a Class III medical device, subject to premarket approval by the FDA. Its approval, when granted, was conditional on the manufacturer’s meeting FDA-imposed conditions, including a requirement that the manufacturer conduct post-approval studies to confirm safety and effectiveness.  Joseph Mink chose the device for his own hip replacement, he claimed, after seeing a television advertisement for the device and speaking with a local doctor and company representative who told Mr. Mink that he would be monitored and tested for 10 years after surgery at the manufacturer’s expense.  Mr. Mink went ahead with the surgery.  But the doctor left town and Mr. Mink ended up paying for follow-up testing—and ultimately a reversal of the hip replacement—himself.

Mink filed a complaint against the manufacturer including claims for negligence, strict product liability, breach of contract, and misrepresentation. The district court dismissed all of the claims, finding them barred by Florida law and/or preempted by federal law.  The Eleventh Circuit, in an opinion written by Judge Beverly Martin and joined by Judge William Pryor and by Judge Danny J. Boggs visiting from the Sixth Circuit, reversed in part.

The Eleventh Circuit reviewed the Medical Device Amendments’ provisions for express and implied preemption of state-law claims. The express preemption provision, Section 360k(a), “does not allow a state to impose a requirement on a Class III medical device that is ‘different from, or in addition to’ any federal requirement on the device.”  The Eleventh Circuit noted that the Supreme Court, in Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996), made clear that the provision does not preempt all state-law claims—“[t]he Court explained that state common law claims could still be pursued by plaintiffs if the claims were based on the violation of federal law.”

The implied preemption provision, Section 337(a), “requires that, with exceptions not relevant here, ‘all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.’”  Under this provision, “traditional state-law tort claims survive implied preemption so long as they don’t seek to privately enforce a duty owed to the FDA.”  The Eleventh Circuit noted that a Florida case cited by the defendant, Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., 216 So. 3d 665 (Fla. 2d DCA 2017), “mistakenly” stated “that as a general matter, ‘[c]ommon law damage claims are inadequate to escape federal preemption.’”  The Eleventh Circuit clarified that as a matter of federal law, some such claims can survive preemption.

Turning to Mr. Mink’s specific claims, the Eleventh Circuit held that he could not state a claim for negligence based on improper training, because the claim was barred by Florida’s learned-intermediary doctrine. His negligence claim for “failure to warn,” which was premised on the manufacturer’s alleged failure to report adverse events to the FDA, was impliedly preempted by the Medical Device Amendments.  But his negligence and strict liability claims based on an alleged manufacturing defect were properly pled, not preempted, and should not have been dismissed:  these were viable state-law claims based on a state-law duty—to use due care in manufacturing a medical device—that is “parallel to” the requirements imposed by federal law.

The breach of contract claim was properly dismissed based on concessions about the nature of the alleged agreement made during oral argument. And the misrepresentation claim—based on the doctor’s alleged assurances about free testing and monitoring—should not have been dismissed because it was an adequately stated tort claim outside the reach of the statutory preemption provisions (which were concerned with the safety and effectiveness of the device, not the company’s alleged promises about free testing).

Posted by Valerie Sanders.


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