We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot of thought into it. From time to time, however, we see an opinion that is just plain wrong, and we have to call it out. That is the case today with Mink v. Smith & Nephew, Inc., No. 16-11646, 2017 WL 2723913 (11th Cir. June 26, 2017). The plaintiff sued the manufacturer of a metal-on-metal hip replacement device for negligence and strict product liability, among other claims, alleging that the manufacturer did not meet federal requirements in the manufacture of the device, that it improperly trained surgeons, and that it failed to report adverse events. Id. at **6-8.
The device is a Class III device approved through the FDA's rigorous premarket approval process. That means express preemption applies, and because the plaintiff was suing to enforce federal requirements on the manufacturing of a device, implied preemption applies, too. The district court so ruled and dismissed the plaintiff's claims. Id. at *2. But the Eleventh Circuit came to the opposite conclusion, and the opinion caught our eye for two reasons. First, the Eleventh Circuit professes to know more about Florida law than the Florida courts. What do we mean by that? Well, the Medical Device Amendments state that federal law preempts all state law requirements "different from or in addition to" federal requirements. Under the widely misunderstood "parallel claim" exception, plaintiffs can sometimes pursue state law claims that "parallel" federal claims, but this requires that state law actually recognize such a cause of action.
Here, the Eleventh Circuit allowed the plaintiff's manufacturing defect claims to proceed as "parallel claims" because Florida recognizes a strict product liability claim based on a manufacturing defect and the plaintiff alleged that the defendant "violated the Florida common law duty to use due care in manufacturing a medical device." Id. at *7. This is okay as far as it goes, but what was the basis for the manufacturing defect and the alleged breach of duty? The manufacturer did not comply with the FDA's requirements. Id. at *8. The plaintiff was suing because the manufacturer allegedly violated federal requirements.
That is federal preemption. Moreover, a Florida court recently held in the context of MDA express preemption that neither federal law nor Florida state law creates a private right of action to enforce federal medical device requirements. Id. at *5 (discussing Wolicki-Gables v. Doctors Same Day Surgery Ctr., Ltd., 216 So. 3d 665 (Fla. Dist. Ct. App. 2017)). To make matters worse, the Florida Supreme Court held more than twenty years ago that penal and regulatory laws do not create a private right of action under Florida law absent a clear legislative intent to do so. See Murthy v. N. Sinha Corp., 644 So. 2d 983, 986 (Fla. 1994). Congress has expressly said that the FDCA and the Medical Device Amendments do not create a private right of action, and the Florida legislature has never created such a right of action either. The Eleventh Circuit apparently knows better.
The second reason this opinion caught our eye is the Eleventh's Circuit's apparent motivation—that unless it reversed the district court's order dismissing the plaintiff's claims, the plaintiff would not be allowed to proceed. Id. at *5. We sometimes characterize opinions as "result oriented," but rarely are circuit courts so blunt. This court took umbrage with the idea that a plaintiff would not be able to pursue product liability claims against the manufacturer of a premarket approved device. The Supreme Court thought differently in Riegel.
The court did hold that claims based on inadequate training were expressly preempted because no such claim exists under Florida law (i.e., there is no "parallel"), and the claim based on the failure to report adverse events was impliedly preempted because it was similar to a "fraud on the FDA" theory, per Buckman. The district court, however, came to correct result for the correct reasons when it dismissed the plaintiff's claims. The Eleventh Circuit should have affirmed it.
This article is presented for informational purposes only and is not intended to constitute legal advice.
