A new opinion we were sent the other day (thanks to Craig May), Sadler v. Advanced Bionics, Inc., C.A. No. 3:11-CV-00450-H, slip op. (W.D. Ky. March 8, 2013), is no exception.
The basic facts are the same. The defendant’s product failed due to leakage in a component called a “feedthru,” which of course went on, allegedly, to injure the plaintiff. Slip op. at 2. This problem arose after the defendant substituted a new vendor (called “Vendor B” in the opinion) for this component. Id. at 4. The defendant, not expecting a change in component part suppliers to make any significant difference in the component itself, didn’t file a PMA supplement over the change. Id. As things turned out, the new supplier produced a feedthru that leaked. Initially, there was uncertainty over whether the problem was a leak (that is to say, a sealant problem), as opposed to internal condensation (which would have implicated the manufacturing environment). Id. The devices were recalled twice, first (in 9/04) over condensation and then, a second time (in 3/06), for the leaks. Id. at 4-5. Still later, the FDA brought an enforcement action over the problems with the device, which the defendant manufacturer ultimately settled. Id. at 5.
By the time Sadler was ripe for summary judgment, four claims remained in dispute: negligence, “product liability,” negligence per se, and fraud (implied warranty and punitive damages had fallen by the wayside). Id. at 5. As always, with a Class III device, the central arguments on summary judgment concerned preemption. But preemption was not the only issue.
The plaintiff’s claim that the defendant should have obtained a PMA supplement when changing suppliers went first. The device as a whole had received PMA approval as had other supplements. The failure to obtain one more did not deprive the device or any part of it of PMA status and thus did not defeat preemption. Sadler, slip op. at 14.
The court then detoured to dispose of negligence per se – and it did so for a non-preemption-related reason. Remember our post back in January on negligence per se trivia? Well, one of the trivia points was this:
In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited. St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).
At the time we knew of no cases involving drugs or devices where this Kentucky-specific peculiarity had been asserted. Not so any longer. Sadler was under Kentucky law, and that law independently precluded FDCA-related negligence per se:
Plaintiffs’ negligence per se claims are void for a different [i.e., non-preemption] reason. Under Kentucky law, plaintiffs must bring negligence per se claims under KRS §446.070, which codified the common law negligence per se tort. [St. Luke citation omitted] The Kentucky Supreme Court determined that the General Assembly did not intend [this act] to embrace the whole of federal laws and the laws of other states and thereby confer a private civil remedy for such a vast array of violations. [T&M Jewelry citation omitted] Therefore, violations of federal law do not support negligence per se claims under Kentucky law. [another St. Luke citation omitted] Plaintiffs’ negligence per se claims, which are premised upon violations of federal law, are not cognizable as a matter of Kentucky law and must be dismissed.
Sadler, slip op. at 14-15 (citations and footnotes omitted). Readers heard it here first.
Fraud and misrepresentation went next. Under standard Riegel analysis, such claims amounted to “asking the Court to find that FDA-approved labels were in fact unlawful.” Id. at 16. Alternatively, they alleged fraud on the FDA, and were barred by Buckman. Id. at 15-16. Fraudulent omissions, which necessarily would implicate post-marketing disclosures, fared no better. “[R]ecognizing that the FDA requires continuous updates as part of the premarket approval application and supplement process that specifically address warnings and recalls associated with medical devices, the Sixth Circuit also held that state law failure to warn claims based on fraudulent omissions can be expressly preempted.” Id. at 17 (citing Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005)). Kentucky law predicates fraudulent omission on a pre-existing duty to disclose, but any such state-law duty would be “in addition to” FDA requirements:
Plaintiffs cite no federal duty to disclose to the public or to patients the omitted information. Therefore, to the extent Plaintiffs assert that [defendant] was under some state law duty to disclose, this amounts to an additional requirement, which §360k expressly preempts.
Id. at 18. This was no “free pass” to fraud, the court noted, because “the FDCA and MDA endow the FDA with ample power to regulate medical device manufacturers.” Id. at 18 n.15.
Part of plaintiff’s design defect claim survived preemption to the extent that the plaintiff alleged a departure from the relevant PMA supplement through the use of a different supplier (which made the faulty component). Sadler, slip op. at 20-21. However, to the extent that plaintiff asserted violation of a duty to submit a new supplemental PMA, that claim was preempted. “[F]ailure to file a PMA Supplement is a violation of an administrative obligation . . . [and] [a] state law claim seeking a remedy for this violation is a disguised claim to privately enforce the federal law,” preempted under Buckman and 21 U.S.C. §337(a). Id. at 20 n.20.
Likewise a piece of plaintiff’s manufacturing defect claim survived, but not much. “Most” FDA Good Manufacturing Practices “impose only administrative standards or flexible guidelines rather than mandate manufacturing requirements,” and are thus too vague to serve as a parallel claim. Sadler, slip op. at 21. Only one GMP cited by the plaintiff “impose[d] a concrete requirement . . . that embodies a standard of care related to the safety and effectiveness of the device.” Id.
Other CGMPs cited in the Complaint are too general to impose a federal requirement on medical device manufacturers, such that enforcing a state law claim based on violations of those CGMPs would impose an additional requirement on manufacturers, which is preempted under 21 U.S.C. §360k.
Id. at 21 (footnote listing these too-vague GMPs omitted).
In general, the fate of the plaintiffs’ negligence claim tracked what survived, and what, did not, in the plaintiff’s strict liability defect claims. See Id. at 27 (finding preemption “for the reasons stated above”). However, the court did separately determine that there could be no claim for “failure to conduct life cycle testing” because the FDA did not require such tests. Id.