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We had to comment on the most intriguing case of Hughes v. Boston Scientific Corp., 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009). Hughes involved a PMA device, something called a “HydroTherm Ablator,” that allegedly malfunctioned and injured the plaintiff. Thereafter, the defendant (1) changed its adverse event reporting algorithm in response to FDA concerns, and (2) still later, instituted a Class II recall of the device.
Faced with the inevitable Riegel-based preemption motion, the plaintiff did two interesting things: First, she tried to turn what was basically a warning-based cause of action into a “manufacturing defect” claim:

[T]his so-called “manufacturing defect” manifests itself through [defendant’s] failure to properly label, warn and correct perceived faults in the [device] because [defendant] failed to provide proper injury and malfunction data to the FDA. Under the plaintiff’s theory, if [defendant] had properly informed the FDA of the [device’s] fault rate and malfunction errors, then the FDA would have required different or supplemental warnings and labeling and perhaps manufacturing changes.

2009 WL 3817586, at *10.
The second thing plaintiff did was to relabel what was essentially a fraud-on-the-FDA claim as “negligent misrepresentation” and “negligence per se” – all based upon the defendant’s changing the algorithm upon which its adverse event reporting was based. 2009 WL 3817586, at *10.
Neither of these innovations worked, although the court did call the plaintiff’s theories “novel and intriguing.” 2009 WL 3817586, at *10.
The court quite correctly held, in light of the policies that led to preemption in Buckman, that scienter – whether the alleged mis-reporting to the FDA was considered “fraudulent” or “negligent” – didn’t matter a hill of beans. It was still second guessing the adequacy of the defendant’s reports to the FDA combined with speculation that, with “true” information, the FDA might have done something differently that would have prevented the device from being used. As such, that raised all the policy grounds that supported preemption in Buckman:

The Buckman holding did not turn on intentional versus negligent violation of FDA regulations, but on the principle of maintaining a “federal statutory scheme” put in place by Congress. The Supreme Court found that allowing the Buckman plaintiffs’ claim would “exert an extraneous pull on the scheme established by Congress, and it [was] therefore preempted by that scheme.” Under this rationale, claims asserting misrepresentations, intentional or otherwise, made to the FDA regarding Class III medical devices are preempted by federal law.

2009 WL 3817586, at *11 (Buckman citations and quotes omitted). In other words “negligent misrepresentation on the FDA” is just as preempted as fraud on the FDA, and for the same reasons.
But there’s more. “Novel and intriguing” theories produce novel and intriguing opinions – especially when rejecting such theories. Otherwise they can produce really bad law.
The court then turned both barrels on the negligence per se claim – by both barrels, we mean both state law (failure to state a claim) and federal law (preemption).
The court recognized that FDCA-based negligence per se was widely rejected as a matter of state law – because state negligence per se doctrines do not operate in the face of contrary legislative intent. “[N]umerous courts have rejected negligence per se claims based on alleged violations of FDA regulations as contrary to Congressional intent.” 2009 WL 3817586, at *11. We’re pleased to note that, of the nine decisions in the ensuing string citation, six of them involved orthopedic bone screws (where we first came up with these state-law-based defenses to FDCA-based negligence per se). As we said yesterday – you scratch our precedent, we’ll scratch yours.
Citing another Bone Screw case (if the defendant was Sofamor, Danek, Smith Nephew, or Acromed, and the date is between 1995 and 2001 – chances are its a Bone Screw case), the court goes on to recognize that only “substantive violations” (your product didn’t conform to the intended design) rather than “administrative violations” (failure to go through FDA procedures properly) could qualify as negligence per se under state law:

[S]ince such administrative requirements lack independent substantive content, they do not impose a standard of care, the breach of which could form the basis of a negligence per se claim. The defendant contends likewise, i.e., that the reporting regulations contained in the MDA which the plaintiff maintains were not properly met in this case are the type of administrative tools used by the FDA to facilitate the administration of its underlying regulatory scheme and are, thus, administrative, and not substantive, federal regulations. This court agrees.

2009 WL 3817586, at *12. That’s two important non-preemption based defenses to FDCA-based negligence per se. They do come in handy.
Switching back to preemption, the court in Hughes observed that negligence per se claims remained preempted where they “would necessarily impose requirements on the device that are ‘different from, or in addition to,’ the requirements of the FDA.” 2009 WL 3817586, at *12. That’s another defense to remember in this type of case – the purportedly “parallel” claim may well, upon closer examination, not really be “parallel” at all.

[T]here is more to a negligence per se claim (under applicable state law) than a simple prima facie showing that a statute or regulation has not been followed. In other words, the violation in and of itself does not constitute negligence per se. Rather, the defendant may still prevail by showing that he or she acted reasonably under the circumstances. As such, common law tort principles of the reasonableness of the defendant’s actions invade the cause of action. Once a state’s tort law becomes ingrained with the cause of action, it runs afoul of Riegel.

2009 WL 3817586, at *12 (discussing Bausch v. Stryker Corp., 2009 WL 2827954,(N.D. III. Aug. 31, 2009)). The court concluded this would be the case with plaintiff’s negligence per se under Mississippi law.

This court elects to follow the well reasoned and majority rule rejecting negligence per se claims arising out of violations of FDA regulations. Further, the court finds that the attempt by the plaintiff to enlarge or expand the reach of Riegel by claiming that misrepresentation of, or failure to report correct data, to the FDA amounts to a manufacturing defect, while a novel theory, is not warranted under existing law.

2009 WL 3817586, at *12.Finally, the plaintiff tried to claim that the subsequent recall voided the defendant’s device approval and precluded preemption. Harkening back to some of the things we discussed in our “Total Recall” post, the court held that, not only didn’t the recall not preclude preemption (“this recall only further serves to prove that regulation of Class III medical devices such as the HTA is the exclusive province of he FDA, 2009 WL 3817586, at *12) – it also amounted to an inadmissible subsequent remedial measure:

[E]vidence of subsequent remedial measures is inadmissible to prove negligence, demonstrate culpable conduct in a breach of warranty claim, or establish product defect. . . . Thus, any evidence of the voluntary HTA recall is irrelevant to the facts of this case and inadmissible under Rule 407, especially in the face of complete preemption of the plaintiff’s claims.

2009 WL 3817586, at *12.Hughes is definitely a precedent we’re going to be scratching whenever we come up against FDCA-based negligence per se claims.