The plaintiff in Hearn v. Advanced Bionics Corporation, No. 06cv114-KS-MTP, 2008 WL 3896431 (S.D. Miss. Aug. 19, 2008) attempted to win a do-over of a straightforward defense preemption win.
The district court had granted in part and denied in part the defendant’s motion for summary judgment based on preemption as a result of the Class III PMA approval of the medical device in question, a cochlear implant that malfunctioned and was replaced with surgery. After the court’s ruling, the parties settled and the court entered judgment of dismissal. Id. at p. 2.
Approximately five months later, plaintiff moved for a relief from judgment, arguing that after the settlement, she discovered that the manufacturer had “knowingly misrepresented the true facts of the status of the FDA approval” to induce a settlement. Id. Having relied on such representations and “discovery fraud,” plaintiff did not seek a rescindment of the settlement agreement (in fact, she kept the settlement proceeds!), but sought sanctions and damages under various claims for relief. Id. Essentially, the plaintiff argued that the defendant “knowingly misrepresented” that an FDA investigation was commenced post-approval, “at the conclusion of which the FDA would challenge Advanced Bionics’ compliance with the pre-market approval process.” Id. at p. 5.
Based on these allegations, the plaintiff unsuccessfully sought to have the judgment vacated using Rule 11, Rule 60 and the court’s inherent powers. On denying these requests, the court made clear that even if the plaintiff were to succeed in establishing misconduct, the court’s ruling on the motion for summary would be unchanged. That is, even if the plaintiff’s claims were accurate, “the Defendant would still be protected by the preemption defense for items that received and complied with pre-market approval from the FDA.” Id. at p. 6. Further, the court’s order granting the summary judgment did not detail which state law claims were preempted, but only stated a point of law; thus, had the case continued and the evidence demonstrated either non-compliance with the federal requirements or the manufacturer failed to properly obtain the premarket approval for the device, the preemption argument might have “presumably fail[ed].” Id. at p. 8. However, given the procedural status of the case, the court denied the plaintiff’s motion and advised that her recourse–if any–was to file a new action against the manufacturer for fraudulent misrepresentation or to seek other similar relief.