Two of the cases on our medical device preemption scorecard have been:
Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008). Express warranty and failure to test claims are preempted under Riegel. Allegations amounting to fraud on the FDA are preempted by Buckman. Plaintiff has appealed this case.
McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008). Express warranty and failure to test claims are preempted under Riegel. Allegations amounting to fraud on the FDA are preempted by Buckman. Plaintiff has appealed this case.
Well, we’re pleased to let you know that the indicated appeal has been decided, and the preemption dismissals have been affirmed. See McGuan v. Endovascular Technologies, Inc., 2010 WL 445602, slip op. (Cal. App. Feb. 9, 2010). Unfortunately, it’s an unpublished opinion.
What’s with California? Why do they see fit to publish an atrocity like Conte, but then not publish McGuan? And their case citations look funny too….
McGuan is interesting because of how the court dealt with some fraud on the FDA allegations that seem to be more substantial than the usual litigation-driven embellishments we’re used to hearing from the other side. According to the opinion, the manufacturer conducted a post-approval audit of the device that found sufficient problems to spark a recall. The FDA wanted to see the audit report, and according to the court, the defendant “provided evasive, if not false, information to the FDA.” Slip op. at 5. The FDA reapproved the device, perhaps on the basis of this misinformation. Id. Eventually there was a DoJ investigation, too. That resulted in a guilty plea in 2003. Id. at 5-6.
Was that enough to preclude preemption? The unanimous appellate panel in McGuan thought not.
The device in question, something called an “Ancure,” was a PMA device. That means that there’s express preemption under Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). The court pointed out that neither of the plaintiffs alleged that the defendant violated FDA regulations. Slip op. at 10.
We wish we had dumb plaintiffs like those.
In any event, the FDA’s reapproval of the device meant that the FDA had reviewed the initial problems with the device and decided to issue a PMA anyway. That was enough to preempt most of the plaintiffs’ claims:
Since the FDA reapproved the [device] prior to plaintiffs‟ surgeries, the FDA gave its approval of the device’s design, testing, intended use, manufacturing methods, performance standards, and labeling. Thus, to the extent that plaintiffs’ complaints allege that the Ancure Device was unsafe and its warnings were inadequate, they are seeking to impose requirements that are “different from, or in addition to‟ the MDA. Consequently, the state law claims for strict product liability, negligence, breach of express warranty, breach of implied warranty, and violations of the Consumer Legal Remedies Act are preempted under the MDA.
Slip op. at 10. A “fraudulent concealment” claim was also preempted. Id. at 11.
But what about the defendant’s conduct that ultimately led to the guilty plea?
Well, the plaintiffs put those allegations into an amended complaint that added a fraud claim which alleged that defendant “withheld from the FDA, surgeons and public, reports of serious failures and resulting problems caused by” the device and that these “misrepresentations that were calculated to deceive the medical community, governmental agencies, and Plaintiff.”
Plaintiffs can’t do that under Buckman. Regardless of express preemption, parallel claims, and whatever, you can’t bring fraud on the FDA claims. Slip op. at 12. Plaintiffs asserted that the FDA had taken “strong action” after investigating things, and sought to invoke the “policed” fraud exception that two concurring justices mentioned in Buckman. Slip op. at 13. It didn’t fly, because the Buckman concurrence required both an FDA finding of fraud and the Agency’s removal of the product from the market. Didn’t happen, held McGuan:
[N]either requirement is present in the case before us. Though defendants were prosecuted and entered into a plea agreement for fraudulent conduct that occurred before March 2001, the FDA took no action against defendants for their conduct in seeking reapproval in August 2001. Instead, the FDA continued to allow the [device] to be marketed, and even approved a premarket approval supplement in April 2002. Since the FDA failed to take action against defendants for any alleged fraudulent conduct after March 2001, Buckman is controlling. Accordingly, plaintiffs’ state law tort claims for fraud-on-the-FDA are preempted by federal law.
Slip op. at 13. While these claims were based on allegations of FDCA violations, there was no exception for them. Preemption under Buckman is implied, not express, and further civil litigation after the government had resolved its own prosecution “would also ‘conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.'” Slip op. at 14 (quoting Buckman).
The plaintiffs’ last gasp was to argue that Altria Group, Inc. v. Good, 129 S.Ct. 538 (2008), somehow trumped Buckman. It didn’t. The court pointed out that Good involved a much narrower express preemption provision, the FDA, unlike the FTC in Good, had its role in prosecuting fraud affirmed by the court in Buckman. Slip op. at 14-15.