California Appeals Court Backs MDA Preemption

By Susan J. Matthees –

A new preemption decision has just come down from a California appeals court (the sixth circuit appellate district).  In two consolidated cases,  McGuan v. Endovascular Technologies, Inc., et al. and Johnson v. Endovascular Technologies, Inc., the appeals court upheld a lower court’s ruling that the Medical Device Amendments Act of 1976 ("MDA") preempt these two personal injury and products liability actions.

Each case involved plaintiffs who suffered injuries after they were implanted with the Ancure Endograft System (Ancure Device).  They were consolidated on appeal.  The appeals court relied on the decision in Riegel v. Medtronic, but with an interesting new twist that may broaden the reach of that case.

The Ancure Device was designed, manufactured, and distributed by Endovascular Technologies ("EVT"), a subsidiary of Guidant.  FDA approved the device in September 1999, but a number of safety problems related to the device soon arose.  Guidant investigated and ultimately recalled the device in March 2001.  After the recall, Guidant allegedly “provided evasive, if not false, information to the FDA” in response to FDA’s request for an audit report.  FDA then approved a modified version device in August 2001.  EVT ultimately entered into a plea agreement in June 2003 for shipping misbranded medical devices between September 1999 and March 2001.  The device was off the market as of June 23, 2003.

Both plaintiffs had the Ancure Device implanted after 2001 and allegedly suffered severe injuries.  McGuan sued under the usual theories of strict product liability, negligence, breach of express and implied warranty, but also added a cause of action for fraudulent concealment.  Johnson likewise added to the usual theories a cause of action for fraud and misrepresentation.  The trial court granted defendants’ motion for summary judgment on the ground that plaintiffs’ claims were preempted by 21 U.S.C. § 360k(a).

Plaintiffs appealed, arguing that their causes of action were not preempted because of the fraudulent conduct by the defendants.  McGuan alleged that defendants “had the duty and obligation [to the plaintiff] to disclose . . . the true facts concerning the Ancure Device product” (i.e., that the device was dangerous and defective).  The court of appeals, however, stated that in order to prevail on this cause of action, a jury would have to find that the warnings were inaccurate.  FDA approved the warnings, so a verdict for the plaintiff would impose warnings that are “different from, or in addition to” those imposed by FDA and thus be preempted.  Thus, the court held that allegations that the defendant has defrauded the plaintiff are not sufficient to evade Riegel preemption. 

Johnson alleged a similar fraud cause of action, but added that the fraud was against “governmental agencies.”  Here, the appeals court concluded that this claim was preempted under Buckman Co. v. Plaintiffs’ Legal Comm, in which the U.S. Supreme Court held that state law fraud-on-the-FDA claims are preempted by federal law.  Johnson tried to distinguish her case from Buckman on the grounds that, unlike in the case against EVT and Guidant, the defendant in Buckman had not been investigated by FDA.  Johnson pointed out that in a concurring opinion in Buckman, Justice Stevens suggested that there might have been a different outcome if “the FDA had determined that petitioner had committed fraud during the § 510(k) process and had taken the necessary steps to remove the harm-causing product from the market.”  The court of appeals was not persuaded, explaining that although FDA investigated the defendants in this case, the agency did not take action and allowed the device to be marketed, so the situation Justice Stevens described did not apply.  In addition, because FDA found no violations of federal law after March 2001, a decision for plaintiff would “conflict with the FDA’s responsibility to police fraud consistently.”