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By: Michael P. Bruyere and Michael J. Eshman
As federal courts and parties wrestle with the issue of pre-emption and parallel state-law claims in medical device litigation, the U.S. Supreme Court elected not to weigh-in on the 9th Circuit’s decision in Stengel v. Medtronic, Inc. See Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013), cert. denied, 2014 WL 2807193 (U.S. June 23, 2014). While the impact of the decision will vary by state, we expect that the Stengel decision will give new life to failure-to-warn claims that have been routinely dismissed based on federal pre-emption.
Generally speaking, under the Medical Device Amendments (“MDA”), the federal requirements pre-empt state laws that are different from, or in addition to, any requirements under the MDA or that relate to the safety or effectiveness of the device. 21 U.S.C. § 360k(a). Interpreting this provision, the U.S. Supreme Court has left open the door for plaintiffs to circumvent pre-emption under the MDA by alleging parallel state-law claims that are not different from, or in addition to, the requirements under the MDA. See e.g., Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999 (2008), Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 121 S.Ct. 1012 (2001).
In Stengel , the plaintiff claimed that a medical pain pump left him permanently paraplegic. Stengel, 704 F.3d 1224 (9th Cir. 2013). In an effort to circumvent pre-emption, the plaintiffs attempted to amend their complaint to allege that the manufacturer breached its state-law duty to report adverse events involving the medical pain pump to the Food and Drug Administration (“FDA”). The district court rejected the argument and granted Medtronic’s motion to dismiss, but the 9th Circuit court of appeals reversed and allowed the amendment. The court found that there was an Arizona state-law duty to warn third parties in these types of cases that paralleled the federal-law duty to report adverse events to the FDA imposed by the MDA. The court, therefore, found that the state-law claim paralleled the federal requirements, and the claim was not pre-empted.
We anticipate this success for the plaintiff’s bar will lead to more attempted claims based on a failure to warn the FDA. The survival of such a claim at the motion to dismiss stage will vary by state and depend on whether the state recognizes this type of duty to warn a third party. The 9th Circuit determined that such a duty exists under Arizona law. In a more recent decision out of Minnesota, the federal district court rejected a similar argument because the plaintiffs did not point the court to “any applicable jurisdictions that recognize a state common law failure-to-warn claim based on a failure to properly issue reports to a federal agency, such as the FDA.” Pinsonneault v. St. Jude Medical, Inc., 953 F.Supp.2d 1006, 1015 (D. Minn. 2013).
In states, like Arizona that even recognize such a duty, plaintiffs will still have to overcome the hurdle of proving that the device manufacturer deviated from the requirements of the FDA in reporting adverse events and that the alleged deviation was the proximate cause of his/her injuries. In this regard, the full, practical effect of Stengel may be somewhat limited. We also anticipate that as more circuits weigh-in on this type of claim, the U.S. Supreme Court may still take the opportunity to address the argument in another case in the future.