Southern District of Ohio Found Plaintiffs' Claims Were Preempted When Based on a Component of a Larger Pre-Market Approved Medical Device

On September 22, 2016, the Southern District of Ohio held that the plaintiffs' consolidated claims (which regarded Medtronic's Infuse component, a part of a larger medical device) were preempted under the Medical Devices Amendments to the FDCA.29

The Court found that the MDA's preemption clause created a two-step test to determine whether state-law claims are preempted: first, the court determines whether the federal government established requirements for medical devices; and, if so, the court determines whether the state's law runs parallel or imposes different requirements than the federal requirements.30 While the plaintiffs argued that the FDA did not approve the Infuse component specifically, the Court held that the FDA's approval applies to "all components of an approved device, even when a physician uses the components separately" and, thus, the Court found the federal government had established requirements for Infuse.31

As to whether any of the plaintiffs' state law claims were parallel claims, the Court held that the plaintiffs' failure-to-warn claims were expressly preempted because the FDA forbids Medtronic from providing any warning other than that approved by the FDA.32 Regarding the plaintiffs' argument that the claims were premised on "Medtronic's failure to file adverseevents reports with the FDA," the Court, noting that "[a]dverseevent reports are not warnings," held there was no parallel Ohio state law duty to report adverse events to the FDA.33 Second, because the claim concerned effectiveness and safety, the Court also held that the plaintiff's breach of express warranty claim was expressly preempted because the FDA already concluded that the device was safe and effective.34 Third, finding no parallel state duty, the Court dismissed the plaintiffs' off-label promotion claim, holding that "[t]he concept of 'off-label use' is a creature of the FDCA" and, accordingly, the claim was impliedly preempted as an attemptto enforce the FDCA, an enforcement power left exclusively to the FDA.35

In addition to preemption, the Court noted that while Ohio adopted comment k of Section 402A of the Restatement (Second) of Torts, (which, the plaintiffs argued, meant that whether a medical device was unavoidably unsafe was a factual determination that could not be made at the pleadings stage), the Court held that the FDA's classification as a Class III medical device inherently meant that it was "unavoidably unsafe" and thus the claim was dismissed.36

Aaron is a useful case supporting preemption in certain medical device cases – an example of a court refusing to permit plaintiffs to make an end run around established standards by using artfully crafted claims. Notably, the Court held that manufacturers are forbidden, under the MDA's pre-approval process, from making changes to the safety or effectiveness sections of a device's warning label. Similarly useful is the Court's holding that adverse-event reports are not warnings and, therefore, do not defeat failure-to-warn preemption. If claims are brought against manufacturers of Class III medical devices, especially in the Sixth Circuit, Aaron is worth closer review to determine if it supports the manufacturer's attempt to dismiss some or all of the plaintiff's claims.

Footnotes

29. Aaron v. Medtronic Inc., --- F. Supp. 3d ----, No. 1:13-cv- 301, 2016 WL 5242957 (S.D. Ohio Sept. 22, 2016).-

30. Id. at *5.

31. Id. at *6-7.

32. Id. at *8.

33. Id. at *8-9. Similarly, the Court held that the plaintiffs' design defect claims were expressly preempted because "a state-law claim that would require a medical device to have a design different from that approved by the FDA through the [pre-market approval] process is a frontal 'attack on the risk/benefit analysis that led the FDA to approve' the device." Id. at *9 (citing In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1206 (8th Cir. 2014)).

34. Id. at *10.

35. Id. at *12-13 (quoting Gavin v. Medtronic, Inc., No. 12-0851, 2013 WL 3791612 (E.D. La. 2013).

36. Id. at *15-18.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.