Eastern District of Louisiana Addresses Preemption of LPLA Claims by the Medical Device Amendments of 1976

March 2 2020 | Committees

A recent decision in the United States District Court for the Eastern District of Louisiana looked at whether the Medical Device Amendments of 1976 (“MDA”) preempted a plaintiff’s Louisiana Products Liability Act (“LPLA”) claims. In Allo v. Allergan USA, Inc., No. CV 19-12493, 2020 WL 814855 (E.D. La. Feb. 19, 2020), the plaintiff, Sheridan Allo, alleged that she was injured by a breast implant manufactured by defendant, Allergan. The device at issue was a Class III medical device that received pre-market approval by the FDA. Allo asserted that the device was unreasonably dangerous under the LPLA: 1) in construction or composition; 2) due to inadequate warning; and 3) due to violation of an express warranty. She also asserted a redhibition claim.

Allergan moved for dismissal under Federal Rule of Civil Procedure 12(b)(6), asserting that the MDA expressly preempted Allo’s claims. The court recognized that state-law tort claims are expressly preempted where “(1) ‘the federal government has established requirements applicable to the device’; and (2) the claims are based on state-law requirements that are ‘different from, or in addition to, the federal ones, and that relate to safety and effectiveness.’” Id. at *2, quoting Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012). However, where a plaintiff’s state-law claims are based on failure to comply with a federal regulation, those claims are not preempted, and are considered to be “parallel claims.”

The court held that Allo’s construction and composition claim, as well as her redhibition claim, were not preempted under the MDA. In support of both of those claims, Allo alleged that the device “did not meet FDA regulations governing shell thickness.” Allo, 2020 WL 814855 at *3. The court found both claims to be permissible parallel claims.

As to Allo’s claims based on failure-to-warn and breach-of-express-warranty, the Court found that those claims were preempted. With respect to the failure-to-warn claim, the court held:

[Allo] fails to identify any FDA regulation that Allergan’s FDA-approved warning violated. Instead, she complains that Allergan failed to warn that its product could contain a ‘curvilinear defect.’ FDA regulations did not oblige Allergan to so warn. So, Allo’s claim is not parallel; it seeks to impose state-law warning requirements that add to, or differ from, federal ones.

Id. at *3. With respect to the express warranty claim, the court noted that Allo did not identify any FDA regulation allegedly violated by Allergan. Further, the court found that Allo did not allege that Allergan made any express warranty. Id. Therefore, the court dismissed Allo’s failure-to-warn and breach-of-express-warranty claims under Rule 12(b)(6).

 

Written by Cami Capodice and Alex Robertson for the Pharmaceutical and Medical Device Committee

        

Cami Capodice                 Alex Robertson   



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