Ravindranath V. Purohit v. Abbott Laboratories Inc.

Summary

The United States District Court for the District of Nevada grants Abbott Laboratories Inc.'s motion to dismiss a strict-products-liability claim involving a Trifecta replacement heart valve. The court holds that the claim is expressly preempted under the Food, Drug, and Cosmetic Act because the plaintiff did not identify a specific FDA requirement from which the device allegedly deviated. The court dismisses the complaint, denies leave to amend as futile, and directs the Clerk to close the case.

Holdings

1. A state-law claim involving an FDA-approved Class III medical device is not within the narrow parallel-claim exception to express federal preemption unless the plaintiff plausibly alleges that the device deviated from a particular FDA requirement and that the deviation also violated state tort law. Because Purohit identified no particular FDA requirement that Abbott violated, his claim was preempted.
2. A device defect, malfunction, recall, or voluntary withdrawal from the market does not, by itself, establish that the manufacturer violated a particular FDA requirement and therefore does not plead a non-preempted parallel claim.
3. Leave to amend was properly denied as futile because Purohit did not identify any particular FDA requirement he could allege Abbott violated or propose facts that would cure the preemption defect.

Questions Presented

1. Whether the plaintiff's Nevada strict-products-liability claim concerning an FDA-approved Class III medical device was expressly preempted because the complaint did not identify a violation of a particular FDA requirement.
2. Whether a device failure, alleged defect, manufacturer knowledge, or market withdrawal was sufficient to plead a non-preempted parallel claim.
3. Whether the plaintiff should be granted leave to amend his complaint.

Disposition

dismissed