Nevada Court Rejects Purported Parallel Claim Based on a Purported Violation Based on a Purported Defect Based on Market Withdrawal
Litigation attorney Eric Alexander published a blog for Drug & Device Law discussing the U.S. District Court for the District of Nevada's decision in Purohit v. Abbott Labs., Inc. involving a Class III bioprosthetic heart valve. In the case, the court rejected the plaintiff's attempt to plead a "parallel" manufacturing defect claim through a chain of inferences tied to an alleged malfunction and the device's later market withdrawal. It also held that failure and withdrawal alone do not plausibly establish a deviation from U.S. Food and Drug Administration (FDA)-approved specifications or avoid Federal Food, Drug & Cosmetic Act (FDCA) preemption. Mr. Alexander highlights the court's reliance on U.S. Court of Appeals for the Ninth Circuit precedent and its decision to deny leave to amend where the plaintiff could not identify any specific FDA requirement allegedly violated.