A.F., an infant by and through her mother and natural guardian Yael Fogel, and Yael Fogel, individually, Plaintiffsv.Sorin Group USA, Inc., CarboMedics, Inc., Sorin Group Canada, Inc., and John Doe Manufacturing Companies and/Corporations 1 Through 10, whose names are unknown at this time who manufactured, designed, produced, sold, or distributed the Mitroflow LXA19 Aortic Pericardial Heart Valve and all its component parts used during the August 5, 2013 surgery performed on the infant plaintiff, Defendants
OPINION AND ORDER This case is about a young child who received a prosthetic heart valve that failed and had to undergo surgery to replace it, during which she suffered a stroke, partial paralysis, and seizures. The infant, A.F., and her mother, Yael Fogel (collectively, “Plaintiffs”), brought this diversity action against Sorin Group USA, Inc.; CarboMedics, Inc.; and Sorin Group Canada, Inc. (collectively, “Defendants”)1 for injuries allegedly caused by the prosthetic Mitroflow Aortic Pericardial Heart Valve (the “Valve”) that failed. Defendants have moved to dismiss the Complaint for failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons set forth below, Defendants’ motion to dismiss is GRANTED IN PART and DENIED IN PART.I. Background2Defendants are the manufacturers, sellers, and distributors of the Valve, which is a Class III medical device regulated by the Food and Drug Administration (“FDA”) under the Medical Device Amendments of 1976 (“MDA”).3 Compl. 48, Doc. 1. In late 2006 and through 2007, Defendants submitted an application and several amended applications for premarket approval of the Valve, which is the process by which the FDA evaluates the safety and effectiveness of Class III medical devices. Id. 49-50. As part of that process, Defendants submitted numerous types of information, including details on the device’s components and manufacturing process, proposed indications for use that listed “no contraindications,” and a clinical study of 699 patients that did not include any patients under the age of 27.4 Id.
