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Edward D. Laird, Jr. and Brian D. Carr Involved in Expansion of Riegel v. Medtronic Principles in New York State


In Lake v. Urologix, Inc., 2008 WL 5244823, the first reported New York State case to address and expand the substantive holding of the United States Supreme Court case of Riegel v. Medtronic, Edward D. Laird, Jr. and Brian D. Carr successfully argued that the plaintiffs' claims against Carter Conboy's medical device client should be dismissed. In this case, the plaintiff claimed that he was injured as the result of co-defendants' use of a medical device created to treat the symptoms caused by benign prostatic hyperplasia, or an enlarged prostate, in a procedure known as transurethral microwave therapy. The plaintiff and his wife brought five causes of action against the defendants based on these claims.

In the Riegel v. Medtronic case, decided in February 2008, the United States Supreme Court held that claims asserted under New York law for strict liability, breach of implied warranties, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of a Class III devicewhich receives premarket approval are preempted by the federal MDA (Medical Device Amendments of 1976). Therefore, if a device received Class III premarket approval, these claims cannot be asserted against the manufacturer pursuant to the MDA. Since the medical device at issue previously received Class III premarket approval, based on this holding, the majority of the plaintiff's claims against the manufacturer were dismissed by the Court.

Although not specifically addressed in the Riegel v. Medtronic case, Mr. Laird and Mr. Carr also successfully argued that the remaining cause of action against their client for breach of an express warranty was preempted by the MDA since the warranties provided by the product manufacturer were previously approved by the FDA. Without evidence of any additional express warranty given beyond those approved by the FDA, the Court dismissed the plaintiffs' claims against the manufacturer, thereby expanding the breadth of the Riegel v. Medtronic holding to include a breach of express warranty claim as one of the claims preempted by the MDA.