Reserve National Insurance Co. v. Crowell Et Ux

holding that 21 U.S.C. § 360k(a) of the MDA preempts state strict liability, negligence, and breach of express and implied warranty causes of action against Class III medical device manufacturers because state law actions as well as FDA regulations are requirements under the MDA | interpreting the term “loss” by “examining the policy as a whole and the interplay between the defined concept of ‘loss’ and various related provisions” | citing, e.g., Malone v. White Motor Corp., 435 U.S. 497, 98 S.Ct. 1185, 55 L.Ed.2d 443 (1978) | strict liability, breach of express and implied warranties, negligent design, manufacturing and sale, misbranding, and failure to warn claims preempted by the MDA | state tort claims for strict liability, negligent design, manufacture, marketing and sale, misbranding, misrepresentation and failure to warn are preempted by the MDA | preempting claim that defendant manufacturer fraudulently obtained PMA of device | when statute is clear, agency interpretation must give way | when statute is clear, agency interpretation must give way | no implied right of action | no implied right of action | no implied right of action | no implied right of action