Howard, et al v. Zimmer, Inc., et al, No. 11-5109 (10th Cir. 2013)

After Dr. Brian Howard received a knee implant manufactured by Sulzer Orthopedics, Inc. that failed to bond properly, Howard and his wife filed suit against Sulzer alleging negligence per se. Following the completion of earlier consolidated litigation, the district court dismissed the Howards' negligence per se claim, predicting that it would not be cognizable under Oklahoma state law. The Tenth Circuit stayed the Howards' appeal pending the resolution of a question of state law certified to the Oklahoma Supreme Court. That question was answered, and the Tenth Circuit now reversed the district court's grant of summary judgment and remanded for further proceedings. The Oklahoma Court held that Oklahoma law allowed private individuals to maintain a parallel claim for negligence per se based on violation of a federal regulation whose enforcement lies with a governmental entity. The court further concluded that "[t]he existence of a provision in federal law providing that all enforcement proceedings 'shall be by and in the name of the United States' did not prohibit a state law claim for negligence per se based on violation of the federal regulation." Noting that Howard did not claim he should have been entitled to bring a private action under the FDCA, but rather brought a state claim based on duties that "parallel, rather than add to, federal requirements," the court determined that Howard's negligence per se claim should have been allowed to proceed.