As a defective medical device lawyer, I was disappointed several years ago by the U.S. Supreme Court’s ruling denying people injured by dangerous medical devices the right to sue. Specifically, the court ruled in Riegel v. Medtronic that failure to warn claims under state law were expressly preempted by FDA regulations. Since then, a few plaintiffs have attempted to proceed with a legal theory alleging negligence rather than failure to warn, with mixed results. In Howard v. Zimmer, Inc., the Oklahoma Supreme Court permitted such a claim to go forward by answering a secondary question about how federal law might affect Oklahoma law. The court was responding to a request from the Tenth U.S. Circuit Court of Appeals to clarify Oklahoma law, in a case involving an injury from an allegedly defective knee implant.
Brian and Suzanne Howard sued various entities related to the manufacture of a knee implant that was unsuccessfully implanted in Brian Howard. Howard, who is himself a doctor, alleged that the implant was not successful because the manufacturer, Sulzer Orthopedics, left an oily residue on it in violation of federal medical device regulations. He claimed that Sulzer was per se negligent for failing to follow FDA Good Manufacturing Practices, which include a process to remove oily residue. The original district court (the site of an MDL against Sulzer) granted summary judgment for Sulzer on preemption grounds, and the case was appealed to the Sixth Circuit, which disagreed and remanded the case. On remand, the case was moved to the Howards’ home district in Oklahoma, which dismissed, saying the negligence per se claim was not cognizable under Oklahoma law. On appeal, the Tenth Circuit asked the Oklahoma Supreme Court to determine whether this is true.
Oklahoma has adopted a statutory substitute for common-law negligence, and a violation of it is negligence per se. Six months before the Oklahoma high court received this case, it decided Covel v. Rodriguez, which permitted jury instructions that said violation of federal regulations may constitute negligence per se. Indeed, the court noted, violations of regulations are highly relevant to the question of negligence. Furthermore, it noted, Howard is not attempting to create a nonexistent private right of action under the FDCA, but alleging that negligent failure to follow its rules led to his injuries. And the Supreme Court, in Riegel v. Medtronic, expressly said claims like these parallel federal regulations, rather than exceeding them. A three-judge dissent argued that the federal regulation at issue is too vague to support negligence per se.
This ruling pleases me greatly as a pharmaceutical injury attorney. The Oklahoma Supreme Court’s opinion notes that court have been divided on this issue, but the Sixth (in the instant case) and Seventh Circuits have upheld the right to pursue what the high court called “parallel actions” seeking state-law damages for violations of federal regulations. Indeed, because support for this position is drawn directly from Riegel, it seems likely to succeed at the U.S. Supreme Court if that court takes up the issue. As the Oklahoma court also observed, failing to permit this would also leave injured patients without any remedy, even for gross and obvious violations of safety regulations. This was a concern for me when Riegel came out, and I’m please to see that it’s not just dangerous medical device lawyers who are aware of the dangers to patients.
If you believe you were hurt by a medical device with a serious safety flaw, Carey, Danis & Lowe can help. For a free, confidential consultation, call us today at 1-877-678-3400 or send us a message online.
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