By Amy Berger, J.D.
Consolidated claims against an artificial hip manufacturer for strict products liability and strict liability for failure to warn were expressly preempted by federal law because both claims added to or differed from federal regulations. State law claims parallel to FDA regulations and imposing a traditional state duty predating federal requirements survived both express and implied preemption (In re: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, March 26, 2018, Blake, C.).
Smith & Nephew developed, designed, produced and sold the Birmingham Hip Resurfacing artificial hip implant (BHR). The FDA approved BHR in 2006 as a Class III device, and Smith & Nephew later issued two recalls for it. More than 200 separate lawsuits were filed against Smith & Nephew—since consolidated—alleging eight common law violations: strict products liability, negligence, strict liability for failure to warn, negligent failure to warn, negligent misrepresentation, negligence per se, breach of express warranty, and manufacturing defect.
Strict liability expressly preempted. Initially, the court determined that all strict liability claims were expressly preempted because FDA premarket approval is the agency’s recognition that a device is fit for the market. Once a device has received such approval, a device cannot be labeled unreasonably dangerous by state law without imposing different or additional requirements to federal regulations. Moreover, the FDA has the sole power to determine that a device is too dangerous for the market based on new information.
Claims not expressly preempted. Most remaining claims, however, survived express preemption because each paralleled FDA regulations and their elements may be satisfied by violations of federal regulations. For example, negligence claims could demonstrate Smith & Nephew’s alleged failure to comply with duties already required by the FDA. Likewise, failure to warn claims based on the manufacturer’s alleged failure to report specific events to the FDA were not expressly preempted because Smith & Nephew had an obligation to report adverse events. Similarly, although federal regulations would not be violated by claiming BHR was safe based on FDA approval, claiming it was safer than other products is outside of the FDA-approved warranties and within Smith & Nephew’s ongoing obligations to disseminate truthful and non-misleading information. Finally, manufacturing defect claims paralleled federal requirements because relying on deviation from the FDA’s approved design does not differ from or add to the manufacturer’s preexisting federal obligation.
The court noted that any conduct not imposed by the FDA, such as changing the labeling or communicating information to patients or the medical community, would be preempted.
Implied preemption. The remaining claims also survived implied preemption. Each remaining claim was a traditional state law claim that predated the FDA’s regulation of medical devices.
The case is Civil Action No. CCB-17-2775.
Attorneys: Emily Jeanette Beeson (Egerton Law) for Ronald Shough. Sara J. Gourley (Sidley Austin LLP) and Terri Steinhaus Reiskin (Dykema Gossett PLLC) for Smith & Nephew, Inc.
Companies: Smith & Nephew, Inc.
MainStory: TopStory CaseDecisions FDCActNews GCNNews MDeviceNews PreemptionNews SafetyNews MarylandNews
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