By Jim Dickinson
In October, the Maryland Court of Special Appeals overturned parts of a lower state court ruling that held that federal law preempts all of a plaintiff’s claims against Medtronic over its Infuse Bone Graft device except for fraud claims.
The lower court had also held that the plaintiffs failed to plead fraud with particularity and thus dismissed all claims against the company.
The appellate judges’ decision notes that the lower court relied on one of the first of what are now numerous federal district court decisions concerning the Infuse device.
“We shall hold,” the appeals court wrote, “that federal law does not expressly or impliedly preempt the plaintiffs’ claims concerning misrepresentations or express warranties that the manufacturer may have made in voluntary communications with the public or with members of the medical profession. We shall also hold that the plaintiffs failed to plead common-law fraud with particularity, but that the circuit court, on remand, should allow them an opportunity to re-plead.”
Thus, the appeals court reversed the lower court conclusion that federal law preempts the claims for fraud, negligent misrepresentation, and violations of the Maryland Consumer Protection Act insofar as those claims are based on false statements of material fact that Medtronic may have made in voluntary communications with the public or members of the medical profession in the context of off-label promotion of the Infuse device. It also reversed the circuit court’s conclusion that federal law preempts claims for the breach of any express warranties that Medtronic may have made with the public or members of the medical profession outside the context of the FDA-mandated and approved labeling for the device.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET]