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Court Decision Regarding Medtronic's InFuse Device Could Be a Problem for the Medical Device Industry


Posted in Regulatory and Compliance by Jamie Hartford on February 21, 2014

In Coleman v. Medtronic, a California court accepted the legal proposition that a plaintiff can state a claim for a manufacturing defect premised on nonspecific allegations of failure to comply with current good manufacturing practices.

 


By Jim Dickinson

         

Princeton, NJ-based attorney Michelle Yeary (Dechert LLP) says a California state court decision regarding allegations of off-label use and promotion of Medtronic’s InFuse lumbar tapered fusion device may cause problems for drug and medical device companies in the future.

In Coleman v. Medtronic, one of many cases involving the InFuse device that focus on off-label use and promotion, the plaintiff based claims on allegations of manufacturing defect, failure to warn, and off-label promotion.

Yeary says the court properly dismissed two failure-to-warn theories as preempted but elected to allow a claim of failing to provide adverse event information to FDA after the agency had approved the device. The court also accepted the legal proposition that a plaintiff can state a claim for a manufacturing defect premised on nonspecific allegations of failure to comply with current good manufacturing practices, she says.

“In other words,” Yeary writes, “plaintiff doesn’t have to plead how the defendant violated federal regulations. A ‘general allegation’ is enough.”

However, according to Yeary's posting, the biggest problem with the Coleman case is that it allows negligence per se to escape preemption. While many other courts have ruled that only the federal government can enforce the Federal Food, Drug, and Cosmetic Act and the Medical Device Act, the California court based its decision on a food case that held that states could enforce identical requirements with regard to food under the Nutrition Labeling Act. Yeary says Congress has not enacted anything that detracts from or contradicts its original decision to prohibit private enforcement with respect to drugs and devices, but Coleman ignores this fact.

“Ignoring that distinction means that there’s nothing to prevent the craziness of California food litigation from now spilling over into prescription drug and medical device litigation,” Yeary concludes.

Jim Dickinson is MD+DI's contributing editor.

 [image courtesy of KITTISAK/FREEDIGITALPHOTOS.NET]


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