4th Circuit Court Issues Decision in Medical Device Case



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The 4th Circuit recently precluded a common law negligence claim from proceeding. 


The plaintiff instituted the civil action relative to an alleged malfunction of a drug-infusion pump.  The 4th Circuit found that the claim was preempted as it alleged that the device should have been designed in a manner other than that contemplated by the premarket approval under the Medical Device Amendments (?MDA?).  The 4th Circuit explained that in 1976, Congress passed the MDA in order to provide federal oversight relative to medical devices.  In providing the federal oversight, certain claims made pursuant to state laws were preempted.  In short, the MDA prohibits a state from making requirements that:


  • are different from, or in addition to, any applicable requirement under the MDA; and
  • relate to the safety or effectiveness of the device.


The 4th Circuit explained that the MDA established three classes of medical devices:  


  • Class I devices are subjected to the lowest level of oversight.  Examples include elastic bandages and examination gloves.  They are ones for which general controls ?are sufficient to provide reasonable assurance of [their] safety and effectiveness.?  21 U.S.C. ?360c(a)(1)(A)(i); 
  • Class II devices include powered wheelchairs and surgical drapes and have a heightened oversight, such as ?performance standards [and] postmarket surveillance.?  21 U.S.C. ?360c(a)(1)(B)(i); 
  • Class III devices have the highest level of oversight.  The devices are useful ?in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health??  21 U.S.C. ?360c(a)(1)(C).


The drug-infusion pump, which was a Class III device, obtained the FDA?s premarket approval.  Thus, the state law claim was precluded.


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