According to a story in the Archives of Internal Medicine, “medical devicesare reviewed by the US Food and Drug Administration (“FDA”) using2 alternative regulatory standards: (1) premarket approval (“PMA”),which requires clinical testing and inspections; or (2) the510(k) process, which requires that the device be similar toa device already marketed (i.e., there needs to be a “predicate” device). The second standardis intended for devices that the FDA deems to involve low ormoderate risk.” (http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30)
A study of the FDA’s high-risk List of DeviceRecalls from 2005 through 2009 determinedthat, of the 113 recalls from this period that could cause serious health problemsor death, only 21 of the 113 devices had been approved throughthe PMA process (19%), eighty were cleared through the 510(k)process (71%), and an additional 8 were exempt from any FDAregulation (7%).
Tort lawyers play an important regulatory role. Given that nearly 80% of the medical devices recalled for life-threateningor very serious hazards were originally cleared for market usingthe less stringent 510(k) process or were considered so lowrisk that they were exempt from review, tort litigation is necessary to cause manufacturers to more safely prepare medical devices for sale.
If you have been injured by a medical device or the failure of a medical device, call Bill Robertson or Zach Ross at 941.364.2400.