Boston Scientific settles with DoJ
This article was originally published in The Gray Sheet
Executive Summary
The Department of Justice will drop civil charges against Boston Scientific for product adulteration and misbranding after the firm pays $74 mil. in damages. The complaint concerns Boston Scientific's continued distribution of the Nir-On Ranger with Sox coronary stent delivery systems in 1998 after the firm learned that the stent-deploying balloons could leak or burst at pressures below those specified on the labeling. The Natick, Mass. firm continued to distribute the stents even after running internal tests, consulting outside counsel and convening a field action committee to address reports of balloon failure. Following talks with FDA, the firm began a Class II recall in October 1998 (1"The Gray Sheet" Oct. 12, 1998, p. 28). The company "took a risk" that the flaws it detected in-house "would not occur in the marketplace," U.S. Attorney Michael Sullivan observed. However, he added that "this case does not involve any risk to [patients]." In settling, Boston Scientific claims no liability. The firm no longer sells products on the Nir platform...