Latest Example of the Rigged Health Care System: BTG Pleaded Guilty to " Misbranding " for Marketing a Device Never Proven to Do Any Good

Just before the US Presidential election, yet another story of how the health care system is rigged slipped just barely into public view.   The only media report with any detail about itcame from the Corporate Crime Reporter on November 7, 2016.The Selling of an Unproven Invasive DeviceThe basics were:Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pled guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct.So,Biocompatiblespled guilty to a misdemeanor charge in connection with the company ’s misbranding of LC Bead, in violation of the Food, Drug and Cosmetic Act.LC Bead was cleared by the U.S. Food and Drug Administration (FDA) as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations.LC Bead has never been cleared or approved by FDA as a drug-device combination product or for use as a drug-delivery device or ' drug-eluting ' bead.In fact, whileThe FDA sought assurances in 2004 that Biocompatibles would not use FDA clearance for the device for embolization to market the device for drug delivery, according to a statement of offense to which the company agreed.Biocompatibles told the FDA that ' under no circumstance ' would the company use the embolization clearance to market the device for drug delivery.However, two years late...
Source: Health Care Renewal - Category: Health Management Tags: crime deception impunity legal settlements medical devices Source Type: blogs