Pharma can’t seem to do anything right these days. Falsified clinical trials, political agendas, now this. – dg
MARCH 15, 2010, 11:40 A.M. ET
Boston Scientific Corp. (BSX) suspended sales of medical devices that restore normal heart rhythm and manage heart failure, saying it failed to submit for U.S. regulatory approval certain changes in the way it makes the products.
The news sent Boston Scientific shares plunging 16% to $6.51 in recent trading. A big portion of the products affected–implantable cardioverter difibrillators, or ICDs, in the U.S.–represented about 15% of total company sales last year, and it’s not clear how long sales of the products will be suspended.
The documentation snafu is the latest setback for the Natick, Mass., company’s ICD business. Boston Scientific acquired Guidant in 2006 after reports of safety problems with Guidant’s ICDs, and Boston Scientific suffered years of negative fallout over the issue.
The news could also damage the credibility of the company’s new management team in the eyes of investors. “The announcement will weaken quality perception of a company that was on the brink of recovery,” Morgan Stanley analyst David Lewis wrote in a note.
On Monday, Boston Scientific said it stopped shipment and is retrieving inventory of all ICDs, as well as its cardiac resynchronization therapy defibrillators, or CRT-Ds. The company said it had found two instances of manufacturing changes that, while successfully validated, weren’t submitted to the U.S. Food and Drug Administration.
The errors put the company’s ICD devices out of compliance with FDA regulations, according to an analyst note from Bernstein Research. Boston Scientific said it plans to work closely with the FDA to resolve the situation, while saying it had no indications the manufacturing-process changes poses a risk to patients and it is not recommending that implanted devices be taken out…