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Industry News
Company NewsRecalls put company in regulators crosshairsStepped-up government scrutiny of Boston Scientific Corp. stems from heightened concern over medical safety and disappointment that the company made new missteps after resolving previous problems with the Food and Drug Administration, analysts said yesterday.The Natick medical-device maker, which has been working to settle patent suits and federal investigations dating back years, recently was notified of fresh investigations begun by the Department of Justice and the Securities Exchange Commission into problems that forced it to recall implantable heart defibrillators this month. “The bar is being raised to more meticulous compliance and to communication with regulators on a more regular basis,’’ said analyst Rick Wise, managing director at the health care investment bank Leerink Swann. “Boston Scientific has become a high-profile case.’’While the scope of the new inquiries could not be determined, analysts said federal investigators most likely are focusing on whether investors were blindsided by Boston Scientific’s failure to get required FDA approval for changes in its manufacturing processes for the defibrillators.
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