Boston Scientific Faces $5 Million-a-Day Paperwork Problem
Boston Scientific is back in the regulatory doghouse after the medical-device maker failed to report to the FDA changes in how it manufactures its line of implantable heart defibrillators
The company has recalled the devices and halted further shipments until it resolves the reporting issue with the FDA. The business accounts for 15% of its revenue, which totaled $8.19 billion in 2009. Sanford Bernstein analyst Derrick Sung, tells the WSJ’s Jonathan Rockoff the sales suspension will cost the company $5 million a day.
In addition to the financial hit, the news is another black-eye for the Natick, Mass., company, which has struggled with quality control and other regulatory issues over much of the past decade. In January 2006, the FDA cited Boston Scientific for “ongoing systemic” quality control problems that included manufacturing concerns about its Taxus drug-coated stent.
That was about the same time the company beat out Johnson & Johnson in a bitter takeover battle for Guidant. In addition to Guidant’s implantable heart rhythm device business, Boston Scientific acquired a host of that company’s quality issues in the deal. Among other things, the FDA refused to approve several important new products until Boston Scientific cleaned […]
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