FDA Complicity in Medical Device Scandal Exposed

The Food and Drug Administration's (FDA) delayed response to a flawed heart defibrillator has been criticized for costing a college student's life, highlighting the agency's alleged complicity in the silence. A report by Barry Meier revealed that the FDA received a report from the manufacturer, Guidant Corporation, detailing the flaws months before issuing a safety alert. The report, which was submitted in mid-February 2004, included data on 10 devices that suffered short circuits, which was crucial information for doctors and patients.

Key Takeaways:

• Guidant Corporation submitted an annual report to the FDA in mid-February 2004, which covered the period from June 1, 2003, to May 31, 2004, with an eight-month lag, unlike previous years when the report was submitted within three months.
• The report revealed that 10 problematic devices suffered short circuits during the year, which was not made public until June 2004, after the publication of an article by The Times.
• The FDA received the report but failed to take action in response to it, citing the need to review proprietary information.
• The FDA claimed that the failure data was included in a report that contained proprietary information, which made it difficult to release.
• The agency suggested that requiring companies to submit failure data separately would be an inefficient use of time and resources.

Statistics:

• 10 heart defibrillator devices suffered short circuits during the year 2003-2004.
• The FDA received Guidant's annual report in mid-February 2004, but failed to take action until June 2004.
• The college student who died in March 2004 was unaware of the short-circuiting problem and his doctors were not informed either.
• 90 days is the timeframe within which the FDA policy requires it to review annual reports.

Sources:

• Barry Meier, report in The Times [no date provided]
• Food and Drug Administration (FDA) policies and regulations [no date provided]