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Medical equipment industry

FDA Denies Request for Information on Faulty Guidant Defibrillators

Strategic Insights

— 1 min read

Scott + Scott, LLC, a law firm specializing in complex litigation, including securities fraud, was surprised to learn that a New York Times Freedom of Information Act Request to the Food and Drug Administration (FDA) for information on faulty Guidant defibrillators was denied. The information sought by the Times concerned the Guidant Ventak Prizm 2 DR, which the company produced thousands of between 2000 and 2002. The devices had electrical flaws that caused them to short-circuit, and Guidant claims to have discovered the problem in 2002, but Scott + Scott has information that it may have known about the issue in 2001.

Key Takeaways:

  • The FDA denied the New York Times' Freedom of Information Act Request for information on faulty Guidant defibrillators, citing that the information was deemed "corporate trade secrets."
  • The information sought by the Times concerned the Guidant Ventak Prizm 2 DR, which was produced between 2000 and 2002 and had electrical flaws that caused them to short-circuit.
  • Guidant claims to have discovered the problem in 2002, but Scott + Scott has information that it may have known about the issue in 2001.
  • The FDA's denial of the FOIA request comes as a Senate inquiry led by Senator Charles E. Grassley (R-Iowa) has been ongoing, with the Senator questioning why such information was not being disclosed.
  • The Medicines and Healthcare products Regulatory Agency (MHRA) is making urgent inquiries into the product problems at Guidant and their significance upon United Kingdom patients.
  • Guidant's failure rate of 1% is based only on the number of devices returned to the company for inspection, and internal, unpublished post-market clinical trials show a failure rate of around 8%.
  • Insider trading at Guidant is estimated to be over $60 million.
  • The chief medical officer of Guidant sold more than $3 million of her shares in May, just prior to the company's announcement to doctors of malfunctions in their defibrillators.

Statistics:

  • Over 60 million dollars in insider trading at Guidant.
  • 3 million dollars sold by the chief medical officer of Guidant in May.
  • 50,000 faulty defibrillators recalled by Guidant on June 16, 2005.
  • 28,000 devices to be recalled by Guidant on July 18, 2005.

Sources:

  • Scott + Scott, LLC
  • New York Times
  • Food and Drug Administration
  • Guidant Corporation
  • Senator Charles E. Grassley
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Wall Street Journal
  • Star Tribune

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