Boston Scientific Faces Criticism Over Taxus Stent Recall

Strategic Insights -

Boston Scientific Corp. is facing backlash over the recall of its flagship Taxus drug-coated stent, following reports of malfunctioning devices that have led to several deaths and injuries. The company has received a total of 95 complaints about Taxus stents with balloons that did not deflate properly, with 43 of those complaints linked to three deaths and 43 injuries. Despite the company's efforts to reassure doctors and patients, several prominent hospitals have stopped implanting the Boston Scientific products, citing concerns over patient safety and potential lawsuits.

Key Takeaways:

  • Boston Scientific has received a total of 95 complaints about Taxus stents with balloons that did not deflate properly, with 43 of those complaints linked to three deaths and 43 injuries.
  • The company has stopped implanting the Taxus stent at several prominent hospitals, including Lahey Clinic in Burlington and Boston's Beth Israel Deaconess Medical Center and Brigham and Women's Hospital.
  • The FDA approved changes to Boston Scientific's production and inspection processes on May 5, after the company first discussed manufacturing problems in April.
  • The recall affects 85,000 Taxus stents and 11,000 Express2 bare-metal stents, which lack the Taxus drug coating.
  • Boston Scientific's share price fell 3% on the day of the recall, losing $1.25 to close at $36.15, the lowest this year.
  • One prominent cardiologist criticized Boston Scientific, saying it was trying to downplay the incidence of problems by comparing the numbers of deaths and injuries to the number of Taxus stents implanted so far.
  • Johnson & Johnson's Cordis unit, which makes the Cypher drug-coated stent, sent a salesperson to the Lahey Clinic to see what the company could do to win back the hospital's stent business.
  • Tufts-New England Medical Center continues to use Taxus stents, as the number of complaints was low, said Carey Kimmelstiel, director of interventional cardiology.

Statistics:

  • 95 complaints about Taxus stents with balloons that did not deflate properly.
  • 43 of those complaints linked to three deaths and 43 injuries.
  • 85,000 Taxus stents affected by the recall.
  • 11,000 Express2 bare-metal stents affected by the recall.
  • 500,000 Taxus stents implanted in patients.
  • Boston Scientific's share price fell 3%, losing $1.25 to close at $36.15.

Sources:

  • The Boston Globe, "Boston Scientific Disclosure Expected To Force Recall of Stent", July 20, 2004
  • Knight Ridder/Tribune Business News, "Boston Scientific Disclosure Expected To Force Recall of Stent", July 20, 2004