According to Bloomberg News, two executives from Synthes Inc., a medical device maker, pleaded guilt for their role in the company's illegal trials of bone-mending cement that led to the death of three patients. The 52-count indictment accuses executives at Synthes Inc, which is based in West Chester, Pa., of bypassing FDA approval of the trials while knowing that their products, Norian XR and Norain SRS, posed significant risks.
Michael D. Huggins and John J. Walsh pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines. Each faces as much as one year in prison and a $100,000 fine according to United States attorney Michael Levy. Mr. Huggins' lawyers, Gregory Poe and Catherine Recker said in an e-mailed statement that "Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong."
Showing posts with label Medical Device. Show all posts
Showing posts with label Medical Device. Show all posts
Tuesday, July 21, 2009
Wednesday, June 17, 2009
Medical Device Maker and Executives Indicted
On June 16, 2009, Synthes, Inc., and four of its executives were indicted on federal charges that they improperly promoted a bone filler for purposes not approved by the FDA. The indictment sends a strong message to similar companies. Usually Federal Prosecuters seek fines through civil lawsuits rather than bringing criminal charges.
Synthes and Norian Corporation are accused of encouraging the use of its bone filler, Norian XR, in unauthorized human trials. Norian XR was used in spinal procedures including verteplasty and kyphoplasty. Verteplasty and Kyphoplasty are procedures wherein a cementlike material is injected into a spinal fracture. Three people died during these human trials, though a direct link to Norian XR in these deaths had not been made yet.
Norian XR was approved by the FDA in 2002 for general bone repair. However, the company was warned against promoting the bone filler for spinal surgeries. The warning was based on information linking use of the bone filler in spinal procedures to the development of large bloodclots.
Norian faces potential fines of $28 million and Synthes faces fines of $8million. If convicted, the the executives could serve up to one year in prsion. The individuals charged in the indictment are Michael B. Huggins, president of Synthes Spinal Division; Thomas E. Higgins, Senior Vice President for Global Strategy; Richard E. Bohner, Vice President for Operations; and John J. Walsh, a Regulatory Affairs Executive.
Synthes and Norian Corporation are accused of encouraging the use of its bone filler, Norian XR, in unauthorized human trials. Norian XR was used in spinal procedures including verteplasty and kyphoplasty. Verteplasty and Kyphoplasty are procedures wherein a cementlike material is injected into a spinal fracture. Three people died during these human trials, though a direct link to Norian XR in these deaths had not been made yet.
Norian XR was approved by the FDA in 2002 for general bone repair. However, the company was warned against promoting the bone filler for spinal surgeries. The warning was based on information linking use of the bone filler in spinal procedures to the development of large bloodclots.
Norian faces potential fines of $28 million and Synthes faces fines of $8million. If convicted, the the executives could serve up to one year in prsion. The individuals charged in the indictment are Michael B. Huggins, president of Synthes Spinal Division; Thomas E. Higgins, Senior Vice President for Global Strategy; Richard E. Bohner, Vice President for Operations; and John J. Walsh, a Regulatory Affairs Executive.
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