By Catherine D. Bertram
The New York Times reported that Columbia University has closed the research arm of its Kreitchman PET Center, a prominent brain-imaging clinic, after the U.S. Food & Drug Administration found in 2008 and January 2010 that the Center had injected patients with drugs containing high impurity levels. Lab staffers are accused of falsifying records to hide the improper injections from auditors.
A positron emission tomography, or PET, scan requires the patient to be injected with radioactive drugs, which move through the brain and allow the PET scan to build a three-dimensional model of the brain. But the drugs have a short shelf life, and the FDA regulates them to keep patients safe. The impurities could have been especially damaging to the Center’s patients, many of whom were schizophrenic or depressed. Columbia’s own investigation apparently did not find evidence of harm to any patients.
About the author:
Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C. Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital. Ms. Bertram is a member of the bar for the U.S. Supreme Court. She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook. She can be reached by email at firstname.lastname@example.org or by phone 202-822-1875 in her office in Washington, D.C.