General Electric Named in Lawsuit Alleging Dangerous CT Scan Equipment. The Kosieradzki • Smith Law Firm filed a medical product liability lawsuit against General Electric in the United States District Court, in Minneapolis, Minnesota on February 12, 2010. The complaint alleges that CT imaging machines manufactured and sold by General Electric emitted unsafe levels of radiation. Kosieradzki • Smith's client alleges that as a result of GE’s negligence, she was exposed to unsafe levels of radiation when she underwent radiologic CT scanning at a hospital in 2004. The lawsuit alleges that the CT scan emitted unsafe levels of radiation, which caused multiple myeloma, a type of cancer that is linked to radiation poisoning. The complaint alleges that CT imaging equipment manufactured by General Electric was designed and intended to be used in the treatment of a patient’s condition and illness, including the diagnosis of stroke or other brain-related disease. Click here to review the Complaint filed with the U.S. District Court. “Patients go to hospitals with the expectation that whatever health concerns they are dealing with will be dealt with safely. Hospitals spend a lot of money on sophisticated equipment like CT scanning machines to help take care of their patients,” said Mark Kosieradzki, Henry’s attorney. “Patients and their medical providers should be able to expect that companies like GE will not put dangerous equipment in that setting.” The lawsuit alleges that in October 2009 the U.S. Food and Drug Administration (“FDA”) released a notification to healthcare professionals indicating that it had become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke. The FDA notice stated that, for an 18- month period, beginning in February 2008, 206 patients had received radiation doses that were approximately eight times the expected level. Instead of receiving the expected dose of 0.5 Gray (abbreviated as “Gy”) (maximum) to the head, these patients received 3-4 Gy. The FDA further indicated that “the magnitude of these overdoses and their impact on affected patients were significant.” Click here to review the October 2009 FDA Alert. Click here to review the FDA's December 2009 update. The complaint alleges further that the FDA indicated that it had commenced a safety investigation, suggesting that the situation may reflect more widespread problems with CT quality assurance programs. A nationwide alert was issued by the FDA warning hospitals to check CT brain scan procedures. |
