The FDA knew ten years ago that NECC was running a shoddy operation, and now (after 32 deaths due to fungal meningitis) Congressional investigators want some answers. According to Bloomberg News, the FDA found sanitation and procedural lapses during a routine inspection in 2002. Similar problems were found at a California facility that same yet, resulting in 3 deaths. Paperwork suggests the FDA 'suggested' suspending NECC's operations but was legally unable to close the operation and was instead required to defer to state authorities. There has already been some legal positioning taking place in that regard. Last week, James Coffey, the director of the Massachusetts pharmacy board was dismissed. Additionally, the group's lead attorney, Susan Manning, was put on administrative leave in the wake of allegations that they mishandled complaints about NECC's operations. FDA Commissioner Margareg Hamburg will be called before an oversight and investigations committee (11/14/12) to answer specific questions about the agency's role in the tragedy. The Senate's health committee is planning a separate hearing November 15th. Now another drug distributor is being investigated. Ameridose LLC, which has the same management as NECC, apparently also failed to investigate contamination observed at least 53 times during sterility testing. The government has said about 14,000 people received shots of the NECC steroid, which is injected into the spinal cavity to relieve neck and back pain.
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If you or a loved one received a steroid shot and became sick, contact us for a personal consultation at the Law office of T. Verner Smith: (731) 423-1888 or (615) 371-6136.
NBC News reports fungal meningitis and other infections linked to contaminated injection drugs have resulted in 354 cases in 19 states. Deaths have now reached 28, according to the CDC.
Cases of fungal meningitis, stroke presumed to be caused by the infection and other central-nervous-system infections climbed to 347. Another seven infections have been reported in people who received mold-tainted injections in joints such as the hip, knee, elbow, or shoulder.
The contaminated drugs were produced by the New England Compounding Center of Framingham Massachusetts (NECC), which has recalled all of its products and has been stripped of its pharmacy license.
The FDA has released new documents showing company officials documented mold and bacteria at several sites in the company's clean rooms dating from January through September. Massachusetts health officials also documented contamination and problems with the steam sterilization equipment known as an autoclave. In addition, NECC was dispensing vast quantities of sterile drugs without having the individual patient prescriptions required for compounding pharmacies. (source: nbc news & other news sources 10/30/12)CLICK HERE FOR OUR PAGE DEVOTED SPECIFICALLY TO THE LATEST NEWS ON THIS SUBJECTIf you or a loved one received a steroid shot and became sick, contact us for a personal consultation at the Law office of T. Verner Smith: (731) 423-1888 or (615) 371-6136.
MEDICAL RECALL for HEART DAMAGE TESTS
If you or a loved one underwent a heart test between June 29, 2011 and March 12, 2012 which included the use of these particular immunoassayies and lot numbers, you/they may have suffered serious health consequences as a result. Contact our office at (731) 423-1888 for information regarding how you may be entitled to compensation.
The FDA has issued a Class 1 RECALL for Roche Diagnostics biochemical tests Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays (lot numbers 163176 and 163177) which were distributed between June 29, 2011 and January 13, 2012. Doctors who used these tests to determine heart damage (as an aid in the diagnosis of a heart attack) may have received a falsely low result and these incorrect results may have caused serious adverse health consequences, including death.
On March 12, 2012, Roche Diagnostics Operations sent an “URGENT MEDICAL DEVICE REMOVAL” letter to all its customers (doctors, clinics, laboratories & hospitals) who received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter described the product, problem, and actions to be taken. A Class 1 FDA recall is the most serious type of recall and involve situations in which there is a reasonable probability that use of these products would have caused serious consequences.
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