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Product defect may lead to medical malpractice in recall

The U.S. Food and Drug Administration oversees the quality and safety of drugs in the United States. When a defect is discovered, the agency can issue a recall, but it is possible that some medical centers may have already administered the medication and others may continue to do so even after the recall. Continuing to administer suspected tainted medication is a form of negligence and can result in a medical malpractice suit.

Our readers in the Hartford, Connecticut, area may be interested in this developing national story regarding tainted steroidal injections. The FDA issued a recall when bacterial meningitis was detected in supplies of the drug methylprednisolone acetate, which was distributed by the New England Compounding Center. Another four deaths were reported in the last week as the death toll continues to rise nationwide.

The FDA's criminal prosecution team has seized files from the NECC in an attempt to determine exactly where quality control failed and how contaminated injections managed to reach medical centers. Fungal meningitis is not easily transmitted or considered contagious. Nearly 14,000 patients could have been infected if they received injections containing the contaminated drug.

Hospitals and doctors must stay up to date on the latest FDA recalls and follow all guidance provided by the agency. Failure to do so can cause further confusion and make it harder to track down and eliminate contaminated or defective products. Those who believe they have suffered due to defective medications or incorrect hospital policies should seek to understand their rights and responsibilities under the law.

Source: Hartford Courant, "UPDATE 2-U.S. meningitis deaths rise, FDA faces new questions," Oct. 17, 2012

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