FDA to Focus On Increase in Insulin Pump Recalls

(I-Newswire) March 19, 2010 - New York, Mar 19, 2010 -- The attorneys at Bernstein Liebhard LLC are disturbed by the news of the growing number of insulin pump related recalls.
According to The Wall Street Journal, there have been 18 insulin pump-related recalls by the FDA over the last five years. These recalls, such as the Medtronic recall last year, relate to hardware and software problems with the pumps, which have caused serious, and sometimes fatal, injuries to users.

The hardware and software problems stretch beyond the Medtronic recall and span different manufacturers and products. Some other insulin pump manufacturers involved in the recalls besides Medtronic are Roche Holding AG, and Johnson & Johnson. As a result of the increasing incidence of pump malfunctions, on March 2, 2010, the FDA announced that it is convening a panel of medical experts in order to “minimize the risks associated with the devices in these recall situations.”

The recalled insulin pumps are generally used by people with type 1 diabetes. Since they rely on the insulin pump to administer medication daily, insulin pump malfunctions could have a severe effect on the reported 375,000 Americans using insulin pumps. Reuters reports that the FDA looked closely into 17,000 reports of insulin pump-related health problems from 2006 through 2009, and reviewed 310 fatality reports. Forty-one of these patients suffered from diabetic coma, low blood sugar, or other problems before death.

Last year, the voluntary Medtronic recall involved certain lots of their Quick-set infusions used in MiniMed Paradigm insulin pumps. These infusions are used to deliver the medication from the insulin pump to the patient. Malfunctions in the infusions affected the dosage of insulin which resulted in injury and sometimes death. Affected infusions are MMT-396, MMT-397, MMT-399, and lot numbers starting with the number 8. In May 2008, Medtronic also recalled their SynchroMed II insulin pumps. The Medtronic recall took place after the company received a letter warning that insulin pumps without propellant had been inserted in patients.

A lawsuit was filed against Medtronic and some of its subsidiaries in U.S. District Court in the Southern District of Texas on November 30, 2009. The Medtronic lawsuit involves claims for damages under theories of strict liability, negligence, failure to warn, defective design and manufacturing, and breach of warranty. The Medtronic lawsuit also seeks punitive damages, claiming that Medtronic was aware of the risk of their products and production deficiencies. Some side effects caused by using the recalled insulin pumps are confusion, fainting, dizziness, difficulty speaking, sweating, seizures, coma, and death.

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