FDA Addresses Risks Associated with Insulin Pumps
On March 2, 2010, the FDA announced a growing number of hardware and software problems with certain insulin pumps. According to The Wall Street Journal, there have been 18 insulin pump-related recalls by the FDA over the last five years. The problems span different manufacturers and products. Some insulin pump manufacturers involved in the recalls are Medtronic Inc., Roche Holding AG, and Johnson & Johnson. As a result, the FDA 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 insulin pumps 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.”
Medtronic Recalls Insulin Pumps
Last year, Medtronic voluntarily recalled 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.
Disetronic Medical Systems Inc. Recalls Insulin Pumps
Disetronic Medical Systems Inc., a subsidiary of the Roche Group, recalled their Accu-Chek Spirit insulin pumps for defective “up” and “down” buttons. Problems with these buttons could prevent users from altering any previously set program on their insulin pumps.
Animas Corp. Recalls Insulin Pumps
Animas Corp., a Johnson & Johnson subsidiary, recalled varieties of the Animas insulin pump due to a battery defect. The defective battery in the insulin pump could put patients at risk for hyperglycemia and hypoglycemia.
A lawsuit was filed against Medtronic and some of its subsidiaries in U.S. District Court for the Southern District of Texas on November 30, 2009. Medtronic faces potential 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.
Insulin Pump Recall Lawyers
Thousands of Americans rely on their insulin pumps to provide them with the medication they need on a daily basis. If you or a loved one has suffered injuries as a result of the use of an insulin pump, you may be entitled to compensation. To speak to one of our insulin pump recall lawyers for a free case evaluation please contact us.