FDA Probing Medtronic, Roche And J&J Insulin Pump Injuries & Deaths

The U.S. Food & Drug Administration (FDA) is probing into 17,000 reports of insulin pump related health problems from 2006 to 2009 – 310 of those which resulted in death. Medtronic MiniMed, Roche Holding AG and Johnson & Johnson are some of the largest insulin pump manufacturers in the U.S. and have recalled many of these medical devices used by Type 1 diabetes patients.

Defective insulin pumps

Insulin pumps provide insulin to to those who suffer from Type 1 diabetes – a chronic disease that occurs when the pancreas does not produce enough insulin to properly control blood sugar levels and approximately 375,000 Americans use insulin pumps on a daily basis. Insulin pump manufacturers have instituted numerous medical device recalls in the past three years and the FDA has received approximately 17,000 reports of insulin pump related health problems from 2006 to 2009 – 310 of those resulted in death.

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FDA investigation

The FDA is investigating the matter after reporting that there is “an increasing trend in software and hardware device problems across manufacturers” and that it is convening a panel of medical experts in order to “minimize the risks associated with the devices in these recall situations.” Some of the recalls likely include those by:

• Medtronic. Medtronic recalled certain lots of its Quick-set infusions used in MiniMed Paradigm insulin pumps due to a potential defect in how air pressure vented – causing delivery of improper amounts of insulin and the potential for serious injury or death. The company also received an FDA warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pumps after insulin pumps without propellant had been inserted in patients.
• Roche Holdings AG. Disetronic Medical Systems Inc., a unit of the Roche Group, recalled its Accu-Check Spirit insulin pumps due to a potential defect in some of the devices up and down buttons which prohibited users from changing programmed settings.
• Johnson & Johnson. Animas Corp, part of the Johnson & Johnson empire, recalled some of its Aimas insulin pumps due to defective battery caps that could cause the pumps to stop administering insulin and cause patients to experience hyperglycemia or hypoglycemia (too much or too little blood sugar, or glucose).

Defective insulin pump lawsuits

Medical device recall attorneys say that numerous lawsuits have been filed against the above insulin pump manufactures and others alleging negligence, failure to warn, defective design and manufacturing and breach of warranty. If you’ve been injured by a defective or dangerous insulin pump, contact a product liability lawyer right away to discuss your situation as you could be entitled to damages such as lost wages, medical bills or pain and suffering.

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Case Studies: FDA Investigation and Insurance Implications for Insulin Pump Injuries & Deaths

Case Study 1: Product Liability Insurance for Insulin Pump Manufacturers

In the case of the FDA probing Medtronic, Roche, and J&J insulin pump injuries and deaths, product liability insurance becomes crucial for the insulin pump manufacturers. Product liability insurance provides coverage in the event of claims or lawsuits alleging harm caused by defective products.

With the FDA investigation and the recalls of their medical devices, these manufacturers may face legal actions and potential financial liabilities. Product liability insurance helps protect the companies by covering legal defense costs, settlements, or judgments associated with these claims, ensuring that they can fulfill their obligations while mitigating the financial impact.

Case Study 2: Medical Malpractice Insurance for Healthcare Professionals

For healthcare professionals who have prescribed or used the defective insulin pumps in their medical practice, medical malpractice insurance is essential. If patients experience harm or death due to the malfunctioning insulin pumps, they may file medical malpractice claims against the healthcare professionals involved.

Medical malpractice insurance provides coverage for legal defense costs, settlements, or judgments arising from such claims, safeguarding healthcare professionals from potential financial burdens and allowing them to continue providing medical services to their patients.

Case Study 3: Health Insurance Coverage for Patients

Patients who have been affected by the defective insulin pumps should review their health insurance coverage to ensure they have adequate coverage for any necessary medical treatments, hospitalizations, or related expenses.

The injuries or deaths resulting from the malfunctioning insulin pumps may require extensive medical care and ongoing treatment.

It is important for patients to understand their health insurance coverage, including any limitations, copayments, or deductibles, to ensure they can access the necessary healthcare services without incurring significant out-of-pocket costs.