It’s been one month since Medtronic, the Minneapolis Minnesota based company who makes medical and surgical devices, recalled their Sprint Fidelis defibrillator lead on October 15th 2007. Since then, the company has been sued by patients and shareholders for negligence, withholding information, theft – and the list goes on and on.

A quick recap

Medtronic recalled its Sprint Fidelis defibrillator lead (model numbers 6930, 6931, 6948 and 6949) on October 15th 2007 after it concluded that the lead wire may fracture – causing the defibrillator device to unnecessarily shock the heart multiple times when not needed or fail to shock the heart when required.

Defibrillator leads are small wires that attach a defibrillator (a small device that is implanted in the chest that monitors a patient’s heart rhythm and sends an electrical shock when the rhythm becomes abnormal) to the heart itself.

At least five deaths have been linked to the Fidelis which is implanted in nearly 235,000 patients worldwide – approximately 172,000 of those are located in the United States. The U.S. Food and Drug Administration (FDA) has reportedly already received 1600 reports of the product malfunctioning or causing injury. Medtronic has issued the following letters that provide patients and physicians with information on what to do:

• Patient letter: www.medtronic.com/fidelis/patient-letter.html
• Physician letter: www.medtronic.com/fidelis/physician-letter.html

Lawsuits filed

Since the October recall, the company has been sued several times by patients and shareholders – and legal experts predict that more are coming. There are currently several patient lawsuits (most involving more than one patient and seeking class action status), at least four shareholder lawsuits (also seeking class action status) and one suit for civil theft. Here’s an overview of the lawsuits:

• Patients. The patient lawsuits generally allege that the company was negligent, failed to warn them of the defects, caused them physical injury, intentionally and negligently inflicted emotional distress, breached implied and express warranties, that the company was unjustly enriched, that patients will need additional medical monitoring and have or will suffer economic losses. Damages in these cases vary.
• Shareholders. The shareholder lawsuits generally allege that the company knew about the product’s defects months before the recall and made false and misleading statements to investors. The shareholder’s suits seek damages for any investor who purchased Medtronic shares between June 25th 2007 and October 15th 2007 – the date of the recall. Shares dropped nearly 20 percent after that date.
• Theft. The civil theft lawsuit alleges that a patient had his device removed after it malfunctioned and sent it back to Medtronic for analysis. The company destroyed the device which would have been evidence in a lawsuit. Damages in the case are not known.

Additional information

For additional information, consumers can contact:

• Medtronic at 800-551-5544, ext 41835; www.medtronic.com
• FDA, 1-888-INFO-FDA (1-888-463-6332); www.fda.gov

Medical companies often put profits over safety and it’s just not right – especially in situations like this where the consequences may be severe. If you or a loved one has been injured or died as a result of this device, consider contacting an attorney to discuss your situation – without obligation. To contact an attorney near you whose practice focuses in this area of law, please click here.