Medtronic Defibrillator Lead Linked to 13 Deaths
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An independent panel of physicians now says the death count from the Medtronic Sprint Fidelis cardiac wire is closer to 13, more than the five deaths the company previously revealed.
Last month, the company told doctors about the increased number of patient deaths and suggested that leaving the lead intact was perhaps the best choice for the majority of patients. Four of the patient deaths resulted from removing the defective lead.
The defective lead was in the heart of about 270,000 patients when Medtronic pulled the device in October 2007.
Patients have filed lawsuits over the Sprint Fidelis lead which delivered either too many shocks or didn’t deliver an appropriate shock to steady a heartbeat. The cases charge product liability, negligence, fraud, and breach of contract, among other charges.
Patients can ensure they are safe from defective medical devices and drugs only when their makers fully and openly disclose the side effects. It sounds simple and reasonable, but unfortunately litigation, or the threat of litigation provides a strong incentive for companies to avoid design defect or failure-to-warn lawsuits.
The Medical Device Safety Act of 2009 returns to consumers the ability to hold a company accountable for a defective product that the company, in some cases, knowingly markets to the public.
The public can sign on to support the Act in an online petition.
Once you’ve been injured, filing a lawsuit helps you recover what it might cost you for a lifetime of medical care, but it does not reverse the harm. Forcing transparency with the threat of a lawsuit might, and let's not forget it's an American right.
It’s too bad that companies don’t just do the right thing and insist on the highest standard of safety to minimize harm, but clearly they don’t.