The FDA recently issued a serious warning to hospitals, physicians and patients who have used or been implanted with Medtronic’s heart devices, stating that certain parts of the instruments are causing inordinate numbers of injury and death throughout the country. Medtronic lawyers at Pintas & Mullins Law Firm are currently working with victims of Medtronic device defects and know first-hand how dangerous they can be.
Specifically, the FDA warning names Medtronic’s medical guidewire product, which is inserted through cardiac arteries to guide device placement. About 15,000 of these guidewires were recalled in late October 2013 after the company received numerous reports of serious patient injuries. One patient suffered a cardiac arrest from the product, though theyfortunately recovered.
The injuries were apparently due to the outside coating detaching from the guidewires, which blocked blood vessels, preventing blood from entering the heart. Guidewires are coated to enable them to slide through arteries, veins, and capillaries more easily. The global recall was categorized as a Class I by the FDA, which is its most serious recall, meaning the product could reasonable cause catastrophic injury or death in patients.
Medtronic’s Recent Issues
This is not the first recall issued by Medtronic this year; in early June 2013, its MiniMed Paradigm Insulin Infusion pump was recalled due to issues with the tubing connector. The Paradigm sets are used by diabetes patients to regulate blood glucose levels. Any liquids that came in contact with the inside of the tubing connectors could block the pump’s priming vents, causing too little or too much insulin to be delivered.
It is not the first time this year that Medtronic has received a warning letter from the FDA either. In late September 2013, the FDA outlined several violations it found at Medtronic’s MiniMed facility in California. During its inspection of the facility, the FDA found that the company failed to establish and maintain corrective and preventative procedures. This could adversely affect the quality and safety of Medtronic’s MiniMed devices in several ways.
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The Infuse Bone Graft, most notorious of Medtronic’s devices, has been subject to immense litigation recently, and even as far back as 2003. The Infuse is implanted surgically to promote bone growth and replace any damage spinal disks, however, Medtronic marketed the device for uses the FDA never approved it for, such as neck procedures. The Infuse was approved exclusively for lumbar (lower back) surgery as well as specific oral and dental procedures.
Despite this, the company encouraged surgeons to use the Infuse in procedures involving the cervical spine (neck) and other areas, which helped the product generate over $3 billion in sales, but which was also highly illegal. Injuries associated with inappropriate Infuse device placement include nerve damage, respiratory depression, difficulty speaking, swallowing or breathing, and airway compression. Most injuries begin to manifest between two and 14 days after surgery.
One recent lawsuit over the device revealed that Medtronic systematically paid off doctors not only to promote the Infuse, but to conduct studies on it confirming its safety as well. One surgeon was paid more than $800,000 over three years to “conduct” (see: fabricate) studies that yielded positive results for the product.