Medtronic Inc., one of the world’s largest heart device manufacturers, faces massive litigation due to its dangerous and defective products.
Thousands of injured patients have filed lawsuits against Medtronic over its Infuse Bone Graft, Eclipse Spinal Sphere, Synchromed Pain Pump, Infusion Pump, and spinal stimulator products.
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Medtronic recalled the SynchroMed infusion pump in 2012 and 2013 after it was linked to 14 deaths. The device delivers pain medication and to patients with chronic conditions. The most common complication with SynchroMed is the accidental injection of a drug into patient’s tissue.
Flaws in the SynchorMed System can lead to:
One man, Richard Stengel, had a SynchroMed pain pump implanted. A mass of tissue grew over the pump in response to an infection. He had the mass and the pump removed but was left paralyzed from the waist down.
Stengel and his wife sued Medtronic, claiming the company did not properly warn about the pump’s risks, and that neither the FDA nor the public were informed of the risk of tissue masses like the one he suffered. The lawsuit is ongoing.
Another Medtronic recall was initiated in 2013 concerning the MiniMed Paradigm Insulin Infusion Sets. Defects in these devices caused either too little or too much insulin to release, leading to serious illnesses. All 37 devices in the Paradigm Infusion family are involved in the recall.
Medtronic’s Infuse Bone Graft is also at the center of thousands of injury lawsuits, scathing medical reports, and federal investigations. These patient lawsuits are just the latest news in the decade-long Infuse controversy. The Infuse is used in spinal fusion surgeries to stimulate bone growth. It has been used in more than 500,000 patients, with sales amounting to hundreds of millions of dollars each year.
Since its approval in 2002, it’s become clear that Medtronic marketed Infuse illegally, paid doctors to write favorable Infuse articles, and used faked data to prove it would be superior to traditional spine surgery methods.
In 2011, The Spine Journal dedicated an entire issue to the growing risks of the Infuse. The report included Medtronic’s failure to properly report the true side effects from its clinical trials and the conflicts of interest by researchers in its studies. Medtronic paid researchers millions of dollars each to publish articles overstating the device’s benefits and understating its risks.
Infuse is only approved for surgery on the lower spine, in a specific surgical fashion. The device was never approved for use in the upper spine, or for insertion through the back.
Due to Medtronic’s aggressive marketing, patients throughout the country were implanted with the Infuse for upper spine fusions, causing extensive and severe injuries. By 2013, two studies reported that Infuse had little benefit over traditional spine surgery, and caused severe complications.
Symptoms of an improperly implanted device include mobility problems, numbness, and worsened pre-existing problems. We review Infuse injury cases involving:
Medtronic illegally marketed and paid medical experts millions of dollars to promote its products for unapproved uses, which it knew was dangerous, injuring thousands of patients in the process.
Our team of Medtronic attorneys has been working on these types of medical device lawsuits for nearly three decades. We are reviewing Medtronic claims involving SynchroMed pain pumps, spinal stimulators, insulin pumps, and the Infuse bone graft. Call us for a free case review, at any time of day or night. We are here to serve you.