The attorneys representing Keim and his parents filed a Medtronic Infuse Problems lawsuit claiming that the device caused her cancer, uncontrolled bone growth, and urination injuries. They pointed out that the device used in her surgery did not contain all the parts intended for it. The lawyers argued that the preemption doctrine shielded Medtronic from a lawsuit, but the attorneys argued that one component had never received FDA approval.
The U.S. Senate is reviewing Medtronic’s Infuse lawsuits after a year of investigation. The lawsuit claims that Medtronic failed to properly test the device and failed to provide necessary safety information to doctors. The company allegedly received kickbacks from physicians and hospitals who inserted the device. These kickbacks and thousands of dollars in consulting and royalty payments created a conflict of interest that ultimately led to dangerous treatments. As a result, more patients experienced deteriorating health problems after the surgery.
The company says it is cooperating fully with the FDA and expects ongoing scrutiny of Infuse. The drug is a biological agent that stimulates bone growth, and more than a million people have had the device implanted in their spines. However, 85% of Infuse users received the drug in ways not approved by the FDA. Infuse sales peaked at $800 million a year in 2011, but have fallen sharply since.
Uncontrolled bone growth
The medical device Medtronic marketed as the “best alternative” to spine surgery, the Infuse, has caused severe complications in patients. Other doctors found significant problems. Patients developed nerve damage, chronic radiating pain, and even needed additional surgeries to remove bone overgrowth. Some patients also suffered sterility or urogenital problems. Infuse was approved without a clinical trial, which is why it went on the market with far fewer safety tests than biological drugs.
When the Infuse Bone Graft was first introduced to the market in 2002, it showed great promise for treating patients with degenerative bone diseases. But, after a few years, many patients suffered a variety of complications. Several lawsuits were filed against Medtronic, accusing the manufacturer of misleading marketing. The FDA issued a warning to doctors about the potential risks of this device. Infuse patients have reported severe complications, including extreme swelling of the neck and breathing difficulties.
Plaintiffs in the Medtronic Infuse Problems lawsuit claim a variety of injuries relating to the device. During the Class Period, Medtronic employees allegedly manipulated medical studies to increase its stock price. After the truth came to light, the stock dropped by more than 25 percent. In response, attorneys at Morgan & Morgan began investigating the product. As a result of these findings, more plaintiffs have filed lawsuits against the company.
The plaintiffs have accused Medtronic of marketing Infuse off-label, causing injuries and deaths in some cases. While the company has settled hundreds of lawsuits, thousands more are pending. The settlements are projected to total about $460 million, and Medtronic has set aside $300 million to resolve pending cases. The proposed settlement will likely resolve the pending cases and will put an end to future litigation.
In a recent Medtronic Infuse problems lawsuit, two former employees alleged that the company paid physicians to promote the device’s off-label use. The whistleblower lawsuit claims that the companies paid doctors thousands of dollars in consulting fees for promoting the use of their devices. But the lawsuit also alleges that the companies ignored warnings about the dangers of using Infuse for off-label uses.
The company has consistently invoked the Riegel Supreme Court decision, which held that a company with FDA approval is immune from tort claims. But a recent state judge has struck down this preemption defense. The plaintiff argues that Medtronic failed to warn the FDA of the side effects of Infuse and aggressively pursued off-label uses. Ultimately, the lawsuit alleges that Medtronic misrepresented the risks and benefits of Infuse and failed to warn its patients.
Financial ties between Medtronic and researchers
In a recent investigation, the U.S. Senate Finance Committee found that doctors with financial ties to Medtronic failed to disclose adverse side effects in company-sponsored research papers. The committee also asked whether physicians overstated the benefits of Infuse and understated its risks. As a result, the company agreed to pay $85 million to settle a shareholder lawsuit. But the question remains: How much money is too much?
Infuse, a spinal implant that was approved by the FDA in 2002, is a prime example. Although the device is approved for spine surgery, some researchers have raised questions about its safety. For example, patients may experience severe side effects, such as cancer, a fatal swelling in the neck, and radiating leg pain. To answer that question, the Senate Finance Committee has requested information from Medtronic about its interactions with medical journals, the FDA advisory board, and physician consultants. They also want to see documents detailing payments to Infuse clinical investigators.
Settlements with Medtronic
The federal False Claims Act protects physicians’ independent medical judgment. A federal government investigation found that Medtronic had violated the law by paying physicians kickbacks, including royalties, consulting agreements, and lavish trips. In addition, shareholders sued the company for misleading claims regarding the use of Infuse. In 2012, the company settled a class action suit for $85 million. Despite the legal hurdles, the company has settled many other claims and has set aside $140 million in anticipation of future settlements.
The companies have also agreed to pay settlements in the Infuse lawsuits filed by patients. While Medtronic denies any wrongdoing, it must follow new requirements for its research, marketing, and promotional efforts. As of the fourth quarter of 2013, Medtronic estimated that it would pay out $120 million to $140 million to settle these cases. It also agreed to pay out $12 million to five states for settling claims that the company manipulated research articles about the Infuse device to promote the device. The FDA issued an alert in 2012 regarding the problems associated with the device, and the company is now paying out a portion of that settlement. Ultimately, the settlement would settle the cases, and end future lawsuits.