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Medtronic Tries to Settle Infuse Cases but Many Patients May Still See Their Day in Court

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More than 6,500 reports of injuries related to Medtronic’s Infuse bone growth product have flooded into the U.S. Food and Drug Administration (FDA) since 2002. About 3,300 were registered with the agency’s medical device reporting system last year alone. Now, the company is settling as many cases as possible while patients await their day in court.

Medtronic told investors last week that it will pay $22 million to settle about 950 claims and is setting aside $140 million to settle future claims, according to MedPageToday.com.

Infuse contains both a device and a drug known as BMP-2. It was intended for use in spinal fusion surgeries. Over the years, however, the product has been used for off-label cervical spine surgeries and in lateral approach and posterior approach spinal procedures that has caused a wide range of complications and side effects, including uncontrolled bone growth at or near the site of surgery, sterility, nerve damage resulting in severe pain, and even cancer.

Infuse is also expensive. According to a Spine journal article published in January, use of BMP-2 increased the average hospital charge by more than $13,000 per patient, more than $900 million total, from 2002 to 2008, MedPageToday.com reported.

Medtronic carried out markedly less testing of Infuse on patients than other drug-device combinations, despite serious concerns about Infuse that popped up before its approval. Clinical trials usually consist of between 1,000 and 3,000 people; Infuse’s clinical trial consisted of only 277. Infuse was treated as a combination device, instead of a biologic agent, which would have required more rigorous testing with a larger group of study participants, according to MedPageToday.com

MedPageToday and the Journal Sentinel revealed last year that a small group of spine surgeons had co-authored papers that failed to link Infuse and several serious complications. The surgeons were paid millions of dollars in royalties by Medtronic, and in some cases, the medical journals publishing the papers didn’t fully disclose the relationship between the company and the authors, MedPageToday.com reported.

Patients hoping to recoup some of their financial losses and shine a light on the FDA’s lackadaisical approval methods and Medtronic’s dishonesty are now facing a legal hurdle in the form of pre-emption. Pre-emption makes it a challenge to sue medical device makers over products that have received FDA approval, according to MedPageToday.com.

Under federal law and Supreme Court rule, medical devices should be readily available to treat patients with life-threatening and potentially disabling conditions. Once a device goes through the FDA approval process, claims are then barred, MedPageToday.com explained.

Those suing Medtronic argue that financially connected spine surgeons essentially encouraged other spine surgeons to use Infuse for off-label purposes by acting as paid promoters of the product, thereby losing its protection. As of yet, none of the cases have resulted in finding liability against Medtronic, but more cases are expected to go before a jury. Right now, many of the cases are in the early procedural stages, according to MedPageToday.com.


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