Medtronic announced that it has agreed to settle its inventories of filed and unfiled product liability claims related to Infuse Bone Graft.
Medtronic is a medical technology company focusing on treating cardiac and vascular diseases, diabetes and neurological and musculoskeletal conditions.
According to a Milwaukee Journal Sentinel report, after the release of the Infuse Bone Graft, clinical studies published in professional journals omitted information about complications. In 2012, the U.S. Senate Committee on Finance issued a report saying that marketing employees at Medtronic were involved in drafting and editing favorable articles about Infuse and that the company paid surgeons whose names lent weight to the studies.
1. Under the terms of the agreement, Medtronic, subject to certain conditions, will resolve the claims of an estimated 950 claimants for a total payment of approximately $22 million.
2. The company allegedly paid $210 million over 15 years in royalties and other payments to a group of 13 physicians and two corporations linked to physicians, according to a Milwaukee Journal Sentinel report. Many lawsuits also allege that Medtronic promoted the use of Infuse for indications not approved by the U.S. Food and Drug Administration, though its payments to physicians.
3. Infuse includes rhBMP-2, a recombinant bone morphogenic protein, to achieve a fusion. A series of articles published in The Spine Journal found complications with rhBMP-2 were much higher than originally reported. In 2013, the Yale Open Data Access project announced the results of studies that found that pain and cancer were more commonly reported among the patients who received Infuse as opposed to those who received iliac crest bone grafts. However, YODA also recommended more research done on the topic.
The studies, which were published in the Annals of Internal Medicine, concluded that while iliac crest bone grafts and Infuse were effective, Infuse correlated with adverse outcomes. The safety and efficacy of BMP use may depend on the dosage, whether it's used with a cage and surgeon experience. Many spine surgeons continue to use rhBMP-2 in complex cases where it might otherwise be difficult to achieve a fusion.
4. According to the company's financial results, BMP revenue plummeted from $119 million during 2013 Q2 to $96 million in 2014 Q2. BMP revenues in the United States have been steadily decreasing over the past few years, but the more recent Q3 data shows relatively flat BMP and spine sales. In fact, United States revenue from BMP actually increased $2 million from the second quarter to the third quarter of fiscal year 2014. International BMP revenue also increased over $1 million over the second quarter to $15 million for the third quarter of 2014.
5. According to a Medtronic press release, the company will continue to stand behind Infuse Bone Graft and will vigorously defend the product and company actions in the remaining cases. The agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by the company.
In a North American Spine Society poll conducted last year, 40 percent of surgeons said they were mildly concerned about retrograde ejaculation risks associated with BMP; around 58 percent of surgeons said they were concerned with cancer risks. Around 41 percent of the respondents said they decreased their frequency and dose of BMP due to concerns raised over the past few years while 30 percent have made no changes.
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