Lawyer Releases New Video with Up to Date Information about the Alleged Dangers of the Infuse Bone Graft
(PRWEB) July 15, 2013 -- The Infuse Bone Graft has been on the market since July 2002, but only recently have patients learned about the alleged risks associated with the device. One of the first indications that this device may be dangerous came when The Spine Journal published an article in April 2011. The article stated that earlier medical studies about the device underreported the frequency of complications. In fact, earlier studies did not report a single adverse event. But, the article found that Infuse Bone Graft complications actually ranged “from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimate 40% greater risk of adverse events… including life-threatening events.” The article also alleged that these complications were concealed because on average Medtronic paid doctors between $12 million and $16 million for each study (i). Recently, the company tried to increase its product’s credibility by commissioning Yale researchers to conduct a trial completely independent of financial pressure. However, the Yale trial revealed that the “[Infuse Device] has no proven clinical advantage over bone graft and may be associated with important harms.” According to the trial, these “important harms” include increased risks of retrograde ejaculation, urogenital problems, swelling in the neck and throat, and cancer. The authors also noted that early studies misrepresented benefits and harms “through selective reporting, duplicate publication, and underreporting” (ii).
Growth in patient awareness of the Infuse Bone Graft has led some to seek legal advice from lawyers and attorneys across the country. In June 2013, Reuters reported on one of the most recent cases, David et al. v. Medtronic Inc., et al (No. BC-510542). The lawsuit was filed on May 31, 2013 in the Los Angeles County Superior Court of California on behalf of 37 patients who received the device for off-label uses. The primary injury alleged by the suit is unwanted bone growth. The plaintiffs are now seeking both compensatory and punitive damages (iii).
Attorney Paul d’Oliveira stated, “Patients need to understand that the Medtronic Infuse Bone Graft has only been approved for one use, anterior lumbar interbody fusion (ALIF). It has not been accepted for use in other parts of the spine, especially the cervical region (neck). Uncontrolled bone growth in this area is very serious because it can make breathing, speaking, and swallowing very difficult and in serious cases it is life-threatening. I put together this new video to alert patients to this risk.”
d'Oliveira & Associates has been investigating these medical devices and they work with some of the more experienced Medtronic lawyers who handle these cases. The law firm has numerous resources on the Infuse Bone Graft including infographics and videos. For more information call 1-800-992-6878 or fill out a contact form online.
(i) The Spine Journal, April 2011.
spine.org/Documents/TSJJune2011_Carragee_etal_CriticalRev.pdf
(ii) Annals of Internal Medicine, Yale Study, June 2013.
annals.org/article.aspx?articleid=1696646
(iii) Reuters, June 21, 2013.
blog.thomsonreuters.com/index.php/medtronic-profited-from-improper-bone-graft-sales-california-suit-claims/
Paul d'Oliveira, Personal Injury Lawyer, http://www.good-legal-advice.com, 1-800-992-6878, [email protected]
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