Bone Graft Product under Fire

Posted by on Feb 25, 2015 in Medical Malpractice | 0 comments

Arizona-based medical device manufacturer Medtronic is feeling the heat as an increasing number of individuals are filing claims of product liability for its INFUSE Bone Graft product. Approved in 2002 by the Food and Drug Association (FDA) for use in specific spinal repairs, in 2004 for tibia procedures, and in 2007 for dental applications, INFUSE Bone Graft was lauded as a breakthrough in bone surgery.

INFUSE Bone Graft is used to encourage bone growth with the use of recombinant human bone morphogenetic protein (rhBMP-2), a synthetic protein. It is used in areas where bone needs to be grown.

The product ran into trouble when complaints started coming in that Medtronic concealed potentially harmful side effects from using the product from the medical community and the public and that it marketed the product for off-label uses. Quite a few lawsuits have been filed against product manufacturers, such as Medtronic for INFUSE Bone Graft, in both federal and state courts for various injuries, including infections, bone and nerve damage, urinary complications, sterility, and some contend that there is a link between the product and cancer.

In one case, a 33-year-old construction worker decided to have bone graft surgery in 2011 when pain from back injuries sustained in a car accident persisted. He was assured that the surgery would improve his quality of life and reduce his pain. Instead, the hardware supporting the bone graft shifted to his nerve root and made his back pain worse to the point of debilitation. Revision surgery was only partially successful and now the man can only walk with a cane and is on disability as he is unable to work.

Medtronic has already paid a hefty sum in fines to the Department of Justice for off-label marketing of INFUSE and been involved in two whistleblower lawsuits as early as 2006, as well as a shareholder lawsuit that ended in a $85 million settlement. The latest legal troubles for Medtronic has not yet been referred to multidistrict litigation (MDL) but with more and more lawsuits being filed, there are speculations that an MDL is not far off.

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Complexities of Medical Malpractice Law in Massachusetts

Posted by on Jun 16, 2014 in Medical Malpractice | 7 comments

The law is generally beyond the ken of the ordinary person. Even when it is not in legalese, the many ands, ifs, and buts that typically apply to any law can make a layperson’s head spin, and require the assistance of a lawyer specializing in that particular type of law to make heads or tails of it. Medical malpractice law is no exception, and the fact that each state has different laws governing it that continually evolves makes it even more complex.

Medical malpractice law in Massachusetts is a good example. There was a recent change in the state’s medical malpractice system that took effect in the last quarter of 2012. These reforms (see Mass. Gen. Laws Chapter 231 sections 60L and 79L) are designed to encourage early settlement or resolution of medical malpractice cases. A Massachusetts medical malpractice lawyer would be updated on these changes, but not necessarily a general practitioner in personal injury cases, so it is important to be specific when asking for legal advice and representation.

Medical malpractice in Massachusetts is defined as injury sustained by a patient undergoing treatment as a result of a breach in the standard of care expected of a healthcare professional or facility. While the standard of care is a fluid concept depending on a number of factors, Massachusetts utilizes a tribunal consisting of a doctor (a specialist in the relevant field), a judge, and a lawyer to establish the applicable standard for each case. However, even if the tribunal determines that the facts of the case does  not support a medical malpractice claim, the plaintiff can still proceed with the case after posting a bond, and use other expert witnesses to show that there was a breach, and that that breach was the proximate cause of the injury.

There is a three-year statute of limitations for medical malpractice in Massachusetts, although because of the reforms to the law mentioned above, there is a required cooling off period of up to one year during which the plaintiff and defendant/s can come to a resolution and hold off on filing in civil court. At any rate, if discovery occurs after three years after the alleged causative event, the plaintiff can still make a claim provided it is done no later than 7 years after the event.

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