Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Medtronic InFuse draws patient lawsuit

This article was originally published in The Gray Sheet

Executive Summary

Maker of the recombinant human bone morphogenetic protein product denies promoting an off-label neck implant that allegedly caused the death of a California woman last August. In a suit filed Dec. 2 in Los Angeles federal court, the family of Shirley Nisbet charges that Medtronic improperly promoted InFuse, which is only approved for the lower spine and certain dental and tibial fracture indications. The surgery followed a July 1 FDA warning against off-label use of the bone growth product in the cervical spine due to the potential for life-threatening complications (1"The Gray Sheet" July 7, 2008, p. 10). Medtronic recently received a subpoena from the Department of Justice seeking information on off-label use of InFuse (2"The Gray Sheet" Nov. 24, 2008, p. 20). The inquiry follows the September initiation of a U.S. Senate investigation into allegations that the firm provided incentives to physicians for use and promotion of spine products, including off-label InFuse. The allegations stem from a 2002 lawsuit over alleged spine product kickbacks, which was settled by Medtronic in 2006 for $40 million without any admission of wrongdoing (3"The Gray Sheet" Oct. 6, 2008, In Brief)

You may also be interested in...

Evidence On Off-Label Bone Morphogenetic Protein Benefit Is Limited

A draft technology assessment released April 23 by the Agency for Healthcare Research and Quality finds no evidence of improved health outcomes for most off-label uses of bone morphogenetic protein to promote bone healing following a fracture

Stryker Unit Charged With Fraud, Misbranding For Illegal Marketing Scheme

Stryker's biotech division and four former and current executives face charges of wire fraud, conspiracy, device misbranding and false statements related to the marketing of its OP-1 orthopedic bone growth biologic/device combination products

Regulatory News In Brief

Updated FDA review clock guidance: Agency issues June 30 1guidance detailing the different actions FDA may take on pre-market approval applications and clarifying FDA's timeline goals for applications filed from FY 2008-2012 versus those filed from FY 2003-2007. The 2007 FDA Amendments Act removed interim cycle goals, which often stopped the "review clock" and inadvertently prolonged the review process, maintaining FDA decision goals only. FDA will follow the review goals proposed as part of the new user fee legislation (2"The Gray Sheet" April 23, 2007, p. 7). Cycle goals are also abolished for applications filed in FY 2007. Performance goals will no longer vary from year to year, and FDA now has the option of issuing major deficiency letters for 180-day supplements, as well as for PMAs and panel-track supplements, the guidance points out. The document replaces October 2003 guidance based on the review clock in the 2002 user fee legislation (3"The Gray Sheet" Oct. 13, 2003, p. 22)

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts