Product Liability
This article was originally published in SRA
Executive Summary
Medtronic defibrillator lead lawsuits growing in North America
Medtronic defibrillator lead lawsuits growing in North America
Thousands more claimants are expected to join litigation in the US and Canada relating to Medtronic's recalled Sprint Fidelis defibrillator leads, according to law firms representing plaintiffs suing the company1,2. Minnesota-based Medtronic recalled the devices worldwide in October 2007 because of their potential to fracture; five patient deaths have been linked to broken leads3.
The first US lawsuits were filed in Minnesota and Puerto Rico the day after the recall was announced, and others have joined the litigation since. Among the most recent is a class-action suit filed in California on 31 December, alleging that Medtronic misrepresented the safety of the leads and failed to warn that they were prone to breakage4. All federal cases will be centralised in one court, according to Elizabeth Cabraser of Lieff Cabraser Heimann & Bernstein, and a decision on where they will be heard is expected by early March.
A spokesman for Medtronic told RAJ Devices it was too early to tell how many claims would be included in the litigation, as cases were still being filed. The company would include the number of claims in its next quarterly filing to the Securities and Exchange Commission.
Meanwhile, thousands of cases are expected to come under class-action litigation going forward in Canada5. The scope of the litigation in other countries is not as large as it is in the US, Medtronic said6.
ICD recall lawsuits settled
Separately, Medtronic has entered into a $114.1 million agreement settling lawsuits relating to another recall, that of its Marquis line of implanted cardioverter defibrillators7. The settlement covers more than 2,600 lawsuits, including suits consolidated into a single multidistrict litigation in the US District Court in Minnesota along with those filed in state courts.
Medtronic recalled 87,000 ICDs and cardiac resynchronisation therapy defibrillators in February 2005 because of the potential for battery failure8. The company had identified nine devices exhibiting rapid battery depletion caused by a shorting mechanism. Medtronic was not aware of any deaths or patient injuries linked to the devices.
References
1. Personal communication, Lieff Cabraser Heimann & Bernstein LLP, 14 January 2008
2. Personal communication, Rochon Genova LLP, 16 January 2008
3. The Regulatory Affairs Journal - Devices, 2007, 15(6), 427-428
4. Lieff Cabraser Heimann & Bernstein LLP press release, 31 December 2007, www.lieffcabraser.com/press_releases/20071231-medtronic.htm
5. See Reference 2
6. Personal communication, Medtronic, 16 January 2008
7. Medtronic press release, 21 December 2007, wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1198267966114&lang=en_US
8. Medtronic press release (reprinted on FDA website), 11 February 2005, www.fda.gov/oc/po/firmrecalls/medtronic02_05.html