Medtronic Litigation Update 2010
The Eight Circuit Court of Appeals has notified the parties of a new date for oral argument in plaintiffs' appeal of the dismissal of complaints against Medtronic for its faulty heart devices. Oral argument had originally been set for January 2010. The appeal will now be heard on April 12, 2010, in St. Louis, Missouri.
On the same day Medtronic recalled its Sprint Fidelis heart lead in 2007, injured heart lead patients represented by Lieff Cabraser filed the first personal injury lawsuits against Medtronic. Eventually, all Medtronic lawsuits in federal court were coordinated for pretrial purposes before U.S. District Court Judge Richard K. Kyle of the District Court of Minnesota.
On January 5, 2009, Judge Kyle found that under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, the Food and Drug Administration has exclusive authority to make all decisions as to the safety and effectiveness of medical devices. Judge Kyle concluded that Medtronic, Inc., is shielded from having to account for severe injuries suffered by patients who received its Sprint Fidelis heart leads. The cases themselves, however, have not been dismissed.
In response, Plaintiffs' Counsel filed a motion seeking permission to file an amended master complaint against Medtronic. Based on the documents recently produced by the FDA pursuant to several Freedom of Information Act requests, we plead new facts in the Master Complaint demonstrating that Medtronic: (1) knowingly sold defective defibrillator leads; (2) should have amended the warnings on the Sprint Fidelis heart leads to include the heightened risk of fracture; and (3) violated FDA regulations.
In May 2009, Judge Kyle dismissed more than 200 of the Sprint Fidelis cases pending before him. He found that all claims having to do with the Sprint Fidelis devices are preempted and that no individual can bring a private lawsuit against Medtronic and its subsidiaries. The case of one client represented by Lieff Cabraser was dismissed. On behalf of the client, we filed a joint appeal with the other 199 dismissed cases.
The appellate court was to hear oral argument in the case on January 14, 2010 in St. Louis, Missouri. However, one of the judges on the three judge panel has recused himself. As a result, the court cancelled oral argument and, as of January 12, 2010, has not set a new date for it.
Important, New Legislation To Restore Patient Rights
In March 2009, the Medical Device Safety Act was introduced in Congress to amend the Food, Drug and Cosmetic Act to make clear that it does not provide medical device makers total immunity from claims by patients that suffered grave injuries from a faulty device. Learn more about the Medical Device Safety Act.
