Medtronic Litigation Summary
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, the Plaintiffs 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.
On October 15, 2010, the U.S. Court of Appeals for the Eighth Circuit affirmed the District Court's order of dismissal. Read a copy of the Court's order.
Legislation to Restore Patient Rights
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..