Many people wonder whether they should pursue a lawsuit against Medtronic for the defective wire in their Sprint Fidelis lead. This article explains the differences between a Class action settlement and a Court-sanctioned roulette. The failure rate of class action settlements and the discovery process are both important elements to consider before filing a lawsuit. Read on to learn more about how class action settlements and failure rates work.
Class action settlement
A proposed settlement in the Medtronic Sprint Fidelis Lead class-action lawsuit will settle the claims of those implanted with the device. The settlement will award $26 million to Class Members who successfully establish that their Lead was prematurely explanted. The money will also go to Public Health Insurers and cover litigation and administration costs. The settlement was approved by the Ontario Superior Court of Justice on April 1, 2020.
Plaintiffs in the case argued that Medtronic was negligent in failing to warn consumers of defects and known risks associated with the device. Although the FDA approved the device, Medtronic failed to provide consumers with adequate warnings. Plaintiffs argued that these warnings were not sufficient and that the company had failed to file timely reports of adverse events. The court agreed with the plaintiffs, citing Riegel and a case law decision in which the U.S. Supreme Court had held that state laws had priority over federal ones and that a class action would be futile if plaintiffs failed to meet federal standards.
Plaintiffs in the Medtronic Sprint Fidelis Lead lawsuit are attempting to play “court-sanctioned roulette” by amending the master consolidated complaint. But a federal judge has blocked that possibility. On July 30, Judge Richard Kyle of the U.S. District Court for the District of Minnesota denied a motion for discovery based on the fact that the plaintiff’ counsel’s son is a partner at the law firm Fredrikson & Byron in Minneapolis. Despite his practice as a criminal defense attorney, he has never worked on a Medtronic case before.
The plaintiffs argued that Medtronic was negligent in failing to warn consumers about the defective design of the Sprint Fidelis Lead. Their proposed amended complaint, filed within 30 days of the district court’s dismissal, added more factual detail and did not assert a violation of a federal requirement. But it continued to allege equitable relief and attack the FDA PMA.
The failure rate of the Medtronic Sprint Fidelis lead was cited in a joint report from the Mayo Clinic and Minneapolis Heart Institute. Based on data from more than 3,000 patients, the researchers estimated a 12.1% failure rate after three years. However, this rate may increase with time, according to a University of Ottawa study. In late 2007, Medtronic recalled the lead, and the company confirmed it involved five deaths. However, experts said that it was difficult to explain the disparity between the study and Medtronic’s data.
According to the lawsuit, the high failure rate of lead could be linked to up to 12 patient deaths. Many patients have also suffered serious complications caused by lead fractures. In the meantime, Medtronic has agreed to cover the cost of the defective lead and contribute up to $800 in medical costs. Plaintiffs should file lawsuits immediately if they have experienced this issue. But before filing a lawsuit, patients should consult with their doctors and seek medical advice from a heart doctor.
The FDA did not require extensive testing before approving the Sprint Fidelis Lead. This is a key factor in the plaintiffs’ case because it argues that Medtronic had an obligation to provide more information to consumers. The FDA stated that if it had conducted clinical trials, there would be more evidence of problems with the lead wires. But even if the FDA had required extensive testing, it would not have stopped the company from selling its defective product.
This is a case about a faulty device that was implanted into a patient’s heart. The Sprint Fidelis leads were first introduced in 2004 and are still in over one hundred thousand defibrillators worldwide. But the defective leads eventually caused five deaths. The company defended the device by sending “Dear Doctor” letters to physicians informing them that the defect may have been a result of improper surgical technique.