On October 15, 2010, the Court of Appeals for the Eighth Circuit issued its opinion affirming the District Court’s dismissal of the Medtronic heart lead recall case. You can read a copy of the Opinion.
8th Circuit Court Issues Opinion Affirming District Court’s Dismissal of Medtronic Heart Lead Case
October 16th, 2010Medtronic Announces Settlement of Heart Lead Litigation
October 14th, 2010Today, Medtronic issued the following press release:
“Medtronic Settles US Lawsuits on Sprint Fidelis Family of Defibrillation Leads
MINNEAPOLIS – October 14, 2010 – Medtronic, Inc. (NYSE:MDT) today announced that it has entered into an agreement to settle existing U.S. lawsuits relating to its Sprint Fidelis® family of defibrillation leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949) that were the subject of a field action announced on October 15, 2007.
Under the terms of the agreement, Medtronic has agreed, subject to certain conditions, to settle U.S. lawsuits and claims pending as of October 15, 2010 for a total payment of $268 million. The payment includes an amount for attorneys’ fees and administrative expenses. The parties will file joint requests to terminate the Multi-District Litigation (MDL) and Minnesota state court proceedings related to the Sprint Fidelis leads and to dismiss the plaintiffs’ appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.
The parties will also request dismissal of other Fidelis-related cases throughout the country. Medtronic can cancel the agreement if certain conditions are not met, and the agreement can be terminated by either party if the MDL proceedings are not terminated.
The cases in the settlement are those arising in the United States from the October 15, 2007 Sprint Fidelis field action, including cases currently filed either in the MDL or in state courts. All settling plaintiffs must satisfy any insurance claims and subrogation interests of Medicare or Medicaid from their settlement payments. No additional sums for these cases will be paid by Medtronic for third-party claims or attorneys’ fees.
The settlement is a compromise of disputed claims, and the parties have not admitted any liability or the validity of any defense in the litigation. Medtronic expects to record the Sprint Fidelis lead litigation settlements as a special charge in its second fiscal quarter ending October 29, 2010.”
Oral Argument Set in Appeal of Dismissal of Federal Cases Against Medtronic for Faulty Heart Devices
March 15th, 2010The 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.
Medical Study: Medtronic Sprint Fidelis heart lead fracture rate is increasing exponentially
February 4th, 2010“The hazard of [Sprint] Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer’s performance update,” doctors at the University of Rochester concluded in findings published in the January 2010 issue of the American Journal of Cardiology [abstract only]. The study found that the three-year survival rate of 426 Medtronic leads inserted in the hospital’s patients was 90.8%, meaning 9.2% failed. This follows a report from December 2009 which estimated the failure rate of the Sprint Fidelis lead may eventually reach 30% of all patients.
On February 4, 2010, the Wall Street Journal noted that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device [login required].
Studies Show Need for Medical Monitoring
January 6th, 2010The Huffington Post reports on the recent release of studies by the Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics, which show “how the FDA lacks stringent scientific standards to evaluate cardiovascular medical devices. This underscores the need to pass the Medical Device Safety Act (MDSA).” The MDSA aims to allow hundreds of thousands injured by faulty medical devices to hold the manufacturers accountable for their defective products and end the policy of preemption of consumer lawsuits.
The study by JAMA showed that premarket approval of several kinds of cardiovascular devices was based on small studies, with significantly less scrutiny than that needed to approve pharmaceutical drugs. The American Journal of Therapeutics found that about 40 percent of the heart studies examined lacked specific safety targets and failed to follow patients over the long-term.
Read the full article on the Huffington Post website.
FDA Reveals It Fell to a Push by Lawmakers
September 25th, 2009The New York Times reports that the Food and Drug Administration has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting. The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.
But after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.
All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner (who resigned amidst controversy in August 2009), said he had acted properly.
As noted in the wake of previous similar problems, this highlights the importance of passage of the Medical Device Safety Act, which would restore the right of patients injured by faulty medical devices to hold manufacturers accountable. The safety of millions of Americans with medical devices should not be put in the hands of one person at the FDA. The civil justice system provides an independent check and balance on corporations to ensure that their products are safe.
Families Press for Safer Medical Devices and Passage of Medical Device Safety Act
August 18th, 2009After her daughter Katie died during surgery to remove a defective Medtronic heart defibrillator wire, Michele Meyer became an activist for patients rights. Meyer’s daughter and others had their rights taken away as a result of a 2008 Supreme Court decision that gave medical device manufacturers immunity from legal claims. Meyer is working hard to restore the right to sue negligent manufacturers of faulty medical devices. These families are pressing Congress to pass the Medical Device Safety Act.
Other families affected by the preemption ruling include the Bairds, whose 16 year old son died after his Medtronic Sigma pacemaker malfunctioned, and the Beadlings. Wife and mother Jan Beadling has been shocked several times and has been left with serious and permanent injuries as a result of a faulty Medtronic heart lead and currently has no legal recourse.
Earlier this month, Meyer joined the Bairds, Beadlings, and many others in Washington to attend a hearing before the Senate Health, Education, Labor and Pensions Committee and give voice to their concerns about medical device safety.
Jan Beadling is impassioned about the cause. She stated, “This legislation is crucial to protecting patients. I’m concerned about the next person harmed by these dangerous products.”
FDA Head of Medical Devices Resigns; Controversy Highlights Need for Passage of Medical Device Safety Act
August 13th, 2009Two days ago, it was reported that Dr. Daniel Schultz resigned from his post as the head of the FDA’s medical devices division. Earlier this year, nine scientists wrote letters to President Obama and other political leaders alleging that there was “systemic corruption and wrongdoing that permeates all levels of FDA,” including within the medical device approval process, which put the safety of Americans at risk.
The scientists claimed that they were pressured to approve certain devices and threatened those that failed to do so with disciplinary action. In one glaring example, the scientists claim Dr. Schultz approved a Regan Biologics knee repair device in 2008, despite the scientists’ repeated rejections of the device because it posed “an increased risk” in comparison to similar devices.
In a January hearing, the Government Accountability Office criticized the FDA, saying the agency had not been inspecting the production of medical devices as regularly as it was required to. High-risk devices, such as pacemakers, should be inspected every two years but the agency had been inspecting high-risk products only every six years.
This development highlights the importance of passage of the Medical Device Safety Act, which would restore the right of patients injured by faulty medical devices to hold manufacturers accountable. The safety of millions of Americans with medical devices should not be put in the hands of one person at the FDA. The civil justice system provides an independent check and balance on corporations to ensure that their products are safe.
Families Across the Nation Ask Senators To Make Medical Devices Safer
August 7th, 2009On August 4th, a number of a families who have suffered as the result of malfunctioning medical equipment, gathered on Capitol Hill in support of the Medical Device Safety Act, a bill that would allow consumers to hold manufacturers accountable for defective products and, thereby, promote safer devices for all patients.
Molly DeGroh of McHenry, Illinois recounts the nine devastating jolts of electricity from a malfunctioning defibrillator and lead that shocked her daughter Avery. At the hospital, a chest X-ray showed a broken lead, which would’ve been nearly impossible for three-year old Avery to have broken.
Iowan Mike Mulvhill of Bettendorf shared a harrowing story of being shocked while driving through a construction zone in Ohio on a road trip to the East Coast. The defibrillator that had been implanted a little more than a year earlier for an irregular heart beat and pulse rate had shocked him with 22 unexpected, painful charges to his heart. After emergency surgery at Ohio State University, the trauma and effects of the ordeal have forced Mulvhill into early retirement.
Mike Collins of Georgetown, Texas who is afflicted with the heart condition hypertrophic cardiomyopathy, received six improper shocks from a defibrillator implanted in 2007. Collins thinks it’s important that this bill is passed: “There is a major injustice in the situation. The companies need to be held responsible for what they do.”
Senate Hearing Highlights Victim’s Medical Device Nightmare, Asks Congress to Hold Manufacturer Accountable
August 5th, 2009Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving when he saw a blue light flash before his eyes. His heart defibrillator was malfunctioning and sending electrical shocks throughout his body. Mulvihill’s nightmare continues because he cannot hold the manufacturer of his faulty medical device accountable due to a U.S. Supreme Court decision that gave device manufacturers complete immunity.
On August 4, 2009, Mulvihill, a client of Lieff Cabraser, testified before a U.S. Senate Committee, asking for Congress to pass the Medical Device Safety Act (MDSA), legislation that would restore the right of patients to hold manufacturers of defective medical devices accountable.
View video of the August 4, 2009 Senate hearing on the MDSA.
