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“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.
Update – January 12, 2010 - Oral argument before the Eighth Circuit Court of Appeals had been scheduled for Thursday, January 14, 2010, in St. Louis, Missouri. One of the judges on the three-judge panel has recused himself. As a result, the court cancelled oral argument and, as of today, has not set a new date for it.
Update: January 12, 2010 – The oral argument set for Thursday, January 14, 2010, in St. Louis, Missouri, noted below has been cancelled. As of January 12, 2010, a new date for oral argument has not been set.
The oral argument in the appeal of dismissal of federal cases against Medtronic for faulty heart devices was scheduled for Thursday, January 14, 2010, at 9 a.m. The appellate panel hearing the appeal in Anna Bryant, et al. v. Medtronic, Inc., et al., was to meet at the Thomas F. Eagleton Courthouse at 111 S. 10th Street, St. Louis, Missouri, in the Northeast Courtroom on Floor 27.
The 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.
The San Francisco Chronicle reports that two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents. Safety targets often weren’t clearly spelled out in the research submitted by device makers and important patient information was missing, according to one study conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center.
A separate analysis by researchers at the University of California, San Francisco, found heart devices frequently got the FDA’s blessing based on research done outside the United States in small groups of patients. Many device studies lacked standards most scientists expect: randomization and a clear goal. Dr. Jeffrey Shuren, the FDA’s acting device center director, said the agency is taking a close look at its device program and making changes. It wants manufacturers to adhere to tougher research guidelines that will be out in 2010, Shuren said.
Plaintiffs appealed U.S. District Court Judge Richard Kyle’s decision granting Medtronic’s motion to dismiss each of the plaintiffs’ claims based on the legal doctrine of preemption. The case, filed in the United States Court of Appeal, Eighth Circuit, is titled Anna Bryant, et al. v. Medtronic, Inc., et al., Case no. 09-2290. The appellate court hears oral arguments during one week per month.
The court rescheduled the date for oral argument in this case from the week of December 14, 2009 in St. Paul, Minnesota, to the week of January 11, 2010 in St. Louis, Missouri.
Update: January 12, 2010: The oral argument set for Thursday, January 14, 2010, in St. Louis, Missouri, has been cancelled. As of January 12, 2010, a new date for oral argument has not been set.
The New York Timesreports 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.
Twice in 2009, six year-old Avery deGroh of McHenry, Illinois, and her parents have traveled to Washington, D.C. to share with Congress her story and ask for passage of the Medical Device Safety Act. The bill would overturn a Supreme Court decision granting immunity to medical device manufacturers for producing faulty products. Avery received a heart device when she was two. Due to a defect, less than a year later the device malfunctioned and sending painful and terrifying electric shocks to her heart. Below is a recent profile by NBC News Chicago of Avery and her family, and their effort to convince Congress to enact the Medical Device Safety Act.
After 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.”
Two 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.
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