Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Congressional dems seek reversal of Supreme Court Decision

A new study published Monday in the Heart Rhythm medical journal suggests that the more than 200,000 recipients of  Medtronic heart defibrillator leads may be at a greater risk than previously thought.

The leads, known as Sprint Fidelis lead, connect electrical defibrillators to the hearts of patients with aberrant cardiac rhythms and deliver a jolt to the heart as needed to return the heartbeat to a normal rhythm. The devices were recalled by Medtronic two years ago after fractures were spotted in the devices, which caused them to fail. Medtronic says the faulty leads may have contributed to five deaths.

Removing the leads can put patients at serious risk. Medtronic and some health experts have advised that the leads not be removed unless the device showed signs of fracturing. An estimated 150,000 Sprint Fidelis leads remain in patients.

But the latest study, conducted by Dr. Robert G. Hauser of the Minneapolis Heart Institute and Dr. David L. Hayes of the Mayo Clinic, suggest that patients’ risk increases as the devices age. The report has some experts suggesting that, contrary to previous advice, for some patients, removing the Fidelis lead may be appropriate if the benefits outweigh the risks.

The study is based on data from 3,000 patients who had any brand of defibrillator leads implanted at the Minneapolis Heart Institute or the Mayo Clinic between 2004 and 2008. Twenty-eight percent of the leads were the Sprint Fidelis brand. The data showed that 3.75 percent of the Sprint Fidelis leads failed compared to 0.6 percent for other leads. The data also showed the failure rate was increasing.

Medtronic stands on its own data, issuing a statement: “It is important to note that data collected from center to center would be expected to vary. We believe that our analyses are representative of overall Fidelis performance.”

According to the New York Times, Congressional Democrats plan to reintroduce legislation that would nullify a Supreme Court decision last month to dismiss lawsuits against Medtronic for the defective leads, citing a ruling last year that shielded makers of certain medical devices from product liability lawsuits.

This entry was posted on Wednesday, February 25th, 2009 at 11:51 am and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.