By KEVIN CHIRI

Editor and Publisher

RESERVE – A St. John attorney has filed his fourth lawsuit seeking class action status for what he calls defective defibrillators installed by the three leading pacemaker manufacturers in the country.

Reserve attorney Daniel Becnel Jr., well-known nationally for his class action work on most high profile cases, filed his fourth lawsuit in just over the past 10 years against a company which is the leading manufacturer of the defibrillators.

Becnel joined with other attorneys on Tuesday in filing his suit in United States District Court against Medtronic, and two of its subsidiaries, for the most recent revelations of problems with their defibrillators.

Medtronic has stopped distribution for their defibrillators due to lead wires that may have contributed to as many as five deaths.

More than 268,000 of the defibrillators with the new, thinner wire leads into the heart, have been implanted into patients, and Medtronic along with the FDA estimate that problems have occurred in less than 1 percent of those leads.

A defibrillator monitors a patient’s heartbeat, and if it senses an abnormal heart rhythm, delivers an electronic shock to reset the heart to a normal beat. The defibrillator system involves a device that is surgically implanted near the shoulder, with a battery inside, and then having one or more leads connecting inside the heart with a small hook on the end.

However Becnel said the problem which has begun occurring is that the wires are beginning to fracture, and the wires can then shock the person, or not work at all.

&#8220These wires are very thin, and vulnerable to the constant stress which occurs as they are used,” he said. &#8220The wire begins to fray, and as it frays, it can actually fracture open.”

This is the fourth lawsuit Becnel has filed against one of the major defibrillator manufacturers. He has previously won over $300 million in two cases which were settled, with a third case against Medtronic now very close to settlement, and expected to bring another $100 million or more.

His first case was against Teletronics, filed 13 years ago, for the same problem of fractured leads, and was settled in 2000 for over $100 million.

His original case against Medtronics was for a defective battery, and involved nearly 5,000 plaintiffs. A settlement is expected to be close on that case and will pay &#8220probably over $100 million.”

Becnel also successfully litigated a case against Guidant, the second largest defibrillator company, for defective batteries and it paid over $200 million in just the past year.

Becnel said that a lot of people had the formerly bad defibrillators replaced after one of his previous lawsuits. But now they have gotten the new product which is proving to have new problems.

He got a call from one such client from Baltimore, Maryland just this week, who is now &#8220scared he is going to die.” Becnel said he is a quadriplegic who has had a stroke, even though he is only 47 years of age.

&#8220He called me and said he had a Medtronic defibrillator put in which apparently has the bad lead. He is going crazy thinking he is going to die with the thing. I feel sorry for him,” Becnel said.

Medtronic admitted publicly that it found &#8220a small chance of fractures in particular locations” and has asked doctors to stop implanting the leads and return all unused leads to the company.

The company is not recommending patients have the devices surgically replaced since &#8220they are more likely to experience complications from removal.” Instead, the company said, they have asked doctors to reprogram the device to alert the patient that a fracture may have occurred. Possible indicators could include audible alerts or inappropriate shocks.

The devices are only specific defibrillators with Sprint Fidelis leads and patients should contact Medtronic Patient Services at 1-800-551-5544 if they are unsure what they have.

&#8220We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect,” Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in a published news story. &#8220However patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.”

Medtronic shares dropped nearly 13 percent on Monday after the disclosure.

Becnel said he is committed to helping people with such a problem, even though it now adds to over 20 class action suits he currently has pending in his files.

&#8220I feel sorry for these people and even though this is another suit I have to handle, which requires a tremendous amount of work, I feel an obligation to help these people,” he said.

Becnel said that it costs approximately $50,000 for someone to have such an operation to implant the defibrillator, with the product actually costing $25,000.

&#8220It’s obvious that this is about the money, everything is about the money,” Becnel said. &#8220There should have been more testing, but there was so much money to made with these things, that they were rushed to the market place. Now you see what is happening.”