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Heart Device Manufacturer Sued Following Recall

September 1, 2005

A maker of implantable defibrillators for heart patients has been sued by two Florida residents after the manufacturer recalled the devices and the patients underwent a second round of surgery to install replacements.

In separate actions in Palm Beach Circuit Court, David Downes of Martin County and Kathy Higginbotham of Nassau County are charging the manufacturer, Medtronic Inc. of Minneapolis, with negligence, fraud, liability, breach of express and implied warranty, fraud and infliction of emotional distress.

An attorney for the plaintiffs said his clients found themselves in 'Catch-22 situations' after they were notified in February by their physicians that the manufacturer had recalled the devices. Medical implant makers do not notify patients directly of recalls. 'Both of these individuals were faced with either risking death with the real possibility that the device implanted surgically would malfunction or, on the flip side of the coin, they could risk a surgery to remove the device and implant a second device,' the lawyer said.

Both plaintiffs chose to undergo a second operation. The recalled devices were Medtronic IDC Marquis 7274 defibrillators, devices that passively monitor heart rhythms. If the rhythm degrades significantly, the device restores a normal heartbeat with a jolt of 700 volts of electricity to the heart muscle.

Medtronic spokesman Rob Clark said the company has not seen the two suits filed by Leopold, but that it has been sued by about 10 people nationally who replaced the recalled model. The company also is the target of as many as 15 state class action suits stemming from the same recall, Clark said. All the suits will most likely be combined for purposes of discovery, or a federal class action could consolidate them at some point. The recently filed suits seek no specific dollar amounts in damages.

The litigation comes at a time when questions have been raised about the long-term reliability of implant devices. Over the years, Medtronic, Guidant Corp. of Chicago and St. Jude Medical have combined to make hundreds of thousands of them for heart patients. Earlier this week, Guidant received federal approval to relaunch one of its models in the wake of a recall triggered by defects in a switch component, according to published reports.

Higginbotham, a secretary for an insurance company, said she was 47 when her heart stopped in a restaurant in November 2002. She was revived at the scene and had the defibrillator implanted the following month. When she learned that the devices had been recalled, she decided instantly to get a new one installed. 'Now I'm getting these hospital bills, and it's not because of anything I did,' she said. The lawsuit does not list the amount the hospital claims she owes. Higginbotham received a new implant in February. Downes' implant was replaced in April. In each case, the faulty implant was replaced by another Medtronic device, the ICD Marquis 7278.

At prices of up to $35,000 each, implantable defibrillators sell for three times the price of pacemakers, which are designed to maintain proper heart rhythms through regular applications of electric current.

Vice President Dick Cheney, a heart patient, had a Medtronic defibrillator implanted in 2001. About 240,000 pacemakers and defibrillators are implanted in heart patients annually, according to Clark, the Medtronic spokesman. Death rates for implant procedures are less than 2 percent. In the case of the 7274 model, Clark said company scientists discovered that nine of the 87,000 devices used in patients had failed with no deaths or injuries. Further studies indicated the Medtronic-made batteries had a failure rate of one in 10,000. Company scientists concluded that the failure rate could rise to 1.5 percent in the second half of the devices' seven-to-10-year lifespan, so all of the implants were recalled.

Pacemakers and defibrillators are subject to no special oversight by the Food and Drug Administration, Clark said. Most are placed on the market without clinical testing as long as they conform in design and are substantially equivalent to devices previously marketed. As a result, the attorney said, the devices are never officially certified as 'safe.' The annual worldwide market for pacemakers and implanted defibrillators is about $2.5 billion.

Medtronic has manufactured implantable cardiac devices for about 15 years, and several million of them are in use. Five years ago, the company recalled 8,000 MicroJewell II defibrillators because the devices were taking too long to charge, thus delaying their delivery of electrical current to the heart muscle when rhythms went awry.

Since 1997, there have been about 25 manufacturer-initiated recalls of defibrillators and pacemakers, most involving programming failures or trouble with the charging process. In February and April, Medtronic recalled more than 2,300 external defibrillators of the sort used by paramedics after a defect may have 'prevented patient resuscitation' in eight cases, according to Forbes magazine. At the time, Medtronic chief executive Arthur Collins told the magazine that bad batteries had affected only 0.01 percent of the company's recalled implanted cardiac devices.

Two years ago, in a case called Jackson v. Chiusano, a Pennsylvania judge ruled that medical devices like pacemakers and defibrillators are not protected from claims under the doctrine of strict liability, which insulates manufacturers of prescription drugs. In 1996, the U.S. Supreme Court found in Medtronic v. Lohr that manufacturers of pacemakers were not exempt from negligence claims under the Medical Device Act.

A decade ago, a number of suits resulted from a recall by Teletronics Systems of Miami Lakes of pacing leads that carry electrical impulses to patients' hearts. The FDA determined that the leads had the capacity to fracture and puncture a patient's aorta. The recall came after 12 percent to 25 percent of the company's 45,000 Accufix-J-Lead pacemakers were determined to be subject to failure. At least 18 patients died, 32 were injured, and thousands of others underwent replacement surgery. The company agreed to a $62 million settlement of a class action suit.