A pacemaker made by Guidant.
CHARLESTON - As far as the law is concerned, those individuals whose pacemakers fail are the lucky ones.
At least that's the thought to which Wheeling attorney Barry Hill subscribes.
"What will happen is as time goes on, these devices only have a useful life of so many years," said Hill of Hill Williams. "Depending on the type of device and how it operates, it ranges anywhere from 2 ½ years to 9-10 years."
"Once it's replaced for that reason and the person never had an event, there's no case."
Last June, Guidant Corp. announced it was recalling 50,000 of its implanted defibrillators, which are used to prevent cardiac arrest in the event of a rapid heartbeat. A few months earlier, Medtronic had announced that there was a problem with the batteries used in its defibrillators that led to rapid depletion.
Hill Williams is part of a group that consists of three other law firms and has 221 cases against Guidant and 180 against Medtronic in two federal Multi-District Litigation cases in Minnesota.
Some, like the family of the late Sheryl Hawley, have a bona fide case against one of the manufacturers. Hawley, a 48-year-old Georgia resident, died suddenly on Aug. 19, 2005, when the defective routing on her Guidant defibrillator caused 80 percent of the shock it administers during a cardiac episode to be delivered to the case of the device and not her heart, Hill said.
Others who are more fortunate with their health will not be so lucky in court. Hill said it will be hard to prove that the infliction of emotional distress caused by these recalls was intentional. Without physical injury, there may be no claim to be made.
That's even though the users of these devices have to wait and see the hard way if their defibrillator is defective or not.
"Time works in favor of the company on these," Hill said. "Once the product is replaced and its never been subject to the recall or been replaced for that reason, all you have is a device that, for a period of time, you thought might fail."
Hill likened the issue to ownership of a car. The vehicle could break down at any time after purchase, but if it finally fails after 10 years and 200,000 miles, the owner should have known to replace it earlier.
Of course, a healthy heart is a much more valuable entity than a transmission, and the stress inflicted on the users of Guidant and Medtronic defibrillators remains hard to prove as anything other than a mistake.
In three lawsuits filed over the Sago mine disaster, where 12 miners passed away in January at the Upshur County mine, families are partly suing for the stress inflicted by reports that were released and stated the miners had been found alive underground.
For hours, the families celebrated before finding out the reports were false. The difference between that case and the cardiac device cases, Hill said, is the presence of physical injury and the intentional releasing and non-denial of the false reports.
"I'm sure if Guidant and Medtronic could take this back, they would," Hill said. "They didn't create a bad product on purpose. That's not good business."
Hawley found that out the hard way. After receiving the safety notice and discussing it with her electrophysiologist, she decided not to have the defibrillator replaced, pursuant to Guidant's recommendation, Hill said.
Seventeen days later, while at work, she went into cardiac arrest and died in a few minutes.
It's one of the ironies in the cases, that the device has to be removed and replaced for a full interrogation to determine if it is safe or not. Some people can not afford such a procedure.
"A lot of them, in consultation with their physicians, had potentially defective units replaced with good ones," Hill said. "Others, for a variety of reasons, did not. One is there is no one to pay for it.
"Another is they have had problems since the potentially dangerous unit was put in, and the doctors don't think the benefit (of replacement) will equal the risk."
There are several different potential problems with Guidant's devices, Hill said. Hawley's defibrillator did not act properly when it was needed, while others deliver a shock when it's not needed.
"Which is basically like getting kicked in the chest by a horse," Hill said.
He adds that there will probably be 5,000 cases consolidated into the Guidant MDL. His group's representative on the plaintiffs steering committee, a small group of lawyers that takes on the responsibility of discovery and appearing at monthly hearings for all the consolidated cases, is Philadelphia attorney Sol Weiss of Anapol Schwartz.
On the Medtronic MDL, it is Bernard Smalley of the same firm.
Other firms that make up the group are Hill, Peterson, Carper, Bee and Deitzler of Charleston and Clark, Perdue, Arnold and Scott of Columbus, Ohio.
Hill said the case against Medtronic may drag on for several years, but claims the case against Guidant may be over within the next year.
He also adds that had the cases not been consolidated into MDLs, one individual's case could cost as much as $1 million for an attorney to investigate.
Morgantown resident Robert Feathers' case is included in the Medtronic MDL. He filed his lawsuit Aug. 18 originally in Monongalia Circuit Court.
His complaint says, "The pacemaker was provided by the defendant in a defective condition, and as a result of which it may not function properly and has not provided the relief and piece of mind the defendant had represented."
Though, according to Hill, that may not be enough to warrant compensation. Feathers might have to find out the hard way if he's entitled to damages.
"Frequently, a problem is such that if (the defibrillator) is checked by a physician it can be just fine, but fail the next day," he said. "Routine checks may or may not demonstrate the existence of a problem."