Sunday, July 15, 2007


Jul. 15, 2007 (McClatchy-Tribune Regional News delivered by Newstex) --
Sometimes change is spurred by tragedy.

After Joshua Oukrop, a 21-year-old Grand Rapids man, died in 2005 when his Guidant Corp. heart defibrillator short-circuited and failed to revive him, a lawsuit by thousands of other defibrillator patients led not only to a large financial settlement but also significant changes in how such devices are monitored.

Manufacturers, doctors and patient advocates agree: Patients are now privy to far more information about the cardiac devices implanted in their bodies.

After Oukrop's family and doctors went public, press coverage and patient outrage followed. A doctors' group called for more scrutiny of pacemakers and defibrillators made by three companies with ties to the Twin Cities. The Food and Drug Administration promised to do a better job of tracking flaws in devices.

On Friday, some 4,000 aggrieved patients settled a massive lawsuit with Boston Scientific Corp. (NYSE:BSX) , which acquired Guidant last year. The lawsuit alleged the company hid safety information from patients. Boston Scientific will write a check for $195 million to settle, ending a bitter chapter for the company, which employs about 3,000 people in Arden Hills.

But what has really changed in the medical device industry as a result of the Guidant controversy? 'It may not be perfect, but there's a new spirit of full disclosure and more understanding by device manufacturers that patients and physicians need to partner with them to help us make good choices,' said Lisa Salberg, founder and president of the Hypertrophic Cardiomyopathy Association, a New Jersey-based organization for patients and families with the heart condition. 'It is very encouraging.'

Patients prescribed a drug are more than likely aware of its brand name. But historically, many patients implanted with defibrillators and pacemakers relied on their doctors to choose a device and remained clueless about the particular brand used. Usually, they were given a card to tuck in their wallet that bore the device's model name and number, and a phone number to call in case of emergency.

Defibrillators are stopwatch-sized devices implanted in the chest that shock the heart if an irregular rhythm is detected, while pacemakers help the heart beat in a regular rhythm. The three makers of these devices -- Medtronic Inc. (NYSE:MDT) , Boston Scientific Corp. (formerly Guidant) and St. Jude Medical Inc. (NYSE:STJ) -- are either based or have major operations in the Twin Cities.

Device performance

Now, patients can assess a device's safety record by perusing performance reports posted on each manufacturer's website.

While these reports have long been publicly available, the information contained in them now is more standardized between manufacturers and easier for patients and physicians to understand, said Rob Clark, a spokesman for Fridley-based Medtronic, the world's largest maker of defibrillators and pacemakers.

Data in these reports include how many units of a particular device have been implanted in the United States, how many have malfunctioned and whether the device failed to provide therapy as result. Product advisories or recalls are posted, as well.

'I think that Boston Scientific, in particular, has really stepped up with its performance report, which is the best in the industry right now,' said Dr. Robert Hauser, senior consulting cardiologist with the Minneapolis Heart Institute, and one of Joshua Oukrop's physicians who went public with his concerns. 'Medtronic has enhanced its report, and St. Jude is at least getting on the radar screen.'

The standardized language in these reports was recommended in a 2005 report in the wake of the Guidant controversy by the Heart Rhythm Society, a Washington-based group of heart specialists.

It is unclear whether such data would have saved Joshua Oukrop's life because Guidant didn't issue a safety advisory about his device until after his death. (Six others died as a result of malfunctioning Guidant devices.) Oukrup's family could not be reached for comment Saturday.

But several doctors and industry observers say companies are under increased pressure to provide accurate and timely information about the safety of their products.

One reason: the spectre of potentially costly litigation. Charles S. Zimmerman, lead co-counsel in the Guidant case, said Friday's settlement 'advances serious public interest in making our medical devices better and safer while appropriately compensating people who were hurt.'

Direct information

Manufacturers like Medtronic are also creating channels to communicate with patients directly.

In the past, device manufacturers would notify the FDA and doctors if there was a problem with a device. It was left to physicians to inform patients, although in the Guidant case, many panic-stricken patients heard about the recalls through the media.

The Guidant controversy indicated that many patients want to know about safety issues involving their device directly from the manufacturer, Salberg said. 'Patients are active participants in their health care,' she said. 'They don't want information filtered, they want it direct.'

Some patients may not want the plethora of information about their device at their fingertips. But in Salberg's view, the Guidant controversy spurred industry and government regulators to listen to patients with new vigor. 'They're listening now in a way I had not perceived before,' she said.

Janet Moore -- 612-673-7752 --  jmmoore@startribune.com

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