Guidant Flaw Not Disclosed for 3 Years

Short circuit found in heart device after Minnesotan's death 

BARRY MEIER / New York Times 24may2005

[Other articles below]

A medical device maker, Guidant Corp., did not tell doctors or patients for three years that a unit implanted in an estimated 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of those units to short-circuit and malfunction.

	Top: a Guidant Ventak Prizm 2 defibrillator Middle: Joshua Oukrop Bottom: Lee Oukrop, left, with photo of son
	Mindfully.org note: Here's another sad story about corporate greed and callousness. There's nothing new here. It just doesn't normally get much press.  But if the company were open with us, it might say,  "Don't take this personally.   It's only business."  It's not so shocking when you think about it. A corporation has more rights than a person. And it's only purpose is to profit. . . for the top brass and shareholders.  How many millions of people have part ownership through stock in corporations just like this one? Many people are members of a credit union that invests in stocks. It's the American way, isn't it? But what a beast we've allowed to propagate! Here's another thought while you're on the subject: Many young people need such devices just to stay alive. Of course it can't be blamed on one problem -- one chemical or one incident. But perhaps it's the fact that everyone's life is full of pesticides, plastics, genetic engineering, microwaves, and nuclear power and weapons. And our stress levels are off the charts as a result of working hard and long enough to afford health care that we hope will keep us alive. We get all stressed-out worrying about maintaining health care coverage, knowing full-well that doctors don't know how to keep us healthy. (They don't know nutrition or toxicology beyond a couple hours or so they might get in school.)  We all, with few exceptions, expect far too much in our lives. And our lives have gotten so very far from what life really is -- what really matters.

Meanwhile, the U.S. Food And Drug Administration plans to meet today with Guidant Corp. officials to discuss malfunctions with some of the company’s cardiac defibrillators, an agency spokeswoman told Bloomberg News.

Regulators intend “to work with the firm to get to the bottom of the situation,” FDA spokeswoman Kathleen Quinn said in an interview today.

The matter has come to light after the death in March of a 21-year-old college student from Minnesota, Joshua Oukrop, with a genetic heart disease. Guidant acknowledges that his device, which is known as a defibrillator, short-circuited. The young man was in Moab, Utah, on a spring break bicycling trip with his girlfriend when he got off his bicycle complaining of fatigue. He then fell to the ground and died of cardiac arrest.

The young man's death is the only known one involving the device.

Guidant subsequently told his doctors that it was aware of 25 other cases in which the defibrillator, a Ventak Prizm 2 Model 1861, had been affected or disabled by the same electrical flaw. Guidant said it had changed its manufacturing processes three years ago to fix the problem.

The physicians say that, had they known earlier, they would have replaced the unit in their patient because he was at high risk of sudden death.

In interviews in recent days, a top Guidant executive, Dr. Joseph M. Smith, said that the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because their failure rate was very low and replacing them might pose greater patient risks.

But late Monday, after learning that the New York Times was about to publish an article about the device, the company issued an advisory to doctors about it. In that advisory, which physicians could receive as early as today, Guidant is recommending that the unit not be replaced because of the electrical problem.

In February another defibrillator maker, Fridley-based Medtronic Inc., notified doctors that the battery used in one of its models was draining far faster than expected. At that time, the company had received nine reports among 87,000 affected units, an incidence of failure of 0.01 percent, which is lower than the figure for the affected Guidant defibrillators, which is 0.07 percent, based on 37,000 units manufactured before the modification. The Medtronic devices have not been associated with a death or an injury.

However, in its advisory to doctors, Medtronic said its testing indicated that the problem could worsen over time and affect 0.2 percent to 1.5 percent of its units. The Guidant problem, Smith said, has remained constant over time.

The Guidant executive, Smith, who is the chief medical officer of Guidant's cardiac rhythm management division, which is based in Arden Hills, rejected any suggestion that financial or liability concerns had influenced the company's decision. He said that the Model 1861 was among the most reliable defibrillators available, adding that Guidant believed it would cause more harm than good by publicizing the issue because replacement defibrillators might not perform as well and because surgery also posed risks.

"We choose to extraordinarily communicate when we have a product that does not live up to our expectations," Smith said. He added that issues that could improve patient outcomes would also warrant a doctor's alert. "In this case, neither condition was met," he said. Guidant, which is based in Indianapolis, is one of the nation's largest makers of medical devices with $3.8 billion in sales last year, with almost half of that coming from implantable defibrillators.

In December, Johnson & Johnson announced that it planned to buy Guidant, which makes a wide range of medical devices, in a deal worth $25.4 billion.

In interviews, doctors in the Minnesota case who treated Joshua Oukrop said they were angered by Guidant's decision not to notify physicians because they said the company had received enough reports about the flaw to establish a pattern and because high-risk patients could suffer potentially catastrophic results.

Dr. Barry J. Maron of Abbott Northwestern Hospital in Minneapolis said that Smith was simply using numbers to support his stance.

"It is a statistical argument that has little to do with real people," Maron said.

All the electrical malfunctions involving the particular model occurred in units produced during a two-year period prior to mid-2002, when the company fixed the flaw. The problem has not happened in any devices made since.

FDA regulations permit companies to inform the agency in two different ways about manufacturing modifications to improve safety, either while the company is making it or later, when a device maker files its annual report with the agency. A Guidant spokeswoman, Annette Ruzicka, said that it reported the November 2002 change as part of an annual report submitted to the FDA in August 2003.

Joshua Oukrop, suffered from a relatively common genetic disease, hypertrophic cardiomyopathy, which can cause abrupt cardiac arrest.

Joshua's father, Lee Oukrop of Grand Rapids, Minn., said that when his son was 17, he began fainting and falling down at marching band practice or playing softball. His older son, Jacob, had been previously diagnosed with the heart diseaseso he brought Joshua to see Maron in 2001. The physician, after determining that the teenager's condition was severe, urged that he immediately receive a defibrillator, and an implant was soon performed.

For over three years, Oukrop said, his son's life was normal.

When Guidant inspected the device after Joshua's death, it found that the unit had short-circuited when it was charging up. Because the short-circuit also destroyed the device's memory, it is not possible to know whether the failure occurred while Joshua was in cardiac arrest or at some other point.

Meanwhile, the U.S. Food And Drug Administration plans to meet today with Guidant Corp. officials to discuss malfunctions with some of the company’s cardiac defibrillators, an agency spokeswoman told Bloomberg News.

Regulators intend “to work with the firm to get to the bottom of the situation,” FDA spokeswoman Kathleen Quinn said in an interview today.

Shares of Indianapolis-based Guidant, which is being acquired by Johnson & Johnson, fell 46 cents to $73.77 as of 11:52 a.m. in New York Stock Exchange composite trading.

Guidant Sold Heart Device After Discovering Flaw 

THOMAS M. BURTON and ANNA WILDE MATHEWS / Wall Street Journal 2jun2005

Guidant Corp. continued to sell a heart defibrillator — and allowed it to be surgically implanted in patients — even after discovering a rare malfunction in 2002 that caused some of the devices to fail to operate.

The Indianapolis company earlier said it became aware of the problem in 2002 and made a manufacturing change but didn't say what happened with the original devices. People familiar with the matter now say the company continued to sell the original device, and allowed it to go into patients, knowing that two devices had malfunctioned.

People familiar with the events said Guidant concluded in 2002, and still maintains, that the malfunction, in which the device short-circuited and failed to administer electrical therapy to patients, was so rare that it didn't warrant a recall of the product. They didn't specify the number of devices installed in patients after the malfunction was found, but Guidant has estimated that a total of about 24,000 are still implanted in patients' chests.

Guidant is in talks with the Food and Drug Administration about the defect in the Ventak Prizm 2 Model 1861 defibrillator, and the company had no public statement yesterday on the talks. Guidant sent out a notice last week that there have been 26 cases of malfunction out of 37,000 devices made. One of these cases involved the death of a 21-year-old college student from Grand Rapids, Minn., Joshua Oukrop.

The people familiar with the events didn't immediately know whether the young man's defibrillator was one of those that were sold, and surgically implanted, after the defect was discovered. Calls to the Oukrop home and to one of his doctors in Minneapolis, Robert G. Hauser of Abbott Northwestern Hospital, weren't returned.

Doctors and patients were generally unaware of any problem until last week, when the company sent out its notice, though it had notified federal regulators, beginning in 2002, whenever it knew of a malfunction.

A malfunction in an electrical heart defibrillator, even if rare, can be extremely serious. That is because the underlying medical condition is so serious. Defibrillators are designed to dispatch a jolt of electricity to patients whose hearts have begun quivering so rapidly that they are unable to pump blood. The electricity is designed to restart a normal heart rhythm, and has saved many patients' lives. When the device doesn't work, the abnormal rhythm generally will result in death within minutes.

Guidant's notification to doctors last week about the short-circuiting problem came after physicians presented information about the Oukrop case at a heart-rhythm society medical meeting. The company said last week that it concluded in 2002 not to send out a recommendation to remove the product, in large part because of the risk of infection or other operative risk from installing a new device.

Moreover, the company said in its May 23 notice that, even though it notified the FDA about the early short-circuiting in 2002 and about the manufacturing change, it believed that even the new, remedied version of the defibrillator didn't have a statistically better profile than the earlier version. Dr. Joseph M. Smith, the company's chief medical officer, said in an interview last week that this was because the short-circuiting problem was so rare in the first place.

An FDA statement yesterday said, "No clinical events have been reported in units with the modified design." The agency said it met with Guidant and that the company "told us that they had submitted 26 adverse event reports to us. We are checking our database to confirm receipt of these reports. We also have requested additional information from the firm about the scope of the problem and their analysis of the failure mode. We are now in the process of reviewing information from our meeting with Guidant to determine whether further regulatory action may be warranted."

Medtronic Inc. of Minneapolis, a crosstown competitor of Guidant's St. Paul, Minn., defibrillator business, also found a manufacturing flaw in one of its Marquis defibrillators. This defect, the company found, could mean that the battery would become depleted too quickly in as many as 1.5% of the 87,000 devices made.

Medtronic sent out a notification to doctors about the defect in February and has received a huge response from doctors. In the U.S., 11,000 of the machines have been surgically removed and replaced with a different device, and 2,000 more such removals have taken place overseas.

A Medtronic spokeswoman, Valerie Lind, said, "As soon as we decide to communicate with physicians, we do it quickly. Sales representatives begin talking with doctors within the first day or two." She said that the "vast majority" of devices do get pulled off hospital inventory shelves immediately, but that it's possible that a small number could get implanted in the first day after a recall.

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