Princess Health and Guidant Executives Sued for Securities Fraud. Princessiccia

Princess Health and Guidant Executives Sued for Securities Fraud. Princessiccia

fraud Guidant

Gusty 14:09 Add Comment

Those hits just keep on coming for Guidant Corp. The Indianapolis Star reported that Guidant and six of its top executives were named as defendants in a securities fraud lawsuit. The suit charges that the executives "concealed long-standing, life-threatening defects" in its products to prop up its stock price prior to the company's proposed merger with Johnson & Johnson. The suit alleges that the six executives, including Guidant Chief Executive Officer (CEO) Ronald W. Dollens, sold Guidant stock worth $39.5 million this year prior to the publication of the first news article by the NY Times about problems with Guidant's implantable cardiac defibrillators (ICDs).

Princess Health and Guidant Executives Sued for Securities Fraud.Princessiccia

Princess Health and Guidant Executives Sued for Securities Fraud.Princessiccia

fraud Guidant

Gusty 14:09 Add Comment

Those hits just keep on coming for Guidant Corp. The Indianapolis Star reported that Guidant and six of its top executives were named as defendants in a securities fraud lawsuit. The suit charges that the executives "concealed long-standing, life-threatening defects" in its products to prop up its stock price prior to the company's proposed merger with Johnson & Johnson. The suit alleges that the six executives, including Guidant Chief Executive Officer (CEO) Ronald W. Dollens, sold Guidant stock worth $39.5 million this year prior to the publication of the first news article by the NY Times about problems with Guidant's implantable cardiac defibrillators (ICDs).

Princess Health and Now Stuck Switches for Guidant. Princessiccia

Princess Health and Now Stuck Switches for Guidant. Princessiccia

Guidant ICD manufacturing problems

Gusty 13:20 Add Comment

The NY Times reported yet another problem with implantable cardiac defibrillators (ICDs) made by Guidant. This time it was a magnetic switch that could become stuck in the "off" position. Apparently, this flaw is not so serious as previous ones (see most recent post here), because it can be fixed without removing the devices. A Guidant consultant suggested that the problem affects about 6000 devices. The models affected were the Contak Renewal 3, Contak Renewal 4, Contak Renewal 3 AVT, Contak Renewal 4 AVT, and Renewal RF. The company "urged doctors ... to stop implanting" the device, but "did not say how it planned to fix the problem, when it expected to do so, or how it would fix units already implanted in patients," according to the Times. Also, "Guidant declined a request to interview its chief executive, Ronald W. Dollens."
Again, one would have hoped that the company could have done better with quality control, given that each of these devices cost about $25,000.

Princess Health and Now Stuck Switches for Guidant.Princessiccia

Princess Health and Now Stuck Switches for Guidant.Princessiccia

Guidant ICD manufacturing problems

Gusty 13:20 Add Comment

The NY Times reported yet another problem with implantable cardiac defibrillators (ICDs) made by Guidant. This time it was a magnetic switch that could become stuck in the "off" position. Apparently, this flaw is not so serious as previous ones (see most recent post here), because it can be fixed without removing the devices. A Guidant consultant suggested that the problem affects about 6000 devices. The models affected were the Contak Renewal 3, Contak Renewal 4, Contak Renewal 3 AVT, Contak Renewal 4 AVT, and Renewal RF. The company "urged doctors ... to stop implanting" the device, but "did not say how it planned to fix the problem, when it expected to do so, or how it would fix units already implanted in patients," according to the Times. Also, "Guidant declined a request to interview its chief executive, Ronald W. Dollens."
Again, one would have hoped that the company could have done better with quality control, given that each of these devices cost about $25,000.

Princess Health and More Short Circuits for Guidant. Princessiccia

Princess Health and More Short Circuits for Guidant. Princessiccia

Guidant ICD manufacturing problems

Gusty 06:44 Add Comment

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.

Princess Health and More Short Circuits for Guidant.Princessiccia

Princess Health and More Short Circuits for Guidant.Princessiccia

Guidant ICD manufacturing problems

Gusty 06:44 Add Comment

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.

Princess Health and No Federal Standards for Reporting Flawed Medical Devices. Princessiccia

Princess Health and No Federal Standards for Reporting Flawed Medical Devices. Princessiccia

Guidant ICD manufacturing problems

Gusty 12:53 Add Comment

The NY Times reported about recent recalls of implanted cardiac devices. One important point the reporter made was that so far the US Food and Drug Administration (FDA) has no uniform standards for notification of physicians when problems are found with implantable devices. Currently, it is up to the device manufacturer to decide when to report problems. Apparently, it is acceptable for the manufacturer to "consider potential loss of business to competitors and legal liability" when making such decisions.
The results of this lack of standards include the decision by Guidant to delay reporting of short-circuits in one model of implantable cardiac defibrillator (ICD). (See previous post here.) Guidant had judged that replacing such defibrillators would "unnecessarily" expose patients to surgical risks. Thus, Guidant justified its decision to withhold information about the possibility of ICD failure, apparently based on a judgment that the reduction in possible benefit due to ICD failure was less important to patients than the risks of ICD replacement.
But by withholding information about ICD reliability, Guidant seemed to be substituting its judgments about how to balance benefits and harms for those made by patients and doctors. As Dr. Eric N. Prystowsky said, "You are not my father. You are not my mother. You are just a company selling products. You have to let me make these decisions."

Princess Health and No Federal Standards for Reporting Flawed Medical Devices.Princessiccia

Princess Health and No Federal Standards for Reporting Flawed Medical Devices.Princessiccia

Guidant ICD manufacturing problems

Gusty 12:53 Add Comment

The NY Times reported about recent recalls of implanted cardiac devices. One important point the reporter made was that so far the US Food and Drug Administration (FDA) has no uniform standards for notification of physicians when problems are found with implantable devices. Currently, it is up to the device manufacturer to decide when to report problems. Apparently, it is acceptable for the manufacturer to "consider potential loss of business to competitors and legal liability" when making such decisions.
The results of this lack of standards include the decision by Guidant to delay reporting of short-circuits in one model of implantable cardiac defibrillator (ICD). (See previous post here.) Guidant had judged that replacing such defibrillators would "unnecessarily" expose patients to surgical risks. Thus, Guidant justified its decision to withhold information about the possibility of ICD failure, apparently based on a judgment that the reduction in possible benefit due to ICD failure was less important to patients than the risks of ICD replacement.
But by withholding information about ICD reliability, Guidant seemed to be substituting its judgments about how to balance benefits and harms for those made by patients and doctors. As Dr. Eric N. Prystowsky said, "You are not my father. You are not my mother. You are just a company selling products. You have to let me make these decisions."

Princess Health and Guidant's Short Circuit, Reloaded. Princessiccia

Princess Health and Guidant's Short Circuit, Reloaded. Princessiccia

Guidant ICD manufacturing problems

Gusty 06:02 Add Comment

The NY Times reported that after Guidant discovered a defect in its implantable cardiac defibrillator (ICD) that allowed the device to short-circuit and fail, it continued to ship ICDs with the defect even after it had started manufacturing redesigned devices without the flaw.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.

Princess Health and Guidant's Short Circuit, Reloaded.Princessiccia

Princess Health and Guidant's Short Circuit, Reloaded.Princessiccia

Guidant ICD manufacturing problems

Gusty 06:02 Add Comment

The NY Times reported that after Guidant discovered a defect in its implantable cardiac defibrillator (ICD) that allowed the device to short-circuit and fail, it continued to ship ICDs with the defect even after it had started manufacturing redesigned devices without the flaw.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.

Princess Health and Guideant's Short Circuit. Princessiccia

Princess Health and Guideant's Short Circuit. Princessiccia

Guidant ICD manufacturing problems

Gusty 14:03 Add Comment

The New York Times reports yet another story of flawed implantable cardiac defibrillators (ICDs). This time, Guidant Corporation revealed that its ICDs manufactured from 2000 to 2002, can short circuit, fail, and thus become unable to prevent cardiac arrhythmias. Guidant corrected the design flaw that allowed these failures to occur in ICDs manufactured after mid-2002.
However, it only got around to notifying physicians and the public about the problem recently, after the company was informed that the Times was working on an article about the problem. The company's argument was that short-circuits are rare: only 25 cases of short-circuts are known. Furthermore, replacing the ICD requires an invasive procedure, and hence is not risk-free.
However, doctors and patients ought be able to decide about whether to take this risk, based on full disclosure of the relevant data.
This is the third problem with ICDs that has appeared in this blog. The others involved problems in devices manufactured by Access Cardiosystems, and by Medtronic.
The NY Times article notes that ICDs cost about $25,000 a piece, and that Guidant sold about $1.9 billion worth last year. Given the low cost of very sophisticated modern electronics, this unit price seems very high. IT should at least buy unimpeachable reliability. Why managed care has not been able to bargain down the prices of such devices remains an open question. But meanwhile they surely account for some of the seemingly inexorable rise of health care costs.
But regardless of what $25,000 ought to buy, there seems to be no good excuse to hide data about this device's flaws from the public and from doctors.

Princess Health and Guideant's Short Circuit.Princessiccia

Princess Health and Guideant's Short Circuit.Princessiccia

Guidant ICD manufacturing problems

Gusty 14:03 Add Comment

The New York Times reports yet another story of flawed implantable cardiac defibrillators (ICDs). This time, Guidant Corporation revealed that its ICDs manufactured from 2000 to 2002, can short circuit, fail, and thus become unable to prevent cardiac arrhythmias. Guidant corrected the design flaw that allowed these failures to occur in ICDs manufactured after mid-2002.
However, it only got around to notifying physicians and the public about the problem recently, after the company was informed that the Times was working on an article about the problem. The company's argument was that short-circuits are rare: only 25 cases of short-circuts are known. Furthermore, replacing the ICD requires an invasive procedure, and hence is not risk-free.
However, doctors and patients ought be able to decide about whether to take this risk, based on full disclosure of the relevant data.
This is the third problem with ICDs that has appeared in this blog. The others involved problems in devices manufactured by Access Cardiosystems, and by Medtronic.
The NY Times article notes that ICDs cost about $25,000 a piece, and that Guidant sold about $1.9 billion worth last year. Given the low cost of very sophisticated modern electronics, this unit price seems very high. IT should at least buy unimpeachable reliability. Why managed care has not been able to bargain down the prices of such devices remains an open question. But meanwhile they surely account for some of the seemingly inexorable rise of health care costs.
But regardless of what $25,000 ought to buy, there seems to be no good excuse to hide data about this device's flaws from the public and from doctors.