Essay on "Postmortem: The State of Guidant"

Essay 7 pages (2406 words) Sources: 6

[EXCERPT] . . . .

However, it is reasonable to also ask whether the decision makers at Guidant maintained the perspective that they were between 'a rock and a hard place' and did the best they could under the circumstances. Maybe the decision makers felt they had a fiduciary duty to their stockholders, which required them to protect their investments? Within a 'duty ethics' framework, this seems like a reasonable position to take. Unfortunately, Guidant also had a duty to be honest with the FDA and forthcoming to doctors and patients. If the duty to stockholders and patients were to be weighed using a balance scale, the average American, who does not hold Guidant or Boston Scientific stock, would probably feel the duty to patients outweighs a duty to stockholders because the loss of life outweighs the loss of capital gains. A similar conclusion would be reached using a 'rights ethics' perspective, since Guidant does not have the right to protect its profit margins at the expense of a patient's right to life.

Guidant could also argue, using utilitarian ethics, that the amount of good their devices provide outweighs the potential for harm. For example, only 61 deaths were attributed to ICD malfunction between 1990 and 2002, compared 2.67 million implants being conducted (HRS and FDA, 2005). Therefore, protecting their ability to manufacture ICD devices is critical to saving millions of lives. However, this argument fails to recognize that neither the FDA nor cardiologists are calling for Guidant to stop ICD production, only to improve its ICD designs and quality control safeguards. Taking such measures will help to protect the greater good, which is consistent with utilitarian ethics, and more pragmatically, will help protect the ICD market.

Detailed Recommendations

Recommendations for improving the reporting of device failures were outlined by a panel of experts from the Heart Rhythm Society and the FDA (HRS and FDA, 2005). Of primary importance is the standardization of passive surveillance reporting, including device implantation and adverse events. The key players in passive surveillance are treating physicians and the FDA. Both mandatory and voluntary recording were recommended. Another recommendation is to establish an enhanced surveillance system, which would allow physicians at major medical centers to enter and track data live with the hope of being able to identify emerging problems quickly. Other recommendations included establishing more stringent benchmarks for studies that are used to gain device approval.

With respect to the interactions between the FDA, device manufacturers, and physicians, the recommendations are less certain. One of the primary concerns from the perspective of manufacturers is that reporting a single failure to a physician could potentially trigger a recall (HRS and FDA, 2005). Panel suggestions included establishing a recall threshold, thereby encouraging information transfer between these three parties. The nature of a device malfunction is also important, since physicians may be faced with deciding to replace the device in some patients and not others. As one panelist mentioned "a rate of 1 in 5000 of an incident with little clinical significance or outcome is different from a rate of 1 in 5000 where the incident is a major failure with negative outcomes" (p. 14).

The overarching ethical guidelines were stated explicitly by a panelist, Dr. Smith (HRS and FDA, 2005). These were (1) "patients come first, (2) actions and decisions should be based on sound engineering and medical principles, (3) communications should be initiated when it benefits patients or physicians, and (4) actions must comply with applicable laws and regulations" (p. 20). Based on what is known about the Guidant ICD recalls, all of these ethical guidelines were violated.

Conclusions

The increasing failure rate of ICD devices has led to a reduction in confidence in this method as a viable medical intervention for patients at risk for sudden cardiac failure. While considerable effort has gone into creating medical and device industry standards, it is too soon to tell whether this will generate a significant beneficial impact on patient health and confidence. From an ethical perspective, the recent history of ICD recalls is a prime example of how not to manage suspected and actual device failures. The cost to patients and their loved ones is incalculable and the cost to the parent corporations can easily run into the billions.

References

CNN Money. (2006, Jan. 25). Guidant goes with Boston Scientific. Money.CNN.com. Retrieved 14 Nov. 2012 from http://money.cnn.com/2006/01/25/news/companies/guidant_jnj/index.htm.

FDA (U.S. Food and Drug Administration). (2005, July 22). FDA News Release: FDA announces Guidant's Class I Pacemaker recall. FDA.gov. Retrieved 14 Nov. 2012 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108465.htm.

FDA (U.S. Food and Drug Administration). (2009, Oct. 8). Medical Devices: Boston Scientific/Guidant recall: Questions & answers (April 10, 2007). FDA.org. Retrieved 14 Nov. 2012 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm135175.htm.

GMI Ratings. (2012, Mar. 2). Boston Scientific's Guidant acquisition led to fines, settlements and penalties; But that's just the beginning of its woes. SeekingAlpha.com. Retrieved 14 Nov. 2012 from http://seekingalpha.com/article/407411-boston-scientific-s-guidant-acquisition-led-to-fines-settlements-and-penalties-but-that-s-just-the-beginning-of-its-woes.

Gollob, Michael H. And Seger, John J. (2001). Current status of the implantable cardioverter-defibrillator. Chest, 119, 1210-1221.

HRS (Heart Rhythm Society) and FDA. (2005). Proceedings document from the Policy Conference on Pacemaker and ICD Performance. HRSOnline.org. Retrieved 14 Nov. 2012 from http://www.hrsonline.org/Practice-Guidance/Clinical-Guidelines-Documents/Proceedings-Document-from-Policy-Conference-on-Pacemaker-and-ICD-Performance.

Meier, Barry. (2005, Nov. 10). Guidant issues data on faulty heart devices. New York Times. Retrieved 14 Nov. 2012 from http://www.nytimes.com/2005/11/10/business/10device.html?pagewanted=print&_r=0.

Olshansky, Brian. (2004). Pacemakers and defibrillators: Frequently asked questions. UIHealthCare.com. Retrieved 14 Nov. 2012 from http://www.uihealthcare.com/topics/medicaldepartments/internalmedicine/pacemakersanddefib/index.html.

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