Medical technology and devices have developed exponentially in the recent decades, but they come with inevitable consequences including risks and defects. Guidant, a medical device company, released an implantable cardioverter defibrillator (ICD) in 2000. Meant to save patients suffering from heart problems, the device contained a defect that sometimes caused it to fail. When cases surfaced revealing repercussions of this defect, Guidant faced a difficult situation and battled with the standards of ethical conduct. At first glance, it seems the company made poor decisions to deal with this. However, upon further investigation, it becomes evident that Guidant’s actions were sensible and ethical, and that they handled the situation as best they could.

Medical technology has proliferated in recent decades, providing important, and often life-saving, advances but also risks and complications. These include recent developments in prosthetic vessels, cortical electrodes to record brain activity, and cardiovascular stents to treat narrow arteries, just to name a few. A particular medical device of interest is the implantable cardioverter defibrillator (ICD), which is introduced and explored in this paper. With all medical devices, there come risk and malfunction, and complications arise regarding the right course of actions to handle the situation.

The first case of malfunction surfaced in 2005 when Joshua Oukrop, a college student with an ICD, entered cardiac arrest. The ICD, which is supposed to shock the heart and return the heartbeat to normal, did not fire. As a result, he passed away. After close examination, doctors and engineers found that the connection between the device and the leads to the heart, which is what delivers the shock, had short-circuited. At this point, Guidant, the company that manufactured this ICD, admitted that earlier testing of their product had already revealed this defect back in 2002, but failed to notify patients and doctors that the devices sold between 2000 and 2002 contained these defects (Baura, 2011). Surely, the question was raised regarding whether Guidant took an unethical course of action in dealing with the defects of their product. However, after thorough research and consideration of all factors in play, it becomes evident that Guidant’s actions could be considered necessary and sensible. Their devices were only meant to be a preventative solution; Guidant did improve and notify authorities of this defect, and the failure rate of the ICDs is a mere 0.002% – near infinitesimal.

Guidant launched the defective product in 2000, called the Guidant Prizm 2DR ICD. As with an automated external defibrillator (AED), it shocks the victim’s heart in the event of a heart attack, arrhythmia, or cardiac arrest. It is implanted near the collarbone and has electrical wires that run to the walls of the heart, which will shock the heart if needed to return its heartbeat to normal. Patients who are at risk for these heart conditions would buy this product so that their daily lives are not interrupted by the need to have access to an AED at all times. However, medical devices and products like these are engineered and created by humans, and thus have the capacity for error and malfunctions.

Because Joshua’s death could have been prevented by the ICD, some may make the erroneous assumption that his death was directly caused by the short-circuiting defect when the ICD was supposed to fire. Despite this, it should be noted that the company never guaranteed 100% efficacy of the product, and they made this fact known to customers. The ICD is meant to be a backup, and when it is needed, it can either save a life or have no effect or impact on the victim. In no way should the device worsen the victim’s condition. Based on these facts, there are two scenarios worth considering. The first is that the patient at risk for a heart problem goes about his daily life being cautious of his condition but does not get an implant. One day, his heart might malfunction, and if help is not available, he may die. The second scenario is that the same patient, with the same risk, goes about his life being cautious as well, but this patient gets an ICD implanted in case of an emergency. Now, if his heart malfunctions, the worst-case scenario is that the device also malfunctions and he dies as well, because the device does not fire and so has no effect. These two scenarios are identical except the second person paid the money to buy an ICD as a backup, and the first did not. The only difference is the money that went into getting the ICD. For this reason, Guidant pays a big sum of money to the victim’s family; it is not to “pay” for the loss of the patient, but rather it is a “refund” of the device. Of course, much more often than not, the ICD saves the lives of the patients. Even in the worst case, the ICD does not harm or kill the patient any more than a patient would be harmed without the ICD. Patients know that the ICD is meant to be only a preventative measure, not a guarantee that lives will be saved. Thus, it is neither fair nor correct to say that the ICD is the cause of death.

Some also argue that Guidant did not take necessary steps to alleviate this problem, but there is proof otherwise. Further investigation into Joshua’s case revealed that Guidant’s engineers did change the design immediately after testing had revealed this defect in 2002. For the two years that the defected device was marketed and sold, 37,000 patients received the faulty devices (Stahl, 2007). Guidant reported each failure case – 26 out of the affected 37,000 (0.07%) – to the Food and Drug Administration (FDA), which was published on FDA’s Manufacturer and User Facility Device Experience Database. The company also met and explained to select cardiologists involved in the implantation of the ICD the risks and defects that the ICD had (Baura, 2011). By 2005, Guidant had released warning screens to all physicians associated with the defective ICDs to notify them of this possible risk. Finally, also in 2005, Guidant published a story to New York Times notifying the public about the defect. All affected ICDs, which dropped to 24,000 by 2005, were recalled due to this defect (Baura, 2011). All in all, Guidant had complied with all required laws such as notifying the FDA, making design changes, and recalling the device. Although it took a critical few years to take this course of action, one must consider that testing and repairing a device for a defect, when it has happened only in 26 of 37,000 devices, is extremely difficult and indeed time consuming. Evidently, Guidant had done everything required of them and complied with all the engineering guidelines within a reasonable time frame.

Taking into account the fact that the device can only help and cannot harm, that the company did repair, warn, and notify the public, and that the failure rate is so low deem Guidant’s and its engineers’ actions, all in all, imperative, sensible, and ethical.

Perhaps the most important aspect to be explored in a case like Guidant’s is the failure rate and the actual risks. As stated earlier, there were only 26 reports of device failure out of 37,000 affected devices. This is a solid 0.002% failure rate per month. Compared to the average industry rate of ICD failure, which is 0.01% per month, Guidant’s ICD failure rate is five times lower (Baura, 2011). Furthermore, research shows that the death rate of open-heart surgery has been 0.3% in the past years, which would have been even higher ten years ago when the Guidant case was relevant (Ezekowitz, Armstrong, and McAlister, 2003, 445). Taking into account the extremely low failure rate of the Guidant ICDs, it is actually statistically safer to leave the defective device in because of the higher mortality rate for open-heart operations. More specifically, Guidant stated, “The odds of the defect causing harm to the patient were lower than the risk of the replacement surgery plus the odds of a random failure in the new unit.” Clearly, it is extremely rare for this short-circuiting defect to occur, and in many ways, it is not worth it for most people to go in for a replacement surgery.

In all ethical cases, including this one, it is possible to find room for improvements, especially from an engineering point of view. According to the Code of Ethics published by the National Society of Professional Engineers, engineers have the duty to fully disclose all risks and warnings “in an objective and truthful manner.” It would follow that the most relevant point of opposition is that Guidant’s engineers should have notified affected patients and physicians about the defect right away rather than waiting until they had repaired the defect 3 years later. Although the engineers did comply completely with the courses of actions required of them, the fact that stakeholders, including the patients, their families, and physicians, were not informed for 3 years is the concern noted here. Still, it is worth discussing the flipside. If the engineers had notified the public right away, it would have effectively discouraged a number of patients from getting an ICD implanted due to fear of failure or reevaluation of the ICD’s value. However, studies have shown that an ICD can prolong life for 8-10 years and reduce risk of death by 43% with a 95% confidence interval (Ezekowitz, Armstrong, and McAlister, 2003, 445). Based on this statistic, it is indisputable that it is much safer to have an ICD implanted, and that dismissing an ICD’s value and effectiveness might cost more lives than not. Although it is practically better to not have revealed the defect right away, the argument of whether or not it was ethical to withhold this information is still in question. According to the New Oxford American Dictionary, being ethical means avoiding something that does harm to people or the environment. In this case, whether Guidant’s actions were ethical depends only on the consequences. Based on the above facts and previous arguments that the ICD is more helpful than harmful, the company’s actions are indeed moral and acceptable.

Taking into account the fact that the device can only help and cannot harm, that the company did repair, warn, and notify the public, and that the failure rate is so low deem Guidant’s and its engineers’ actions, all in all, imperative, sensible, and ethical. Despite the fact that Guidant held off publically announcing the ICD’s defect, it was likely for the better because of the high efficacy and success rates of having the ICD implanted nevertheless. Considering that the product’s successes have dramatically exceeded its failures, the actions of the company were not only justified, but morally imperative. As philosopher Jeremy Bentham once said, “it is the greatest good to the greatest number of people which is the measure of right and wrong” (Burns, 2005, 46). By this standard, Guidant and its engineers have indeed taken ethical actions.

 

References

Baura, Gail. Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Academic Press, 2011. Print.

Burns, J. H. “Happiness and Utility: Jeremy Bentham’s Equation.” Utilitas 17.01 (2005): 46–61. Cambridge Journals Online. Web.

Ezekowitz, Justin A., Paul W. Armstrong, and Finlay A. McAlister. “Implantable Cardioverter Defibrillators in Primary and Secondary PreventionA Systematic Review of Randomized, Controlled Trials.” Annals of Internal Medicine 138.6 (2003): 445–452. Silverchair. Web.

Stahl, Eric. “Guidant Prizm II DR ICD Recall.” Major Recalls of Organ Replacement Devices. Brown University, 1 Apr. 2007. Web. 18 Apr. 2015.