Ethical failures in Guidant Corporation's ICD recalls

Postmortem: The State of Guidant ICD Recalls

Guidant ICD Recalls

Since the first implantable cardioverter-defibrillators (ICDs) were used in a patient in 1980, the use of these devices has expanded from intervening to prevent additional potentially-lethal cardiac arrhythmia events to their use as a preventive measure in patients suspected of having an increased risk for the development of dangerous cardiac arrhythmias. However, the malfunction rate of ICD devices has been increasing in recent years, leading to a number of voluntary and mandatory recalls. When this pattern is contrasted with a declining malfunction rate for pacemakers, a similar but less complex device, it is hard not to wonder if manufacturers are using cost-cutting measures at the expense of patient health. The Guidant Corporation ICD recalls are used here as a case study in what can go wrong ethically, and it is quite a long list. These ethical transgressions include providing misinformation to the U.S. Food and Drug Administration, making false product claims, and keeping information from physicians that could have potentially saved lives. The response from key players in the ICD field was the formulation of standards to help guide both device manufacturers and physicians through the ethical arena when devices are suspected of, or actually causing problems. Through a process of greater cooperation by all parties, the expectation is that patient lives will be saved and the waning confidence in the use of cardiac implantable devices as medical interventions will be reversed.

Postmortem: The State of Guidant ICD Recalls

Introduction

Close to 350,000 deaths occur annually in the United States due to sudden cardiac death (reviewed by Golob and Seger, 2001). The ability to quickly defibrillate an arrhythmic heart is essential to saving lives and implantable cardioverter-defibrillators (ICDs) have been used to achieve this goal in hundreds of thousands of patients worldwide. Providing 5 to 15 seconds of defibrillation has been shown to be sufficient for achieving a near 100% success rate in reestablishing a normal cardiac rhythm. In addition, extensive testing has shown ICDs to be far superior to drugs in preventing sudden cardiac arrest, although a few researchers have cast doubt on the validity of these claims (Tung, Zimetbaum, and Josephson, 2008). Despite these reservations, nearly 30,000 ICDs are being implanted into patients annually. Recent estimates suggest ICDs are responsible for a 28% reduction in overall mortality and a 51% reduction in death due to sudden cardiac death (reviewed by Passman and Kadish, 2007).

In recent years, there have been a number of ICD recalls issued by both the U.S. Federal Drug Administration (FDA) and manufacturers. To better understand the impact of these important medical devices, the issues surrounding the recall of ICDs manufactured by Guidant Corporation (GDT) will be examined in detail as an example of what can go wrong ethically.

Why ICDs are Important

The failure rate of ICDs is approximately 20-fold higher than pacemakers (reviewed by Passman and Kadish, 2007). The likely reason for this difference is related to the relative complexity of the devices (Olshansky, 2004). A pacemaker is designed to sense a heart rate above or below normal and then correct it through an electrical pulse. In contrast, an ICD is designed to not only act as a pacemaker, but to primarily detect cardiac arrhythmias and send a shock to the heart to restore a normal rhythm. For this reason, ICDs are bigger and more complex devices. However, while the rate of malfunctioning pacemakers has declined between 1986 and 2007 due to engineering and manufacturing improvements, the incidence of malfunctioning ICDs has actually increased during the past decade (reviewed by Passman and Kadish, 2007). When this pattern is considered in light of the shift toward using ICD implantation as a preventive measure for high-risk patients, which has resulted in a 20-fold increase in implantations over the past 20 years, the stakes become very high indeed (reviewed by Tung, Zimetbaum, and Josephson, 2008). Concerned parties naturally wonder if the increasing ICD failure rate is the result of engineering and manufacturing cost-saving measures at the expense of patient lives.

Guidant ICD Recall

On July 22, 2005 the FDA issued an advisory that Guidant Corporation was voluntarily recalling 40 ICDs that they manufacture (FDA, 2005). The voluntary nature of this recall tends to hide how serious the concerns are, since the FDA classified this recall as a Class I, the most serious kind. A Class I recall implies that the device malfunction would reasonably be predicted to lead to a serious life-threatening health condition or death.

While this recall seems to imply that Guidant has recognized it has a serious problem with its line of ICDs, the back story is more complex and deeply troubling. A New York Times article about the Guidant recall discusses the flurry of lawsuits alleging doctors were not notified of the failure rates or the nature of the failures (Meier, 2005). At a Heart Rhythm Society meeting, physicians agreed that the ICD industry as a whole needs to provide doctors with the kind of information that can allow them to decide which device is best for their patients. Such information is routinely kept from the public and likely represents a significant health threat to patients.

The significance of the ICD industry practice of keeping failure rates and the nature of failures from the public is made evident by Guidant ICD malfunctions (Meier, 2005). The Prizm DR 1851 had a high overall failure rate of 2%, but of the 254 confirmed failures, a full 7% resulted in devices not working at all. For these patients, the risk of death from cardiac arrhythmia is essentially equivalent to not having a device implanted. The Guidant Contak Renewal ICD also has serious problems. Of the 33 confirmed malfunctions, 72% are believed to have resulted in the device not functioning and three patients are believed to have died as a result.

Due to the concerns expressed by cardiologists about the lack of information regarding ICD failure rates and the nature of these failures, device manufacturers have met to try and resolve these shortcomings (Meier, 2005). While these good faith efforts seem to be a good start, on the legal front a messy war has begun to rage over ownership of an industry in trouble. Johnson & Johnson (JNJ) was in the process of buying Guidant, but after the recall was announced they made the claim that the financial burden created by the recall rendered their $25.4 billion contract null and void.

After months of renegotiations, Johnson & Johnson offered $24.2 billion in January of 2006 (CNN Money, 2006). When Boston Scientific (BSX) made an offer of $27 billion, Guidant jumped at the chance. While this purchase allowed Boston Scientific to acquire one of the two largest cardiovascular device manufacturers in the world, the problems that came along with the deal seem never ending. As of 2010, Boston Scientific has had to pay out $234 million to settle claims alleging device flaws on behalf of patients. An additional $296 million in fines were paid for misleading the FDA. An additional 30 lawsuits were still pending as of May, 2012. Additional fines and penalties will probably be assessed in the near future for not paying taxes and making false claims. As a result of these problems, ratings companies have downgraded the value of Boston Scientific stock. With the FDA, Internal Revenue Service, and the Department of Justice breathing down the back of Boston Scientific, there does not seem to be an end to the woes incurred by the Guidant Corporation purchase.

The Defects in Guidant ICDs

The complications that arise through the use of ICDs are many and distinguishing between those related to medical problems and those attributed to device malfunction can sometimes be difficult. For this reason, medical professionals working in this area are required to go through an intensive training program recommended by the Heart Rhythm Society (reviewed by Passman and Kadish, 2007).

From the medical perspective, the most common complications experienced by European patients were pocket hematomas (1.9%), lead dislodgement (1.4%), chronic pain (1.6%), and infections (0.3%) (reviewed by Passman and Kadish, 2007). The most common complications experienced by Medicare patients were lead dislodgement (4.8%), hematoma or hemorrhage (2.5%), infection (1.4%), and collapsed lung (1.0%). The overall complication rate for Medicare patients is about 11% and death occurred in 0.9% of patients.

Device malfunctions are of particular interest and concern because they are theoretically preventable. The 2005 Guidant ICD recall was based on a defect that caused the devices to leak, which damaged the internal electronic components and led to device failure (FDA, 2005). The 2006 recall of Guidant ICDs were due to a problem with a capacitor that did not meet design requirements (FDA, 2007). The 2007 Guidant ICD recall was due to a faulty capacitor in the power supply circuitry that led to premature battery failure.

The Ethics behind the Guidant Recalls, or the Lack Thereof

The ethical violations were revealed by the settlement of malpractice and personal injury claims, payment of fines and penalties for providing misinformation to the FDA, and making false claims about Guidant products (GMI Ratings, 2012). 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.