When people think of medical malpractice, they often think of surgeons making a mistake during a procedure or doctors missing a diagnosis. However, medical malpractice can also come in other forms, as well. One of them has to deal with defective medical equipment. When a device is supposed to keep you healthy but fails or even makes the problem worse, it can still be medical malpractice, in addition to a potential products liability issue. Implantable heart defibrillators made by Guidant are an excellent example of how a medical device can backfire or prove to be so defective that it causes more harm than good to the people who have paid for them and are depending on them to keep them alive and healthy.
How Implantable Defibrillators Work
Defibrillators are electronic devices that are implanted in a patient's chest to artificially stimulate their heart when a problem is detected. They are slightly smaller than the size of a pack of cigarettes, but can still be life-changing devices for people who suffer from heart arrhythmia or who have irregular heartbeats: The defibrillator can sense when the heart is beating incorrectly and give it a small electrical shock to get it back in order. This allows people who have otherwise debilitating heart conditions to live normal and even physically active lives without worrying about whether their heart's arrhythmia will prevent it from keeping up. Implantable defibrillators can also be a crucial first line of defense for people who are at significant risk of a heart attack due to ventricular fibrillation or tachycardia.
Implantable defibrillators work by attaching electrical wires from the defibrillator battery, which is implanted in a patient near their heart, to the heart itself in a surgical procedure. The defibrillator battery, which can last up to a decade, is also attached to a tiny computer that monitors a heart's beating. If the beating slows down or speeds up in an irregular way, the computer senses the problem and issues a series of electrical shocks to the heart to bring it back to normal.
A common source of confusion about defibrillators is how they are different from pacemakers. Implantable defibrillators are similar to pacemakers in that they offer electrical assistance to help a weak or improperly functioning heart. However, they are different in that pacemakers regulate the timing of every beat of the heart, while a defibrillator only works when it senses that there is a problem with the heart's rhythm. This makes pacemakers a very “hands-on” type of implantable heart defibrillator that keeps the heart working properly, while defibrillators are more “hands-off” in that their purpose is to prevent the heart from failing.
Intended Use of Implantable Defibrillators
Implantable defibrillators are meant to regulate the heartbeat of the person who receives it, preventing the heartbeat from getting too irregular. Importantly, there are a variety of different ways for a heart to beat irregularly, with each one requiring a different series of electrical shocks from a defibrillator to correct. Advanced defibrillators are able to detect which of these medical conditions is present, and respond with an appropriate series of electrical shocks to bring the heart back to normal.
Two types of arrhythmic heartbeats that require defibrillator treatment are ventricular fibrillation and ventricular tachycardia. Both of these conditions can trigger a serious heart attack. Ventricular fibrillation happens when the electrical currents that naturally flow through the heart's ventricles become disorganized, leading to the heart's ventricles “quivering” instead of pumping blood from the heart back through the bloodstream. Ventricular tachycardia, on the other hand, is when the natural electrical flow through the heart makes the heart pump regularly, but far faster than normal. When ventricular tachycardia is sustained for longer than a few seconds, it can become dangerous.
Implantable defibrillators fix these issues by sensing the type of electrical irregularity in the heart after monitoring how the heart is beating. Based on this diagnosis, the defibrillator sends electrical currents into the heart to coerce it into beating in a regular way and at a pace that is not dangerous for the patient. In this way, the defibrillator can prevent a serious heart attack from happening. This makes defibrillators a common and life-altering medical device for people who have weak or compromised hearts, as they can allow those people to live normally and even actively without having to worry about a sudden cardiac arrest.
However, one company that makes these defibrillators, Guidant Corporation, has come under fire for producing medical devices that are prone to failure, putting countless innocent people at risk of a serious medical condition.
History of the Guidant Corporation
One of the primary companies to make implantable defibrillators is Guidant Corporation. Guidant formed in 1994 as the publically-traded company after spinning off from the organization Eli Lilly and Company. Eli Lilly had created a medical devices division as early as 1978, when they bought a handful of companies that were influential or rapidly growing in the industry.
In January 2006, Guidant Corporation was bought by two other companies, Boston Scientific and Abbott Laboratories, to become their wholly-owned subsidiary company for $27.2 billion. The merger process, however, was fraught with difficulty. The original purchaser was supposed to be the company Johnson & Johnson, and had been set to go into effect in December, 2004, over a year earlier, for $25.4 billion. That deal had been approved by the board of directors at Guidant Corporation in April, 2005, but less than a month later Guidant admitted to a handful of cases where defects in their defibrillators caused the device to fail, leading to one death. To make matters even worse, a New York Times article was published the same day as Guidant's admission, detailing how Guidant had known of defects in its implantable defibrillators for years before they notified doctors and physicians that something could go wrong. This led to a recall of several models of Guidant's implantable defibrillators, as well as several models of pacemakers, as well. The scope of the problem continued to increase until the recalls included more than half of their total pacemakers produced by Guidant. Johnson & Johnson reacted to the news by threatening to pull out of their deal. Guidant sued Johnson & Johnson to enforce the merger, and settled on a renegotiated price of $21.5 billion. That was the time that Boston Scientific came into the picture, offering an unsolicited bid of $24.6 billion and starting a bidding war that Boston Scientific eventually won, with the help of Abbott Laboratories.
Device Failures and Long Line of Defibrillator Recalls
The defibrillator failures that created the recalls that almost ruined the sale of Guidant for billions of dollars had another, and far more important, result: Innocent people got hurt.
Different models of Guidant's defibrillators had different issues. Most, however, had a very basic problem: They simply did not provide the electrical shock that was the sole purpose for implanting them and connecting them to the patient's heart. As a result, innocent people who paid to have them implanted and who were counting on them to regulate their heart rate and to prevent serious heart attacks were left unprotected.
Over the course of several years, spanning from before Guidant's purchase by Boston Scientific and Abbott Laboratories to after the merger was finalized, a handful of defibrillator devices failed and were found to be defective, resulting in sweeping recalls. The first batch of recalls was by Guidant Corporation. It came in June 2005, and impacted:
- Prizm 2 DR, Model 1861,
- Contak Renewal, Model H135, and
- Contak Renewal 2, Model H155.
In June, 2006, Boston Scientific expanded the scope of the recall to include additional defibrillators and some pacemakers, as well, including:
- Several models in the Insignia and Nexus line of pacemakers,
- Contak Renewal TR and TR 2 pacemakers,
- Ventak Prizm 2 defibrillators, and
- Both Vitality and Vitality 2 defibrillators.
The defibrillator models impacted by the 2005 recall were found to have failed at least 45 times, resulting in two confirmed deaths, including to a 21-year-old college student from Minnesota who had a genetic heart disease.
In all, an estimated 50,000 defibrillator devices were covered in the 2005 recall, alone.
Guidant's Cover Up
Guidant knew about the propensity of their defibrillator devices to fail long before 2005, though.
In the article released by the New York Times on the eve of the Guidant's merger with Johnson & Johnson, reporters found that Guidant was aware of the malfunction in their defibrillator devices for at least three years before opening up about it. Nevertheless, the company continued to use the devices in implants, with more than 24,000 receiving one. To make matters even worse, Guidant did not tell doctors of the potentially catastrophic flaw in several models of their defibrillator devices, leading medical professionals to continue to recommend and implant those devices in innocent patients, and to trust that the device would work. Had doctors known that the devices could fail, they would have called their patients to notify them of the problem and replaced the defective device.
In addition to not telling doctors about the malfunctioning device, Guidant also did not tell another important party, the Food and Drug Administration (FDA). The FDA regulates medical devices like Guidant's defibrillators, and needs to be notified of problems with the devices or told of any proposed changes to how they work. When Guidant discovered the defects in several models of their defibrillators, they made internal decisions to change how the wiring was done to correct the problem. However, Guidant told the FDA that the change in the wiring as not “being done to correct device flaws that threaten patient safety,” but was instead “to improve process throughout” the device.
Those misleading statements to the FDA were the basis for a criminal charge by the Department of Justice against Guidant for withholding information from the FDA. Guidant ended up being convicted on the charge in 2011, which required the company to forfeit over $42 million in earnings and carried a nearly $254 million penalty. Guidant was also sentenced to three years of probation for covering up the defects in the device and putting patients at risk. This probation period allows for random record inspections and forces the company to make quarterly reports.
Symptoms of Potential Defibrillator Failure
If you or a loved one relies on one of the recalled defibrillator implants, there are a handful of symptoms that could signal a serious heart event and a defibrillator failure. These include:
- A suddenly rapid heart rate,
- Shortness of breath, or
- Loss of consciousness.
Should any of these symptoms occur, get medical attention immediately.
Steps to Take to Find Out If You Are Impacted by the Recalls
If you have had a Guidant defibrillator implanted, there are things you can do to ensure that the device you paid for and are relying on to keep your heart working will function properly:
- Contact your doctor to find out if the implant you have is one of the models that has been recalled, or if you feel the implant give an electrical shock,
- Follow up with your doctors as scheduled after the surgery to make sure the device is still working properly,
- Follow any instructions you receive from Guidant or Boston Scientific regarding your defibrillator implant, and
- See a doctor immediately if you hear a beeping sound coming from the defibrillator.
Medical Malpractice Attorneys at Gilman & Bedigian
Medical devices like Guidant's defibrillators are meant to be life-saving, and are repeatedly promised to provide the protection we need to have healthy lives. When those devices fail, they can lead to a serious medical condition or heart attack that drastically impacts your life. You deserve to be compensated.
The personal injury and medical malpractice attorneys at the Maryland law office of Gilman & Bedigian strive to represent innocent victims of medical malpractice instances, like those involving defective Guidant defibrillators. Contact us online or call our law office at (800) 529-6162 for a free consultation.