Knee disfigurement following surgery resultsin a jury verdict of $12.7 million
By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY
Steven J. Auletta, Esq.
Associate
Kaufman Borgeest & Ryan
Valhalla, NY
Alvin Safran
Director of Risk and Claims Management
The New York Hospital Medical Center of Queens
Flushing, NY
News: In 2003, the plaintiff, then 15 years old, underwent knee surgery with the defendant physician. Following the surgery, the physician prescribed a cold-therapy device, which was made by the defendant product manufacturer. After using the device, the plaintiff suffered frostbite and required multiple reconstructive surgeries. The case involved a malpractice claim against the defendant physician and a negligent design claim against the defendant product manufacturer. There were also fraud claims against the physician. The jury awarded the plaintiff $5.2 million in compensatory damages, as well as $7.5 million in punitive damages.
Background: In 2003, the plaintiff, then a 15-year-old woman who was a competitive track and field athlete, underwent knee surgery with the defendant physician, an orthopedic surgeon who is also the head physician for an NFL team. Following the surgery, the defendant physician prescribed a cold therapy device, which was made by the defendant product manufacturer. The plaintiff was to apply the device to her knee to speed her recovery.
Cold therapy devices, such as the one at issue in this litigation, are used to reduce swelling and promote healing following surgery. They are designed to maintain a constant temperature or temperature range, and they are advertised as being safer than applying ice. As the body temperature is lowered, blood flow might be reduced and nerve impulses might slow down, which can purportedly prevent the patient from detecting pain. During this trial, the jury heard testimony that a patient using the cold therapy device might not feel frostbite setting in because of numbness caused by the device.
Shortly after she began using the device, the plaintiff suffered frostbite at the site where the device was used. She allegedly asked the defendant physician about the cause of her injury, but he claimed he had never seen anything like it. However, the physician had previously settled a claim with a former patient who also suffered frostbite from using the same device. He also allegedly failed to inform the plaintiff that he owned the company that rented the devices to his patients and that he stood to gain financially from prescribing the device.
The plaintiff alleged that she spent several months with an open wound before she was told that she had frostbite. She eventually required several reconstructive surgeries, and she might require more in the future. The jury awarded the plaintiff $5.2 million in compensatory damages, including past and future economic damages and pain and suffering. The jury found the defendant physician 50% at fault, his company 10% responsible, and the product manufacturer 40% responsible.
The jury also awarded punitive damages of $7 million against the defendant product manufacturer, and $500,000 against the defendant physician.
What this means to you: This case has a large component to it that involves a medical device. Medical malpractice cases involving malfunction, breakage, or other type of device defect can be interesting, complex cases. Such cases also prevent a significant opportunity for healthcare providers to reduce or at least defer liability.
Incidents that involve device malfunction in which it is suspected that the device malfunction caused or contributed to patient injury or illness must be handled carefully. In addition to reducing liability to the physician using the device, such incidents involve potential regulatory compliance for user facilities in accordance with reporting requirements under the Safe Medical Devices Act.
Although much of the following applies to hospital policies and procedures, it is most important that physicians understand them and comply with them. It is the physician's liability that stands to be mitigated by enforcing diligent compliance.
A medical device incident might be as simple as opening a box containing a device and noting that the device is broken. In that scenario, an occurrence report documenting as much information about the device as possible (e.g. lot number, serial number model number, etc.) should be completed. The manufacturer should be voluntarily notified. An inspection of stock for similar devices should be conducted to make sure there are no additional broken units. Devices that are discovered to be defective should be tracked to proactively look for any trends with particular devices.
If a device is used on a patient and breaks or in some other way malfunctions, and it is certain that this device did not cause or contribute to patient harm, the same steps should be taken as in the prior scenario.
If the device malfunctions and is suspected of having caused or contributed to patient harm, the same steps as the first two scenarios should be taken. In addition the device should be sequestered. It should be put through a careful chain of custody documenting all persons who have had possession of the device from the time at which it malfunctioned until the time it reaches its final location (usually the bio-med department). The hospital policy should explain that when the malfunctioning or defective device is part of a surgical specimen, the pathology department must be aware that the device was involved in an incident and needs to save it. The device must be left exactly as found. The settings should not be changed, and there should be no attempt to manipulate the device. If the device is a life-sustaining device, it is important for the chairperson of the department and other users of the device to know that the device has been taken out of service.
We hope that this situation very infrequently. Unfortunately, that lack of frequency usually makes compliance with hospital policy more difficult. All too often, without thinking, a broken or malfunctioning or otherwise defective device is tossed into the nearest trash can. Another common error is try to fix the malfunction immediately or try to determine what caused the malfunction. It should be clearly understood that any manipulation of the device or its settings will result in spoliation of evidence. It is also important to remember that when the Food and Drug Administration (FDA) uses the term "medical device," it does not distinguish between large electronic units and disposable devices. Therefore all of the above recommendations apply to both. The device should remain sequestered until such time as risk management states that it may be returned to service. It might be necessary to keep the device sequestered for potential evidence purposes until the appropriate state's statute of limitations expires. Because this occurrence generally is rare, it is a good idea to notify risk management with any questions immediately. Once the evidence is tampered with, it is too late.
Contracts and agreements with manufacturers often require that devices that malfunction be returned to the manufacturer. Facilities that use these devices have mandatory reporting requirements, and any contract should always make exceptions for legal evidence and regulatory reporting requirements. If the manufacturer is insistent on examining the device, the user facility may invite the manufacturer to visually inspect the device. The manufacturer may be permitted to take pictures of the device. Again, any touching or manipulation of the device or its settings will compromise the evidence.
The potential liability reduction for physicians, as well as all medical providers, for complying with these recommendations is so great that strong consideration should be given to having recurring education sessions or reminders to enforce policy.
Reference:
Superior Court, San Diego, California, Case No. GIC870982.
ews: In 2003, the plaintiff, then 15 years old, underwent knee surgery with the defendant physician. Following the surgery, the physician prescribed a cold-therapy device, which was made by the defendant product manufacturer.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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