MANAGING THE LEGAL LIABILITIES AND RISKS INHERENT IN THE DELIVERY OF ASSISTIVE AND REHABILITATION TECHNOLOGY SERVICES AND DEVICES

Jonathon Z. Schuch, M.E., Assistant Professor of Physical Medicine and Rehabilitation

Betty H. Breeden, RN, ARM, FASHRM, Educational Coordinator, Department of Risk Management

University of Virginia, Charlottesville, VA 22908

ABSTRACT

This paper describes strategies for effectively managing the legal liabilities and risks associated

with the delivery of assistive and rehabilitation technology (AT/RT) services and devices. Because

services and products are delivered to consumers, assistive technology practitioners and

rehabilitation technology suppliers assume significant legal responsibility for their actions, to the

extent that the consumer has a legally enforceable right to AT/RT services that meet or exceed

professional standards and to AT/RT products that will not cause injury under normal use (1).

Professional and product liability issues are presented in relation to the delivery of AT/RT services

and devices, followed by a discussion of eleven strategies that, when followed, reduce the risk of

injury to the consumer or others, thereby containing the legal risk associated with the delivery of

AT/RT services and devices.

BACKGROUND

Assistive technology practitioners (ATP's) and rehabilitation technology suppliers (RTS's)

provide assistive and rehabilitation technology (AT/RT) services and devices to consumers. These

services and devices are extremely broad in scope and complexity, depending upon consumer

need and service provider capabilities. Yet, in all cases, regardless of breadth or depth, the ATP

or RTS  is legally responsible, or liable, for the services and, to a variable degree, for the

products he or she provides. Most unfortunately, the services and products provided by ATP's

and RTS's can cause injury and death (2). As a result, the ATP or RTS assumes significant

liability for their actions.

The liability shouldered by ATP's and RTS's falls into two categories, professional liability and

products liability. Professional liability is synonymous with malpractice, which has been defined

by the courts as unprofessional conduct in the handling of professional matters, resulting from

ignorance, carelessness, want of professional skill, or disregard of established rules (3). Products

liability "deals with the liability of manufacturers, distributors, retailers, and others for damage

caused by defects or dangers in their products, whether the damage be suffered by those with

whom they deal or by others" (1). In a broad sense, products liability relates to liability arising

from the use of a product (1).

While ATP's and RTS's might think that they are free of products liability when they simply

provide a commercial product, that may not necessarily be the case. Some courts consider

negligence within products liability claims. In these instances, a seller or supplier is subject to

liability for negligence relating to his or her function in the distribution of a product (1). For

example, a supplier of a product is under a duty to provide adequate directions or instructions for

the proper use of a product, when required by law or circumstances; failure to do so constitutes

negligence (1).

Stricter products liability standards apply when ATP's and RTS's combine AT/RT components

to form systems, modify commercial products, or manufacture custom products for consumers.

In cases where components are combined, the courts are hesitant to hold the manufacturer of the

components responsible under the strict liability doctrine. In fact, the courts often rule that the

"manufacturers cannot be responsible for a combination which they did not recommend and

which they had no way of guarding against at the manufacturing stage" (1). When ATP's or RTS's

modify or manufacture products, they are fully liable under products liability law. This holds true

even for simple modifications, such as the trimming of a commercial wheelchair cushion to fit a

particular wheelchair.

While the liability risks are quite high for ATP's and RTS's, it can be said that too little attention

is paid to this issue. A review of the RESNA Proceedings from 1982 - 1995 yielded no article

specifically addressing liability issues. Ellingson briefly touched on the issue in 1983 (4), as did

Axelson and Chesney in 1995 (2), but the issue of injury, liability, and risk management has not

been addressed beyond that. Nor has is been addressed in the RESNA publication Assistive

Technology. In the final analysis, though, ATP's and RTS's bear significant risk of liability in the

provision of AT/RT services and products.

STATEMENT OF THE PROBLEM

The problem under consideration relates to risk and the effective management of risk. First, and

most tragic, is the risk placed upon the consumer or general public, that being the risk of

unnecessary injury or death. The second risk is the legal and financial liability borne by the ATP

or RTS as a consequence of the injury to the consumer. If the ATP's or RTS's do not take

specific steps to reduce the risk of injury to the consumer or others, they place themselves at

extremely high risk for a liability judgement made against them. Similarly, ATP's or RTS's might

take the proper steps to reduce the risk of injury, but neglect certain procedures for effectively

managing their liability. In these cases, even though a consumer's injury might not be the result of

malpractice or products liability, the ATP or RTS risks being unable to adequately prove this.

Consequently, they remain at high risk for a liability judgement against them.

As can be seen, the risks are high. But, to a large extent, they are manageable. In the section

that follows, strategies for effectively managing legal liabilities and risks are presented.

APPROACH

The approach to effectively managing liability can be separated into distinct strategies. Such a

separation assists the ATP and RTS in assessing their current risk management practices and

incorporating neglected procedures into their overall service delivery process. Eleven strategies

are presented below.

1. Stay within the boundaries of your expertise or competence

ATP's or RTS's should not stray beyond the limits of their expertise or competence. Doing so risks

immediate malpractice repercussions. The dilemma relates to one's perception of competence. It

is not the RTS's or ATP's perception of competence, but is the court's, that dictates liability. Is an

ATP or an RTS who has no formal training in structural analysis liable for drilling a hole in the

frame of a wheelchair, which might result in structural failure and consumer injury? Legal rulings

suggest he or she is liable.

2. Acquire expert oversight and/or consultation

If an RTS or ATP is at risk of straying beyond their boundary of expertise, they should seek the

services of an expert for supervision or consultation. Doing so greatly reduces the risk of liability

for the service provider, as long as the relationship is formal in nature and is properly

documented.

3. Seek out risk management experts for guidance

The benefits of consulting a risk management specialist cannot be overstated. The specialist can

offer suggestions to improve one's overall risk management practices, as well as serving as a

consultant prior to accepting specific cases that may be deemed risky. The specialist can offer

additional support unique to particularly risky cases.

4. Maintain contact notes with every case

Document each contact made with the consumer and the consumer's primary care providers.

Documentation should list all participants of the contact, as well as detail communication, actions

and interactions, findings, and unusual occurrences. The note should be signed and dated for each

contact made, whether it be direct contact, telephone contact, or contact through an intermediary.

5. Maintain a detailed record of all services and products delivered

This record should detail the what, why, when, where, how and who of services and products.

Comprehensive records detailing device selection, modification, and customization need to be

included. Photographs are essential to demonstrate the products and their alterations, as well as

their proper fit and function. How can the ATP or RTS prove that the product has been altered

by another party, if they lack documentation detailing the product's original form? "Where the trier

of the facts reasonably can find that the product is unchanged from the condition it was in when

sold and the unusual behavior of the product is not due to any conduct on the part of the plaintiff

or anyone else who has a connection with the product, logic dictates that it is a distinct possibility

that there is some defect in the product" (1).

6. Fully document risks

Fully document all risks associated with a case. Detail the risks or problems that existed prior to

intervention, the prior attempts to alleviate the risks or problems, the reason for the request of the

service or product, and any new risks posed by the new service or product being provided. If it

can be demonstrated that the consumer is at greater risk resultant to no service or product than

with a service or product containing inherent risks, the court will often rule in favor of the

intervention.

7. Provide training on proper use, care, maintenance, and evaluation of devices

As stated earlier, suppliers of products have a duty to provide adequate directions or instructions

for the proper use of a product. Failure to due so may constitute negligence. In the best of worlds,

the instructions should be provided to the consumer in a hard copy form.

8. Follow up on services and products

Follow up with the consumer and the primary care providers demonstrates an effort to ensure that

the services and/or products are effective and continue to safely meet the consumer's needs.

Follow up also facilitates intervention in the event that problems or dangers arise.

9. Have consumers return modified or customized equipment when they no longer use it.

If a person other than the primary consumer gains possession of a modified or customized product

and is injured by its use, the supplier may be found liable for damages. To avoid this problem, the

supplier should make the return of the product a condition of the terms of service. This absolves

the supplier of liability in the event that the primary consumer then chooses not to return the

product.

10. Use of a liability waiver.

Liability waivers should not be relied upon. They are rarely, if ever, enforceable. A disclaimer

prepared after consultation with legal counsel may be utilized.

11. Do use an informed consent document.

The informed consent document is not a waiver of claims. Rather, it serves as additional

documentation of the appropriateness of the service and/or product. The document should

contain the details described in strategies 2,5,6,7,and 9. Both the service provider and the

consumer should sign and retain copies of document.

IMPLICATIONS

The implications are clear. Incorporation of a risk management strategy into the AT/RT

delivery process significantly reduces the risk of injuring consumers and members of the general

public. Consequently, the risk of malpractice and products liability claims are effectively managed.

On the other hand, failure to incorporate risk management strategies into the delivery process

leads to potentially devastating and life threatening dangers.

DISCUSSION

As can be seen, injury prevention, liability, and risk management are significant issues affecting

RTS's and ATP's as they deliver AT/RT services and products. As a professional society of

ATP's and RTS's, we don't hear a great deal about court rulings related to AT/RT liability. Are

we lucky, so far? Are we that effective at managing our risk? Is a significant accident or injury

waiting to happen?

RESNA is beginning to address this issue through its QA initiative. But ATP's and RTS's

cannot rely on RESNA to be the sole provider of risk management. `Rather, it is the

professional's and the employer's responsibility to take tangible steps to prevent consumer

injuries, thereby effectively managing liability and risk.

While this paper does not pretend to have all of the answers to these issues, it is hoped that it

can serve as a catalyst for thought and consideration of a comprehensive strategy for managing

liability and risk, and most importantly, for reducing the unnecessary injuries brought about by

AT/RT intervention.

REFERENCES

1. Ginnow, A. O. (ed.): Corpus Juris Secundum, 72 Supplement. St. Paul, West Publishing Co.,

1975.

2. Axelson, P. W., and Chesney, D. A. Potential Hazards of Wheelchair Lap Belts. In: Proceedings of the RESNA '95 Annual Conference. Vancouver, Canada: 1995; 314-316.

3. Words and Phrases, Volume 26. St. Paul, West Publishing Co., 1953; 328.

4. Ellingson, E. F. The Legal Responsibility of Engineers: Where Does The Rehabilitation

Engineer Fit In? In: Proceedings of the Sixth Annual Conference on Rehabilitation Engineering.

San Diego, California: 1983; 421-423.

Jonathon Z. Schuch, M.E., Assistant Professor

University of Virginia

Box 35-BRH

Charlottesville, Virginia 22908

(804) 982-3845