Wound care and nursing home liability: new technologies can help caregivers heal pressure ulcers. But are providers using them?

Nursing home litigation involving pressure ulcers (commonly called bedsores) has typically focused on causation--whether long-term neglect on the part of the defendant caused the wound--not on the treatment. Defendants typically claim that certain pressure ulcers cannot be successfully treated due to the patient's poor health or that the sores were unavoidable because the patient incurred them in another setting, such as a hospital. These arguments have destroyed or devalued many cases. (1)

A plaintiff attorney who fails to challenge these defenses ignores half the case. Pressure ulcers can be healed, and providers who fail to heal them may be acting negligently. Nursing homes are ignoring effective advances in wound treatment in favor of superficially less expensive alternatives, despite federal rules and regulations that support the use of newer, high-tech "alternative interventions." (2)

Armed with knowledge of these advances and requirements, attorneys can put nursing homes on the defensive regarding treatment, rather than just causation. Failure to explore various treatment options for a chronic wound can constitute additional evidence of neglect and can support the awarding of further damages. A defendant should not be allowed to assert that a wound was untreatable unless all available treatments were tried without success.

The mere existence of pressure ulcers may indicate that the patient received substandard care. Sores that don't heal can lead to amputations and sometimes even death. For these reasons, lawsuits prosecuting nursing homes for neglect have become increasingly common and, in cases involving pressure ulcers, have led to substantial recoveries.

Many of those verdicts included significant exemplary damages. For example, in Fuqua v. Horizon/CMS Healthcare Corp., (3) in which a resident who lived at a nursing home for about three years developed at least 16 pressure sores, some of which became severely infected, the jury awarded the plaintiff a substantial verdict--almost all of it in punitive damages. Criminal prosecution of such neglect is also becoming more common.

Development

Elderly patients who are chairbound, bedridden, or unable to reposition themselves often succumb to pressure ulcers. They affect as many as 23 percent of nursing home residents. (4) Other sources estimate that at any given time, over 1 million Americans suffer from pressure sores. (5) Peripheral vascular disease, diabetes, and arteriosclerosis, all common among elders, may contribute to the formation of pressure ulcers by degrading a patient's circulatory system. General decreases in activity, mobility, and flexibility likewise take their toll on the system's ability to circulate blood, with its life-giving oxygen and nutrients, throughout the body.

But many aspects of nursing home care exacerbate pressure ulcers, including:

Positioning. Is the patient properly positioned to reduce pressure, friction, and shear on vulnerable parts of the body? Is the patient properly repositioned at appropriate intervals?

Hygiene. Is timely bathroom assistance given? Does the patient soil himself or herself due to incontinence or lack of assistance? Is the patient kept clean and dry?

Nutrition. Does the patient receive sufficient nutrition to keep tissue healthy and heal wounds?

Hydration. Is the patient receiving enough fluids? Among the effects of hydration is the ability to heal the body at the cellular level.

When assessing a case in which the patient suffers Stage III or IV ulcers that appear to have arisen abruptly, be suspicious. Ulcers of this severity usually do not appear suddenly and probably would not progress this far with proper basic care. The presence of various underlying health problems should alert caregivers to a patient's increased risk of developing pressure ulcers. The issue is not only whether the treatment met the applicable standard of care, but one of neglect: Was the provider negligent per se or neglectful and grossly negligent in its failure to meet basic care requirements?

Both medical standards and the law require a base level of care for a wounded patient. Federal law provides that a patient who enters a facility without pressure sores should not develop them unless the individual's clinical condition demonstrates that they were unavoidable. (6) The law also mandates that a resident with pressure sores receive treatment necessary to promote healing, prevent infection, and keep new sores from developing. (7)

Most state regulations mirror the federal requirements. In many states, failure to comply with a statutory mandate is negligence per se. Also, practitioners recommend regular reassessments of wound progress, with a change in treatment if there is no decrease in wound size after two to four weeks of the existing treatment. (8)

Treatment

Defendants often argue that a wound is "unavoidable" due to the patient's general limitations of age; they assert that those limitations make the wound difficult, if not impossible, to prevent. Or they claim that a patient's specific, preexisting problems, such as immobility or dementia, make the wound "unavoidable." They may also contend that a wound is "unhealable" for the same reasons--that, essentially, nothing more could be done to achieve better results. Unless alternative treatments have been tried, do not accept these claims.

Plaintiff's counsel must look at the treatments given with a critical eye. The traditional treatment for pressure ulcers is the application of a dressing. The most common and least expensive type is simple saline and gauze in a wet-to-dry dressing. Closely related to that type are dressings using film, gel, foam, or collagen that contain aloe or other healing agents. Although occasionally successful, these relatively inexpensive treatments are frequently ineffective for chronic, nonhealing wounds.

Recent years have seen the development of radically different advances in wound treatment. Some of these alternative treatments, and products used for them, include:

Noncontact normothermic wound therapy, sold under the name Warm-Up Therapy. (9) It operates by raising the temperature of a wound to core body temperature. The product consists of a noncontact, domed wound cover with a battery-powered heating card inside. It provides a warm and moist environment for the wound, which increases circulation and allows the body to heal itself.

Growth-factor treatments. These are creams or other substances that contain a genetically engineered, platelet-derived growth factor to promote healing. Treatment consists of simply placing the substance on the wound. One common example of such products is Regranex. (10)

Artificial skin grafts. One such product is Apligraf graftskin, a living skin substitute that is placed on a clean, uninfected wound, then covered with a traditional dressing. Like human skin, skin grafts consist of living cells and structural proteins, and they should ultimately become a permanent part of the patient's tissue. (11)

Negative pressure-wound therapy. Under this method, a foam cover is placed over the wound and attached to a vacuum device. The treatment is designed to remove swelling, remove exudate from the wound, and increase circulation. One example of a device for this treatment is the V.A.C., made by Kinetic Concepts, Inc. (12)

There are numerous treatments for pressure ulcers, and the examples provided by no means exhaust the list. But they do provide a starting point for questioning your expert, your opponent, or your opponent's expert.

While no treatment can heal every wound, it is reasonable to expect a provider to regularly examine a patient's sore and determine whether the treatment is working. As noted above, federal regulations require providers to ensure that a resident with pressure sores receives the necessary treatments and services to heal. This regulation means that if no progress is made after a number of weeks, alternatives must be tried. Otherwise, a provider would be free to continue using the cheapest treatment available even when it is clearly not working.

An expert should be familiar enough with the clinical efficacy of alternative treatments (13) to testify that one or more of these treatments would, to a reasonable degree of medical probability, have significantly improved or healed the wound, and that the provider was negligent for having continued the prescribed course of care. Upon cross-examination, your expert will doubtless have to concede that he or she cannot say for certain that the wound would have responded to an alternative treatment. But your focus should be on the treatment the provider actually rendered, which did not work, and the failure to explore and provide alternatives that might have worked.

In such cases, structuring the examination of the health care provider is relatively simple. First, establish the treatment or treatments used to heal the wound. Second, make the witness admit the obvious--that these treatments did not work. Third, make the witness acknowledge that alternative treatments such as those listed above were not tried, even though the wound did not respond to traditional care. Ask the witness why alternative treatments were not considered. Finally, inquire whether the provider believes it should seek alternative treatments for a nonhealing wound.

Once this groundwork is laid, question the provider about his or her familiarity with those new treatments, including how long they have been available, their relative expense, and so forth. If the provider's witness is not familiar with the options you raise, ask whether the witness has ever heard of the various reference books and medical journals in which such treatments are discussed. If the witness has not, you can consider your examination a job well done.

If the provider does admit to having heard of one or more of these treatments, the examination could proceed as follows ("Warm-Up" is used here simply because information and studies regarding it are readily available. Insert any of the treatments listed above, or any others that your expert agrees and will testify are applicable to your client.):

Q: Why didn't you use Warm-Up on Mrs. Jones?

A: I didn't have any reason to believe that it would help. There are a lot of products on the market that just don't work.

Q: Did any of the treatments you tried on Mrs. Jones heal the wound?

A: No.

Q: Then why weren't you willing to try Warm-Up?

A: The treatments we were using met the standard of care, and I didn't believe anything else available would have any greater success.

Q: Did you have any specific knowledge or experience with Warm-Up that gave you reason to believe it would not be an option for this patient?

A: No.

Q: Were you aware of a clinical study involving Warm-Up in which eight patients in a veterans hospital, each of whom had a pressure ulcer for significantly longer than Mrs. Jones, were healed by Warm-Up in less than three months?

A: No.

Q: By your own records, you admit that you treated Mrs. Jones's pressure sore for [number of] weeks without any significant improvement, don't you?

A: Yes, we tried to treat the wound for some time, but due to Mrs. Jones's medical complications, as I described, this wound persisted despite treatment.

Q: Why, when the treatments you tried failed to show benefit over [number of] weeks, didn't you at least consider Warm-Up?

A: Well, I was not aware of any clinical studies showing that Warm-Up works.

Q: Are you aware of any clinical studies showing that the treatments you tried worked?

A: ["No," in almost all cases. Apparently, few, if any, traditional wound treatments have been the subject of reported clinical trials.]

Q: Are you aware of any of the following medical journals? [Your expert and research should uncover applicable ones to name here.]

A: Yes, I've heard of those.

Q: Would you agree that those journals are peer-reviewed?

A: Yes.

Q: Do you testify that you have never read any of the clinical trials regarding Warm-Up published in those journals?

A: Yes.

Q: Is Warm-Up more expensive or less expensive than the treatment that you prescribed?

A: I believe it's more expensive.

Q: Is that why you didn't try it?

A: No. That had nothing to do with it. We didn't try it because it is not the standard of care.

Q: Doesn't the standard of care require you to try another available treatment if your patient is suffering and the one you are using doesn't work?

A: No. We met the standard of care in this case, and we are not required to try treatments that we don't believe will work.

Q: Are you aware of federal regulations that require you to try alternative treatments for patients?

A: The law doesn't require us to try treatments that won't work.

Q: What other treatments did you try, if any?

A: None. The treatment we rendered was proper, and given Mrs. Jones's condition, it is my opinion that nothing would have achieved greater results.

Q: If there was another wound treatment that was less expensive than the one you are using, would you have tried it?

A: No. Expense has nothing to do with it. There are a lot of wound treatments on the market that just don't work.

Q: Can you name any wound-care supply that is cheaper than the gauze and saline you used for [number of] weeks on Mrs. Jones?

A: No.

Q: So you continued to use the cheapest available treatment on Mrs. Jones regardless of the law and regardless of the fact that the treatment you were using didn't show measurable progress?

A: We met the standard of care.

The stage is now set for your expert to testify to the efficacy of these newer, alternative treatments. Although none will work 100 percent of the time, some are remarkably effective and are certainly worth trying on a chronic, nonhealing wound. This testimony could be followed by questioning the efficacy and cost of treatments given to your client. There is probably no treatment less expensive than simple wet-to-dry saline and gauze dressings.

In your review of the records and your questioning of the providers, you should also remember that no matter what treatment is used, healing depends greatly on proper nutrition and hydration, maintenance of good hygiene and basic cleanliness, appropriate positioning of the patient, and other aspects of general care.

Caregivers and defense experts will argue that patients are prone to pressure wounds, that they are unable to heal because they are elderly or have preexisting health conditions, or simply that nothing else could be done. It is your job to challenge these positions. Review the medical records diligently and understand your patient's medical history. Note the facility's and caregivers' preventative methods and the treatments they used. Question the providers and their experts about their knowledge of the medical technology and their duties, both under statute and according to the standard of care. In being an informed advocate, you serve not only your client; you serve the public as a whole.

Notes

(1.) See David T. Marks, Neglect in Nursing Homes, TRIAL, Feb. 1996, at 6.

(2.) See 42 C.F.R. [section] 483.25(c)(2) (2002).

(3.) No. 4-98-CV-1087-Y-N.D. (N.D. Tex. Feb. 14, 2001).

(4.) Marilyn Pajk, Pressure Sores, in MERCK MANUAL OF GERIATRICS [section] 15, ch. 124 (Mark H. Beers & Robert Berkow eds., 2000).

(5.) CHRONIC WOUND CARE: A CLINICAL SOURCE BOOK FOR PROFESSIONALS 152 (Diane Krasner & Dean Kane eds., 2d ed. 1997).

(6.) See 42 CFR [section] 483.25(c)(1).

(7.) See id. [section] 483.25(c)(2).

(8.) CATHY THOMAS HESS, WOUND CARE 37 (3d ed. 2000).

(9.) For additional information, visit www.warm-up.com.

(10.) For additional information, visit www. regranex.com.

(11.) For more information, visit www.apligraf.com.

(12.) For more information, visit www.kcil.com.

(13.) See Steven Santilli et al., Use of a Noncontact Radiant Heat Bandage for the Treatment of Chronic Venous Stasis Ulcers, 12 ADVANCES IN WOUND CARE 89 (1999); Joseph Hamori et al., A Prospective, Randomized Trial of Vacuum-Assisted Closure Versus Standard Therapy of Chronic Nonhealing Wounds, 12 WOUNDS 60 (2000); Vincent Falanga & Michael Sabolinski, A Bilayered Living Skin Construct (Apligraf) Accelerates Complete Closure of Hard-to-Heal Venous Ulcers, 4 WOUND REPAIR AND REGENERATION 201 (1999).

Cheryl G. Rice practices law with Egerton, McAfee, Armistead & Davis in Knoxville, Tennessee.