A Closer Look at the Legal Implications of Pressure Injuries

Malpractice lawsuits are common for patients with pressure injuries, and their consequences can follow clinicians even when the charges are dismissed. This author takes a look at how plaintiffs can prevail in pressure injury lawsuits, and how clinicians can prevent both pressure injuries and lawsuits involving them.

The malpractice system exists to provide patients and their families with a modicum of justice in civil court when patients suffer because medical care is not provided according to accepted standards. Plaintiffs can be awarded money to cover the cost of past and future medical care and lost wages (“compensatory damages”), and courts can award additional money as part of the defendant’s punishment (“punitive damages”) when the practitioner’s behavior is found to be especially harmful.

While we want there to be a system by which practitioners and institutions are held accountable for medical mistakes or poor care, we also want this process to be fair. Meritless malpractice litigation increases the cost of medical care (because physicians feel they must practice defensive medicine) and reduce the availability of medical care because practitioners and institutions eventually close their doors due to the associated costs (e.g., liability insurance premiums).

Texas provides an interesting example of the way that medical liability tort reform can reduce frivolous litigation generally—but perversely, can increase litigation pertaining to wounds, particularly pressure ulcers. Before 2003, huge judgments in excess of physicians’ malpractice insurance limits were bankrupting practitioners of all specialties in Texas. As a result, liability insurance companies were going under, and insurance premiums had become so expensive that many physicians retired or left the state, worsening an existing physician shortage.

In 2003, Texas passed House Bill 4, the Medical Malpractice and Tort Reform Act, and voters also approved Proposition 12, an amendment to the Texas Constitution that authorized the state legislature to cap noneconomic damages in health care liability cases.¹ There is no cap on compensatory damages but there is a $250,000 limit on noneconomic damages against individual physicians, and a total “stacked” noneconomic cap of $750,000 for judgments against health care institutions. The result of tort reform was a dramatic reduction in both malpractice suits and liability insurance premiums, and a significant increase in the number of practicing physicians. Why did these successful reforms increase litigation about pressure injuries?

An internet search reveals the close association of the term “pressure injuries” with “elder abuse” on the websites of attorneys who specialize in plaintiff’s litigation. There is a reason for this. In Texas, the cap on punitive damages does not apply to cases of child or elder abuse. Linking a pressure injury to elder abuse can dramatically increase the potential financial settlement, of which the plaintiff’s attorney receives a percentage. Pressure ulcers can and do occur as a result of neglect and abuse. They also can occur under the best care possible. Litigation around pressure ulcers is nearly always focused on whether the care provided met current standards or represented medical negligence.

Getting Real Money for Pressure Injuries from Doctors and Hospitals

In 2019, Jehle and colleagues published a retrospective analysis of the VerdictSearch legal database on all U.S. cases related to pressure ulcers over a 32-year period from 1987 to 2019.² Of the 141 cases identified, the overwhelming majority were for negligence (75.9%), followed by malpractice (22.7%). Individual providers were sued only 7.1% of the time. Most of the time, a hospital was listed as the defendant (61.7%) followed by nursing homes (31.2%). Only 20% of individual providers lost in court, whereas hospitals lost about 63% of the time and nursing homes lost 75% of the time. Individual providers were responsible for a mean of $400,000 in payouts compared to approximately $1.6 million for hospitals and $4 million for nursing homes.

Keep in mind that the VerdictSearch database only includes cases that go to trial, which is a significant minority of cases. This means there are many more pressure ulcer related lawsuits in the U.S. than these numbers imply, most of which are settled out of court.

For nursing homes, pressure ulcers may be the most common reason for lawsuits. And why not? The plaintiff prevails 75% of the time and the average judgment paid by a nursing home is $4 million dollars. Given the amount of money involved, it is worth exploring the strategies by which plaintiffs’ attorneys win pressure injury lawsuits against both facilities and physicians.

How Plaintiffs’ Lawyers Win Pressure Injury lawsuits

A number of common mistaken beliefs and misguided initiatives favor the plaintiff in pressure ulcer litigation.³

• Pressure ulcers are “never events”
    o Pressure ulcers are not on the list of serious preventable events (“never events”) identified by the Centers for Medicare and Medicaid Services (CMS) under Subpart (F)(c), which are: leaving an object in the patient, performing the wrong surgery (wrong body part, wrong patient, wrong procedure), air embolism following surgery and incompatible blood products. Nevertheless, pressure ulcers are commonly and mistakenly referred to as “never events.”⁴

• All pressure injuries are preventable
    o This false narrative persists despite the fact that a prospective study by Mosqueda and colleagues, funded by the California Department of Justice, showed that full-thickness pressure ulcers occur even under excellent care in long-term care facilities.⁵

• Two-hour turning is required to prevent pressure injuries
    o A prospective, randomized controlled trial funded by the National Institute of Health (NIH) (and to date, the only prospective trial focused on the impact of turning in pressure ulcer prevention) showed that even among high-risk patients, turning patients every four hours did not increase pressure ulcer formation compared with turning every two hours.⁶
    o When plaintiffs are able to convince a jury that two-hour turning is the standard of care and required for prevention, institutions which are not able to produce evidence of around the clock, two-hour turnings are accused of negligence if a pressure injury occurs.

• The use of the term “injury” in relation to pressure ulcers
    o Even though medical personnel understand terms like “ischemia reperfusion injury” refer to injuries at the cellular level, lay people on juries assume the common meaning of the word “injury” to mean harm caused by health care providers.⁷
• Misguided quality initiatives
    o New pressure ulcers on inpatients are reported as “hospital harms” without regard to the circumstances surrounding their development.⁸
    o The National Qualify Forum, the premier safety organization in the U.S., indicates that Stage 4 pressure ulcers are “care management events” and includes them in a list which includes artificial insemination with the wrong donor sperm or wrong egg.⁹

• Pressure ulcer “prevention” protocols
    o The term “prevention” implies that pressure ulcers can (always) be prevented and when they do occur, it is because the prevention protocol and/or care failed to prevent them.

• Marketing campaigns by dressing manufacturers
    o Dressing manufacturers worsen the litigation problem by promoting pressure injury “get to zero” campaigns, which imply that it is actually possible to prevent all pressure injuries if only we worked harder.        

Unlike most other untoward clinical events, pressure ulcerations are visible, and their appearance can be horrific to the patient and the family members. It is not surprising that jurors assume they occur as a result of negligence, particularly when healthcare institutions reinforce mistaken beliefs about them.

However, by far the most powerful weapon in the arsenal of the plaintiff’s attorney is the current pressure ulcer staging system. The numeric nature of the staging system implies progression through the stages, even though the website of the National Pressure Injury Advisory Panel (NPIAP, formerly the NPUAP) states differently.¹⁰ However, the NPIAP website defines the mechanism of pressure injury as “localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device.” This definition implies an “outside to inside” progression.

Juries, comprised largely of non-medical people, are told that a pressure injury “progressed” to, for example, a Stage 4. The use of the term “progression” implies that the ulceration could have been stopped at an earlier stage if only the clinicians had been providing proper care. This misperception continues despite overwhelming evidence that there are at least two different mechanisms of pressure ulcer formation, one of which is an “inside to outside” phenomenon from loss of vascular supply to an area.^11,12 The risk factors for severe pressure injuries are different than for more superficial pressure injuries and are largely hemodynamic.

A commonly successful approach to winning pressure ulcer lawsuits is to imply that the Stage 4 ulcer was the “progression” of a Stage 2 injury/ulcer that occurred months earlier (usually at a different institution or under a different caregiver). If hospitals and practitioners fail to document the resolution of a Stage 2 ulcer by the time of discharge, they can expect to be held liable for new and more severe pressure injuries which occur after discharge, even though they may be separate events.

Plaintiffs often allege that pressure injuries contributed to the wrongful death of a patient. Although this can happen, in the absence of deep tissue infection, patients are more likely to become septic from urinary tract infections and pneumonia than from a cutaneous wound. Be precise about terms like “infection” vs. “colonization.” Do not be shy about obtaining a small sample of tissue for quantitative culture of the wound.

Another often unrecognized fact about the staging system is that in 2016, the definitions of the various ulcer stages were changed by the NPUAP.¹³ Since then, a Stage 2 ulceration is defined as “exposed dermis” or an intact serum-filled blister. If granulation tissue or slough are present, the ulcer is considered a Stage 3. Figure 1 is a superficial, granulated ulceration on the knee of a child with spina bifida who sometimes crawls without her knee pads. Since 2016, this ulceration would be considered a Stage 3, but prior to that, it would have been classified as a Stage 2. The result of this change is to portray pressure ulcers as more severe than they may, in fact, actually be, and it means ulcerations that are due to moisture and friction are conflated with those caused by pressure-related vascular infarctions.

How Practitioners Can Reduce the Risk of Pressure injury litigation

We want to reduce the risk of pressure injuries to patients and not just the risk of litigation associated with them. All wounds are a symptom of disease and pressure injuries are symptomatic of many diseases (e.g. poor nutrition, poor hydration, fragile skin, immobility, muscle weakness, etc.). It is important to remember that the majority of pressure injuries occur at home. Wound care practitioners should counsel all patients on the importance of nutrition, maintaining healthy skin, using pressure offloading surfaces, proper transfer techniques to minimize skin damage and adequate hydration. These interventions are the first defense against the development pressure injuries.

While not exhaustive, the following are ways that clinicians can reduce the risk of litigation around pressure ulcers:

• Document patient and family education around pressure injury prevention (e.g., the importance of nutrition, hydration, skin care, etc.).

• When pressure injuries occur, record all of the associated patient risk factors and address mitigation strategies for the modifiable ones.

• Identify the non-modifiable factors (e.g., hypotension) that may have contributed to a medically unpreventable pressure injury. Keep in mind that “unavoidability” is a concept associated with Centers for Medicare and Medicaid Services (CMS) payment policy and should not be conflated with medical unpreventability.  

• Describe the precise location of the injury. Terms like “buttock” are imprecise and could represent any area from the sacrum to the ischial spines. Lawsuits have been lost when a severe pressure ulcer on the sacrum was linked to incontinence-associated dermatitis that occurred months before in the gluteal cleft, because both locations were simply described as the “buttocks.”

• Document when ulcerations heal or close.

• Recommend nutritional supplements and check labs as appropriate.

• Clinicians should be clear when the patient has been discharged from their service and they are no longer responsible for patient care.

• Be wary of signing skilled home nursing orders that include orders for all the patient’s medications (e.g., diabetes and hypertension) if you are not responsible for prescribing and monitoring those medications.

• Describe the lesion you see. The staging system is confusing and areas that represent different stages can coexist. It is better to describe granulation tissue, slough, etc.

• Be honest and communicate well with patients and family members. Set expectations and answer questions in non-technical terms.

• Involve hospital “risk management” departments early.

In Conclusion

Patients and their family members have varying motivations for filing a suit related to pressure injury formation. Family members may feel guilty that they placed the patient in a facility or that the injury occurred at home, or they are angry at the loss of a loved one and need to identify a responsible person or reason, or they were unhappy with various aspects of the care provided, or the pressure ulcer itself is frightening to see and they have been told that pressure ulcers are all preventable. A recurring theme among family members who file malpractice suits is that they, “simply could not get their questions answered.”¹⁴ A family conference takes much less of the clinician’s time than dealing with a malpractice suit.

Patients may also believe they are owed a monetary settlement for their suffering and that since it will be paid by an insurance company, filing a lawsuit is simply the means to receiving an insurance payment. They may be unaware that clinicians will be formally accused of either negligence or malpractice and even if the case is “non-suited” (dismissed), the mere fact the suit was filed will follow a practitioner for the rest of their lives when they obtain or renew hospital privileges or when they join care organizations.

For the clinician, a malpractice lawsuit is never “over,” and prevailing in court, even when care has been exemplary, is an uphill battle.

Caroline E. Fife is Chief Medical Officer at Intellicure Inc., The Woodlands, TX; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands; and co-chair of the Alliance of Wound Care Stakeholders.

 

1. Berlin J. Coming of age: celebrating 15 years of Texas tort reform. Tex Med. 2018;114(9):14-21. Available at https://www.texmed.org/Template.aspx?id=48427
2. Jehle CC, Hartnett D, Snapp WK, et al. Assessment of malpractice claims associated with pressure ulcers. Plast Reconstr Surg Global Open. 2019l 7(8S):90.  
3. Fife C. Strategies for winning pressure ulcer lawsuits. Available at https://carolinefifemd.com/2019/02/28/strategies-for-winning-pressure-ulcer-lawsuits/ . Feb. 28, 2019.
4. Federal Register. Available at https://www.govinfo.gov/content/pkg/FR-2007-05-03/pdf/07-1920.pdf , May 3, 2007. Accessed Oct. 1, 2020.
5. Liao S, Baker M, Lowe J, et al. A multi-site study to characterize pressure ulcers in long-term care under best practices. Available at https://www.ncjrs.gov/pdffiles1/nij/grants/231614.pdf. August 2010.
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9. “Hospital Harm”—Pressure Injury: the electronic clinical quality measure. Available at https://ecqi.healthit.gov/sites/default/files/ecqm/measures/CMS826v0.html#:~:text=Pressure%20injury%20is%20a%20serious,et%20al.%2C%202011) . Accessed Oct. 1, 2020.
10. National Pressure Ulcer Injury Advisory Panel. Pressure Injury Stages. Available at https://npiap.com/page/PressureInjuryStages
11. Fife C, Gkotsoulias E. On the origin of intraoperative pressure injury: an angiosomal theory of pressure injury formation. Adv Wound Care. 2018; 8(11). Available at https://www.liebertpub.com/doi/10.1089/wound.2018.0905
12. Pressure Ulcer evolution: An inside out job. https://www.youtube.com/watch?v=vsiuD7kbvnY&list=PLmCqFGPJNQn3okP_OziKazbt0oHDPWhnW
13. Fife C. Potholes vs. sinkholes, pressure injuries, DTIs and BFOs. Available at https://carolinefifemd.com/2019/02/08/potholes-vs-sinkholes-pressure-injuries-dtis-and-bfos/ . Feb. 8, 2019.
14. Fife C, Yankowsky K. Lawsuits, technology and wound care. Available at https://www.youtube.com/watch?v=b753P6NpvTY&list=PLmCqFGPJNQn02anQz5KvhAJDaxaQfGtR9