Legal Review & Commentary

Suit alleges reaction to medication led to Stevens Johnson syndrome, death in elderly patient

By Jon T. Gatto, Esq. Lynn Rosenblatt, CRRN, LHRM

Buchanan, Ingersoll & Rooney, PC Risk Manager

Tampa, FL HealthSouth Sea Pines Rehabilitation Hospital

Melbourne, FL

News: During a three- to four-month period, an 86-year-old man with a history of severe and varied health problems was transferred back and forth between a local hospital and nursing home for recurring urinary tract infections (UTIs). A few months later, the man was admitted to the hospital for recurrent urosepsis and scrotal cellulitis. A nurse noted the existence of a rash on that man's back and legs. The internal medicine physician ordered an infectious disease consultation for management of the UTI. The infectious disease physician ordered administration of imipenem and cilastatin, an antibiotic. A new rash appeared in response to the imipenem and cilastatin, and the physician ordered that the man take diphenhydramine. Seventeen days later, the man was taken to surgery, and vancomycin was added to the regimen in response to right scrotal drainage consistent with an abscess. A urology consult resulted in a recommendation to continue the IV antibiotic therapy and proceed with surgery of the left testicle. The imipenem and cilastatin and vancomycin continued after the surgery. After transfer back to the nursing home, the rashes on the man's body became worse. After seven days in the nursing home, the man was transferred back to the hospital, where he died. The man's estate settled with the hospital and nursing home for confidential amounts. The suit against two physicians resulted in a defense verdict.

Background: An 86-year-old nursing home resident had a medical history that included cerebral vascular accident, diabetes, arteriosclerotic heart disease, hydronephrosis, hypertension, and inability to swallow requiring placement of a gastronomy tube. The man was transferred between the hospital and nursing home during a three- to four-month span for recurrent UTIs. Soon thereafter, the man was readmitted to the hospital for recurrent urosepsis and scrotal cellulitis. A nurse assessed the man and noted the presence of a rash on his back and the backs of the man's legs. An internal medicine physician was the man's attending physician for six days and requested and obtained an infectious disease consultation for management and treatment of the UTI from an internal medicine and infectious disease physician. That infectious disease physician, after reviewing laboratory studies, ordered administration of imipenem and cilastatin in light of the fact that the infection may have involved E. coli and other dangerous organisms. The next day, the infectious disease physician was notified that a new rash had developed on the man's arms and upper chest. Acknowledging that the rash could have been caused by the imipenem and cilastatin, the physician treated the rash with diphenhydramine and did not discontinue use of imipenem and cilastatin. Seventeen days after hospitalization, the man was taken to surgery for treatment of the scrotal cellulitis on the left testicle. However, a week prior to the surgery, vancomycin was added to the man's medication regimen to treat right scrotal drainage consistent with an abscess. The man's right testicle was removed during the surgery based on the existence of gangrenous scrotal tissue, despite the fact that the pathology report did not confirm existence of gangrenous tissue. The imipenem and cilastatin and vancomycin were continued after surgery.

A week after surgery, the vancomycin was discontinued, and steroids were administered. The physicians and nurses noticed an improvement in the rash, which had spread all over the man's body. The man was then transferred back to the nursing facility, where a skin assessment revealed dry, red rashes on his chest, back, and legs. Over the course of the next few days, additional blisters and rashes formed and were noticed by nursing home staff. After a week in the nursing home, the man was transferred back to the hospital and died 10 days later.

The man's estate settled with the hospital and nursing home prior to trial but brought suit against the attending physician and infectious disease physician, claiming that they had failed to adequately monitor and treat the man's scrotal cellulitis, which resulted in an abscess and the need for surgery. The claim also alleged that the physician failed to adequately monitor the complications associated with imipenem and cilastatin, which ultimately caused Stevens Johnson syndrome, a rare, serious disorder in which your skin and mucous membranes react severely to a medication or infection. All of these factors combined, alleged the plaintiff, contributed substantially to the man's death. A defense verdict was returned in the case against the physicians.

What this means to you: This patient is the classic nursing home resident with an extensive medical history and chronic ailments that are directly attributable to a long-term disease state and the physical deterioration that commonly accompanies advancing age. Significant in this cascade of deterioration is his pre-existing diagnosis of stroke, which most likely is directly accountable for his recurring UTIs. Stroke patients frequently experience neurogenic bladders that result in urinary retention. A man of this age also is likely to have benign prostatic hyperplasia or BPH, which also is a common cause of urinary retention. His hydronephrosis was directly attributable to urinary retention and a backup of urine into the ureters and kidney, all of which will cause UTIs.

Additionally, UTIs are treated with a multitude of different classes of antibiotics, dependent on the culture and sensitivity of the organism. Most urinary infections are bacterial in nature, and depending on the organism, will usually, at least initially, respond to common drug classes, of which penicillin and sulfonamides are most common. In cases where the patient has recurrent infections, treatment with more common antibiotics becomes less effective as the causative organism(s) become more resistant.

In this case, it is likely that the patient was actually colonized with multiple organisms. Colonization is a term used to describe the condition where the patient harbors the organism but does not actually demonstrate symptoms. In the case of urinary tract colonization, the organism can actually infect and reside in the bladder wall and, when the individual's immune system becomes threatened, the organism multiplies and the patient becomes symptomatic.

If the rash was of new onset, it could have been directly related to an offending organism or perhaps attributable to the antibiotics that had been used to treat the chronic urinary infections at the nursing home. Without knowing the medications he was on, it is impossible to attribute it to an interaction or acquired reaction.

What we do know is that the organism was most likely resistant, as imipenem and cilastatin are commonly used with multiantibiotic-resistant organisms. Since this was an institutionalized patient, it is not inconceivable that the physician was dealing with a super bug that is common with a chronically ill patient who had had multiple hospital admissions. We also knew that the patient did experience an outbreak of a new rash after starting the imipenem and cilastatin, and the physician did suspect that it may have been a reaction to the antibiotic. The physician treated it with diphenhydramine, but we are not told if it was effective.

Meanwhile, the patient experienced drainage from the right testicle and was started on vancomycin to treat right scrotal drainage consistent with an abscess. But a week later, he was taken to surgery for treatment of the scrotal cellulitis on the left testicle. The man's right testicle was removed during the surgery based on the existence of gangrenous scrotal tissue, despite the fact that the pathology report did not confirm existence of gangrenous tissue.

The antibiotics were continued after surgery, and the vancomycin was discontinued a week later. There is no mention that the patient had regular lab draws to determine the level of the antibiotic circulating in the bloodstream following administration. Very high levels are an indication of impending toxicity with the potential for organ failure, particularly the kidneys.

Many of the patient's symptoms are classic to the patient's overall debilitated conditions from his dysphagia, for which he had a PEG, to his chronic kidney problems. The very fact that he had been on vancomycin could have predisposed him to liver inflammation. It can also be caused by herpes simplex or herpes zoster, which is the same virus associated with shingles, a common malady in the elderly, particularly when the autoimmune system is under stress. So, it is entirely possible that the nursing home and hospital staff attributed his overall decline to chronic disease and end-of-life decline. Besides, Stevens-Johnson is a rare phenomenon and generally treatable if the cause is determined and remedied before it becomes a systematic problem.

In this case, the physicians successfully defended their care to a jury. The hospital and nursing home settled most likely to avoid the cost of a jury trial. Had they not settled, it is entirely possible that they could have been exonerated, as well. Based on expert testimony, the jury most likely was unable to determine that treatment he received and the probable diagnosis of an allergic response to the antibiotics held greater weight than the man's overall chronic debilitation.

Given the outcome at trial, it may have been prudent for both the hospital and the nursing home to have collaborated with the attorneys representing the physicians in a unified defense, something that rarely happens. Generally, lawsuits involving both physicians and providers are seen as the enemy camps and this, as this case proves, can be counterproductive.

Reference

• Los Angeles County Superior Court, Case No. BC359018.