action
or inaction on the part of physicians led to allegations of
professional liability, and how risk management techniques
may have either prevented the outcome or increased the
physicians’ defensibility. The ultimate goal in presenting
these cases is to help physicians practice safe medicine. An
attempt has been made to make the material more difficult to
identify. If you recognize your own claim, please be assured
it is presented solely to emphasize the issues of the case.
Presentation
A
37-year-old woman came to her family physician and reported
stepping on a nail two days earlier. The patient had severe
swelling and pain in the right foot distally near the great
toe. She also complained of an earache.
Physician
action
The
family physician diagnosed cellulitis secondary to the
puncture wound and ordered a bone scan. He also prescribed
the antibiotic Levaquin. The radiologist interpreted the
bone scan as suggestive of bony involvement and possible
infection in the proximal and distal phalanx of the great
toe of the right foot.
Upon
review of the bone scan report, the family physician
instructed the patient to continue the Levaquin and have a
repeat bone scan in four days. The repeat bone scan was
interpreted as highly suggestive for osteomyelitis and
perhaps associated soft tissue infection. The patient was
referred to an orthopedic surgeon.
The
orthopedist recorded the patient’s history of stepping on a
nail in her backyard with her left foot three weeks ago. The
patient reported that she tried to push off with the right
foot and stepped on a nail with that foot as well. Her left
foot was symptom free but her right great toe continued to
hurt. The orthopedist’s impression was acute osteomyelitis
of the right great toe secondary to foreign body puncture
wound. He recommended surgery with incision and drainage to
open the cortex of both bones. He planned to place a central
line and send her home on IV antibiotics. His report states,
“I explained all of this to her today in addition to the
problems associated with trying to cure osteomyelitis. It is
difficult to maintain a high level of antibiotics in the
bone to cure the disease.”
The
incision and drainage were performed on July 16. A
subclavian catheter was placed on the left for IV antibiotic
administration. Tissue cultures, but no bone fragments, were
sent to pathology for culture and sensitivity. The physician
ordered Gentamycin to be administered to the patient via a
home health care agency. The initial order for Gentamycin
administration was 80 mg every 8 hours.
Lab
results on July 17 indicated that the patient was below
therapeutic peak and trough levels. On March 19, the
physician increased the Gentamycin dosage to 100 mg every 8
hours.
The
patient returned to the office on July 20 complaining of
some heaviness in her chest. A chest x-ray revealed no
evidence of pneumothorax. Her subclavian catheter was in
good position. Her tissue culture revealed Staphlococcus
non-aureus species and a Bacillus. A lab report on this date
revealed that the patient had still failed to achieve
therapeutic peak and trough levels of Gentamycin.
On July
21, the orthopedist increased the Gentamycin dosage to 180
mg every 8 hours. A home health care agency was monitoring
the patient and obtaining blood samples to check her
therapeutic peaks and troughs. According to the infusion
therapy worksheet, the peaks and troughs were checked on
July 19 (dosage increased to 100 mg), July 21 (dosage
increased to 130 mg), July 24 (dosage increased to 150 mg),
July 27 (dosage increased to 180 mg), July 30 the patient
was not available, and August 2 (same dosage). The
collection date was usually the day before the report dates
above. The IV therapy was discontinued on August 11. Her toe
looked excellent and the osteomyelitis had resolved.
The
patient returned to the orthopedist on August 30. She
reported developing profound dizziness two days after
discontinuing her central line and IV Gentamycin. She had
seen an otolaryngologist for the dizziness. An MRI of the
brain was interpreted as normal and her auditory canals
appeared to be normal. The orthopedist reviewed her peaks
and troughs and noted that they had always been well within
normal limits. The patient reported to him that she has had
a profound deafness in her right ear dating back to when she
was a teenager. The physician’s impression was labyrinthitis,
possibly secondary to Gentamycin.
Approximately one month later, the patient called the
orthopedist’s office almost hysterical. Vestibular testing
conducted by the ENT indicated she had lost her vestibular
function. She reported that she was unable to drive or do
anything due to imbalance. She also complained of nausea.
The ENT had given her Antivert for dizziness but she was
afraid to take anything due to the problems with the
Gentamycin. The orthopedist recommended Vistaril for the
nausea and anxiety.
The
orthopedic chart contained a consult letter from a second
ENT. Her evaluation included audiometric findings of a
significant hearing loss in the patient’s left ear
(previously reported as right ear), which developed about 20
years ago of sudden onset. The examination showed normal
external auditory canals and normal tympanic membranes. The
patient was able to ambulate without assistance but was very
cautious and unsteady. Testing suggested bilateral
vestibular hypofunction. They were hopeful for a good
recovery but thought it may take as long as a year.
The ENT
recommended aggressive vestibular rehabilitation therapy.
The patient and her husband were concerned that a
significant mistake was made in her medical management. The
ENT advised them that the fact that she had developed
bilateral vestibular hypofunction from Gentamycin therapy
does not in and of itself mean that appropriate precautions
were not taken. Vestibular ototoxicity may, in some cases,
be essentially an idiosyncratic reaction.
The
patient returned to the orthopedist to inquire if the bone
scan could be repeated. The physician advised he would like
to wait six months, but he suspected her osteomyelitis was
cured. She was to return in six weeks but did not keep the
appointment.
Allegations
A lawsuit
was filed against the orthopaedic surgeon and the home
health care agency. No serious allegations were brought
against the agency because it was felt that they were
following the orders of the orthopaedist. Allegations
against the physician included:
• failure
to prescribe an adequate course of treatment;
•
prescribing Gentamycin when it was not indicated;
•
prescribing excessive amounts of Gentamycin;
•
prescribing toxic levels of medication;
• failure
to reasonably inform plaintiff of possible consequences of
treatment;
• failure
to refer plaintiff to a specialist;
• failure
to monitor plaintiff’s medication levels;
• failure
to reasonably supervise employees and agents;
•
prescribing Gentamycin for a longer period of time than was
reasonable;
• failure
to act within the reasonable standard of medical care;
• failure
to order diagnostic tests; and
• failure
to properly interpret diagnostic tests.
Legal
implications
During
the I&D performed on the patient, there were no bone samples
submitted to pathology to seek a definitive diagnosis of
osteomyelitis and obtain culture and sensitivity data. The
lack of this information left the indications for the use of
a potentially toxic antibiotic in question. The patient was
tested on multiple occasions after the date of loss with a
demonstrated level of zero vestibular function, showing a
permanent injury in this relatively young plaintiff.
The
amounts of Gentamycin prescribed by the physician exceeded
the Physicians Desk Reference black box warnings that
carried a recommended dosing schedule not to exceed 7 mg/kg,
in patients with what is to be considered a life-threatening
condition. The dosage recommended for lesser conditions was
recommended not to exceed 5 mg/kg. This patient’s dosing
schedule included amounts that were as high as 8 mg/kg. The
plaintiff contended that the highest indicated dosage was 5
mg/kg. It was noted by the defendant’s expert that the
physician’s final order to increase the Gentamycin level was
entered after the patient’s lab reports indicated that she
had achieved a therapeutic level of the drug.
Helpful
to the defense were the results of the patient’s peak and
trough measurements. These never reached toxic levels and
only reached therapeutic levels after the administration of
progressively increased doses of Gentamycin. The plaintiff
contended that the pattern of the patient’s response to
therapy should have raised the physician’s index of
suspicion for lab error, given the sub-therapeutic results
in the face of increasing dosages.
Disposition
The lack
of a pathologic diagnosis of osteomyelitis combined with
Gentamycin administration at dosages in excess of those
recommended for life-threatening conditions were weaknesses
in this case. This, combined with the permanent nature of
the patient’s injuries, led to the decision to settle this
case.
Risk
management considerations
Medication errors continue to be a prevalent allegation in
lawsuits against physicians. The orthopedic surgeons who
reviewed this case felt that more in-depth testing was
needed to make a definitive diagnosis of osteomyelitis. The
lack of information left the physician’s indications for the
use of a potentially toxic antibiotic in question. In
addition, the amounts of Gentamycin prescribed exceeded the
PDR black box warnings. The defendant’s final order
to increase the Gentamycin level was entered after the
patient’s lab reports indicated she had achieved a
therapeutic level of the drug.
Obtaining
a comprehensive medical history on new patients is essential
to planning appropriate care and managing risk. A complete
medical history on this patient would have made the
physician aware of her hearing problems and perhaps altered
the choice of antibiotic.
The
information and opinions in this article should not be used
or referred to as primary legal sources nor construed as
establishing medical standards of care for the purposes of
litigation, including expert testimony. The standard of care
is dependent upon the particular facts and circumstances of
each individual case and no generalization can be made that
would apply to all cases. The information presented should
be used as a resource, selected and adapted with the advice
of your attorney. It is distributed with the understanding
that neither Texas Medical Liability Trust nor Texas Medical
Insurance Company is engaged in rendering legal services. ©
2007 TMLT
