Reporter the IMPROPER PERFORMANCE: OB/GYN CLOSED CLAIM STUDY

the
TEXAS MEDICAL LIABILITY TRUST
Special issue: Obstetrics/gynecology 2003
Reporter
IMPROPER PERFORMANCE:
OB/GYN CLOSED CLAIM STUDY
by Michele Luckie, Risk Management Representative
The following closed claim study is based on an actual malpractice claim from Texas Medical Liability Trust. This case
illustrates how 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 physician's defensibility. An attempt has been
made to make the material less easy to identify. If you recognize
your own case, please be assured it is presented solely for the
purpose of emphasizing the issues of the case.
Presentation
The patient is a 26-year-old gravida 2 para 1 whose
previous pregnancies resulted in the cesarean section
delivery of twins 6 years earlier and an elective abortion
the following year. She called her obstetrician to inform
him of a positive home pregnancy test and schedule her
initial prenatal exam. The patient presented for her first
prenatal visit approximately one month later complaining of nausea and episodes of spotting and bleeding. A
sonogram was performed which showed a healthy 14week fetus. There was no explanation for the spotting.
She was started on prenatal vitamins and advised to
decrease her activity until the bleeding stopped.
When the patient was next seen, she was 18 weeks
pregnant. She informed her physician that she felt she
had been leaking fluid for approximately three weeks.
The obstetrician obtained cultures for chlamydia, group
B strep, and gonorrhea and all were negative. The patient
did have a severe yeast infection and Diflucan was prescribed. A sonogram was performed that showed a lack
of amniotic fluid around the fetus and a heart beat of 138.
The patient was informed that because of the large
amount of fluid lost, it was unlikely that the rupture
would seal over and fluid reaccumulate. Termination of
the pregnancy was discussed and the patent was advised
to admit herself to the hospital for bed rest and monitoring of the infection. The patient refused and went home
with instructions for strict bed rest and to take her temperature every 4 hours and notify the physician if it was
over 100 degrees. She was to return in 3 days, NPO after
midnight before her return, in order to proceed with the
termination. When she returned to the office, she was
still leaking fluid. A sonogram revealed severe oligohydramnios.
Physician action
The physician explained to the patient and her husband that there had been no reaccumulation of fluid and
the pregnancy was not salvageable. He then discussed
the termination options available. She could be induced,
go into labor and deliver the fetus or undergo a D & E
(dilation and evacuation). The risks and benefits of both
methods were discussed and the patient decided to have
the D & E.
The patient was scheduled for surgery on the same
day. The cervix was dilated and the endometrial cavity
was suction curetted. Ringed forceps were then used to
remove placental and fetal parts. During this process, a
loop of intestine was pulled into the vaginal cavity with
the suction curette. The physician realized that there had
been a uterine perforation. Instrumentation was
removed and a Pfannenstiel-type incision was made on
the abdomen to repair the uterus. Once the uterus was
identified, a posterior laceration that extended from
nearly the fundus to the cervix was repaired. He next
inspected the bowel and found a tear. Upon this finding,
he called in a general surgeon to assist. The surgeon proceeded with an exploratory laparotomy and repaired a
10 cm laceration in the mesentery of the rectosigmoid
colon. There was no perforation into the lumen of the rectosigmoid colon. The remainder of the procedure was
without untoward event.
The patient was discharged three days later with standard post-operative treatment instructions. She was to
follow-up with the Ob/Gyn in 4 days. At 6:00 pm the
following day, the patient presented to the ER and was
seen by the defendant’s partner, who was on call. She was
admitted for post-operative ileus. A naso-gastric tube
was placed in the patient’s stomach for suctioning.
Following a gastrografin enema, she experienced relief of
her symptoms and the return of bowel function. She was
discharged after six days.
The physician next heard from the patient via telephone a month later complaining of bleeding and cramping. A partner saw her in the office three days later. His
impression was mild metritis for which he prescribed
Doxycycline and asked her to return in 7-10 days. The
patient never filled the prescription and did not return to
the office. No further follow-up was documented.
After the plaintiff filed this claim, she sought care from
another gynecologist after months of chronic pelvic pain.
She subsequently underwent a laparotomy, lysis of adhesions, total abdominal hysterectomy and bilateral salpingo-oophorectomy.
Allegations
• Failure to employ a safer, more appropriate alternative to D&E
• Failure to determine if the uterus was retroverted or
antiverted prior to beginning the procedure
• Failure to hospitalize the patient after the initial
sonogram revealed significant loss of amniotic fluid
• Failure to perform a Nitrazine test
Legal principle
Negligence is defined as the lack of ordinary care, i.e.
the degree of care that a reasonably prudent physician
would have exercised under the same or similar circumstances. When an allegation of negligence has been made,
one of the four elements that must be proven is that the
physician deviated from the accepted standard of care.
The TMLT consultants were generally supportive of the
care this patient received. However, they also expressed
some concern about the physician’s experience in performing D & E procedures. While they agreed that dilation and evacuation is an accepted method of termination
at 18 weeks, they also indicated that physicians who are
very well trained and experienced in this type of procedure may be most appropriate to perform it. The defendant physician stated in his deposition that he performed
one or two of these procedures a year.
In addition, the consultants were critical of the lack of
documentation about the discussion with the patient
regarding the various approaches that could be taken to
evacuate the uterus under the circumstances. They felt it
could certainly be argued that, if she had understood
2 Obstetrics/gynecology
there was a less traumatic or safer way to terminate the
pregnancy, she would have chosen that over the D & E.
The physician stated in his deposition that it is his practice to thoroughly discuss available treatment options
with patients, but generally he does not document the
discusssion in the patient record.
Disposition
This claim was settled on behalf of the physician for
$150,000.
Risk management considerations
In this case, the doctor felt he was qualified to perform
a D & E and proceeded in his care of the patient. However,
consultants were concerned about the physician’s experience with this procedure. Unfortunately, a known surgical
complication occurred. When a case like this results in a
lawsuit, the informed consent process is often an issue. Poor
documentation of this discussion with the patient can compromise the defense of a malpractice claim. Texas law places
the responsibility for the informed consent process with the
physician.
The informed consent discussion should take place in
the physician’s office whenever possible. This provides a
more familiar atmosphere for the patient and takes away
some of the anxiety of being in a hospital or outpatient surgery center when having this discussion. The associated
risks, benefits, and alternatives to the treatment plan/procedure along with a reference to the conversation should be
documented in the medical record and include the patient’s
understanding and desire to proceed.
Patients who don’t keep scheduled office appointments
are a challenge for all medical practices. In this case, the
physician stated that, when the patient did not return to the
office as directed, he felt that she must have improved after
taking the prescribed antibiotic. This, of course, was not the
case. Patients don’t keep follow-up appointments for many
reasons and sometimes it’s because they are unhappy with
the care they have received. If no attempt is made to contact these patients and an adverse outcome occurs, the
physician may be perceived as not caring. Does this mean
that you need to call every patient who doesn’t keep an
appointment? No, but it’s a good idea to have a process in
place that ensures the charts of patients who did not keep
scheduled appointments are reviewed for medical necessity and continuity of care. Document in the record that the
patient was a “no show.” Patients with chronic conditions,
post operative patients, and those whose condition require
a revisit should be contacted either by phone or letter and
reminded that it is important to their health to follow
through with scheduled appointments. Documenting these
calls or letters demonstrates your efforts to contact these
patients should a problem arise.
risk
management 101
FDA: Hormones get box warning and label changes
February 2003
The labeling of all estrogen and estrogen
with progestin products for use by postmenopausal women will undergo important safety changes. Those changes reflect
the FDA’s analysis of data from an arm of
the Women’s Health Initiative that raised
concerns last summer and are part of a
series of actions to provide advice to physicians who prescribe these products and
risk management information to women.
“FDA’s actions will help inform health
care providers and their patients so that
they can appropriately balance the benefits
and risks to make the best possible decisions about use of these drugs,” said FDA
Commissioner Mark McClellan, MD, PhD.
In addition, the agency issued a new boxed
warning that reflects the new risk information. It also outlines specific changes to
indications for which these products are
approved.
Overall, these warning and label
changes are designed to emphasize the
importance of individualized decisions
that appropriately balance the benefits and
the potential risks involved. The boxed
warning, the highest level of warning
information in labeling, also highlights the
increased risks for heart disease, heart
attacks, strokes, and breast cancer associated with these hormones. It notes that these
products are not approved for heart disease prevention.
Approved indications also have been
modified to clarify that the drugs should be
used only when the benefits clearly outweigh the risks. For instance, when prescribed solely for the prevention of
postmenopausal osteoporosis, approved
nonestrogen treatments should be carefully
considered first. While the FDA did not
make any modification for the treatment of
moderate to severe vasomotor symptoms,
it did advise prescribing these therapies at
the lowest dose for the shortest duration of
time.
The FDA is asking all manufacturers of
estrogen and estrogen-progestin products
to add similar warnings and change the
enclosed patient information leaflet
because all hormone products are believed
to carry similar health risks.
With quality patient care and prudent
risk management in mind, the basic tenets
of sound medical decision making should
be followed in evaluating patients regarding their options for HRT. In assessing
whether patients should begin or continue
a regimen of HRT, a thorough history and
physical including family and social history as well as any risk factors, should be
completed and documented. A comprehensive discussion regarding not only the outcome of the WHI study but also any other
pertinent available information should be
discussed. The risks, benefits and alternative therapies should be discussed.
Everything should be comprehensively
documented in the patient record including the patient’s understanding of the
information presented, along with a note
indicating the patient’s informed consent
and decision regarding treatment.
Sources
1. www.fda.gov
2. Rossouw, J., MBChB, MD, et al., Risks
and Benefits of Estrogen Plus Progestin in
Healthy Postmenopausal Women, JAMA,
July 17, 2002, 321-333.
ACOG opinion regarding GBS screening
The Centers for Disease Control and
Prevention (CDC) released revised guidelines in 2002 for GBS perinatal disease.
These new guidelines replace those issued
in 1996 and have a significant impact on all
obstetricians and pediatricians. The change
in clinical practice follows new data and
recommendations from the CDC which
show routine prenatal screening is more
effective than the risk-based approach.
Results have shown far fewer cases of
early-onset group B strep disease in newborns (occurring during the first week of
life).
Vaginal and rectal GBS screening cultures should be performed at 35 to 37
weeks gestation on all pregnant women
except for those who had GBS bacteriuria
during the current pregnancy or gave birth
to a previous infant with invasive GBS dis-
ease. These patients should receive prophylaxis regardless of the result of any
vaginal culture. The risk factor approach is
no longer recommended unless a vaginal/rectal culture has not been performed.
Patients with an unknown GBS status (culture not done or not ready) should receive
intrapartum prophylaxis if delivery is
before 37 weeks gestation, if rupture of
membranes is 18 hours or longer, or if the
intrapartum temperature is 100.4 degrees
or above.
“We now have strong evidence to make
the case that routine screening for GBS is
the superior method in preventing transmission of the bacteria from mother to
child during delivery,” notes Laura E.
Riley, MD, an infectious disease specialist
and chair of ACOG’s Committee on
Obstetric Practice. The committee’s opin-
ion supports the CDC’s revised guidelines
that a screening based approach for the
prevention of early onset GBS disease in
the newborn be adopted.
“We have achieved great success in
reducing the transmission of infectious diseases from mothers to newborns in recent
years. By recommending universal GBS
screening of all pregnant women, we look
to further decrease perinatal morbidity and
mortality rates in this country,” notes Riley.
Sources
1. Cole, David, Bernstein, Peter S.,
Medscape Ob/Gyn & Women’s Health, An
update on perinatal Group B streptococcal
Disease, posted 11/14/02.
2. www.acog.org, ACOG News Release,
November 29, 2002.
Obstetrics/gynecology
3
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Austin, Texas
the
Reporter
TEXAS MEDICAL LIABILITY TRUST
P.O. Box 160140
Austin, TX 78716-0140
800-580-8658 or 512-425-5800
Fax: 512-425-5998
E-mail: [email protected]
Web address: www.tmlt.org
Editor
Jane Mueller
Managing Editor
Barbara Rose
Contributing Editor
Michele Luckie
The Reporter is published by Texas Medical Liability
Trust as an information and educational service to
TMLT policyholders. All articles and any forms, checklists, guidelines and materials are for general information only, and should not be used or referred to as
primary legal sources nor construed as establishing
medical standards of care. They are intended as
resources to be selectively used and always adapted
— with the advice of the organization’s attorney —
to meet state, local, individual organizations and
department needs or requirements. The Reporter is
distributed with the understanding that Texas Medical
Liability Trust is not engaged in rendering legal services. © 2003 TMLT
PIAA Release
Senate Holds Hearing, Insurance Industry Experts Dispel Medical
Malpractice Myths in D. C. Press Conference
Rockville, MD
February 12, 2003
Three insurance industry trade groups
came together 2/11/2003 to set the record
straight on the causes of the current medical malpractice crisis. The Physician
Insurers Association of America (PIAA),
the Insurance Information Institute (III),
and the Alliance of American Insurers
(AAI) presented statistical evidence that
clearly places responsibility for the current
medical liability and health care accessibility crisis on the shoulders of a dysfunctional tort system and its out-of-control costs. A
series of exhibits showed the escalation of
jury awards and settlements, the strength
of medical malpractice insurers’ investment portfolios, and the rising costs to the
health care system of the vast numbers of
meritless malpractice cases that are filed
every year. Stated Larry Smarr, PIAA
President, “We realize that this is an emotional issue for many, including those for
whom the services of doctors are increasingly unavailable. If the facts can get as
4 Obstetrics/gynecology
much air time as the myths and soundbytes, I am confident we will find an effective solution to this national problem.”
In addition, the group presented strong
statistical support for caps on non-economic damages, showing the lower premiums
paid by doctors in states with strong tort
reforms already in place. For example, in
California, Kansas, and Colorado, caps on
non-economic damages and other tort
reform measures have resulted in a more
stable and predictable insurance market,
which has translated to lower premiums
for physicians in those states.
Mr. Smarr also presented similar evidence at a Senate hearing on the medical
liability crisis later in the afternoon. There
he testified that from 1992 to 2001, the average claim payment amount has risen at a
compound annual growth rate of 6.9 percent as compared to 2.6 percent for the
CPIU.
A complete transcript of this press conference is available at www.thepiaa.org.
Got R is k?
Identifying the common risk
exposures in your medical practice
Who should attend?
This seminar is intended for medical office staff
including nursing staff, office managers, front
office staff, and medical records personnel.
Registration
To register or for more information, contact
Natalie Gilmore at 800-580-8658 ext. 5911 or
e-mail [email protected].
Thursday, April 3
Bexar CMS
San Antonio, TX
Thursday, April 10
Rancho Viejo
Country Club
Harlingen, TX
Thursday, April 17
Tyler Sheraton
Tyler, TX
Thursday, April 24
Norris Conference Center
Austin, TX
Tuesday, April 29
Harris CMS, Museum
of Health & Medical
Science
Houston, TX
Tuesday, May 6
Dallas CMS
Dallas, TX
Wednesday, May 7
Tarrant CMS
Fort Worth, TX