Investigating the group B strep case.

For more than two decades, a bacteria known as group B strep (GBS) has been a leading cause of newborn injury and death. In almost all these cases, the babies were infected by their mothers before or during birth.

Group B strep (group B streptococcus agalactiae) frequently is found in genital and rectal cavities. About 20 percent of women of childbearing age are carriers of GBS at any given time. Often, these women show no signs or symptoms of infection or illness.

If left untreated, pregnant women who give birth while they are infected can pass the infection on to their newborns. A GBS infection in a newborn is serious. It can cause pneumonia, sepsis, and meningitis.

Annually, about 7,600 infants develop GBS-associated illnesses. The bacteria kills about 310 infants every year. In addition, a substantial number of infants suffer permanent neurologic injury, including extensive brain damage.(1)

Many of these injuries and deaths can be prevented by treating infected pregnant women with antibiotics shortly before they give birth. Studies show up to a 30-fold reduction in GBS infection in newborns whose mothers receive antibiotics during labor.(2)

For years, the standard of care in many medical communities was to neither test for GBS nor treat pregnant women who tested positive. Consequently, a doctor often was not liable when an infant be came disabled or died as a result of contracting GBS during birth. The doctor simply said, "I am not responsible for not treating a condition I had no duty to discover."

On May 31, 1996, the Centers for Disease Control and Prevention (CDC) published a comprehensive report on group B strep.(3) It concludes with recommendations that are significantly more demanding for preventing GBS-related diseases than previous recommendations published by the American College of Obstetricians and Gynecologists.

The next month, the American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice issued an opinion citing and essentially adopting the CDC recommendations.(4)

In August 1997, the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists jointly published the fourth edition of the Guidelines for Perinatal Care.(5) These also include the CDC recommendations.

Published recommendations and guidelines are not necessarily standards of care, but most obstetric practitioners follow the recommendations of some publication for prevention of GBS-related disease in newborns. Therefore, these publications can be used to support a GBS-related claim that arose after they were published.

The CDC recommendations, ACOG committee opinion, and the new AAP/ACOG guidelines cannot be used to support a GBS-related malpractice claim that occurred before they were published. But plaintiff lawyers might be able to use the medical literature cited in the CDC report.

That literature supports the argument for a higher standard of care than many obstetrical practitioners followed before May 1996. Much of that literature was published in the 1970s and 1980s and may be beneficial to plaintiffs' claims regardless of when an injury or death occurred.

Before 1996, many doctors also relied on a technical bulletin published by ACOG in July 1992.(6) It did not advocate any particular strategy for GBS prevention. What it did say' is that screening pregnant women for GBS was an option. It also said that women who test positive and who exhibit certain recognized "risk factors" could benefit from receiving antibiotics during labor. The risk factors are--

* onset of labor at less than 37 weeks gestation

* rupture of membranes at less than 37 weeks gestation

* rupture of membranes more than 18 hours before delivery

* maternal fever during labor

* prior delivery of a GBS-infected child. Screening of all pregnant women also has been advocated by pediatricians since 1992.(7)

Obstetric liability

All physicians practicing obstetrics should now offer screening to their patients at 35 to 37 weeks gestation. Any physician who has not at least offered the option could be liable for malpractice if the newborn subsequently develops any GBS-related complications.

The 1996 CDC recommendations and the new AAP/ACOG guidelines stop short of recommending screening of all pregnant women. Instead, these publications recommend informing all women of the GBS-prevention strategy.

Where an infant develops GBS and the mother was not given the option of treatment, liability may rest on a combination of two legal doctrines--informed consent and loss of chance.

Most, if not all, states have case law supporting a patient's right to make an informed decision as a prerequisite to treatment. A patient has a right to choose whether to be screened for GBS and to choose whether to receive antibiotics.

If informed consent is not an issue, the lawyer may be able to argue loss of chance if the state has adopted that legal theory.(8) This theory applies if a child's chances of avoiding GBS infection were reduced because the mother was not treated with antibiotics during labor and delivery.

Most states that have adopted the doctrine apply it equally to illness, injury, and death claims. Loss of chance is proven through expert testimony. The expert testimony can show that published medical literature supports the hypothesis that the incidence of GBS infection in newborns occurs less frequently in cases where mothers who test positive are given antibiotics at least two hours before delivery than in cases where mothers who test positive receive no treatment.

Because screening for GBS does not place the patient at risk, most patients choose screening when the risks of the child contracting GBS are adequately explained. The popular prenatal book What To Expect When You're Expecting advises its readers--

Though it's true that a baby who contracts a

group B streptococcus infection from its

mother at birth can become ill and even die,

with modern obstetrical practice this doesn't

have to happen.

[T]here are two recommended approaches

for protecting newborns. One is to test (via

vaginal swab) all expectant women at 35 to 37

weeks and treat those who are positive with antibiotics

during labor. The second is to treat,

during labor, high risk women: those in

preterm labor, or with a fever, prolonged ruptured

membranes (18 hours or more), a prior

child with GBS, or GBS in their urine during

pregnancy. In most cases this will protect the

newborn from becoming infected. If necessary,

the baby can also be treated.

So while you shouldn't worry, you should

be sure that you've been tested and that if the

test is positive, you are treated at the appropriate

time.(9)

The Centers for Disease Control and Prevention advocates informing all women of their test results. Group B strep carriers should be told of the potential benefits and risks of receiving antibiotics to prevent GBS transmission to newborns.

The 1996 ACOG committee opinion recognizes that informed patients will likely choose antibiotic treatment: "When a strategy is used that incorporates late prenatal cultures and offers of intrapartum chemoprophylaxis to women who are carriers but have no other risk factors, most of these women can be expected to accept intrapartum treatment."(10)

The standard of care demanded by the informed patient, and now practiced by the informed obstetrician, appears to be--

1. Inform all obstetric patients of GBS, its risks to newborns, and available treatment strategies.

2. Test the expectant mother for GBS by cervical culture at 35 to 37 weeks gestation.

3. Inform all obstetric patients of the results of their GBS cultures.

4. Assume that a woman who tests positive for GBS during her pregnancy is a GBS carrier at labor and delivery.

5. Tell any patient who tests negative that she could still carry the bacteria when she goes into labor.

6. Advise any patient who has tested negative of the conditions that carry a higher risk of a woman passing GBS on to an infant during labor, including

* onset of labor at less than 37 weeks,

* premature rupture of membranes,

* prolonged labor,

* fever during labor, and

* previous birth of a child with GBS.

7. Treat any patient who has tested positive at any time during pregnancy with antibiotics during labor and delivery unless the patient has been told of the risks of infection and has declined treatment. When risk factors are present, tell the patient that antibiotic treatment is strongly advised.

8. If the mother tested positive for GBS or if any of the risk factors were present, tell her to advise the newborn's pediatrician about this.

9. If a woman's GBS status is unknown and any of the risk factors are present, assume that she is carrying GBS and strongly advise treatment with antibiotics during labor.

10. Record the mother's GBS test result in the prenatal chart and make sure it is included with the labor and delivery notes.

11. Record the mother's GBS status, any exhibited risk factors, and any treatment during labor and delivery in the labor and delivery chart and make sure these notes are transferred to the newborn's chart.

12. Tell the nursing staff in the nursery if the child was born of a GBS-positive mother, if any of the risk factors appeared during labor and delivery, or if the mother was treated with antibiotics.

Pediatric liability

At birth, the reSponsibility for GBS vigilance and treatment passes to the nursery staff and the pediatrician. The guidelines for pediatricians are found in the Revised Guidelines for Prevention of Early-onset Group B Streptococcal (GBS) Infection.(11)

When the newborn may have been exposed to GBS during labor and delivery (for example, if the mother was GBS positive when screened or exhibited any of the recognized risk factors), the generally accepted standard of care demanded by the informed patient, and practiced by the reasonable pediatrician, is--

1. In addition to close observation of the child and management based on clinical findings, perform a complete blood count (CBC) and blood culture of the infant.

2. If the mother was GBS positive and exhibited one or more of the recognized risk factors but was not treated, treat the child with antibiotics until the results of the CBC are known, regardless of whether the mother exhibited one or more of the recognized risk factors.

3. If there are any unusual values in the CBC, treat the child with antibiotics and keep the child for continued observation.

4. If the blood culture is GBS positive, treat the child and keep him or her hospitalized for continued observation. If the child has already been discharged, call the parents for an immediate office or emergency room visit.

5. At the infant's discharge, tell the parents to observe the infant closely at home for any signs or symptoms of illness. Tell the parents the signs of GBS-related illness in the child may include--

* a change in temperature (up or down),

* a change in color,

* a change in feeding habits,

* a change in sleep patterns (sleeping more than usual or less than usual), or

* a change in activity (irritable or lethargic).

6. Tell the parents to call the pediatrician immediately at the first suspected sign of illness, no matter how slight.

7. Tell the parents to schedule the infant's first pediatric office visit no more than one week after birth.

Because of the potential gravity, of GBS infection in infants, parents should be instructed to call the pediatrician about any noticeable change. Something as simple as a change in sleep or feeding patterns may be the first sign of illness. An infant can be gravely ill even if he or she has no fever.

Parents also should be told that if the pediatrician is not available, they should immediately take the child to the emergency room and tell the staff that the mother was a known or suspected GBS carrier.

A claim

The investigation of a claim of medical negligence in a GBS case should begin with a search of the medical records to see if the mother's GBS status was determined during her pregnancy. Was she positive? Was she informed of GBS risks? When she presented in labor, did she exhibit any of the recognized GBS risk factors?

Regardless of exhibited risk factors, should she have been given prophylactic antibiotics during labor and delivery? If antibiotics were administered, were they given intravenously for at least two hours before delivery?

Closely examining the charting and transmission of information is crucial. Was the mother's prenatal GBS status properly documented by the obstetric practitioner in the office records? Was that information correctly transferred to the mother's labor and delivery chart? Was everyone in attendance during the labor and delivery aware of the mother's GBS status?

Were her vital signs properly monitored and charted? Did any of the recognized risk factors develop during labor? Even if a mother did not have a fever, were there other signs she was suffering from an infection during labor? Were other factors that have been associated with GBS present, such as a mother under 20 years of age, or insertion of a fetal scalp electrode?

The infant's medical records should also be examined. Was documentation of the mother's GBS status transferred to the infant's chart? Was the infant watched for development of GBS infection? Were a blood culture and count performed? Were the parents advised of the risk of GBS infection and what to watch for?

Consultations with an obstetrician/perinatologist and a pediatrician/neonatologist, at a minimum, are necessary to adequately evaluate any potential GBS case. Other specialists to consult include a maternal-fetal medicine specialist and a pediatric infectious disease specialist.

While the standard of care regarding prevention of GBS transmission is improving, children continue to suffer injury and death from infection. Plaintiff lawyers can do much to ensure that injured parties receive just compensation.

Notes

(1.) American Academy of Pediatrics, Committee on Infectious Diseases & Committee on Fetus and Newborn, Revised Guidelines for Prevention of Early-onset Group B Streptococcal (GBS) Infection, 99 PEDIATRICS 489 (1997) [hereafter Revised Guidelines].

(2.) CENTERS FOR DISEASE CONTROL & PREVENTION, PREVENTION OF PERINATAL GROUP B STREPTOCOCCAL DISEASE: A PUBLIC HEALTH PERSPECTIVE, MORBIDITY & MORTALITY WKLY. REP., May 31, 1996, at 1.

(3.) Id.

(4.) AMERICAN COLLEGE OF OBSTETRICIANS & GYNECOLOGISTS (ACOG), COMM. ON OBSTETRIC PRACTICE, PREVENTION OF EARLY-ONSET GROUP B STREPTOCOCCAL DISEASE IN NEWBORNS, OPINION NO. 173 (1996) [hereafter ACOG COMM. OPINION].

(5.) AMERICAN ACADEMY OF PEDIATRICS & AMERICAN COLLEGE OF OBSTETRICIANS & GYNECOLOGISTS, GUIDELINES FOR PERINATAL CARE (4th ed. 1997). The guidelines for the standard of care in GBS management found in the third edition (1992) are outdated, but they may apply to cases arising before publication of the fourth edition.

(6.) AMERICAN COLLEGE OF OBSTETRICIANS & GYNECOLOGISTS, GROUP B STREPTOCOCCAL INFECTION IN PREGNANCY, TECHNICAL BULL. NO. 170 (1992). This bulletin was withdrawn by ACOG in August 1996. It appears to have been superseded by ACOG COMM. OPINION NO. 173, supra note 4.

(7.) American Academy of Pediatrics, Committee on Infectious Diseases & Committee on Fetus and Newborn, Guidelines for Prevention of Group B Streptococcal (GBS) Infection by Chemoprophylaxis, 90 PEDIATRICS 775 (1992).

(8.) The loss of chance doctrine was first articulated in Hicks v. United States, 368 F.2d 626, 632 (4th Cir. 1966) ("When a defendant's negligent action or inaction has effectively terminated a person's chance of survival, it does not lie in the defendant's mouth to raise conjectures as to the measure of the chances that he has put beyond the possibility of realization. If there was any substantial possibility of survival and the defendant has destroyed it, he is answerable.").

(9.) ARLENE EISENBERG ET AL., WHAT TO EXPECT WHEN YOU'RE EXPECTING 315-16 (2d ed. 1991).

(10.) ACOG COMM. OPINION, supra note 4, at 3.

(11.) Revised Guidelines, supra note 1.

George E. McLaughlin is an associate with Bachmann, Hess, Bachmann & Garden in Wheeling, West Virginia.