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Informed Consent: The Legal Issues of GBS
by Jim Kuntz


Legal Resources bottom News, Letters, & Stories
As members of the Group B Strep Association we are all acutely aware of the importance of prenatal screening for GBS as well as the importance of early diagnosis by a physician should a child present clinical symptoms of the disease. Being at the University of Nebraska College of Law when my son fell victim to late onset GBS, I took it upon myself to look for articles concerning the legal implications for failure to prenatally screen for GBS. To my surprise, I found nothing written on the subject-matter. Consequently, I decided to write an article concerning the legal doctrine of informed consent and its application to GBS.

The article argues for universal informed consent and makes a legal argument that failure to prenatally screen for GBS is medical malpractice. While the GBSA and I originally believed we could summarize the article for this newsletter, I believe it would be very difficult and confusing to consolidate the entire document in the next four pages.

The GBSA will be offering my article to those who are interested, but my objective today is to aid those who are considering litigation on behalf of their GBS infected child by giving a simplified version of what needs to be proven in GBS litigation. The views expressed in this newsletter and my article are purely my own, are not designed to be legal advice, and do not necessarily reflect that of the GBSA or any associated law firm or institution.

Throughout history, the legal system has had a limited, but important, impact on the evolution of the patient-physician relationship. The role of a patient in determining the course of medical treatment has evolved over time in response to changes in the status of physicians and medical knowledge. Legal standards have similarly evolved, giving greater weight to patient autonomy by creating a role for patients in determining whether to undertake the risks of treatment. This is called informed consent.

Informed consent responsibilities placed on medical professionals reflect concerns about the risks borne by patients who rely on the physician's advice or treatment. In the context of GBS, a doctor's failure to prenatally screen or their failure to diagnose GBS does not necessarily mean they committed medical malpractice. The determination of medical malpractice will be based on what the physician's conduct or omission was as well as where the GBS injury took place.

In the United States there are two different informed consent approaches which dictate the duty of care a physician must provide to their patient. The majority of states follow the medical community standard approach to informed consent. The medical community standard compels a physician to disclose facts that a reasonable medical practitioner in a similar community and of the same school of medical thought would have disclosed to his or her patient regarding the proposed treatment. A family bringing a law suit in this type of jurisdiction must establish the physician's failure to inform the patient through the introduction of expert testimony that demonstrates the physician had a duty to disclose.

The majority of calls I have received from GBS parents and their attorneys fall within the medical community standard. Within a medical community standard jurisdiction, a medical expert would need to testify that prenatal GBS testing is a standard practice in the community or the physician's acts or omissions with regard to GBS diagnosis were contrary to the medical practice in that community.

The major problem confronted within medical community jurisdictions is finding an expert witness who is knowledgeable about GBS and who is willing to testify against other physicians. The physician community is very closely knit, and understandably many physicians do not want to get the reputation of working against their peers. However, as GBS litigation becomes more prevalent, there are sure to be more and more physicians willing to testify concerning the disease.

The minority of states follow the reasonable patient standard approach to informed consent. Litigants within a reasonable patient community have a much greater chance of success in GBS litigation. The reasonable patient standard requires a physician to disclose those risks which would be material to the decision of a reasonable person in the patient's position as to whether or not to submit to a proposed treatment. In the case of GBS, the question would be whether a reasonable patient would want to know there was a prenatal screening test for GBS given its incidence rates and the availability of treatment for the infection. This standard dispenses with the need for expert testimony and thus enables the plaintiff a much better opportunity to demonstrate physician malpractice.



Early Onset GBS - Prenatal GBS Screening
Let's put informed consent and medical negligence into the context of GBS testing and look at a hypothetical situation:

A pregnant woman is not offered prenatal GBS screening or claims to have been inadequately informed and not understood what she was refusing. The woman subsequently gives birth to a baby infected with the GBS bacteria. The baby either dies or is later found to have a neurological deficiency. The mother claims if she had been properly informed she would have accepted GBS screening and medical procedures to try to treat the disease. The treatment would have reduced the mortality or morbidity rate of the newborn by as much as 86 percent.

To prove negligence on the part of the physician, a plaintiff must convince a jury of three things: (1) the physician failed to inform the patient about the availability in the medical community of GBS testing and its purpose; (2) the GBS testing would have been done if the availability of the test had been disclosed to the patient; and (3) because the physician did not perform the GBS prenatal screening, the plaintiff's child either died or has a permanent neurological deficit.

While this may sound simple to prove, there are no GBS cases recorded to date where a physician or facility was found liable for failure to screen for GBS. Because there is no legal precedent, and the legal community in general is unaware of GBS, many attorneys will not take on a GBS case based on the type of facts above. Surprisingly, however, lawsuits of this fashion may be the best opportunity for GBS screening to become routine for all pregnancies.

Case in point, in 1974, a blood test to screen for neural tube defects like spina bifida became available. Despite its obvious benefits and minimal patient risk in conducting the test, widespread use of the test in the United States was resisted by the medical profession until 1985. It was not until strong impetus for adoption was provided by the medical malpractice concerns of professional organizations such as the American Medical Association that obstetricians began to utilize neural tube screening. As medical malpractice suits and awareness of potential liability increased, neural tube screening quickly became a part of standard prenatal care.

The same result will likely be true for GBS over the next decade. By making incidence comparisons between GBS and other diseases or infirmities like neural tube defects, and following the legal reasoning behind neural tube medical malpractice cases, the possibility of finding negligence on the part of the physician or the facility for failure to screen for GBS greatly increases. With the recent failed attempt to legislatively mandate prenatal GBS screening in Iowa, because of medical community lobbyists, it is my personal belief that litigation is the way to strike fear into the hearts of practitioners in obstetrics and make routine prenatal GBS screening a reality.



Failure to Diagnose GBS
The failure to diagnose rubric is the traditional and predominant GBS case that medical malpractice law firms will accept. An example of a failure to diagnose case would be a woman suffering from a urinary tract infection late in her pregnancy but the physician does not determine the type of organism which is causing the infection. The bacteria turns out to be GBS from which the child shows clinical symptoms and later dies or is deficient in some regard.

Similarly, a mother who displays any of the high risk factors of GBS like maternal fever or premature rupture of membranes, but is not treated nor screened for the disease, would likely have a claim against the medical practitioners if their child is negatively affected by the disease. Other successful lawsuits would likely be where the newborn displays unusual symptoms of lethargy, unresponsiveness, or their vital signs are unstable yet the medical physicians and facilities do not take affirmative steps to diagnose or treat the unknown infection, which later turns out to be Group B Strep.

While failure to diagnose cases are not always successfully litigated, some of the attorneys who I have been in contact with have settled GBS lawsuits with hospitals, pediatricians, and obstetricians alike. As with failure to screen GBS cases, each successful lawsuit creates a higher likelihood that physicians will begin to routinely screen for the disease in the future for fear of being found negligent if they do not. While this is clearly not the best way to encourage universal screening for GBS, history has shown litigation is one way to persuade physicians to utilize prenatal screening tests.


Late Onset GBS
The same legal principles discussed under early onset GBS apply to late onset GBS cases as well. Failure to diagnose lawsuits will be based on the same foundation as discussed above. However, it will be much more difficult to prove medical negligence for failure to screen for GBS in late onset cases.

The difficulty in claiming a physician was negligent for failing to prenatally screen a pregnant woman for GBS arises from the newborn not necessarily acquiring the late-onset infection from the mother. For example, in one study, only seven of twenty-one cases of late-onset GBS infection occurred in infants whose mother had measurable colonization of the GBS bacteria at the time of delivery. Because there is limited proof the baby became infected from the mother, it will be difficult to prove that not being offered prenatal GBS screening was the cause of an infant acquiring the GBS infection.

While it may be difficult to prove negligence in late-onset cases it is important to know late-onset infection can take place through horizontal transmission from infant to infant where nursery populations are high and one of the other infant's mothers in the nursery has a heavy colonization of GBS bacteria. Thus if a lawsuit is pursued in a late-onset case, the nursery population and any clinical symptoms displayed by mothers of babies within the nursery at the time of the infant's stay in the hospital should be a consideration.


Statute of Limitations
Regardless of whether you are in a medical community standard or a reasonable patient jurisdiction, there are time limits for bringing a GBS lawsuit. In most states the time limit, otherwise known as the statute of limitations, for bringing a medical malpractice claim is between two and four years from the date of occurrence.

If a child dies from GBS as a result of medical negligence, the two to four year clock begins ticking upon the child's death. However, in the cases where the child may suffer from a latent neurological defect caused by GBS, the clock may not begin to tick until a reasonable person would be aware of the problem. For example, my son contracted late-onset GBS at the age of six weeks. Because of what I believe to be aggressive and immediate treatment for GBS by my pediatrician, my son seemed to be one of the lucky few that got through the disease unscathed. This belief continued for his first 18 months. However, at about 18 months, my wife and I noticed his speech development was noticeably slower than normal. It was at this point we became concerned about his speech development and have undergone periodic testing of his speech to ensure that he is developing properly.

Because my wife and I were unaware of any potential problems until the 18 month point, my statute of limitations to bring a medical malpractice lawsuit did not begin until we became aware of the neurological speech defect. Once we became aware of the defect, we would have two to four years (depending on the state in which we live) to file a lawsuit on behalf of my child. We have not brought a lawsuit to date because, thankfully, my son has made up on some lost time and is very close to where he should be in speech development.

The statute of limitations is critical. Once the time period to bring a suit passes it is almost impossible to bring the lawsuit at anytime in the future.


In Closing
The preceding information is meant to share some insights into the legal aspects of GBS and bringing a medical malpractice lawsuit. It is not meant to provide any type of legal advice, but is rather meant to inform you of some of your legal options. I encourage any and all of you who are considering legal action to consult with a law firm who specializes in medical malpractice cases. The first consultation is generally without cost and the attorney will be able to better clarify your options and probability of success.

Jim Kuntz, August 1996
Father of Nicholas, Late Onset Survivor

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