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Hereditary Cancer Litigation: A Status Report

Hereditary Cancer Litigation: A Status Report

ABSTRACT: During the past few decades, cancer patients have sued their physicians for negligence in diagnosing or managing their disease, based on the charge that the clinician failed to consider the patient's genealogy when trying to arrive at a diagnosis. Other suits have charged that the clinician is liable for failing to investigate other members of the cancer patient's family, regardless of whether they were his or her patients. Although these cases have been successful only sporadically, they underscore the importance of obtaining a complete cancer history not only of the patient but also the immediate family. With the advent and more widespread use of gene analysis studies, more such cases are likely in the future. [ONCOLOGY 10(2):211-217, 1996

Introduction

When the US Congress enacted the National Cancer Act in 1971,
the scientific community was given an immediate charge to curb
the occurrence of those diseases classified as malignant neoplasms
[1]. This legislation strengthened public health and private health-care
resources previously engaged in the study of diagnostic, therapeutic,
and rehabilitative services for persons so afflicted. In particular,
the act promoted the development and implementation of screening
activities.

As in previous instances in which federal money was used to stimulate
action, litigation followed. Civil suits were filed for perceived
failures to comply with newly identified approaches to the management
and control of cancer. Suits specifically charging professional
negligence were filed against physicians involved in the screening,
diagnosis, and counseling of cancer patients and their families.

Two particular types of suits are found in court records that
pointedly involve cancer cases in which genealogy is at issue:
(1) those that involve the management of the patient with cancer
that charge the clinician with failure to consider the presenting
patient's genealogy when either attempting to make a diagnosis
or counseling other immediate family members, and (2) those that
involve the insurance coverage of patients with a heritable cancer.

Management-Oriented Cases

The early civil suits filed by dissatisfied patients or their
families charged physician negligence and liability during the
management of the case when the physician:

  • failed to perform an adequate history and physical examination
    addressing complaints or fears of the patient [2],
  • relied on a negative examination or failed to perform a follow-up
    examination when the patient reiterated his or her fears and suspicions
    of cancer to the physician [3],
  • caused an inappropriate delay in the diagnosis of a cancer
    syndrome that resulted in a significant alteration in the prognosis
    and/or treatment regimen [4], or
  • made a diagnosis of cancer when none existed, and a cancer
    phobia resulted, with or without unnecessary surgery, radiation,
    or chemotherapy [4].

Later cases involving the mangement and/or counseling of cancer
patients and their families added two charges:

  • failure to suggest monitoring or screening procedures for
    the siblings, children, or even parents of the patient with an
    identifiable hereditary cancer [4], or
  • failure to keep adequate records of cancer incidents in a
    family when the physician assumed the care of the family with
    a heritable cancer history [4].

Key Rulings

Although incidents of negligence suits against physicians using
these charges are uncommon, the few recorded suits have been used
as a basis for some landmark civil suits claiming physician negligence.
Court rulings that support filings of negligence against a physician
involved in cancer diagnosis include the following:

  1. A federal case in which an appellate author wrote that the
    appropriate standard of care for breast cancer diagnosis includes
    "that a history be taken to determine her age, her age at
    first pregnancy (if any), the history of any breast cancer
    in the family
    and whether or not she was using birth control
    pills." [5](Italics added by the author.)
  2. A Virginia court ruling that allows the plaintiff to provide
    to the court expert testimony that the use of a family disease
    history could have enhanced the chance of successful disease treatment
    and recovery. The failure of the managing physician to inquire
    into the related disease history of the patient is considered
    negligence [6].
  3. Nebraska court rulings that a national standard of care for
    the diagnosis of breast cancer prevails, and that failure to meet
    this standard compromises not only the immediate diagnosis and
    treatment of the patient but also leaves such an individual more
    susceptible to future disease and/or treatment complications [7].
  4. The ruling, in O'Brien v Stove, that the omission of
    a genealogical survey during initial patient evaluation is an
    assignable fault to the clinician, as it is a failure to meet
    the standard of care and not just an error in judgment or a mistake.
    The ruling concluded that assignment of liability to that clinician
    could result from such omission [8].

Encouraged by such rulings, attorneys found that it is not difficult
to design a negligence suit against a physician who misses or
belatedly diagnoses a heritable cancer. With the aforementioned
recorded verdicts favoring plaintiffs, lawyers are able to incorporate
these court decisions into civil suits in which the specific charge
brought against the physician is a failure to use a patient's
genealogy in the management of the presenting cancer patient and
his or her family.

Suits are currently at contest against clinicians who failed to
investigate other members of the cancer patient's family, regardless
of whether they were his or her patients. Third-party liability
has became a popular charge against health-care workers. Such
complaints seek liability not only for patient's costs but also
for perceived future damages to the patient and other family members.
In these suits, the complaint has surfaced that a family member,
as a third party in a cancer family, might have been treated differently
if a genealogy had been considered in the management of the diagnosed
case.

Hereditary Breast Cancer Litigation

The recorded litigation cited above most often pertains to cases
of hereditary breast cancer (HBC). Few complaints have been filed
by colon cancer families or in cases where central nervous system
tumors were missed in families with a history of von Recklinhausen's
disease; multiple pigmented atypical nevi skin lesions were overlooked
in patients with familial atypical multiple melanoma syndrome;
or gliomas were missed in families with a history of retinoblastoma.

It is reported that HBC represents 9% of all breast cancers [9].
The syndrome is characterized by earlier age of onset, (average
age, 45 years) common bilateral involvement, greater frequency
of multiple primary cancer sites (breast and ovary), and an autosomal
dominant inheritance pattern of cancer susceptibility (associated
with the BRCA-1 and BRCA-2 genes ) [10,11]. These cases are of
particular interest to attorneys reviewing health-care practices.
When such suits have proved successful, the plaintiffs have received
large monetary awards for the perceived negligence of the responsible
physician.

Prior to the last decade, there were no specific biologic or chemical
markers to satisfy the suspicion of the clinician faced with a
potential HBC patient. The family history was the sole link to
initiate early detection of disease not only in the presenting
patient but also in the immediate family. Due to the recent advances
in molecular genetic studies mentioned above, aggregations of
similar cancers in families have been discovered. In many instances,
discovered cancer cases have been shown to be consonant with Mendelian
inherited cancer susceptibility syndromes. Molecular genetic studies
have identified the precise location in the genome of the putative
gene located at chromosome 17q locus (BRCA-1) and at 13q (BRCA-2)
[10,11].

Legal researchers also have become cognizant of these scientific
techniques that can determine with significant accuracy those
patients who are predisposed to the development of HBC and hereditary
breast-ovarian cancer (HBOC). They have become aware that such
genetic profiles are available to clinicians and that, when used
with the family cancer history, can screen and identify those
siblings, children, and parents at high risk for cancer. Attorneys
familiar with these developments now use such information to attempt
to obtain compensation for those cancer patients whose disease
might have been thwarted or modified through early detection.

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