Hereditary Cancer Litigation: A Status Report

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.