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Duty to warn

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Physicians and counselors traditionally owe no duty to individuals with whom they have never met or entered into any treatment relationship. However, following the decision of the California Supreme Court (in Tarasoff v. Regents of the University of California),376 it has become clear that when a serious risk to the health or life of a third party is recognized, a duty of reasonable care evolves that demands protective action. Examples include contact with blood relatives at risk in situations of threatened violence, exposure to infection (HIV/AIDS), and now harmful genes. For colorectal cancer there is evidence that over 50 percent of families at risk do not receive the necessary information.377379 A salutary lesson is provided in the study of 43 families with at least one sudden unexplained death.380 Identification of a genetic cardiac disorder (e.g. long QT syndrome) was made in 40 percent of the families who harbored 151 presymptomatic carriers! The loss‐of‐chance legal doctrine makes it incumbent upon geneticists/counselors to impress on their patients the need to warn blood relatives if a serious genetic threat is determined. This counsel should be in writing and documented in the medical record. Litigated examples include failure to warn of the risk of medullary thyroid cancer, familial adenomatous polyposis with colon cancer, and the fragile X syndrome.381 From the judicial opinions in these cases382 we learned that: (i) moral duty is not equal to legal duty; (ii) the duty to one's family members of avertible risk serves the interests of justice; (iii) given precedents of third party disclosures in the fields of psychiatry and infectious disease, there has been a willingness to extend the duty to warn.

Sudden death as a consequence of a monogenic disorder invokes specific responsibilities not only by the pathologist performing the autopsy but also the geneticist or genetic counselor, if involved with the family. Determination of the cause of sudden death, if not clearly obvious, may be ascribed to an arrhythmia. Cost issues aside, there is the need to consider gene sequencing for the long QT syndrome, the Brugada syndrome, and catecholaminergic polymorphic ventricular tachycardia. At the very least, a tissue sample should be frozen without preservative for subsequent DNA studies. Where cardiac pathology points to a cardiomyopathy, similar considerations pertain. Counseling of next of kin in such cases is important, more especially since they may face a 50 percent personal risk. On occasion, a patient at high risk may refuse to be informed about a specific genetic test result. However, if that result implicates a specific disorder that not only places that individual at risk but as a consequence may cause harm to others, the ethical imperative would demand communication of that unwanted information.383

Important legal precedents serve as further guidance. In the Pate v. Threlkel case (1987),384 the mother of Heidi Pate was diagnosed and treated for the autosomal dominant form of medullary thyroid cancer. Three years later, the same diagnosis was made for Heidi. She sued her mother's physicians asserting that they had had a duty to warn her and her siblings. The Florida Supreme Court held that a reasonably prudent physician had a legal duty to warn of a genetically transferable disease.

The case Safer v. Estate of Pack385 followed a similar theme. The father of Donna Safer was diagnosed in 1956 and surgically treated for colon cancer associated with multiple polyposis. Despite a total colectomy, he died when Donna was only 10 years of age. Subsequently, at the age of 36 years, she was diagnosed with metastatic colon cancer due to autosomal dominant multiple polyposis. She sued her father's surgeon's estate (he died in 1969) for not warning him of the genetic nature and transmissibility of that cancer. The Appellate Court in New Jersey decided that a physician had a duty to warn those known to be at risk of a genetic disorder and went on to state that duty may not always be satisfied by warning the patient.386 About 5 years later, in 2001, the New Jersey Legislature enacted a broad genetic privacy law387 that without consent a physician is prohibited from disclosure of genetic information.386, 388

A failure to make a diagnosis of the fragile X syndrome in the symptomatic daughter of Kimberly Molloy was followed by her giving birth to a son with this disorder. She sued the three physicians who treated her daughter (Molloy v. Meier).389 The Minnesota Supreme Court (2004) concluded that physicians owed a duty to a third party and that legal action was permissible for the failure to warn.389

More recently, and in the United Kingdom, the duty to warn came into sharp focus. A man with Huntington disease expressly forbade his doctor from informing his daughter of his diagnosis. She subsequently (and accidentally) learned of the diagnosis when she was already pregnant. She sued her father's physicians (ABC v. St. Georges Healthcare NHS Trust)390 for failure to inform her, claiming she would have terminated her pregnancy. The High Court denied the claim, holding that there was no duty of care. However, the Court of Appeal (2017) overturned this decision, indicating that clinicians may owe a duty to warn a patient's relatives.391

The aforegoing cases, including the decision by the UK Court of Appeal, made it clear that confidentiality in genetics is not absolute324, 392, 393 with some exceptions.

Following the ruling of the Court of Appeal, the case returned to the High Court for trial, where the decision was against the claimant (ABC).391 Notwithstanding that ruling the Court “introduced a novel legal duty of care owed by doctors to third parties in certain circumstances.”391

Earlier, the UK General Medical Council regarded the transfer of genetic information as justified if failure to do so exposes others to a risk of death or serious harm.324, 394 The Joint Committee on Genomics in Medicine concurred393 and advised that if a breach of confidentiality is to be made, consent for disclosure should be sought, discussion should be held with professional colleagues (e.g. ethics committee), and disclosure should be kept to a minimum, and all actions documented.395 Internationally, many authors have opined and wrestled with these issues and mostly saw the necessity of communicating with relatives of the proband.396400

Genetic Disorders and the Fetus

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