Overview
Every physician dreads the prospect of a patient suffering unintended consequences of their care. Many physicians also struggle with the appropriate type and amount of information to give their patient after an adverse event. Obviously, it is unacceptable to lie to a patient or their family regarding any event. However, a recent survey of over 2,600 doctors indicated wide variation in the disclosure of important information after an adverse event.[1] This may be due in part to a lack of understanding of disclosure requirements. The following article is intended as a summary of a physician’s obligations under current New Jersey law to disclose information after an adverse event and the potentially serious consequences of misleading a patient or failing to disclose material information. Ethical and administrative codes are not covered in this summary.
In a recent case a physician accused by a patient of fraud following an adverse event was successfully defended. The Supreme Court of New Jersey ruled that at this time doctors may be sued for lack of informed consent, but not fraud, relating to post-surgical discussions. In the future, however, fraud claims may be permitted where there is harm “separate and distinct” from any alleged negligence. For example, if a surgeon cut a nerve but told the patient subsequent numbness was due to nonexistent diabetes, and prescribed unnecessary medication which caused an adverse reaction, the harm of the reaction would be due to fraud, not alleged negligence, and the doctor might have to pay “punitive” damages from personal assets, not an insurance policy.
The Patient Safety Act of 2004 requires physicians to inform health care facilities licensed by New Jersey of all “serious preventable adverse events” and “adverse events related to an allergic reaction” during the episode of care, or if discovered afterward, in a “timely fashion”. The facility must assure the patient and Dept. of Health and Senior Services are notified. As an example, where a patient suffers a chemotherapy overdose and serious bodily injury due to staff error, the facility, patient and State must be notified according to the Patient Safety Act (PSA).
However, events not meeting statutory or common law criteria may not have to be reported.
For instance, a medication error recognized before harm occurred may be reported to the facility, patient and State on a voluntary basis. Other cases may cause the physician to be uncertain as to whether reporting is required. Physicians may wish to contact their insurance company and seek the advice of counsel regarding how to proceed following an adverse event so as to best protect themselves, their patients and facilities from further medical/legal consequences. Doctors should also be familiar with their facility’s policies and procedures for disclosure of adverse events.
Fraud and Informed Consent/Refusal
The two sources of law discussed in this article are common law and statutory law. Common law evolves from decisions made and followed by courts over time. Two common law doctrines which patients’ attorneys may seek to apply to disclosure following an adverse event are fraud and informed consent/refusal. Fraud generally involves a statement of material fact, known to be untrue at the time it is made, with the intent that it be relied upon by another, with the other party relying upon that statement and suffering harm as a result.[2] Informed consent generally requires a physician to disclose information which a reasonable patient would find “material” to their choice among providers and reasonable medical alternatives, including non-treatment, for their condition.[3] Its corollary, “informed refusal,” typically involves the failure to warn a patient of potential risks of refusing a recommended course of treatment or monitoring of their condition.[4] Statutory law is set forth by legislative bodies. It may impose duties to disclose information which are greater, less than or equivalent to common law requirements.
[1] “Choosing Your Words Carefully”, Archives of Internal Medicine, Vol.166, Aug. 2006, p.1585-93.
[2] Howard v. UMDNJ, 172 N.J. 537 (2000).
[3] Mathies v. Mastromonaco, 160 N.J. 26 (1999).
[4] Salvetti v. Sladowski, A-2456-04T3 (App. Div.
2006).