Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”1 This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”2 The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.3 A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a) , which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute ( Colo. Rev. Stat. Ann. 13-25-135 ), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence … shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,4 the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.5

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.6 The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.7

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139 .

2. Institute of Medicine: To Err is Human: Building a Safer Health System . National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc. , 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6 .

7. N Engl J Med. 1991 Jul 25;325(4):245-51 .

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu .

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