Legal Review & Commentary: Hospital medication errors causes drug reaction that is nearly lethal — $121 million verdict awarded

By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY

Allison N. Angel
Law Clerk
Kaufman Borgeest & Ryan
New York, NY

Barbara Reding, RN, PLNC
Licensed Health Care Risk Manager
Hernando, FL

News: When seeking treatment for seizures, a woman wound up permanently disabled by an extreme and potentially fatal allergic reaction to prescribed medications. In a malpractice action brought on her behalf by her mother, three hospitals were found guilty of mismanaging the woman's medications, failing to properly respond to her symptoms, and failing to provide the treatment necessary to prevent permanent damage. The $121 million verdict allocated 90% of the liability between two city hospitals, 5% to a third hospital, 4% to one of its neurologists, and 1% to the plaintiff. The plaintiffs' award was reduced to $119.8 million per the fault apportionment.

Background: A 37-year-old mother of two suffered permanent brain damage, skin lesions, cerebral thrombosis, and burns to 80% of her body while seeking treatment for seizures in 2004. The woman, now incapacitated, was treated by several hospitals and prescribed Dilantin and Carbotatrol for her condition. Yet an extreme allergic reaction to the anti-seizure medications led to the development of Stevens-Johnson Syndrome, a rare and severe systemic disorder affecting the skin and mucous membranes. It often begins with flu-like symptoms, followed by a painful rash that spreads and blisters, eventually causing the top layer of skin to die and separate from the body. Once 30% of the body surface area is affected, the condition is referred to as toxic epidermal necrolysis. Both conditions can be fatal, with a mortality rate of 15% in Stevens-Johnson Syndrome patients and up to 40% for those with toxic epidermal necrolysis.

Most Stevens-Johnson Syndrome lawsuits are brought as products liability actions against the pharmaceutical companies who manufacture the medications. However, a growing number of lawsuits are being filed as malpractice claims against healthcare providers for failing to recognize and adequately treat Stevens-Johnson Syndrome at its onset. This was precisely the argument raised by plaintiff on behalf of her daughter at trial. More specifically, plaintiff alleged that the hospitals were negligent in their failure to properly prescribe medications, monitor the effects of said medications, and recognize that the woman's swollen face, eyes, and throat were symptomatic of an allergic response to the anti-seizure medication.

According to the trial, the woman returned to the emergency department when her swelling began, but she was discharged without seeing a neurologist and without instructions to discontinue the medication. Days later she visited a second emergency department where she was diagnosed with Stevens-Johnson Syndrome. Unfortunately, the woman's condition continued to worsen until she was again transferred to a third facility and treated with intravenous immunoglobulin, which reportedly stopped the progress of her skin lesions. The woman then began to show signs of respiratory distress, and unsuccessful attempts to oxygenate her resulted in cardiac arrest, coma, and permanent anoxic brain damage. Now 45 years old, she is unable to care for herself and requires full-time nursing care.

After a seven-week trial, the jury awarded the plaintiff $121 million in damages, which the defense described as excessive. Although the woman earned less than $40,000 a year prior to her hospitalization, the jury awarded her $10 million in lost earnings. Similarly, the jury award of $5 million for past medical expenses far exceeds the plaintiff's actual total costs, $583,000 since 2004. As for fault apportionment, the jury allocated 90% of the liability between two city hospitals, 5% to a third hospital, 4% to one of its neurologists, and 1% to the plaintiff. The plaintiffs' award was reduced to $119.8 million per the fault apportionment.

What this means to you: The jury verdict in this matter is surprisingly substantial. It is no surprise, however, that the defense considered the total plaintiff award to be excessive. It is difficult to understand, for example, how $5 million dollars is compensatory for actual incurred expenses of $583,000. Lost wages of $40,000 per year for a 37-year-old who might have continued to work for 30 additional years, with allowance for reasonable salary increases, would not begin to approach a lost wages sum equal to $10 million dollars. Full-time nursing care for 30-40 years presents a rational explanation for a several million dollar award in combination with salary loss and medical expenses; the extent of the award in this case makes a statement and appears to be punitive in nature.

As previously stated, there are risks associated with a jury trial, primarily from the well-disposed witness (plaintiff) and understanding jury aspect. This case, involving a young mother of two who incurs permanent brain damage and incapacity due to adverse and allergic responses to medication administration while under clinical care, has the potential to kindle an enormous sense of loss, injustice, and empathy in any juror.

A patient's right to expect safe and appropriate medication management when seeking medical care and treatment is supported through The Joint Commission standards, Medicare regulatory requirements, patient rights and responsibilities acts, and state agencies for healthcare administration, to name a few. While no one can consistently predict or prevent an allergic reaction in a patient to a medication, there is a duty to assess, monitor, and provide immediate intervention as needed to control and minimize negative outcomes when an allergic response is recognized. Knowledge of a patient's clinical and medication history, including previous modes of treatment and response to same, is one of the strategies used to reduce risk to the patient and the provider. The old adage, "start low and go slow" has been an effective means of administering a medication that is new to a patient. This approach allows for adequate monitoring and intervention time in the event the patient is observed to be experiencing a less-than-desirable effect from the medication. This approach also minimizes the amount of medication received by the patient in the event a reaction to the medication appears.

It is also the responsibility of the patient to report any untoward responses or concerns related to medication and its use to their healthcare provider, whether it is their primary care physician, community clinic, or emergency department personnel. It is also the responsibility of the patient to seek medical assistance and to comply with care instructions as provided by their healthcare team members.

In this case, a severe allergic reaction leading to the development of Stevens-Johnson syndrome left a 37-year-old woman permanently incapacitated and disabled. Not only did she experience the discomfort of a systemic reaction, skin lesions, painful rash, and blisters, but the failure to adequately treat her extreme response to anti-seizure medications led to cardiac arrest, coma, and anoxia, leaving her with permanent brain damage. In recognizing the patient's right to safe medication administration and the life-threatening, permanently negative outcome for this woman, the jury's award seems less excessive and perhaps rightfully punitive in assessing most of the liability to the hospitals and a physician. At the same time, the jury, in its appropriation of 1% liability to the patient, clearly understood and expressed its recognition of patient responsibility in this matter.

It is interesting to observe the medico-legal move to ultimately hold practitioners who prescribe medications responsible for monitoring and treating undesirable responses to the medications they prescribe instead of accounting liability to the pharmaceutical firms that manufacture the medications. Pharmaceutical companies are, without doubt, responsible to research and develop safe and well-tested products under the supervision of the Food and Drug Administration and their own risk management practices and protocols. The drug manufacturers, however, do not prescribe or administer the drug to patients, nor are they responsible to observe, monitor, and immediately respond to adverse reactions in patients. The medical team is front and center when it comes to medication administration and patient assessment.

Another risk issue is that of multiple practitioners treating and prescribing for the same patient, often without the knowledge or review of previous treatment modalities by other practitioners. The practice of medicine today has become highly specialized, losing in the specialization process the overall broad-spectrum knowledge of the individual patient the general practitioners (family doctors) of the past had enjoyed.

Whatever information, documentation, or evidence of care was presented at trial by the defense, it was obviously not sufficient in disproving the allegation of medical mismanagement and malpractice. The duty to care was established, the breach of that duty was clear, as evidenced by the patient's permanent injuries and loss of function, and irrevocable harm occurred. The jury award might be viewed as a wake-up call to healthcare providers that the patient's right to safe and appropriate care will not be compromised.

Reference

2012 WL 3264018 (N.Y. 2012).