With the flourishing of neonatology and the number of practitioners has come an explosion of litigation centering on events occurring in the neonatal period. The many reasons usually cited for this (even seemingly contradictory factors such as patient awareness of medical advances versus an increased tendency to view caregivers as fallible) all play a part. But the main reason such a large percentage of the malpractice cases that are actually pursued to completion (as opposed to settled or dropped along the way) involve injuries acquired in the perinatal period is that these injuries are typically so physically and financially devastating.
The economic factors in medical malpractice litigation are such that only cases involving permanent catastrophic damage and requiring expensive long term care are worthwhile for a plaintiff's attorney to invest his time and money in. Some of these economic considerations include the enormous costs ($40,00 on the average) of gathering expert witnesses and conducting discovery in malpractice cases, the ceiling or "cap" on damages that exists in many state for medical malpractice cases, and the fact that among such cases that go to trial, 75% are decided in favor of the physician or hospital.
In addition to the survival of an increasing population of premature infants (many of whom sustain permanent injuries to vital organs, including eyes, lungs, and brain, that cause lifelong disabilities) comes the reality that a clinician caring for a newborn infant is far more likely to be served with a subpoena for deposition or trial than, say a dermatologist or a gastroenterologist. The neonatal specialist is constantly playing with high states - both medically and legally.
When I attended law school in the mid 1960's, students were taught that medical malpractice litigation was of theoretical concern only. To win a medical malpractice case, one would have to have expert testimony, something that, at the time, was considered impossible because "you couldn't get a doctor to testify against another doctor."
Insurance companies and other institutions have spent a large amount of time and money attempting to discern the nature and extent of medical malpractice and its ensuing litigation. Prompted by the medical malpractice insurance crisis, several public investigations such as the study by the United States government of unnecessary surgery began turning up facts and conclusion. In one federal inquiry, a congressional subcommittee reported finding that 2.4 million needless operations were performed yearly in the United States, leading to 11,900 unnecessary deaths annually.
Then the results of a California study sponsored and conducted by the medical profession itself reached the press. At first, some of the leading physicians in California loudly opposed releasing the results of their own study. But other physicians argued that once the public knew the research was being done, the results would be awaited and demanded.
The California study began when the California Medical Association and the California Hospital Association joined resources in an attempt to beat down the rising costs of medical malpractice insurance by, first, finding out many iatrogenic injuries were actually occurring. They limited their study only to those patients who were injured while in the hospital. Obviously, if the insurance companies could determine how many patients were getting hurt, how badly, and what it would cost, they could rationally set premiums and reserves high enough to reimburse patients for injuries and illnesses occasioned by poor treatment.
Three physicians with extensive medical-legal experience were selected and appointed by the associations to conduct the study: Don Harper Mills, MD, JD, of Los Angles, John S. Boyden Jr, MD, of Salt Lake City; and David S. Rubsaman, MD, JD, of Berkeley. Traveling across California, these physicians eventually reviewed a sample of 20,864 hospital charts randomly selected from 23 representative hospitals in California during a 1-year period. The results were statistically projected to the 3,011,000 hospital admissions in California for the year. The result of their investigation was that "disability caused by health-care management" amounted to 140,00 instances for that year.
In their report, the physicians astounded fellow physicians further by the way the figures broke down: 112,000 cases (80%) were temporary disability (lasting 30 days or less), and another 9,100 (6.5%) involved no functional handicaps although the disabilities were permanent in nature (i.e., loss of an organ or function not considered necessary for daily living and working). Only 5,300 (3.8%) were associated with lasting functional disabilities. The final 13,600 (9.7%) disabilities caused by health care management resulted in death, but 25% (3,400) occurred in patients that probably would have died within 1 year from unrelated, underlying diseases or conditions (e.g. a patient with terminal cancer who died prematurely from a reaction to an anticancer drug).
The findings were worse than the most pessimistic critics had predicted. Even if we leave aside as unimportant the 8,600 disabilities that lasted 30 days or less and forget about the 9,100 permanent disabilities resulting in nothing more than the "loss of an organ or function not considered necessary for daily living and working" and focus on 3,400 people who died but would have died anyway from some other cause within a year, we are still left with the 15,500 Californians who either died from or were permanently disabled by there "health-care management."
The Los Angeles Times noted that when the data was analyzed to determine how many of the three million hospitalizations had the grounds for a meritorious medical malpractice lawsuit, it turned out that 23,800 patients appeared to have such a basis: 23,800 cases of malpractice in this day of million dollar malpractice verdicts! And that's 23,800 cases of malpractice according to the medical and hospital associations' own study. That's just 1 year. That's just California.
The most interesting point, from the standpoint of the associations' project however, was that the search disclosed approximately five times the number of actionable malpractice lawsuits compared with the number of lawsuits actually filed. Attorneys generally file about 5,000 medical malpractice complaints per year in California. This figure of 5,000 includes many cases that fall outside the figure of 23,800 admitted by the physicians to be the number of hospital-related incidents that are attributable to medical fault. For example, the 5,000 includes injuries that occurred while the patient was following the physician's instructions at home, injuries that happened in physician's offices, free-standing x-ray facilities, outpatient clinics, and so on. The 5,000 figure also includes people who were disabled by pharmaceutical malpractice, chiropractic or podiatric malpractice, dental malpractice, nursing home malpractice, laboratory malpractice, ambulance attendant malpractice, and several other categories - all of which were excluded from the physicians' 23,800 figure. Thus only a portion of the 5,000 cases filed by lawyers in California coincide with the 23,800 acknowledged by the medical and hospital association investigators to be meritorious potential claims.
The Los Angeles Times reported that a major study of medical malpractice by Harvard University found that almost 4% of patients sustained an injury resulting in disability while hospitalized in New York State and that more than 25% of the injuries were caused by negligence.
According to the Los Angeles Times, the study covered all admissions to 51 hospitals during 1984: some 30,121 patients. The Times also concluded that hospital administrators continued to underreport incidents, including life-threatening events, to state authorities. The study was conducted by a team of Harvard physicians, lawyers, administrators, nurses, and statisticians over a 4-year period at a cost of $3.1 million. The study was commissioned in 1986 by the New York State Department of Health as an offshoot of major reform of the state's malpractice insurance act.
The study found that 3.7% of patients who were hospitalized that year received an injury in the hospital resulting in measurable disability. Statisticians translated this into 99,000 injuries among the 2.7 million patients who were admitted that year. Among these who were disabled, 28% of the injuries were cased by negligence: a total of 27,00 patients. Of the medical injuries that occurred, 14% were fatal, and almost half of the fatalities, the researchers said, were caused by negligence. They concluded that were 13,451 deaths and 2,550 cases of permanent total disability resulting from medical injury in New York hospitals during the year studied, and they estimated that 6,985 deaths were caused by negligence.
What all of this means to the clinician caring for the newborn is that, sooner or later and more likely repetitively, he or she will be involved in litigation arising out of day-to-day activity in the neonatal unit. The clinician caring for the newborn may be a defendant in a lawsuit, be a percipient witness to events in another professional's lawsuit, be called on to serve as an expert witness for the plaintiff or the defense, or a combination of these roles.
As a trial lawyer who has specialized in medical malpractice litigation for the past 20 years, I will try to give readers my thoughts regarding the most common causes of medical malpractice, how medical litigation can best be avoided, and what clinicians should do when litigation inevitably occur.
Whether a particular malpractice case arises out of a delayed diagnosis, a misdiagnosis, improper treatment, a prematurely truncated treatment, or whatever, the problem can usually be traced finally to a failure of communication. The failure to communicate can run in either direction: from physician to nurse, physician to physician, nurse to nurse, patient to physician, nurse to patient, laboratory to physician, and physician or nurse to chart. Obviously, the more hurried the contact aimed at communication becomes, the more susceptible it is to go awry and the more likely malpractice is to occur, accompanied by malpractice litigation, with or without actual concomitant malpractice.
If an injury occurs because of miscommunication caused by absent or sloppy charting, this is immediately apparent to lay jurors who can understand poor communication when it is pointed out to them. Poor communication is, by definition, below the standard of care.
Even worse, of course, is the alteration of records. These changes are easily spotted by expert reviewers and are questioned by those who examine documents (experts in identifying alteration of documents). Changed records invariably serve, when pointed out to the jury, to highlight the original errors as well as inflame the triers of fact. They undermine even valid defenses by destroying the defendants' credibility. Changed documents also can be the basis for punitive damages against the individuals found to be responsible. Punitive damages cannot be covered by malpractice insurance; they are the personal debt of the responsible individuals. And debts based on charges of fraud, which is what changing records are, cannot be discharged in bankruptcy.
Another time when good charting helps the clinician as well as the patient is when the clinician is called on as a percipient witness - a person who actually was present and saw the events in question transpiring. This is a different function than that of an "expert" witness, who is called on to interpret, criticize, defend, or otherwise help the jury understand an event that the expert has merely been informed of, although usually not present at the time. If the clinician has been careful to reduce to writing the pertinent observations and events as they were occurring, it will be easier to remember and recount them perhaps 5 years later at the time of trial. More important, of course, good charting reduces the risk of injury in the first place (and therefore of malpractice litigation, with its depositions and trials).
[Editor's note: Especially good record keeping includes the reasoning behind one's decisions, which at a later date may serve to convince a jury that you were both careful and caring. If one can convince a jury that you possess these attributes, the battle is already half won.]
Finally, and most important, as an expert witnesses, clinicians are called on as communicators. Experts serve, first to interpret, from the chart and from other information, the truth of what has transpired. They communicate this first to the attorney for the side that hires them to review the matter and help the attorney. They communicate it to the judge and jury in the course of litigation to enable the trier of fact to understand and assess the responsibility. To be a good expert witness is simply an extension of what it takes to be a good clinician: that is, to be either a good clinician or a good expert witness, you must be a good communicator. A percipient witness tells the jury what happened and an expert witness tells the jury what should have happened. If the witness is a good communicator, the jury will understand.
This brings us to the aspect of communication that goes right to the heart of the therapeutic relationship: informed consent. One of the best means I know to avoid medical malpractice from occurring is to observe the so-called "doctrine of informed consent." When lecturing on this legal proposition to physicians and nurses, I am often confronted with the hostile reaction that the entire area is somehow a judicial infringement of their right to practice medicine - something to help the lawyers and harm the physicians. In truth, it should be seen as a shield for the physician rather than as a sword for the litigators. It should not be seen as a weapon given out to handicap the medical profession in a kind of eternal war with the patient - a way of putting patients on a higher footing and leading them up to no good.
Indeed, I think the doctrine of informed consent helps the medical practitioner even more than it helps the patient. By taking the time to explain to the patient's parents what is happening and to describe the thinking process behind what is being done for the patient, the neonatologist (1) honors the parents' intelligence, (2) acknowledges their right of control over what is, in fact, their child, and (3) allows them to share in the decisions being made.
[Editor's note: In addition, it acknowledges publicly the potential fallibility of any decision-making process.]
If a decision appears in retrospect to be erroneous, at least the parents may recall the reasons for the decision that at the time seemed compelling. From the standpoint of minimizing parents' resentment over disappointing results and promoting understanding of the position and efforts of the people rendering treatment, the doctrine of informed consent should be viewed as an important medical instrument given to neonatologists to promote better communication between themselves and parents as well as nurses, other physicians, and so forth.
As more physicians and nurses begin explaining both the risks and the alternatives, the dangers and the choices, letting the parents in on the thought processes used and the problems involved, not only will lawsuits be minimized but rapport and cooperation with parents will be improved and less malpractice will occur.
[Editor's note: In the process of explaining the pros and cons of any decision-making process to the patient or patient's parents, frequently the best choice becomes clearer to the physician as well!]
Physicians should encourage nurses to be open with parents and to understand the doctrine of informed consent because nurses often spend more time in direct patient contact and are the people with whom some parents feel most comfortable speaking. Nurses have their own "duty to disclose," governed by many of the same policy considerations that underlie the physician's duty to do so, and it is not only inappropriate but also legally extremely dangerous for a physician to discourage nurses from carrying out their duty to disclose. I cannot think of a more fertile ground for obtaining punitive damages against a physician or hospital than in this particular area. You may remember that the Paul Newman movie, The Verdict, was based on it.
Furthermore, contrary to widely held assumptions, the duty to inform does not end with advising parents of the dangers or risks of treatment. There is an additional and equally important requirement that the parents also be informed of any alternative course or treatment that may be available. The parents who stand in the legal shores of their neonate, must be informed of all possible options to consider so that the range of choices presented does not amount to a stacked deck. It is one thing to tell a parent that the proposed treatment has risks and dangers; it is quite another thing to tell the parent that a treatment is available that does not pose those same risks or dangers or that would be of greater benefit but is more expensive. In other words, the parents must have freedom, not merely the illusion of freedom.
As to how much information to give the parents, there is a dangerous tendency to rely on the "custom in the community." Under the law of the State of California and elsewhere, if death or serious bodily harm is involved, the question of custom in the community is irrelevant. Full disclosure is required under the law even though it is not required by community standard.
The law aside, however, it seems to me that relying only on common practice is not effective medically either and could tend to promote further failures of communication. The problem is that "common practice" does not focus directly on the needs of the patient, if focus on the conduct of other practitioners whether that conduct is good or bad. It simply passes the buck by saying that care providers should inform parents of the same things that other care providers inform parents. Thus it perpetuates a failure of communication.
In the leading decision on informed consent, the California Supreme Court wrote: (2)
A medical doctor, being the expert, appreciates the risks inherent in the procedure he is prescribing, the risks of a decision not to undergo the treatment, the probability of a successful outcome of the treatment. Once this information has been disclosed, that aspect of the doctor's expert function has been performed. The weighing of those risks against the individual's subjective fears and hopes of the patient is not an expert skill. Such evaluation and decision is a non-medical judgement reserved to the patient alone.
Communicating freedom of choice is a way in which patients' parents can be kept partners and participants in their child's treatment. It thus makes them allies of the medical team, not adversaries. Allies are more likely to understand failure and appreciate success. The more they understand, the better it is for all.
I will go even further and say that, in my opinion, the clinician should see disclosure as more than a mere "duty". Given the fiduciary and professional nature of the relationship between clinician and parent-patient, I think clinicians should conceive of disclosure as an intrinsic right. Viewed as a "right to inform" belonging to clinicians themselves that arises from care of a patient, the real nature of disclosure emerges as something that benefits both parties to the relationship and therefore benefits the relationship itself. If they view disclosure as a duty and disclose only grudgingly, with fear and trepidation, grudge and fear will characterize the relationship with the parents. If, on the other hand, they view disclosure as something that will educate the parents, the likelihood is that the parents will be in a better position to prevent malpractice from occurring because they are hyper-alert and hyper-attentive to the needs of their own child. It is the truth, ultimately, that will set us free.
Which brings us to the seemingly sticky question of what to tell parents when malpractice occurs and the clinician knows it but the parents do not. Actually, I do not believe the question is all that sticky. For example, if the malpractice produces no lasting injury (and will not produce a lasting injury in the future), I believe that the detriments of informing the parents of such an occurrence greatly exceed the benefits. Clinicians have no duty to tell parents they think a patient is a victim of malpractice when having the knowledge will do the parents and the patient no good but could poison the terrain so that more malpractice would be likely to occur in the future.
On the other hand, if a preventable error causes a severe, disabling injury, (e.g. cerebral palsy caused by a failure to manage hypoglycemia or an electrolyte imbalance in a timely manner), the situation is different. The parents are unlikely to recognize and appreciate the fact or significance of such an occurrence. And yet the entire family would be left to care and provide for a member with a lifelong and tragic disability. Failing to advise the family of this fact is inhumane. If a caregiver goes further and attempts to cover up the malpractice and it is discovered, the specter of punitive damages will arise.
Clinicians often ask me, "Aside from informed consent, what is the law that I should be aware of to be followed in my neonatal practice?" The answer, of course, is that there is no "law of neonatology." Every case is different. And the worst mistake a clinician can make, in my opinion, is to take his or her eye off the ball by trying to decide what the "legal" ramifications are in a particular situation rather than focusing on the medical and personal ramifications. If the clinician makes the choices that are most correct in the human sense, "the law" will come along afterward and find a way to justify it. Similarly, if the wrong thing is done from a human standpoint because the eye is on the medical-legal aspects, the law will find a way to condemn it. Let me give you a personal example.
I was preaching this point about the law following good medicine long before I was engaged to act as a defense attorney in the now-celebrated case of two Kaiser Permanente doctors who were indicted for murder after they discounted oxygenation and hydration they had instituted earlier on a comatose patient.
The decedent in that case, Clarence Herbert, was a 55-year old security guard at Santa Anita Racetrack who had been in the hospital for some 92 days throughout the year before the admission that led to his death. His condition stemmed from a gangrenous bowel that necessitated an ileostomy. Following the ileostomy, he was readmitted for an elective closure of that condition, which he considered to be uncomfortable and degrading. The surgery went smoothly, lasting approximately 1 hour, and there was no evidence of hypotension or any intraoperative problems. He was left in the care f the recovery room nurses by the nurse anesthetist when he appeared to be emerging from the anethesia uneventfully.
After Mr. Herbert had been in the recovery room for about 45 minutes, however, he apparently suffered respiratory depression evidenced by circumoral cyanosis. The recovery nurse bagged the patient and simultaneously rang the code bell while the patient slipped into cardiorespiratory arrest. He was resuscitated without regaining consciousness and transferred to the intensive care unit in what was shortly determined to be a comatose condition. The following day, a neurologist examined the patient and found him to be in a coma, exhibiting decerebrate posturing.
The cardiologist wrote the following order: "Supportive care, do not treat cardiac arrhythmia; no not treat hyper or hypotension." During the next 48 hours after the arrest, the family was informed that the patient had suffered a sever anoxic insult and that the prognosis was poor. They were led to understand that in all likelihood, much of the patient's brain was "dead" and that there was little possibility of any functional recovery. As soon as they heard this, all members of the immediate family became extremely aggressive in their demands that the ventilator, which was assisting respiration, and all other means of life support be stopped. In their own words and in their own handwriting, they wrote an instruction to the physicians that "all machines sustaining life" must be withdrawn; this instruction was signed by all nine members of the patient's immediate family. An EEG was performed that showed generalized abnormal and slow activity - short of the criteria for "brain death" normally required by California law for the discontinuance of life support.
Two days and 20 hours after the arrest, the internist disconnected the patient's respirator. Like Karen Quinlan, the patient breathed spontaneously. Thus, he was surviving on IV and antibiotic, which were not discontinued. When the family members observed that the IV's were still running, they became angry, objecting both to the IVs and to the placement of any medication in the IVs. Several heated scenes ensured between family members and the nursing staff over these continued means of life support.
Four days and 19 hours after the arrest, the physicians ordered that the IV line and fluids be discontinued, and the patient died 5 days later. One finding on autopsy was "dehydration". At the time, no cases had every allowed the discontinuance of life support by means of withdrawing fluid and nutrition. "Guidelines" drawn up by the Los Angeles County Medical Association, the county health care system, and the country district attorney had permitted discontinuation of assisted ventilation but not IV fluids. California had a "brain death" statute that allowed discontinuance of life support when a patient met certain criteria, which included a flat EEG. Mr. Herbert, by everyone's agreement, did not meet the criteria for brain death and nobody every considered him "brain dead" in any technical sense.
At the trial, I called as an expert witness for the defense a nationally known Jesuit ethicist, Father John J. Paris, (see Chapter 39, which was written by Father Paris), who testified that under the circumstances of this case, the discontinuance of hydration did not, it itself, reflect the requisite criminal intent to commit murder. He insisted that a distinction had to be made between "killing" and "allowing to die" (from the underlying terminal illness). In a tightly reasoned analysis, Farther Paris fitted the action of the defendant physicians, neither of whom were Catholic, into what he testified was the tradition of Catholic theology and ethical thought. Although he is a Catholic priest, Father Paris received his training at secular universities, and he made clear that he was speaking not as a purveyor of a Roman Catholic position but as an ethicist and historian.
The physicians were acquitted at the trial level, and the case went all the way to California Court of Appeals, resulting in one of the most quoted published opinion in the field. "A physician has no duty to continue treatment, once it has proved to be ineffective. Although there may be a duty to provide life-sustaining machinery in the immediate aftermath of a cardio-respiratory arrest, there is no duty to continue its use once it has become futile in the opinion of qualified medical personal."
The California court brushed aside as being a distinction without a difference the fact that, in this case, not just a respirator was discontinued but also IV hydration and nutrition. The court quoted the judge who wrote the opinion in the famous Karen Ann Quinlan case: "The focal point of decision should be the prognosis as to the reasonable possibility of return to cognitive and sapient life, as distinguished from the forces continuance of that biological vegetative existence." The Kaiser physicians had done the human thing, and the law came around to support them.
[Editor's note: The years between the accusation and the acquittal must have seemed like an eternity. I wonder whether these doctors thought doing the human thing was worth it? I certainly hope so.]
What the neonatal clinician needs to do to avoid providing care that is later deemed to be "malpractice" is to give the best information and the best neonatal care he or she can. The clinician must ask, "What would I want to know if this were my child?" and "What would be the best thing to do from a humanistic standpoint?" rather than speculate about what the law would be in any particular situation. The law will follow good medicine, not the reverse.
- Cobbs v Grant, 8C3d, 104 CR 505 (1972).
- Barber v Superior Court of California, 147 Cal App 3d, 1006, 195 CR 484 (Cal Ct App. 1983).