Born in the USA (31 page)

When they don't think they can win a case, lawyers for doctors, hospitals, and insurance companies settle cases out of court and include a gag order on families and their lawyers in the settlement that makes it a crime for them to discuss the case publicly. For this reason, it is very difficult for scientists, policy makers, and health care consumers to discover the extent of the litigation involving Cytotec induction. Obstetricians and hospitals don't want the public to know about these cases for fear that the news
would encourage more Cytotec victims to sue and because it would damage the public image of obstetricians by increasing public awareness of the fact that they are using powerful drugs on women in labor that have not been approved by the FDA for this purpose. In a 2004 article, I reported on sixteen cases of induction with Cytotec with adverse outcomes and I have been asked to review several more cases since my article was published.
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I am certain this is only the tip of the iceberg. Of the cases I'm familiar with, two were in Oregon, and both settled for well over a million dollars; one was in Washington State and it too settled for more than a million dollars; a case in New York State settled for more than a million dollars; and cases in Massachusetts, South Carolina, Texas, Florida, Connecticut, Maryland, and Pennsylvania all settled for very large sums. The only case I know of that settled for a large sum and did not include a gag order was the case in Idaho, and in that instance, the lawyers tried to get a gag order but the appalled judge would not allow it.

To my knowledge, to date every case of litigation involving Cytotec induction has been settled before coming to trial, with two exceptions, and those cases were partially settled but did go to trial. It's not hard to understand why. As discussed in
chapter 4
, when a doctor uses a drug that is not approved by the FDA or the drug company for induction, and their choice results in a damaged or dead woman or baby or both, any trial would likely draw media coverage and it would be hard for the doctor or hospital to win. Nevertheless, even with all the attempts to hide the tragic outcomes of vigilante practices with settlements and gag orders, the truth has a way of leaking out.

Lawyers with experience in obstetric litigation have told me that most cases are won by the defense because, in general, the public has a deep need to believe what doctors say, and because it is easy to find doctors willing to defend other doctors but very difficult to find doctors willing to testify against other doctors. Malpractice litigation is not a level playing field in other ways as well. The family in a case usually has limited means, whereas the defense (doctors and hospitals) have malpractice insurance, with very large resources at hand—nearly a David and Goliath situation. In most cases, the defense tries hard to delay going to trial. They can make it costly for the family by bringing in many doctors to testify for the defense (which results in a lot of expensive depositions), in the hope that the family will give up before the case can be heard by a jury. Cytotec litigation is an exception to the rule, as it is difficult to defend against the FDA and the pharmaceutical industry, and a family with a dead mother or a dead or braindamaged baby is always an object of sympathy to a jury.

Another strategy used by obstetric organizations is to try to get the American public to feel sorry for the doctors who “can't afford” to pay their insurance premiums, despite the fact that on average, obstetricians take home in the neighborhood of $200,000 a year (after taxes and insurance expenses). President Bush has been sympathetic to their “plight” and urges giving doctors a break by capping awards to families for noneconomic damages at $250,000.
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ACOG has taken it a step further and turned this into a game of semi-blackmail, suggesting that obstetricians won't keep delivering babies if something isn't done to help them. In an editorial in August 2002, ACOG complains about “the erosion of the ability to make a good living” and threatens that “without state and federal legislation, many rural areas will be without obstetricians because of difficulty getting professional liability insurance.”
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In a May 2002 news release, ACOG insisted, “Problems in the nation's medical liability system could severely jeopardize the availability of physicians to deliver babies in the U.S.”
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And again in a news release in July 2004, ACOG reported that a medical liability survey reaffirmed that more obstetrician/gynecologists are quitting obstetrics.
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I can't help but believe that this kind of scare tactic is likely to backfire. In
chapter 5
, I discussed how doctors in Madera County, California, played the same game by refusing to attend births at the county hospital. Midwives were hired instead, at a significant salary savings, and the number of babies dying at birth fell dramatically.

When the topic of settlement caps comes up, I am inclined to remind people of the family in Idaho whose son was born with extreme brain damage due to an unnecessary Cytotec induction. All the medical specialists, including pediatric neurologists, who have seen this little boy agree that, now at five years of age, the child has severe cerebral palsy so he can't crawl, much less sit or walk; has severe mental retardation, so he can't talk and knows only family members; is unable to feed and swallow normally and must be fed with a tube; and is probably blind. The specialists also all agree that all these severe disabilities are due to what happened during labor and birth.

For more than four years, this family has provided around-the-clock nursing care for their son, a heroic effort that will probably need to continue for the next forty years. Every health care professional who has worked with this boy writes in the chart about the child's devoted and loving family. The cost of their son's medical care is staggering, but beyond the financial burden, the pain and suffering this family has endured, and will continue to endure for many years to come, is hard to imagine.

Contrast the money issues this family in Idaho has with the money issues of the two obstetricians who gave the mother her unnecessary Cytotec induction. There is nothing wrong with hard-working obstetricians earning a reasonable income. But it is unreasonable, even offensive, for obstetricians to try to increase their net income by lobbying for caps on the amount a jury can award a family in obstetric cases as a way to get their malpractice insurance premiums down. In the President's State of the Union Address in 2006, he called on Congress for the fourth year in a row to pass medical liability reform, and ACOG, commenting on this in a news release, calls such lawsuits “frivolous,” a comment that could well be put into perspective by the family and their community in Idaho.
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I do not believe that the American public wants obstetricians and insurance companies to become richer at the expense of families with damaged or dead women or babies.

In cases that do go to court, one of the most effective strategies used by doctors to limit damages for malpractice is called “community standard of practice.” This is an extraordinary bit of reasoning that goes like this: Whatever a doctor is doing, if it is done by other doctors in that community, it can be called the “standard of practice” and should be considered proper regardless of bad outcomes. This is like saying that although the speed limit on the highway is sixty-five miles per hour, if a number of drivers are going eighty miles per hour, the acceptable speed on the highway is really eighty miles per hour. When this reasoning is argued in court, it means that to be relieved of responsibility, a doctor who has been sued for doing something terrible need only find a few doctors in his neighborhood or even from quite far away if in the same state who are willing to testify that they do it too. This reasoning is still common despite the fact that every obstetric textbook now teaches that evidence-based practice—that is, practice that is in accordance with what scientific evidence says is effective and safe—is the best standard of practice, and it is no longer acceptable to adopt as a standard of practice that which merely reflects what some doctors do.

As discussed in
chapter 2
, in the Idaho case that resulted in a severely brain-damaged baby, the obstetricians being sued were the only two obstetricians in a small-town joint practice, and they used this reasoning in their deposition. They were questioned concerning their management of the Cytotec induction, and it was established that they did not follow hospital protocol in their use of the drug. When Dr. X was asked whether he
believed that it's okay for doctors not to follow hospital protocol, as he did not, he replied, “The judgment of the individual allows them to do that if they want to,” and “The way that Dr. Y and I used [the drug] at the time is the standard of care.” Dr. Y then added, “There is no national standard of care.” When asked if he is familiar with the standard of care in his community, he replied, “I am familiar with what I do.”

When asked, “Do you rely on FDA approval in any way in your selection of drugs to administer to patients?” Dr. X replied, “No,” and added, “the use of a drug in pregnancy, whether the manufacturer endorses it or not, is my decision, based on clinical judgment.” When he was asked if the selection and dose of drug is “his call and nobody else's,” he replied, “It is.” When asked if a hospital protocol is binding, Dr. X replied, “I don't think that it is. I think it has room for physicians to order more doses and choose routes and do what they feel comfortable doing.” Dr. X also stated that he does not consider the textbook
Williams Obstetrics
to be authoritative. Dr. Y concurred, saying that he does not rely on obstetric textbooks.

When two obstetricians can say that they, and only they, establish their standards of practice, based on what they “feel comfortable” doing, and that they are free to ignore the FDA, hospital protocols, and obstetric textbooks, it is a dangerous form of vigilantism and medical anarchy. In a community such as theirs, where they are the only obstetricians in town and all the family physicians and nurses follow their lead, there is no way for a woman even to determine if she is receiving high-quality health care, let alone choose from among a range of birth options. Would you want to have a baby there?

The attitude taken by these two obstetricians is in keeping with a long tradition in the medical profession. When physicians are asked to account for their practices, and feel their backs against the wall, they pull out their ace, as Dr. X did in his deposition response: “It's a matter of clinical judgment.” This is a kin to the concept of “community standard of care” and reduces the physician's culpability even further. Although the consensus wave of the future in medical practice is evidence-based practice, many doctors still believe that much of what they do for a patient is no more than a judgment call based on experience. This perspective allows them to insist that unless you were there at the time, and unless you have had as much clinical experience as they have, you can't question what they did. In other words, it is never appropriate to question a doctor's choices.

Some take it even further. In addition to having little or no training in science, most physicians in clinical practice also have little or no training
in public health and epidemiology. Consequently, a surprising number of physicians have a hard time grasping the concept of evidence-based practice. They cannot understand how data gathered on a group of patients (C-section rates for a given hospital, for example) apply to an individual patient. Some of these physicians have published papers in clinical journals that object to applying recommended rates for C-section to individual hospitals and individual clinicians.
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When defending their choices in a legal case, these doctors tend to take the out-of-date, reactionary position that it is necessary to consider all aspects of each individual case and, in the final analysis, use clinical judgment. This position, what anthropologists call “authoritative knowledge,” has been very useful for obstetricians—not only as a litigation defense, but also as a weapon in their never-ending battle to protect their territory and as a way to reject what valid epidemiological evidence says they should be doing.

Another variation on the “only we can judge what we do” defense is to try to get the courts to require that only a board-qualified obstetrician can testify against a board-qualified obstetrician. Like most medical and surgical specialties, obstetricians have a “board” that consists of a small group of “senior” obstetricians (many on staff at medical schools and university hospitals). The board establishes a system of examinations, which an applicant can take to become “board-qualified.” Although the system is supposed to provide quality assurance, it ironically has the opposite effect as well, in that it makes enforcing the obstetric omertà easier and the task of finding doctors willing to testify against an obstetrician much more difficult. Since the process of becoming “board-qualified” is not an “official” governmental one and is administered only by a nongovernmental organization of peers without any mechanism for oversight or regulation, it is inappropriate and dangerous for the courts to agree to this restriction. Nevertheless, this is now the law in some states.

On a national level, obstetric organizations such as ACOG have made no secret of the fact that many of their policies and recommendations are based not on a desire to promote practices that are good for patients, but on a desire to avoid or hamper litigation against their members. In
chapter 2
, I described in detail two recommendations in particular where ACOG has put protecting members from lawsuits above patients' needs. The first example is Committee Opinion number 207, published in September 1998, with the title “Liability Implications of Recording Procedures or Treatments,” in which ACOG recommended against allowing a patient's family to create a birth video, saying that “recording solely for the purpose
of patient memorabilia or marketing is not without liability, and each institution should weigh these competing concerns.”