Today's New York Times carries a column by recently-resigned budget director Peter Orszag, which begins with Orszag complaining that the health insurance reform bill did not do enough to federally "reform" state medical malpractice laws. He argues that Congress should "shield from malpractice liability any doctors who followed evidence-based guidelines in treating their patients" and "provide safe harbor for doctors who follow evidence-based guidelines." He says, "[A]nyone who could demonstrate that he has followed the recommended course for treating a specific illness or condition could not be held liable."
This is a horrendous idea.
Clinical practice guidelines should never be the legal basis for determining whether or not patient harm was the result of negligence. And allowing use of guidelines only by a physician or facility to defend itself against a medical malpractice claim and not by an injured patient to show negligence is without any justification and is fundamentally unfair.
There is already a general recognition that conflict of interest and specialty bias are ongoing problems in the development of clinical practice guidelines. If medical and specialty societies are allowed to participate in writing guidelines they know will be exculpatory for their members, conflicts of interest and bias will escalate. For example, specialty societies, like the American College of Obstetricians and Gynecologists (ACOG), have been aggressive leaders in the medical lobbies' push for liability limits in the last few years and remain committed to that goal. It would be fundamentally unjust for patients to have their cases judged by liability standards chosen by ACOG for the purpose of exculpating fellow obstetricians.
But the reality is that no matter who writes them, it is impossible to develop single authoritative guidelines for every medical condition, let alone to trust any entity to suddenly become the sole arbiter of acceptable medical practice. It is estimated that more than 1400 sets of clinical practice guidelines exist today. While some standards, such as those in anesthesia, are clear and easily complied with, others, such as in obstetrical cases, are complicated and can be contradictory. Moreover, as they are written for "average patients" and cannot encompass the huge variation in how patients present, there may be good reason to vary from a guideline's recommendation for a patient.
That is why to date, only a few states have ever attempted to develop and use certain guidelines as legal standards. These limited state experiments, which began and ended in the 1990s, provide little support for adoption of guidelines as national policy.
For example, in the 1990s, Maine established a program that allowed doctors in four specialties--anesthesiology, emergency medicine, obstetrics and gynecology, and radiology--to participate in a program allowing use of guidelines as exculpatory evidence in lawsuits. Other specialties were encouraged to take advantage of this program but did not. The program expired, and the Maine Bureau of Insurance concluded, "the medical demonstration project had no measurable effect on medical professional liability claims, claims settlement costs, or malpractice premiums."
In 1996, Florida also began a demonstration project for cesarean deliveries, but reportedly "garnered relatively little support among physicians--only 20% of physicians eligible to participate chose to do so and the project ended in 1998....Three other states (Kentucky, Maryland, and Minnesota) adopted test projects in the 1990s, though none of the projects is fully operational today (the Maryland and Minnesota projects have fully expired)." In other words, the medical profession itself has not accepted clinical practice guidelines as appropriate legal standards, even for exculpatory purposes.
Finally, one-way use of guidelines, as Mr. Orszag proposes, raises fundamental issues of fairness, including significant due process and equal protection considerations under both the federal and state constitutions.
Patient safety can benefit from clinical practice guidelines when triggered by the desire to reduce unwarranted variation in practice and provide patients with benchmark quality care rooted in science. In fact, both sides in malpractice litigation currently make limited use of clinical practice guidelines in settlement negotiations, or even to help lawyers decide whether or not to file suits. However, what Mr. Orszag is suggesting raises serious concerns about fairness and patient safety.
Hundreds of thousands of preventable medical errors occur each year in hospitals, costing us tens of billions of dollars annually, according to the Institute of Medicine. Placing more obstacles in the way of the sick and injured, only 1 in 8 of whom even file a claim for compensation anyway, is no way to solve our health care problems.