Beyond the Boundaries of Ethics Research: the SUPPORT Study

premieA study designed to identify the safest oxygen levels for premature babies is under heavy fire for causing high levels of blindness, and perhaps even unnecessary deaths, among the 1316 very small infants who were enrolled.  Critics charge that 23 major research hospitals, including noted New England facilities Tufts Medical Center, Brown University, Women & Infants Hospital and Yale University, subjected babies to added risks, while failing to tell their parents about the potential dangers.

The SUPPORT (Surfactant, Positive Pressure, and Oxygenation Randomized Trial) study, conducted from 2004 to 2009, was designed to find out whether premature babies whose immature lungs required oxygen support were more likely to die or become blind if their oxygen levels were targeted to either a high or a low range.  As with any medical research study, the participants—or in this case, their parents—signed a consent form that was supposed to make sure they fully understood the risks and benefits of the study.  Yet in March of this year, the Office for Human Research Protections (OHRP), an arm of the federal Department of Health and Human Services (DHHS), charged the University of Alabama Birmingham (UAB), one of the lead participating hospitals, with failing to tell the parents that the amount of oxygen their baby received might affect whether the baby would develop blindness, a brain injury, or even die.  Instead, the only risk mentioned was that the device used to monitor the baby’s oxygen levels might cause skin breakdown.  While the consent form suggested to parents that babies who received lower levels of oxygen might have fewer eye problems, it failed to point out that the converse might also be true: babies assigned to receive more oxygen would be at higher risk for ROP.  And nowhere in the consent does it say that a baby might be at higher or lower risk of death, depending on the random assignment to one group or the other.

A month later, Public Citizen, a private non-profit group that advocates for patient safety, fired off a letter to DHHS Secretary Kathleen Sebelius, claiming that the violations occurred at all of the participating hospitals, not just UAB, and calling for OHRP to go further by requiring the facilities to apologize to parents for what they had done, and to institute corrective measures to prevent similar lapses in the future.

Several parents whose babies died have already filed lawsuits against UAB.  As the deficiencies in the consent form, and the adverse effects on some of the babies become more well-known, it is likely that there will be more, including here in Massachusetts and Rhode Island.

The cause of the controversy focuses on the researchers’ decision to assign babies randomly to receive either a higher (91-95%) or lower (85-89%) oxygen concentration.  Normally, the amount of oxygen a premature baby receives is carefully individualized depending on the infant’s medical condition and other treatments he is receiving.  Neonatologists attempt to keep the oxygen levels as low as possible to avoid the complication known as retinopathy of prematurity (ROP), where an abnormal growth of blood vessels in the eye can lead to blindness and other vision problems. The results from the study showed a statistically significant (unlikely to be due to chance or coincidence) increase in blindness for the babies who received higher oxygen levels, and in death for babies who received lower levels.

Not surprisingly, the researchers have their defenders.  They claim that all of the oxygen levels received by babies in the study were within the standard range of treatment, and pointed out that, in fact, the babies in the study had a lower death rate than a supposedly similar group of premature infants.

The treatment of the patients and parents in the SUPPORT study is particularly disturbing, because it involves very vulnerable babies and parents who most likely would go to the ends of the earth to improve the outcome for their children.  Understandably, the researchers wanted to increase participation in their study–for which they needed the parents’ consent.  But however well intentioned the doctors were, there is no justification for making decisions based on random assignments rather than the best interests of each individual baby.  In this case, it is likely that the lack of information induced many parents to enroll their babies in the study when they would not otherwise have done so.

There is no question that medical research can lead to tremendous improvements in patient care and outcome.  But particularly in studies like SUPPORT, where the subjects are tiny premature babies, the institutions conducting such research must be vigilant to insure that their patients’ rights are protected.  It is likely that many of the study participants’ parents are still unaware of the harm their babies faced—or even actually suffered—as a result of their decision to participate.   It is never too late for the hospitals to explain to these parents what actually happened, and to try to atone for the breach of trust and, in some cases, physical damage, they have caused.

Read the letter to the UAB from OHRS here

Read Public Citizen’s letter to DHHS Secretary Kathleen Sebelius here

Read the original published report of the SUPPORT trial here

Examining the “Risk” of Malpractice

risk_factorA common defense lawyer’s explanation for a bad outcome is that what happened is “a risk of the procedure.”  But what does that really mean?  And what does it mean for a patient who suffers one of the known complications of a procedure or surgery?

As used by defense lawyers, “risk of the procedure” tries to convince a jury that the health care provider wasn’t negligent, that what happened was unvoidable, and happened despite appropriate actions by the provider.  But the explanation that a bad outcome was “a risk of the procedure” doesn’t answer the real question in a malpractice case, which is “Was the doctor negligent?”  Sometimes, there is a bad outcome even though the doctor did everything in a completely appropriate manner.  But sometimes, the bad outcome was the result of bad medical practice.  And that’s the definition of malpractice.

A good example of the difference comes from a case we handled recently.  A man had developed fluid around his heart and needed a procedure known as pericardiocentesis, where a needle is inserted into the space around the heart to drain out the fluid.  As you might imagine, any time a needle is in close proximity to the heart, there is a potential for injury,  So, one might say, injury to the heart is a known risk or complication of pericardiocentesis.

But if that injury occurs, it may or may not be due to negligence.  In our case, two important facts led us to conclude that the man’s death from injury to his heart was due to negligence, and was not  just an unavoidable complication.  First, although there are imaging techniques that are commonly used to allow the doctor to see the needle’s progress in real time, the doctor in our case chose not to use them.  He did the procedure “blind.”  And worse, when the heart monitor showed abnormalities indicating that the needle was touching the heart, the doctor did not stop the procedure.  Instead, he pushed on, puncturing the heart and causing the man’s rapid death.

The defense in this case urged the jury to conclude that what happened was “a risk of the procedure”–just bad luck, really, and that the doctors had done nothing wrong.  However, we were able to show that when something is a known risk, it’s even more important for the doctors to try to prevent that risk from occurring.  And that makes sense.  If you know the driveway is slippery and you might fall–you take precautions.  Maybe you spread salt on the pavement.  Maybe you walk more carefully.  Likewise, if a doctor is doing something that has a risk of harm, the negligence may be in not taking appropriate steps to prevent that harm.

This idea of taking appropriate precautions ties into the concept of informed consent.  When a patient gives informed consent, he acknowledges that he is aware that some risk is involved, even if everything is done perfectly–and he accepts that risk.  But that patient still has the right to expect the doctor to take every reasonable precaution to minimize or prevent that risk.  Put another way, the patient does not consent to malpractice, nor does he give up his right to bring a claim if the doctor is negligent in causing the injury.

This distinction, between an injury that occurs despite proper care by the doctor, and an injury that is caused by negligence, is important when evaluating a case where the injury is a “known risk” of the procedure.  That doesn’t end the inquiry–the crucial question is whether that “risk” should have been anticipated and prevented.  If so, there may be a valid malpractice claim.

Informed Consent in the Legal System

gavel and stethoscopeA common call that we receive comes from a patient who feels that she did not receive “informed consent” from her physician.  The patient had a procedure or took a prescribed medication, and something went wrong.  There was a complication or side effect, the patient doesn’t feel the doctor told her this might happen, and now she’s very unhappy.

That unhappiness does not necessarily translate into a successful medical malpractice claim, even if the patient truly wasn’t told about the complication or side effect.  That’s because informed consent in a legal sense means something more than a lack of information.  Each state has slightly different legal requirements, but in Massachusetts, a patient bringing a claim for lack of informed consent must prove four things: 1) that he wasn’t informed about a risk or complication; 2) that the risk or complication is something that a reasonable patient in his position would want to know about; 3) that the risk or complication actually occurred; and 4) that if the patient had known about the risk or complication, neither he nor a reasonable patient in his position would have agreed to the treatment, procedure or medication in question.

That last part is a major stumbling block in many cases.  Most patients understand that surgeries carry certain risks, and that medications may have side effects.  Yet every day, patients have surgery and take medications, fully understanding that the outcome may not always be what they hope or expect.  Informed consent, in the legal sense, provides a remedy only if the patient can prove that she wouldn’t have had the treatment or taken the medication if she’d been aware of the risks.  The patient’s word isn’t enough; the patient also has to prove that a reasonable patient wouldn’t have had the treatment either.  And in many cases, that’s quite difficult.

The purpose of the legal cause of action for informed consent is not to guarantee that no complications will occur, or even to provide compensation if a there is a complication.  It is simply to make sure that patients understand what might go wrong when they get medical treatment, and have the opportunity to decide whether the anticipated benefit of the treatment outweighs the possible risks.  As a practical matter, unless the risks are very great, or the potential benefits very small, most patients would choose the treatment.

A cause of action for informed consent is most likely to be successful when there are reasonable and legitimate alternatives to the doctor’s chosen course of treatment.  Some examples include situations where a proposed surgery is truly elective or cosmetic, where there are options for both medical and surgical treatment, or where something about the patient’s individual situation makes a usual treatment less appealing.

A final note:  in most jurisdictions, the doctor’s obligation to inform the patient applies not just to surgical procedures.  Doctors must tell patients about the different treatment choices or medications available to them, including the alternative of no treatment, or doing nothing.  This principle often becomes important during certain labor and delivery situations, where the mother may need to decide whether to have labor induced, whether to undergo a trial of labor, or whether to allow labor to continue in the face of fetal heart rate abnormalities.  Patients have the right to make these decisions in an informed manner.

Informed Consent in a Medical Setting

patient signing ICMost doctors and patients have heard about informed consent, but very few of them have a clear understanding of what it means.  Part of the confusion stems from the fact that the concept of informed consent has different meanings in different settings.  When doctors speak of informed consent, they mean the process by which patients are given medical information about their condition and treatment.  When lawyers use the same phrase, they mean a legal cause of action that has specific proof requirements that vary from state to state.  The difference is important if you are thinking about a medical malpractice claim.  It’s not as simple as proving that the doctor didn’t tell you something.

Historically, doctors made decisions about a patient’s medical treatment without consulting the patient.  The rationale was that the doctor had the medical training, the doctor knew best, and that a patient would not think to question a doctor’s judgment.  Over time, that has changed, particularly where there is more than one reasonable course of action: whether to treat with medication or surgery, whether to watch a condition or treat it, whether to perform an elective surgery, among others.  Doctors now understand–and the law recognizes–that patients, not doctors, have the right to make those types of decisions.

Many organizations have attempted to help patients and doctors through the process of shared decision making.  One independent research group, the Informed Medical Decisions Foundation, has created a series of  “decision aids” to help doctors focus on what’s important to patients in making treatment decisions, including what may be the effect of particular choices on a patient’s quality of life.  The American Medical Association emphasizes to physicians that the informed consent process is not just a formality.

Despite these efforts and warnings, many in the medical profession have lost sight of the purpose of informed consent, and often treat the important process of shared decision-making as just one more item to be checked off the list.  Doctors and hospitals have developed standard forms that contain vague and general listings of the worst risks imaginable–paralysis, brain damage, death–as well as more common complications such as organ injury or infection.  For the most part, these forms are used for a wide variety of patients and treatments, and there is little, if any, effort to tailor the form (or the information) to the particular patient or treatment at hand.  They look like exactly what they are: an attempt to avoid legal liability, rather than a genuine effort to inform the patient.

Patients, too, have become desensitized to the process, as they become accustomed to signing forms full of fine print, often containing both medical and financial information, without reading the form or questioning the health care provider.  If the treatment goes smoothly and the patient does well, this wink-and-a-nod approach to informed consent goes unnoticed.  But when something goes wrong, the health care provider may find that it doesn’t have the legal protection it would like, while the patient, quite understandably, may feel that the informed consent process was given short shrift.

And when that happens, the patient often calls a lawyer.  That’s where the disconnect between medicine and law comes into play.  Even if the patient was truly unaware of a potential risk or complication, that’s not necessarily enough to bring a claim for lack of informed consent.  Check back later this week for a discussion of informed consent in the legal sense.