Baby Miller case decided by Texas Supreme Court

One year, five months, and twenty-seven days after oral argument, the Texas Supreme Court decided the Baby Miller case today. The court, whose ranks were depleted by retirements, voted 7-0 to affirm the Court of Appeals in an opinion written by retiring Justice Craig Enoch. A few quick thoughts:

1. This is a devastating loss for the family, which has a lifetime of expensive nursing and medical care to pay for. With post-judgment interest, the judgment for the family had to have been worth over $100 million by now. The Court of Appeals reversed and rendered a take-nothing judgment, and today the Supreme Court said, "that's right."

2. The major damage done by the Court of Appeals to the Natural Death Act (now the Advance Directives Act) was technically left alone by the Supreme Court. It affirmed on other state-law grounds and said it didn't need to reach the NDA/ADA issue. But the court offered some dicta that ought to make it clear the court thought the Court of Appeals blew it, which it did (big time). So my major hope for the opinion -- that the NDA/ADA would be restored to its natural meaning -- was half-way realized.

3. The court also side-stepped the Baby Doe issue in the case. It describes the Baby Doe rule as an appropriations/funding rule, which is satisfied by the fact that Texas has CPS policies and procedures in place to respond to reports of failure to provide medically indicated treatment to infants. Period. It does not seem interested in reading Baby Doe as establishing a standard of care, at least unless CPS has been called into a case, which it was not in this case, so as far as the court is concerned: no big deal. But in any event, the court said "this is a state-law, not federal-law, case so we won't technically decide the Baby Doe issue." This is okay with me (even though I think Baby Doe does implicate state law and does establish a standard of care as a matter of state law). Anything the court could have said about Baby Doe (other than what it did say) could only have made a bad rule worse.

The really disquieting part of the decision is its reliance on the 1920 Moss case (link requires Westlaw subscription).

First of all, it's an opinion by the Texas Commission of Appeals of the Texas Supreme Court, not the Supreme Court itself; this is an oddity of Texas judicial history that makes the precedent potentially not as strong as it might otherwise be.

Second, and following from the first, the Supreme Court (in 1920) "approved the judgment in the case," which is generally regarded as weakening the precedential value of an opinion. If the court adopted the opinion of the commission, the precedential value would be higher.

Third, the holding of Moss is this: A surgeon was liable for performing surgery on a minor without the consent of the patient's parents because although "there was an absolute necessity for a prompt operation, [surgery was] not emergent in the sense that death would likely result immediately upon failure to perform it. In fact, it is not contended that any real danger would have resulted to the child had time been taken to consult the parent with reference to the operation. Therefore the operation was not justified upon the ground that an emergency existed."

Amazingly (in light of the Miller court's use of Moss), the Moss opinion ends with this: "The law wisely reposes in the parent the care and custody of the minor child, and neither a physician nor those in temporary custody of the child will be permitted, in a case of this character, to determine those matters touching its welfare." So the Miller supreme court is "guide[d]" (the court's term) to affirm the court of appeals decision against the parents on the basis of an opinion from 1920 of dubious precedential value containing a ringing endorsement of parents' prerogatives to give or withhold consent and setting a very high standard for an exception (more than "an absolute necessity for a prompt" intervention, there must be an emergency "in the sense that death would likely result immediately upon failure to perform the [intervention]." Curious.

Fourth, in Moss, the surgeon relied in good faith on the apparently valid consent of the child's aunt. He had no reason to suspect there was a lack of consent. In Miller, there was every reason to know there was no valid consent. Moss looks like a case that stands for the simple proposition that we will presume consent in a true emergency as long as there's no reason to believe consent has not or would not be given. But of what relevance is that rule to the Miller case?

Fifth, assume that Moss is good law. Does it really support this result? After all, the hospital seems to have had just about the entire day either to get the parents' consent or to get a court order to override the parents' refusal, and it did neither. I don't think Moss really says this is alright.

Curiouser and curiouser.

Big Increase Seen in People Lacking Health Insurance

Robert Pear of the New York Times has an article on the Census Bureau's report on health coverage and the uninsured. Texas's percentage of uninsured is the highest in the country (24.1%), more than triple the rate for Minnesota, the lowest (8%). Why? Here are two reasons: "Texas, facing fiscal problems and unwilling to raise taxes, cut back Medicaid and its Children's Health Insurance Program this year." Our state CHIP saga is particularly deplorable. The state left over $600 million in federal matching funds on the table because of its unwillingness to allocate money to the program. No state funds = no federal match. Details here.

New form of defensive medicine.

Modern Healthcare's Daily Dose has a short piece today about a new report from the Center for Studying Health System Change. As DD reports, "Some physicians are reacting to higher malpractice premiums by declining elective referrals, sending patients to emergency rooms and refusing on-call duty."

End-of-life care and the battle over medical proxy's right to decide.

The Boston Globe published a lengthy article in Sunday's edition about an elderly woman in a locked-in state and the attempts by Mass. General to provide palliative care only, over the objections of her daughter/surrogate decision maker.

The Times got it wrong.

An article in today's New York Times follows up on research first published last year in the medical journals Brain (abstract only; full text requires subscription) and Neurology (abstract). The gist of the research is that many "permanently unconscious" patients are in neither a coma nor a permanent vegetative state; instead, they may be experiencing some degree of consciousness:

The implications of this research, both for medical ethics and practical policy, are potentially huge. Traumatic brain injuries are a significant health problem in the United States, but the study and treatment of them are clouded with a sense of hopelessness, a feeling that consciousness is too mysterious to be understood. When faced with patients in a vegetative state, doctors can do little more than wait to see if they wake up. No treatment has ever been definitively shown to help patients recover consciousness, and doctors can't predict which patients will emerge from a vegetative state and which won't. If patients don't show signs of recovery in a few weeks, they usually wind up at home with their families or in nursing homes, and they rarely see a neurologist again. In 1976, in a famous court case, the parents of Karen Ann Quinlan, a woman who had been in a vegetative state for about a year, won the right to take her off a ventilator (after which she lived until 1985). ''There's a point where people give up'' and discontinue aggressive treatment, says Joseph J. Fins, chief of the division of medical ethics at Weill Medical College. ''The question is, Are we giving up too soon on the ones who might become more functional?'' Schiff and his colleagues say that the answer, in too many cases, may be yes.

Indeed, some of the patients may be able to recover, however fleetingly, quite remarkable levels of conscious interaction with others, through deep massage:

Giacino works hard to tease out hints of awareness in a patient. Sometimes he can actually coax patients into consciousness by working his fingers deep into their muscles. Neurologists have found that the stimulation of the nerve endings in the muscles can be powerful enough to arouse activity in networks of neurons in the brain. Giacino has a particular knack for the technique, and after a few seconds of muscle work, he can get some minimally conscious patients to speak. Some tell him their names, others tell him to leave them alone. As soon as he removes his hands, they slip away again.

Marie Conniff has seen Giacino work this transformation many times. On New Year's Day in 1998, her son Scott was on duty as a New York policeman when a drunken driver rammed his car. Today, Scott sits in a wheelchair, his gaze often drifting across the room. Sometimes he laughs, sometimes he growls like a bear. He gives hard kicks to a big orange beach ball hanging from the ceiling. When Giacino begins to work her son's muscles, Conniff finds herself startled at how well Giacino can bring Scott back, in the look on his face, the clarity of his movements. ''I see a lot of what I had before he got hurt,'' she told me.

Until now, I have been very skeptical of claims that patients in a persistent or permanent vegetative state were "disabled" patients in need of protection against discriminatory policies that give up on the disabled as if they were already dead. The accepted paradigm for PVS is that the neocortical hemisphere is, for all intents and purposes, dead. This article -- quite misleadingly -- suggest that it is quite plausible that some number of such patients, diagnosed as PVS in accordance with protocols published by the American Academy of Neurology, experience relatively high levels of functioning, some of which might be recovered through appropriate therapies. Some of researchers whose work is discussed in this article have written to The Times to dispute any such implication. (I'll provide a link when and if The Times publishes their letter.) They want to clarify that PVS is and continues to be a valid diagnosis from which there is no return to sentience.

Medicare reform.

Saul Friedman argues in today's Newsday ("GRAY MATTERS: Ideology and Meanness in Medicare Debate") that "as it now stands, any legislation that is likely to emerge based on the bills passed in June by the House and Senate would be hopelessly inadequate, too costly and too complicated for most Medicare beneficiaries. I doubt that the members of Congress who are writing it could explain it to their aging parents. More important, the legislation is a kind of pact with the devil, for the price of a paltry drug benefit is the eventual privatization and death of Medicare. In addition, the legislation would not only encourage private insurance companies to sell prescription drug coverage, the House version would help beneficiaries pay the premiums to lure them to sign up for a better deal with private insurance and desert Medicare. The intended result is the demise of Medicare, which leaves health care for the nation's elderly in the hands of dozens of private insurance and drug companies." Friedman continues:

While Medicare's opponents may take cover in ideology in the debate over these larger issues, ideology can't explain the myriad outrages buried in the 800 pages of the legislation that would cost the taxpayers unnecessary billions and pick the pockets of the sickest and oldest among us.

One extraordinary example is a provision prohibiting the government from saving money by using its buying power to negotiate volume discounts with drug companies to get the best prices on drugs for beneficiaries. Indeed, the legislation would exempt drug companies from the cost controls that govern every other Medicare provider - doctors, hospitals and laboratories.

There's more to read -- and to fume over -- in Friedman's excellent review of all that's wrong with what's going on in the Conference Committee that is trying to harmonize the House and Senate bills. I agree with Friedman: If the price tag for a prescription drug benefit we can't afford includes the ruination of the Medicare program, let's hope the conferees come up empty-handed.

When an untested drug is a patient's last chance.

An article in the Boston Globe this week explored the problems faced vby patients with terminal illnesses who have run out of drugs to help them fight their disease. In the view of some, "the current ways to get experimental drugs -- through clinical trials, 'compassionate-use' or 'expanded-access' programs -- are tragically inadequate." In response, some patients' groups are suing the FDA "to create a new level of review called Tier 1 Initial Approval. Under this plan, patients would be able to get an experimental drug if it has passed Phase I trials, if the patient has been rejected from clinical trials of the drug, and if nothing else has worked. Perhaps most controversially, they also want to allow patients to pay manufacturers for the drugs, an issue that opens a Pandora's box of ethical and liability questions." Opposition to the proposed new classification is mounting. "Nancy Roach, a director of the Marti Nelson Cancer Foundation based in Vacaville, Calif., . . . opposes the Tier 1 idea, saying, 'It would rip the heart out of clinical research.' . . . At the end of a Phase I (safety trial), a drug may have been tested in only a few dozen people. (It is not until Phase II and Phase III trials that a drug is tested in more people and researchers study dosages and efficacy.) 'You don't give drugs to people unless there's a good reason to, you know how to give them, and the person has some chance of benefiting,' she said." The widely respected physician-ethicist, Marcia Angell is also against the idea: "'New drugs are far more likely to fail than to succeed,' she said, 'so the chances are that a patient will be hurt by a drug rather than helped.' . . . She said she also is appalled that patients might end up paying manufacturers for experimental drugs. Drug companies already 'are profitable beyond any industry,' she said. 'They are protected by the government. They have monopoly rights, patents, tremendous tax breaks.' And the opposition doesn't stop there. Alan Goldhammer, associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said it would be "potentially reckless" for manufacturers to release drugs after only Phase I trials because at that point there is "no proof of efficacy at all."

Boston Children's Hospital.

More cases, going back three years, not just one (the main focus of the Mass. Department of Public Health's scathing report last week), are starting to emerge. (See story in today's Pembroke Mariner.)

Children's Hospital in Boston.

With The Boston Globe's archive policy, it's hard to find the links to all of its articles about the investigations into deaths there over the past year. Here's everything I can find (with no guarantees that these links will continue to work forever):
September 18 | September 19 | September 20 | September 22 | September 23

There's a bit of a media frenzy going on, but it's a compelling story with the additional lesson that if it could happen at one of the country's best hospitals, it could happen in yours, too.

214th birthday of the Judiciary Act of 1789.

Please allow a former teacher of Civil Procedure and Federal Courts to note the anniversary of the passage of the Judiciary Act of 1789. Building on the sketchiest of language in Article III of the Constitution (which provides for "one supreme Court, and . . . such inferior Courts as the Congress may from time to time ordain and establish"), the Act gave us the District Court/Court of Appeals/Supreme Court structure we have today, though with very different functions for the lower courts. The Act also filled in the details of diversity jurisdiction; created removal jurisdiction, the predecessor of the All Writs Act, and a rule that compels discovery in actions at law to the same extent as proceedings in chancery; codified the "no adequate remedy at law" rule for equitable actions; created rules of procedure for trials and appeals; defined the (nondiscretionary) appellate jurisdiction (as opposed to the discretionary jurisdiction over writs of review) of the Supreme Court; and created the office the the United States Attorney in each federal judicial district. All of this and more can be tracked from 1787 to 1982 through the "Landmark Judicial Legislation" page of the Federal Judicial Center.

Medical error at a children's hospital

The Boston Globe has printed another good article on the recent deaths at the local children's hospital, this time focusing on the systemic, root causes (still a matter of conjecture) and considering whether there's something in the culture of teaching hospitals -- or at least some of them -- that stands in the way of effective communication, accountability, appropriate decision making, and safe system design. Important questions all.

Proposition 12: the dawning of a new day . . . .

Here's a good one from the unbeatable Ben Sargent . . . http://www.ucomics.com/bensargent/2003/09/16/

Case study of medical error in one of the best pediatric hospitals in the US.

This Boston Globe article should be required reading for anyone who is serious about addressing medical error in complex, high-quality, tertiary-care academic medical centers. "Communication and accountability problems" is the generic term for what went wrong at Children's Hospital in Boston, but the devil's in the details. For even more detail, the Massachusetts Department of Health has published a 24-page report on this and three other deaths at the hospital from August 2002 to July 2003. I haven;t found the report on the MDPH web site but I've e-mailed them about any plans they might have to post it and will provide the link as soon as I have one.

End-of-life decision making.

This week's New England Journal of Medicine published a contribution to much-needed research into the way decisions are made about life-supporting treatments. A Canadian group concluded (abstract only; full text requires subscription) on the basis of their study of 851 critically ill patients in 15 ICUs: "Rather than age or the severity of the illness and organ dysfunction, the strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physician's predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors." One problem with this approach, as Larry Schneiderman points out in an article on South Africa's Health24.com web site: "Doctors believe they know what patients want in terms of life support, and that family members can fill in blanks. But Schneiderman says his own research suggests that what physicians think critically ill people want is in fact nearer to what they would choose for themselves. Family members, too, aren't especially reliable translators of their loved one's wishes. . . . We're always relying on surrogate decision makers or physicians, Schneiderman says. But there's plenty of evidence that it doesn't correlate too well with what patients truly desire."

Does HIPAA apply to the NFL?

As we all know, HIPAA gives patients a right of access to their own medical records. Right? Right. Unless, that is, you are a professional football player, according to an article in today's Grand Forks Herald (picking up on the story originally run by the Charlotte Observer). Under the collective bargaining agreement between the NFL and the players' association, players can see their medical records twice a year -- and never during the regular season. According to the article, DHHS isn't quite sure whether HIPAA applies to the NFL (neither am I: Is the NFL a "covered entity"? It seems like a stretch). And you would think that players can contract that right away for valuable (very valuable) consideration. But Boston University's George Annas is surely right when he says, "It's so behind the times. The whole country has been moving to open access to your own records, whether they're medical, police, credit or education records. No one would argue with that anymore.

"The problem with secret records is people are making decisions about you, and you don't know why. In this case, when you're talking about professional football players, (teams) could be making decisions about whether they should play or not. Their livelihood and future health could be at stake."

Dubya takes Prop 12 on the road.

Trial lawyers, says the President in today's weekly radio address, are driving up health care costs and taking their fees away from deserving plaintiffs: "I have proposed reasonable limits on the lawsuits that are raising health care costs for everyone. . . . [And] we need to address the broader problems of frivolous litigation. We need effective legal reforms that will make sure that settlement money from class actions and other litigation goes to those harmed, and not to trial lawyers." As pointed out by AP writer Jennifer Loven (see, e.g., the San Francisco Chronicle's version of the AP story), this is a theme that Bush got mileage out of when he was governor and he has to be thinking it has a great populist ring to it for the upcoming election year.

The Safety of Imported Drugs

An editorial in today's New York Times describes the wackiness of the pharmaceutical industry's global pricing strategy. The FDA seems to be playing into that strategy with stern warnings that drug imports might be contaminated or improperly stored or transported. The FDA's position is predictable: given a choice between consumer choice and consumer safety, they will always go with safety, even when the safety concerns are more theoretical than real. (I don't mean to imply there can't be -- or aren't -- real safety concerns. The FDA has sent a warning letter to CanaRx based on that company's shipment of insulin at room temperature when the drug needs to be kept refrigerated. The real question, though, is what is an acceptable safety margin for drugs purchased at an affordable price, as opposed to drugs that are not purchased or administered properly because they are too expensive.) My hometown of Springfield, MA, is leading the way among state and local governments by pursuing an official policy of Canadian drug purchases for city employees, and Illinois is considering the same thing. Many individuals have been importing their drugs from Canada for years, despite a law that says generally only manufacturers are allowed to import drugs. As the Times editorial says, unfair pricing practices are driving this issue, and both the safety and the pricing problems can be worked out if Big Pharm and the FDA can find the desire to do so.

Another North Texas physicians' group charged with price-fixing.

The FTC has filed a complaint against yet another north Texas IPA. (See my earlier post on the last such action, in June of this year.) You can get a copy of the administrative complaint here. This IPA denies the charges of concerted refusal to deal and price-fixing by the 600-member group, which the FTC claims is not a risk-sharing entity and is neither clinically nor financially integrated.

Comfort Foods Switch Off Stress, Scientists Find

No kidding.

Really, did we need a paper in The Proceedings of the National Academy of Sciences on this to know what is now headline news in The New York Times? Here are some of the not-earth-shattering conclusions:

-- "Comfort foods like chocolate cake and ice cream literally blunt the body's response to chronic stress."

-- "This makes sense from an evolutionary viewpoint. . . . Animals that are acutely stressed stop eating, lie low and pull fat and protein from their bodies. But they cannot do that forever. . . . 'After a few days, they need to get out and get a real fix,' [the author] said. 'They need high-energy foods, like a tub of butter, to put money in the bank.' Once energy stores are replenished, a signal, probably from fat, flows back to the brain saying it is all right to calm down [and] the chronic stress cycle is turned off."

-- "'"[I]f you are overly stressed, it's probably a good idea to overeat, at least in the short run,' said [one of the authors]. 'But if you develop a thick tire of fat around your abdomen, you need to figure out a way to reduce your stress or you'll be inviting all sorts of chronic health problems.'"

-- "In an insidious sidelight, stress hormones also activate fat receptors in the abdomen and belly in ways that increase deposits of fat, he said. The more abdominal fat people have, the better they shut down chronic stress but the more vulnerable they are to diabetes, heart disease and stroke."

-- "Chronic stress, perversely, also excites the compulsive pleasure-seeking component of the system, [the author] said. 'If you use sex, drugs or rock 'n' roll instead of high-energy food to get stress-reducing pleasure, you miss out on the metabolic feedback,' he said. 'You don't shut down the chronic stress system. You just seek more cocaine. Things like saccharin won't cut it. You need the real thing or the system won't stay in balance.'"

Anyone for transcendental meditation and a pint of Häagen-Dazs?

Democrats find bright side of loss on Prop. 12

Here, in an article from the Austin American-Statesman, is a somewhat more plausible spin from the losing side of the Prop. 12 battle: Viewed as a Republicans vs. Democrats battle, getting 49% of the 1.46 million votes case was the best showing the Democrats have made in a statewide election in many years. I'm not sure how accurate it is to spin this as GOP vs. Dems, though, with top Republicans like Deborah Hankinson and Jim Baker spearheading the opposition to Prop. 12.