Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Sunday, July 23, 2006
Criminal Law III: More on the NOLA murder prosecutions
The American Way of Death III
We read this poem every year in Law, Literature & Medicine, where third-year law students from SMU and fourth-year medical students from UT-Southwestern wrestle with Dickinson's verses, among many others.
Because I could not stop for Death –
He kindly stopped for me –
The Carriage held but just Ourselves –
And Immortality.We slowly drove – He knew no haste
And I had put away
My labor and my leisure too,
For His Civility –We passed the School, where Children strove
At Recess – in the Ring –
We passed the Fields of Gazing Grain –
We passed the Setting Sun –Or rather – He passed us –
The Dews drew quivering and chill –
For only Gossamer, my Gown –
My Tippet – only Tulle –We paused before a House that seemed
A Swelling of the Ground –
The Roof was scarcely visible –
The Cornice – in the Ground –Since then – 'tis Centuries – and yet
Feels shorter than the Day
I first surmised the Horses' Heads
Were toward Eternity –courtesy of the Academy of American Poets
The American Way of Death II
As Paduda points out, these numbers are consistent with a study led by Dartmouth's John Wennberg. As summarized by NewsTarget.com:Intensive care costs comprise 30 to 40 percent of hospital spending and may continue to grow as the population ages, according to a new Mayo Clinic study. Older people with chronic illnesses have the highest rates of intensive-care-unit (ICU) use at the end of their lives, the study found. The country's aging population has an increased prevalence of chronic diseases, signaling that ICUs may treat more and more people in the years ahead. . . .
The study was set in Olmsted County, home of Rochester-based Mayo Clinic, and looked at 818 residents who were admitted to an ICU in 1998. Of those people, one in five died after having received ICU care in the last six months of life. Patients in the last year of their lives accounted for one-fourth of the ICU days used by county residents.
The Dartmouth Atlas Project studied the records of 4.7 million Medicare enrollees who died from 2000 to 2003 and had at least one of 12 chronic illnesses. The study demonstrates that even within this limited patient population, Medicare could have realized substantia savings — $40 billion or nearly one-third of what it spent for their care over the four years — if all U.S. hospitals practiced at the high-quality/low-cost standard set by the Salt Lake City region.
The American Way of Death I
In Ashley's care (with which I have no quarrel), there was no focus on dying until — reluctantly — she went into hospice two weeks before the end of her life. Fortunately, hospice did give us all some preparation for what was to come, but I recall no substantive discussion with the oncologist, or the nursing staff, or the surgeons about what to expect as Ashley died, how to handle it, and what to do — only discussions about how to fight the cancer, until it was clear that fighting was over. Then, it seemed, the entire oncology department removed itself from the picture; even the pain management center seemed to fall short of helping. No one, no organized section of the medical community, came forward to help in the transition from aggressively treating the cancer to helping the patient die. Hospice stepped up to the plate within the scope of its purview, but the medical community, in retrospect, seemed to have hit a wall, as if their jurisdiction to help Ashley in any way ended when it was clear that she would die.
Ashley liked and respected her physicians, liked the nurses who helped with her chemotherapy; for the year and a half of her illness, these people had become, in a way, a part of her family. They knew her by name, knew about her life, what she did, what she liked, her family. For a while, she saw and talked to them nearly as much as the rest of her family. And suddenly, they were gone. Out of the picture. Part of her past. One nurse came to Ashley's memorial service, a gesture that showed us that Ashley had been important to them too; other than that, I did not see any of the members involved in her medical care again. While they were trying to beat this cancer, to win the battle, they were there en masse. When no more chemotherapy or radiation would be administered, they were gone. Looking back, I see this as a sad departure, almost an abandonment. They were there to help her try to live, but they were not there to help her die. . . .
Ashley's situation was unique, because she had several people in her immediate family and close circle of friends who were able to devote themselves to her during her illness and dying process. As time has passed since her death, and I have studied medical ethics and end-of-life issues, it has become clearer to me that there is a gap in the scope of medical care for terminally ill persons: How does the medical community help people die? Can the physicians who govern the treatment of an illness also embrace the care of the patient and the patient's family in the dying process? The disconnect that happens when the "fight" is over is a disservice to the patient. And it's a disservice to the health care professionals as well. They're out of touch with part of the course of the patient's illness, even if they can't cure the illness.
Ashley was very fortunate in so many ways. But what happens to patients who don't have family and friends with the ability or willingness to help them weather the rigors of treatment, or help them die when and if the time comes? Who supports these patients? Who helps their families and friends, who must try and manage this with little or no training or guidance?
Hospice can be a huge help, but it's still a blunt separation from the medical teams that were treating the patient. The transition in care might be the flick of a light switch, but the transition in terms of spirituality, psychology, acceptance for the patient — or the patient's family — cannot be so simple.
If the act of dying isn't shuttled into the closet, if the medical community could embrace it as a natural part of life, the process could be an easier one on everyone — less frightening, less painful, less lonely and rudderless. Death is ugly, scary, and final. But I doubt that any of us want to die feeling impotent, abandoned, no longer in the embrace of the physicians who cared for us when they hoped we might live. A natural part of death for everyone is grief, anxiety, fear, maybe anger. But it can also be a time of growth and enlightenment.
Ashley wasn't timid about dying. The medical profession shouldn't be either.
Saturday, July 22, 2006
Criminal Law II: follow-up on the Memorial Hospital case
- the state attorney general has no power to indict or prosecute for these alleged crimes;
- the physician and nurses involved have not been charged with any crime, only arrested, which is the extent of the state AG's authority;
- there has been no grand jury investigation into the deaths at Memorial hospital;
- there is not yet an official medical examiner's report into the cause of death of the four patients whose deaths lead the AG to arrest the health care workers;
- the Orleans Parish D.A., Eddie Jordan, has the prosecutorial authority in these cases, and he's taking a wait-and-see attitude; and
- there is at least some feeling among Louisiana lawyers that the AG's aggressive grandstanding crosses the line into unethical behavior and is related to his plan to run for reelection in 2008.
There's a good article from the L.A. Times on all this.
Criminal Law I: promoting off-label uses of approved drugs
Now, it's horn-book law that physicians can use approved drugs for off-label uses. And it's equally well-settled, though perhaps a little less well-known, that pharmaceutical companies cannot themselves promote their approved drugs for nonapproved (or "off-label") uses without formal FDA approval; they have to limit their claims for the drug's safety and efficacy to those uses for which they submitted data to the FDA and received that agency's marketing approval. (Max Mehlman has a good essay on this. The FDA's rule is here.)
But it is apparently perfectly okay for a pharmaceutical company to pay a physician to promote the off-label use of the company's approved drug or, as the Times article puts it: "Despite the F.D.A.’s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor 'continuing medical education' sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields — including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies."
So how did Dr. Gleason get into so much trouble? It's not that clear. Perhaps the FDA decided to rein him in because it viewed his claims concerning Xyrem's safety -- i.e., that it was as safe as table salt and safe for children -- extravagant and dangerous, considering that its active ingredient is GBH (the "date rape drug"). Or perhaps it's because Dr. Gleason did not agree to cooperate with the government's investigation of his former benefactor, Jazz Pharmaceuticals, which has not yet been charged with anything. What is clear is that the FDA's rules don't provide much guidance for this practice and the basis for a criminal prosecution in Dr. Gleason's case is shaky at best. Stay tuned . . . .
Friday, July 21, 2006
Texas hospitals and immigration
Thursday, July 20, 2006
House fails to override presidential veto
An excellent primer on the stem cell issue
Wednesday, July 19, 2006
President signs fraudulent Fetus Farming Prohibition Act
The news stories on the president's veto haven't mentioned the other bill that was sent to him for his signature, but now that a transcript of the veto/signing ceremony is available from the White House, I can report that he has signed S.3504, the purpose of which is "to prohibit any person or entity involved in interstate commerce from: (1) soliciting or knowingly acquiring, receiving, or accepting a donation of human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such tissue; or (2) knowingly acquiring, receiving, or accepting tissue or cells obtained from a human embryo or fetus that was gestated in the uterus of a nonhuman animal. Imposes fines and/or imprisonment for violations of this Act." It was introduced about a month ago, had no hearings, and produced no committee reports. The nonexistence of this "problem" was conceded by Congressman Joe Barton at the beginning of the House debate on this bill yesterday:
Cong. Rec. H5345 (July 18, 2006)(emphasis added).I rise today in the strongest possible support of S. 3504, the Fetus Farming Prohibition Act. Every so often, we deal with a subject on this floor that is so ugly that the language almost is unable to qualify and quantify that ugliness. Today is one of those moments. When you know what fetus farming is, words like obnoxious and repugnant seem timid.
As we know, fetus farming is the gruesome idea of creating a human fetus purely for research to harvest its organs. This bill would ban that practice, and we cannot ban it, in my opinion, soon enough. Most scientists today share the belief that human life should not be created just for the purposes of experimentation, or for harvesting the organs of one person to be given to another. The vast majority of scientists in our Nation uphold the ethical and moral principles on which our country forever rests, the inalienable right to life and the inherent value of human life in whatever form it may take.
These scientists are working tirelessly with the knowledge that their efforts are to benefit life, benefit humanity, not to benefit one person for profit at the detriment of another person.
Unfortunately, Mr. Speaker, we have seen clear examples in other countries that some scientists see things somewhat differently.
It is towards these scientists that the pending legislation is directed. Rather than waiting for a horror story to appear on the front pages or allowing for the possibility of scientific advancement taking us down a slippery slope, this bill gives a clear signal that fetus farming in all of its forms will not be tolerated in the
United States, nor will we allow human fetuses or embryos to be bought and sold for research like cattle.
President carries out veto threat on stem-cell measure
"This bill would support the taking of innocent human life of the hope of finding medical benefits for others. It crosses a moral boundary that our society needs to respect, so I vetoed it," Bush said at a White House event where he was surrounded by 18 families who "adopted" frozen embryos that were not used by other couples, and then used those leftover embryos to have children.
"Each of these children was still adopted while still an embryo and has been blessed with a chance to grow, to grow up in a loving family. These boys and girls are not spare parts," he said.
I suppose you can admire his consistency on this issue, though I am more inclined toward Art Caplan's comment that it's a foolish and uninformed consistency. As for the shameless display of of these 18 kids, no one (1) ever doubted that frozen embryos have the capacity to be implanted in a womb and nurtered to maturity or (2) suggested that children so produced were merely "spare parts." That comment well illustrates the vacuousness of the president's policy. And unless I miss my guess, there isn't a state in the country that allows couples to adopt an embryo. Embryo donation is expressly permitted in a number of states, and many (but not all) have paternity rules for the resulting child, but adoption of an embryo? Outside of the federally-funded Snowflakes program -- which appears to result in a purely private, contractual arrangement -- I don't know of a state that has provided for such adoptions by law.
Caplan on Bush's veto of stem-cell bill
President Bush’s embryonic stem cell policy began with lies and has now ended with one.
Bush reserved his first veto as president for one of the only valuable things this do-almost-nothing Congress has managed to actually get done.
With a flourish of a veto pen that has remained dormant no matter how dopey Congress has been, the Senate bill allowing public funding of embryonic stem cell research has been consigned to the legislative trash can. . . .
With his veto the president has now reaffirmed a policy that never made any sense, garnered no scientific support to speak of, was abandoned by both houses of Congress and the leaders of his own party and, most importantly, got no traction with those most in need of the benefits of the research — patients and their families.
The president has now told doctors, researchers and patients to drop dead. Science policy in the Bush administration is best made in the White House, not by scientists and not by Congress.
HCA nearly bought out in recent days
Stem cell minuet proceeding almost as planned; Bush set to veto the most meaningful of three bills
The House voted on S. 3504 (the Fetus Farming Prohibition Act) yesterday (roll call vote 379). The Senate's roll call votes are here: S. 3504 vote, S.2754 vote, and H.R.810 vote. The only wrinkle in the whole scenario occurred when the House failed to pass an amended version of S.2754, the Alternative Pluripotent Stem Cell Therapies Enhancement Act (roll call vote 380). The bill got enough votes (273) to pass on a straight up-or-down vote, but a 2/3 vote (285 in favor) was needed to pass it on an accelerated "suspension" calendar. As a result, the president may have only one bill he can sign today, unless something happens in the House this morning. Alternatively, according to the Washington Post, it's possible the president will wait until he has all three bills before he vetoes H.R.810.
Tuesday, July 18, 2006
Tenet physician and 2 nurses arrested for murder in Louisiana
As reported by Associated Press (courtesy of the Houston Chronicle):
Memorial Medical had been cut off by flooding after the Aug. 29 hurricane swamped New Orleans. Power was knocked out in the 317-bed hospital and the temperature inside rose over 100 degrees as the staff tried to tend to patients who waited four days to be evacuated.
In court papers, state investigators said Pou told a nurse executive three days after the hurricane that the patients still awaiting evacuation would probably not survive and that a "decision had been made to administer lethal doses" to them.
Overdoses of morphine or Versed can stop the heart and lungs.
The allegations are that the three administered lethal doses of morphine (a pain killer) and Versed (a sedative). The AP story continues: "Tammie Holley, an attorney for about a dozen families whose relatives died at Memorial, said the presence of the sedative in addition to morphine is important in determining whether the staff members intended to kill. Versed, or midazolam, is used to induce unconsciousness before surgery, according to a medical Web site. 'If it was only morphine, there would be no way to know if they were administering it to control their pain,' Holley said.
- press release from the office of La. Attorney General Charles C. Foti, Jr., which includes the following statement: "I believe this case is a strong one and that these charges are based on sound legal and medical evidence. I also believe that there may be more arrests and victims that cannot be mentioned at this time and that this case is not over yet. While I am aware of the horrendous conditions that existed after Hurricane Katrina ravaged New Orleans and left so many stranded without food, water, electricity and the basic necessities, I believe that there is no excuse for intentionally killing another living human being. The fact is, the law was broken and it is my job to seek justice for the victims in this case. It gives me no pleasure to report what happened here today and my heart goes out to the families and loved ones of those victims."
- no press release from Tenet (press releases are posted here), although it has been quoted as saying through a spokesman: "Euthanasia is repugnant to everything we believe as ethical health care providers, and it violates every precept of ethical behavior and the law. It is never permissible under any circumstances."
Personally, I am inclined to believe that these cases involved attempts to provide pain control and relieve suffering for dying patients who last hours in a hellish environment would otherwise have been wretched. "Double-effect euthanasia" is easy to misinterpret, since so much depends upon the intent of the health-care professional, but there are medical facts that are more or less consistent with an intent to treat, as opposed to an intent to kill, and we will have to know more of those facts before a firm opinion is possible.
The AP story addresses this through Steve Miles:
Dr. Steven Miles, a professor of medicine at the University of Minnesota's bioethics center, said that instead of trying to kill, it is more likely that those charged were trying to relieve patients' pain "in a resource-poor environment and were doing the best they could."
He said that there are documented cases where patients have required seemingly lethal morphine doses to relieve extreme pain, and that he doubts the charges will be proven. "I'm inclined to believe this was palliative sedation that's been misread," Miles said.
Mercy killings would be "not only highly frowned upon, but also rare," Miles said. "It's highly unlikely that's what happened here."
Art Caplan and Steve Miles are also quoted in a later AP story, "Ethicists: No Way to Justify Mercy Deaths" (courtesy of Newsday).
Monday, July 17, 2006
Union boss to Fortune 500 CEO's: let's reform health care together
Saturday, July 15, 2006
SSRN roundup: health law
- Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
Yale Law School, Law & Economics Working Paper No. 237
John R. Lott Jr. and John E. Whitley
American Enterprise Institute (AEI) and University of Adelaide - School of Economics
Date Posted:May 22, 2000
Last Revised:June 10, 2002
Working Paper Series 8966 downloads - Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
Yale Law & Economics Research Paper No. 254
John R. Lott Jr. and John E. Whitley
American Enterprise Institute (AEI) and University of Adelaide - School of Economics
Date Posted:May 16, 2001
Last Revised:June 5, 2001
Working Paper Series 5758 downloads - Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
Columbia Law and Economics Working Paper No. 287
U Illinois Law & Economics Research Paper No. LE05-002
U of Texas law, Law and Econ Research Paper No. 030
Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005
Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
Date Posted:October 25, 2005
Last Revised:January 23, 2006
Accepted Paper Series
1624 downloads - What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
Stanford Law Review, Vol. 52
Jonathan Zittrain
Oxford Internet Institute
Date Posted:March 9, 2000
Last Revised:June 30, 2000
Accepted Paper Series
1248 downloads - TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
U Chicago Law & Economics, Olin Working Paper No. 140
Alan O. Sykes
University of Chicago Law School
Date Posted:February 19, 2002
Last Revised:March 7, 2002
Working Paper Series
1026 downloads
Capital punishment and organized medicine: still a no-go in Mo.
The nub of the problem, of course, is that "[t]he American Society of Anesthesiologists and the American Medical Association [Op. E-2.06] say physicians should not take part in executions, and Orin F. Guidry, the president of the A.S.A., recently issued a letter to members reiterating that position in light of the Missouri ruling." Dr. Guidry's description of the ASA position on physician participation is a little more nuanced than The Times lets on, but the ASA apparently comes out the same place as the AMA: "ASA does not have a detailed position on anesthesiologist participation in lethal injection but the 2001 House of Delegates 'Approved a recommendation that ASA support the American Medical Association’s position regarding physician nonparticipation in executions.' . . . . Clearly an anesthesiologist complying with the Missouri ruling – and despite this court’s position on ethical obligations - would be violating the AMA position which ASA has adopted. It is my belief that the court cannot modify physicians’ ethical principles to meet its needs."In a sworn deposition, the Missouri doctor, whose name is being withheld by the state, acknowledged that he had sometimes given the condemned a smaller dose of anesthesia — used to reduce the pain of the lethal drugs to come — than the state had said was its policy.
The doctor said he was solely responsible for counting out dosage amounts of the three drugs administered in sequence, knew of no written protocol by the state for carrying out executions and was at times “improvising.”
He also said he is dyslexic, sometimes mixing up phone numbers or cable bill account numbers. “So it’s not unusual for me to make mistakes,” the doctor, identified in court records as John Doe I, said.
He indicated in his testimony, however, that he had made no mistakes in his death chamber work and that the mistakes elsewhere were “not medically crucial.”
Judge Gaitan said he was “gravely concerned” about the doctor’s dyslexia and criticized the lack of “checks and balances,” ruling on June 26 that the state was subjecting the condemned to “an unnecessary risk that they will be subject to unconstitutional pain and suffering when the lethal injection drugs are administered.”
The judge ordered Missouri to hire a board-certified anesthesiologist (John Doe I is a surgeon), and gave the state until today to submit a formal, written set of procedures, including increased monitoring of inmates and an assurance of sufficient anesthetic drugs.
But in the state’s filing last night, officials said they had sent letters to 298 certified anesthesiologists who reside anywhere near the state’s death chamber in Bonne Terre, and were turned down by all of them.
Guidry ends his letter with some blunt observations:
We are being reluctantly placed on a slippery slope. If the courts demand that inmates be sufficiently anesthetized, then I would have to agree with the court that the only way to assure that would be to have an anesthesiologist prepare and administer the drugs, carefully observe the inmate and all pertinent monitors, and finally to integrate all this information. I don’t think that any of us would want to say that untrained individuals under current death chamber conditions can reliably produce a satisfactory level of unconsciousness. Our core skill is that we can induce an appropriate level of anesthesia. Are we willing to say that untrained individuals can also do so with a reasonable degree of success?
However if the only way to accomplish this appropriate level of anesthesia is with an anesthesiologist using all of our tools AND anesthesiologists will not participate, then are anesthesiologists stopping capital punishment and making public policy?
Not in my opinion. Lethal injection was not anesthesiology’s idea. American society decided to have capital punishment as part of our legal system and to carry it out with lethal injection. The fact that problems are surfacing is not our dilemma. The legal system has painted itself into this corner and it is not our obligation to get it out.
Friday, July 14, 2006
Has the Texas legislature made performing abortions a capital offense?
Does a physician’s failure to comply with the requirements of either § 164.052(a)(18) (restricting third-trimester abortions performed on viable unborn children) or § 164.052(a)(19) (requiring parental consent for abortions performed on unemancipated minors) of the Texas Occupations Code, as provided by § 1.42 of S.B. 419 (2005 TEX. GEN. LAWS ch 269, § 1.42) subject the physician to liability under the criminal homicide provisions of ch. 19 of the Penal Code?
As reported in this morning's Kaiser Daily Women's Health Report, which drew heavily from a story in yesterday's Austin Statesman-American, Swinford wants to test an interpretation of the new law by the Texas District and County Attorneys Association:
The analysis says that because it is illegal both for abortions to be performed on a minor without the consent of a parent or guardian and for a physician to perform a third-trimester abortion, doctors who perform them could be prosecuted for murder. The analysis -- written by Shannon Edmonds, the group's director of governmental relations -- says, "This was undoubtedly an unintended consequence but one that law enforcement authorities should be aware of." Edmonds, who said he is unaware of any such prosecutions, said, "After every (legislative) session, there are changes in the law that are real head-scratchers, some intentional and some are unintentional. ... This is just a way to illustrate how unintentional consequences can result in something extreme" (Embry, Austin American-Statesman, 7/13). Swinford, who disagrees with the interpretation of the law by the TDCAA, said the law is intended to provide
criminal penalties for the failure of physicians to obtain parental consent or to comply with restrictions on abortions conducted at or after 28 weeks' gestation, but "certainly not to subject a physician to prosecution for capital murder."
Both the Kaiser report and the news story missed a crucial part of the story. Shannon Edmonds' analysis turns on a little-discussed amendment to the Penal Code in 2003 that expanded the definition of "individual" in the homicide portion of the Penal Code to include an unborn child at any stage of development starting at conception. Although the Penal Code exempts physicians who perform lawful abortions, that exemption wouldn't apply to physicians who perform unlawful abortions. And since the 2005 amendments to the Occupations Code make it unlawful for a physician to perform most late-term abortions or abortions on minors without parental consent (subject to a judicial-bypass provision), the argument would be that physicians who violate the new provisions would fall outside the 2003 law's exception for lawful abortions.
This is almost undoubtedly not what the legislature intended. With the Texas Legislature, though, you can never be quite sure. And by providing specific, lesser penalties for violations of the Occupations Code, the Legislature could be understood to have intended these penalties as an alternative to the Penal Code's death penalty. But when it comes to harsh penalties and the Texas Legislature, you can never be quite sure.