HealthLawProf Blog

Medical Ethics Breached on Guantanamo

According to an article in today's New York Times, "The International Committee of the Red Cross has charged in confidential reports to the United States government that the American military has intentional used psychological and sometimes physical coercion 'tantamount to torture' on detainees at Guantanamo Bay, Cuba."  The Red Cross' inspection team "of humanitarian workers, which included experienced medical personnel, also asserted that some doctors and other medical workers at Guantánamo were participating in planning for interrogations, in what the report called 'a flagrant violation of medical ethics.'"  The charges, which are denied by the Administration, include providing interrogators access to medical files as part of the interrogation process.  It is unclear from the article whether the Red Cross also accused the military doctors of consultating with interrogation teams to calibrate the level of pain to be administered to prisoners.

Yet Even More on Raich and the Oral Arguments

Tony Mauro from The Legal Times weighs in on the oral argument yesterday in Raich v. Ashcroft.  In his opinion, the justices were not receptive to the arguments of those supportive of medicinal marijuana statutes.

The article states,

"The Supreme Court on Monday appeared ready to accept Bush administration arguments that California's medical marijuana law interferes too much with federal efforts to combat illicit drugs.

In spite of the conservative majority's interest in strengthening state powers, most justices seemed skeptical of the argument that California could defy the federal Controlled Substances Act by allowing purely in-state, noncommercial distribution of marijuana for medical use. Ten states have followed the lead of California, whose voters in 1996 passed Proposition 215 to allow marijuana use in cases of medical necessity.

"We face a mess," said Justice Stephen Breyer at one point, lamenting the prospect of states and federal governments having to distinguish between marijuana that was grown and used locally for medical purposes from that which crossed state lines and is subject to federal regulation.

Rather than enacting medical marijuana laws state by state, Breyer said, the Food and Drug Administration should be petitioned to reclassify marijuana in a way that would allow doctors to prescribe it.

"That seems to be the obvious way to get this done," Breyer said. "Medicine by regulation is better than medicine by referendum."

For more information and viewpoints, see the scotusblog.

NJ Posts Med Mal Histories of Doctors

Under  a recently enacted New Jersey law, a state government Web site publishes  doctors' malpractice histories.   The Web site was authorized by the New Jersey Health Care Consumer Information Act, N.J.S.A. 45:9-22.21, and includes malpractice payments in the past five years as well as the medical school, licensing history, hospital privilege restrictions, disciplinary actions and other information about the state's more than 32,500 doctors, osteopaths and podiatrists.

Some lawyers report that the increased publicity may be having a chilling effect on settlements. "Doctors do not want to settle at all now that it has to be reported to the databank for any payment whatsoever," says defense lawyer Richard Amdur, who claims that he used to settle about a third of his cases but estimates that he now that number has declined to between 10 to 15 percent.   Other lawyers claim that the publicity makes no difference.  According to one defense attorney, the issue for doctors becomes the potential for an increase in premiums that follow a malpractice payout.


The Web sites missing information on some doctors appears to be a larger problem, however, for those who may choose to use and rely on it.   According to a report in the New Jersey Law Journal, "The effect of the data gap is compounded by the comparison of each doctor's records with those of other doctors in the same specialty. Each doctor's malpractice experience is rated as average, above average or below average, so without complete data, a doctor might be categorized as above average because of missing data on peers."   

It should be interesting to see how this web site eventually works or does not work.  It may provide the consumer (and plaintiff's attorney) with some helpful information but it may also increase the cost of medical malpractice claims if individual doctors prefer to go to trial rather than have a new addition to their medical malpractice history.

More on Raich Oral Arugment

Add to yesterday's early reports on the Supreme Court oral argument in Ashcroft v. Raich these excellent accounts:

• Linda Greenhouse in The New York Times
• PBS' News Hour report

VBAC Under Attack

On another obstetrical front, The New York Times on Monday ran a story about hospitals that have prohibited obstetricians from performing vaginal deliveries for women who have previously had Caesarean sections.  Although the recent shift in attitude is explained early in the article by reference to recent studies that have increased the predicted rate of uterine rupture and catastrophic blood loss from 0.5 percent to 1 percent, "[s]ome doctors and hospitals freely acknowledge that fear of being sued has driven their decisions," in addition to "concern for patients' safety":

Hospitals say they cannot comply with guidelines issued in 1999 by the American College of Obstetricians and Gynecologists, which call for a doctor to be available "immediately" throughout active labor during such a birth, to perform an emergency Caesarean if needed. Previous guidelines had called for them to be "readily" available.

I guess they can call this a liability question if they want, but if the leading accrediting college for OBs has had this as a standard of care for the past 5 years, does "risk management" add anything to the debate (unless ACOG's standard was driven by liability concerns and not by science)?  The article does not tar ACOG with that brush:

Dr. Charles Lockwood, chairman of the department of obstetrics, gynecology and reproductive sciences at Yale and an author of VBAC guidelines issued by the American College of Obstetrics and Gynecology, said alarms began to sound in the late 1990's.

"What precipitated this were reports in the literature and reports that came to the college itself about women who had ruptured their uterus, particularly in rural settings, with no doctor and no anesthesiologist around," Dr. Lockwood said. "Babies died, and women lost the uterus in some cases."

That prompted the obstetrics college to change its formal recommendations for vaginal births after Caesareans in 1999, saying a doctor should be immediately available during labor to perform an emergency Caesarean.

And yet the med-mal demon immediately reappears in the article:

"[The ACOG standard] had a chilling effect," Dr. Lockwood said, particularly on hospitals in rural areas that did not have anesthesiologists available around the clock, and on doctors in solo practices who could not stay with a patient throughout her labor.

"I think the real death knell to VBAC's was the malpractice crisis," Dr. Lockwood said.

Med Mal Saga, Political and Personal, in Post

Saturday's Washington Post ran a long front-page article that detailed a 16-year-old obstetrical med mal case and its relationship to the political battle currently brewing in Maryland over tort reform.

Much is being written -- in journals, accreditation standards, and hospital policies -- about admitting errors and the potential power and pitfalls of apologizing for bad outcomes.  The contradictory strands of this debate are well illustrated by this story, which involves a 42-week gestation-age newborn who became stuck in the birth canal and whose delivery resulted in shoulder dystocia and injury to one eye.  Four paragraphs, in particular, summarize the medico-legal problem from the perspectives of the mother, Donnette Dennis, and her physician, Kevin Kearney:

Kearney visited Dennis the next morning. By then, he had seen the lack of tone in Richard's right arm.

"He just told me what had happened in the delivery room, that he was sorry for what he had done," she said. "He was sorry about what happened to Richard's arm."

Kearney said he left the hospital heartbroken. He doesn't remember apologizing to Dennis but said that if he did, it wasn't to convey that he "goofed." In fact, he felt certain he handled the procedure correctly.

It may be the most vexing aspect of shoulder dystocia, he said. If the baby is born with an injury, there is no way to know whether it occurred during delivery or during the baby's descent. The only certainty, Kearney believes, is that the doctor handling the delivery will be sued.

The defense presented evidence that shoulder dystocia occurs because of naturally occuring pressure within the birth canal before an obstetrician ever touches the infant.  Despite this apparently strong evidence attacking the causation element of the plaintiff's case, a jury found that Dr. Kearney's decision against a C-section fell below the standard of care in such cases.  For advocates of apologies to patients, the description of the trial must be somewhat chilling:

Along with medical testimony, attorneys from Schochor's firm presented two other pivotal pieces of evidence. The first, from Kearney's deposition, suggested that he panicked during the birth. He told attorneys he pulled down hard on Richard's head -- harder than during typical deliveries. The second critical detail: Kearney's apology. Why would he seek forgiveness if he had done nothing wrong?

One of the proposals pending in the Maryland legislature would, in Kearney's view, "make apologies inadmissible in court [and] have kept his words from being twisted."

Catherine Morris has assembled a good on-line bibliography on "Acknowledgement, Apology and Forgiveness."  I particularly recommend Lee Taft's article in The Yale Law Journal, Apology Subverted: The Commodification of Apology, 109 Yale L.J. 1135 (2000) (WestLaw password required).

Oral Argument in Medical Marijuana Case

Early news reports focus on (1) Justice Breyer's comment this morning that patients who want relief from the federal government's stance against the medical use of marijuana should take their pleas to federal drug regulators before coming to the Court, as well as (2) several justices' references to America's large problem with drug addiction.  Souter and Scalia were also described as skeptical of the patients' arguments.

Some of the sources:

• Associated Press (ABC News)
• Reuters
• Bloomberg News
• N.Y. Times

New Article on ADA and Mental Illness

If you find that you have some spare time on your hands (i.e., perhaps the thought of drafting your exam is too much after a lovely Thanksgiving break),  you may want to review  Elizabeth Emen's interesting article, "The Sympathetic Discriminator: Mental Illness and the ADA."  She examines the fact that individuals with mental illness often experience discrimination because others (including fellow co-workers) often feel negative emotions around them.   She contends that an open recognition of that emotional costs will help the courts better understand the tension in the ADA when applied to mentally disabled individuals and promote a less contradictory application of the ADA to those individuals. 

A portion of the abstract follows: 

 
"Discrimination against people with mental illness occurs in part because of how those with mental illness can make other people feel. A psychotic person may make others feel agitated or afraid, for example, or a depressed person may make others feel sad or frustrated. Thus, a central basis for discrimination in this context is what I call hedonic costs. Hedonic costs are affective or emotional costs: an influx of negative emotion or loss of positive emotion. In addition, the phenomenon of emotional contagion, which is one source of hedonic costs, makes discrimination against people with mental illness peculiarly intractable. Emotional contagion is a largely unconscious process by which we absorb the emotions of nearby others. Research on emotional contagion indicates that people with mental illness are likely to prompt others to absorb their negative emotions, and that emotional contagion increases the more we like someone. Contrary to the much-vaunted contact hypothesis that workplace integration increases liking and decreases discriminatory animus, then, integration of people with mental illness may instead give coworkers and employers more reason to want to avoid people with mental illness."

The full article is available on the SSRN website and will be appearing in the Georgetown Law Journal next year.

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Happy National Family History Day!

We hope that you had a terrific Thanksgiving!  If, however, you are feeling guilty about that extra helping of turkey or pumpkin pie, you might want to celebrate next year in the manner of the U.S. Surgeon General. 

The U.S. Surgeon General Richard H. Carmona has launched a national public health campaign, called the U.S. Surgeon General's Family History Initiative to help focus attention on the importance of family health history and to encourage all American families to learn more about their family health history.

The Surgeon General reports on what many health professionals have long known  -- that many common diseases such as heart disease, cancer, and diabetes - and even rare diseases - like hemophilia, cystic fibrosis, and sickle cell anemia, can run in families. He wants Americans to be more aware of the illnesses suffered by their  parents, grandparents, and other blood relatives so that they can help their doctor predict the disorders to which they may be at risk and to take action to keep them  and their family healthy.

To celebrate this new initiative, Surgeon General Carmona declared Thanksgiving 2004 to be the first annual National Family History Day.

So next year you might want to spend time getting to know your family better rather than eating that second helping of stuffing.   Ok, it was only a suggestion . . . .

Complete release at http://www.hhs.gov/familyhistory/

Medical Marijuana Case Argued Today.

Just a reminder that the Supreme Court hears oral argument today in the case of Ashcroft v. Raich, No. 03-1454, the case that challenged John Ashcroft's attempt to nix the California medical marijuana law by playing the pre-emption trump card of the Controlled Substances Act.  Here's a quick catalog of on-line resources:

• California's "medical marijuana law" (Health & Safety Code § 11362.5);
• Controlled Substances Act;
• complaint (PDF);
• 9th Circuit opinion (PDF);
• cert. petition of U.S. (PDF);
• Supreme Court's docket sheet in No. 03-1454; and
• petitioner's and respondent's principal merits briefs and government's reply brief (PDF)

Commentary:

• Today's Washington Post neatly summarizes the case. 
• See also summary posted by Medill School of Journalism, Northwestern Univ.
• Google News search for "medical marijuana" (includes link to PBS' "Religion & Ethics Newsweekly" story (Nov. 19, 2004) and to good overview in the Nov. 29 issue of the Christian Science Monitor)

Stem Cells - Big News!

Big Breakthrough --  A recent news report states that stem cells have helped a formerly paralyzed Korean woman walk again.   From the news:

SEOUL (AFP) - A South Korean woman paralyzed for 20 years is walking again after scientists say they repaired her damaged spine using stem cells derived from umbilical cord blood.

Hwang Mi-Soon, 37, had been bedridden since damaging her back in an accident two decades ago.

There is also another story from Brazil involving the successful use of stem cells to help an individual regain mobility.  With all these stories, the United States might want to expand the use of umbilical cord stem cells and to re-think its position on stem cell research in general.

Last week her eyes glistened with tears as she walked again with the help of a walking frame at a press conference where South Korea (news - web sites) researchers went public for the first time with the results of their stem-cell therapy.

They said it was the world's first published case in which a patient with spinal cord injuries had been successfully treated with stem cells from umbilical cord blood.

Though they cautioned that more research was needed and verification from international experts was required, the South Korean researchers said Hwang's case could signal a leap forward in the treatment of spinal cord injuries.

The use of stem cells from cord blood could also point to a way to side-step the ethical dispute over the controversial use of embryos in embryonic stem-cell research.

Seattle Hospital Apologizes for Lethal Error on Website

The on-line version of Modern Healthcare (subscription required) reports that Seattle's Virginia Mason Medical Center posted on its web page an apology for a preventable medical error that resulted in patient's death.  The hospital's statement, which may be viewed in its entirety here, begins:

Recently a preventable medical error occurred at Virginia Mason that we believe caused the death of one of our patients. We have offered our heartfelt apologies to the family of the patient and are doing everything we can to help them in this time of grief. But perhaps the only way we can make our apology real is to do everything we can to prevent medical errors in our system. Those efforts start with admitting that we make errors -- as in this case, owning up to errors, learning from them and fixing the systems that allow them to happen.

The MH article cites the Associated Press' report that "a technician mistakenly injected a 69-year-old woman with a toxic skin-cleaning antiseptic, rather than a harmless dye, during an operation two weeks ago. [Medical director of quality Robert] Caplan said both fluids were clear. The hospital has replaced the skin cleanser with an antiseptic-infused swab."

Living Wills: Do They Work?

In the March/April 2004 issue of The Hastings Center Report, Carl Schneider and Angela Fagerlin wrote a piece entitled, "Enough: The Failure of the Living Will."  For reasons best known to the Associated Press (slow news day?), Laura Meckler of the AP ran a story on this topic on Thanksgiving Day. 

The criticisms of the living will are straightforward and well-known:

• "[E]nd-of-life medical questions often involve much more complicated medical and moral questions. Many living wills are so vague as to be useless."
• "People change their minds after they write their living wills but don't update them."
• "Many living wills never make it to the bedside, left in a file cabinet or safety deposit box."
• "And family and doctors often do a poor job of deciphering the patient's wishes even when they have the wills in hand."
• "Since 1990, hospitals have been required in most states to offer all patients the chance to fill out a living will. But despite the law and despite several high-profile end-of-life legal disputes, most people still don't have living wills."

On the other hand, "Naomi Naierman, president of the American Hospice Foundation, acknowledged there can be problems with living wills and other end-of-life plans. But doing nothing is far worse, she said.

"'You're only leaving a mess behind if you don't have directives for when you cannot speak on your own behalf,' said Naierman, whose organization promotes living wills. 'It's a terrible burden to leave with the family.'"

The article provides a lengthy vignette that is supposed to illustrate the limitations of living wills:

Jeanne and James Hanchett thought they were prepared. Both physicians, they had filled out living wills saying they did not want extraordinary treatments. Each had given the other legal power to make medical decisions.

While watching his beloved Pittsburgh Steelers play at Three Rivers Stadium, James Hanchett's head fell onto his wife shoulder. Mrs. Hanchett and bystanders tried to revive him. "There was no response at all," she said.

Paramedics arrived about 25 minutes after he suffered the heart attack and put a tube into his lungs to get them moving again. But Mrs. Hanchett, a semiretired pediatrician, knew it was too late.

At the emergency room, she told the doctor to stop resuscitation attempts. He refused, saying, "'If it were my mother or wife, I would want this to continue,'" Mrs. Hanchett recalled.

She said the doctor dismissed her when she told him that her husband had a living will and that she had power of attorney.

"So I turned on my heel and walked out. I didn't want to start screaming and yelling. I had to call our children," she said.

It was 29 hours before she succeeded in persuading doctors to remove the equipment.

"I'm a bit angry, mostly frustrated," she said, a year later. "We had done everything we thought we should do and it was ignored."

What this illustrates, however, is that if you call 911, you can expect the paramedics to do what they are trained and required by law to do: attempt to resuscitate.  Living wills aren't designed to overcome this problem.  That's what nonhospital DNR's are for.

As Schneiderman and Fagerlin suggest, the better answer may be the medical power of attorney.  Personally, I usually recommend both the MPA and the living will, for a variety of reasons.  There is no question that the living will hasn't, and often won't, solve subtle treatment problems.  But is it better than nothing?  I tend to agree with Naomi Naierman.  And in tandem with an MPA, the living will can be better yet.

On a bioethics listserv today, a colleague posted the following message:

>I would welcome the List's comments on the following scenario:
>
>A psychiatric patient is treated and released from a psych unit of a
>hospital. Nothing comes up during this stay that would lead treating
>staff to suspect that the patient has committed a crime or poses a
>danger to others. However, following the patient's discharge, several
>members of the health care staff read in the local paper a police
>profile of a person suspected in an armed robbery. These staff members
>believe the profile (which includes a police sketch) is of the psych
>patient released from the hospital. Aside from the legal issues raised
>by this case (which are governed by state law and HIPAA), the staff
>members want to know whether it is ethically permissible to notify the
>authorities of the identity of the suspect. For example, would it be
>permissible for the staff member to notify the authorities anonymously?
>The staff member is not certain that the psych patient is the suspect,
>though the patient fits the fairly detailed profile to a tee.
>
>Anyone faced this sort of situation before? Thanks in advance for your
>thoughts.

The first three responses, from bioethicists on the listserve with real name-recognition in the field, were that notifying the officials would be (1) permissible, (2) impermissible, and (3) mandatory. 

Now, I don't offer this mini-colloquy as proof of anything, certainly not as proof that the field of bioethics lacks coherence.  But these responses made me take a bit more seriously than I might have an editorial from Michael Cook in The Age (Melbourne), in which he takes on "Julian Savulescu, the Uehiro professor of applied ethics at Oxford, who recently returned home to tell Australian parents that they have a moral obligation to genetically modify their children. An obligation, mind you, not just a nice idea":

Savulescu insists that this isn't Nazi eugenics, because Nazi eugenics was "a state-imposed vision".

He's wrong, of course. Eugenics is eugenics is eugenics. Eugenics means that people are bred like cattle to get the best genetic traits. And this is what Savulescu is advocating. He simply wants to achieve it through free-market, libertarian eugenics rather than through old-fashioned command economy eugenics. And as everyone in a globalised world realises, the libertarian approach has been far more effective at changing public preferences than Nazism or communism.

Savulescu is becoming a celebrity, but more for his brazen cheek in mentioning the unmentionable and trampling ancient taboos underfoot than for the depth of his arguments. His reasoning can accommodate any behaviour you want, as long as you make a freely chosen rational decision and accept the consequences. Stay tuned for further instalments.

Eugenics means that people are bred like cattle to get the best genetic traits. And this is what Savulescu is advocating.But rather than bat the shuttlecock of human genetic engineering back and forth across an ethical net, I'd simply like to ask what credentials Savulescu possesses to give him such prominence in the Melbourne media. Isn't it a bit unfair to the rest of Australia's fruitcakes to invite him to give public lectures? They have loopy ideas too. Why isn't anyone interviewing them?

The answer, of course, is that Julian Savulescu works at Oxford and is a bioethicist. But do these two qualifications really guarantee his credibility as a minor guru when he pays us a visit?

Only if you still suffer from cultural cringe. Oxford, ancient Oxford, the Oxford of postcards and poetry, radiates 800 years of scholarship. Savulescu, however, works in a new Oxford, a competitive, funding-hungry Oxford. A Japanese benefactor offered the new Oxford a generous endowment to create the Uehiro chair in "applied ethics" - a code word for the philosophy of Peter Singer. Oxford took the Japanese shilling and hired one of Singer's most distinguished disciples, despite the fact that even among bioethicists Singer is regarded as weird and narrow.

So wipe the Oxford glaze off Savulescu's outrageous proposals. Pretend that he teaches at the University of Lincolnshire and Humberside. How sensible do they sound now?

Nor does working as a bioethicist make you a font of wisdom. In fact, it is becoming increasingly clear that calling yourself a bioethicist is not necessarily an advance on qualifications in astrology.

The word "bioethics" was invented by American academics as recently as 1970. The new field metastasised quickly, invading medicine, ecology and sociology as well as traditional philosophy. But unlike sharp-edged disciplines such as physics or mathematics, the goals, methods and boundaries of bioethics are as murky as the bottom of the Yarra.

A couple of weeks ago, for instance, an article in the world's leading medical journal, The Lancet, called bioethics a "bankrupt" discipline. Professor Roger Cooter, of University College London, wrote that "hardly wet behind the ears, bioethics seems destined for a short lifespan". He argues that some US bioethics centres have been funded by pharmaceutical companies; that it has a narrow and old-fashioned notion of ethics; and that bioethicists themselves can't even agree how it started or what it means. And Cooter is by no means alone in his assessment.

Not meaning to offer a comment on Savelscu's work, which I haven't read, I am struck by the responses on the bioethics listserve today.  Evidence of bioethics' incoherence? Evidence of its rich and diverse underpinnings? Or . . . . ?

Med-Mal Reform Developments in 8 States (Redux)

The Nov. 23 Kaiser Daily Health Policy Report reviewed med-mal-related developments in 8 states.  Here are the leads:

• Arkansas: A 2003 state tort reform law (Act 649) has not led to reduced malpractice insurance premiums, according to a report by the Arkansas Insurance Department, the Arkansas Democrat-Gazette reports.
• Florida: Circuit Judge Janet Ferris on Nov. 15 temporarily barred the implementation of Amendment 8, which would allow the revocation of the medical licenses of physicians who lose three malpractice lawsuits, until the last day of the state legislative session, the AP/South Florida Sun-Sentinel reports (Royse, AP/South Florida Sun-Sentinel, 11/16). (Previously noted on this blawg.)
• Maryland: Gov. Robert Ehrlich (R) on Thursday said that he will present a revised malpractice insurance reform bill to Democratic legislative leaders this week that would not rely on the state general fund, the Washington Times reports.
• Georgia: Senate Republicans last week announced that in the 2005 legislative session they will press for an agenda that includes tort reform legislation, the Atlanta Journal-Constitution reports.
• Massachusetts: The state Board of Registration in Medicine last week released a report that found total malpractice jury awards and settlements in the state have fallen 8% over the past three years, from a peak of $129 million in 2001 to $119 million in 2003, the Boston Globe reports (Allen, Boston Globe, 11/16).
• Michigan: American Physicians Assurance, the state's largest medical malpractice insurer, has begun a contest for enrollees of the plan in an effort to reduce the number of malpractice lawsuits filed by patients, the Detroit News reports.
• Ohio: State representatives over the last two weeks have begun considering a measure that would limit noneconomic and punitive damage awards in medical malpractice lawsuits, CongressDaily reports.
• Oregon: The Oregon Medical Association is drafting a package of proposals to lower medical malpractice insurance rates that it plans to submit to the state Legislature, the Associated Press reports.

Interpreters Lower Risk in Hospitals

The Associated Press reports that a program currently underway at Temple University, and nine other universities, aims to increase the number of highly trained interpreters in America’s hospitals.  A recent study found that, although hospitals receiving federal funding are required to provide interpretation services, fewer than ¼ of all hospitals had professional interpreters on staff.

In another small study, interpretation errors occurred on an average of 31 times during each of the 13 recorded doctor visits.  About 22 percent of patients using untrained interpreters, such as family members or friends, had interpretation errors of potentially serious medical consequence, compared with 12 percent for those with a staff interpreter. 

Medical Data Network Would Improve Care, Create Privacy Issues

An interesting New York Times article (free registration required) reports on advances in medical data networks.  The issue was addressed last week by a panel of experts, during a conference hosted by Rockefeller University. 

According to the article, approximately 31 percent of the nation’s annual health care bill is attributable to administrative expenses.  The implementation of a sophisticated data network would reduce both costs and the number of patient deaths caused by medical errors (it is estimated that 45,000 to 98,000 people die each year from medical errors attributed to misunderstood handwritten prescriptions and hospital charts or lost laboratory test results). 

In addition to administrative and patient-safety benefits, a comprehensive database could provide the ability to assemble and distribute up-to-the-minute epidemiological studies.  Of course, a network packed with so much patient information is sure to raise plenty of privacy concerns. The proposed data network is part of a 10-year plan being promoted by the National Institutes of Heath. 

Brain Dead, Medically Dead, Legally Dead, or Really Dead?

That's the title of a talk I frequently give around town.  It's intended to be a humorous reminder that "brain death" isn't some sort of watered-down version of death; it's the real thing.  All 50 states are more or less clear on this, except for New York and New Jersey, where it is possible for families to opt out of the neurological criteria for death and wait for cardiorespiratory death to occur.

It's also apparently not a clear concept in Utah, where physicians last month pronounced death on a 6-year-old cancer patient, Jesse Koochin.  Even though their son's body had begun to decompose, his parents disagreed and obtained a preliminary injunction that required "life support" (a misnomer in these circumstances) to be continued until a court hearing could be held a few weeks later.  The parents and hospital (Primary Children's Medical Center in Salt Lake City) reached an agreement under which the parents were allowed to take him home on a ventilator, where home hospice care would be provided, and the hospital would refrain from filing a death certificate.

Jesse's heart stopped last Friday and resuscitative attempts were unsuccessful.  News articles and broadcasts routinely stated that November 19th is the date Jesse "succumbed" to cancer or is the date he died (see the Salt Lake Tribune article and the KSL-TV news broadcast that evening).

The Tribune article repeats an assertion that appears in a number of news stories about Jesse: "The murky question of what should be done when parents disagree with a doctor's determination of death remains. There are no laws saying doctors have to keep patients they believe   are dead on life support."  The AP story by Debbie Hummel ends on a similar note:

In Utah, there is no case law regarding whether doctors have to keep patients they believe are dead on life support. The law says a person is dead if physicians have determined "irreversible cessation of all functions of the entire brain, including the brain stem."

Statutes provide guidance in cases where a patient has an advance medical directive or family members want to remove their loved one from life support. But they do not state what should happen when a family disagrees with a doctor's determination of death.

This doesn't strike me as an advance-directive problem, because there are simply no treatment options for a patient declared dead according to neurological criteria (unless a state legislatively abandons "brain death" or carves a hole in their statute to provide for conscientious objectors).  In ordinary practice, if a family's disagreement with the diagnosis of death has to do with the competence of the neurologists, the accuracy of their exam, or the criteria they applied, a second opinion would be appropriate.  Beyond that, however, the law is silent because once death occurs, the patient no longer presents a medical case.  Correction: the law isn't entirely silent.  Once death occurs, the state's laws on the handling and disposition of dead bodies, as well as the criminal laws against the abuse of a corpse, apply.  Hospital policies, as well as the word choices and practices of health care providers, should reflect these realities.  And local judges should be reluctant to sow confusion and prolong the suffering of families with decisions that are uninformed about the law.

Bioethics and Public Health

Ronald Bayer and Amy Fairchild, both at Columbia, have published an article in Bioethics: "The Genesis of Public Health Ethics," 2004. 18(6):473-492.  Their abstract has been posted on the SSRN website:

As bioethics emerged in the 1960s and 1970s and began to have enormous impacts on the practice of medicine and research - fuelled, by broad socio-political changes that gave rise to the struggle of women, African Americans, gay men and lesbians, and the antiauthoritarian impulse that characterised the New Left in democratic capitalist societies - little attention was given to the question of the ethics of public health. This was all the more striking since the core values and practices of public health, often entailing the subordination of the individual for the common good, seemed opposed to the ideological impulses of bioethics. Of what relevance is autonomy-focused bioethics for public health, with its mix of justifications including those that are either implicitly or explicitly paternalistic or that seek to impose strictures on individuals and communities in the name of collective welfare? To examine the deep divide between the central commitments of bioethics and the values that animate the practice of public health, we focus on a series of controversies implicating the concepts of privacy, liberty, and paternalism. Recognising the role of moral values in decision-making was a signal contribution of bioethics in its formative period. Over the past three decades a broad array of perspectives emerged under the rubric of bioethics but individualism remains central. As we commence the process of shaping an ethics of public health, it is clear that bioethics is the wrong place to start when thinking about the balances required in defence of the public's health.

Big Pharma and Patents.

As reported in today's Wall Street Journal (subscription required), later this month Pfizer Inc. will face its first courtroom patent challenge against Lipitor, the cholesterol pill that is the biggest-selling drug in the world. Ranbaxy Laboratories Ltd., an Indian generic-drug company seeking to expand in the U.S. market, is trying to crack two patents that Pfizer says protect Lipitor through 2009 and 2011. If Ranbaxy shows that the patent protection shouldn't apply or that its copy of Lipitor doesn't infringe on Pfizer's patents, then it would be allowed to market a cheaper copycat version.

The battle over the Lipitor patents is emblematic of a much larger pattern:

After years of strong profits, generic-drug companies have hit a rough patch this year. Big buyers like wholesalers and national drugstore chains are driving harder bargains. And big pharmaceutical giants have found ways to put pressure on generics with their own generic products.

In the next five years, however, branded drugs with annual sales of $72.9 billion are expected to lose patent protection, according to analyst Gregory Gilbert of Merrill Lynch. Mounting concerns about prescription-drug costs will also fuel use of generics.

Industry critic Marcia Angell has assailed the use of patents by pharmaceutical companies to reap profits that far outstrip any reasonable return on their investment in drugs. An early version of her critique appeared as an editorial in the New England Journal of Medicine ("The Pharmaceutical Industry — To Whom is It Accountable?", NEJM. 2000;342:1902-1904 - requires subscription; letters to the editor are here). She expanded her critique in this year's The Truth About the Drug Companies: How They Deceive Us and What To Do About It; an abridged version appeared this summer as "The Truth About the Drug Companies," New York Review of Books, July 15, 2004.

The industry trade association, PhRMA, hasn't taken all of this lying down.  In anticipation of the publication of Angell's book, it issued a 28-page refutation of her points.

Medicare Prescription Drug Plan - More Costly for Some

The Associated Press reports on a new independent analysis by the Kaiser Family Foundation that shows that the  Medicare Prescription Drug plan isn't saving everyone money.   Although approximately 19 million people will benetif from the new Medicare drug benefit, 10 million others will pay the same or more for their medications.

"The biggest winners are low-income Americans who will receive government assistance that is projected to reduce their drug spending by 83 percent when the drug insurance program begins in 2006, said the Kaiser Family Foundation. The poorest of these people would spend an average of $90 for medicines, said the study by Kaiser, a health care think tank.

The signature component of last year’s Medicare law, the prescription drug benefit will vary widely in its impact on the 29 million older and disabled Americans that the Congressional Budget Office projects will enroll, the study said. The CBO said the average savings will be 37 percent in 2006."

In response, the federal Centers for Medicare and Medicaid Services sent a four-page rebuttal of the report, claiming that it is flawed and tends to "understate savings and exaggerate the number of people who would pay more."

http://www.msnbc.msn.com/id/6559717/

JAMA Editors Call for New Agency to Monitor Drugs

As the Vioxx issue continues to concern many Americans, the December 1st issue of JAMA contains six articles concerning the conflicts of interest that exist in the current method of drug approval and the need for better postmarketing  surveillance.  In an editorial entitled, Postmarketing Surveillance--Lack of Vigilance, Lack of Trust, several JAMA editors called for the creation of a new and independent group, separate from the FDA, to monitor drug safety after a drug have been released on the market.  They further call on Congress to provide the necessary funding for such an independent group.

A preview of the December 1st volume may be found at JAMA's website.  The New York Times provides a further brief report on these issues.

If you are interested in learning more about what JAMA might be publishing in the future, you can register at JAMA's website to receive the table of contents of upcoming issues via e-mail. 

Medicinal Marijuana Update

The SCOTUSBLOG reports that the Acting Solicitor General Clement filed the Government's Reply Brief in Raich v. Ashcroft.  Oral argument has been scheduled for November 30th with Acting SG Clement arguing for the government, and Professor Randy Barnett (Boston University School of Law) arguing on behalf of the respondents. 

Textbook Selection

For those of you that are trying to decide on a textbook for a Spring Health Law course, you might want to check out the new Health Care Law and Ethics books by Hall, Bobinski and Orentlicher.  Aspen Publishers has divided the longer text book into a three part set of shorter books that may be used for health law seminars and other health law classes that do not require the comprehensive coverage provided by the complete text.  The three texts are:  Bioethics and Public Health Law, Medical Liability and Treatment Relationships and The Law of Health Care Finance and Regulation.  As you are well aware, the Health lLaw:  Cases, Materials and Problems by Furrow, Greaney, Johnson, Jost and Schwartz has been published for a number of years in a series of shorter topical books.  Now, you have more choices in textbooks and can even mix and match your health law text selections.  Of course, there exist a variety of other health law texts on the market and I have tried a number of them in the quest to keep myself fresh and well-educated on a wide variety of health law topics and viewpoints.  Best of luck with your selection!

Antitrust: ALJ Says Physician Group Unlawfully Conspired

Here's an item I meant to include last week, now back in my inbox today in the form of this helpful summary from AHLA's "Health Law Highlights":

In an initial decision announced November 16, an Administrative Law Judge (ALJ) upheld the Federal Trade Commission's (FTC's) complaint against a physicians' group alleging that the group conspired to fix prices in certain contracts its doctors entered into to provide medical services to the patients of health plans. According to the FTC, nearly all of North Texas Specialty Physicians' (NTSPs') participating physicians are parties to some non-risk contracts and that "[w]ith respect to these non-risk contracts, NTSP often has sought to negotiate for, and often has obtained, higher fees and other more advantageous terms than its individual physicians could obtain by negotiating individually with payors." In its decision, the ALJ stated that, "In this case, Complaint Counsel [FTC staff] has proven that Respondent [NTSP] engaged in horizontal price fixing through its negotiation, on behalf of its member physicians, of economic terms of non-risk contracts with health plan services for the provision of physician services."

The full text of the initial decision is here (PDF).  As reported in Modern Healthcare, North Texas Specialty Physicians "has been the only IPA to challenge the FTC in the agency's three-year, industrywide investigation of physician price-fixing, which so far has resulted in 20 consent decrees with physician organizations."  The other cases are summarized, beginning at page 7, in the FTC's publication, "FTC Antitrust Actions In Health Care Services and Products" (PDF).

UNOS Opposes Advertising for Transplants

Not surprisingly, the United Network for Organ Sharing "is asking hospitals to discourage patients from advertising for donors and, if possible, to refuse to perform transplants that arise from these campaigns" (Newsday, Nov. 19).  As UNOS explained in its press release, "Most deceased organ donation takes place anonymously through the national organ distribution system. At times donors or donor families want to donate to a specific person they know, and we support that. But we strongly oppose public or private appeals that effectively put the needs of one candidate above all others and pose concerns of fairness. Transplant candidates rely on the public's trust in the fairness of the allocation system and support of that system through donation. Public appeals may jeopardize that trust."

The UNOS board was responding to news reports that "a Houston man, Todd Krampitz, bought a pair of billboards and gave a series of media interviews soliciting a liver donor. It worked: Someone died, and the person's family had heard about Krampitz and opted to donate directly to him.

"Normally, when people die their organs go to whomever is at the top of the waiting list, determined by many factors including who would obtain the greatest medical benefit from a transplant, who would die soonest without one, the locations of the patient and donor.

"'There's integrity to that. That process is public, it's transparent, it's accountable,' said Dr. Mark Fox, chairman of the network's ethics committee."

New Book on Anthrax Vaccine and the Military as Alleged Test Subjects

Interested in reading mysteries or possibly even conspiracy theories, Jon Cohen of Slate reviews the new book, Vaccine A:  The Covert Government Experiment That's Killing Our Soldiers - and Why GI's Are Only the First Victims, by Gary Matsumoto.  Mr. Cohen doesn't find the book convincing in its argument that the government deliberately tampered with the anthrax vaccine given to soldiers during the first Gulf War but states that it does provide an overview of some of the problems with the vaccine and the quick decision to use it on those soldiers shipping out to Iraq in the early 1990s. 

According to Mr. Cohen, in Vaccine A, Mr. Matsumoto alleges that the U.S. military's anthrax vaccine causes a constellation of autoimmune diseases and symptoms such as lupus, rashes, hair loss, and aching joints that fall under the rubric known as Gulf War Syndrome.  Mr. Matsumoto argues that the problems result from the military secretly spiking the vaccine with squalene, "a fat naturally found in the body that, when injected as part of a vaccine, supercharges the immune system's ability to make antibodies."  He further  "accuses the Department of Defense of slipping this experimental vaccine past the Food and Drug Administration and involving unwitting troops in a human test" that he "equates with Nazi experimentation and the infamous Tuskegee syphilis study." Mr. Cohen contends that Matsumoto's book fails to answer the question of why the military would subject its soldiers to such an experimental and potentially dangerous vaccine.   He also finds the book rather sloppily researched.  If you have an interest in vaccines and vaccine contamination,  Mr. Cohen recommends a different book on the polio vaccine and its early troubles.  In his conclusion, he states,

"Vaccine accidents do happen, they do get covered up, and they deserve close scrutiny. One of the most famous vaccine accidents is the contamination of the first polio vaccines with a monkey virus, and a new book on the accident by Debbie Bookchin and Jim Schumacher, The Virus and the Vaccine, has many parallels with Vaccine A. But the research in this book is meticulous, and Bookchin and Schumacher's tone is so measured and thoughtful that my mind opens to their controversial thesis (that the monkey virus accidentally injected into people through polio vaccines causes human cancers). I'm not convinced that the monkey virus does, in fact, cause harm, but I am convinced that the question merits serious attention. Matsumoto, in contrast, with his sloppy errors, remote possibilities trumped up as facts, and outright dismissal of evidence that doesn't support his thesis, leaves me groaning."

Abortion Amendment Passes With Budget Bill.

As discussed here yesterday, the omnibus budget bill, H.R. 4818, contains an amendment to federal abortion law that has drawn the ire of 9 women senators and pro-choice advocacy groups.  As expected, the Senate adjourned (at 12:31 a.m. this morning) having taken one record vote, to approve the bill, 65-30.  The House had approved the spending bill (344-51) earlier in the day.

As reported by The Washington Post, "The abortion language remained in the spending bill, but late yesterday, Senate opponents agreed not to block its consideration after Senate Majority Leader Bill Frist (R-Tenn.) promised to schedule a vote in the near future on a bill drafted by Sen. Barbara Boxer (D-Calif.) to repeal the provision."  Even if Sen. Boxer's bill passes in the Senate, no-one gives the repeal effort much of a chance in the more conservative House.

"Good Tissue Practice" Addressed by FDA

On Nov. 18, the FDA announced publication of "a final rule on current good tissue practice (GTP), the last of three rules to be finalized as part of the Agency's overall plan to make human cells and tissues even safer. GTP includes the methods, facilities and controls used to manufacture these products. With this final rule, FDA's efforts to establish a new, comprehensive, and risk-based approach to this promising and innovative field of medicine can be realized. The new approach will be fully implemented on May 25, 2005."  The final rule is here and will be published in the Federal Register soon. 

All tissue-related FDA documents are collected on this web page.  The FDA describes its previous final rules this way: "[T]he agency has published two final rules and one interim final rule to implement aspects of the proposed approach. On January 19, 2001, we issued regulations to create a new, unified system for registering HCT/P establishments and for listing their HCT/Ps (registration final rule, 66 FR 5447).  Part of the definition of 'human cells, tissues, or cellular or tissue-based products' became effective on January 21, 2004. On January 27, 2004 (69 FR 3823), we issued an interim final rule to except human dura mater and human heart valve allografts from the scope of that definition until all of the tissue rules became final. On May 25, 2004, we issued regulations requiring most cell and tissue donors to be tested and screened for relevant communicable diseases (donor-eligibility final rule, 69 FR 29786)."

Reasonable Accommodation for a Dolphin?

Just for fun, a heartwarming story about a dolphin and an artificial fin designed by Bridgestone.  What will they think of next?

Med-Mal Reform Developments in 8 States

The Kaiser  Daily Health Policy Report recently published its review of recent med-mal reform developments in eight states. Here are the leads:

• Florida: More than half of rural physicians over the past year have limited medical services, and most cited increasing medical malpractice premiums as a "key reason" for limiting service, according to a 2003 study published Monday in the Archives of Internal Medicine, the St. Petersburg Times reports. . . . Voters on Nov. 2 passed Amendment 7, which will allow patients in the state to review records of medical errors committed by physicians in medical facilities. Voters also approved Amendment 8, which will allow the revocation of the licenses of physicians who lose three malpractice lawsuits. In addition, Florida voters passed Amendment 3, which allows plaintiffs in malpractice lawsuits to retain 70% of the first $250,000 in damages awarded and 90% of damages awarded in excess of that amount.
• Georgia: About 59% of state residents believe it is "very important" to pass a bill to limit medical malpractice insurance premiums, and 25% said such a bill is "somewhat important," according to a Georgia Hospital Association survey released Monday, the Florida Times-Union reports.
• Maryland: While Democratic state lawmakers support taxing HMOs to "help defray the costs" for the Medical Mutual Liability Insurance Society of Maryland -- the medical malpractice insurer that covers about 75% of the state's private practice physicians -- Gov. Robert Ehrlich (R) has "vowed" not to raise taxes and said the state should consider drawing from its general funds to help pay malpractice insurers, the Washington Times reports.
• Missouri: Medical malpractice claims fell to "a record low" in 2003, and total payouts to plaintiffs in malpractice cases dropped about 21%, according to a report released last week by the state Department of Insurance, the St. Louis Post-Dispatch reports.
• Nevada: Voters in the state last week approved Question 3, a medical liability reform measure on the Nov. 2 statewide ballot, by a 59% to 41% margin, but physicians in the state "now must wait and see" whether the measure will reduce malpractice insurance premiums in the state, the Las Vegas Sun reports (Kanigher, Las Vegas Sun, 11/5).
• Utah: The Utah Supreme Court on Friday upheld the $250,000 state cap on noneconomic damages in malpractice lawsuits in a case that involved a six-year-old boy with brain damage, the Salt Lake Tribune reports. In the case, a Utah jury awarded $1,250,000 in noneconomic damages to the parents of the boy, who experienced severe brain damage when a physician failed to deliver him with forceps, in addition to $22,735 for medical costs and $1 million for future expenses.  (NOTE: the case is Judd v. Drezga, 11/5/2004.)
• Virginia: Physicians at the Medical Society of Virginia annual meeting last weekend launched a "White Coats on Call" campaign to promote medical liability reform, the Washington Times reports. According to outgoing MSV President Mitchell Miller, as many as 100 physicians daily will visit Richmond throughout the next session of the state Legislature to highlight the increased costs of malpractice insurance in the state (McElhatton, Washington Times, 11/8).
• Wyoming: Voters in the state last week passed Amendment C, a medical liability reform measure on the Nov. 2 statewide ballot, but rejected Amendment D, a companion measure, resulting in a "split" that supporters maintain could limit the ability of the state Legislature to address the issue of high malpractice insurance premiums, the AP/Billings Gazette reports (Bohrer, AP/Billings Gazette, 11/4).

Politics of Abortion Snags Spending Bill.

Conference negotiators are close to a deal on the Consolidated Appropriations Bill (H.R. 4818), an omnibus $388 billion spending package that is needed to keep the federal government running after midnight tonight.  One of the last issues to resolve is a rider that, according to the L.A. Times, "would make it easier for healthcare providers to refuse to provide abortions or abortion referrals."  Nine women senators (8 Democrats and Olympia Snowe (R-Me.)) wrote to Sen. Ted Stevens (R-Alaska), chairman of the Senate Appropriations Committee, voicing their opposition to the provision: "Should this provision become law, federal, state or local government may no longer require any institutional or individual healthcare provider to provide, pay for or refer abortion services. This will mean that medical providers in hospitals and clinics across the country will likely be victims of demonstrations and intimidation as this provision allows that they be forbidden from providing abortion care to women who need it, and also to deny women referrals to another provider."  (The full text of the senators' letter is on Sen. Diane Feinstein's web site (PDF).)

The paper also reports NARAL's opposition to the provision: "NARAL Pro-Choice America, an abortion rights group, also assailed the provision, contending that it would bar physicians at health maintenance organizations, for-profit hospitals and others from even talking to their patients about abortion. The group called the provision a 'backdoor gag rule.'"  (NARAL's press release is here.)

The provision itself is variously and confusingly described by parties for and against in a Washington Post article this morning: "Under the provision, sponsored by Rep. David Joseph Weldon (R-Fla.), state governments could lose federal funds if they were found to discriminate against any 'health care entity' that opts not to provide abortion services or referrals. Supporters of the change say it would protect Catholic hospitals and health insurers from 'harassment' by state officials. In a letter yesterday, the nine senators said it would expose abortion providers to more intimidation by antiabortion groups."

According to the ACLU web site, the "Federal Refusal Clause" -- which NARAL says has twice been inserted by the House into bills that have (until now) been rejected by the Senate -- is S.1397, which would amend 42 U.S.C. § 238n to read as follows [changes indicated in boldface]:

§ 238n. Abortion-related discrimination in governmental activities regarding training and licensing of physicians licensing, and practice of physicians and other health care entities

(a) In general
The Federal Government, and any State or local government that receives Federal financial assistance, may not subject any health care entity to discrimination on the basis that—
     (1) the entity refuses to undergo training in the performance of induced abortions, to require or provide such training, to perform such abortions to perform, provide coverage of, or pay for induced abortions, or to provide referrals for such training or such abortions;
     (2) the entity refuses to make arrangements for any of the activities specified in paragraph (1); or
     (3) the entity attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.

(b) Accreditation of postgraduate physician training programs
     (1) In general
In determining whether to grant a legal status to a health care entity (including a license or certificate), or to provide such entity with financial assistance, services or other benefits, the Federal Government, or any State or local government that receives Federal financial assistance, shall deem accredited any postgraduate physician training program that would be accredited but for the accrediting agency’s reliance upon an accreditation standards [1] that requires an entity to perform an induced abortion or require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training, regardless of whether such standard provides exceptions or exemptions. The government involved shall formulate such regulations or other mechanisms, or enter into such agreements with accrediting agencies, as are necessary to comply with this subsection.
     (2) Rules of construction
          (A) In general
With respect to subclauses (I) and (II) of section 292d (a)(2)(B)(i) of this title (relating to a program of insured loans for training in the health professions), the requirements in such subclauses regarding accredited internship or residency programs are subject to paragraph (1) of this subsection.
          (B) Exceptions
This section shall not—
               (i) prevent any health care entity from voluntarily electing to be trained, to train, or to arrange for training in the performance of, to perform, or to make referrals for induced abortions; or
               (ii) prevent an accrediting agency or a Federal, State or local government from establishing standards of medical competency applicable only to those individuals who have voluntarily elected to perform abortions.

(c) Definitions
For purposes of this section:
     (1) The term “financial assistance”, with respect to a government program, includes means governmental payments provided as reimbursement for carrying out health-related activities.
     (2) The term “health care entity” includes an individual physician or other health professional, a postgraduate physician training program, and a participant a participant in a program of training in the health professions , a hospital, a provider sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization or plan.
     (3) The term “postgraduate physician training program” includes a residency training program.

More Nonprofits Sued Over Charity Care

Modern Healthcare reports that "Carolinas HealthCare System, Charlotte, N.C., and Wake Forest University Baptist Medical Center, Winston-Salem, N.C., were named in class-action lawsuits brought by uninsured patients who claim the providers charged them too much for care compared with what publicly and privately insured patients would have paid."  Although the suits are reportedly based on a breach-of-contract theory -- and thus may resemble class-action suits brought this summer by Richard Scruggs and attorneys working with him -- they are not listed on Scruggs' Not-For-Profit Hospital Class Action Litigation site.  Numerous "copycat" lawsuits have been filed since Scruggs' suits first started to appear, of which these may be two more.  (The Modern Healthcare site requires registration.)

Kentucky Governor/Doctor - Problems with the Death Penalty

This is an interesting article about a dilemma that Governor Fletcher of Kentucky may face with respect to keeping his medical license and signing off on death warrants as the Governor of Kentucky.    Thanks for Professor Fred Harris for the article.

According to the Associated Press, Governor Fletcher, also a licensed Doctor, risks potentially losing his medical license.   The article states,

"When Gov. Ernie Fletcher signed a death warrant for a convicted killer this month, he may have done more than start the clock ticking on an execution. Some say Fletcher, a doctor, may have put his medical license at risk.

American Medical Association guidelines bar doctors from taking part, directly or indirectly, in executions. And Kentucky requires doctors to follow AMA ethical guidelines. . . .

A group of doctors is seeking an opinion from the Kentucky Board of Medical Licensure on whether Fletcher can sign death warrants without running the risk of having his medical license revoked. The board is not scheduled to take up the matter until at least January, and would not comment in the meantime."

The New York Times on Saturday November 20th, also has a further update discussing Governor Fletcher's potential problems fulfilling his Governorship duties as well as his duty to remain true to the guidelines controlling his medical license.

Congressional Investigation of the Flu Vaccine Shortage

The following provides some informative links to recently released documents from Rep. Henry Waxman's office about what went wrong this year and in previous years with our flu vaccine supply. 

More than 1,000 pages of documents obtained by Rep. Henry Waxman (D-CA) reveal, in striking detail, "that despite being aware of major problems at the [Chiron] vaccine manufacturing facility as early as June 2003, [the Food and Drug Administration] missed repeated opportunities to correct them." (The Chiron facility was located in Liverpool, England,, but Chiron is a California company whose operations are regulated by the FDA.) Sixteen months later, British regulators shuttered the facility because of contamination problems and the United States was left with a massive flu vaccine shortage. The incident draws focus to bipartisan concerns about the impact of the Bush administration's personal and financial ties to the drug industry. Sen. Charles Grassley (R-IA) said, "The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny. One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must the FDA's first and only concern."

Waxman staff summary of FDA docs at http://democrats.reform.house.gov/Documents/20041117132027-14753.pdf

Washington Post story (Nov. 18^th) quoting Grassley (above ) http://www.washingtonpost.com/ac2/wp-dyn/A58470-2004Nov17?language=printer

Highlights provided by the American Progress Fund in its Progress Report for

Nov. 18, 2004

. http://www.americanprogressaction.org/site/pp.asp?c=klLWJcP7H&b=83210

FDA VISITED PLANT IN JUNE 2003, FOUND HIGH LEVELS OF CONTAMINATION: In June 2003, the FDA inspected the plant and "found high levels of overall bacterial contamination." FDA inspectors, in some instances, "found records of bacteria concentrations that were more than a thousand times higher than inspected." The inspectors also "identified poor sanitary practices that could contaminate sterile parts of the production process." Significantly, the FDA found the company was not doing enough to correct the problems.

TOP OFFICIALS REJECT INSPECTORS' RECOMMENDATION FOR MANDATORY ACTION: The FDA team that visited the facility recommended official enforcement action

against the facility. That means issuing a warning letter to Chiron outlining the problems that must be fixed. If Chiron failed to fix the problems, the FDA could have initiated legal action against the company. Instead, FDA officials overruled the recommendation of inspectors and instead submitted a request for voluntary action by Chiron. 

FDA DELIVERS REPORT TO CHIRON NINE MONTHS LATE: Even when it recommends voluntary action, the FDA is "supposed to send the manufacturer the full inspection report to help the manufacturer understand what corrective actions are needed." The report wasn't sent to Chiron until a year later – June 2004 – nine months after it was supposed to have been sent. The biggest problem: by that time "manufacture of the 2004 vaccine supply was already well underway." Chiron requested a meeting with the FDA after the 2003 inspection, but the agency never granted the request.

FOR 16 MONTHS FDA DOESN'T INSPECT THE PLANT: For 16 months, the FDA failed to send inspectors to the plant to see if Chiron had fixed the problem. FDA Commissioner Lester Crawford "defended the decision not to send inspectors into the plant." Crawford claimed that occasional conference calls with the company were "a form of 're-inspection.'" (For more on the Chiron debacle, check out this column.)

CRAWFORD FALSELY CLAIMS THAT 2003 PROBLEMS WERE UNRELATED: At an Oct. 21 press conference, Lester Crawford claimed, "what happened in 2003 has no relevancy for 2004." That isn't true. When the FDA's own inspectors finally visited the facility last month – after it was shut down – they reported that at least three sources of contamination were "not corrected from [the] previous inspection of 2003."   

CRAWFORD SAID HE WOULD DO VIRTUALLY EVERYTHING THE SAME: The FDA's negligence has put the health of tens of millions of Americans at risk. But appearing before the House Reform Committee Crawford testified, "except for the late delivery of its full report, the FDA has done nothing wrong – and would do nothing differently if given the chance." Sound familiar?

DEA and the Treatment of Pain.

The DEA published its "Interim Policy Statement on Dispensing of Controlled Substances for the Treatment of Pain" in the Federal Register on Tuesday, November 16, 2004.  The link is here (PDF).

The DEA published a document on its website in August 2004 entitled "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel."  The DEA subsequently withdrew the document because it contained misstatements. This interim policy statement explains how some of the statements in the August 2004 document were erroneous. The DEA plans to address in a future Federal Register document the issue of dispensing controlled substances for the treatment of pain.

The three previous misstatements discussed in the interim policy statement involve the investigation of diversion behaviors, refills of Schedule II prescriptions, and reselling of controlled substances.  The DEA recommends that this interim policy statement be distributed to hospitals' outpatient pain management centers, emergency rooms, and other units of hospitals where controlled substances are ordered for the treatment of pain. It also recommends that an announcement of the interim policy statement should also be made in the next communication to the medical staff from the pharmacy department and generally as physicians in a variety of specialties prescribe controlled substances for the treatment of pain.   Thanks to Lew Lefko, of Haynes and Boone in Dallas, for bringing this notice to our attention.

Tax-exempts and Political Activity.

On Friday, November 12, 2004, the IRS released a National Office Technical Advice Memorandum (TAM 2004-46-033) that addressed a payroll-deduction Politcal Action Committee arrangement established by a tax-exempt healthcare organization. According to the TAM, the entity "began an effort to make all . . . employees aware of their ability to participate in [the PAC] through payroll deduction.  During regularly scheduled meetings, department heads and the management . . . briefly discussed the Plan.  Managers were asked to develop a simple and efficient method of informing employees they had a right to participate . . . through payroll deduction. A video that featured [the Chairman of the Board of Trustees] explaining the impact of political input on the hospital industry was distributed to managers for use in communicating with employees.  Donation cards were made available to employees at the meetings and managers were encouraged to get a signed form from each employee, irrespective of the employee's decision to participate, in order to avoid duplicative efforts.  Employees were told that their participation in the Plan was strictly voluntary. The cards included an option to decline participation in the Plan."

The TAM concluded that the arrangement violates the political activity prohibition and triggers the § 4955 excise tax (10% tax on the amount of the political expenditures; and on the knowing agreement to make political expenditures, a 2-1/2% on the amount thereof).  A copy of this TAM is available on the AHLA website or the IRS website (PDF).

Bills Address End-of-Life Care.

As reported in the Nov. 17 Bend (Ore.) Bugle, Sen. Ron Wyden (D. Ore.) has "introduced  two pieces of legislation Tuesday aimed at providing better care options for dying patients. . . .  The first Wyden bill, the Palliative Care Training Act, recognizes the need for a larger pool of health care professionals who know how to help terminally ill patients to have a better quality of life. The second bill, the Medicare Hospice Demonstration Act, seeks to test ways to improve the Medicare hospice benefit."  Neither bill is yet on Thomas or the senator's web page.  Wyden's press release on the bills is here.

ADA Amendments from the National Council of Disability

On December 1, 2004, the National Council on Disability (NCD) will release its report Righting the ADA.  The report will contain NCD’s legislative proposal, entitled, “ADA Restoration Act.”   The NCD hopes that its proposal will restore the protections of the Americans with Disabilities Act that have been restricted by some of the recent ADA U.S. Supreme Court decisions.

If you cannot wait until December 1st, the NCD asks that you contact contact Mark Quigley or Julie Carroll at 202-272-2004 or 202-272-2074 TTY for further information. 

Goody-Bye to the Employer-Sponsored Health Insurance Tax Deduction?

The Washington Post reports today on some of the President's plans for revising the tax code.   Although these are tentative, it does appear that some drastic changes are in store - including the elimination of the tax deduction for employer-sponsored health insurance.   The Post states,

"The Bush administration is eyeing an overhaul of the tax code that would drastically cut, if not eliminate, taxes on savings and investment, but it is unlikely to try to replace the existing tax code with a single flat income tax rate or a national sales tax, according to several sources familiar with ongoing tax deliberations.

During his reelection campaign, President Bush piqued interest among conservatives and liberals alike when he said replacing the income tax with a national sales tax was "an interesting idea." Just after the election he signaled that tax policy would be a centerpiece of his domestic agenda, reiterating his pledge to name a bipartisan panel to draft a fundamental tax reform proposal. That sent conservatives scurrying into either the flat tax or sales tax camp to muster political momentum.

But before the tax panel is even named, administration officials have begun dialing back expectations that they will move to scrap the current graduated income tax for another system.

Instead the administration plans to push major amendments that would shield interest, dividends and capitals gains from taxation, expand tax breaks for business investment and take other steps intended to simplify the system and encourage economic growth, according to several people who are advising the White House or are familiar with the deliberations.

The changes are meant to be revenue-neutral. To pay for them, the administration is considering eliminating the deduction of state and local taxes on federal income tax returns and scrapping the business tax deduction for employer-provided health insurance, the advisers said. "

I cannot believe that this would be acceptable to Congress but who knows . . . .  I don't seem to be able to predict anything in politics these days.

"To pay for those large tax cuts, the administration is looking at eliminating both the deduction for state and local taxes, and the business tax deduction for employer-sponsored health insurance. That would raise nearly $926 billion over five years, according to White House and congressional documentsTo pay for those large tax cuts, the administration is looking at eliminating both the deduction for state and local taxes, and the business tax deduction for employer-sponsored health insurance. That would raise nearly $926 billion over five years, according to White House and congressional documents."

ERISA PREEMPTION

From the BNA Health Law Reporter:

TWO APPEALS COURTS REVERSE 'COMPLETE PREEMPTION' RULINGS, SEND STATE LAW CLAIMS WITH ERISA OVERTONES BACK TO STATE COURT

Recent federal appellate rulings denounce misuse of the "complete preemption" doctrine to remove state claims involving Employee Retirement Income Security Act plans. The Sixth Circuit holds that retirees' claims of fraudulent inducement to accept early retirement benefits cannot be recast as claims under ERISA's civil enforcement provision, Section 502, and thus must be remanded to state court. . .

Meanwhile, the Third Circuit rules that a hospital's state law breach of contract action against a health plan for wrongly granting plan participants discounted rates cannot be maintained under Section 502 because the participants had not assigned their claims to it. Both courts stress that mere conflict preemption under ERISA Section 514 will not support removal. . . .

http://pubs.bna.com/ip/BNA/law2.nsf/is/a0a9z1t3p5

http://pubs.bna.com/ip/BNA/law2.nsf/is/a0a9z4w7e6

Helpful Website

"The National Human Genome Research Institute, part of the National Institutes of Health, has launched a Policy and Legislation Database. The free, searchable database focuses on genetic testing and counseling, insurance and employment discrimination, newborn screening, privacy and confidentiality of genetic information, informed consent and commercialization and patenting. The site includes an interactive map of the United States that enables users to click on any state to view its legislation and laws. Users also can search the database by keyword, content type, topic and source. The database contains links to full-text copies of federal and state laws and statutes; federal legislative materials; and federal administrative and executive materials, including regulations, institutional policies and executive orders. Abstracts are also provided."

Research Institute at http://www.genome.gov/PolicyEthics/LegDatabase/pubsearch.cfm

Thanks to Robert Ambrogi's LawSites blog and his post at

http://www.legaline.com/2004/11/database-of-genetic-testing-law-and.html

Bioethics Class Visits NICU.

They're not law students, but the 13 members of Peter Singer's freshmen seminar, "Ethical Choices," nonetheless recently had an opportunity to view first-hand the excruciating choices typically debated in "Bioethics and Law" classes around the country.  As described in an article in the Nov. 15 Daily Princetonian, "Singer had brought his students to the ward to show them the living faces of a medical debate featured prominently in his scholarship and his seminar: whether it is ethical to end an infant's life when medical data predict she has a low chance of surviving."  Actually, Singer's claims go considerably beyond this statement, and the article eventually gets to the argument that has made Singer's views so controversial:

     Born 14 weeks premature, the 2-hour-old infant the class had come upon had a slim chance of surviving, le