HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, May 9, 2007

Update on "Pillow Angel" Surgery

Some of you may remember the surgery performed on Ashley at the request of her parentsCNN reports that the hospital alllegedly violated Washington state law by failing to obtain a court order before performing a hysterectomy.  It looks to me like the parent's attorney may have to explain how he/she reached the conclusion that a court order was unnecessary.   According to CNN:

A hospital that performed a controversial procedure that stunted the growth and sexual development of a profoundly disabled child violated Washington state law by sterilizing her, according to an investigative report released Tuesday. The case has raised medical ethics questions and rankled disability and feminist groups.

The Washington Protection and Advocacy System, a private group vested with federal investigative authority for people with disabilities, found that Seattle Children's Hospital and Regional Medical Center violated the constitutional and common law rights of a girl identified only as Ashley by performing a hysterectomy without a court order from the state.   "Washington law specifically prohibits the sterilization of minors with developmental disabilities without zealous advocacy on their behalf and court approval," said Mark Stroh, WPAS executive director, in a statement.

Children's Hospital, in acknowledging its error, said that beyond implementing changes to ensure that sterilization of disabled children doesn't happen again without a court order, it will seek court approval for other procedures involved in the controversial growth attenuation therapy.  "We deeply regret that a court order was not obtained," Dr. David Fisher, medical director at Children's Hospital said in a statement. "The parents consulted an attorney and obtained a legal opinion that concluded the treatment was permissible under Washington state law without the need for a court order. This is where our system broke down. We take full responsibility."

Ashley, 9, has a condition called static encephalopathy, which means an unchanging brain injury of unknown origin.  "It was like seeing a baby in a much larger body," said Dr. Douglas Diekema, director of education at Treuman Katz Center for Pediatric Bioethics in Seattle and chairman of the bioethics committee of the American Academy of Pediatrics, who was brought in to consult on this case. "She would never talk, never walk, and was dependent on her parents to meet all her needs. Her cognitive function was the equivalent of that of an infant, unlikely to ever change." Family members call her their "pillow angel." . . . .

In 2004, when Ashley was 6, her uterus and breast buds were removed, and she received a high-dose estrogen therapy. As a result, Ashley was frozen as a child. She attained her full growth at 4 feet 5 inches and 75 pounds, with no reproductive capacity.  Ashley's parents say that compassion, not convenience of care, was their motive.

Writing on their blog, her parents said, "Ashley's smaller and lighter size makes it more possible to include her in the typical family life and activities that provide her with needed comfort, closeness, security and love: meal time, car trips, touch, snuggles, etc." . . . .

The parents, in an updated entry on their blog Tuesday, reiterated that "given Ashley's developmental state and prognosis ... voluntary procreation was not applicable to her case and will never be."  "Sterilization is not the intent of the 'Ashley Treatment,' but a byproduct of it," they wrote, adding that while they support laws protecting against involuntary sterilization, they believe the law is "too broadly based" to "distinguish between people who are or can become capable of decision-making and those who have a grave and unchanging medical condition such as Ashley."

Diekema told CNN the ethics committee recognized that Washington state law was not perfectly clear with regard to whether a court order would be necessary to do the hysterectomy in someone who could not consent to the procedure.

One nationally known ethicist said he believes the hospital erred.  "I absolutely agree this procedure should have been reviewed by a court," said medical bioethicist Arthur Caplan. "There was not enough due process to look out for the young girl's rights, so I think that was a severe failure in deciding to do this procedure."

For some other views about the surgery, click here.

May 9, 2007 | Permalink | Comments (0) | TrackBack (0)

Interesting Research Proposal Information

Michelle Mello and David Studdert of the Harvard School of Public Health and the University of Melbourne have made information about their work on a proposal for policy experiments with administrative compensation for medical injury ("health courts") available online at http://www.hsph.harvard.edu/faculty/michelle-mello/current-projects/
Additionally, the project is being featured this week on the blog of the Portfolio of the Robert Wood Johnson Foundation, Pioneering Ideas (http://blogs.rwjf.org/). They will be publishing several posts about our research, and the blog will also feature posts by their partner in this effort, Paul Barringer of Common Good, as well as commentary by the Foundation.  Comments are welcome.
You can also read about other current projects of Law and Public Health researchers at Harvard at http://www.hsph.harvard.edu/faculty/michelle-mello/current-projects/ and http://www.hsph.harvard.edu/faculty/michelle-mello/recent-research-highlights/.
You can ask to be included on announcements of forthcoming research papers using the email form at http://www.hsph.harvard.edu/faculty/michelle-mello/contact-us.html

May 9, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 8, 2007

FDA: Food and Drug Contamination

The New York Times on Sunday ran an article discussing how some imported drugs contain a poison syrup, diethlene glyclol (normally found in antifreeze) rather than glycerin, a more expensive syrup, which is safe to use in a variety of pharmeutical products. 

Over the years, the poison has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — a result of counterfeiters who profit by substituting the sweet-tasting solvent for a safe, more expensive syrup, usually glycerin, commonly used in drugs, food, toothpaste and other products.

Toxic syrup has figured in at least eight mass poisonings around the world in the past two decades. Researchers estimate that thousands have died. In many cases, the precise origin of the poison has never been determined. But records and interviews show that in three of the last four cases it was made in China, a major source of counterfeit drugs. . . . .

Last week, the United States Food and Drug Administration warned drug makers and suppliers in the United States “to be especially vigilant” in watching for diethylene glycol. The warning did not specifically mention China, and it said there was “no reason to believe” that glycerin in this country was tainted. Even so, the agency asked that all glycerin shipments be tested for diethylene glycol, and said it was “exploring how supplies of glycerin become contaminated.”

China is already being accused by United States authorities of exporting wheat gluten containing an industrial chemical, melamine, that ended up in pet food and livestock feed. The F.D.A. recently banned imports of Chinese-made wheat gluten after it was linked to pet deaths in the United States.

Beyond Panama and China, toxic syrup has caused mass poisonings in Haiti, Bangladesh, Argentina, Nigeria and twice in India.

Today, the Diane Rehm show explores further some of the FDA's recent lapses in safety - particularly with regard to the melamine found in chickens as well as other parts of the U.S. food supply.  Perhaps we need to re-consider our priorities when spending money on protecting the public - the FDA should not be relying on industry standards to prevent these terrible events.

May 8, 2007 | Permalink | Comments (0) | TrackBack (0)