HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, November 18, 2006

Breast Implants are Back

The FDA announced that is will permit silicone breast implants to be sold again.  According to CNN.Com,

The approved silicone implants are made by two companies, Inamed Aesthetics, now a part of Allergan, and Mentor.

The FDA says these implants are approved "for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older."

Daniel Shultz, director of the FDA's Center for Devices and Radiological Health, told reporters that younger women's breasts continue to develop through their teens and early 20s, and the agency wanted to make sure breast development was completed before women had devices implanted.

In 1992, then-FDA Commissioner Dr. David Kessler took silicone breast implants off the market, citing concerns over their safety, including how often they ruptured in a woman's body and whether leaking silicone could lead to diseases as some women claimed.

After the ban, the implants were available only to women in clinical trials who needed them after surgery, especially after breast cancer. At that point, lawsuits over the products drove one of the manufacturers, Dow Corning, into bankruptcy.

Since then, most studies have failed to link the implants to serious or chronic diseases such as cancer and lupus, but questions remained over how often the implants rupture and what happens if the silicone enters the body. . . .

The consumer advocacy group Public Citizen, which has long opposed silicone implants, criticized the decision and called it "a terrible reminder of the double standard for women versus men" and noted that the FDA has not approved silicone gel testicular implants because of inadequate testing.

More can be found at this NPR.org site.

November 18, 2006 | Permalink | Comments (0) | TrackBack (0)

Friday, November 17, 2006

Homosexuality and the US Military

The Washington Post reports that the U.S. Military has re-classified homosexuality - moving it from a mental disorder to "circumstance."  This change has not impact on the military's don't ask,  don't tell policy.  The Post reports,

The revision came in response to criticism this year when it was discovered that the guidelines listed homosexuality alongside mental retardation and personality disorders.

Mental health professionals said Thursday they were not satisfied by the change.

"We appreciate your good-faith effort to address our concern that the document was not medically accurate," James H. Scully, head of the American Psychiatric Association, wrote David Chu, undersecretary of defense for personnel and readiness. "But we remain concerned because we believe that the revised document lacks the clarity necessary to resolve the issue."

The guidelines outline retirement or other discharge policies for service members with physical disabilities. The rules include sections that describes other specific conditions, circumstances and defects that also could lead to retirement, but are not physical disabilities.

Among the conditions are stammering or stuttering, dyslexia, sleepwalking, motion sickness, obesity, insect venom allergies and homosexuality. . . .

November 17, 2006 | Permalink | Comments (0) | TrackBack (0)

Patient Dumping on Skidrow

The Los Angeles Times reports on hospital dumping in that city.  It is really shocking - this isn't just tranferring a severaly ill patient to another hospital but dumping them literally on the street in dangerous sections of LA.  The Times reports,

After a year of investigation, the Los Angeles city attorney's office has identified 10 hospitals it suspects of dumping discharged patients on skid row and is now preparing to take legal action to stop the practice, according to two sources familiar with the planned litigation.

The action comes after talks between the city attorney and a hospital trade group broke down in April. City Atty. Rocky Delgadillo said he had hoped to negotiate a legally binding agreement with hospitals that would have established practices for discharging the homeless. But the hospitals balked at what they considered too-stringent regulations and the city attorney's intransigence. They also objected to a proposal that the American Civil Liberties Union be involved in monitoring the agreement.

Now sources familiar with the investigation say the city attorney, the ACLU and the pro bono law office Public Counsel are preparing civil litigation targeting several hospitals for unfair business practices. The city attorney has not ruled out filing criminal charges as well, the sources said. . . .

Officials have spent months examining more than 40 allegations that hospitals dropped patients on skid row after discharge, often against the wishes of the patient. The investigation yielded 15 potential cases, top city attorney officials said.  The latest incident of alleged patient dumping occurred last week when a man with a foot wound was dropped off by taxi after being discharged from a Covina area hospital. Prosecutors said the man went to skid row's Union Rescue Mission, where he was in so much pain that he had to be rehospitalized immediately.

Delgadillo said hospitals have resisted changing their practices — in some cases "threatening to close doors on emergency rooms" if there were more costly regulations.

Jim Lott, executive director of the Hospital Assn. of Southern California, which represents most of Los Angeles County's hospitals, blamed the talks' failure on a heavy-handed, "take-it-or-else" approach by the city attorney. But city attorneys said the inability of the hospital association to be able to "legally bind" its members led to the end of the talks.

Officials have not revealed the names of all the hospitals they are investigating. But the Los Angeles Police Department has publicly identified several that it suspects of dumping, including Kaiser Permanente's Bellflower Medical Center, Martin Luther King Jr./Drew Medical Center and Los Angeles Metropolitan Medical Center. Those facilities have denied any wrongdoing. . . .

Jeff Isaacs, chief of the city attorney's Criminal and Special Litigation Branch, said his office's investigation suggested that some medical centers in the suburbs dumped patients on skid row instead of in their areas because "it was one way to guarantee they would not come back again." Several hospitals have strongly denied such motivation.

The state Legislature recently passed a law aimed at curtailing dumping across city boundaries, but it won't take effect until January.

The city attorney's office acknowledged that legal proceedings could be difficult given both the transient nature of many victims and the lack of a specific state statute prohibiting the discharge of patients onto skid row. Officials said, however, that potential criminal charges might include false imprisonment and "dependent adult" abuse. "These are the most challenging cases because the victims are the perfect victims. We have a challenge just finding them," Deputy City Atty. Carolyn Phillips said.

The city attorney is also looking at whether hospitals that engage in dumping could be penalized for violating the federal Emergency Medical Treatment and Active Labor Act, which requires medical facilities to screen and stabilize all patients and penalizes them for releasing those who are medically unstable.

Isaacs said the city attorney's office is also considering suing offending hospitals for violating a state law that deals with unfair business practices. The law allows a corporation to be sued for unscrupulous behavior and has been used in the past to successfully sue slumlords.

In the meantime, Lott said, his organization is pursuing its own policy changes. The association, which represents more than 170 hospitals in Southern California, has recommended that all hospitals get signed waivers from patients before they are released on skid row. The hospitals also are working on a plan to have Volunteers of America, a skid row charity, provide van service from hospitals to homeless service providers. The association also would seek to reserve 45 beds for homeless people at hospitals across the county for longer term recoveries.

Prosecutors and others, however, accuse the hospitals of dragging their feet. Mark Rosenbaum, legal director of the ACLU of Southern California, said that although he still hopes for a resolution, the hospitals so far have shown "they don't really want to solve the problem."  Dan Grunfeld, president and chief executive of Public Counsel, said the continuing dumping shows that a "systemic approach" is needed to change the way hospitals discharge the homeless.  "Dumping someone in skid row can be tantamount to killing them," he said.

Today's NPR Morning Edition has some more details as well as a video of a female patient woman being dropped off on skidrow. 

November 17, 2006 | Permalink | Comments (0) | TrackBack (0)

Thursday, November 16, 2006

Universal Health Care

Ezra Klein has an interesting post on what Universal Health Care (:UHC") will look like here in the United States.  He argues:

As for what UHC will look like? My best guess is that eventual reforms will heavily subsidize private insurance coverage up to 300 or 400% of the poverty line, but the private coverage will be provided under a heavily-regulated government umbrella that eliminates adverse selection, mandates various coverage components, and generally imposes a basic floor of coverage. This may happen under an expansion of the Federal Employee Health benefits Program. It will be paid for through a dedicated VAT tax, and the uninsured will be eliminated through an individual mandate.

There is, obviously, a certain error range here.  I could certainly see a Medicare Plus scheme, a la Jacob Hacker, where businesses and individuals are offered the option to buy into an enhanced Medicare program, but can, if they choose, retain private insurance options. The problem with something like that is that insurers will have all the more reason to cherrypick, but the ability of government to bargain down prices will probably chop apart the relative premium savings of the private sector. It's also possible to outlaw underwriting and cherrypicking altogether, though I see that as somewhat -- though not totally -- unlikely. A healthy, fit, young friend of mine was just denied coverage on the individual market for the sole reason that he took an anti-anxiety drug over the last year. No health problems, no congenital deformities, he just had the audacity to actually utilize some health care. That's an unsustainable situation, and whatever the reforms look like, I don't expect it to continue for much longer.

I agree that our current health care system is a mess but I am not sure that this is the answer - hopefully now that the elections are over we will start having more conversations about how to better deliver health care to all who live here..

November 16, 2006 | Permalink | Comments (0) | TrackBack (0)

Horse Cloning Continues

This recent turn to cloning horses should make the future years of horse racing even more exciting.  I realize some horse owners may think that this is unfair (and certainly those that were looking forward to using their retired horses as a means to bring in money from "stud fees" may be disappointed) but for the rest of us - how exciting that we may be able to see the same horses run over and over again. . .  .  The AP reports,

Barrel racer Charmayne James knew scientists had figured out how to clone mice, sheep and cats. But if any creature deserved to be cloned, she thought it was her gelding Scamper, the retired 10-time world champion. The result, Clayton, has exceeded James' expectations. The foal even bristles, just like Scamper, when touched on a certain spot behind his ear.

"Scamper was one of the greatest horses ever, and I know that now more than ever," James said. "I wanted to get in and save his genetics, because if they were ever able to clone a horse, Scamper would be the horse to clone."

James paid an Austin-based ViaGen Inc. $150,000 to clone Scamper. After four failed attempts, Clayton was born Aug. 8. His birth had been kept secret until Wednesday.

Genetic material was extracted from a cell sample taken from Scamper, then transferred to an egg that had its own genetic material removed. An embryo was grown in an incubator before it was transferred to a mare. . .

Scamper won a record 10 Professional Rodeo Cowboys Association world championships from 1984 to '93 and helped make James the first million-dollar cowgirl and the all-time leading money winner in barrel racing. Scamper is the only barrel racing horse in the Pro Rodeo Hall of Fame.

James, who lives in Athens, Texas, plans to breed Clayton to help "get better, sounder quality barrel horses out there." For now, she has no plans to race Clayton, saying he's to valuable to risk getting hurt.

The PRCA has no limits on using cloned horses in competition, but Clayton wouldn't be allowed in any events sponsored by the American Quarter Horse Association, which does not register horses that are cloned or their offspring.

The first cloned horse was born in 2003 in Italy. In 2005 Texas A&M University created the first cloned horse in the United States. Earlier this year, ViaGen announced it had cloned two top-earning cutting horses in Oklahoma.

$150,000 for a cloned horse!  I guess that could be seen as a bargain since cloning your cat could cost approximately $50,000.  It is rather surprising that this horse story does not discuss the potential medical harms to the clone as well as ethical concerns surrounding the entire issue of cloning. 

November 16, 2006 | Permalink | Comments (0) | TrackBack (0)

Wednesday, November 8, 2006

Webcast!

Common Good and the Harvard School of Public Health will be webcasting their upcoming event, Health Courts and Administrative Compensation: Opportunities for Safety Enhancement.

Speakers at the event include: Harvard School of Public Health Professors David Studdert and Michelle Mello, Dr. Dennis O'Leary, President of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and Massachusetts State Senator Robert O'Leary.  These speakers and others will discuss how an administrative approach to injury compensation could enhance safety and quality, as well as legal and policy issues likely to be raised by proposed demonstration projects.

The webcast will begin at 1 p.m. EST on Wednesday, November 8th.  Access the webcast and more information at http://cgood.org/healthcare-events-70.html.  The event agenda can be found here: http://cgood.org/healthcare-events-70.html?display=agenda.

Here is some further information:

The goal behind health courts is to create a reliable system that sends consistent signals to providers about what constitutes appropriate care, lowers administrative costs, and improves patient safety and the quality of care.  We’ve seen significant interest in the concept from a wide variety of groups, including providers, consumers, and business groups.  Legislative proposals to create health courts (or pilot projects) are pending at both the federal and state levels.  There were hearings on health courts in both the U.S. House and Senate this past summer, which you can read more about on our website here:  www.cgood.org/healthcare.html.

In addition, our research team at Harvard recently published an article about how health courts could improve patient safety in The Milbank Quarterly.  You can read our press release about the article here:  http://cgood.org/healthcare-newscommentary-inthenews-326.html  and you can access the full article at this link:  http://www.milbank.org/quarterly/8403feat.html .

November 8, 2006 | Permalink | Comments (0) | TrackBack (0)