Legal warning over umbilical cord blood collection

Interesting article about cord blood collection in the UK - Legal warning over umbilical cord blood collection. The article implies that is illegal to collect cord blood without a license; however, a lack of uniformity among hospital policies, with some hospitals not allowing collection, leads some parents to take matters into their own hands:

The Human Tissue Authority (HTA) has written to more than 150 organisations following concerns that parents, including new fathers, are collecting the blood themselves using kits delivered to their homes.

Some midwives have said they are being put under pressure to collect the blood illegally and there are fears this could be compromising patient care.

The Royal College of Midwives supports the HTA's actions, saying, "[t]he time during the birth when cord blood is collected is one of the riskiest times, in terms of safety. Therefore, it is essential that midwives are able to concentrate on the birth and are not put under pressure to carry out unregulated and unlawful cord blood collections."

FDA raids Miami birth center; Placentas, medical records confiscated

On Christmas Eve, federal, state, and local authorities executed a search warrant on the Miami Maternity Center following a 10-month joint investigation by the Florida Department of Health, the US Food and Drug Administration, and Miami Dade Police Department’s Medical Crimes Unit. Birth center staff were allegedly dehydrating and encapsulating placentas in a process that resulted in placentas from various birth mothers becoming commingled. Midwife Shari Daniels denies the allegations, according to news reports:

"They charged in here as if I were making crack cocaine," Daniels complained. "They could have sent one person and we should have shown them everything." She suggested that the raid might have been caused by angry obstetricians, who charge several times what she does to deliver a baby. "The local docs are screaming their heads off.''

Jodi Selander, owner of Placenta Benefits, a placenta encapsulation service, writes on her blog:

I am (obviously) a huge proponent of placenta encapsulation. However, I can not in any way condone this type of activity. I created the Training & Certification program specifically to avoid these types of situations.

As an advocate for the movement toward legitimizing the use of placenta for its natural purpose, this story is absolutely outrageous. People who operate with such a total lack of regard for the gravity of the process and who apparently do not realize that the FDA is not on our side, set the movement back and make it harder for the rest of us who are being safe and working toward legitimacy.

Please, people - don’t think that you can find free instructions for drying placentas on the internet and just set up shop. This is serious. You need to comply with government standards and regulations. Get some training. Work with us. Together we can do it. But not when people like this are operating out there.

White Collar Crime News blogger Jef Henninger has a lawyer's take on the situation:

I hate to see good people get caught up in criminal cases when the entire problem could have been easily avoided if a good attorney got in there and essentially performed an audit on the entire business....I don’t know enough about the facts of this case to really figure out what the situation is here, but I see no indication that anyone was harmed. At the most, it seems like they had sloppy business practices while they performed a service that the people wanted; but the FDA does not agree with. This seems like it would be a good case for a lawyer to argue that this is a technical violation of civil law and not a criminal violation as no one was actually harmed.

And, as I have mentioned before, I would love to have an expert's opinion about the HIPAA implications of confiscation of medical records. What happens to a person's right to his or her own medical records when those records become evidence? I assume that HIPAA exempts healthcare providers from liability when complying with a legitimate court order or other legal process, but do the police, prosecutors, and court personnel have the same duty as healthcare providers do to keep protected health information confidential? What if the health of a woman and her baby are compromised because her prenatal records are unavailable? Is there liability? Is anyone but me asking these questions?


Update 1/08/2008: For more information and continuing updates, please visit The Placenta Blog.

Placenta Victory

Sunrise Hospital, threatened with a second lawsuit, reversed their policy to allow the release of healthy placentas to women upon request, reports The Placenta Blog.

This Week's Legal News

Breasts, placentas, midwives, and the TSA -

Woman wins settlement in breastfeeding case:

Watch-maker and clothier Fossil Inc. agreed to pay $3,600 to a woman who was barred from breast-feeding her infant while visiting a company showroom, the New York Civil Liberties Union said on Tuesday.

Lass King, 37, a buyer for a Maine clothing store and a mother of two, said she received a letter of apology and the payment from Fossil after threatening the company with a lawsuit.

In its letter to King, Fossil also said it had issued a policy affirming that breast-feeding was permitted in all Fossil stores and showrooms, said Galen Sherwin, director of the NYCLU's Reproductive Rights Project.

Representatives of Fossil could not immediately confirm details of the settlement.

New York law states that women are permitted to breast-feed "in any location, public or private, where the mother is otherwise authorized to be."

Hospital told to return placenta to mom:

A woman has won a court fight to keep the placenta after her daughter's birth. She had planned to grind it up and ingest it as a way to fight postpartum depression, but now plans to bury it.

Clark County District Court Judge Susan Johnson granted a preliminary injunction Tuesday, ordering Sunrise Hospital and Medical Center in southern Nevada to return the placenta to Anne Swanson. Hospital officials said they will comply.

What is interesting was that the plaintiff was expecting a ruling on a temporary injunction, not a ruling on the merits (see Swanson vs. Sunrise Hospital for the blow-by-blow). Doesn't sound as if the hospital will fight this decision, but they are not changing their policy either:

Amy Stevens, system vice president for Sunrise Health, which operates Sunrise Hospital, described the ruling as specific to Swanson. She said the hospital must comply with strict regulations in handling human biohazardous waste.

There is no Nevada law prohibiting hospitals from returning placentas to mothers. But several Las Vegas area hospitals told the Las Vegas Review-Journal the organ is usually destroyed unless a physician designates it for medical tests or a patient seeks it for specific religious or cultural reasons.

USA Today ran a piece this week on placentophagia (Ingesting the placenta: Is it healthy for new moms?) which mentions the Swanson case.

After numerous complaints, the Transportation Safety Administration (TSA) has changed its policy regarding breastmilk:

TSA is also modifying the rules associated with carrying breast milk through security checkpoints. Mothers flying with, and now without, their child will be permitted to bring breast milk in quantities greater than three ounces as long as it is declared for inspection at the security checkpoint.

Breast milk is in the same category as liquid medications. Now, a mother flying without her child will be able to bring breast milk through the checkpoint, provided it is declared prior to screening.

Birth Without Boundaries lawyer Jake Marcus comments:

Under the old TSA rule, pumped breastmilk had to be packaged in 3 oz containers all of which had to fit into one 12 oz ziplock bag. Birth Without Boundaries has assisted many women whose pumped milk was confiscated and dumped by TSA security officers, either because it was not packaged according to regulation or because the TSA officer did not know what the regulation was. All of our complaints to the TSA have gone unanswered, until now.

Marcus also recommends that women traveling with expressed milk carry a copy of the modified policy, just in case they encounter an employee who has not yet gotten the memo.

Judge dismisses Mendon midwife lawsuit:

A federal judge has dismissed a lawsuit filed earlier this year by a former Mendon midwife in a bid to have her license to practice in Vermont reinstated.

Roberta Devers-Scott claimed in the lawsuit that the state violated her due process rights, leading to the revocation of her midwife license. Secretary of State Deborah Markowitz, whose office oversees professional licensing of midwives in Vermont, was among the defendants named in the lawsuit.

Judge J. Garvan Murtha issued a six-page ruling in U.S. District Court in Brattleboro granting a motion filed on the defendants' behalf dismissing the lawsuit, ruling, in part, Markowitz had immunity from the lawsuit.

Michael Sussman, Devers-Scott's attorney, said Friday he planned to appeal the judge's ruling to the 2nd Circuit Court of Appeals in New York City.

And that's what is making news this week.

Placentas, Protests, and Property Rights

Before Anne Swanson gave birth at Sunrise Hospital in Las Vegas, she requested that her placenta be saved so that she could take it home. At the time of discharge, however, the hospital refused to release the placenta to her. According to placenta activist Jodi Selander, "There are no laws in NV that state a hospital can not release a placenta, yet the hospital refused because it 'was not comfortable' doing so." (link)

Swanson is now waging a legal battle against Sunrise for possession of the placenta. The hospital normally keeps placentas in cold storage for three days, then disposes of them. According to Swanson, the hospital has informed her that it will not release the placenta without a court order, and will destroy it on May 15th. A pro-placenta rally was held on Monday, May 7, and supporters are planning a push for legislation, similar to that passed by Hawaii last year, which would require hospitals to release non-infectious placentas to patients on request. The Hawaiian statute states:

§321-30 Human placenta. Upon negative findings of infection or hazard after appropriate testing of the mother, the human placenta may be released by the hospital to the woman from whom it originated or to the woman's designee. The department shall establish a release form which shall stipulate appropriate measures for the safe release of human placenta.

That seems pretty simple and covers all the bases, doesn't it?

I know that stopping the spread of infectious disease is serious business, and proper disposal of hospital waste is an important part of that. We don't want needles and body parts thrown in dumpsters, where they might be discovered by dogs, rats, and homeless people. But look at it this way: Baby comes out of mommy's uterus - baby gets taken home. Placenta comes out of mommy's uterus - placenta gets thrown away. Placenta is infectious waste. Baby isn't. Huh? Yes, I know that the baby is a living, breathing human, and the placenta is an organ. But for some people, placental burial is an important religious or cultural ritual, and for others, it is about having control over one's body and retaining ownership of its products.

Now, to turn to the broader legal question: does a person have a property interest in his or her own cells, organs, or body parts? I'm not going to give this question the full treatment, but the leading case on this issue seems to be Moore v. Regents of University of California, 793 P.2d 479, 51 Cal.3d 120 (1990). In this case, university researchers used tissue taken from Moore's diseased spleen to create a cell line which they later patented. The Supreme Court of California held that Moore did not have property rights to or a financial interest in his cells (Wikipedia). Part of the Court's reasoning was that California statutory law restricts a patient's control over his or her medical waste, citing California Health and Safety Code section 7054.4:

[n]otwithstanding any other provision of law, recognizable anatomical parts, human tissues, anatomical human remains, or infectious waste following conclusion of scientific use shall be disposed of by interment, incineration, or any other method determined by the state department [of health services] to protect the public health and safety."

Of course, each state may come out a little differently on this issue (California Supreme Court decisions not being binding on the rest of us). And even if a person does have an ownership right to their body parts doesn't mean they necessarily have a possessory right to them. As we learn on the first day of property class in law school, property rights are like a bundle of sticks.

If you are finding this fascinating, you may want to read Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participants' Property Rights in Their Biological Material, Wash. & Lee L. Rev. (Winter 2004). I didn't - it was too long and I dont' have the time. But I did get out my bluebook for that cite, which I'm hoping makes up for the fact that a cited to a Wiki a couple paragraphs ago.

Anyhow, hope that give you something to - er - chew on.

Links:
Diva/Mamma (the go-to blog for this case)
Placenta Benefits
Placenta befouled, mom told (Las Vegas Review-Journal)
Making pills from placentas (Las Vegas Review-Journal)
Action News 13 Las Vegas (video)

Placentas in Strange Places

Placentas keep showing up on college campuses...

The state Office of the Medical Investigator in Albuquerque [New Mexico] is reporting the fetus found Friday in the bathroom at Diné College in Shiprock was not a fetus after all.

The material found was actually the placenta from a childbirth, according to OMI.

Investigators believe a woman gave birth, possibly at home, then delivered the placenta at the school.

While no one has come forward reporting a problem giving birth, there is no longer a criminal investigation in the case.

Link

Midwife Buries Placenta, Loses Job

Can you believe I have a goggle news alert set up for "placenta?". Occasionally it even turns up articles not relating to Tom Cruise.

From the New York Law Journal, Baldwin Midwife Wages Legal Battle to Upend Suspension of Privileges:

A Baldwin midwife is waging a legal battle for restoration of her privileges at Nassau University Medical Center in East Meadow that were suspended after she removed a placenta from the hospital to bury it in her garden.

Jeanette Breen, 60, who has been delivering babies at the medical center since the early 1990s, was suspended on Nov. 9, 2005, shortly after she left the hospital with the placenta.

The patient gave Ms. Breen, who is a registered nurse and a licensed midwife, permission to take the placenta. However, Ms. Breen did not seek prior authorization from the medical center, which claims that she violated the hospital's policy and state law for the disposal of regulated medical wastes.

Many patients of midwives view placentas as natural products of conception that should be given a proper burial instead of being discarded as medical waste.

The article then goes on to state New York law on the issue:

The hospital contends that Ms. Breen's removal of the placenta violated the state Public Health Law, which prohibits the improper disposal of medical waste. According to Section 1389-aa, that includes any "tissue, organs and body parts," except teeth and contiguous bone and gums, removed during surgery or other medical procedures.

Ms. Breen's lawyer notes that the law does not specifically mention placentas. Moreover, he argues that her actions fall under an exception that allows patients to retain body parts removed during surgery if they have a religious reason for doing so. Mr. Reiser said that his client had a "cultural" justification for removing the placenta from the hospital.

The article notes that the hospital had an unofficial policy of allowing patients to take home their placentas when they make a personal request.

Previous Placenta Posts:
Placentas in the News
Placenta Found At Wellesley College
Update: Placenta Found At Wellesley College

Update: Placenta Found At Wellesley College

Placenta mystery solved: Mom, baby found safe, no charges filed

Apparently, I was right.

And the Boston Herald is just as facinated with placentas as I am.

Placenta Found At Wellesley College

Possible Placenta Found At Wellesley College

Oh, darn. Guess I shouldn't have drained the birth tub out into the arboretum.

No, seriously, this is not funny because if someone is going to just toss a placenta somewhere (as opposed to, say, a ziplock bag in the freezer), they could have easily tossed the baby out too. Which is I'm sure what the police are thinking.

Blawg Review and other Carnival Rides

The first Pediatric Grand Rounds is up at Unintelligent Design.

I've not been linking to Blawg Review lately. Where is my loyalty? Sorry, Ed.

Last week, Prof. Maule of Mauled Again wrote a right-on description of The Mommy Blawg. Having hosted a Blawg Review, I know how hard it is to sift through all the entries, view all the blawgs, and make quick sense of them. Good job.

Blawg Review #54, on Brandy Karl's bk!, introduces my Placenta piece with this quote from Alice's Adventures in Wonderland:

Soon her eye fell on a little glass box that was lying under the table: she opened it, and found in it a very small cake, on which the words "EAT ME" were beautifully marked in currants. "Well, I'll eat it," said Alice, "and if it makes me grow larger, I can reach the key; and if it makes me grow smaller, I can creep under the door: so either way I'll get into the garden, and I don't care which happens!"

She writes, "More than you ever wanted to know about placentas and related curiosities from the Mommy Blawger, who explores the topic in near-excruciating (only so because of the topic) detail." You think that's excruciating? Just wait until my piece on umbillical cords. That will be excruciating.

Placentas in the News (or: Everything You Ever Wanted To Know About Placentas But Were Afraid to Ask)

Item One: The Hawaii legislature has passed a measure allowing parents to take home their baby's placenta, a practice currently prohibited by state health rules. ("Hawaiian parents seek right for birth ritual")

Here's a question - what experience have any of you had requesting or receiving your placenta after a hospital birth? Please leave me a comment. I would also be interested to know what country, state, or metro area you live in. And what reason was given if the placenta was not released to you.

In California, you must have a license to transport medical waste, which makes things a little tricky for homebirth midwives (Placenta Disposal).

With my first birth, I merely requested in my birth plan to be shown the placenta, something which did not happen. (The Doctor or Midwife has to look it over anyway, they might as well do it in front of you.) With my second, a homebirth, I got to examine it but I did not choose to keep it, something I now regret. I think it got thrown out with the trash. Our third son's placenta is happily sitting in our freezer next to the ground beef and frozen chicken breasts. Some day we will plant something nice over it, like a tree or a rosemary bush. Then we will never be able to sell that house. Just kidding.

Once I blogged about a thief who stole food from a freezer - including a placenta.

The placenta was, after all, a baby's companion since, well not quite since conception, but close. It was the source of the baby's nutrition, oxygen, and so forth, and it deserves some respect. I'm not really a fan of lotus birth, but I can definitely see the attraction.

Item Two: Okay, this happened in February, but I had a one month old baby and didn't get around to blogging it:

From 1996 to 2003, hospitals throughout Oregon, Washington and California quietly collected the placentas of as many as 700 women who suffered difficult births. They sent the placental tissue to a Portland institute underwritten by the insurance industry. The institute, called Cascadia Placenta Registry, was separate from the hospital's own pathology labs; it existed in large part to help doctors sued for malpractice.

This marshaling of evidence often happened without patients' knowledge or direct consent. One of the patients, Angela Desbiens, didn't know her placenta had been squirreled away as evidence until after she sued Providence St. Vincent Medical Center for failing to prevent fetal distress.

In the process, Desbiens learned that Cascadia had sliced her placenta into chunks, making it harder for other pathologists to analyze. She also discovered that Cascadia used incorrect information about the birth, as well as genetic data from some other patient, to draw its unsurprising conclusion that the hospital wasn't to blame for her child's brain damage.

Hat tip to the American Journal of Bioethics Blog.

Item Three: Tom Cruise and the very, very pregnant Katie Holmes have been the subject of much birth gossip lately, but Tom doesn't do much to squelch those rumors, does he? He is reported to have told GQ Magazine he would eat the placenta ("Is it safe to eat a placenta?"), but later made it clear to Diane Sawyer that he wouldn't ("Cruise Downplays Placenta Plan").

Ok, let's answer that question. Placentas have a great deal of prostiglandins and oxytocin, and they can be used in an emergency to slow postpartum hemorrhage when eaten or placed in a woman's mouth between her cheek and gum. Personally, I think it would be much saner just to let midwives administer pitocin. Ya think?

Placentas also have, apparently, a large amount of iron and other nutrients, so if they are consumed, after either being cooked or freeze dried and placed into capsules, they supposedly help the woman gain back her strength after the birth (see Medicinal Uses of the Placenta). Ok, I am going to draw a line here. If you want to eat your own placenta, fine. Personally, I would have to be bleeding to death before I would do so, but that's just me. But please, don't eat anyone else's. That's just gross. And probably not safe, either.

Must we go here? Apparently we must:
Placentophagy from Wackipedia
Wikibooks Cookbook