Collecting cord blood poses legal risks

A column analyzing the impact of recent court decisions on physicians

By Bonnie Boothis a longtime staffer and former editor of the Professional Issues section, left the paper to study law. She wrote the "In the Courts" column during 2005-08. Posted Feb. 13, 2006.

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When a woman learns she is pregnant and subscribes to her first parenting magazine, she often is inundated with offers related to pregnancy and childbirth. Among the offers is likely to be more than one direct-mail solicitation from private core blood banks, encouraging her to consider storing her baby's umbilical cord blood.

More than 20 companies are in the business of collecting cord blood and storing it in case that child -- or another member of the family -- becomes ill with a disease for which the blood could be used as treatment.

When parents decide to store their child's cord blood, they reach an agreement with the company of their choosing. But it is the physician or some other member of the delivery team who collects the blood. Often physicians are the ones who will receive a kit with a postage-paid, self-addressed container for sending the blood to the company for storage.

Elizabeth A. Green, an attorney in the Law Offices of Aryeh Guttenberg in Baltimore, said because physicians rarely collect cord blood, they probably have not considered whether performing the procedure puts them at legal risk.

But it does.

Because physicians are not a party to the contract, they are not protected should something go wrong. And while many physicians view the collection as "simply doing something the patient wants," Green warns that physicians are vulnerable to a lawsuit in several ways.

Here are two scenarios that could end with a physician being named in a medical malpractice lawsuit.

  • A physician might agree to collect the cord blood and forget to do it. If the blood is needed at a later date, the parents could come after the physician, because they wanted the doctor to collect it and he or she did not.
  • A physician might collect the cord blood, but something goes wrong in the collection process. When the parents go to use it, it is tainted or there isn't enough for treatment.

Green said she doesn't believe parents are likely to prevail in court in either of these situations, because assessing damages would be too speculative. The "shelf-life" of core blood is undetermined, although research puts it at 15 years or longer. It would be pure speculation whether the blood would have helped had it been usable. Nevertheless, even if a judge eventually tossed the lawsuit out of court, you've still been sued, and no one wants to be sued.

But there are other scenarios in which parents stand a better chance of winning in court, she said.

Instead of filing a traditional medical malpractice lawsuit, patients could pursue a breach of contract claim if the core blood turns out to be unusable. Parents probably would sue physicians, hospitals and any other person or entity involved in the collection. In this instance, a physician who played a role in collecting the blood could be considered an agent of the core blood company.

Green said physicians who charge parents for collecting cord blood are considerably more likely to be sued under a breach of contract claim.

And, she added, cord blood collection can create more legal risk during delivery. If the delivery team becomes too involved in collecting the blood, something else happens -- the mother goes into cardiac arrest, for instance -- and complications ensue, a lawsuit becomes more likely.

Minimizing risk

Few deny there are benefits to saving a child's cord blood and that during a normal delivery there is no risk to mother or baby in collecting it. So, is there a way for physicians to try to insulate themselves against the risks of participating?

Green says yes. How it's done shouldn't be much of a surprise in the day and age of the consent form that discloses the risks of virtually any medical procedure.

Protection can be as simple as one form. Green said expectant mothers already sign multiple forms before giving birth and that physicians and hospitals should make sure they get consent forms specific to cord blood collection from parents who want them to collect it. Physicians should not assume a hospital form covers them. They should have their own form and make sure it is signed.

Private core blood storage was studied by the American College of Obstetricians and Gynecologists in 1997 and the American Academy of Pediatrics in 1999. At that time, neither was prepared to recommend cord blood storage, and they have not changed their positions.

ACOG says that physicians should, as with all new medical interventions, resist marketing pressures and evaluate the potential benefits and risks, both emotional and physical, to patients before becoming involved in the collection.

AAP agrees, noting pregnant women and their families are particularly vulnerable emotionally to marketing efforts framed in terms of their child's future well-being. Those patients might look to their physicians for information. In fact, AAP is re-examining the issue and considering recommending government regulation of the activities and methods of core blood companies, including their advertising methods.

Green, the mother of four, said that in a recent conversation with an ob-gyn from the group that delivered her children, the doctor seemed skeptical of the need for such a form -- until the end of their conversation. By that point he was ready to discuss the issue in a group meeting the next day.

Collecting and preserving cord blood is still an expensive process. Collection and storage for the first year can cost upwards of $1,200, and subsequent storage runs around $100 annually. This is one of the reasons physicians are called upon so seldom for collection.

But private companies are stepping up marketing campaigns. Green said that during her first pregnancy in the late 1990s, she received virtually no solicitations for the procedure. But by her fourth pregnancy, last year, she was struck by the number of advertisements she saw. She said companies have hired representatives, much like those in the pharmaceutical industry, to visit physicians and talk to them about cord blood collection and preservation.

She advised physicians to start discussing the issue with each other, get consent forms in shape and become more informed about the topic. Even if they only rarely perform the procedure, they only need to perform it once to open themselves to legal risk.

Bonnie Booth is a longtime staffer and former editor of the Professional Issues section, left the paper to study law. She wrote the "In the Courts" column during 2005-08.

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