ASRM Legally Speaking

Beyond ART….new legal issues emerge as technologies develop.

Couple’s Wrongful Birth Claims Turn on Conflict of Law Question

In a striking example of both the significance and variability of the law, a lab’s liability for misreading an amniocentesis test will turn on what state law applies to its conceded failure to meet the standard of care. The case involves a Maryland couple who sought to avoid having a child with cystic fibrosis (CF). After delivering their first child and learning they were both CF carriers and aborting their second pregnancy when pre-natal testing showed that child would be born with the disease, Karen and Scott Hood again underwent amniocentesis during their third pregnancy. The fluid was sent to Lab Corp., Inc., located in North Carolina. The lab was informed both parents were carriers. The lab admitted to misreading the chromatograph and mistakenly reporting that the fetus was not a carrier or affected. The couple carried to term, and at three months their son was found positive for CF.

The couple sued in federal court under Maryland law which recognizes “wrongful birth” actions and allows damages for extraordinary costs of child-rearing. In contrast, North Carolina does not allow recovery for "wrongful birth" claims, on the rationales that it does not want to hold health care professionals responsible for genetic abnormalities they did not cause and to discourage legal liability for actions that would result in an abortion. Lab Corp. has argued that North Carolina law should apply. As the federal court noted, "[d]eciding the choice of law is critical, because if this court were to apply the laws of North Carolina, the Hoods would not have a cause of action.” Ironically, North Carolina does recognize “wrongful conception” claims, where a pregnancy would not have occurred absent a health care professional’s negligence. The federal court has “certified” to the Maryland Court of Appeals the question of which state law should apply, which will have to render an opinion before the case can proceed.

The case presents a classic example, in an unusual setting, of what is known as a “choice of law” analysis, where two states have dramatically different approaches to the legal theories and recovery limits for the same wrongful actions. The defendant lab claims that it would be unfair to subject it to laws in any state where a family happens to reside and that it should be held only to the standards of the state where it is located. Additional arguments turn on legal intricacies of “standard of care” exceptions and whether the law of the injury or last negligent act occurred, and the lab’s argument that any tort claim belonged solely to the wife, not the husband. The couple has argued that, especially for a national company doing business throughout the country (the lab reportedly operates in 35 testing locations with more than 1,000 patient service centers, including eight in Maryland), it would be unfair to allow a company to “forum shop” for a favorable location and that any standard of care exception that might make North Carolina law applicable should be rejected as a matter of public policy since Maryland law so clearly protects “the rights of parents to make their own family planning decisions”.

Ironically, since North Carolina recognizes "wrongful conception" claims, prior to establishing a pregnancy, the family would have been able to recover under that state’s laws had they been misdiagnosed through either carrier testing or PGD (pre-implantation genetic diagnosis). As PGD becomes more widespread, that legal distinction may be difficult to maintain; otherwise it will open a new venue for arguments as to when conception occurs or life begins.

With the increasing interstate nature of many ART and reproductive genetics scenarios, unanticipated legal intricacies and inconsistent laws may be significant in the event of subsequent complications or disputes. Hood v. Lab.Corp. of America, Civ.No.CCB-04-3879 (USDC MD)(6/01/06)

Massachusetts Stem Cell Legislation Hits Regulatory Snag

Demonstrating how volatile the terrain can be for stem cell research at both state and federal levels, Massachusetts legislators are attempting to reverse recent restrictive regulations that threaten to limit stem cell research approved by the legislature in 2005. The regulations were adopted by a public health council whose members are appointed by the governor. Lawmakers claim the regulations go beyond both the letter and intent of the law, and are a deliberate and politicized attempt to restrict legally permitted research activities. The council has acknowledged working closely with the Governor, who opposes research except on leftover embryos, and is widely perceived as a contender for the Republican presidential nomination. Legislators and scientists expressed concern that the new regulations expanded the law’s prohibition on creating embryos solely for the purpose of “donating” them (which would apply to donors) to a prohibition on creating embryos solely for the purpose of “using: them, a subtle but significant distinction that could preclude scientists from creating such embryos. The Boston Globe (8/30-31/06).

Couples Wins Exception to HFEA Rule on Frozen Embryo Storage Limits

Pointing up the unpredictability of individual situations and blanket rules, HFEA has backed away from its five-year limit for storing frozen embryos intended to be used by a gestational surrogate in an individual case. The current rules allow 10 years’ storage for a woman to use her own embryos, but only five if they were created with the intention of having another woman carry the pregnancy.

The couple has one six-year-old child, after which the mother, Michelle Hickman, age 33, had an emergency hysterectomy. Wanting a large family, the couple created and stored embryos and has been searching for a gestational carrier. Friends who had volunteered were ruled out medically, and the five-year storage limit was reached in May 2006. The clinic had continued to store the embryos, in violation of their license, while the couple appealed to HFEA for permission to continue to store the embryos and export them to a clinic outside of Great Britain. Although refusing further comment, HFEA noted that storage time can extend beyond its stated limits in “extremely extenuating circumstances,” and the couple’s clinic has recently informed them the timelines is now “open-ended” for them to locate a clinic abroad willing to accept the embryos. Timesonline.co.uk (8/03/06)

New Zealand Reviews Frozen Egg Request

A New Zealand woman is seeking permission from that country’s Health Minister to have the first child conceived in New Zealand through frozen eggs. Two earlier attempts by other women were unsuccessful. Both predated last year’s Human Assisted Reproductive Technology Order, which banned the use, but not the freezing, of frozen eggs, stemming from safety concerns over current freezing and thawing techniques. The request is under consideration by an advisory committee to the Health Minister. New Zealand’s approach to egg freezing contrasts with that in the United States, where an increasing number of private medical and donor programs have been considering and developing egg freezing options for both donors and intended mothers, for both medical and social reasons (although this is regarded as experimental by ASRM). nzherald.co.nz (8/23/06)

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