Jnlinc - V<il 10. No 6. 2(X)5 692-704 Reproduciive BioMedicine Oiithw: \vn-\v.rhiii(>nlini'.com/Ariule/l726 on web 14 April 2005

Ethics, legal, social, counselling

Reproduction, genetics and the law

Susan L Crockin, Esq., has a legal and consulting practice limited to the legal aspects ofthe assisted reproductive technologies, reproductive genetics, embryo law and adoption.As a recognized author and lecturer in the field, she has taught Bioethics and is a frequentvisiting law professor and conference speaker. She is the author of two books, multiplechapters and articles, and, since 1990, a quarterly column, 'Legally Speaking'", thatreviews court decisions in these unique areas of the law.

Susan L Crockin, Esq.

Susan L CrockinLaw Office of Susan L Crockin, 29 Crafts Street, Newton, MA 02460, USACorrespondence: e-mail: susan.crockin@crockinlaw.com

AbstractBoth reproductive medicine and genetics are seeing rapid, and in some instances revolutionary, medical and scientific advances.Courtshavebeencailedupontoresolveavariety of novel disputes arising from these areas, and more can be anticipated as thesetechnologies continue to develop and their use becomes more widespread. This article discusses some of the most relevant areasof the law and litigation that currently bear on reproduction and genetics or that may be anticipated to do so in the future. Specificdevelopments and judicial decisions addressing them include: legal theories of wrongful birth and wrongful life and theirapplication to children bom with genetic impairments; a physician's duty to wam family members about a relative's geneticdisease; disputes over reproductive materials and non-reproductive cells and tissues: unauthorized genetic testing in theworkplace; and genetic discrimination. It is hoped that this discussion will be of value to medical and legal professionals andpolicy makers who work with these concepts in the increasingly inter-related fields of law and medicine.

Keywords: generic discrimination, misuse of reproductive material. POD. reproductive genetics, reproductive technologv law.wrongful conception

IntroductionReproductive genetics, meaning Ihe use of reproduciive andgenetic technologies to both provide prospective parents withinformation about a future child and to avoid having a childwith a genetic abnormality, is a rapidly evolving area ofmedicine. As with many of the new reproduciive lechiiologies.courts have been called upon to resolve a variety of disputesarising from reproductive geneiics, and more can beanticipated as these technologies continue to develop and theiruse becomes more widespread.

Reproductive genetic testing has been used for several decadesto inform prospective parents about their risk of producing achild with a genetic disorder. Prospective parents can bescreened to determine if they are carriers of a genetic disease("carrier screening') before they initiate pregnancy. Most ofthe time, however, carrier screening occurs once pregnancyhas already begun. In addition, prenatal testing can beperformed, in which the fetal DNA is tested for genetic defectsusing amniocentesis or chorionic villus sampling (CVS).

In past decades, the number of genetic tests available wasfairly limited. Now. however, there are tests for over 1000genetic diseases available either commercially or as part ofresearch (GeneTests®http://www.genetests.org), and theavailability of these tests has influenced standards of medicalcare. For example, in 2001, the American College ofObstetrics and Gynecology and the American College ofMedical Genetics recommended thai the genetic test for cysticfibrosis be made available to all couples seeking preconceptionor prenatal care, and offered to all couples in ethnic or racialgroups considered at higher risk for carrying the CF gene( G r o d y et ai.,2{K)]).

In the pasi 10 years, .scientists have developed a method calledpreimplantation genetic diagnosis (PGD) to test embryosdirectly for genetic defects before they are implanted into awoman's uterus. This lechnology requires that the womanundergo IVF in order to obtain eggs and create the embryos fortesting. In PGD. embryologists remove one or two cells froman embryo and perform genetic testing on the DNA from thecelt(s). Those embryos found to be free tVom the genetic defect

Ethics, legal, social, counselling - Reproduction, genetics and the law - SL

can then be selected for implantation. In the future, scientistsmay even be able to correct genetic abnormalities before birthusing gemiline jzene therapy.

Both assisted reproduction (often referred to as 'assistedreproductive technology") and genetics have raised novelissue.s for the courts over the past few decades. Donorinsemination, which predates most of the newer, morecomplicated technologies, is not routinely considered a formof assisted reproduction from a medical perspective. Thecombination of these technologies has increa.sed the range andcomplexity of the decisions Judges have been called upon tomake. Assisted reproduction has raised a variety of legal issuesincluding: (i) control and custody of embryos; (ii) access toassisted reproduction services; (iii) parentage of childrenconceived through donor gametes: and (iv) liability formisappropriation of gametes and embryos.

Genetic technologies have also raised many legal issues,including: (i) ownership and control of genetic material andinformation; (ii) misappropriation of genetic material; (iii)discrimination based on genetic information, e.g. inemployment or insurance; (iv) liability for failure to detect orwarn about a genetic disorder through genetic testing; and (v)privacy rights and compelled testing.

In considering legal questions in the context of novelreproductive genetic technologies, courts are likely to drawupon existing precedents (previously decided cases in relevant,if not identical, contexts) for guidance. For example, the legaltheories of "wrongful birth' and "wrongful life", discussedbelow, first arose before the advent of prenatal andpreconception genetic testing, but have since been asserted inthese contexts. This article will provide a discussion of themost relevant areas ofthe law and litigation that currently bearon reproductive genetics or that can be anticipated to do so inthe future.

Court cases arising from ohildrenborn with genetic or other birthdefectsCarrier screening and prenatal testing tor some geneticcondiiions. such as Tay Sachs disease and Down syndrome,have been available tor many years, and before prenatalgenetic testing vi-as available, doctors employed other tests toassess fetal health. There is thus a large body of case law in theUnited States arising from lawsuits against health careprofessionals following the birth of a child with an impairmentthat was either not discovered in the fetus through prenataltesting or not foreseen prior to conception by proper screeningor diagnosis of the parents. Legal theories or 'claims'supporting such lawsuits are generally referred to as wrongfulbirth and wrongful lite claims, although various courts maycharacterize such theories simply as negligence, professionalnegligence, or medical malpractice.

Wrongful birth claims are those brought by parents allegingthat, but for the defendant's negligence, they would haveaborted or never conceived the child. Wrongful life claims arethose brought by (or on behalf of) children alleging that, buttor the defendant's negligence, they would not have been born.

Claims for wrongful binh and wrongful lile are most oftenbrought against the physicians who performed or tailed tooffer or perform prenatal testing or preconception genetictesting, hospitals or medical practices that employed suchphysicians, and genetics laboratories that provided or failed toprovide the testing services.

There is also a large body of law involving children, healthy orotherwise, bom foliowing a failed sterilization, abortion orpregnancy diagnosis. Courts throughout the US differ widelyin their terminology, characterizing these claims variably as"wrongful conception", 'wrongful pregnancy", professionalnegligence, medical malpractice, or simply negligence. (Forease of reference, all such claims will be referred to here aswrongful conception.) Wrongful conception claims aregenerally filed by parents against the physician land thehospital or medical practice employing him or her) whoperformed the negligent sterilization or abortion or who failedto diagnose a pregnancy. These cases and the analyses thecourts apply may provide relevant precedent for casesinvolving reproductive genetics testing since parents willsimilarly claim that, 'but for" the mis.sed diagnosis, they wouldnot have attempted a pregnancy. This theory may be an evenstronger legal basis for such claims, since in almost everyinstance the pre-conception procedure will have beenundertaken for the very purpose of hoping to avoid conceivinga child without a genetic abnormality, and therefore bothcausation and injury may be provable.

Before turning to particular cases, it should be noted that thesame legal principles apply regardless of whether the child'simpairment is genetic or not, and often regardless of when itwas discovered (i.e. after birth, during pregnancy, or pre-conception), so that older court decisions may provideguidance in newer areas as well. As can be seen in subsequentsections of this article, these legal principles have beeninvoked by courts in the relatively few cases that ha\e beenbrought involving new reproductive genetic technologies.

It should also be noted that the claims, or "causes of action',meaning the legal theories that a court will permit to support alawsuit, are typically governed by state law. and therefore varyfrom state to state. Thus, this overview should be used as aguide rather than definitive evidence of the status of the law ina particular jurisdiction. Finally, this overview focusesprimarily on court decisions from the highest state courts,since these provide 'precedent' (rules or interpretations oflaw), which lower courts in that same state must follow. Somefederal court decisions that have interpreted a state's laws arealso reviewed, since those interpretations are often given greatweight within a state.

Wrongful birth court decisions

Within a state, cases are initiated in a trial (lower) court, whichrenders a decision that is binding on the parties to the dispute,but not binding as legal precedent for other or future cases inthat state. If the losing party appeals, the decision may bereviewed by an intermediate appellate court and/or the state'shighest appellate court. The ruling by a state's highest courtmust be followed by all other courts within that state. In somecircumstances, such as when the disputing parties are fromdifferent states and the amount of money involved in the

Etiiics, legal, social, counselling - Reproduction, genetics and the law - SL Crockin

dispute is sufficiently large, a federal court may have•jurisdiction', meaning the legal authority to hear the case. Inthose situations, the case may instead be brought and tried infederal court. Wr{)ngful birth claims arc ruled by state, notfederal law. so a federal court hearing a wrongful birth case willbe called on to interpret the applicable state law. The ruling by afederal court is not binding on state courts, but is often givensignificant deference.

Twenly-six states have high state court or federal court decisionsihat recogni/c and uphold wrongful birth claims (Table I).These courl.s almost universally allow recovery of damages forextraordinary expenses due to the cbild's affliction, but prohibitrecovery of normal child-rearing expenses. The decisions differregarding whether damages are recoverable for Ihe parents'emotional distress.

Sixteen of these wrongful birth cases involved children with agenetic impairment such as Down syndrome, Tay Sachsdisease, or cy.siic fibrosis (Table 1). Seven involved childrenwith non-genetic congenital defects such as rubella syndrotne orbirth defects resulting from cytomegalovirus. One case involvedspina bifida, the causes of which are not clearly understood, andin two cases in Nevada the courts did not discuss whether or notthe impairment bad a genetic component. The nature of theimpairment (genetic or non-genetic) generally has no bearing onthe legal outcome in wrongful birth actions.

A minority (six) l^'i state high courts or federal courts thai haveconsidered the issue have refused to recognize wrongful binhactions (Table I). All six such cases involved children withgenetic impairments. These courts rejected such claims eitherbecause of a specific statute prohibiting them, or ba.scd on thecourt's judgincnt that the existence ol' a human life, even withsevere impairments, cannot constitute a cognizable legal injury,i.e. an injury that Ihe law is willing to redress.

There are also a significant number of states (IQ) that have nostate high court or federal court case law addressing the validityof wrongful birlh claims in those states. The majority of these 19states have no intcrmediale appellate case law either. Those fewstates with intermediate appellate case law tend to vary in theirapproach to wrongful binh claims and damages in a parallel

manner lo the states with high court decisions. Trial courtdecisions are not discussed here, becau.se they do not carry thesame precedential value as appellate cases.

Wrongful life court decisions

In contrast to wrongful birth claims, the vast majority (25) ofstates wilh stale high court or federal court decisions haverefused to recognize claims for wrongful life (Table 2). Ofthese, the majority (IK) involved children with geneticimpairments; the minority involved children with non-geneticcongenital impairmcnls. The overwheltiiing reason given forrefusing to recognize wrongful life claims is Ihe inability orunwillingness of courts or jurors to weigh the value of animpaired life against the value of non-existence.

Only four stales have high state court or federal court decisionsthat recognize wrongful life claims. All of these cases, exceptthe Washington case, involved children with geneticimpairments. These decisions have generally allowed recoveryof damages only for extraordinary expenses required to Ireatthe child's ailment, and have not permitted recovery of generaldamages for having been born with an impairment.

As with wrongful birth, there are also a significant number ofstates (22) that have no slate high court or federal court caselaw addressing the validity of wrongful life claims. Similarly,the majority of these slates also have no intermediate appellatecase law, Those relatively few states with decisions by anintertnediate appellate court tend to vary in their analysis in thesame manner as do the states wilh high court decisions. Heretoo, trial court decisions are not discussed because they do notcarry the same precedential value as appellate cases.

Wrongful conception court decisions

The vast majority of states (32) have state high court or federalcourt decisions recognizing wrongful conception claims(Table 3). Of the 32 stales, there are 35 state high court orfederal court opinions. 33 of which are negligent sterilizationcases, one is a failed abortion case (Pennsylvania), and oneinvolved failure to diagnose a pregnancy (Alaska). Only sixstates reject such claims.

Tahic I. State high courts' or federal ct>urts" decisions on wrongful binh according to state.

:inii mid uphnhlinii cUiinis for wKnif^jiii hinhAlabama, ,'\rizona, California, Colorado. Delaware, Washington, D.C., I-'lorida. Idaho, Illinois. Indiana, Kansas, Maine,Maryland, Massachusetts. Nevada, New Hampshire, New Jersey. New York. Oklahoma, Pennsylvania. South Carolina. Texas,Virginia, Washington, West Virginia, Wisconsin

Based on ca.ses iiivotviiiii children n-itli :^eiiciic impairiuentsAlabama, California, Colorado, Delaware, Washington, D.C., Florida, Illinois, Indiana, Maine, Massachusetts. New Jersey,New York, Pennsylvania, South Carolina. Virginia. West VirginiaBased on c<isc.s involvin)^ cliildren wilh non-i-enetic con}:;cniial imixiiniwntsArizona. Idaho, New Hampshire, Oklahoma, Texas. Washington. Wisconsin.Presence oj n frenetic component not discussedNevada

Rcjiisinii Id uphold claims for wroniifiil hirlhGeorgia. Kentucky, Minnesota, Missouri, North Carolina, and UtahNo case.sNineteen states have no court cases

Ethics, legal, social. coLinsclling - Reproduction, genetics and the law - SL Crockin

Table 2. Stiite hiyh cntiris' or federal courts" decisions on wrongful life according \o state.

Rci<>};nizi'iti oud upholtliiii; citiiiiisJor wroiiiifiil lifeCalifornia. Maine, New Jersey, WashingtonRi'iti.siiiii chibiis for wroiii^fiil lifeArizona. Colorado, Delaware, Florida, Idaho. Illinois. Kansas. Kentucky, Maryland. Massachusetts, Michigan. Minnesota,Missouri. New Hiimp.shire. New York. North Carolina, Ohio. Pennsylvania. South Carolina. Texas. Utah. West Virginia.Wisconsin. Wyoming

liivolviiiii chikiri'ii wilh i^i'iiciic inipairmenisColorado. Delaware, Florida, Illinois, Kansas. Kentucky. Maryland, Massachusetts, Minnesota, Missouri, New York. NorthCaroline, Ohio. Pennsylvania. Soth Carolina. Utah. West Virginialiivolviiiii childri'ii wilh iioii-i;i'iic!ic iiiiii^i'iiilal iiiijHiiriDciils

Arizona, Idaho, New Hampshire. Texas. Wisconsin, Wyoming, IndianaNo lawAlaska. Aiahania. Arkansas. Connecticut. Washington, D.C.. Georgia, Hawaii. Iowa. Louisiana. Mississippi, Montana,Nebraska, Nevada. New Mexico. North Dakota. Oklahoma, Oregon. Rhode Island. South Dakota. Tennessee. Vermont. Virginia

Tiihle 3. Slate high L.-ouris' or federal courts' decisions on wrongftil life according to state.

ii! iiiid uphoidiiiii claims for wroiiiifid coiiccplioii initijorilv iiivolviiiii healthx children)Alabama. Alaska. Arizona. Arkansas. Connecticut, Washington. D.C.. Florida. Georgia, Illinois. Indiana. Kansas, Louisiana,Maine. Maryland, Massachusetts. Minnesota. Missouri. New Hampshire. New Mexico, North Carolina. Ohit). Oregon,Pennsylvania, Rhode Island, Tennessee, Utah. Vermont. Virginia. Washington, West Virginia. Wisconsin. Wyoming

L'i'lioUliiii; vkiiiu.s in cases involving cluldrcn niih iinpairincntsConnecticut (orthopedic abnormality). Florida (congenital defects), Georgia (club foot). Louisiana (albinism). North Carolina(genetic defect), Ohio (birth defect). Pennsylvania (neurofibroniatosis)Sidles also iiulndini; cosis of rcarini; Iwallhx child in fullNew Mexico. Oregon, WashingtonStales allowiiii; i i>sis of retiring heallhy cliild hiil offset hv henefils ofrcariiii; childArizona, Connecticut, Maryland, Massachusetts. MinnesotaDenyiiii; recttverv since il wus not a foreseeiihle consequence ofne^lii-eni sterilizationOhio. LouisianaHirlh impairment considered when asscssiiii; other ddinai-e.s hut no! tdlowini> costs of child rearingFlorida, Georgia, PennsylvaniaAlso acccplinii cosis of child rearingNorth CarolinaCase-h\-case approachConnecticut

Rcjectini' claims for wroni^fid tom eptionIowa (failed abortion). Kentucky. New York. Oklahoma. Texas (last three for negligent sterilization) (all involving healthychildren)

Incliidin^ii both heallhy chiUhen and Iho.se born wilh coiifienilal impairmeiUsTexasHeidthx children onl\New York. Oklahoma. Kentueky. Nevada

No lawCalifornia, Colorado, Delaware. Hawaii (decision but only addressed civil procedure issues, not underlying action). Idaho.Michigan. Mississippi, Montana, Nebraska. New Jersey. North Dakota, South Carolina, South Dakota

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Of the majority of states that recognize wrongful conceptionclaims, most of the cases (28) involved healthy children.Relatively few (seven) involved impaired children. In thosecases involving healthy children, most states (21) do not allowrecovery for child-rearing expenses, but only for any actualdamages related to the sterilization or other procedLre(s).pregnancy, and birth, which generally include medicalexpenses, pain and suffering of the mother related topregnancy and childbirth, lost wages of the mother, and 'lossof consortiutn' (financial compensation for the loss ofcompanionship, in this context usually of a spouse). A minorityof stales also allows recovery of the costs of child rearing,either in full or offset by the benefit derived by the parents ofraising a healthy child (Table 3).

In the seven cases involving children born with impairments,two states denied any recovery related to the birth defectbecause the birth defect was not a foreseeable consequence ofIhe negligent sterilization. Three states allowed considerationof the defect in assessing other damages (such as emotionaldistress or special medical needs) but did not allow child-rearing expenses. One state allowed recovery of the costs ofraising the child without any offset for benefit to parents.Another state adopted a 'ca.se-by-case' approach where thecourt found the value of the benefit (of having a child) shouldmitigate or offset the damages to the extent equitable.

A minority of states (six) have state high court or federal courtcases rejecting claims for wrongful conception. Of those sixstates, all addressed claims involving healthy children, and oneof them. Texas, addressed claims involving both healthychildren and children with congenital impairments. All ofthese cases were negligent sterilization cases, except for theIowa decision, which was a failed abortion case. The courtsrejected the claims based on a lack of injury or damage to iheparents, refusing to consider the birth of a healthy child to bea legally cognizable injury. The court in Iowa rejected suchclaims on the basis thai ihe benefits of a healthy cbildoutweigh the associated monetary burdens. Texas, the onestate addressing both healthy children and impaired children,rejected all such claims and concluded that a birth defectmakes no difference to the legal analysis because it is not aforeseeable consequence of a failed sterilization.

A relatively small number of states (I3i have no slate highcourt or federal case law on wrongful conception (Table 3).

Defendants in wrongful conception or wrongful birth casesmay seek to deny culpability on the basis that the plaintiffconsented to the treatment or the procedure. While a court mayexamine a consent document lo see whether it addresses theconduct at issue, generally courts have found that suchdocuments do noi remove or reduce a professional's liabilityresulting from negligent conduct, such as medical malpractice.Courts have determined that, as a matter of public policy.professionals should not be able to protect themselves fromtheir own negligence, as opposed to any inherent risks of aprocedure or condition, through disclaimers or waivers thatattempt to transfer the risks to patients or non-professionals.Some courts have also noted that patients are not in an equalbargaining position with a medical professional and it wouldbe unfair to enforce a waiver for that reason. Tbe extent towhich language in signed consent forms that outline risks may

limit professional exposure is therefore unclear, particularlybecause state laws and courts vary regarding tbe degree towhich they lake such forms into account.

State statutes addressing wrongfulbirth/wrongful lifeA state's laws can comprise both statutes and court decisions.A state can develop a body of common law from that state'scourt decisions, and then pass a statute that essentially codifiesthat body of common law, supplants the common law. orcomplements it. depending on the wording of the statute.Following the enactment of a statute, court cases may thenstart building a body of law interpreting thai statute. Ten stateshave enacted legislation (Table 4). In six of these, state lawsprohibit actions for both wrongful life and wrongful birth. Twoprohibit only wrongful life actions. One limits damages for thebirth of. and to a child harmed as a result of. professionalnegligence. At least three of the states that have enactedstatutory bans oti wrongful birth or wrongful life claims havedone so in support of eacb state's stated public policies ofrespecting the right to life of all humans, bom or unborn,healthy or unhealthy, and disfavouring abortion. The statutesin these states provide that a cause of action shall not arisebased on a claim that, 'but for" the act or omission of another.a person would bave been aborted. Maine's legislative intent isreflected in its statutory language: '(i)t is the intent of theLegislature that the birth of a normal, healthy child does notconstitute a legally cognizable injury and tbat it is contrary topublic policy to award damages for the birth or rearing of ahealthy child' (Me. Rev. Stat. Ann.. 2(K)3a). A few states haveenacted statutes that prohibit recovery of child-rearingexpenses in actions for wrongful conception or negligentsterilization (Me. Rev. Stat. Ann.. 2003b; Mich. Comp. Laws,2004).

Wrongful birth/life cases arisingthrough assisted reproductivetechnologiesWrongful birth and wrongful life issues bave arisen in a smallnumber of cases involving children bom through the use ofassisted reproduction, donor gametes, and PGD.

Court decisions involving PGD

Wrongful life issues were identifted and rejected by a court inone of the only two cases reported to date involving PGD (bothwere trial level cases involving children born with cysticfibrosis after mistaken assurances that the tested embryo wasnot affected). A Massachusetts trial court rejected claimsbrought on behalf of an affected child and by his parents, andrefused to recognize the injury based on a new legal claim of•preconception tort' (Doolan vs IVF America, 2000). Instead,the court characterized the claims as ones for wrongful life,which it ruled were precluded by precedent in that state. Thecourt further found that the defective gene itself, not thedefendant physicians, had caused the defect, a distinction thatalso carries over to cases involving donor gametes withundetected or unreported genetic abnormalities, as discussedbelow. The court's opinion did not address whether the consentforms adequately outlined the risks of PGD or whether PGD

Ethics, legal, social, counselling - Reproduction, genetics and the law - SL Crockin

Table 4. State statutes addressing wrongful birth and/or wrongful life.

Enacted statutesCalifornia. Indiana. Maine. Michigan, Minnesota. Missouri. North Dakota. Pennsylvania. South Dakota, UtahProhibit both wron^iful lije and hirihMichigan. Minnesota. Missouri. Pennsylvania, South Dakota. UlahProhibit nroniifiil life onixIndiana. North DakotaLiniii damages for professional negligence onlyMaineProhibit recovery of child-rearinfi, e.\penses for wrongful conception or negligent sterilizationMaine, Michigan

was considered an experimental procedure. The second PGDcase involved access to certain research records and isdiscussed below in the context of breach of professional duty.A small number of other alleged failures of PGD have resultedin lawsuits, but have settled and therefore no court decisionshave followed.

Court decisions involving geneticabnormalities from donor gametes

Two cases have been brought against professionals who failedto identify or inform intended parents of a genetic abnormalityin their chosen sperm or egg donor, after which a child wasborn with a serious genetic abnormality. In one ease, aCalifornia sperm bank failed to report a sperm donor's familyhistory of kidney disease, although he had allegedly noted it onhis donor intake form. The child was subsequently bom withautosomal dominant poly cystic kidney disease (APK.D}(Johnson vs Superior Court. 2002). In the second, a New Yorkassisted reproduction medical programme overlooked andtherefore failed to notify the intended parents that theirselected egg donor had tested positive as a carrier for cysticfibrosis (Paretta vs Med. Offices for Human Reproduction.200,'̂ ). They conceived and their child was bom with thedisease.

In the California sperm bank case, multiple legal issues wereraised and argued, including whether or not the bank wasprotected under state statutes designed to protect health careproviders. The California trial court held that the sperm bankwas exercising professional skills as a health care provider,even it" not engaged in a physician-patient relationship, andtherefore fell within Ihat state's statutory protections. Thecourt rejected the parents' arguments that the bank wasoperating solely as a commercial business sellingspermatozoa. As with the PGD cases, tbe court found that thedonor's genes, and not the defendant sperm bank, caused thechild's genetic abnormalities, and therefore the sperm bankcould not be held legally responsible for the child's disease.Following Califomia's established law. the court rejected thechild's claim of wrongful life. The New York court alsorejected both general damages and arguments that thedefendant professionals, rather than the donor, had 'caused' thechild's abnormalities. The New York trial court alsocharacterized and rejected the claim as one for wrongful life.refusing to recognize either a tort of 'negligent preconception

or pre-implantation counselling" or any obligation to performPGD. and relied on older New York case law which disallowsgeneral damages.

Other court cases involvingreproductive geneticsIn addition to the extension of wrongful birth/wrongful lifetheories to encompass new reproductive technologies such asPGD, other issues are beginning to arise from genetic testing,genetic information, and genetic material in the context ofassisted reproduction. The remainder of this article provides asummary analysis of those relatively few cases, as well as alimited number of recent cases that, although not directlyinvolving reproductive genetics, present related issues andthus may be helpful in understanding legal approaches thatmay be used to resolve conflicts involving reproductivegenetics. Given the small number of cases and the fact thatstate laws differ, the cases are more illustrative of currentapproaches than predictive of how specific future disputes maybe resolved.

Court decisions involving failure to warnfamily members

Cases involving reproductive genetics are likely to arise froma patient, a patient's parent, or a research subject claiming thata health professional caused harm by his or her negligent orintentional act or failure to act. In order to find a healthprofessional liable, he or she must be found to have had a dutyto the plaintiff(s) and to have breached that duty by fallingbelow the applicable standard of care, and the breach has tohave caused the alleged injury. Courts must therefore definethe types of relationships that give rise to a duty, the scope ofthat duty, the standard of care owed as a result of that duty, andwhen the statute of limitations (the time during which thelawsuit may be initiated) for a breach of thai duty begins torun. Where a child has resulted from the negligent act. somecourts have followed their state's wrongful birth, wrongful life,or wrongful conception analyses, as discussed above, whileothers have analysed the case under privacy, negligence andmedical malpractice principles.

Failure to provide accurate genetic information has been thebasis of claims against both treating physicians andresearchers. Courts have frequently looked to whether or not

Ethics, legal, social, counselling - Reprodiiction, genetics and [he law - SL Crockin

the defendant had a relationship wilh. and thus a duty to, theplaintiff patient or family member. Researchers, as opposed totreating physicians, are generally held not to have a physician-patient relationship with their research subjects, and thus havebeen found not to have a duty to wam patients or familymembers as to a genetic vulnerability. For example, in a caseinvolving a state-wide randomized, blinded control study ofnewborns for cystic fibrosis. the researchers were found nolliable to the parents or younger affected sibling for notlearning of. or warning the parents about, the older child'spositive test (Ande vs Rock. 2002). The plaintiffs had beenpart of a state-wide cystic fibrosis research protocol in whichexcess blood was drawn from all newborns and used to testthem for cystic tlbrosis. Under the research protocol, theparents of half of the newboms were told of a positive test andthose infants were put on a nutrition plan, while the test resultsof the second half were not revealed. The goal ol the study wasto ascertain whether nutritional supplements slowed theprogression of cystic fibrosis. The plaintiffs were in the groupwho were not notified, and therefore did not leam of (heirchild's diagnosis until the child reached the age of 2 years, andafter they were pregnant wilh a second child. Thai child wasalso diagnosed with cystic fibrosis, and one of the parents"claims was that had they been given the newborn screeningresults, they would not have conceived their second child.

In a widely cited non-genetics research case, however, aMaryland appellate court came to the opposite conclusion(Grimes vs Kennedy Krieger Insl., 2001). That court foundthat a 'special relationship' was created between theresearchers and their minor subjects and therefore negligenceand breach of contract claims could be brought on behalf ofminor plaintiffs against researchers who conducted anallegedly non-therapeulic research experiment (i.e. one thatprovided no benefit to the research subjects) and involvedmore than minimal risk. The court noted that minors werevulnerable research subjects, and that informed consent byparents on behalf of their children for non-therapeutic researchraised serious legal, moral and ethical concerns.

In one of only two reported cases involving PGD. where achild was born with cystic fibrosis after a mistaken assurancethat the tested embryo was not affected, an Illinoisintermediate appellate court refused to allow a plaintiffaccess to the IRB-approved research protocol documents,ruling they were privileged by state statute and nol designedto facilitate truth seeking in private malpractice cases (Doe vsMasonic Med Ctr. 1998). The couple had sought theacknowledged experimental procedure to ensure their secondchild would not be born with the disorder after their firsichild was bom with it.

Courts have come to different conclusions regarding atreating physician's duly to a patient's immediate familymembers. For example, in a few reported assistedreproduction cases a husband has sued his wife's physicianfor performing artificial insemination with donorspermatozoa without the husband's consent. Two courts,based on their slate's relevant statutes, have come toopposite conclusions on the question ot whether or not thephysician owed a duty to the patient's husband (Kerns vsSchmidt, 1994; Shin vs Kong, 2000).

Inherited conditions also raise ihe issue of whether and whoma treating physician has a duty lo warn, how that duty, oncedefined, is met. and how to balance that duty with a duty ofconfidentiality u> the patient. While it is impossible togeneralize or identify trends given the limited number of casesand variety of state laws and standards, certain analyticalissues are evident. A few cases are illustrative.

In a Minnesota case (Molloy vs Meier, 2004). that state'shighest appellate court ruled that there was a duty to wam abiologically related parent in a case involving a child withfragile X. After the child was born, her mother remarried, andthe mother and new husband were falsely reassured, based onincorrectly read test results, that the child did not have fragileX. The mother then proceeded, with her new husband, toconceive a child who was also affected with fragile X. Thecourt affirmed the lower appellate court's finding, including aduty to wam family members about the tlrst child's conditionexisted, which would be met by telling either biological parent.The intermediate court explicitly noted that there was no dutyowed to the wife's new spouse, because he bad no biologicalrelationship wilh the first child, a finding the parties did notappeal and which was thus not ruled on. The higher courtnoted that the parties conceded the duty to wam would havebeen met by informing an appropriate 'contact person', such aseither of the custodial parents or Molloy as the non-custodialbiological parent. In allowing the claim, the court framed theparents' claim as one for wrongful conception, and not aswrongful birth or life (both of which had been prohibited bystale statute). The court also addressed a statute of limitationsissue, mling that under the circumstances the damage did notoccur and thus the statute did nol begin lo mn until theconception of the second child. The intermediate courtacknowledged that doing so created the possibility thai casesinvolving inherited genelic defects might not be discoveredand therefore filed until years, and potentially decades, afterthe wrongtui act. That potential problem, it found, was an issuelo be addressed by the legislature.

In two cases involving adult-onset inherited genetic disorders,courts found a duly to warn family members, although therequirements the courts imposed for meeting that dutydiffered. First, in a Florida case brought by the adult daughterof a ihyroid cancer patient (Pate vs Threlkel. 1995). the courtfound the parent's treating physician had a duty to warn familymembers, but that such duty would be met by the physicianwarning only the patient. The eourt explicitly acknowledgedthat the disorder, medullary thyroid carcinoma, was a'genetically transferable disease'. The court found that mostpatients would tell family members, and that any otherrequirements could compromise confidentiality and be undulyburdensome on a physician.

Second, in a New Jersey case (Safer vs Estate of Pack, 1996).an intennediate appellate court found a broader duty to wamthe plaintiff. The case was brought by the adult child of apatient who had died (when the plaintiff was a child) of coloncancer resulting from multiple polyposis, an inheritedsyndrome that in virtually alt untreated eases leads to coloncancer. Noting that it disagreed with Ihe Florida court's rulingon how that duty could be met, the New Jersey court found thatin some instances a duty to wam of a genetic risk might not besatisfied solely by informing the patient rather than his or her

Ethics, legal, social, counselling - Rt'prciduction, genetics and the law - .S7. Crotkin

family members direetly. Finding "a duty to warn of avertablerisk from genetic causes' is 'by definition a matter of familialconcern', the court found a duty was owed to "members of theimmediate family of the patient who may be adversely affectedby a breach of that duty".

Both the Florida and New Jersey cases were brought by thechild of a patienl and neither court further defined the terms'immediate' or 'family member". The Florida court did notethat the prevailing standard of care, meaning the averagedegree of skill and care exercised by members of the medicalprofession in the same or similar locality given the presentstate of medicine, created a duty 'that is obviously for thebenefit of certain identified ihird parties', lo whom a duty istherefore owed, including 'a patient's children |who| fallwithin the zone of foreseeable risk'. The court also noted thatthe slandard of care, as in any malpractice ease, is determinedby a consideration of expert testimony on the question of theaccepted or prevailing medieal custom in and for that type ofeonimunity.

Given ihe extremely limited case law, the scope of a healthcare provider's duty to wiim family members of genetic risksremains an un.settled area al this time.

Court decisions involving compelledtesting to determine parentage

Genetic testing, both voluntary and compelled, has beenwidely available for many years and literally thousands ofcases have been reported thai involve testing in the context ofproving palernity for Ihe purpose of requiring child support orproving identity in criminal prosecutions, both of which areoutside the scope of this article. Since the advent of theassisted reproductive lechnologies. a few cases have beenreported in which one party seeks lo compel genetic testing lodetermine the parentage of a child. Hfforts to legally compelsuch testing have for the most part been unsuccessful. Coutishave generally followed established state law on whenpaternity testing is and is not permitted, and most states requirethat the person seeking to have the child tested must firstdemonstrate a minimal, "threshold' level parental relationship,or attempted relationship, to attempt lo prove their ownparentage of the child. Thus, in a lawsuit brought by a womanalleging that her embryos had been implanted into the wrongwoman, a court refu.sed lo compel genelic testing of i4-year-old twins who had never lived with, or developed anyrelationship with, the plaintiff who elaimed to be their geneticmolher (Prato-Morrison vs Doe, 2002). Similarly, in a lawsuitbrought by a man who in a written contract previouslyacknowledged being a sperm donor, a court refused to testtwins being raised by a lesbian couple (Lamaritata vs Lucas.2002). However, as discussed below, where gamete or embryo"mix-ups' may be involved and the claim is brought promptly,genetic testing may be part of the litigation.

Court decisions involving disputed use ofreproductive material

Disputes over the use of reproductive material, including eggs,spermatozoa and embryos, can arise in a variety of contexts,such as contested parentage of bom children, custody of frozenembryos, misappropriation of gametes by health care

providers, or control over gametes or tissue by donors,intended parents, and researchers. All raise standard of careissues for the professionals involved and thus require adetermination of what level of care professi{)nals are to be heldto. Discussed here are only those cases and theories with animpact on reproductive genetics.

Cases involving parentage or custody disputes over already-born children are typically analysed using legal theories oftort, negligence, or breach of contract, as well as applicablefamily law prineiples or statutes. These cases are largelybeyond the scope of a summary of reproductive genetics law.Cases can, however, arise following the alleged wrongfulimplantation of reproductive material, for example, if gametesor embryos are mixed-up during IVF, In such cases, in additionto lawsuits between patients to resolve competing claims oflegal parentage, claims will probably be filed against thehealth professionals involved in causing the mix-up. When ananonymous egg or spermatozoon is utilized, claims may belimited to those brought by one set of parents against theprofessional who supplied the genetic material or performedthe medical procedures. These latter cases may be analysedunder a 'wrongful life' theory, and in some cases damages forhealthy children have been rejected if the state does notrecognize this theory (Harchiner vs Univ of Utah, 1998).Where mix-ups result in competing claims of parentage,family or probate litigation has been highly publicized, andinvolves difficult and novel judicial decisions about legalparentage [for example, Perry-Rogers vs Fasano, 2001; Perry-Rogers vs Obasaju,200l: Robert vs Susan, 2003). C//J/). denied2003 Cal LHXIS 6671 (Cal,. 2OO3)|,

One dispute involving control and use ul' healthy donorgametes in Texas illustrates the inadequacy of the law, even ina state with laws addressing eontrol of donor eggs or parentageof the resulting children. In that case, a commercially recruitedegg donor learned that her donated eggs had been 'split' orshared between two couples at the same IVF clinic at thesuggestion of their physician. The donor had entered into awritten legal agreement with the first couple only, whichreportedly contained an explicit provision that only that couplecould use the eggs. The donor and the second couple, who hadcreated but then been precluded from using the embryoscreated with some of those eggs, each filed lawsuits against thephysician and broker. In recommending the sharingarrangement, the physician reportedly had relied on Texas law,which states that egg donors are not parents of childrenresulting from their donated gametes (Texas Family Code,2003). At least two multi-party lawsuits were filed, by thedonor and by the second couple. The donor's suit wasreportedly settled for an undisclosed financial settlement fromthe doctor and clinic and the second couple, who ultimatelywere allowed to use the embryos, were dismissed from thatlawsuit (Houston Chronicle, 2002). A lawsuit between thebroker and physician resulted in a verdict for the broker (TX3/22/05)

In another unique fact pattern illustrating the complexity ofthese issues, a single woman and married couple litigated thelegal parentage of a child born to the single woman, whom sheintended to be from a donated embryo, instead the physicianaccidentally transferred an embryo created for the marriedcouple as part of their own infertility treatment (Robert vs

Ethics, legal, social, counselling - Reproduction, genetics jnd the law - SL Crockin

Susan, 2003). Because the eouple had used donor eggs tocreate their embryos (and their one resulting child to date), thechild at the centre of the dispute was the genetic child of themarried man but not of his wife. The irial court has ruled thatthe single woman was the child's mother and the married manwas the father (and not a donor a.s she had argued, since henever intended to donate his spermatozoa or embryos). Thatcourt further found that the father's wife, who had no geneticor gestational claim to the child, had no legal claim tomaternity. The court did not address the fact that the wife wasthe intended mother of any child who might result from theembryos she and her husband had created. The single motheralso sued the physician, resulting in a settlement.

In the mid-1990s, a highly publicized series of both civil andcriminal court cases arose involving three physicians at theUniversity of California-Irvine's Centre for ReproductiveHealth. It was discovered that, without iheir patients'knowledge or consent, the physicians had taken eggs andembryos from reportedly hundreds of patients, and implantedthem in other patients. Drs Ricardo Asch. Jose Balmaccdu andSergio Stone were all criminally charged based on allegationsof insurance fraud and false income tax return filings.Two of the doctors fled the country: Dr Stone was convictedand served time in jail. Civil suits were filed by andagainst the university, which settled the majority of over 100separate patient lawsuits brought ajzainst it basedon research misconduct and misappropriation of gametes,embryos and funds by the physicians (sechttp://www.uci.edu/fc/chronology.htm!). The scandalultimately led the California General Assembly to pass thenation's first law making it a crime to steal human eggs andembryos (Welch. 2000).

In one of the very few reported court decisions stemming from(he scandal, a couple sued another family to try to determine ifthey were the genetic parents of 14-year-old twins. The trialcourt refused to order blood tests or visitation, and dismissedthe case. That court's ruling was upheld on appeal, with theappelhitc court ruling that no link to the twins had heen shown,but that, even if the couple suing had shown such a link, thebest interests of the teenage children was to dismiss the case(Prato-Morrison vs Doe, 2002).

There have been a growing number of cases involving controlover frozen embryos or pre-embryos, usually following acouple's divorce. The term pre-embryo is often used to clarifyin-vitro fertilized eggs that have not been implanted or gonebeyond the very early stages of development (Jones and Veeck.2002). One notable trend has been toward not permitting theuse of frozen embryos for procreation over the objection of aspouse or a former spouse, notwithstanding any prior consentor agreement by the parties. A very recent jury trial ended witha finding in favour of the former husband who claimed an IVFprogramme transferred previously frozen embryos to his wifeto have a second child without his knowledge or consent, andcontrary to his wishes (Gladu vs Boston IVF). The couple hadpreviously conceived twins at the IVF programme, using freshembryos created with the man's spermatozoa and donor egg.At issue was the language and status of the cryopreservationconsent document he signed ai the time the embryos werecreated. He argued it was a contracl. and required theprogramme physicians to obtain his consent at the time of any

subsequent transfer. The IVF programme contended thedocument was an informed consent document, and that thehusband's prior consent, unless withdrawn by him, could beproperly relied upon for subsequent embryo transfers. The juryfound the physicians were not negligent but found theprogramme liable for breach of contract, and awarded the manUS$98,000 in child support, and US$10,000 in emotionaldistress damages. The case illustrates the difficulty incategorizing documents and actions taken by patients andprofessionals in this area. Although this jury apparently foundthe consent document at issue was a legal agreement and didnot give the programme the right to future implantationswithout subsequent consents, there is little precedent in thisarea and no assurance that other juries or couils would reachthe same conclusion.

Some courts have questioned whether assisted reproductionclinics" cryopreservation forms are entbiceable contracts, eitherbetween the patients and the programme or between the twopatients themselves. The issue of enforceability can arise if thereis a subsequent disagreement between a husband and wife overwhether and how to use or dispose of their embryos or in adispute between patients and a medical programme. Priorconsents or agreements with medical programmes to use frozenembryos for other than procreation (i.e. for research or to discard)have generally been upheld. The very few reported disputesbetween patients iind providers that ha\c raised the issue of whoha.s control of embryos have generally found that the patient, notthe provider or clinic, had their right to control the embryos (DelZio vs Columbia Presbyterian Med. Ctr. 1978: York vs Jones.1989).

Access to and use of cryopreserved (frozen) spermatozoa, andthe resulting parentage of children born from spermcryopreserved prior to the death of the genetic contributor,have also been the subjects of recent litigation in a growingnumber of states. No consensus has yet emerged as to thedegree of proof required prior to allowing, for example, awidow to use her deceased spouse's spermatozoa, or whatrequirements must be met prior to any resulting child beinglegally recognized as the child of the decedent. Massachusettshas set out a three-prong test for determining parentage andinheritance; proof of genetic parentage, proof of the decedent'sconsent to use the sperm, and proof of the decedent's intent tosupport the child (Woodward vs CommV of Soc. Sec. 2002).A lower federal court in Arizona precluded posthumousrecognition of legal parentage and denied Social Securitysurvivor's benefits to twins conceived more than 10 monthsafter their genetic father's death (Gillett-Netting vsComm'rofSoc. Sec. 2002). based on an interpretation of Arizona'sintestacy laws (laws dealing with inheritance when one hasdied without a legal will) which expressly provided that only achild surviving the deceased parent or in gestation at the timeof death may inherit. However, the appellate court reversed.finding the children were legal heirs ad rejecting theapplicability of the narrower laws. Whether posthumouslyconceived children are entitled to legal recognition andinheritance rights varies from state to state, depending on boththat state's statutory inheritance laws and judicialinterpretation.

Ethics, legal, socjjl, counselling - Reproduction, genetics and the law - SL Crockin

Court decisions involving use ofnon-reproductive genetic materialControl and use oi' other bodily tissue or genetic material,spcvifically that contained in non-reproductive tissue, has been[he subject of limited litigation to date. The most well knownsuch case involved disputed ownership and control over theblood and tissue obtained from a piiticiit diagnosed wilh hairy-cell leuk:icniiii(Moore vs Regents of Univ. of Cal., 1990). Thetreating physician had recommended the removal of thepatient's spleen and thereafter, over a period of several years.had him return tor further removal of blood and tissue. Duringthai time, he and his colleagues successtully engaged in whalthe court described as "potentially lucrative medical research'in which ihcy developed and patented a ceil line from thepatient's T lymphocytes. The patient sued the treatingphysician and his colleagues who used the cells without hisknowledge or permission.

The court ruled on two claims, allowing one while rejectingthe other. Kirst. the court ruled the claim could proceed on thebasis of an alleged breach of the physician's disclosureobligations to his patient, and held ihat a treating physicianmust disclose any interests he has unrelated to his patient'shealth, 'whether research or economic, that may affect hisjudgment". Second. Ihc ct>urt rejected the patient's claim forconversion, meaning Ihe unauthorized and wrongful exerciseo\ control over another person's personal property (i.e.stealing). Noting that no court had ever imposed conversionliability for use of human cells in medical research, the courtdeclined to 'impo.sc a ion duty on scientists to investigate theconsensual pedigree of each human cell sample used inresearch'. The court noted thai it would compromise theexchange of scientific knowledge and threaten economicincentives lo conduct importanl medical research to extend thetheory of conversion to this circumstance. In Ihe ct>urt's words,"llfl ihe use of cells in research is a conversion, then withc\ery cell sample a researcher purchases a licket in a litigaiionlottery'.

Another more reccni. and still ongoing, case has also arisen inthe contcxi of a patent dispute (Greenberg vs Miami Children'sHosp. Research Institute. 2002). A patients' rights group suedmedical researchers who discovered the gene for Canavandisease and then filed a patent for il wiihoiit the group'sknowledge. The plaintiffs argued ihat they had worked tt)gather tissue, identify families, and provide financial supportto the defendant researchers, with the intention of assisting inthe development of non-commercial advances in research andtreatment. In their lawsuit, they claimed the defendants hadbreached a duty of informed consent, as well as a fiduciaryduty to them, had been 'unjustly enriched' by the discoveryand patent, and had fraudulently concealed and converted theirpR>pcrty, as well as misappropriated 'trade secrets', in this casethe list of patients suffering from the disease.

The federal court dismissed most ofthe patient group's claims.Similar to the few cases involving genetic information ormaterial noted earlier, and noiing with approval the caseinvolving the patient with hairy celt leukaemia, the federaldistrici court refused to impose a duty of disclosure on medicalresearchers regarding their economic interests in the absenceof a physician-patient relationship, finding that such a duly

would be unworkable and would kill medical research. It alsofound no fiduciary relalionship under applicable slale (Florida)law. finding that such a relationship required both trust andacceptance, and the latter was missing. The court refused tofind that undertaking the research itself created such arelationship. It also rejected any claim that the plaintiffs had aproperty interest in the tissue or resulting information andtherefore rejected the conversion claim. The only claimallowed to stand was one for 'unjust enrichment', i.e. that theresearchers may have unfairly been enriched in collecting theirlicense fees since plaintiffs contributed so much to the researcheffort and would not have done so had they known theresearchers intended to commercialize the tcsling processresulting from the genetic material they contributed lo themrather than keeping any testing developed in the publicdomain. Because the plaintiffs alleged an ongoing researchcollabt)ratidn, as t)pposed to simply a donor-doneerelationship, the court denied the researchers' attempt to 'seekrefuge' tiehind the patent, as well as their argument that theplaintiffs had obtained what they sought: the isolation of thegene and the development of a screening test for it.

Genetic discriminationAs genetic testing becomes more widely available, concemshave been repcaledly voiced over the polenlial misuse ofgenetic intbrmation, particularly in the workplace and by healthinsurance companies. A number of state laws have been enactedthat prohibit genetic discrimination in employment orinsurance. As of late 2(H)3. approximately 31 states had statutesprohibiting employer discrimination in the workplace, while 34states had statutes strictly prohibiting the use of geneticinformation for risk selections and risk classification purposes.In addition. Arizona, Vermont, and West Virginia requireactuarial justification for the use of genetic information: Texasbans use of genetic information in group health plans, andAlabama prohibits discrimination based on predisposition tocancer. HIPAA, the first federal law directly addressing geneticinformation, prohibits group health plans, usually meaning over50 individuals, to discriminate in insurance on the basis of'heallh siatus-related taclnr", including genetic information(National Conference of State Legislatures).

In October 2003. Ihe US Senate unanmiousty passed IheGenetic Iniormalion Nondiscrimination Act. Similar efforts inthe tJS House of Representatives have been unsuccessful(Genetic Nondiscrimination in Health Insurance andEmployment Act, 2003). Federal or state constitutionalprelections may also be implicaled, and certain federal lawscurrently iti place stich as the Americans with Disabilities Act(ADA) (19*^0). The Title VII of the Civil Rights Act (2000) (asto employmeni only) may also afford some protections.

The ADA is potentially relevant to many legal issues that mayarise concerning reproductive genetics, although to date therei.s little case law to guide its application to these issues. TheADA prohibits discrimination against individuals withdisabilities (i) by employers of 15 or more employees; (ii) inpublic accommodations; and (iii) by state and localgovernments. tJnder the ADA, an individual has a disabilityand is therefore prolected against discrimination if theindividual (i) has an impairment, genetic or otherwise, thatsubstantially limits a major life activity; (ii) has a record of

F.thics, legal, social, counselling - Rcproduc;ion. genetics and thu law - .SL Crockin

such impairment; or (iii) is regarded as having suchimpairment. While a broad discussion of geneticdiscrimination is beyond the scope of this article, the followingdiscus.sion illustrates the ways in which genetic informationmay impact on employment, the provision of healthcare, andother contexts. For many people, reproductive genetic testingis Ihe first time they are presented with the option to oblaingenetic testing, both carrier and prenatal testing, and concernsabout the possible future employment and insuranceramifications of learning this information for themselves andElieir ulTspring could intluence their decisions.

Unauthorized testing in the workplace

To date, there have been relatively few reported courtdecisions involving genetic testing in the workplace, and noneinvolving genetic testing by health insurers. Two notable caseshave involved unauthorized testing by employers. Each caseincluded claims under the ADA. which will be discussedbelow. But. Ihe alleged surreptitious nature of the testing isnoteworthy and is therefore separately addressed here. In thefirst case (Norman-Bloodsaw vs Lawrence Berkeley, I99S), alarge research laboratory thai was operating under a contractwith the federal government and was jointly operated by thefederal government and the state of California performedunauthorized testing of certain employees for both genetic andnon-genetic conditions as part of a general health examination.Plaintiffs claimed that black employees were singled out fortesting for the sickle-cell anaemia trait and women (forobvious reasons) were singled oul for pregnancy tests. Theplaintiffs claimed that the government-affiliated employer hadviolated their state and federal Constilutitinal rights to privacy,their statutory rights under Title VII of the Civil Rights Act,which prohibits employment discrimination based on race,colour, religion, sex. or national origin, and their rights underthe ADA. After the trial court dismissed all of the plaintiffs'claims, the tederal Court of Appeals tor the 9th Circuitreversed in part, finding that the employees should bepermitted to bring their claims based on Constitutional privacyviolations and Title VII. and that factual issues existedregarding ihe privacy claims that should be resolved by thelower court. As discussed below, the coun found that theADA was not violated. The EEOC. however, takes the positionthat entrance exams such as medical tests arc legal onlyif the examination is required of every individual hiredfor that particular job category (see

http://www.eeoc.gov/policy/docs/guidance-inquiries.html).

The second case involved secret DNA testing of employeesof ihc Burlinglon Northern Santa He Railway who submittedinternal teports or work-related itijury claims. The EqualEmployment Opportunity Commission (EEOC) receivedcomplaints from employees that their DNA was beingsecretly tested by the railroad. The railroad required the testfor employees who filed internal reports or submitted work-related injury claims based on carpal tunnel syndrome, andwas conducted without the workers' knowledge andtherefore without their voluntary and informed consent(Press Release EEOC. 2002). In that case, both the EEOCand the employees" union filed claims, all brought under theADA, resulting in an agreed upon injunction and a US$2.2million settlement (EEOC vs Burlington N, 2002). That caseis discussed more fully in the following section.

Cases brought under theAmericans with Disabilities Act(ADA)

The ADA, genetics, and the workplace

The ADA prohibits covered employers from discriminatingagainst employees with disabilities in the terms and conditionsof employment and in benefits provided. The worker musl bea "qualified individual with a disability", meaning one who isable to perform the essential functions of the Job, with orwithout reasonable accommodalions. The Act. however, alsohas a specific 'safe harbour' cxcmptitig many of the decisionspcrtainitig to insurance (including health insurance) from itsantidiscrimination provisions. The impact of this safe harbourprovision on the ability of employer-based health plans to denycoverage tor assisted reproduction or ba.scd on the results ofgenelic tests is unclear.

The ADA'S employment provisions also limit the ability ofemployers to ask employees about their disabilities and toconduct medical testing. Prior to a conditional offer ofemployment, the ADA prohibits medical cxatninations or tests.These are permitted following a condilional offer ofemployment as long as the tests are required of all applicantsfor a particular job category atid significatit restrictions on theuse of the information gathered are complied with. In thelaboratory workers' case discussed above, based on the lack ofevidence that the employer had disseminated or used theinformation from the tests, the court found the employer hadnot violated the confidentiality and record keepingrequirements In the ADA (Nornian-Bioodsaw vs LawrenceBerkeley Lab., 1998).

In the Burlington Northern case, the EEOC alleged violationof the ADA after receiving complaints from employees thattheir DNA was being secretly tested by the railway after theyhad either filed internal reports or submitted work-relatedinjury claims based on carpal tunnel syndrosne (Press Release,EEOC, 2002). The EEOC first sought a preliminary injunctionagainst the railroad pending further investigation in which itasked the federal district court in Iowa to order the railroad tostop its testing practice (Press Release. EEOC. 2001a). In April2001 the railroad entered into a settlement with the EEOCunder which it agreed not to (i) require its employees to submitblood for genetic tests; (ii) analy.se any blood previouslyobtained; (iii) evaluate, analyse or consider any gene testanalysis previously performed on any of its employees; or (iv)retaliate or threaten to take any adverse action against anyperson who opposed the genetic testing or who participated inEEOC's proceedings (Press Release, EEOC. 2001b). A yearlater, the EEOC again filed suit based on the testing policy(EEOC vs Burlington N. 2002). EEOC and BurlingtonNorthern enlered into a .settlement agreement, as part of whichthe railroad agreed to pay US$2.2 million to 36 employeeswho had been directed to get tested (Hechler, 2002), butadmilled no wrongdoing (Baker and Daniels. 2002). No courttherefore had the opportunity to analyse the EEOC'sallegations that the railroad had violated Ihe ADA.

The EEOC has taken the position, as reflected in a 1995compliance manual, that genetic testing violates the ADA and

Ethics, legal, social, counselling- Reproduction, genetics and llie law - .SL Crockin

ihat basing employment decisions on genetie testing is barredunder the ADA's "regarded as" prong of the detinilion ofdisability (Press Release. EEOC. 2002). Mtireover. aecordinglo one EEOC Commissioner. Ihe EEOC also takes the positionthat Ihe "mere gathering of an employee's DNAmay constitulea violation of the ADA" (EEOC vs Burlington. 2002).Aeeording ti> ihe guidance, the "regarded as" prong "of thedefinition of disability applies to individuals who arc subjectedto discrimination on the basis of genetie information relating toillness, disease, or other disorders. Covered entities thaidiscriminate against individuals on the basis of sueh geneticinformation are regarding the individuals as havingimpairments that substantially limit a major life aelivity"(EEOC Compliance Manual. 2000). The EEOC's aetionagainst Burlington Northern, discussed above, was consistentwith this policy. However, no eourt has ever had occasion toeonsider ihe EEOC's interpretation: thus its enforeeability isuncertain.

The employment provisions also prohibit employers fromdiscriminating againsi an employee because of thatemployee's assttciation wilh an individual with a disability.Although the courts have seldom construed this provision, itmay apply to an individual who is a genetic carrier and haschildren with a genetic illness.

The ADA, genetics, and publicaccommoaation

The ADA's public accommodation provisions apply tohospitals, clinics, and the offices of health eare workers. Iniyy8. the Supreme Court held that an asymptomatic HIV-positive woman who was denied in-ofl'ice dental treatment wasdisabled within the meaning ofthe ADA (Bragdon vs. Abbott,I99S). The Coun held that HIV was a 'physical impairment',and that it substantially limited the "major life activity' ofreproduction, in Ihat she would risk transmitting HIV to bothher partner and child in the process. Thus the woman wasdisabled within Ihe meaning of ihe ADA. By this logic, aperson with genes causing a late onsei disease (e.g.Huntington) or a carrier of a genetic mutation could beconsidered disabled, since they would risk transmitting iheirdisease-causing genes lo Iheir offspring. Thus the Court'sruling may have implications for those with genetie conditionswho are asymptomatic or to those who are carriers of geneticmutations. The courts, however, have not yet had anopportunity lo address [he application of the ADA to geneticcarriers or individuals with asymptomatic genetic conditions.

One recent ease brought and lost by a plaintilf invohed a blindwoman's claim ihal an IVE clinic that refused to continueartificial insemination treatments for her did so in violation ofthe ADA (Chambers vs Univ. Hosp.. 2000). While theuniversity defendant named in the lawsuit .settled with thewoman, the IVF clinic and physician went to trial, arguing thatits refusal was nol because of her blindness but because ofconcerns it had over her mental condition, hygiene and abilityto childproof her home. A jury found in favour of thesedefendants, and the plaintiff has Hied an appeal. Whether ahealth care entity can refuse to provide an individual wiih aparticular genetic test or therapy.or with assisted reproduclion,beeause of a genetic condition, however, has not yet beendeeided by the courts.

Conclusions.lust as reproduction and genelics are making rapid scientificadvances, the legal issues emerging out of these developingtechnologies are complex and. in many cases, unique. To date,court decisions responding to these issues have been varyingand sometimes cc»ntradictt)ry from one jurisdiction to anolher.As these issues continue to arise, new and mtire nuanccd legalrules are likely to be called for. based upon an understandingof both the law and science.

Medical professionals may find themselves thrust into aneducational role, as judges and policy makers will need lobeeome versed in the language and substance of reproductivescience and genetics to reach reasoned results in their efforts toboth respond lo conflicts and to shape policy pntactively in theform of legislation. Law and policy makers will also need loreeognize the many connections to existing areas of the lawand medicine while, at the same time, being eognizant of thoseaspects that are novel. Decision makers are likely to confrontspecific legal challenges involvini: determinations of causationof genetic and chntmosoma! abnormalilies Ihat wilt challengeexisting legal frameworks involving wrongful birth,conception and life.

Existing legal time limits for bringing claims will probablyprove inadequate for discovery of genetic abnormalities thatmay not appear for generations. Further challenges willinvolve defining the applicable standard of care and seope ofduty, as well as discrimination and related issues and theapplicability and limits of existing laws such as the ADA, Theoverarching challenge will be to reach wise decisions andcreate sound policies that are grounded in existing law whilerecognizing and responding sensitively to the new realitiescreated by the advances in reproduction and genetics.

Acknowiedgements

This article was originally commissioned by the Genetics andPublic Policy Centre, a part of the Phoebe R Berman Instituteat the Johns Hopkins University, which is funded through agrant from The Pew Charitable Trusts. The opinions expressedare those of the author and do not necessarily reflect the viewsof the Genetic and Public Policy Centre or the Pew CharitableTrusts,

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Received 26 .hinnary 2005\ refereed 4 February 2005:accepted 17 March 2005.

China seeks good governance of research

As China opens its challenges in science to the widerworld, the correct methods for administering Ihe necessarystimuli for more research, financial and otherwise, andalso a means of governance which is transparent andaccountable, have to be determined. A brief article inNature has outlined is intention to establish norms and acode of conduct to regulate the National Natural ScienceFoundation of China (NSFC). Decisions will be takendemocratically, management based on law, and the use offunds will be effective, A senior policy maker stressed theintention to utilize overseas brainpower and attractoverseas researchers to participate in basic research inChina.

Models studied initially were based on analyses oflegislation in other countries. These included legislativedocuments from Australia and elsewhere. The modelfinally adopted establishes standards for selecting expertsto review peers and panels, and to manage programme.sand results in a fair manner. The NSFC apparently follows

these principles already. Queries arise over the amount ofmoney dedicated to research, which is still modest inrelation to the total spent on research and development.One factor here concerns the very large number of projectsrequiring functions spreading over >8000 projects whichapparently share ~US$340 million. Nature neverthelessregards the new constitution as a positive step that maytempt many overseas Chinese scientists back to their homecountry. But other organizations, including the Ministry ofScience and Technology and the Chinese Academy ofScience, currently account for the largest research itemsand so carry re.sponsibility for further progress. Perhapsthey tiiay follow the lead outlined by the NSFC in order toestablish fair play and good governance from the outset ofChina's expansion.

Reference

Editorial 2005 New accountability in China. Nature 434, 1053.