Preconception Tort Law in an Era of Assisted Reproduction

Fordham Law Review, Abstracts

INTRODUCTION

For five years, a husband and wife have been trying, without success, to conceive a child. They have thought about adopting but would prefer, if possible, to have a their own biological child. The couple undergo testing at a fertility clinic and discover that the husband’s sperm count is extremely low. Specialists at the clinic tell the husband and wife not to be discouraged, because there is a procedure, already used by thousands of couples, that can help them conceive. Clinic doctors can harvest eggs from the wife and sperm from the husband for in vitro fertilization (IVF). Since the husband’s sperm count is too low for ordinary IVF, doctors will assist the process by injecting a single sperm cell into one of the eggs to create a zygote for implantation in the wife’s uterus.

Preconception Tort Law in an Era of Assisted Reproduction: Applying a Nexus Test for Duty, Fordham Law Review, Volume 69 | Issue 6 Article 9, 24 Jun 2008.

The couple choose to undergo the procedure, and fertilization is achieved. Unfortunately, the egg is damaged during the sperm injection process, and the child suffers birth defects. The parents sue on behalf of themselves for the added costs of raising a child with birth defects and on behalf of the child for personal injuries arising out of the fertility clinic’s negligence. The court allows the parents’ claim but dismisses the child’s claim on three grounds: first, the child has no cause of action in negligence because the clinic doctors did not owe a duty of care to a person who was not yet conceived at the time of their negligent act (penetration of the egg with the injection pipette); second, even if there were a duty of care, the child cannot claim that she suffered a net injury because the doctors conferred upon her the offsetting benefit of life itself; and third, creating a duty to future persons is a policy matter of broad implications that is best left to the legislature.

The above hypothetical both illustrates some of the legal obstacles faced by plaintiffs injured as a result of negligent acts occurring prior to conception and demonstrates how emerging reproductive technologies may pose risks of preconception harm. Preconception torts have been the basis for numerous state and federal cases over the past three decades. Although there were only a handful of preconception claims before the 1970s, this area of tort law has been expanding in recent years for at least four reasons: first, improved medical techniques for tracing injuries to causes predating conception; second, the expanding use of medical procedures that have the potential to injure a woman in such a way that a subsequently-conceived child might be injured; third, the discovery of harm from drugs, especially diethylstilbestrol (DES), which can cause injury both to individuals exposed in utero and to their children; and fourth, human exposure to toxic substances that have the potential to alter chromosome structure in parents, resulting in deformities in their offspring. Intentional manipulation of human reproductive cells apparently has not yet given rise to a valid preconception tort claim, 0 but this eventuality is all but assured in an age of rapidly developing genetic and assisted reproductive technology.”

Many courts have weighed policy considerations in deciding whether to allow preconception tort causes of action. This Note, however, suggests that in determining whether to allow preconception tort claims, courts should base their decisions on traditional negligence doctrine rather than policy. Furthermore, this Note argues that courts should not look for a “relationship” between plaintiff and defendant giving rise to a duty of care because this is an inappropriate test for duty in the preconception tort context. Rather, in evaluating a preconception duty of care, courts should determine whether there was a nexus between the alleged injurious activity and the conception and birth of a future child.

Part I of this Note provides an outline of state and federal case law on prenatal and preconception torts. A review of the early rejection and subsequent recognition of prenatal tort claims is necessary to understand the evolution of preconception negligence. This part continues by dividing preconception torts into four categories of cases: medical malpractice, pharmaceutical products, auto accidents, and toxic substance exposure. Because a variety of preconception claims arise in the medical malpractice context, that section is further divided into three subcategories: negligent surgery cases, in which a negligently performed Caesarean section or abortion leads to developmental abnormalities in a subsequent pregnancy; Rh factor incompatibility cases, in which a doctor negligently fails to administer Rho-GAM to a mother whose Rh factor is incompatible with that of her fetus, creating a condition (sensitization) that can harm laterconceived children; and rubella cases, in which a doctor negligently fails to immunize a woman for rubella and she subsequently conceives a child suffering defects attributable to congenital rubella syndrome.

Part II of this Note discusses two reasons why courts must develop a more principled approach to preconception negligence. First, there is currently disarray among and within jurisdictions in handling such cases, resulting in discordant holdings that prevent a coherent approach to preconception tort law. Second, the emergence of advanced medical technologies threatens to increase the incidence of preconception tort claims.

Because the recognition of a preconception tort claim will often hinge on the question of whether there is a duty to an unconceived person, Part III of this Note analyzes the duty element of negligence law in the context of preconception torts. While some have suggested that the duty of care in negligence cases is the sum total of policy considerations, the first subsection of Part III proposes a doctrinal approach that employs a nexus test for establishing the duty of care. The second subsection applies the nexus test for duty to the various types of preconception tort cases that have been presented to the courts to date, as well as to emerging assisted reproductive technologies.

I. PRENATAL AND PRECONCEPTION TORT JURISPRUDENCE

  • A. The Recognition of Prenatal Tort Causes of Action
  • B. Preconception Tort Cases
    • 1. Preconception Torts in the Medical Context
      • a. Negligent Surgery Cases
      • b. Rh Factor Sensitization Cases
      • c. Rubella Cases
    • 2. Pharmaceutical Products Cases

The state and federal courts have issued several opinions on preconception tort liability for pharmaceutical companies. The first of these, Jorgensen v. Meade Johnson Laboratories, involves birth control pills. All but one of the subsequent cases have arisen out of the use of the drug DES. Cases involving harm from defective pharmaceutical products are typically analyzed under the rubric of strict products liability. In the preconception tort context, however, courts curiously have looked beyond injury and actual causation and turned to an assessment of duty and proximate cause.

In Jorgensen, the plaintiffs’ mother took birth control pills from May through November of 1966. In July of the following year, she gave birth to twins suffering from Down’s Syndrome, one of whom died at age three. The complaint alleged that the birth control pills had “‘altered the chromosome structure within the body of the [mother] … and as a result thereof, a Mongoloid deformity was created’ in the twin plaintiffs. The district court dismissed the claim, stating that a preconception tort was not a cognizable claim in Oklahoma and that creating such a cause of action was a matter for the legislature. The Sixth Circuit vacated the dismissal, noting that “the right to sue for prenatal injury has generally evolved from court decisions. ” On the substantive issue, the court used a hypothetical to point out the fundamental problem inherent in a blanket rejection of preconception tort claims: “If the view prevailed that tortious conduct occurring prior to conception is not actionable in behalf of an infant ultimately injured by the wrong, then an infant suffering personal injury from a defective food product, manufactured before his conception, would be without remedy.

The New York Court of Appeals rejected preconception tort liability in Enright v. Eli Lilly & Co. the first of several cases alleging third generation harm from the drug DES. In Enright, the plaintiff’s grandmother took DES during her pregnancy with the plaintiff’s mother, who developed reproductive system deformities as a result of her exposure to the drug. Because of her mother’s reproductive system abnormalities, the plaintiff was born prematurely, afflicted with cerebral palsy and other complications ultimately attributable to her mother’s DES exposure . The trial court dismissed the case for failure to state a cognizable claim, but the intermediate appellate court reinstated the case on the theory of strict products liability. The Court of Appeals acknowledged that in Albala it left open the question whether a different result might obtain under a strict products liability theory. In Enright, however, the court found no basis for departing from Albala’s no-duty rule in preconception tort cases.

In reaching its decision, the Enright court focused on three issues. First, it expressed concern that, owing to the controversial nature of the drug, DES plaintiffs might be treated as a “favored class for whose benefit all traditional limitations on tort liability must give way.” The court concluded that it was not going to permit a cause of action simply because DES was involved.” Second, akin to the defensive medicine concern in Albala, the Court of Appeals worried about “the dangers of overdeterrence-the possibility that research will be discouraged or beneficial drugs withheld from the market… if we are asked to recognize a legal duty toward generations not yet conceived. The court was not worried about underdeterring drug companies from inflicting injuries because “manufacturers remain amenable to suit by all those injured by exposure to their product, a class whose size is commensurate with the risk created.” Third, the court noted that the plaintiff failed to meet the requirements of a statute governing DES litigation requiring actual contact with the drug in order to make out a cause of action.

The Supreme Court of Ohio found the Enright decision persuasive when it held against a third generation DES cause of action in Grover v. Eli Lilly & Co. The Grover court decided the issue on a certified question from the federal district court in the Northern District of Ohio. The district court put the question as follows:

Does Ohio recognize a cause of action on behalf of a child born prematurely, and with severe birth defects, if it can be established that such injuries were proximately caused by defects in the child’s mother’s reproductive system, those defects in turn being proximately caused by the child’s grandmother ingesting a defective drug (DES) during her pregnancy with the child’s mother?

In Grover, the plaintiff’s mother was born with an impaired cervix due to in utero exposure to DES.  The plaintiff, as in Enright, was born prematurely, suffering from cerebral palsy.  Although the opinion gives some attention to the question of duty, the case was ultimately decided on grounds of proximate cause. The court concluded: “Because of the remoteness in time and causation, we hold that Charles Grover does not have an independent cause of action.”

In the most recent third generation DES case, an Illinois appellate court denied a cause of action without reaching the substance of the claim. In Sparapany v. Rexall Corp., the plaintiffs’ grandmother ingested DES in the 1950s, exposing their mother to the drug in utero.  Their mother “developed an incompetent cervix and a malformed uterus.” As a result, one of the plaintiffs was stillborn and the other suffered serious birth defects. The only issue on appeal was whether the Illinois Supreme Court’s decision in Renslow, allowing preconception tort claims, was prospective only and thus barred the plaintiffs’ cause of action.

The Sparapany court held that the plaintiffs’ claims were precluded by plain language in the Renslow opinion limiting its application to “‘cases arising out of future conduct.” Because the plaintiffs’ grandmother ingested DES twenty years prior to the Renslow decision, the defendant’s negligent action was deemed outside the scope of Renslow’s prospective holding. The court refused to remark on the permissibility of preconception pharmaceutical claims triggered by activity after the date of the Renslow decision?’ A specially concurring justice voiced concern about the “unnecessarily premature cut-off of claims by DES grandchildren. The concurring opinion points out that while the Renslow court expressed concerns about the “potential for perpetual claims arising for chemical accident or long-term radiation exposure,” the likelihood that “DES generations will … cease at the third-generational stage … is probably assured.”

Wells v. Ortho Pharmaceutical Corp. is a non-DES pharmaceuticals case in which preconception negligence was claimed. The plaintiff in Wells alleged that her mother’s use of a spermicide contraceptive jelly proximately caused five birth defects: “(1) a clef lip; (2) an abnormal formation and shortening of her right hand; (3) the absence of the distal joint of her right ring finger; (4) the complete lack of a left arm; and (5) only partial development of the left clavicle and shoulder.” The plaintiff claimed that the spermicide caused the defects through one of four mechanisms: “(1) injury to a sperm that ultimately fertilizes an egg; (2) injury to an unfertilized egg; (3) injury to a fertilized egg or zygote; or (4) injury to the developing fetus, either by direct contact with the fetus or by absorption by the mother.” Two medical experts testified to the possibility of preconception injury through the first two mechanisms.  While the court ultimately found the fourth mechanism the most plausible, it did not rule out the alternative theories. Neither the district court nor the circuit court, however, explicitly evaluated the permissibility of a preconception tort cause of action in the pharmaceuticals context. The near universal denial of a cause of action for preconception harm from pharmaceutical products is striking in light of the doctrine of strict liability for products that are unreasonably dangerous in manufacture or design. The next section reveals a similar phenomenon in automobile accident cases. While harm arising out of automobile accidents is almost universally actionable, courts have been reluctant to allow a cause of action for individuals harmed as a result of car accidents occurring before they were conceived.

    • 3. Preconception Automobile Accident Cases
    • 4. Toxic Substance Exposure Cases
  • C. Distinguishing Wrongful Life Claims from Preconception Torts

II. THE INCONSISTENCY AND INADEQUACY OF CURRENT PRECONCEPTION TORT LAW

A. Disarray Among and Within Jurisdictions

On the surface, courts seem to be consistent in the way they handle various types of preconception tort claims. For example, seven out of nine courts that have reviewed Rh sensitization cases have permitted a cause of action based on preconception negligence. The two jurisdictions holding otherwise did so on the basis of statutes of limitations rather than common law tort principles. All five jurisdictions that have examined third generation DES claims have denied them. Likewise, all three courts that have been presented with preconception claims arising out of car accidents have denied a cause of action. More broadly, courts that have evaluated causes of action based upon preconception negligence have generally found that the existence or nonexistence of a duty of care flowing to the unconceived child is critical to the analysis.

Beneath this patina of uniformity, however, a more complicated picture may be uncovered. Even where the outcomes of cases are consistent, the legal analyses employed by the courts are often very different. For example, in the Rh sensitization cases, where the physician-patient relationship usually creates a duty of care, four courts did not undertake a duty analysis, focusing instead on statutes of limitations. Two of these concluded that recovery was barred because the relevant statute ran from the date the mother was injured or should have discovered her injury. Implicit in these holdings is that the relevant injury was to the mother, not the later-conceived child, thus undercutting the idea of a duty of care to the child.

While the courts have been more consistent in the denial of third generation DES claims, this consistency diminishes if the DES cases are placed in the broader category of pharmaceutical products cases. In denying a third generation DES claim, the New York Court of Appeals worried about making DES plaintiffs “a favored class for whose benefit all traditional limitations on tort liability must give way.  Ironically, however, the DES cases are the only pharmaceutical products preconception claims to date in which a cause of action has been denied. Jorgensen (birth control pills) and Wells (spermicide jelly) may be distinguished from the third generation DES claims in that the injuries in Jorgensen and Wells occurred shortly after the negligent conduct, whereas the injuries in the DES cases occurred decades afterward. Courts, however, have not barred preconception Rh sensitization claims even though the harms in many of those cases are realized several years after the negligent activity. Moving to the auto accident cases, the Taylor and Hegyes courts denied preconception tort claims, holding that the motorist owed no duty of care to the future child of the accident victim.  The McAuley court, in contrast, affirmed the existence of a duty of care but chose to deny relief on grounds of proximate cause.

The jurisdictional division in preconception torts is sharpest between New York and Georgia. New York has articulated a brightline no duty rule, barring claims in the medical care, pharmaceutical products, and toxic substance contexts. Georgia, on the other hand, has allowed preconception claims to proceed in both pharmaceutical products and toxic substances cases. The Georgia Supreme Court would have gone so far as to allow a preconception tort claim arising from an auto accident had a physician’s intervening act of negligence not subverted the element of proximate cause. Most jurisdictions that have found a preconception duty of care have, like Georgia, found such a duty across contexts. The New Jersey courts, however, have found a duty to the unconceived in Rh sensitization cases, but not in automobile accident cases.

Although there have been multiple preconception tort cases over the past thirty years, there is no consensus among, and sometimes within, jurisdictions about the framework of analysis. This may prove problematic at a time when the emergence of new genetic and assisted reproductive technologies promises to lend added significance to this area of tort law. As advances in medical science enable doctors to manipulate reproductive cells and the DNA contained within prior to conception, the possibility of harm through preconception negligence will be greatly magnified.

B. Medical Advances and Preconception Torts

III. A NEXUS TEST FOR DUTY AND ITS APPLICATION

  • A. The Nexus Test
  • B. Applying the Nexus Test for Duty to Preconception Case
    • 1. Negligent Surgery
    • 2. Rh Sensitization
    • 3. Failure to Immunize for Rubella
    • 4. Pharmaceutical Products

Most of the preconception claims in the pharmaceuticals context have arisen out of DES ingestion. A woman takes DES while pregnant, causing her child to develop uterine tumors. The woman’s child, in turn, conceives and bears a child who suffers physical defects as a result of the uterine tumors. The nexus between providing a drug to prevent miscarriage and the birth of a grandchild suffering defects would appear to fail a nexus test for duty. The duty element, however, should not be as significant in this type of case because principles of strict products liability apply, rendering the duty element of diminished importance.

There is one way, however, in which a relevant nexus might nevertheless be established. Drug companies are charged with guarding, through clinical trials, against a multitude of risks that might be posed by their products. If the manufacturer should have known, through proper clinical trials, that DES posed a risk of uterine tumors, then the nexus is established. Once knowledge or constructive knowledge of the risk of uterine tumors in the child is established, the nexus between the uterine tumors and the malformation of the future child exposed to such tumors is no longer far-fetched. As with the negligent surgery cases, the line might be drawn at defects closely connected with the bodily integrity of a developing fetus. For example, if DES caused heart defects rather than uterine tumors, it would be difficult to establish a nexus between a mother’s weak heart and her child’s developmental injury, even if actual causation could be established in such a case.

    • 5. Auto Accidents
    • 6. Toxic Substance Exposure
    • 7. Assisted Reproduction: IVONT and ICSI

CONCLUSION

Preconception negligence is already a significant area of tort law. Over the past thirty years, numerous plaintiffs have brought claims alleging injuries resulting from negligent activity prior to their conception. This area of the law promises to become even more important as interventions affecting human reproduction at the cellular level grow more feasible. To date, preconception tort cases have usually arisen where defendants engaged in risky conduct, but did not intend to have an impact on future persons. With the advent of advanced assisted reproductive technologies like IVONT and ICSI, as well as the possibility of inheritable genetic modification and human cloning, the setting has shifted. It is now not only possible, but also likely, that medical interventions targeted at creating or enhancing future persons will cause injuries to some of those persons. Gene therapy and assisted reproductive technologies that act upon reproductive cells prior to conception hold out great promise, but they also pose risks of harm. The time is ripe for courts to develop a consistent approach to preconception negligence grounded in traditional tort doctrine.

In the current state of the law, some courts are skeptical about whether otherwise negligent actors can owe a duty of care to persons not yet in existence. The plaintiff is hard pressed to establish a relationship between himself and the defendant giving rise to a duty. This obstacle can be overcome if courts focus on a different type of relationship: the nexus between the category of activity in which the defendant engaged and the category and manner of harm the plaintiff suffered. In most types of cases presented thus far, and certainly in cases involving assisted reproduction, such an approach will enable the plaintiff to clear the duty hurdle. Courts may still limit causes of action on grounds of proximate cause, but doing so does not involve a determination that the defendant had no obligation to avert the harm suffered by the plaintiff. In some cases where recovery to date has been denied, however, a focus on proximate cause rather than duty may allow the plaintiff to be made whole where a remedy might otherwise not have been available.

Matthew Browne, 2001.

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