UNJUST TIMING LIMITATIONS IN GENETIC MALPRACTICE CASES.

• Author: Marchant, Gary

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. (1) Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. (2) Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, (3) their application to genetic liability cases may sometimes result in fundamental unfairness and unjust results because of the unavoidable delayed discovery of the potential negligence in detecting or addressing the genetic contribution of a patient's condition. (4)

The timing dilemmas presented in genetic malpractice cases are illustrated by a closely-watched pending case in South Carolina--Williams v. Quest Diagnostics, Inc. (5) In that case, a test laboratory failed to recognize the clinical significance of a mutation carried by a child, classifying it as a variant of unknown significance. (6) As a result, the child was not given the appropriate treatment and tragically passed away. (7) The substantive issue in the case is when the laboratory should have recognized the pathogenic nature of the mutation and communicated that information to the child's treating physician. (8) However, the case may be decided on a procedural timing issue, depending in part on whether the lawsuit against the laboratory is considered a medical malpractice case or a general negligence case. (9) The South Carolina District Court certified a question to the South Carolina Supreme Court to determine whether "a federally licensed genetic testing laboratory" is considered a "licensed health care provider" under South Carolina law, and the South Carolina Supreme Court answered affirmatively, meaning that the six-year statute of repose for medical malpractice may apply. (10)

The defendants have now moved to dismiss the case since the case was brought more than eight years after the laboratory's allegedly negligent act. (11) However, the plaintiffs mother did not discover, and had no reasonable means to discover, until long after the statute of repose had run that the laboratory allegedly should have known of the pathogenic nature of the child's mutation at the time of testing. (12) Although this case is still pending as of the time of this writing, if the court were to dismiss the plaintiff's claim as untimely, such an outcome would be an example of a manifestly unjust result in a genetic malpractice case in which a family had no possible way to determine the nature of the genetic condition and the alleged malpractice until well after the time for filing a lawsuit had expired.

While similar problems occasionally pop up in other types of medical malpractice cases, (13) they are likely to be much more common in genetic malpractice cases because the provider error often remains hidden for years or even decades. (14) This then creates a growing tension between the injured plaintiff's right to seek legal recourse in a case, where they have allegedly been injured, against the providers' interest in preventing open-ended liability and the litigation of old cases where the evidence may be stale. This Article addresses this tension and the potential unfairness that may result in genetic malpractice cases due to statutory timing constraints. In Part I, we provide background on the types, purposes, requirements, and prevalence of such timing limitations. In Part II, we provide some additional examples of unfair and unjust outcomes in genetic malpractice cases from applying such timing limits. Finally, in Part III, we offer some potential solutions that recognizes the legitimate need of health care providers to not face open-ended liability while also protecting injured patients from being blocked from seeking a legal remedy when they could not have possibly discovered their potential legal claim before the applicable timing limitation had expired. This problem raises the broader issue of what should lawmakers do when a legal regime that was created for an earlier era and different technology is now challenged by new technology that may not fit or align well with that historical legal regime.

1. BACKGROUND ON LITIGATING TIMING LIMITATIONS

   In torts and other types of litigation, certain state statutes limit the time within which a plaintiff can bring a claim, which are generically called statutory limitations (SLs). (15) These statutory limitations can be in two main categories: statutes of limitation (SoLs) and statutes of repose (SoRs). (16) As elaborated below, SoLs generally run from the time that the plaintiff did or should have discovered that they had a cause of action, whereas SoRs are more harsh, and run from the time that the tortious act occurred, regardless of whether or when the plaintiff discovered the tortious nature of the act. (17) A third type of timing limitation in tort lawsuits are statutes that require a plaintiff to provide timely notification of their intent to sue, which often apply only to defendants that are public institutions. (18)

   These SLs impose bright-line rules to bar claims brought after the times specified. (19) Courts emphasize that the purpose of such SLs involves justice and process concerns, including that evidence deteriorates over time, defendants are entitled to peace of mind at some point, insurers and defendants need a degree of certainty in order to estimate future costs, and societal expectations and standards change over time. (20) For example, the U.S. Supreme Court stated back in 1944 that statutory limitation periods are

   designed to promote justice by preventing surprises through the revival of claims that have been allowed to slumber until evidence has been lost, memories have faded, and witnesses have disappeared. The theory is that even if one has a just claim it is unjust not to put the adversary on notice to defend within the period of limitation and that the right to be free of stale claims in time comes to prevail over the right to prosecute them. (21) In the genetic context, these practical arguments for timing limitations will have particular salience. There is a strong argument that providers need to be protected from open-ended liability, as gene sequencing and testing will generate many "variants of unknown significance" at the time of the testing, but which may have clinical significance later on. (22) Given the well-known hindsight bias of jurors and the liability system, (23) there will be a tendency and temptation to second-guess the provider's initial judgment and attribute greater knowledge than is fair retrospectively the longer the window of liability remains open. (24)

   On the other hand, as discussed further below, the unique timing issues and nature of genetic malpractice cases may result in some plaintiffs not discovering the negligence that harmed them until after the timing statute has expired. (25) Thus, although the purpose and meaning of SLs may seem simple on first impression, their application raises many complex and difficult issues in balancing the interests of the parties. Judge Richard Posner cautioned, "Though rarely the subject of sustained scholarly attention, the law concerning statutes of limitations fairly bristles with subtle, intricate, often misunderstood issues." (26)

   Typically, in negligence claims, (27) the statutory clock does not start until the defendant commits a negligent act and that act caused legally cognizable harm. (28) Many states have added a third triggering requirement, which is when the plaintiff reasonably should have discovered the negligent act. (29) This two- or three-prong requirement is typical for statutes of limitation. (30) Statutes of repose, on the other hand, provide an alternative to the two- or three-prong requirement of statutes of limitations and require only that a negligent act occurred to trigger the statutory clock. (31) Although almost all legal actions have an SoL (extreme criminal charges such as murder being an exception), SoRs are imposed by state legislatures much more selectively. (32) In addition, unlike an SoL, an SoR generally cannot be tolled. (33) A Tennessee court succinctly explained the difference between an SoL and SoR as follows:

   A statute of limitations governs the time within which suit may be brought once a cause of action accrued. A statute of repose limits the time within which an action may be brought, "but it is entirely unrelated to the accrual of a cause of action and can, in fact, bar a cause of action before it has accrued." (34) In order to understand the differential purposes of SoLs and SoRs, it is helpful to consider the history of SoRs, the more recent of the two SLs. SoRs were mostly enacted as part of the tort reform legislation in the 1970s and 80s and were created to protect certain groups such as product manufacturers, government entities, architects and builders, and health care professionals from long liability "tails" that were seen as excessive. (35) The SoRs were intended "to eliminate uncertainties under the related statute of limitations and to create a final deadline for filing suit that is not subject to any exceptions." (36) SoRs pertaining to health care providers' typically begin to run at the moment of "the doctor's last act or the completion of treatment," even if the harm from that last act does not become evident until later. (37)

   Because health care providers are subject to primarily negligence and medical malpractice claims, SLs in negligence and medical malpractice statutes are relevant here. Medical malpractice claims are a subset of negligence claims, but courts do not have...