By Deborah L. Forman
Since the first “test tube baby” Louise Brown was born from in vitro fertilization (IVF) more than 35 years ago, researchers estimate that as many as 5 million babies have been born from this miraculous procedure. When the process goes well, parents achieve their dream of having a child. Unfortunately, as with all medical procedures, sometimes accidents happen and physicians and labs make mistakes. Embryos have been lost; gametes have been switched; and embryos have been transferred to the wrong recipient. Fortunately, errors such as these occur rarely. But when they do, the consequences can be devastating for the parties involved. What recourse do you have as a patient when a mistake has been made? This article will provide an overview of the legal obligations physicians and labs must fulfill and the various actions you can take in the event of an error.
Legal Obligations of Reproductive Endocrinologists and Embryology Labs
Like all physicians, reproductive endocrinologists and embryologists have an obligation to adhere to the standard of care in their profession. That means they must have and use the skills and knowledge of a member of the profession in good standing. The exact requirements in any particular course of treatment are determined by what other physicians would do in that situation. Failure to adhere to the standard of care can subject the physician to liability. A patient who has suffered injury as a result of negligent diagnosis or treatment can sue the doctor for medical malpractice and recover damages. So, for example, if a physician failed to adequately screen an egg donor for transmissible diseases, and the intended parent (or gestational carrier) contracted the disease, she would likely be able to sue and recover damages.
However, where the physician’s negligence involves mistaken use of gametes or embryos, the patient’s right to recover is less clear. In the typical medical malpractice case, the patient has suffered a physical injury. In the mixed-up embryo case, the harm is emotional. While most jurisdictions allow for claims seeking recovery for emotional harm (commonly known as negligent infliction of emotional distress) under some circumstances, many jurisdictions sharply limit that kind of recovery. Often, plaintiffs in those cases must show they were at risk of physical injury themselves, a circumstance that would obviously not apply in the case of lost or damaged reproductive material.
Thus your ability to prevail in a lawsuit for this kind of mistake depends significantly on the controlling state law. In one New York case, for example, a clinic mistakenly implanted an embryo created from gametes of one couple, and intended for their use, into another couple undergoing IVF. The recipient couple ultimately gave birth to twins, one of whom was the child of the other couple. Both couples sued the clinic for the error, and the case was allowed to go forward. By contrast, a Utah court did not allow a couple to recover when the clinic used the wrong donor sperm. The couple had selected donors who resembled the father. The clinic used sperm from a donor who was not approved by the couple and looked quite different from them. The court ruled that the couple failed to show bodily harm resulting from their claimed emotional distress and thus could not recover.
A handful of reported cases have allowed patients to sue for damages where their gametes or embryos were lost, damaged or destroyed while in storage. As gametes and embryos are not persons and not necessarily property, courts sometimes struggle to arrive at a basis for recovery. These cases may involve legal theories other than negligence, such as breach of contract. Again, though, not all courts have agreed on the theory or on what damages are recoverable.
In addition to the potential for lawsuits, errors can subject physicians and clinics to disciplinary proceedings and other kinds of penalties. Physicians and embryologists must meet the standards of practice and ethical requirements of state licensing boards. Failure to do so can result in various penalties, including loss of the medical license. In 2005, the California Medical Board revoked the license of a San Francisco fertility specialist who implanted the wrong embryo in a patient and failed to inform her of the error for two years.
In some cases, physician misconduct can lead to criminal penalties. In the wake of a scandal at the University of California at Irvine in 1990, involving widespread misappropriation of embryos and gametes, the California legislature enacted a law making it a crime to knowingly use gametes or embryos for any purpose other than the one specified by the provider and recipient. Failure to get the specified written consent can also constitute unprofessional conduct, subjecting the physician to fines, as well as any other remedy that might be available.
Fertility doctors and embryologists must also adhere to rules and regulations promulgated by the Food and Drug Administration (FDA). The FDA has extensive requirements and protocols for screening, testing and handling of embryos and gametes. The FDA periodically inspects labs and can sanction providers who fail to comply with FDA requirements. Likewise, tissue banks, labs and embryologists are subject to state licensing requirements.
Labs may also be accredited by various organizations, such as the College of American Pathologists/American Society for Reproductive Medicine (ASRM) and the Joint Commission on Accreditation of Healthcare Organizations. Professional organizations, such as the Society for Reproductive Technology (SART) and ASRM have also developed comprehensive guidelines for all aspects of the laboratory, including quality control and quality assurance, to minimize the risk of errors in collecting, storing and using gametes and embryos. Most recently, the ASRM Ethics committee published an opinion recommending that clinics promptly disclose errors to patients. SART and ASRM are not government agencies. Although a few states have laws recognizing their standards, most do not. Nonetheless, many fertility clinics are members, and failure to meet SART/ASRM standards can result in suspension of the clinic’s membership.
Steps to Minimize the Potential for Errors
Is there anything you can do, as a patient, to avoid these errors? While the fate of embryos and gametes remains largely outside the patient’s control, you can try to minimize the risk by carefully selecting your fertility clinic, by asking questions and by being vigilant during all phases of treatment. Patients can:
- Look for the clinic’s membership in ASRM and SART;
- Make sure the lab is accredited by one of the organizations listed above;
- Research disciplinary proceedings against physicians by accessing state medical board’s records. Commercial companies also provide reports on physician conduct;
- Inquire about the clinic’s labeling protocol—do they use at least two unique identifiers for all vials, specimens, etc.? Does the embryologist personally verify the patient’s identity on the day of retrieval? Is there a second embryologist present as well? What documentation is required for taking sperm samples? What is the policy for handling mistakes? Are errors disclosed?
Measures such as these can help to reduce the chance of an error. But fertility treatment is not a risk-free endeavor. Bad outcomes are always a possibility. Where the bad outcome involves loss, damage to or mistaken transfer of embryos or gametes, the physician or clinic may be liable for damages if the error resulted from fault on the part of the physician or lab. It should be stressed that damage to embryos and gametes while in storage can occur for any number of reasons, and physicians cannot guarantee the survival or quality of the embryos or gametes; nor can they assure implantation or a successful pregnancy. Nonetheless, when errors do occur because of physician or lab error, patients may be able to sue to recover damages and always have the option of making a complaint to the appropriate agency.
Deborah L. Forman, J.D. is a Professor of Law, Whittier Law School, Of Counsel, International Fertility Law Group and a member of The American Fertility Association’s Legal Advisory Council