Sidley’s infertility litigation lawyers have extensive experience handling matters involving assisted reproductive technology (ART), including in vitro fertilization (IVF) and intrauterine insemination (IUI). We have counseled clients whose businesses offer services and products used in infertility treatment through complex and multijurisdictional matters. As the U.S. state and federal governments, as well as global regulatory agencies, continue to intensify their focus on the compliance and enforcement of medical devices and supplies, our lawyers are dedicated to closely monitoring the evolving laws and related litigation trends related to ART. Harnessing our full-service capabilities and global reach, our product liability, mass torts, and consumer class actions teams coordinate with our regulatory groups to devise strategies that mitigate — or preempt altogether — potential manufacturing and operational liabilities for ART.
How We Add Value
When our clients are confronted with infertility-related litigation, Sidley takes a multidisciplinary approach to their needs, harnessing the knowledge of our product liability, consumer class actions, and cross-border regulatory lawyers to protect their businesses. Our litigators have substantial experience in handling related lawsuits filed in state and federal courts, as well as federal multidistrict litigation (MDL) proceedings, having disposed of cases as soon as possible against alleged personal injury, property damage, and class action claims involving ART processes, including before a lawsuit is filed.
We are familiar with and have consulted with or defended as testifying expert witnesses in areas involved in IVF and ART, including reproductive endocrinologists, geneticists, embryologists, Ph.D. laboratory directors, obstetricians, gynecologists, regulatory specialists, and more. We are well-versed in litigating these cases or developing creative strategies to resolve them, as well as in early-litigation risk assessment and client counseling in the ART industry. Additionally, our lawyers keep clients current on evolving laws directly tied to the infertility landscape, including alerting clients to breaking news on related legal occurrences, such as the Alabama Supreme Court Ruling and legislation passed in response to it.
We Know IVF
Our lawyers help guide clients through all overarching aspects of litigation involving ART, including the ability of pharmaceuticals, genetic testing, medical devices, and biochemical products to help stimulate the recruitment of follicles in the uterus and to harvest and fertilize multiple eggs in an IVF cycle. We understand the “stim” phase, followed by a retrieval procedure done under anesthesia to extract multiple, ideally “mature” eggs — as opposed to one egg during the normal menstrual cycle. The eggs are then fertilized, which may be done through IVF or through intracytoplasmic sperm injection (ICSI), depending on the clinic and patient needs or recommendations. We know of the variety of conditions that may affect embryos as they are cultured and that the post-retrieval period involves the culturing of embryos in the hopes of either a day-3 transfer or the development of blastocysts, which are graded and can be genetically tested and vitrified.
We know of, and are able to provide data regarding, the likely alternative causes for the unsuccessful development of embryos or the inability to achieve a successful pregnancy, including, among others: ovarian reserve; age; chromosomal abnormalities; poor egg quality; irregular menses; polycystic ovary syndrome (PCOS); tubal ligation reversal; endometriosis; uncontrolled thyroid conditions or other systemic disease; anatomical issues (e.g., tubal or uterine factors); male fertility factors; use of donor eggs or sperm; history of recurrent miscarriage; obesity; tobacco, marijuana, alcohol use, other drug use; and stress.
Our teams acknowledge that the skill and experience of the fertility doctor, embryologist or laboratory director, and clinic can also affect fertility treatment outcomes, as can any number of conditions within the clinic. IVF success rates for particular clinics are published annually by the Society for Assisted Reproductive Technology (SART). Beyond any issues that may occur with resources used during the medicinal stages, there are additional risks, such as natural occurrences where the embryo may dissolve or miscarriage could occur, as well as rare or unexplained developments.
Several members of our team have had personal experience with the IVF journey, giving our lawyers firsthand perspective and a deep understanding of IVF treatments, along with the challenges surrounding litigating IVF cases.
Related Matters
Our lawyers have substantial experience with complex infertility litigation matters, including:
- Defending Ferring Pharmaceuticals in class action, as well as individual litigation, brought in U.S. state and federal courts involving the company’s 2015 recall of Bravelle, a drug used to help women produce multiple eggs, after some, but not all, batches tested slightly below specification for potency. Ferring subsequently instituted a reimbursement program to provide refunds for the cost of the medicine, but the plaintiffs sued for additional expenses they claim to have incurred and for other alleged injuries. The individual cases in Texas, Maryland, and California were settled on very favorable terms, and we negotiated favorable settlements in the class action in Illinois federal court and multi-plaintiff litigation in California state court. Our lawyers continue to help coordinate the defense of class action and personal injury lawsuits in Canada.
- Serving as the national defense counsel for a manufacturer of embryo cell culture media, reagents, and medical devices in connection with product liability litigation challenging an oil overlay used in IVF for allegedly containing a toxin restricting fertilization and growth. Cases were filed in four jurisdictions across three states, including one class action and remain ongoing.
- Representing the Board of Directors of University Hospitals Health Systems in Cleveland, which experienced a failure of the cooling tank holding frozen embryos. During this issue, approximately 4,000 embryos were allegedly lost in the process. The incident quickly became nationwide news and could have become a crisis; however, the Board retained Sidley to guide it through this cutting-edge investigation.
