Embryos, Eggs & Errors: Examining Fertility Clinic Negligence, Part 1
Starting a family is taken for granted by so many, but is not always simple or straightforward as planned. One in six Canadians struggle with infertility. For those that require help, fertility clinics offer services that substantially improve the odds of conceiving.
People experiencing infertility have benefited greatly from advances in modern medicine and medical technology. From hormone-altering medications, assisted reproductive technologies (such as in vitro fertilization or “IVF”), to surrogacy, previously infertile people or couples have been able to conceive and give birth to a child or children.
Despite the hope and joy that can come from scientific reproductive advancements, there is also a special vulnerability that comes with being a patient of a fertility clinic. The process can be confusing, costly as well as physically and emotionally taxing.
Unfortunately, the privatization of fertility services has meant that corporations are often in control of essential health and safety for these services. In many respects, fertility treatment is unregulated. There are variable costs province to province and clinic to clinic. There are service add-ons that may be promoted to patients, with no way for the patients to assess if they will increase the rate of success or the safety of treatment.
It can be very difficult to accurately compare the success rates between clinics, physicians, or treatment options. There is very little regulatory oversight of practices, methodologies, or safety measures. There are few mandatory reporting mechanisms and inadequate government oversight. The industry’s advancements have unfortunately outpaced regulation.
As a result of the lack of oversight, some infertility patients’ dreams of creating a family have turned into a nightmare.
In Part 1 of this two-part blog post, I define assisted human reproduction and outline how it has (and has not) been regulated in Canada. In Part 2, I will review some specific examples of cases where fertility clinic negligence has caused significant physical, mental, and emotional harm to patients. Unfortunately, over the past few years I have seen a significant increase in these patients seeking legal support, which suggests to me that there may be many others who are suffering as a result of fertility clinic negligence and some who do not know yet know they have been impacted by medical error.
What is Assisted Human Reproduction?
To understand how medical error can occur at a fertility clinic, we must understand what is being done. Any procedure that involves the handling of human sperm, ovum (eggs) or both, outside the body is considered assisted human reproduction (AHR). Specific technologies, such as IVF, intrauterine insemination and ovarian stimulation through the use of medications, have been developed in order to facilitate conception within the body and/or to implant embryos into the body.
Although embryo transplantation experiments on animals were first recorded in the 1890s, it was not until 1973 that the first pregnancy in a human using IVF was announced. Louise Brown, the first baby to be conceived through IVF, was born in the United Kingdom in 1978. In 1983, the first baby conceived through assisted reproductive technology in Canada was born in British Columbia.
IVF involves a complex series of procedures that assist in conception. To start patients are given fertility drugs to induce superovulation (or increased ovum production) and a hormone to help the ovum mature. During this time patients are monitored frequently to determine ovum numbers and size. Next, a minor surgical procedure allows the doctor to remove the ovum. Meanwhile, the sperm are put through a wash and spin cycle to find the healthiest ones. In the laboratory, mature ovum that have been retrieved from the ovaries are manually fertilized with sperm to create an embryo. After a period of a few days, the embryo is either frozen for later use or implanted into the uterus. Pregnancy occurs if the embryo attaches to the uterine wall. These steps form one full cycle of IVF treatment.
During each step of the procedure described above, it is essential for fertility clinics and laboratories to have and following clear procedures for cleaning, storing and labelling genetic material. Failure to do so can result in lost or destroyed biologic material, misused biologic material or improper use of embryos.
Over time fertility treatment has become more popular. Two to four percent of pregnancies in Canada are now a result of various types of AHR. Many provincial governments have also begun to provide some funding for AHR. For example, in 2015 Ontario announced that it would fund one cycle of IVF (per lifetime) for every woman under the age of 43 as well as for single men or men in same-sex relationships. Ontario also funds other AHR procedures including intrauterine insemination and fertility preservation.
How Are Fertility Clinics Regulated in Ontario?
As AHR became more common, the federal government opted to pass legislation in 2004 to regulate some aspects of these technologies and processes and to prohibit others. Among its provisions, the Assisted Human Reproduction Act banned:
- human cloning;
- creation of in vitro embryos for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures;
- maintaining an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation, excluding any time during which its development has been suspended (cryogenically frozen);
- sex selection of embryos;
- payment for surrogacy or intermediaries facilitating surrogacy;
- payment for sperm or ova donations or embryos;
- using human reproductive material for the purpose of creating an embryo unless the donor of the material had given written consent;
- removing human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo unless the donor of the material has given written consent;
- obtaining any sperm or ovum from a donor under 18 years of age except for the purpose of preserving the sperm or ovum or for the purpose of creating a human being that the person reasonably believes will be raised by the donor
In 2010, the Supreme Court ruled some provisions in this Act “ultra vires” (or not in the federal government’s jurisdiction but properly regulated by the provinces). This ruling opened the door to provincial regulation of these activities. To date, Ontario has not passed significant legislation in this area.
While regulated health professionals such as doctors and nurses operating within the AHR sector must follow national and international clinical practice guidelines and are governed by their own regulatory colleges, laboratory fertility technologists/embryologists do not answer to a similar regulatory body.
When AHR procedures are provided in hospitals or hospital-affiliated clinics, they are bound to comply with the Public Hospitals Act. Private clinics may seek voluntary accreditation but are otherwise subject only to the limited oversight provided by the College of Physicians and Surgeons of Ontario’s Out of Hospital Premises Inspection Program.
Help When You’ve Experienced Harm.
Failure to introduce appropriate and required substantive legislation and regulatory monitoring puts patients of these clinics at unnecessary risk. In Part 2 of this blog series, I explore some specific examples of how when something goes wrong at a private fertility clinic, it can go very wrong.
If you or a loved one has suffered harm while using a private fertility clinic’s services and you believe the clinic’s negligence played a role in what happened, you may be eligible to make a claim for compensation and damages. For information regarding protecting for legal rights contact Gluckstein Lawyers.
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