A Complaint filed on January 4, 2024 in the Superior Court of California for the County of Los Angeles against CooperSurgical, Inc. The Cooper Companies, Inc., and others alleges, in part:
Defendants’ defective product and negligent conduct destroyed Plaintiffs’ precious and irreplaceable embryos.
Defendants manufactured, marketed, promoted, distributed, and/or sold media to be used for culturing and developing human embryos. Defendants marketed that their media provided “an optimized in vitro environment,” which is necessary to ensure that fertilized human eggs can survive and develop into embryos viable for implantation.
Defendants further represented that they properly and adequately tested their embryo culture media before making the media available to the public, including to clinics who would use such embryo culture media for the storage of human embryos. They further claimed: “Our world class ISO 13485 and ISO 9001 certified manufacturing site consistently maintains the highest standards for product quality and reliability.”
Despite these representations, Defendants did not sufficiently test the embryo culture media that they manufactured, marketed, promoted, distributed, and/or sold. As a result, they sold defective lots of embryo culture media, which turned out to be toxic to human embryos, eggs, and/or sperm.
Defendants’ manufacturing, marketing, promoting, distributing, and/or selling its defective and toxic culture media resulted in the death of Plaintiffs’ embryos.
Only after Plaintiffs’ embryos died upon coming into contact with Defendants’ defective embryo culture media did Defendants recall multiple lots of its culture media, including a lot that ruined Plaintiffs’ embryos.
ART [Assisted Reproductive Technology] involves fertility-related treatments in which human eggs or embryos are
manipulated. The most common type of ART is IVF.
During the IVF process, eggs are extracted from a woman and fertilized in a laboratory with sperm to create a viable embryo. Later in the IVF process, the embryo is transplanted into a uterus.
The process of extracting human eggs from a woman is lengthy, typically requiring significant medication, including injections, frequent bloodwork to monitor hormone levels, monitoring through ultrasound and other scans to check the development of the eggs, and performing a surgical procedure to collect the eggs.
Following the collection of the eggs, sperm is mixed with the eggs in a laboratory to create embryos, and media is used to cultivate the embryos.
Many people, including Plaintiffs, elect to have their embryos stored for a period of time before the embryo is transferred to a woman’s uterus.
There can be many reasons for undergoing these expensive and extensive procedures well in advance of the embryo implantation, including that human eggs are a limited and precious resource. A woman has a limited number of eggs at birth, and this supply diminishes as part of the natural aging process (commonly referred to as a “biological clock”). Moreover, not only does the quantity of a woman’s eggs diminish with time, but so does a woman’s egg quality,
with miscarriages and chromosomal abnormalities occurring more frequently for women who are older at the time of a natural conception and pregnancy. The most determinative factor in IVF success is the woman’s age when her eggs were extracted.
Embryo culture media plays a pivotal role in the IVF process. The culture media serves as the essential substance in which an egg is immersed, typically in a petri dish, when it is fertilized and during its development in the lab.
Embryo culture media is composed of a salt solution with the addition of other components, such as magnesium, carbohydrates (pyruvate, lactate, and glucose), and amino acids.
After egg retrieval, the embryologist fertilizes the eggs with sperm, and then the fertilized eggs develop to the blastocyst stage—typically, during a typical period of five to seven days when they are in the culture media.
Embryologists closely monitor cell development during this time period to determine if the embryos are developing as intended. The count begins on “Day 0,” or the day the eggs were fertilized with sperm. On Day 1, the embryologists typically assess the eggs to see which have successfully fertilized and become embryos. Between Day 1 and Day 3, the embryos typically begin cell division in the “cleavage stage.” By Day 4, the embryos typically enter the “morula stage,” characterized by a compacted mass of cells. By Day 5, the embryo typically re-expands to the blastocyst stage, in which the embryo shows two distinct groups of cells: an inner cell mass and an outer globe of cells.
All embryo development is slightly different, and some embryos may develop later than others; but typically, fertilized eggs that do not develop to blastocyst by the seventh day are not considered viable. The embryo culture media in a petri dish supports and protects the developing embryos in these critical early stages, just as a woman’s body would do during natural conception.
The resulting embryos then can be transferred to the uterus, where a baby can form.
Defendants marketed and promoted their embryo culture media for use as the essential medium in which fertility clinics can fertilize eggs and create the embryos that would be the future children of fertility clients like Plaintiffs.
Defendants further marketed and represented that their embryo culture media is subject to rigorous testing to ensure it is the highest quality embryo culture media available.
Moreover, Defendants marketed and promoted that all their embryo culture media was properly tested, and thus that it could be relied upon and/or posed no harm in use with growing human embryos.
Specifically, CooperSurgical claims “[q]uality is our cornerstone,” stating its “products undergo thorough quality testing before being released, to ensure consistent quality for your piece of mind.”
Defendants manufactured, marketed, distributed, and/or sold their embryo culture media while promoting that their embryo culture media was tested by superior methods to ensure that the culture was not missing key ingredients and that no embryotoxic exposure occurred.
Defendants knew that sterility and quality control are crucial to ensure that developing embryos in culture media are not harmed. Microbiological contamination or improperly created culture (e.g., culture with missing ingredients) may kill the embryos it contacts.
Microbiological contamination or improperly created culture (e.g., culture with missing ingredients) can cause DNA fragmentation, non-viable embryos, poor-quality embryos, early pregnancy loss, preterm birth, birth defects, and/or predisposition to serious medical conditions.
Microbiological contamination or improperly created culture (e.g., culture with missing ingredients) can increase financial costs to both the patient and the clinics.
Defendants knew or should have known that some of their embryo culture media was not properly and/or adequately manufactured, properly and/or adequately tested, and/or properly and/or adequately inspected for contamination, and thus posed a severe risk to the human embryos that the culture media would contact.
On information and belief, in late 2023, Defendants issued a recall of several lots of their embryo culture media, including LGGG Lots 231020-018741, 231020-018742, and 231020-018743 (the “Recalled Embryo Culture Lots.”)
However, on information and belief, Defendants intentionally did not immediately disseminate notice of the Recalled Lots publicly or throughout the IVF community.
On information and belief, Defendants previously have manufactured and sold numerous products used in ART, including other culture media, that were defective and sometimes recalled.
In approximately November 2023, numerous embryos were created using E.F.’s eggs (from both the 2020 and 2023 retrievals) and Plaintiff G.H.’s sperm.
Plaintiffs’ excitement was short-lived: Plaintiffs’ fertility doctor told them that all of their embryos suddenly stopped growing/had arrested development by Day 5.
Plaintiffs’ fertility doctor was shocked by the highly unusual result that the embryos were not developing into blastocysts, and told Plaintiffs that numerous other clinics also recently experienced these unusual outcomes. Plaintiffs’ fertility doctor also told Plaintiffs that he learned that Defendants’ embryo culture media was the reason and the cause of the destruction of Plaintiffs’ precious embryos.
Plaintiffs are devastated. They may no longer be able to have additional children with their genetic material as a result of Defendants’ conduct.
If you or a family member suffered harm as a result of fertility treatments in California or elsewhere in the United States, you should promptly find a California medical malpractice lawyer or a medical malpractice lawyer in your U.S. state who may investigate your fertility malpractice claim for you and represent you or your family member in a fertility medical malpractice case, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find IVF medical malpractice attorneys in your state who may assist you.
Turn to us when you don’t know where to turn.