A reproductive hormone doctor and biostatistics expert testified Tuesday about difficulties women faced undergoing fertility treatments and a decreased rate of successful births from eggs and embryos affected by a March 2018 freezer tank accident.
SAN FRANCISCO (CN) — Women undergoing fertility treatments paid thousands of dollars and endured grueling side effects like physical pain, anger, depression, weight gain, fatigue and nausea. A doctor testified Tuesday that those sacrifices may have been for naught after a mishap damaged thousands of eggs and embryos at a San Francisco fertility clinic.
“Every one of the plaintiffs have gone through a significant amount of stress and trauma through this process and as a result of their loss of biological materials, their future fertility options have been compromised,” reproductive endocrinologist Stephen Somkuti testified.
Somkuti was the seventh live witness to testify in a jury trial seeking to hold cryogenic tank maker Chart Inc. liable for a March 2018 mishap that prematurely thawed eggs and embryos belonging to three women and one couple at the Pacific Fertility Center in San Francisco. The trial involves only five plaintiffs, but it could establish Chart’s liability for the loss of reproductive tissue belonging to hundreds of other people. The tank contained 3,500 frozen eggs and embryos.
Somkuti, a doctor who specializes in reproductive hormones, explained how a woman’s ability to produce viable eggs starts declining at age 35. Every year that passes brings a higher risk of infertility or genetic defects that could cause conditions like Down syndrome. By age 40, most women have lost 90% of their eggs.
“You’re not going to be able to replace the eggs or embryos with the same chronological age to be able to enjoy that higher pregnancy rate,” Somkuti said. “They’ll be replaced with much more mature reproductive tissue and the potential for genetic abnormalities and lower success rates.”
Somkuti interviewed plaintiffs whose eggs and embryos were affected by the March 2018 tank failure. The plaintiffs say the catastrophe resulted from Chart’s use of a weaker weld near a liquid nitrogen inflow pipe, making the tank susceptible to cracking, leaks and failure. Chart denies those claims and says the accident was caused by fertility clinic employees misusing the product.
One of the plaintiffs, Rosalynn Enfield, was 34 years old when she had 18 eggs retrieved, frozen and stored in the tank in 2013. Fertility treatments caused her to suffer “anxiety, anger, physical discomfort and emotional issues.” Enfield is now 43 years old.
“She expressed a desire for options and she now is unable to use the 34-year-old eggs,” Somkuti said.
On cross-examination, Chart attorney Kristine Reveille insinuated that the tank failure was not as devastating for Enfield as the doctor suggested. She noted that Enfield had two babies in 2017 and 2019 through natural conception and that she had previously told her doctor she only wanted two children.
On redirect, plaintiffs’ attorney Dena Sharp asked Somkuti if people’s family planning choices change over time.
“Some people say, ‘I’m never going to have another child,’ but then after they have their first child, their opinions change,” Somkuti said.
Reveille also asked about a May 2019 report stating that the husband of one of the plaintiffs had a vasectomy and did not bank his sperm prior to the sterilization procedure.
“Vasectomies are typically performed on fertile individuals who want to avoid conception,” Reveille said. “Is that true?”
“Typically” Somkuti replied.
Reveille also asked pointed questions about why some plaintiffs did not make further attempts to freeze eggs and embryos after the 2018 mishap. Somkuti said many decided not to because of financial limitations and the physical and emotional strain that comes with undergoing such treatments.
Also on Tuesday, a statistician told jurors that the March 2018 accident significantly decreased the probability that eggs and embryos from the failed tank will result in a successful pregnancy.
Nicholas Jewell, a biostatistics expert, compared the rates of successful thawing, pregnancies and births for frozen eggs and embryos in 2017 to those that were inside Tank 4 when it failed in 2018. He found the success rate for thawing embryos dropped by more than half from 96.2% to 43.5%. He also found the rate of eggs resulting in live births dropped from 10% to 1.2%, and the rate of embryos ending in live births declined from about 50% to 13.4%.
“You can determine that’s not chance variation,” Jewell said. “That’s a fundamental difference in success rates attributable to the Tank 4 failure because that’s what distinguishes the two groups.”
Jewell said he accounted for other factors in his calculations, but on cross-examination, a Chart lawyer asked Jewell if he knew how other circumstances can affect a pregnancy. Jewell was asked about inflammation or infection of the uterus lining, duration of progesterone exposure, fallopian tube damage, obesity, polyps, thyroids and previous uterine surgeries. Jewell acknowledged he did not know how those conditions affect pregnancy.
“You are aware that for some women, despite their best efforts, they may never get pregnant,” a Chart lawyer asked the statistician.
“Yes,” Jewell replied.
The plaintiffs are suing Chart for product liability and failure to recall the tank’s allegedly defective controller device that measures liquid nitrogen levels and sends off alerts about tank problems.
Chart recalled its cryogenic storage tanks on April 23, 2018, saying it needed to investigate a “vacuum leak and/or failure which may be due to inadequate adhesion of the composite neck to the aluminum unit.”
The fertility clinic and its owners were also sued for the loss of eggs and embryos, but those claims were sent to private arbitration. Prelude Fertility acquired Pacific Fertility in September 2017, and Prelude’s subsidiary Pacific MSO now manages the San Francisco clinic.
According to the lawsuit, one cycle of egg retrieval, freezing and annual storage costs $8,345, and a second cycle costs $6,995. Some women, including a plaintiff known only as S.M. in the original complaint, paid as much as $10,000 out-of-pocket to retrieve, freeze and store eggs.
The trial overseen by U.S. Magistrate Judge Jacqueline Scott Corley is expected to continue through June 10.