A fertility clinic lab in San Francisco continues to use equipment from a company accused of selling a defective tank that failed in 2018 and destroyed more than 2,000 human eggs and embryos.
SAN FRANCISCO (CN) — On the fourth day of a jury trial over a mishap that destroyed thousands of frozen eggs and embryos, a freezer tank manufacturer’s lawyer suggested that fertility clinic employees caused the catastrophe, falsified records and violated their own quality control standards.
“It’s very unusual to backdate measurements in a reproductive laboratory, is it not?” Chart Inc. attorney John Duffy asked a lab worker on the witness stand Thursday.
Metadata shows that Pacific Fertility Center embryologist Gina Cirimele input measurements on March 20, 2018, for liquid nitrogen levels in a Chart-manufactured tank that failed weeks earlier. The backdated entries covered records for Feb. 15, Feb. 28 and March 4, the same day the tank in question failed and destroyed ,500 frozen eggs and embryos belonging to hundreds of people.
On the witness stand, Cirimele denied falsifying data. While she couldn’t remember precisely how the numbers were retrieved, she said they wouldn’t have been added unless she confirmed them with colleagues or found them in handwritten notes.
“If I couldn’t find a value, I wouldn’t just make something up,” Cirimele said. “I wouldn’t falsify a value.”
At the time those numbers were added, the lab was facing a post-tank-failure inspection by the College of American Pathologists, which later put the facility on probation for “deficiencies” identified in its procedures.
Duffy suggested that Pacific Fertility lab director Joseph Conaghan ordered his employee, Cirimele, to falsify the records.
“By lying for him, you save the lab and your job, do you not?” Duffy asked Cirimele. “If you take a bullet for Dr. Conaghan, you keep your job, do you not?”
“I don’t know,” Cirimele replied.
Testifying earlier on Thursday, Conaghan told jurors he would never instruct an employee to fabricate records.
“I have never asked anybody to falsify data,” Conaghan said.
Dena Sharp, an attorney for three women and one couple suing Chart over the tank failure, asked Conaghan if missing measurements for liquid nitrogen levels could have any effect on the tank’s structural integrity or have caused the tank to fail.
“Absolutely not,” Conaghan said.
The plaintiffs say the catastrophe resulted from Chart’s use of a weaker weld near a liquid nitrogen feeder pipe, making the tank susceptible to cracking, leaks and failure. Chart denies those claims and says the failure resulted from fertility clinic employees misusing the product.
Chart’s attorney also suggested Thursday that the clinic violated its own policies by not having a functioning alarm system connected to the tank that failed. Conaghan testified Wednesday that he disabled Chart’s controller device, which sends alerts when liquid nitrogen levels get too low, because the device started malfunctioning and sending out false alarms.
While questioning Conaghan Thursday, Duffy read a passage from the clinic’s quality management plan that sets out policies and procedures for the lab. The plan stated that cryogenic tanks, also called dewars, must have alarm systems connected to them at all times.
“They were not in compliance with the quality management plan at that time,” Duffy said. “You’re storing human tissue in a dewar with no alarm.”
Conaghan replied that “because Chart’s controller was defective, the plan was unable to be implemented.”
After the controller device malfunctioned on Feb. 15, 2018, Conaghan told lab employees to start using a dipstick to manually measure liquid nitrogen levels in the tank each day.
On Thursday, Duffy showed that dipstick to jurors, noting that Chart’s customer service phone number is listed on the top of the measuring tool.
“If your employees are following procedure from Feb. 15 to March 4, they would have seen my client’s phone number in their hands every day,” Duffy said, building on his argument that lab staff did not try hard enough to get the controller device repaired or replaced before the tank failure.
After the March 2018 mishap, Pacific Fertility Center made several changes to its protocols. The facility now has backup monitors and alarm systems for each storage tank. The lab also stores patients’ eggs and embryos in separate vessels to ensure one tank failure won’t wipe out a patient’s entire stock of reproductive tissue.
“As a result of the incident, we decided that’s something we should do going forward,” Conaghan said. “I’ve never seen another lab that does that.”
The College of American Pathologists ended the facility’s probation in about January 2019 and restored its full accreditation status after the lab made several changes to its operations, Conaghan reported.
When asked if he still trusts Chart’s freezer tanks and monitoring devices, the lab director said he no longer has full faith in the company’s technology.
“No I don’t trust them 100% anymore,” Conaghan said. “I certainly have less faith in them than I had before.”
But Conaghan said the lab still uses Chart’s freezer tanks and monitoring devices because it now has reliable backup systems, 20 years experience working with the equipment and because transferring delicate tissue samples to new containers is risky and should be avoided at all costs.
“How many patients’ tissues are stored in Chart’s freezers in your lab today?” Duffy asked.
“Thousands,” Conaghan replied.
The federal jury 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 plaintiffs are suing Chart for product liability and failure to recall the tank’s allegedly defective controller device.
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 originally filed 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.