A tank storing frozen human embryos and eggs at Pacific Fertility Center in San Francisco had failed, potentially destroying the precious cells that scores of people hoped would one day bring them biological children. Some might still be viable, the clinic told them in the alert, but the full extent of the damage was unclear.
On Thursday, after more than three years of litigation in federal court, a jury in California awarded five of the patients who lost embryos and eggs a combined $15 million in damages - a historic verdict that could have far reaching consequences for the loosely regulated U.S. fertility industry.
Jurors found that the storage tank maker, Chart Industries, knew about a defect in its equipment that prevented accurate temperature monitoring but neglected to recall the units or warn the public about the problem. When the part malfunctioned in the Pacific Fertility Center tank, more than 3,500 frozen eggs and embryos prematurely thawed, according to plaintiffs' attorneys. Jurors held Chart 90 percent responsible and Pacific Fertility Center 10 percent responsible for the failure.
The verdict appears to mark the first time a jury has awarded damages in a case involving the destruction of eggs and embryos, according to experts in family law. The outcome could serve as a bellwether not just for the hundreds of other plaintiffs with claims pending against Chart and the fertility clinic but for others whose dreams of becoming parents were dashed by similar errors, they said.
"This is a landmark case," said Naomi Cahn, director of the University of Virginia's Family Law Center. "In the past, many of these cases have settled, but here, we have a definitive jury verdict, holding the tank manufacturer primarily responsible, but with the clinic also responsible."
In court papers, attorneys said that the eggs and embryos lost represented the only chance for some of the patients to conceive children. Adam Wolf, a lead attorney for the plaintiffs, said many of them were still struggling with the grief three years later.
"This is the material that helps people have children and start a family. When eggs and embryos are destroyed, it fundamentally alters people's lives," he said in an interview. "It should be a wake-up call for fertility clinics across the country that their mistakes can prove very costly."
Representatives from Pacific Fertility Center and Chart didn't immediately respond to messages seeking comment Friday.
Pacific Fertility Center was one of two clinics that in March 2018 separately reported problems in liquid-nitrogen tanks where thousands of eggs and embryos were kept. More than 4,000 eggs and embryos were lost at the University Hospitals Fertility Clinic in Cleveland, affecting hundreds of patients. More than 150 families settled claims with the clinic in 2019 but other lawsuits are ongoing.
Other accidents and mishaps have plagued fertility clinics around the country in recent years. In some cases, clinics have used the wrong sperm or embryos, leaving patients to discover later that they aren't a child's biological parents.
The lead plaintiff in the lawsuit against Pacific Fertility Center and Chart had her eggs retrieved and frozen in October 2016 and was paying to have them stored at the center, according to court records. She, like others in the lawsuit, was identified only by her initials to protect her privacy.
According to the lawsuit, she and other patients received an email from the center on March 11, 2018, about a week after the error was discovered, notifying them of "a very unfortunate incident." The message described how storage tank No. 4 had lost liquid nitrogen for a brief period, which may have resulted in the loss of some eggs.
The lawsuit says that the tank systems made by Chart had for years "been failing in large numbers due to a defect that rendered the controllers unable to reliably detect changes in temperature and liquid nitrogen levels or sound alarms."
The complaint alleged negligence, product liability, and other claims. Hundreds of would-be parents who stored eggs and embryos at the clinic eventually joined the case. A judge rejected a request to certify the lawsuit as a class action but allowed the litigation to proceed otherwise.
In court testimony, plaintiffs described how the trauma of losing eggs made them feel helpless.
"It's really painful to be at a baby shower celebrating someone else's family being built and knowing inside you'll never get that," one plaintiff told jurors. "So you start to pull back. You start to isolate."
Experts said the verdict could bring closer scrutiny to the multibillion-dollar industry of fertility clinics and equipment manufacturers that has thrived as reproductive technologies have advanced and more Americans have turned to fertility treatments.
No government agency directly oversees assisted reproduction in the United States, and the only federal law that touches the process primarily regulates the manner in which clinics can advertise their pregnancy success rates. Private groups such as the American Society for Reproductive Medicine set industry standards for facilities that opt in, but the recommendations are voluntary and the organizations have no real enforcement power. At the state level, most assisted reproduction laws are limited to embryonic stem cell research, with little regulating the fertility industry's procedures or practices.
"There is no licensure requirement, there's no monitoring regime, no data registry for adverse events like this one," said Dov Fox, director of the Center for Health Law Policy & Bioethics at the University of San Diego. "There's no system of warnings or disclosures or any other measures to track reproductive facilities or hold the specialists accountable."
Fox noted that the freezer units that store eggs and embryos were developed decades ago to hold livestock semen for breeding. Regulations have hardly evolved since, he said. "These tanks specifically, they're not regulated any better than kitchen appliances or farm tools," he said.
Policymakers may be reluctant to start crafting new rules after years of light-touch oversight. But the size and unprecedented nature of Thursday's jury award may catch their attention.
"After a couple decades of very little action," Fox said, "it could be the thing that alerts policymakers to the need for change."
Published : June 12, 2021
By : The Washington Post · Derek Hawkins