IVF Patients Struggle to Get Recourse for Lost Embryos (Correct)

Every year, thousands of people struggling with infertility or facing health complications turn to fertility treatments and assisted reproductive technology in the fervent hope of becoming parents.

The average in-vitro fertilization patient will spend thousands of dollars and many emotionally draining months freezing eggs or embryos before even reaching the implantation stage of the process.

Though the process doesn’t guarantee parenthood, no one undertakes the journey thinking their embryos will be destroyed by faulty technology.

Last year, scores of hopeful parents were faced with that upsetting reality after CooperSurgical Inc., a reproductive technology product maker, recalled liquid solution used to grow embryos in December 2023. The US Food and Drug Administration posted the recall the following February.

In dozens of lawsuits filed against CooperSurgical across state and federal courts, plaintiffs say their embryos were ruined after exposure to the solution, called culture media. CooperSurgical in turn sued its third-party testing laboratory and alleged the lab’s inadequate testing led to the costly recall and litigation. (CooperSurgical didn’t respond to requests for comment.)

The lawsuits reveal the constraints of using tort law to compensate patients for destroyed embryos and their dashed hopes of parenthood. The litigation could also push courts to clarify the legal status of embryos in order to assign a dollar figure to the patients’ reproductive material and their thwarted plans.

“There is an issue where embryos and eggs and people’s right to have children and to try to have children, it’s not something that can be easily categorized into any of the current buckets that we have,” said Tracey Cowan, a partner at Clarkson Law Firm PC, which represents a portion of the CooperSurgical plaintiffs. “It doesn’t easily fit into just a tort harm or just a property loss. It is something that I think transcends all of those buckets and combines them.”

Embryo destruction doesn’t fit neatly into medical malpractice because the genetic material is external from the body, plaintiffs’ attorneys say. And property damage, product liability, and negligence concepts don’t quite capture the lost potential for a new life, they add.

‘No Corresponding Law’

As more people pursue IVF to grow their families, industry growth coupled with a dearth of regulation will cause preventable errors that lead to more lawsuits, Cowan and other plaintiffs’ attorneys say.

“Every time there’s a big jump forward in some area of technology whether that’s reproductive medicine—whether that’s AI, whether that’s automobiles—there’s a moment in time where people are getting harmed and rights are getting infringed upon, but there’s no corresponding law that’s even remotely appropriate,” Cowan said. “People are trying to fit old definitions of duties and relationships on to this new technology and they don’t match.”

A landmark 2021 jury verdict signals the potential damages that CooperSurgical could face.

Five plaintiffs who sued Pacific Fertility Center and its cryopreservation tank maker in federal district court in San Francisco over a malfunction that destroyed thousands of frozen eggs and embryos were awarded nearly $15 million, and the tank maker was found responsible for 90% of the damages.

That verdict was “a huge statement to the fertility industry, including all of these companies that manufacture products,” Cowan said. She said the verdict demonstrated the value of the chance to have children.

Kearsten and Zachary Walden, one of the couples suing CooperSurgical, learned their embryos had been destroyed early in the morning on Thanksgiving. “It was kind of salt in the wound because Thanksgiving is about family,” Kearsten said in an interview.

In the new year, their fertility provider told the Waldens that CooperSurgical’s culture media caused the embryos’ arrested development.

“How do you continue moving through your day, through your year, knowing that everything you just went through, all the shots, all the doctor’s appointments, all the very intrusive appointments and things—they just amounted to nothing so quickly?” Kearsten said.

The Shadow of Abortion Politics

Since the 2021 Pacific Fertility verdict, the landscape of reproductive politics has shifted dramatically.

The US Supreme Court’s 2022 decision to overturn the right to an abortion in Dobbs v. Jackson Women’s Health Organization also raised questions about fetal personhood. That standard could complicate how reproductive harm damages are calculated.

Lieff Cabraser Heimann & Bernstein LLP approaches the CooperSurgical cases from a reproductive rights perspective and doesn’t advocate for a legal personhood approach to embryos, said Tiseme Zegeye, a partner at the firm and one of the attorneys representing CooperSurgical plaintiffs.

She said plaintiffs’ attorneys are mindful of setting unintentional precedents that could limit IVF access.

Last year, a wrongful death suit based on the inadvertent destruction of patients’ embryos culminated in Alabama’s high court stating that life begins at fertilization, a posture that can limit IVF access by muddying medical providers’ liability for discarded embryos, advocates said.

Within weeks of the decision, the state codified protections for IVF treatments through a law that provides civil and criminal immunity to health-care providers for the death or damage that occurs to embryos during IVF services.

Though the law appeared to restore IVF access, plaintiffs’ attorneys in the CooperSurgical litigation said the liability shields are an overreach.

The law “really limited people’s access to justice,” Zegeye said. Though protecting IVF access is important, “the solution is not taking away people’s right to go to court,” she said.

Zegeye added that courts have been more accepting of treating embryos as a special type of property in these situations.

Limitations of Traditional Tort Principles

But courts still have had to distinguish embryos from other types of property to account for the emotional distress that follows inadvertent destruction of previous reproductive material.

“Typically, what we see in rulings in this area is that embryos are treated as either property or this made-up term called quasi-property, which is basically legal speak for ‘we don’t have a word for this yet,’” Cowan said.

In December, CooperSurgical’s attempt to dismiss a proposed class action over the recalled culture media was rejected by Judge Jon S. Tigar of the US District Court for the Northern District of California.

Tigar said “assuming, without deciding, that embryos would be considered property under California law,” he said the plaintiffs could win emotional distress damages that aren’t typically available for property damage.

He pointed to the Pacific Fertility Center verdict that allowed distress damages for destroyed embryos and eggs, saying that the destruction of a human embryo is “inarguably” in the category of personal property damage. He also said it was too early to strike class claims.

Dov Fox, a health law professor at the University of San Diego School of Law, suggests legislatures should pass laws to establish new causes of action specific to reproductive harms. More specific categories could ameliorate problems with shoehorning reproductive harms into ill-fitting traditional torts like property loss, he said.

Fox said this could take the form of a single tort that covers reproductive negligence or misconduct, or better yet, three different ones that cover a variety of fertility mishaps including mistaken implantation, unintentional destruction, and incorrect fertilization.

“Medical technological advances have invented harms that just didn’t exist a while ago, and it’s just a recognition that these things now happen in ways they never had,” Fox said. “We’ve come around to think that whether you have kids isn’t just about the grace of God, nature, cosmic fate. It is a function now of competent professional conduct.”

Though the loss of parenthood and unique genetic material is irreplaceable, courts and juries can find a way to calculate meaningful damages, he said.

Along with co-author Jill Wieber Lens, Fox outlined a framework for appraising the losses based on plaintiffs’ subjective experience, objective chance at having a child if not for the misconduct, and other traumas accompanying the reproductive journey.

Future of the IVF Market

The global fertility services market was valued at more than $46 billion in 2024 and is expected to exceed more than $140 billion over the next decade.

Investment banks like Harris Williams have attributed industry growth to people delaying starting their families, growing social acceptance of the services, and insurance coverage expansions. Harris Williams, which characterizes itself as a leading adviser in the fertility space, says fertility is one of the fastest-growing health-care sectors.

The American Society for Reproductive Medicine, a nonprofit focused on advancing the science of reproductive medicine, partnered with CooperSurgical to launch a training program in October 2024 to meet the growing demand for embryologists.

Calls to protect and expand IVF access have come from across the political spectrum. Last fall, California Governor Gavin Newsom (D) signed a law requiring large-group health insurance plans to cover IVF procedures. More recently, President Donald Trump signed an executive order directing his administration to propose policy recommendations to help lower IVF costs and expand access to the treatments.

As the use of assisted reproductive services grow, advocates worry about the lack of commensurate guardrails. Not only will the number of mistakes increase, but also a lack of consistent rules for the industry could lead to inflated representations about the technology, they argue.

CooperSurgical and other fertility technology companies, for example, also are facing lawsuits alleging they mislead patients about the accuracy of genetic testing meant to screen embryos for chromosomal abnormalities.

Last year, shortly after the Alabama Supreme Court’s personhood decision, CooperSurgical registered with Thorn Run Partners to lobby the US Senate.

As the litigation over CooperSurgical’s culture media proceeds, Zegeye said many of the plaintiffs are hoping the lawsuits show how the lack of regulation and safeguards throughout the IVF process can impact people’s lives.

“The IVF community is very close and supportive and our clients want to help other families going through it,” she said. “They want these companies to be held accountable to prevent these kinds of disasters from happening again and hurting others.”