CooperSurgical, a major medical supply company, is facing a wave of lawsuits from patients who claim one of its products damaged embryos created through IVF.
Fertility clinics around the world have used the product, a nutrient-rich liquid that helps fertilized eggs develop into embryos. This week federal regulators announced that the company had recalled three batches of the liquid, which was used by clinics in November and December. The number of affected patients is unclear, although experts estimate it to be in the thousands.
On Thursday, a couple in Virginia filed a lawsuit against the company, the eighth in two months by families in the United States. Collectively, the patients say they lost more than 100 embryos bathed in the faulty product, known as culture media.
The plaintiffs allege that the three batches of media lacked a key nutrient, magnesium, a defect that stunted the development of their embryos and rendered them unusable.
The company declined to comment on the lawsuits.
The Food and Drug Administration issued a recall notice Wednesday saying nearly 1,000 culture bottles were affected, about half of which were purchased from clinics in the United States. The filing said the company had notified affected clinics on Dec. 13, telling them “performance issues may result in impaired embryo development” and instructing customers to stop using the product.
Each bottle contains enough liquid for several patients, although it is unclear how many bottles were opened before the December recall. If clinics used even half of the affected bottles, as many as 20,000 patients could have been infected, said Mitchel C. Schiewe, an embryologist and laboratory director at California Fertility Partners, who said briefly in November.
Fertility medicine is a relatively new field with limited oversight by federal regulators. With demand for IVF climbing, CooperSurgical has fought to position itself as a leader in the industry. In the past decade it has acquired five smaller fertility companies.
CooperSurgical generated $1.2 billion in revenue last year, with 40% of that coming from its fertility services and supplies. The company has large sperm and egg banks and sells genetic tests to ensure embryos are healthy.
In a call with investors in January, the company’s CEO noted that the company had achieved 12 consecutive quarters of “double-digit growth” in the fertility business.
The eight lawsuits describe a similar pattern of events. Couples struggled for years to conceive. Many learned they had created healthy embryos around Thanksgiving, only to hear by Christmas that the embryos had suddenly stopped developing.
The first lawsuit involved a Los Angeles couple who claim 34 embryos were destroyed by the defective media. Their lawyer, Tracey Cowan, said the case represented a recent trend in manufacturing problems, a result of the rapid growth and consolidation of companies that supply the fertility industry with everything from freezers and siphons to embryonic media.
“Ten years ago, most of my cases were all medical malpractice,” said Ms. Cowan, a partner at the Clarkson law firm who has filed five cases involving CooperSurgical fluid. “Just recently, in the last few years, we’ve started to see a lot more of these product recalls.”
In the newest case, brought by the law firm Lieff Cabraser Heimann and Bernstein, a Virginia couple described a decade of painful attempts to conceive before turning to IVF last fall. After adopting their son six years ago, the couple, Kearsten and Zachary Walden, were delighted to discover last summer that Mr. Walden’s insurance plan had added fertility coverage.
They quickly made an appointment with a local fertility clinic, and an initial round of treatment yielded six fertilized eggs. The Waldens were hopeful, they said in an interview, until they got a call on Thanksgiving morning notifying them that all the embryos had stopped developing.
“I blamed myself a lot because I was older,” said Ms. Walden, 39, who works in marketing in Norfolk, Va.
She began researching how she could produce healthier eggs on her next round, the last one that would be covered by her husband’s insurance. In January, her clinic informed her that they had used the defective CooperSurgical media on her embryos.
“It’s been a rollercoaster of emotions,” Ms. Walden said. “It was, wait a minute, so it’s not our fault and it’s not our fault. Then it was, how does something like this happen?’
