Failed IVF fluid destroyed embryos, claim lawsuits

CooperSurgical, a major medical supply company, is facing a wave of lawsuits from patients who claim one of its products destroyed embryos created through in vitro fertilization.

Fertility clinics around the world used the product, a nutrient-rich liquid that helps fertilized eggs develop into embryos. Federal regulators this week made public that the company had recalled three lots of fluid 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 Virginia couple filed a lawsuit against the company, the eighth in two months by families in the United States. Collectively, the patients say they have lost more than 100 embryos that had been bathed in the defective product, known as culture media.

The plaintiffs allege that the three batches of media were missing a key nutrient, magnesium, a defect that prevented the development of their embryos and rendered them useless.

The company declined to comment on the lawsuits.

This was announced by the Food and Drug Administration a recall said Wednesday that nearly 1,000 bottles of culture media were affected, about half of which were purchased by clinics in the United States. The filing said the company notified affected clinics on Dec. 13, telling them that “performance issues may lead to impaired embryo development” and instructing customers to stop using the product.

Each bottle contains enough liquid for multiple patients, although it is unclear how many bottles were opened before the December recall. If clinics had used even half of the affected bottles, as many as 20,000 patients could have been affected, said Mitchel C. Schiewe, an embryologist and laboratory director at California Fertility Partners, which he said briefly used the botched media in November.

Fertility medicine is a relatively new field with limited oversight from federal regulators. With the demand for IVF climbing, CooperSurgical has quickly tried to position itself as a market leader. Over the past decade it has acquired five smaller fertility companies.

CooperSurgical generated $1.2 billion in revenue last year, 40 percent of which came from its fertility services and supplies. The company owns large sperm and egg banks and sells genetic tests to ensure that 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 its fertility business.

The eight lawsuits describe a similar pattern of events. Couples struggled to conceive for years. Many discovered they had created healthy embryos around Thanksgiving, only to learn by Christmas that the embryos had suddenly stopped growing.

The first lawsuit involved a Los Angeles couple who claimed that 34 embryos had been destroyed by the flawed media. Their lawyer, Tracey Cowan, said the case represented a recent trend in manufacturing problems, the result of rapid growth and consolidation in the companies that supply the fertility industry with everything from freezers and pipettes to embryo media.

“Ten years ago, most of my cases were all clinic negligence,” said Ms. Cowan, a partner at the law firm Clarkson, who has filed five cases involving the CooperSurgical fluid. “It's only in the last few years that we've started to see a lot more of these product recalls.”

In the latest case, brought to you by law firm Lieff Cabraser Heimann and Bernstein, a Virginia couple described a decade of painful attempts to conceive before turning to in vitro fertilization last fall. After adopting their son six years ago, the couple, Kearsten and Zachary Walden, were thrilled to discover last summer that Mr. Walden's insurance plan had added additional 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 optimistic, they said in an interview, until they received a phone call on Thanksgiving morning informing them that all the embryos had stopped growing.

“I blamed myself because I was older,” said Ms. Walden, 39, who works in marketing in Norfolk, Virginia.

She started researching how she could produce healthier eggs during 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 was a rollercoaster of emotions,” Ms Walden said. “Wait a minute, so it's not our fault, nor is it our fault. Then it was: how could something like this happen?”