Major medical supplies company CooperSurgical is facing a series of lawsuits from patients who claim one of its products destroyed embryos created through in vitro fertilization.
Fertility clinics around the world have used this product, a nutrient-rich liquid that helps fertilized eggs develop into embryos. This week, federal regulators disclosed that the company had recalled three liquids it had used in hospitals in November and December. The number of patients affected is unclear, but experts estimate it could be in the thousands.
On Thursday, a Virginia couple filed a lawsuit against the company, the eighth in two months from families across the United States. In total, the patients say they lost more than 100 embryos contained in defective products known as culture media.
The plaintiffs allege that three batches of media were missing the key nutrient magnesium, hindering the development of the embryos and rendering them unusable.
The company declined to comment on the lawsuit.
The Food and Drug Administration posted a recall notice Wednesday saying nearly 1,000 vials of culture medium were affected, about half of which were purchased by hospitals in the United States. The filing says the company notified affected hospitals on Dec. 13 that “performance issues may result in impaired embryo development” and instructed customers to stop using the product.
Each bottle contains enough liquid for several patients, but it's unclear how many were opened before the December recall. If hospitals had used even half the affected bottles, up to 20,000 patients could have been affected, said Mitchel C. Schiewe, an embryologist and laboratory director at California Fertility Partners. He said he briefly used the wrong badge last November.
Fertility medicine is a relatively new field with limited oversight from federal regulators. With the demand for IVF climbing, CooperSurgical has been competing to establish itself as an industry leader. Over the past 10 years, we have acquired five small maternity companies.
CooperSurgical had $1.2 billion in revenue last year, 40% of which came from fertility services and supplies. The company owns large sperm and egg banks and sells genetic tests to ensure the health of embryos.
On 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 maternity business.
The eight lawsuits describe a similar pattern of events. The couple had struggled for years to get pregnant. Many people find out that they created healthy embryos around Thanksgiving, only to hear that the embryos suddenly stopped growing around Christmas.
The first lawsuit involved a Los Angeles couple who claimed the defective media destroyed 34 embryos. Their lawyer, Tracey Cowan, said the case represented a recent trend in manufacturing issues – the rapid growth and consolidation of companies supplying the fertility industry with everything from freezers and pipettes to embryo media.
Ms. Clarkson Law Firm, a partner in five lawsuits involving CooperSurgical liquids, said: “Ten years ago, most of my cases were all clinical negligence,” Cowan said. “We’ve started seeing more of these product recalls in recent years,” she said.
In the latest case filed by the law firm Lieff Cabraser Heimann and Bernstein, a Virginia couple described a painful 10-year struggle to conceive before turning to in vitro fertilization last fall. After adopting their son six years ago, Kearsten and Zachary Walden were delighted to learn last summer that maternity coverage had been added to Walden's policy.
They quickly scheduled an appointment at a local fertility clinic, and the first treatment resulted in six fertilized eggs. The Waldens said in an interview that they were optimistic until they received a call on Thanksgiving morning saying all of the embryos had stopped growing.
“I used to criticize myself a lot for being older,” said Ms. Walden, 39, who works in marketing in Norfolk, Virginia.
She began researching how she could produce healthier eggs in the next round, the last of which would be covered by her husband's insurance. Last January, her hospital notified her that defective CooperSurgical media had been used on her embryos.
“It’s been an emotional roller coaster,” Mrs Walden said. “Wait. So we are not at fault and we are not to blame. So how does this happen?”