Igenomix, Sequence46, CCRM to be included in suits, attorney says
BY RON SHINKMAN
Patrons of IVF procedures have sued four biotech companies and affiliates, accusing them of overhyping a form of preimplantation genetic testing and allegedly enticing them to waste large sums of money on such exams. More lawsuits are forthcoming, attorneys said.
The suits were filed in late September and early October in federal court in New Jersey, Illinois and California against the Cooper Companies and affiliates CooperSurgical and CooperGenomics; Natera; Reproductive Genetic Innovations and Progenesis. They were brought by 14 fertility clinic patients who opted to have embryos tested for preimplantation genetic testing for aneuploidy, a procedure known as PGT-A.
Use of preimplantation genetic testing in the U.S. has risen dramatically in recent years, from about 17% of IVF procedures in 2014 to nearly 45% in 2018, according to a 2022 study. Testing for aneuploidy is one of several such preimplantation procedures that can be performed.
PGT-A unnecessary, suits claim
The lawsuits claim that PGT-A testing is unnecessary as there is no evidence it leads to more viable pregnancies. As a result, “defendants have affirmatively misled patients with their false and deceptive marketing and advertising in exchange for the opportunity to reap millions of dollars in profit each year from selling PGT-A testing,” the lawsuits state.
The suits note that the average cost of a PGT-A procedure is $5,000, and contend this makes an already pricey IVF procedure even more expensive. Moreover, according to the lawsuits, the biopsies required for PGT-A often damage blastocysts that are later implanted, impairing their viability.
Why some genetics labs were named, but not others
Paula Bliss, one of the attorneys who represents the plaintiffs, told Inside Reproductive Health the suits were filed against this specific group of labs because they market PGT-A more aggressively than others.
“These particular companies’ marketing and promotional materials are really misleading” compared to other labs that offer the procedure, Bliss said, adding that “these are the bad actors.”
Moreover, as many as five other companies will be facing similar lawsuits in the coming weeks, according to Bliss. They include Igenomix, Sequence46 and CCRM Fertility, she said.
Allison Freeman, another of the plaintiff’s attorneys, observed that given the use of PGT-A has significantly increased in recent years, it had become time “to hold the defendants liable for the damages they have caused and continue to cause.”
Norbert Gleicher, M.D., a fertility physician who is medical director and chief scientist for the Center for Human Reproduction in New York City, told Inside Reproductive Health that he was surprised that such suits have not been filed sooner. He has studied PGT-A for some 20 years and does not believe it is effective in any way.
“We’ve never seen the rationale for using it,” he said, adding that it is little more than a cost burden for patients, most of whom lack insurance to cover such a test.
REI Physicians Continue to Debate Mosaicism
Some studies suggest that PGT-A is beneficial for older women, but others are less decisive. As a result, the American Society of Reproductive Medicine recently concluded that “the value of PGT-A as a universal screening test for all patients undergoing IVF has not been demonstrated.”
An IVF physician who asked not to be named told Inside Reproductive Health that the PGT-A technology is rapidly evolving. As a result, there are numerous gray areas in its use. Among them is how to deal with biopsies that demonstrate a mosaic pattern where some cells have normal chromosome structures but others do not. Such embryos often yield healthy births, the physician noted. Gleicher noted that at least 50 to 60 of the patients at his practice have had healthy births from blastocysts demonstrating mosaicism.
Cooper files motion to dismiss, Natera yet to respond
The lawsuits seek damages for fraud; violations of consumer protection laws in Michigan, California, Illinois, New York, New Jersey, Florida, North Carolina, Colorado and Texas; breach of implied warranty and unjust enrichment. Cooper and Reproductive Genetic Innovations filed motions in late December to dismiss their lawsuits, court records show. The judges overhearing those cases will likely issue decisions on those motions in the next several months. Progenesis has asked for its case to enter into a dispute resolution process. Natera has yet to formally respond to its lawsuit, and there are no hearings regarding that case until May 2025.
If the suits are certified by the trial judges as class-actions, potentially thousands of IVF patients who used the testing services provided by the companies could opt-in as plaintiffs. That would put the companies at risk of huge multimillion dollar verdicts if they were to lose at trial. However, such rulings usually come after motions to dismiss the case from the defense are considered, so it is likely many months if not at least a year away.
None of the companies named as defendants responded to requests seeking comment.
