A federal judge has temporarily dismissed a lawsuit from an Illinois family who said a prenatal genetic test failed to indicate their child would be born with chromosomal abnormalities indicative of Down Syndrome.
In July 2017, Kathleen and Ronald Biesterfeld used a Harmony Prenatal Test from Ariosa Diagnostics while awaiting the birth of their son. According to court documents, test results showed the baby’s chance of having the Trisomy 21 anomaly was less than 0.1 percent, so they didn’t seek any additional testing. But when born in early 2018, they said, he “presented with clear signs of Down Syndrome.”
The Biesterfelds sued Harmony and Ariosa in Cook County Circuit Court, alleging violations of several Illinois consumer products laws. Among the allegations are that Ariosa misrepresented that a Harmony test is more accurate than traditional first trimester screens and that a Harmony test examines fetal DNA, when it actually uses placental DNA.
The companies took the case to federal court, and then moved to dismiss the complaint. U.S. District Judge Edmond Chang granted that request in an opinion filed March 31.
According to Chang, the heart of the lawsuit is an Ariosa website promising a Harmony test has a “100% accuracy rate” in detecting Trisomy 21, the anomaly linked to Down Syndrome. The family said it believed the test would “safely and easily test the fetal DNA” to find signs of “Down Syndrome and other genetic abnormalities.”
Chang rejected the companies’ argument that the Biesterfelds undercut their own claim of relying on the website promoting a 100 percent detection accuracy rate by introducing as evidence their test results showing the chance being less than 0.1% as only one figure is absolute. He also said the companies wielded a “much too crabbed and nuanced” reading of its own 100% detection-rate statement to warrant dismissal based only on pleadings.
However, he said the family’s Consumer Fraud and Deceptive Business Practices Act claim falls short because the complaint has “key gaps and unanswered questions” about how the Biesterfelds came to use the Harmony test.
“Was it offered to them by a doctor or did the Biesterfelds order this test on their own?” Chang wrote. “No answer; just the plaintiffs ‘utilized’ the test. Did the Biesterfelds pay for this test out of pocket or was it covered by insurance, or was it in effect costless as part of some other coverage? Again, no answer; just the plaintiffs ‘utilized’ the test. Did the Biesterfelds themselves actually see the crucial online advertising? No answer; instead, the complaint just attaches the online advertisement ‘from May 2018’ — after (the baby) was born.”
Chang also said the family didn’t show what legal injuries it suffered, just a general reference they “sustained injuries, harm, and economic loss for the past, present, and future.”
When they filed a brief responding to the motion to dismiss, Chang wrote, the Biesterfelds said they would’ve terminated the pregnancy had they known the test wasn’t 100 percent effective, as the website claimed.
“That might very well satisfy the damages element,” Chang wrote, pointing to “damages arising out of a so-called wrongful birth,” including the costs of raising a child and his medical expenses. But such claims would have to go into an amended complaint alongside allegations a different test, like amniocentesis, would have succeeded in revealing Trisomy 21.
Lee gave the Biesterfelds until April 20 to file an amended complaint. In addition to information from their response brief, Chang said an amended complaint should include evidence they viewed Ariosa’s website before taking the Harmony test. Although Changsaid it is unlikely the family can make successful claims of warranty breach or negligence, he dismissed those claims without prejudice, as well.
The plaintiffs are represented by attorneys Jerome A. Vinkler and Kelsey J. Burge, of the firm of the Vinkler Law Offices, of Burr Ridge.
Ariosa is represented by attorneys Sherri M. Arrigo and Timothy L. Hogan, of the firm of Donohue Brown Mathewson & Smyth, of Chicago.