Health Law Daily Wrap Up, MEDICAL DEVICES—N.D. Ill.: Consumer fraud claim to proceed against prenatal test provider, (Sep 8, 2025)

By Leah S. Poniatowski, J.D.

Fact disputes, test provider’s unsupported defenses not enough to support dismissal of claim.

A couple whose child died three weeks after birth from the Trisomy 18 chromosomal defect successfully challenged a prenatal test provider’s motion to dismiss their underlying lawsuit premised on the Illinois Consumer Fraud and Deceptive Business Practices Act and related common law claims because there were key facts in dispute and the bulk of the company’s dismissal assertions were either unsupported by case law or not tailored against the consumer law, a federal district court in Illinois ruled, dismissing the motion (Swieczkowski v. BillionToOne, Inc., No. 24-cv-11016 (N.D. Ill. Aug. 28, 2025)).

Background. The BiilionToOne company makes and sells its UNITY Complete test to physicians providing care to expecting parents. The company markets its test as a non-invasive prenatal test that screens for recessive and chromosomal conditions. According to the product’s brochure, the UNITY test has a 99.9 percent sensitivity rate and a 99.9 percent specificity rate, and that it can provide insights into the fetus’ health through a single blood draw at 10 weeks in the pregnancy.

In February 2023, as advised by their doctor, the couple agreed to undergo the UNITY test to screen for risks. According to the couple, their doctor only received the first page of the results, the “Summary of Results” page and were not granted access to an online portal to the full analysis. This summary stated that the fetus was “LOW RISK” for Trisomy 18, being less than 1 in 10,000. Further, the couple allege that this summary did not convey the risk of false negatives. They contended that before testing, the summary page indicated that the risk was much higher—1 in 411.

Based on the UNITY test results, the couple declined further invasive testing for chromosomal issues. Their child was born in early August 2023, but had to be admitted to the neonatal intensive care unit and tested positive for Trisomy 18. The child died three weeks later from the chromosomal condition.

The couple filed a lawsuit based on the Illinois Consumer Fraud and Deceptive Business Practices Act and related common law claims against BillionToOne, asserting that if they had learned about the Trisomy 18 diagnosis, they would not have completed the pregnancy and that based on their reliance of the test results, they have experienced extraordinary pain, suffering, grief, disfigurement, emotional stress, and their medical costs. They also seek punitive damages. The company filed the present motion to dismiss.

Learned intermediary doctrine. The company’s assertion that the learned intermediate doctrine applied to bar the lawsuit was not supported by any case law, the court held. The court explained that the caselaw proffered by the company arose in products liability failure to warn challenges—not under the consumer fraud statute—and was such a “stark contrast” to the couple’s claim that the doctrine did not apply to the case at bar.

Consumer fraud claim. Under the state consumer fraud statute, the couple must allege that there was: (1) a deceptive act or practice; (2) an intent for the consumer to rely on the deception; (3) the occurrence of the deception during conduct involving trade or commerce; and (4) actual damage that was proximately caused by the deception. The company stated that the couple did not see the marketing materials and, thus, could not have relied upon them to meet the proximate causation requirement. Also, the company claimed that the UNITY test did not contain a misrepresentation to meet the statute’s deceptive act or practice element.

According to case law, the state statute has been interpreted to recognize “indirect deception” between a marketer and an injured party. The precedent holds that deceptive act element can be satisfied if there are statements made with the intention of reaching the injured party and influence their actions and are injured by it. The court determined that the couple presented sufficient facts to meet the proximate causation element of the claim from the company’s marketing materials that were reviewed by their doctor.

Under the reasonable consumer standard to determine the occurrence of deception, the court held that, construing the alleged facts in favor of the couple, they met their legal burden. The allegation that they only received the first page of the results which stated that there was a low risk of Trisomy 18, but the company did not include disclaimers about false negative rates and the actual risk presented was not customized to the couple. The company’s assertion that it made no representation that there was no risk to the fetus and, thus, it could not be responsible for any deception or misrepresentation was not persuasive, the court held. Thus, the motion to dismiss the statutory claim was denied. The court added that because the common law fraud claim involved that same arguments, the common law fraud dismissal was also denied.

Negligent misrepresentation. Under the Illinois common law, a claim for negligent misrepresentation requires, among other elements: a duty to communicate accurate information; the injured party reasonably relied on the truth of the statement. The company asserted that it had no duty and that the couple did not rely on the test results.

First, the company stated that its supply of information is to assist healthcare providers and patients in making critical health care choices, not to guide business transactions as the case law maintains. The couple asserted that the company’s business is supplying information to providers and patients in order to guide business transactions, namely what tests and related referrals should be made based on the results of the UNITY test. Although the company argued that the couple’s argument was “too great a stretch” to satisfy the legal element, the company did not provide any case law in support of its argument. Thus, the court held, the company’s failure to support its statement waived the argument.

Second, the company argued that the couple unjustifiably relied only on the summary results of the test. The couple asserted that they only had the summary results and could not access the rest of the test. The court determined that because there was a real dispute of facts on the issue, summary judgment dismissal would be improper.

Remaining claims. The remaining emotional distress and punitive damages claims were improperly included in the Rule 12(b)(6) motion instead of in a Rule 12(f) motion to strike material from a pleading. Because of the procedural impropriety, the court denied the motion to strike. Accordingly, the company’s motion to dismiss the lawsuit was denied.

The case is No. 24-cv-11016.

Judge: Coleman, S.

Attorneys: Robert Joseph Cheris (Anesi Ozmon Ltd.) for Monika Swieczkowski. Mark M. Burden (Donohue Brown Smyth LLC) for Billiontoone, Inc.

Companies: Billiontoone, Inc.

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