`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 1 of 12 PageID #:8
`
`IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS
`COUNTY DEPARTMENT, LAW DIVISION
`
`FILED
`5/11/2021 10:59 AM
`IRIS Y. MARTINEZ
`CIRCUIT CLERK
`COOK COUNTY, IL
`13277136
`
`KATHLEEN BIESTERFELD, Individually )
`as Mother & Next Best Friend of
`)
`NICHOLAS BIESTERFELD, and
`)
`RONALD BIESTERFELD,
`
`)
`)
`)
`)
`)
`)
`ARIOSA DIAGNOSTICS, INC.; ARIOSA )
`DIAGNOSTICS CLINICAL
`)
`LABORATORY; and HARMONY
`)
`PRENATAL TESTING,
`)
`)
`)
`
`Plaintiffs,
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`2021L004834
`
`No.
`
`Defendants.
`
`COMPLAINT AT LAW
`
`COUNT I—VIOLATION OF CONSUMER FRAUD AND DECEPTIVE BUSINESS
`PRACTICES ACT
`
`NOW COME the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother & Next
`
`Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, by their attorneys,
`
`VINKLER LAW OFFICES, LTD., and complaining of the Defendants ARIOSA DIAGNOSTICS,
`
`INC.; ARIOSA DIAGNOSTICS CLINICAL LABORATORY; and HARMONY PRENATAL
`
`TESTING allege as follows:
`
`1.
`
`At all times Plaintiffs resided in the City of Roselle, County of DuPage, State of
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`Illinois.
`
`2.
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`Plaintiffs’ son, NICHOLAS BIESTERFELD, receives treatment from medical
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`providers and therapists operating out of Cook County, Illinois.
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`3.
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`Defendant ARIOSA DIAGNOSTICS, INC. is a corporation headquartered in the
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`City of San Jose, County of Santa Clara, State of California.
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`
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`
`
`EXHIBIT "A"
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 2 of 12 PageID #:9
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`4.
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`ARIOSA DIAGNOSTICS CLINICAL LABORATORY is a division of ARISOA
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`DIAGNOSTICS, INC. and is also located in the City of San Jose, County of Santa Clara, State of
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`California.
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`5.
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`Defendants engage in continuous and substantial business in Illinois including all
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`counties.
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`6.
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`Plaintiffs utilized Harmony Prenatal Test when Plaintiff KATHLEEN
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`BIESTERFELD was pregnant with Plaintiffs’ son, NICHOLAS BIESTERFELD.
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`7.
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`Defendants represented that the Harmony Prenatal Test would safely and easily test
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`the fetal DNA of NICHOLAS BIESTERFELD for Down syndrome and other genetic
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`abnormalities.
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`8.
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`9.
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`Harmony Prenatal Test only tests placental DNA, not fetal DNA.
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`Harmony Prenatal Test was aggressively and falsely sold, promoted, distributed
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`and/or marketed by defendants as a reasonable alternative to amniocentesis and as a reliable means
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`to detect chromosomal abnormalities including Trisomy 21. (Attached hereto as Exhibit “A” is the
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`online advertising from Defendants’ website from May 2018).
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`10.
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`On July 23, 2017, the Defendants generated a report indicating that the chances that
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`NICHOLAS BIESTERFELD would have a chromosomal anomaly for fetal Trisomy 21 was less
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`than 0.1%.
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`11.
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`Defendants did not disclose to KATHLEEN BIESTERFELD and RONALD
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`BIESTERFELD the Harmony Prenatal Test produced T21 false negatives by only testing placental
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`DNA.
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`12.
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`NICHOLAS BIESTERFELD was born on February 6, 2018, and presented with
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`clear signs of Down Syndrome.
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 3 of 12 PageID #:10
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`13.
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`Plaintiffs bring this cause of action pursuant to 815 ILCS 505/2, the Consumer
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`Fraud and Deceptive Business Practices Act, in their individual capacities.
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`14.
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`Section 2 of the Consumer Fraud and Deceptive Business Practices Act provides
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`that it is unlawful to use “unfair or deceptive acts or practices, including but not limited to the use
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`or employment of any deception fraud, false pretense, false promise, misrepresentation or the
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`concealment, suppression or omission of any material fact, with intent that others rely upon the
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`concealment, suppression or omission of such material fact.”
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`15.
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`Defendants used unfair or deceptive acts or practices in one or more of the
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`following ways:
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`A. Misrepresenting that Harmony Prenatal Test is safe, fit, effective, and adequate
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`for human use in detecting Down Syndrome;
`B. Misrepresenting that Harmony Prenatal Test had a 100% accuracy rate in
`
`detecting Trisomy 21 abnormalities;
`C. Misrepresenting the limitations of and alternatives to Harmony Prenatal Test;
`D. Misrepresenting that Harmony Prenatal Test is more accurate than traditional
`
`first trimester screening tests;
`E. Misrepresenting that fetal DNA was being tested when, in actuality, only
`
`placental DNA was being tested;
`F. Misrepresenting the probability and rate at which the Harmony Prenatal Test
`
`could produce false negative results; and
`G. Using deceptive advertising to create the image, impression and belief by
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`consumers and physicians that the use of Harmony Prenatal Test was safe,
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`reliable, and effective for detecting fetal chromosomal abnormalities, and
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`having no reasonable grounds to believe such representations to be true.
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`16.
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`Defendants made the foregoing misrepresentations with the intent that Plaintiffs,
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`and others similarly situated to Plaintiffs, would rely on such misrepresentations.
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 4 of 12 PageID #:11
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`17.
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`Defendants knew or had reason to know that the foregoing misrepresentations were
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`false, unfair or deceptive to Plaintiffs and others similarly situated to Plaintiffs.
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`18.
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`Defendants made the foregoing misrepresentations or engaged in the foregoing
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`deceptive acts and/or practices in the course of commerce.
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`19.
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`Due to Defendants’ misrepresentations and the inherently unfair practice of
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`committing misrepresentations against the public by intentionally misrepresenting and concealing
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`material information, Defendants’ acts constitute unfair or deceptive acts and practices.
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`20.
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`Practices Act.
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`21.
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`Defendants’ actions are prohibited by the Consumer Fraud and Deceptive Business
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`As a direct and proximate result of the misrepresentations made and unfair and
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`deceptive acts and business practices conducted by Defendants, Plaintiffs sustained injuries, harm,
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`and economic loss for the past, present, and future.
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`WHEREFORE, the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother &
`
`Next Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, pray for entry
`
`of judgment against Defendants ARIOSA DIAGNOSTICS, INC., ARIOSA DIAGNOSTICS
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`CLINICAL LABORATORY, and HARMONY PRENATAL TESTING for the damages incurred
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`by Plaintiffs in excess of $50,000, plus punitive damages, together with the costs of this action.
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`COUNT II—COMMON LAW FRAUD
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`NOW COME the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother & Next
`
`Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, by their attorneys,
`
`VINKLER LAW OFFICES, LTD., and complaining of the Defendants ARIOSA DIAGNOSTICS,
`
`INC.; ARIOSA DIAGNOSTICS CLINICAL LABORATORY; and HARMONY PRENATAL
`
`TESTING allege as follows:
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 5 of 12 PageID #:12
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`22.
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`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 22
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`through 33 of Count II.
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`34.
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`ways:
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`Defendants made false statements of material fact in one or more of the following
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`A. Misrepresenting that Harmony Prenatal Test is safe, fit, effective, and adequate for
`
`human use in detecting Down Syndrome;
`B. Misrepresenting that Harmony Prenatal Test had a 100% accuracy rate in detecting
`
`Trisomy 21 abnormalities;
`C. Misrepresenting the limitations of and alternatives to Harmony Prenatal Test;
`D. Misrepresenting that Harmony Prenatal Test is more accurate than traditional first
`
`trimester screening tests;
`E. Misrepresenting that fetal DNA was being tested when, in actuality, only placental
`
`DNA was being tested; and
`F. Misrepresenting the probability and rate at which Harmony Prenatal Test could
`
`produce false negative results.
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`35.
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`The aforesaid representations and/or statements made by Defendants regarding
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`Harmony Prenatal Test were false.
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`36.
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`Defendants knew or had reason to know that the aforesaid representations and/or
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`statements were false when the Defendants made such statements and/or representations.
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`37.
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`Plaintiffs reasonably believed Defendants’ aforesaid representations and/or
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`statements regarding Harmony Prenatal Test were true.
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`38.
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`Defendants made the aforesaid false representations and/or statements as a means
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`to induce Plaintiffs and others similarly situated to Plaintiffs to choose, buy, use, and order
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`Harmony Prenatal Test.
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 6 of 12 PageID #:13
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`39.
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`Plaintiffs reasonably relied on the aforesaid representations and/or statements made
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`by Defendants when Plaintiffs chose Harmony Prenatal Test as their method of prenatal testing
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`during Plaintiff KATHLEEN BIESTERFELD’S pregnancy.
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`40.
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`As a result of Defendants’ aforesaid false representations and/or statements,
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`Plaintiff KATHLEEN BIESTERFELD did not undergo any other testing to detect Trisomy 21
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`abnormalities.
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`41.
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`Harmony Prenatal Test failed to detect an abnormality of Trisomy 21 during the
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`pregnancy of Plaintiff KATHLEEN BIESTERFELD.
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`42.
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`Plaintiffs’ results from Harmony Prenatal Test indicated that Plaintiffs’ son did not
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`have a Trisomy 21 abnormality.
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`43.
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`As a direct and proximate result of the foregoing, Plaintiffs’ son, NICHOLAS
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`BIESTERFELD, was born with Down Syndrome.
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`44.
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`As a direct and proximate result of the foregoing, Plaintiffs have suffered injuries,
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`harm, and economic loss, including past, present, and future.
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`WHEREFORE, the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother &
`
`Next Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, pray for entry
`
`of judgment against Defendants ARIOSA DIAGNOSTICS, INC., ARIOSA DIAGNOSTICS
`
`CLINICAL LABORATORY, and HARMONY PRENATAL TESTING for the damages incurred
`
`by Plaintiffs in excess of $50,000, plus punitive damages, together with the costs of this action.
`
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`COUNT III—BREACH OF EXPRESS WARRANTY
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`NOW COME the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother & Next
`
`Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, by their attorneys,
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 7 of 12 PageID #:14
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`VINKLER LAW OFFICES, LTD., and complaining of the Defendants ARIOSA DIAGNOSTICS,
`
`INC.; ARIOSA DIAGNOSTICS CLINICAL LABORATORY; and HARMONY PRENATAL
`
`TESTING allege as follows:
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`45.
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`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 45
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`through 56 of Count III.
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`57.
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`Defendants marketed, sold, and distributed Harmony Prenatal Test, promoted the
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`product, and expressly warranted to Plaintiffs that Harmony Prenatal Test was fit for the ordinary
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`purpose for which it was intended, specifically that it is a reliable and accurate form of prenatal
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`testing.
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`58.
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`Specifically, Defendants advertised, promised, and warranted that Harmony
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`Prenatal Test had a 100% accuracy rate in detecting abnormalities of Trisomy 21.
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`59.
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`Plaintiff KATHLEEN BIESTERFELD chose to utilize Harmony Prenatal Test
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`because she wanted to test NICHOLAS BIESTERFELD’s DNA during her pregnancy to
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`determine whether NICHOLAS BIESTERFELD had a Trisomy 21 abnormality with 100%
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`certainty.
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`60.
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`Harmony Prenatal Test failed to detect that NICHOLAS BIESTERFELD had a
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`Trisomy 21 abnormality and would be born with Down’s syndrome.
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`61.
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`Harmony Prenatal Test did not have a 100% accuracy rate in detecting
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`abnormalities of Trisomy 21 as warranted by Defendants because Harmony Prenatal Test failed to
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`detect that NICHOLAS BIESTERFELD had a Trisomy 21 abnormality.
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`62.
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`Defendants’ representations and warranties were false, misleading, and inaccurate
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`in that Harmony Prenatal Test is risky and unreliable and can and does lead to false negatives in
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`testing for Down Syndrome.
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 8 of 12 PageID #:15
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`63.
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`As a foreseeable, direct, and proximate result of the aforesaid conduct of the
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`Defendants, Plaintiffs suffered severe and permanent injuries to their person.
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`WHEREFORE, the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother &
`
`Next Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, pray for entry
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`of judgment against Defendants ARIOSA DIAGNOSTICS, INC., ARIOSA DIAGNOSTICS
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`CLINICAL LABORATORY, and HARMONY PRENATAL TESTING for the damages incurred
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`by Plaintiffs in excess of $50,000, together with the costs of this action.
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`COUNT IV—BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY
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`NOW COME the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother & Next
`
`Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, by their attorneys,
`
`VINKLER LAW OFFICES, LTD., and complaining of the Defendants ARIOSA DIAGNOSTICS,
`
`INC.; ARIOSA DIAGNOSTICS CLINICAL LABORATORY; and HARMONY PRENATAL
`
`TESTING allege as follows:
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`64.
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`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 64
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`through 75 of Count IV.
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`76.
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`At all relevant times, Defendants manufactured, distributed, recommended,
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`merchandized, advertised, promoted, and sold Harmony Prenatal Test as a reliable, effective, and
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`safe way of detecting Trisomy 21 abnormalities in fetuses.
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`77.
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`78.
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`Defendants placed Harmony Prenatal Test into the stream of commerce.
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`Plaintiff KATHLEEN BIESTERFELD utilized Harmony Prenatal Test to
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`determine if NICHOLAS BIESTERFELD had a Trisomy 21 abnormality.
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 9 of 12 PageID #:16
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`79.
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`Defendants marketed, distributed, and advertised Harmony Prenatal Test as having
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`a 100% accuracy rate in detecting abnormalities of Trisomy 21.
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`80.
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`810 ILCS 5/2-314(2)(f) sets forth that a good is not merchantable if it does not
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`conform to the promises or affirmations of fact made on the container or label if any.
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`81.
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`Harmony Prenatal Test did not have a 100% accuracy rate in detecting Trisomy 21
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`abnormalities because it did not detect that NICHOLAS BIESTERFELD had a Trisomy 21
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`abnormality.
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`82.
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`Plaintiffs discovered that Harmony Prenatal Test did not have a 100% accuracy rate
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`in detecting Trisomy 21 abnormalities upon the birth of NICHOLAS BIESTERFELD.
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`83.
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`The Plaintiffs alerted Defendants of this breach of merchantability on March 4,
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`2019 via correspondence from Plaintiff’s counsel to Defendants.
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`84.
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`Harmony Prenatal Test was not of merchantable quality, as warranted by
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`Defendants, in that it is unreliable, unsafe, and of limited utility for detecting Down Syndrome in
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`patients like Plaintiff KATHLEEN BIESTERFELD and was thus not fit for the ordinary purpose
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`for which it was intended.
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`85.
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`As a foreseeable, direct, and proximate result of the aforesaid conduct of the
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`Defendants, Plaintiffs suffered severe and permanent injuries to their person.
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`WHEREFORE, the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother &
`
`Next Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, pray for entry
`
`of judgment against Defendants ARIOSA DIAGNOSTICS, INC., ARIOSA DIAGNOSTICS
`
`CLINICAL LABORATORY, and HARMONY PRENATAL TESTING for the damages incurred
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`by Plaintiffs in excess of $50,000, together with the costs of this action.
`
`
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 10 of 12 PageID #:17
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`COUNT V—NEGLIGENCE
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`NOW COME the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother & Next
`
`Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, by their attorneys,
`
`VINKLER LAW OFFICES, LTD., and complaining of the Defendants ARIOSA DIAGNOSTICS,
`
`INC.; ARIOSA DIAGNOSTICS CLINICAL LABORATORY; and HARMONY PRENATAL
`
`TESTING allege as follows:
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`86.
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`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 86
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`through 97 of Count V.
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`98.
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`Defendants had a duty to Plaintiffs to exercise reasonable and ordinary care in
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`designing, researching, testing, manufacturing, marketing, supplying, promoting, packaging,
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`selling, and/or distributing Harmony Prenatal Test into the stream of commerce.
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`99.
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`Notwithstanding the aforesaid duty, Defendants deviated from the exercise of
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`reasonable and ordinary care in one or more of the following careless and negligent acts and/or
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`omissions:
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`a. Failed to inform Plaintiffs and others similarly situated that Harmony Prenatal Test
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`was not fit, effective, and/or adequate for human use in detecting Down Syndrome;
`b. Misrepresented to Plaintiffs and others similarly situated that Harmony Prenatal
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`Test did not have a 100% accuracy rate in detecting abnormalities of Trisomy 21;
`c. Misrepresented to Plaintiffs and others similarly situated the limitations of and
`
`alternatives to Harmony Prenatal Test;
`d. Misrepresented to Plaintiffs and others similarly situated that Harmony Prenatal
`
`Test is more accurate than traditional first trimester screening tests;
`e. Misrepresented to Plaintiffs and others similarly situated that fetal DNA was being
`
`tested when, in actuality, only placental DNA was being tested; and
`f. Omitted from Plaintiffs and others similarly situated the probability and rate at
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`which Harmony Prenatal Test could produce false negative results.
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 11 of 12 PageID #:18
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`100. As a direct and proximate result of one or more of the aforesaid acts or omissions
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`by Defendants, Plaintiffs suffered injuries, harm, and economic loss and Plaintiffs will continue to
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`suffer such injuries, harm, and economic loss.
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`101. As a foreseeable, direct, and proximate result of Defendants’ conduct, Plaintiffs
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`have suffered, and will continue to suffer, emotional distress and financial costs in raising a child
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`with Down Syndrome.
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`102. As a foreseeable, direct, and proximate result of Defendants’ conduct, Plaintiffs
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`have and will continue to suffer loss of income and earnings, past, present, and future and earning
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`capacity.
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`WHEREFORE, the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother &
`
`Next Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, pray for entry
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`of judgment against Defendants ARIOSA DIAGNOSTICS, INC., ARIOSA DIAGNOSTICS
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`CLINICAL LABORATORY, and HARMONY PRENATAL TESTING for the damages incurred
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`by Plaintiffs in excess of $50,000 together with the costs of this action.
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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`Respectfully submitted,
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`Jerome A. Vinkler
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`Kelsey J. Burge
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`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 12 of 12 PageID #:19
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`Attorneys for Plaintiff
`VINKLER LAW OFFICES, LTD.
`7045 Veterans Blvd., Suite A-2
`Burr Ridge, IL 60527
`630-655-9545
`jav@vinklerlaw.com
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`FILED DATE: 5/11/2021 10:59 AM 2021L004834
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