throbber
12-Person Jury
`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
`
`Illinois.
`
`2.
`
`Plaintiffs’ son, NICHOLAS BIESTERFELD, receives treatment from medical
`
`providers and therapists operating out of Cook County, Illinois.
`
`3.
`
`Defendant ARIOSA DIAGNOSTICS, INC. is a corporation headquartered in the
`
`City of San Jose, County of Santa Clara, State of California.
`
`
`
`
`
`
`
`
`
`EXHIBIT "A"
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 2 of 12 PageID #:9
`
`4.
`
`ARIOSA DIAGNOSTICS CLINICAL LABORATORY is a division of ARISOA
`
`DIAGNOSTICS, INC. and is also located in the City of San Jose, County of Santa Clara, State of
`
`California.
`
`5.
`
`Defendants engage in continuous and substantial business in Illinois including all
`
`counties.
`
`6.
`
`Plaintiffs utilized Harmony Prenatal Test when Plaintiff KATHLEEN
`
`BIESTERFELD was pregnant with Plaintiffs’ son, NICHOLAS BIESTERFELD.
`
`7.
`
`Defendants represented that the Harmony Prenatal Test would safely and easily test
`
`the fetal DNA of NICHOLAS BIESTERFELD for Down syndrome and other genetic
`
`abnormalities.
`
`8.
`
`9.
`
`Harmony Prenatal Test only tests placental DNA, not fetal DNA.
`
`Harmony Prenatal Test was aggressively and falsely sold, promoted, distributed
`
`and/or marketed by defendants as a reasonable alternative to amniocentesis and as a reliable means
`
`to detect chromosomal abnormalities including Trisomy 21. (Attached hereto as Exhibit “A” is the
`
`online advertising from Defendants’ website from May 2018).
`
`10.
`
`On July 23, 2017, the Defendants generated a report indicating that the chances that
`
`NICHOLAS BIESTERFELD would have a chromosomal anomaly for fetal Trisomy 21 was less
`
`than 0.1%.
`
`11.
`
`Defendants did not disclose to KATHLEEN BIESTERFELD and RONALD
`
`BIESTERFELD the Harmony Prenatal Test produced T21 false negatives by only testing placental
`
`DNA.
`
`12.
`
`NICHOLAS BIESTERFELD was born on February 6, 2018, and presented with
`
`clear signs of Down Syndrome.
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 3 of 12 PageID #:10
`
`13.
`
`Plaintiffs bring this cause of action pursuant to 815 ILCS 505/2, the Consumer
`
`Fraud and Deceptive Business Practices Act, in their individual capacities.
`
`14.
`
`Section 2 of the Consumer Fraud and Deceptive Business Practices Act provides
`
`that it is unlawful to use “unfair or deceptive acts or practices, including but not limited to the use
`
`or employment of any deception fraud, false pretense, false promise, misrepresentation or the
`
`concealment, suppression or omission of any material fact, with intent that others rely upon the
`
`concealment, suppression or omission of such material fact.”
`
`15.
`
`Defendants used unfair or deceptive acts or practices in one or more of the
`
`following ways:
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`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;
`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
`
`consumers and physicians that the use of Harmony Prenatal Test was safe,
`
`reliable, and effective for detecting fetal chromosomal abnormalities, and
`
`having no reasonable grounds to believe such representations to be true.
`
`16.
`
`Defendants made the foregoing misrepresentations with the intent that Plaintiffs,
`
`and others similarly situated to Plaintiffs, would rely on such misrepresentations.
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 4 of 12 PageID #:11
`
`17.
`
`Defendants knew or had reason to know that the foregoing misrepresentations were
`
`false, unfair or deceptive to Plaintiffs and others similarly situated to Plaintiffs.
`
`18.
`
`Defendants made the foregoing misrepresentations or engaged in the foregoing
`
`deceptive acts and/or practices in the course of commerce.
`
`19.
`
`Due to Defendants’ misrepresentations and the inherently unfair practice of
`
`committing misrepresentations against the public by intentionally misrepresenting and concealing
`
`material information, Defendants’ acts constitute unfair or deceptive acts and practices.
`
`20.
`
`Practices Act.
`
`21.
`
`Defendants’ actions are prohibited by the Consumer Fraud and Deceptive Business
`
`As a direct and proximate result of the misrepresentations made and unfair and
`
`deceptive acts and business practices conducted by Defendants, Plaintiffs sustained injuries, harm,
`
`and economic loss for the past, present, and future.
`
`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.
`
`COUNT II—COMMON LAW FRAUD
`
`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:
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 5 of 12 PageID #:12
`
`22.
`
`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 22
`
`through 33 of Count II.
`
`34.
`
`ways:
`
`Defendants made false statements of material fact in one or more of the following
`
`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.
`
`35.
`
`The aforesaid representations and/or statements made by Defendants regarding
`
`Harmony Prenatal Test were false.
`
`36.
`
`Defendants knew or had reason to know that the aforesaid representations and/or
`
`statements were false when the Defendants made such statements and/or representations.
`
`37.
`
`Plaintiffs reasonably believed Defendants’ aforesaid representations and/or
`
`statements regarding Harmony Prenatal Test were true.
`
`38.
`
`Defendants made the aforesaid false representations and/or statements as a means
`
`to induce Plaintiffs and others similarly situated to Plaintiffs to choose, buy, use, and order
`
`Harmony Prenatal Test.
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 6 of 12 PageID #:13
`
`39.
`
`Plaintiffs reasonably relied on the aforesaid representations and/or statements made
`
`by Defendants when Plaintiffs chose Harmony Prenatal Test as their method of prenatal testing
`
`during Plaintiff KATHLEEN BIESTERFELD’S pregnancy.
`
`40.
`
`As a result of Defendants’ aforesaid false representations and/or statements,
`
`Plaintiff KATHLEEN BIESTERFELD did not undergo any other testing to detect Trisomy 21
`
`abnormalities.
`
`41.
`
`Harmony Prenatal Test failed to detect an abnormality of Trisomy 21 during the
`
`pregnancy of Plaintiff KATHLEEN BIESTERFELD.
`
`42.
`
`Plaintiffs’ results from Harmony Prenatal Test indicated that Plaintiffs’ son did not
`
`have a Trisomy 21 abnormality.
`
`43.
`
`As a direct and proximate result of the foregoing, Plaintiffs’ son, NICHOLAS
`
`BIESTERFELD, was born with Down Syndrome.
`
`44.
`
`As a direct and proximate result of the foregoing, Plaintiffs have suffered injuries,
`
`harm, and economic loss, including past, present, and future.
`
`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.
`
`
`COUNT III—BREACH OF EXPRESS WARRANTY
`
`NOW COME the Plaintiffs, KATHLEEN BIESTERFELD, Individually as Mother & Next
`
`Best Friend of NICHOLAS BIESTERFELD, and RONALD BIESTERFELD, by their attorneys,
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 7 of 12 PageID #:14
`
`VINKLER LAW OFFICES, LTD., and complaining of the Defendants ARIOSA DIAGNOSTICS,
`
`INC.; ARIOSA DIAGNOSTICS CLINICAL LABORATORY; and HARMONY PRENATAL
`
`TESTING allege as follows:
`
`45.
`
`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 45
`
`through 56 of Count III.
`
`57.
`
`Defendants marketed, sold, and distributed Harmony Prenatal Test, promoted the
`
`product, and expressly warranted to Plaintiffs that Harmony Prenatal Test was fit for the ordinary
`
`purpose for which it was intended, specifically that it is a reliable and accurate form of prenatal
`
`testing.
`
`58.
`
`Specifically, Defendants advertised, promised, and warranted that Harmony
`
`Prenatal Test had a 100% accuracy rate in detecting abnormalities of Trisomy 21.
`
`59.
`
`Plaintiff KATHLEEN BIESTERFELD chose to utilize Harmony Prenatal Test
`
`because she wanted to test NICHOLAS BIESTERFELD’s DNA during her pregnancy to
`
`determine whether NICHOLAS BIESTERFELD had a Trisomy 21 abnormality with 100%
`
`certainty.
`
`60.
`
`Harmony Prenatal Test failed to detect that NICHOLAS BIESTERFELD had a
`
`Trisomy 21 abnormality and would be born with Down’s syndrome.
`
`61.
`
`Harmony Prenatal Test did not have a 100% accuracy rate in detecting
`
`abnormalities of Trisomy 21 as warranted by Defendants because Harmony Prenatal Test failed to
`
`detect that NICHOLAS BIESTERFELD had a Trisomy 21 abnormality.
`
`62.
`
`Defendants’ representations and warranties were false, misleading, and inaccurate
`
`in that Harmony Prenatal Test is risky and unreliable and can and does lead to false negatives in
`
`testing for Down Syndrome.
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 8 of 12 PageID #:15
`
`63.
`
`As a foreseeable, direct, and proximate result of the aforesaid conduct of the
`
`Defendants, Plaintiffs suffered severe and permanent injuries to their person.
`
`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, together with the costs of this action.
`
`COUNT IV—BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY
`
`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:
`
`64.
`
`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 64
`
`through 75 of Count IV.
`
`76.
`
`At all relevant times, Defendants manufactured, distributed, recommended,
`
`merchandized, advertised, promoted, and sold Harmony Prenatal Test as a reliable, effective, and
`
`safe way of detecting Trisomy 21 abnormalities in fetuses.
`
`77.
`
`78.
`
`Defendants placed Harmony Prenatal Test into the stream of commerce.
`
`Plaintiff KATHLEEN BIESTERFELD utilized Harmony Prenatal Test to
`
`determine if NICHOLAS BIESTERFELD had a Trisomy 21 abnormality.
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 9 of 12 PageID #:16
`
`79.
`
`Defendants marketed, distributed, and advertised Harmony Prenatal Test as having
`
`a 100% accuracy rate in detecting abnormalities of Trisomy 21.
`
`80.
`
`810 ILCS 5/2-314(2)(f) sets forth that a good is not merchantable if it does not
`
`conform to the promises or affirmations of fact made on the container or label if any.
`
`81.
`
`Harmony Prenatal Test did not have a 100% accuracy rate in detecting Trisomy 21
`
`abnormalities because it did not detect that NICHOLAS BIESTERFELD had a Trisomy 21
`
`abnormality.
`
`82.
`
`Plaintiffs discovered that Harmony Prenatal Test did not have a 100% accuracy rate
`
`in detecting Trisomy 21 abnormalities upon the birth of NICHOLAS BIESTERFELD.
`
`83.
`
`The Plaintiffs alerted Defendants of this breach of merchantability on March 4,
`
`2019 via correspondence from Plaintiff’s counsel to Defendants.
`
`84.
`
`Harmony Prenatal Test was not of merchantable quality, as warranted by
`
`Defendants, in that it is unreliable, unsafe, and of limited utility for detecting Down Syndrome in
`
`patients like Plaintiff KATHLEEN BIESTERFELD and was thus not fit for the ordinary purpose
`
`for which it was intended.
`
`85.
`
`As a foreseeable, direct, and proximate result of the aforesaid conduct of the
`
`Defendants, Plaintiffs suffered severe and permanent injuries to their person.
`
`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, together with the costs of this action.
`
`
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 10 of 12 PageID #:17
`
`
`
`COUNT V—NEGLIGENCE
`
`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:
`
`86.
`
`Plaintiffs restate and re-allege paragraphs 1-12 of Count I as their paragraphs 86
`
`through 97 of Count V.
`
`98.
`
`Defendants had a duty to Plaintiffs to exercise reasonable and ordinary care in
`
`designing, researching, testing, manufacturing, marketing, supplying, promoting, packaging,
`
`selling, and/or distributing Harmony Prenatal Test into the stream of commerce.
`
`99.
`
`Notwithstanding the aforesaid duty, Defendants deviated from the exercise of
`
`reasonable and ordinary care in one or more of the following careless and negligent acts and/or
`
`omissions:
`
`a. Failed to inform Plaintiffs and others similarly situated that Harmony Prenatal Test
`
`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
`
`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
`
`which Harmony Prenatal Test could produce false negative results.
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 11 of 12 PageID #:18
`
`100. As a direct and proximate result of one or more of the aforesaid acts or omissions
`
`by Defendants, Plaintiffs suffered injuries, harm, and economic loss and Plaintiffs will continue to
`
`suffer such injuries, harm, and economic loss.
`
`101. As a foreseeable, direct, and proximate result of Defendants’ conduct, Plaintiffs
`
`have suffered, and will continue to suffer, emotional distress and financial costs in raising a child
`
`with Down Syndrome.
`
`102. As a foreseeable, direct, and proximate result of Defendants’ conduct, Plaintiffs
`
`have and will continue to suffer loss of income and earnings, past, present, and future and earning
`
`capacity.
`
`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 together with the costs of this action.
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
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`Respectfully submitted,
`
`Jerome A. Vinkler
`
`
`
`Kelsey J. Burge
`
`
`
`

`

`Case: 1:21-cv-03085 Document #: 1-1 Filed: 06/08/21 Page 12 of 12 PageID #:19
`
`Attorneys for Plaintiff
`VINKLER LAW OFFICES, LTD.
`7045 Veterans Blvd., Suite A-2
`Burr Ridge, IL 60527
`630-655-9545
`jav@vinklerlaw.com
`
`
`
`
`FILED DATE: 5/11/2021 10:59 AM 2021L004834
`
`

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