ANDERSON et al v. GENOMIC PREDICTION, INC. et al

OCR transcription for search; preserved printed pages are authoritative

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# NOT FOR PUBLICATION

## UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

ADRIAN ANDERSON, et al., individually
and on behalf of all others similarly situated,

Plaintiffs,

Civil Action No. 26-2860 (MAS) (TJB)
MEMORANDUM OPINION

V.

GENOMIC PREDICTION, INC., et al.,

Defendants.

### SHIPP, District Judge

This matter comes before the Court upon Defendants Genomic Prediction, Inc. and
Genomic Prediction Clinical Laboratory's (collectively, "Defendants") Motion to Dismiss (ECF
No. 27) the Class Action Complaint (the "Complaint") (ECF No. 1). Plaintiffs1 opposed (ECF No.
28), and Defendants replied (ECF No. 30). The Court has carefully considered the parties'
submissions and reaches its decision without oral argument under Local Civil Rule 78.1(b). For
the reasons below, Defendants' Motion to Dismiss is granted.

" The individually named Plaintiffs in this class action, bringing this action individually and on
behalf of all others similarly situated, include individual purchasers of Defendants' genetic testing
products: (1) Adrian Anderson; (2) Amanda Malkin; and (3) Maureen Ewing (collectively,
"Plaintiffs"). (See generally Compl., ECF No. 1.) Each Plaintiff also brings this action on behalf
of a class of residents of their respective states of residence (California, Florida, and Pennsylvania).
(See id. 11 328-30.)

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#### I. BACKGROUND2

##### A. Factual Background

###### 1. General Overview

Plaintiffs, individually and on behalf of all other similarly-situated consumers nationwide
and statewide (the "Class Members"), bring the present class action litigation alleging claims
related to Defendants' marketing and sale of preimplantation genetic testing for aneuploidy
("PGT-A" or "PGT-A testing"). (Compl. 11 1, 331.)

Defendants' PGT-A testing, LifeView, is "marketed and sold by Defendants" to both
individual consumers and clinicians as an add-on to in vitro fertilization ("IVF").3 (Id. 11 9-10.)
LifeView "purports to screen [the] embryos for chromosomal abnormalities." (Id.) Individuals
undergoing IVF, therefore, "must decide whether to purchase PGT-A testing prior to the testing
being performed." (Id. | 12.) If an individual purchases PGT-A testing, IVF clinicians then
perform a biopsy of the embryo, sending the collected cells from the embryo to Defendants'
laboratory for PGT-A testing. (Id. [13.) The test results "purport to determine which embryos are
'euploid' or best suited for implantation and which embryos are 'aneuploid' or abnormal and not
suited for implantation." (Id. 1 15.)

Plaintiffs allege that Defendants falsely and deceptively marketed their PGT-A testing "as
a proven, accurate, and reliable method to decrease the chance of miscarriage and increase the
chance of giving birth to a healthy baby" without disclosing that "science does not support this."
(Id. 12.) Instead, scientific literature and studies over the past two decades support that "PGT-A

2 For the purpose of considering the instant motion, the Court accepts all factual allegations in the
Complaint as true. See Phillips v. Cnty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008).

3 IVF is a fertility process involving the fertilization of an egg with sperm to create embryos, which,
upon reaching the blastocyst stage, are implanted to achieve pregnancy. (Id. 18.)

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is unproven, inaccurate, and unreliable." (Id. 12; see also id. 11 78-92, 105-12, 120-21, 126-28,
132-57, 160-66, 168-94 (citing scientific studies and literature regarding PGT-A from 2005 to
2024).) These scientific studies indicate, for example, that "there is no difference between cycles
utilizing PGT-A and cycles not utilizing PGT-A" and "the accuracy rating for PGT-A is
significantly lower than advertised or disclosed." (Id. 118.) In addition, the American Society for
Reproductive Medicine ("ASRM") has, on multiple occasions, opined that "the value of
preimplantation genetic testing for aneuploidy (PGT-A) as a universal screening test for all patients
undergoing in vitro fertilization (IVF) has not been established." (Id. 1 183; see also id.
T1 128,197.) Defendants "were aware of the scientific studies and research concerning PGT-A, as
well the limitations of same, including from major medical associations such as ASRM[.]" (Id.
[ 452.)

###### 2. Defendants' Representations and Omissions

Despite Defendants' awareness of the scientific literature undermining the value, accuracy,
and reliability of PGT-A testing, Defendants have made various statements regarding the benefits
of PGT-A testing. (See generally id.) Specifically, Defendants have stated that their PGT-A
testing: (1) provides the "most advanced genetic screening available"; (2) increases pregnancy
rates; (3) lowers miscarriage rates; (4) reduces the number of cycles of IVF needed; (5) reduces
the number of wasted transfers; (6) increases chance of IVF success and having a healthy child;
(7) leads to more euploid embryos and more embryos available for transfer; (8) increases the
chances of a successful pregnancy; (9) has a lower false positive rate and false negative rate than
NGS-based PGT-A testing; and (10) has a 98-99% accuracy rate. (See id. 11 222-301.) "Each of
these claims," Plaintiffs allege, "[is] false and misleading, unsupported by scientific evidence, and
[were] made while Defendant omitted and withheld material information." (Id. 1301.)

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Plaintiffs allege that Defendants "intentionally suppressed and concealed" material
information from consumers "to sell more PGT-A testing and to avoid the public finding out the
truth about PGT-A." (Id. 11 438, 459.) For example, Defendants failed to disclose that:
(1) "PGT-A can cause damage to the embryo thereby preventing it from developing once
transferred to the womb, and that PGT-A has the possibility of misdiagnosis" (id. 1190);
(2) "numerous scientific studies and opinions of professional organizations" have been published
detailing the issues associated with PGT-A testing (id. 1287); (3) "[c]hromosomal abnormal
embryos may self-correct downstream," making "earlier biopsy results irrelevant" (id. [288);
(4) "there is a substantial probability that an embryo may be misdiagnosed, and [that] the test
results [may be] inaccurate" (id. "[ 290); and (5) "false positives and false negatives [can] occur"
with PGT-A testing (id. [293).

Plaintiffs further allege that they purchased the PGT-A testing "based upon Defendants'
false and misleading statements and omissions of material information, including that [their]
PGT-A testing is the most advanced genetic screening available." (Id. 11 306, 313, 320.) Prior to
purchasing Defendants' PGT-A testing, Plaintiffs reviewed the claimed benefits of Defendants'
PGT-A testing on Defendants' website and flyers. (Id. (1 308, 314-15, 320.) These benefits
included: (1) "increas[ing] pregnancy rates; [(2)] lower[ing] miscarriage rates; [(3)] reduc[ing] the
number of cycles of IVF needed .. . [and] the number of wasted transfers; [(4)] increas[ing] the
chance of success . . . [and having] a healthy child . . . [;] and [(5)] [being] 98 to 99% accurate with
a lower false positive and false negative rate." (Id. 11 306, 313, 320.) In deciding to purchase the
testing, Plaintiffs relied upon Defendants' "false and misleading statements and omissions of
material information." (Id. [1 312, 319, 326.) According to Plaintiffs, neither they nor the Class
Members "could . . . have known of" the scientific literature and research indicating the

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unreliability, inaccuracy, and uncertainty of PGT-A testing (id. 11 305, 457), and absent the "false
and misleading misrepresentations and omissions," they "would not have purchased [the testing]"
(id. 11 312, 319, 326). Plaintiffs and the Class Members, accordingly, "were harmed by paying for
an unproven and unreliable test sold utilizing false statements and omissions." (Id. 1302.)

##### B. Procedural Background

On March 19, 2026, Plaintiffs filed a Class Action Complaint, asserting eleven causes of
action. (See generally Compl., ECF No. 1.) Three of the counts are alleged on behalf of Plaintiff
Anderson and the Class Members: (1) violation of the "unfair and fraudulent prong" of the
California Unfair Competition Law, Cal. Bus. & Prof. Code §§ 17200, et seq. ("Count One") (id.
11 342-57); (2) violation of the "unlawful prong" of the California Unfair Competition Law, Cal.
Bus. & Prof. Code §§ 17200, et seq. ("Count Two") (id. 11 358-63); and (3) violation of the
California Consumer Legal Remedies Act, Cal. Civ. Code § 1750, et seq. ("Count Three") (id.
TT 364-77).4 One count is alleged as to Plaintiff Malkin and the Florida subclass: violation of
Florida's Deceptive and Unfair Trade Practices Act, Fla. Stat. § 501.201, et seq. ("Count Four").
(Id. 11 378-89.) One count is alleged as to Plaintiff Ewing and the Pennsylvania subclass: violation
of Pennsylvania's Unfair Trade Practices and Consumer Protection Law, 73 Pa. Stat. Ann.
§§201-1, et seq. ("Count Five"). (Id. "1 390-97.) Three counts are alleged as to Plaintiffs and the
nationwide and statewide classes under the laws of all fifty states and the District of
Columbia: (1) breach of the implied warranty of merchantability ("Count Six") (id. "[ 398-405);
(2) breach of the implied warranty of usability ("Count Seven") (id. \1 406-16); and (3) breach of
express warranty ("Count Eight") (id. "[1 417-25). The remaining counts are alleged as to Plaintiffs

4 Defendants observe that these Counts, as pled, may reflect "an inadvertent error, because no
claims are brought on behalf of the California Class and the 'Class' includes non-California
plaintiffs." (Defs.' Moving Br. 12 n.7.)

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and the Class Members: (1) fraud ("Count Nine") (id. 11 426-34); (2) fraudulent concealment and
omission ("Count Ten") (id. 11 435-63); and (3) unjust enrichment and restitution ("Count
Eleven") (id. 11 464-72).5

Defendants moved to dismiss the Complaint in its entirety on June 30, 2026. (See generally
Defs.' Mot. to Dismiss, ECF No. 27.) Plaintiffs opposed on July 30, 2026 (Pls.' Opp'n Br., ECF
No. 28), and Defendants replied on August 14, 2026 (Defs.' Reply Br., ECF No. 30).

#### II. LEGAL STANDARD

Under Federal Rule of Civil Procedure6 12(b)(1), a defendant may move to dismiss a matter
for want of standing "because standing is a jurisdictional matter." Ballentine v. United States,
486 F.3d 806, 810 (3d Cir. 2007) (citations omitted). "When subject matter jurisdiction is
challenged under Rule 12(b)(1), the plaintiff must bear the burden of persuasion." Kehr Packages,
Inc. v. Fidelcor, Inc., 926 F.2d 1406, 1409 (3d Cir. 1991). A motion to dismiss for lack of subject
matter jurisdiction may either "attack the complaint on its face . .. [or] attack the existence of
subject matter jurisdiction in fact, quite apart from any pleadings." Mortensen v. First Fed. Sav.
& Loan Ass'n, 549 F.2d 884, 891 (3d Cir. 1977).

A facial challenge asserts that "the complaint, on its face, does not allege sufficient grounds
to establish subject matter jurisdiction." Iwanowa v. Ford Motor Co., 67 F. Supp. 2d
424, 438 (D.N.J. 1999). As such, a facial challenge "calls for a district court to apply the same
standard of review it would use in considering a motion to dismiss under Rule 12(b)(6), i.e.,

5 The claims brought on behalf of the nationwide class are asserted under New Jersey law.
(Compl. 1341.) Alternatively, "if the Court finds that New Jersey law, including all of the New
Jersey law causes of action alleged below, does not apply to Plaintiffs and all Class members
residing outside of New Jersey for any reason, then Plaintiffs and Class members residing outside
of California assert their claims under the laws of their respective states of residence." (Id.)

6 All references to "Rule" or "Rules" hereinafter refer to the Federal Rules of Civil Procedure.

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construing the alleged facts in favor of the nonmoving party." Const. Party of Pa. v. Aichele,
757 F.3d 347, 358 (3d Cir. 2014). District courts considering a facial challenge, then, must
construe the allegations in the complaint as true and determine whether subject matter jurisdiction
exists. Mortensen, 549 F.2d at 891; Cardio-Med. Assocs., Ltd. v. Crozer-Chester Med. Ctr.,
721 F.2d 68, 75 (3d Cir. 1983). "Thus, '[t]o survive a motion to dismiss [for lack of standing], a
complaint must contain sufficient factual matter' that would establish standing if accepted as true."
In re Horizon Healthcare Servs. Inc. Data Breach Litig., 846 F.3d 625, 633 (3d Cir. 2017)
(alterations in original) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).

## III. DISCUSSION

Defendants raise multiple arguments in support of their motion to dismiss: (1) Plaintiffs
lack Article III standing; (2) Plaintiffs failed to comply with pre-suit notice requirements of
California, Florida, and Pennsylvania; (3) Plaintiffs fail to allege actionable misrepresentations,
omissions, or reliance; (4) Plaintiffs fail to state the nationwide claims; and (5) Plaintiffs fail to
state claims under the various state consumer protection laws. (See generally Defs.' Moving Br.,
ECF No. 27-1.) The Court reaches only the first argument because, as explained below, Plaintiffs
lack standing.

"[T]he question of standing in the federal courts is to be considered within the framework
of Article III [of the Constitution,] which restricts judicial power to 'cases' or 'controversies."
Twp. of Lyndhurst, N.J. v. Priceline.com Inc., 657 F.3d 148, 154 (3d Cir. 2011) (alterations in
original) (quoting Ass'n of Data Processing Serv. Orgs. v. Camp, 397 U.S. 150, 151 (1970)). A
party invoking federal jurisdiction bears the burden of demonstrating it has standing. TransUnion
LLC v. Ramirez, 594 U.S. 413, 430-31 (2021). If Article III standing cannot be established on the

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part of the named plaintiffs, a district court "must dismiss a putative class action for lack of subject
matter jurisdiction." Finkleman v. Nat'l Football League, 810 F.3d 187, 195 (3d Cir. 2016).

Under Article III, a plaintiff has standing if it has: "(1) suffered an injury in fact, (2) that is
fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by
a favorable judicial decision." Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016) (citing Lujan
v. Defs. of Wildlife, 504 U.S. 555, 560-61 (1992)). The "injury in fact" inquiry is often
determinative of standing. Ellison v. Am. Bd. of Orthopaedic Surgery, 11 F.4th 200, 205 (3d Cir.
2021). "The requirements for an injury-in-fact are well established: a plaintiff must show that [it
has] suffered 'an invasion of a legally protected interest' that is 'concrete and particularized' and
'actual or imminent, not conjectural or hypothetical." In re Plum Baby Food Litig., 637 F. Supp.
3d 210, 223 (D.N.J. 2022) (quoting Lujan, 504 U.S. at 560).

According to Defendants, Plaintiffs lack standing to assert their economic injury theory of
harm, which is their sole theory of injury because they have not alleged an economic injury-in-fact.
(Defs.' Moving Br. 8-10.) Plaintiffs argue in opposition that they have Article III standing because
they sufficiently "allege[d] a classic benefit-of-the-bargain injury" in that they "paid for-but did
not receive-a test represented to be 98%-99% accurate and to provide specific clinical benefits,
including improved reproductive outcomes." (Pls.' Opp'n Br. 15.)

"Under the benefit of the bargain theory, a plaintiff [may] successfully plead an economic
injury by alleging that she bargained for a product worth a given value but received a product
worth less than that value." In re Johnson & Johnson Talcum Powder Prods. Mktg., Sales Pracs.
& Liab. Litig., 903 F.3d 278, 283 (3d Cir. 2018). "The economic injury is calculated as the
difference in value between what was bargained for and what was received." Id. The plaintiff,
however, "must do more than simply characterize that purchasing decision as an economic injury.

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The plaintiff must instead allege facts that would permit a factfinder to determine, without relying
on mere conjecture, that the plaintiff failed to receive the economic benefit of her bargain." Id. at
281. This requires alleging that the products purchased by Plaintiffs themselves were defective.
Huertas v. Bayer US LLC, 120 F.4th 1169, 1178 (3d Cir. 2024).

As Defendants note, the District of Delaware considered a motion to dismiss regarding
nearly identical claims made in a PGT-A testing class action lawsuit and found that the plaintiffs
lacked Article III standing. (See Defs.' Moving Br. 9-10); Klosowski v. FPG Labs, LLC, No.
24-1210, 2025 WL 2532500, at *3 (D. Del. Sep. 3, 2025).7 There, the court read the plaintiffs'
claims as asserting a "benefit-of-the-bargain theory of injury." Id. at *2 (quoting Huertas,
120 F.4th at 1174). Relying on Johnson & Johnson, the court found "fatal [to] the standing
inquiry" that the plaintiffs failed to allege that their own PGT-A testing failed to "adequately
perform" the intended functions. Id. at *3 (quoting Johnson & Johnson, 903 F.3d at 281).

Here, Plaintiffs' Complaint fares no better. As in Klosowski, Plaintiffs point to numerous
studies and scientific opinions "that purport to undermine the scientific efficacy of [Defendants']
PGT-A testing and the representations" regarding reduced chances of miscarriage and increased
chances of pregnancy. (See id .; see also Compl. 11 18, 141-45, 157, 176, 183-203.) The Complaint,
however, does not allege facts that would enable this Court to reasonably infer that the specific
PGT-A tests purchased by Plaintiffs were defective. (See generally Compl.) "None of the

7 For reasons unclear to the Court, Plaintiffs' Opposition Brief did not address Klosowski, nor did
it address the other analogous case cited by Defendants. (See generally Pls.' Opp'n Br .; see also
Defs.' Moving Br. 10 (citing Tyman v. CCRM Parent Holdings, No. 25-1425, Order (D. Colo. June
17, 2026), ECF No. 29).) In Tyman, the District of Colorado dismissed the complaint for failing to
plead an injury-in-fact, and in doing so, relied on Johnson & Johnson and Klosowski. (See June
17, 2026, Order 6 ("The Court finds the reasoning from the Third Circuit and Klosowski
persuasive. While Plaintiffs point to studies that allegedly undermine the marketing claims made
by Defendants, they make no allegations that they suffered any injury because of the alleged false
advertising beyond simply purchasing PGT-A testing.").)

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[] Plaintiffs allege, for example, that they failed to become pregnant, suffered a miscarriage, or
experienced a medically compromised pregnancy-notwithstanding [Defendants'] alleged
marketing statements that PGT-A mitigates all of those problems." Klosowski, 2025 WL 2532500,
at *3. Rather, Plaintiffs repeatedly allege that they would not have purchased Defendants' PGT-A
testing had they known that the testing and its results were inaccurate and unreliable. (See e.g.,
Compl. 11 31, 71, 213, 303.) It is unclear, however, whether Plaintiffs' results were indeed
inaccurate. Plaintiffs allege that the consent forms they signed during the purchase process
indicated that Defendants' "testing has a diagnostic accuracy of 98% to 99%" (id. 11 309, 316,
323), and Plaintiffs' results each indicated a diagnostic accuracy of 98.6% (id. 11 311, 318, 325).
Given these rates fall squarely within the margin of the stated accuracy rate, without more, the
Court has no grounds to infer that Defendants deprived Plaintiffs of the benefit of their bargains
such that Plaintiffs have asserted an injury-in-fact.8

Plaintiffs' allegations, therefore, are not sufficient to establish Article III standing under a
benefit of the bargain theory of economic harm. See, e.g., In re Plum Baby Food, 637 F. Supp.
3d at 223-25 (finding plaintiffs did not have Article III standing where they claimed a presence of
heavy metals in baby food and alleged that "they did not receive the benefit of the bargain because
they believed they were buying 'healthy, nutritious' baby food products" because the complaint
lacked "factual support of adverse health consequences or plausible allegations of future risk[s]");
Koronthaly v. L'Oreal USA, Inc., 374 F. App'x 257, 259 (3d Cir. 2010) (finding plaintiff lacked

8 Plaintiffs' Reply Brief argues that Defendants "ignore[d] Plaintiffs' specific allegations of injury
in fact," citing Paragraphs 268-81 as those "alleging particularized injuries." (Pls.' Opp'n Br.
8, ECF No. 28.) The Court's review of these paragraphs, however, reveals that they only contain
allegations regarding the inaccuracies of Defendants' advertising claims. (See Compl. 11 268-81.)
The Court notes that Plaintiffs are correct that they need not "prove a specific injury" (Pls.' Opp'n
Br. 8 (emphasis added)), but to survive a motion to dismiss, Plaintiffs must at least allege some
cognizable injury. Johnson & Johnson, 903 F.3d at 281. They have not.

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an injury-in-fact to confer standing where plaintiff asserted "a subjective allegation that . . . trace
amounts of lead in . . . lipsticks are unacceptable" but conceded that plaintiff "ha[d] suffered no
adverse health effects from using the lipsticks"); James v. Johnson & Johnson Consumer Cos.,
No. 10-3049, 2011 WL 198026, at *2 (D.N.J. Jan. 20, 2011) (rejecting plaintiffs' benefit of the
bargain theory related to shampoo that contained methyl chloride because "[p]laintiffs received
the benefit of their bargain so long as there were no adverse health consequences, and the product
worked as intended").9

While this Court must accept as true Plaintiffs' allegations that they would not have
purchased PGT-A testing absent Defendants' misrepresentations and omissions (see Compl.
TT 312, 319, 326), the Court cannot read nonexistent allegations into the Complaint to confer
standing. 10

## IV. CONCLUSION

For the reasons set forth above, Defendants' Motion to Dismiss is granted. Plaintiffs will
be afforded an opportunity to file an amended complaint to address the deficiencies identified
herein. The Court will issue an Order consistent with this Memorandum Opinion.

Machine
3

MICHAEL A. SHIPP
UNITED STATES DISTRICT JUDGE

Dated: October 8, 2026

9 Defendants also argue that Plaintiffs lack standing to assert claims outside their home states.
(Defs.' Moving Br. 10-12.) Because the Court finds that Plaintiffs have no standing to assert any
claims due to the Complaint's failure to allege an injury-in-fact, the Court need not reach this
argument or Defendants' remaining arguments.

10 See In re U.S. Vision Data Breach Litig., 732 F. Supp. 3d 369, 378 (D.N.J. 2024) ("[T]hough the
Court must assume that [p]laintiffs' factual allegations are true, it is under 'no obligation to
consider conclusory or nonexistent allegations."" (citation omitted)); see also Finkelman v. Nat'l
Football League, 810 F.3d at 194 ("Insofar as we construe the complaint to allege that [plaintiff]
paid more for his [product] than he would have absent [defendant's] alleged misconduct, that
contention is a 'bald assertion' unsupported by well-pleaded facts.").