throbber
Civil Action No.:
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`JULY TRIAL DEMANDED
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`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF MISSOURI
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`AUNESTY JANSSEN INDIVIDUALLY
`AND AS MOTHER AND GENERAL
`GUARDIAN
`OF CARSON REIKOFSKI A MINOR,
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`Plaintiffs,
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`v.
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`CVS HEALTH CORPORATION,
`WALGREENS BOOTS ALLIANCE,
`INC.
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`Defendants.
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`COMPLAINT
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`Plaintiff Aunesty Janssen and Plaintiff Carson Reikofski, pursuant to Fed. R. Civ. P.
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`17(c)(1)(A), by and through their undersigned counsel, bring this Complaint for damages against
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`Defendants CVS Health Corporation (hereinafter, “CVS”) and Walgreens Boots Alliance, Inc.
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`(hereinafter, “Walgreens”) (collectively, the “Defendants”) and in support state the following:
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`1.
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`This is an action brought on behalf of Plaintiffs, Aunesty Janssen (hereinafter,
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`“Plaintiff Mother”), the natural and general guardian and mother of Carson Reikofski (hereinafter,
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`“Plaintiff Child”), a minor, arising out of the failure of Defendants to warn about the dangers of
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`prenatal exposure to Paracetamol, also known as Acetaminophen (hereinafter “APAP”) and its
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`propensity to cause autism spectrum disorder ( hereinafter “ASD”) in children. As a result,
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`Plaintiffs have suffered permanent injuries and significant pain and suffering, emotional distress,
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`lost wages and earning capacity, and diminished quality of life. Plaintiffs respectfully seek all
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`damages to which they may be legally entitled.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 1 of 28
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`2.
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`Defendants entirely failed their duty to adequately warn of the hazards of prenatal
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`exposure to APAP, which was a direct and proximate cause of Plaintiffs’ injuries and associated
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`damages.
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`STATEMENT OF PARTIES
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`3.
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`At all material times Plaintiffs have been citizens and residents of Bates County,
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`Missouri, and the United States.
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`4.
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`CVS is incorporated in Delaware, with its principal place of business in Rhode
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`Island.
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`5.
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`Walgreens is incorporated in Delaware, with its principal place of business in
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`Illinois.
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`6.
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`Defendants are both multinational companies
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`involved
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`in
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`the research,
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`development, testing, manufacture, labeling, production, marketing, promotion, and/or sale of
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`APAP through their over-the-counter store brands sold and marketed through their retail stores
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`(hereinafter, the “APAP Products”).
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`7.
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`Defendants are individually and jointly and severally liable to Plaintiffs for
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`damages they suffered, arising from Defendants’ design, manufacture, marketing, labeling,
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`distribution, sale, and placement of the defective APAP Products into the market, effectuated
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`directly and indirectly through their agents, servants, employees, and/or owners, all acting within
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`the course and scope of their agencies, services, employments, and/or ownership.
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`8.
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`Defendants are vicariously liable for the acts and/or omissions of their employees
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`and/or agents, who were at all material times acting on behalf of Defendants and within the scope
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`of their employment or agency.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 2 of 28
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`VENUE AND JURISDICTION
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`9.
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`This Court has subject-matter jurisdiction under 28 U.S.C. § 1332(a), based on
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`complete diversity of citizenship between Plaintiffs and Defendants. See supra ¶¶ 3–5.
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`10.
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`The amount in controversy exceeds $75,000.
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`11.
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`Venue is proper in this Court pursuant to 28 U.S.C. § 1391 because the events or
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`omissions giving rise to Plaintiffs’ claims occurred in this judicial district.
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`12.
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`Defendants have and continue to conduct substantial business in the State of
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`Missouri and in this District, distribute the APAP Products in this District, receive substantial
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`compensation and profits from sales of the APAP Products in this District, and have made material
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`omissions and misrepresentations and breaches of warranties in this District, so as to subject
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`Defendants to in personam jurisdiction in this District.
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`13.
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`Defendants are registered to transact business in Missouri.
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`FACTS COMMON TO ALL COUNTS
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`APAP Is Marketed as the Safe Pain Reliever
`for Pregnant Women, but APAP Can Cause ASD in Children
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`APAP is widely used by pregnant women to relieve pain during the term of their
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`APAP was initially discovered in the late 1800’s.
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`APAP was introduced to the US market in 1955 as the first aspirin-free pain
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`14.
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`pregnancy.
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`15.
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`16.
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`reliever. APAP was originally marketed and sold as a product to reduce fever in children,
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`packaged like a red fire truck with the slogan, “for little hotheads.”
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`17.
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`18.
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`APAP is sold in billions of units annually in North America alone.
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`APAP has long been marketed as the safest, and the only appropriate, over-the-
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`counter pain relief drug on the market for pregnant women.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 3 of 28
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`19. More than 65% of women in the United States use APAP during pregnancy.
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`20.
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`Based upon information and belief, a majority of women who use APAP during
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`pregnancy do so electively for the treatment of headaches, muscle pain, back pain, and infection.
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`21.
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`These pregnant women electively choose to take APAP because Defendants have
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`marketed APAP as a safe pain reliever for pregnant women.
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`22.
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`However, increasing experimental and epidemiological research shows that
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`prenatal exposure to APAP alters fetal development, which significantly increases the risks of
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`neurodevelopmental disorders, including but not limited to, autism spectrum disorder (“ASD”)
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`and attention-deficit/hyperactivity disorder (“ADHD”).
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`23.
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`Undisturbed development of the human brain in utero is vital to the health and
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`wellness of a child’s development. The human brain is vulnerable and extremely sensitive in utero.
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`During this sensitive time-period in utero, certain chemicals have been found to cause permanent
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`brain injury at low exposure levels.
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`24.
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`Once ingested by the mother, APAP is known to readily cross the placenta and
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`blood-brain barrier.
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`25.
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`ASD is a serious neurological and developmental disorder that affects how people
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`interact with others, communicate, learn, and behave.
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`26.
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`There are three functional levels of ASD, with Level 1 requiring support with
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`activities of daily living, Level 2 requiring substantial support with activities of daily living, and
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`Level 3 requiring very substantial support with activities of daily living.
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`27.
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`Treatments for ASD include behavioral management therapy, cognitive behavior
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`therapy, joint attention therapies, medications, occupational therapy, physical therapy, social skill
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`training, and speech-language therapy. Treatment for ASD lasts a lifetime, as there is no cure.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 4 of 28
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`28.
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`ADHD is a chronic neurodevelopmental disorder resulting in attention difficulty,
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`hyperactivity, and impulsiveness.
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`29.
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`In or around 2018, the Center for Disease Control and Prevention (“CDC”) found
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`that 1 in 44 (2.3%) 8-year-old children have been diagnosed with ASD.
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`30.
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`This represents an increase from a prior CDC finding that 1 in 68 U.S. children
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`born in 2002 have ASD, which already represented a more than a 100% increase compared with
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`children born a decade prior.
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`31.
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`Parental awareness and changes in diagnoses do not account for the rapid rise in
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`these diagnoses.
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`32.
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`Rather, neurotic exposures, such as prenatal APAP exposure, explain a trending
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`increase in diagnosis.
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`33.
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`For years, the scientific community has published studies showing that prenatal
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`ingestion of APAP can cause neurodevelopmental disorders, like ASD.
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`34.
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`For instance, since 2013, there have been six European birth cohort studies,
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`examining over 70,000 mother-child pairs, showing the association between prenatal use of APAP
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`and the neurodevelopmental disorders of ASD and ADHD.
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`35.
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`At this time, the overall body of scientific evidence shows that prenatal use of
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`APAP can cause neurodevelopmental disorders, like ASD, in the child.
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`36.
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`During all relevant times herein, Defendants were engaged in the business of
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`manufacturing and selling the APAP Products in the United States, and the weight of the scientific
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`evidence available showed prenatal exposure to APAP significantly increases the risk of
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`neurodevelopmental disorders in children exposed to APAP prenatally, including but not limited
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`to ASD.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 5 of 28
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`37.
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`The scientific evidence regarding the risks of in utero exposure of APAP was
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`available to Defendants, and Defendants knew or should have known that prenatal use of APAP
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`can cause ASD or ADHD.
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`38.
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`Based on information and belief, Defendants have concealed the prenatal APAP
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`exposure-neurodevelopmental link from consumers, like Plaintiff Mother, in part by not reporting
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`the link to the FDA, which relies on drug manufacturers to bring new information about a drug to
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`the agency’s attention.
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`39. Moreover, despite knowing that prenatal use of APAP can cause ASD, Defendants
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`continue to market the APAP Products as the safe pain reliever for pregnant women, making
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`mothers believe they are choosing a safe drug for even minor aches, pains, and headaches.
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`Plaintiff Mother Took APAP Products while Pregnant,
`and It Caused ASD in Plaintiff Child
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`Plaintiff Mother began using the Defendants’ APAP Products in or around October
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`40.
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`2009 when she was pregnant with her Plaintiff Child.
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`41.
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`Over the course of her pregnancy, and during each trimester, Plaintiff Mother
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`electively took the APAP Products daily to treat pain associated with her arthritis.
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`42.
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`Plaintiff Mother believed it was safe for her to take the APAP Products during her
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`pregnancy.
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`43.
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`There is no warning on the APAP Products’ labels specifically addressing the risks
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`of ASD if a mother ingests APAP while pregnant.
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`44.
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`Had Plaintiff Mother known of the risk of taking APAP while pregnant, specifically
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`that it could cause ASD in her child, she would not have taken the APAP Products.
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`45.
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`Plaintiff Child was born on July 4, 2010.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 6 of 28
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`46.
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`Plaintiff Mother started to have concerns about Plaintiff Child’s development when
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`he was around sixteen months old.
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`At that time, Plaintiff was still nonverbal and would engage in repetitive behavior.
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`Plaintiff also started to engage in stimming, or self-stimulatory behaviors.
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`Plaintiff Child was ultimately diagnosed with ASD when he was twenty-two
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`47.
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`48.
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`49.
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`months old.
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`50.
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`Plaintiff Child’s ASD puts an incredible strain on Plaintiff Mother.
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`51.
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`For instance, Plaintiff Child is home schooled.
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`52.
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`Plaintiff Mother must keep Plaintiff Child to a specific schedule that is very limiting
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`and is challenging to maintain.
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`53.
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`Plaintiff Mother has grave concerns for Plaintiff Child’s future.
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`ESTOPPEL AND TOLLING OF STATUTE OF LIMITATIONS
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`54.
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`Due to Defendants’ acts of fraudulent concealment, Defendants are estopped from
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`relying on any statutes of limitations or repose. Such acts include Defendants’ intentional
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`concealment from Plaintiff Mother and the general public that APAP is defective when there is
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`prenatal exposure, while continuing to market the APAP Products with the adverse effects
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`described in this Complaint.
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`55.
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`Given Defendants’ affirmative actions of concealment by failing to disclose
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`information about the defects known to them but not the public—information over which
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`Defendants had exclusive control—and because Plaintiff Mother could not reasonably have known
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`that the APAP Products were defective, Defendants are estopped from relying on any statutes of
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`limitations that might overwise be applicable to the claims asserted in this Complaint.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 7 of 28
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`COUNT I: STRICT LIABILITY – FAILURE TO WARN
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`Plaintiffs incorporate by reference the allegations in all prior paragraphs.
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`At the time of Plaintiffs’ injuries, the APAP Products were defective and
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`56.
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`57.
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`unreasonably dangerous to foreseeable consumers, including Plaintiff Mother, because they lacked
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`an adequate warning.
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`58.
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`At all relevant times, Defendants engaged in the business of testing, developing,
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`designing, manufacturing, marketing, labeling, selling, distributing, and promoting the APAP
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`Products, which were defective and unreasonably dangerous to consumers, including Plaintiff
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`Mother, because they did not contain adequate warnings or instructions concerning the dangerous
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`characteristics of ingesting APAP during pregnancy. These actions were under the ultimate
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`control and supervision of Defendants. At all relevant times, Defendants registered, researched,
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`manufactured, distributed, marketed, labeled, promoted, and sold the APAP Products within this
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`District and aimed the marketing at the ultimate consumer. Defendants were at all relevant times
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`involved in the retail and promotion of the APAP Products marketed and sold in this District.
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`59.
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`Defendants had a duty to warn of the risks associated with the use of the APAP
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`products.
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`60.
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`The APAP Products ingested by Plaintiff Mother during pregnancy were in the
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`same or substantially similar condition as they were when they left possession of the Defendants.
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`61.
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`Defendants expected and intended the APAP Products to reach users such as
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`Plaintiff Mother in the condition in which the APAP Products were sold.
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`62.
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`63.
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`Plaintiff Mother did not materially alter the APAP Products prior to ingestion.
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`Plaintiff Mother ingested the APAP Products as indicated on the APAP Products’
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`labels.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 8 of 28
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`64.
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`Plaintiff Mother was unaware of the defects and dangers of the APAP Products and
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`was unaware that prenatal exposure increases the risk of brain and behavioral development of
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`children in utero.
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`65.
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`The labels on the APAP Products to consumers lack any warning specific to
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`pregnant women. The information that Defendants did provide or communicate failed to contain
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`relevant warnings, hazards, and precautions that would have enabled consumers such as Plaintiff
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`Mother to utilize the products safely and with adequate protection, or decide to not ingest the
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`APAP Products at all.
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`66.
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`This alleged failure to warn is not limited to the information contained on the APAP
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`Products’ labeling. Defendants were able, in accord with federal law, to comply with relevant
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`state law by disclosing the known risks associated with APAP through other non-labeling
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`mediums, i.e., promotion, advertisements, public service announcements, and/or public
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`information sources. But Defendants did not disclose these known risks through any medium.
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`67.
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`At all relevant times, Defendants had a duty to properly test, develop, design,
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`manufacture, inspect, package, label, market, promote, sell, distribute, maintain, and supply the
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`APAP Products; provide proper warnings for the APAP Products; and take such steps as necessary
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`to ensure the APAP Products did not cause users and consumers, and their children, to suffer from
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`unreasonable and dangerous risks. Defendants had a continuing duty to warn Plaintiff Mother of
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`dangers associated with APAP. Defendants, as manufacturers, sellers, and/or distributors of
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`pharmaceutical medication, are held to the knowledge of an expert in the field.
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`68.
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`At the time of manufacture, Defendants could have provided the warnings or
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`instructions regarding the full and complete risks of the APAP Products because Defendants knew
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 9 of 28
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`or should have known of the unreasonable risks of ASD caused by prenatal exposure to and/or the
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`use of such products.
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`69.
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`At all relevant times, Defendants failed and deliberately refused to investigate,
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`study, test, or promote the safety of the APAP Products, or to minimize the dangers to consumers
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`of the APAP Products and to those who would foreseeably use or be harmed by the APAP
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`Products, including Plaintiffs.
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`70.
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`Defendants failed to adequately warn consumers, like Plaintiff Mother, about the
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`significant increased risk of neurodevelopmental disorders in children exposed to APAP
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`prenatally, including but not limited to ASD.
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`71.
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`Defendants failed to adequately inform reasonably foreseeable consumers, like
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`Plaintiff Mother, of the proper usage of the APAP Products.
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`72.
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`Even though Defendants knew or should have known that APAP posed a grave risk
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`of harm to Plaintiff Child, Defendants failed to exercise reasonable care to warn of the dangerous
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`risks associated with use and prenatal exposure.
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`73.
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`Plaintiff Mother was exposed to the APAP Products without knowledge of their
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`dangerous characteristics.
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`74.
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`At all relevant times, Plaintiff Mother used and/or was exposed to the use of the
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`APAP Products while using them for their intended or reasonably foreseeable purposes, without
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`knowledge of their dangerous characteristics.
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`75.
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`Plaintiff Mother could not have reasonably discovered the defects and risks
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`associated with the APAP Products prior to or at the time of Plaintiff consuming APAP. Plaintiff
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`Mother relied upon the skill, superior knowledge, and judgment of Defendants to know about and
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`disclose serious health risks associated with using the APAP Products.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 10 of 28
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`76.
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`If Plaintiff Mother had been properly warned of the defects, dangers, and risks
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`associated with prenatal exposure to APAP, Plaintiff Mother would have utilized the APAP
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`Products safely and with adequate protection, or would have decided to not ingest the APAP
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`Products at all.
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`77.
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`Defendants are liable to Plaintiffs for injuries caused by Defendants’ negligent or
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`willful failure, as described above, to provide adequate warnings or other relevant information and
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`data regarding the appropriate use of the APAP Products and the risks associated with the use of
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`APAP.
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`78.
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`As a direct and proximate result of Defendants placing defective APAP Products
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`into the stream of commerce, and Plaintiff Mother’s ingestion of the APAP Products during
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`pregnancy, Plaintiff Child was exposed to APAP prenatally, causing him to develop ASD.
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`79.
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`As a direct and proximate result of Defendants placing defective APAP Products
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`into the stream of commerce, Plaintiffs have suffered permanent injuries, significant pain and
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`suffering, emotional distress, lost wages and earning capacity, and diminished quality of life.
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`Plaintiffs respectfully seek all damages to which they may be legally entitled.
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`COUNT II: NEGLIGENCE
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`80.
`
`81.
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`Plaintiffs incorporate by reference the allegations in all prior paragraphs.
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`Although Defendants had a duty to use reasonable care in testing, developing,
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`designing, manufacturing, marketing, labeling, selling, distributing, promoting, and preparing
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`written instructions and warnings for the APAP Products, Defendants failed to do so.
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`82.
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`Defendants, directly or indirectly, caused the APAP Products to be sold,
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`distributed, packaged, labeled, marketed, promoted, and/or used by Plaintiff Mother. At all
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`relevant times, Defendants registered, researched, manufactured, distributed, marketed, promoted,
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 11 of 28
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`and sold the APAP Products within this district and aimed at a consumer market within this
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`district.
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`83.
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`Defendants knew, or in the exercise of reasonable care should have known, that the
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`APAP Products were defectively and unreasonably designed and/or manufactured, and/or
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`marketed, and were unreasonably dangerous and likely to injure persons that were prenatally
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`exposed to them. Defendants knew or should have known that Plaintiff Mother was unaware of
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`the dangers and defects inherent in the APAP Products when she was ingesting them during her
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`pregnancy with Plaintiff Child.
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`84.
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`At all relevant times, Defendants had a duty to exercise reasonable care in the
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`marketing, advertisement, promotion, and sale of the APAP Products. Defendants’ duty of care
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`owed to consumers and the general public included providing accurate, true, and correct
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`information concerning the risks of using APAP during pregnancy and appropriate, complete, and
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`accurate warnings concerning the potential adverse effects of APAP and, in particular, the
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`significantly increased risk of causing neurodevelopmental disorders in children through prenatal
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`exposure to APAP.
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`85.
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`At all relevant times, Defendants knew or, in the exercise of reasonable care, should
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`have known of the hazards and dangers of APAP ingestion while pregnant and, specifically, the
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`significantly increased risk of causing neurodevelopmental disorders in children through prenatal
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`exposure to APAP.
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`86.
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`Defendants failed to provide any kind of warning to pregnant consumers, like
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`Plaintiff Mother, about the significantly increased risk of causing neurodevelopmental disorders
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`in children through prenatal exposure to APAP.
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 12 of 28
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`87.
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`Accordingly, at all relevant times, Defendants knew or, in the exercise of
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`reasonable care, should have known that use of the APAP Products could cause Plaintiffs’ injuries,
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`and thus, create a dangerous and unreasonable risk of injury to the users of these products,
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`including Plaintiffs.
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`88.
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`As such, Defendants breached their duty of reasonable care and failed to exercise
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`ordinary care in the design, research, development, manufacture, testing, marketing, labeling,
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`supply, promotion, advertisement, packaging, sale, and distribution of the APAP Products, in that
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`Defendants manufactured and produced defective APAP Products, which carry the significantly
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`increased risk of causing neurodevelopmental disorders in children through prenatal exposure to
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`APAP; knew or had reason to know of the defects inherent in the APAP Products; knew or had
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`reason to know that a user’s or consumer’s use of the APAP Products created a significant risk of
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`harm and unreasonably dangerous side effects; and failed to prevent or adequately warn of these
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`risks and injuries.
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`89.
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`Defendants had a duty to disclose the truth about the risks associated with APAP
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`in their promotional efforts outside of the context of labeling. Defendants were negligent in their
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`promotion of APAP outside of the labeling context by failing to disclose material risk information
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`as part of their promotion and marketing of the APAP Products, including through the internet,
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`television, and print advertisements.
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`90.
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`Despite Defendants’ ability and means to investigate, study, and test the APAP
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`Products and to provide adequate warnings, Defendants failed to do so. Indeed, Defendants
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`wrongfully concealed information and further made false and/or misleading statements concerning
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`the safety and use of APAP.
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`91.
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`Defendants’ negligence included:
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 13 of 28
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`a. Manufacturing, producing, promoting,
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`formulating, creating, developing,
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`designing, selling, and/or distributing the APAP Products while negligently and/or
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`intentionally concealing and failing to disclose the results of trials, tests, and studies
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`of APAP and the significantly increased risk of causing neurodevelopmental
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`disorders in children through prenatal exposure to APAP, and, consequently, the
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`risk of serious harm associated with human use of APAP during pregnancy;
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`b. Failing to undertake sufficient studies and conduct necessary tests to determine
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`whether or not the APAP Products were safe for its intended consumer use and
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`unborn children;
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`c. Failing to provide adequate instructions, guidelines, and safety precautions to those
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`persons Defendants could reasonably foresee would use the APAP Products;
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`d. Failing to disclose to Plaintiff Mother, users, consumers, and the general public that
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`use of APAP during pregnancy presents severe risks of neurodevelopmental
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`disorders in children exposed to APAP prenatally;
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`e. Failing to warn Plaintiff Mother, users, consumers, and the general public that the
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`APAP Products’ risk of harm was unreasonable and that there were safer and
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`effective alternative medications or treatments available to Plaintiff Mother and
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`other users and/or consumers;
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`f. Representing that the APAP Products were safe for their intended purposes for
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`pregnant women when, in fact, Defendants knew or should have known the APAP
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`Products were not safe for their intended purposes;
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`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 14 of 28
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`g. Declining to make or propose any changes to the APAP Products’ labeling or other
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`promotional materials that would alert users, consumers, and the general public of
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`the risks of APAP, including to pregnant women;
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`h. Advertising, marketing, and recommending the use of the APAP Products, while
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`concealing and failing to disclose or warn of the dangers known by Defendant to
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`be caused by the use of or exposure to APAP;
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`i. Continuing to disseminate information to their consumers and the general public,
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`which indicates or implies that the APAP Products are not unsafe for pregnant
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`consumer use; and
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`j. Continuing the manufacture and sale of the APAP Products with the knowledge
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`that the APAP Products were unreasonably unsafe and dangerous.
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`92.
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`Defendants knew and/or should have known that it was foreseeable that children
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`such as Plaintiff Child would suffer injuries as a result of Defendants’ failure to exercise ordinary
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`care in the manufacturing, marketing, labeling, distribution, and sale of the APAP Products to
`
`consumers, like Plaintiff Mother.
`
`93.
`
`Plaintiff Mother did not know the nature and extent of the injuries that could result
`
`in her child from the intended use of and/or exposure to APAP prenatally.
`
`94.
`
`Defendants’ negligence was the proximate cause of Plaintiffs’ injuries, i.e., absent
`
`Defendants’ negligence, Plaintiff Child would not have developed ASD.
`
`95.
`
`Defendants’ conduct, as described above, was reckless. Defendants regularly
`
`risked exposing Plaintiff Mother to the APAP Products while pregnant with Plaintiff Child, with
`
`full knowledge of the dangers of the APAP Products and that it could cause ASD in Plaintiff Child.
`
`Defendants made conscious decisions not to redesign, re-label, warn, or inform the unsuspecting
`
`
`
`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 15 of 28
`
`15
`
`

`

`public, including Plaintiff Mother. Defendants’ reckless conduct therefore warrants an award of
`
`punitive damages.
`
`96.
`
`As a direct and proximate result of Defendant placing the defective APAP Products
`
`into the stream of commerce, Plaintiffs have suffered permanent injuries, significant pain and
`
`suffering, emotional distress, lost wages and earning capacity, and diminished quality of life.
`
`Plaintiffs respectfully seek all damages to which they may be legally entitled.
`
`COUNT III: BREACH OF EXPRESS WARRANTY
`
`Plaintiffs incorporate by reference the allegations in all prior paragraphs.
`
`At all material times, Defendants manufactured, marketed, sold, distributed, and
`
`97.
`
`98.
`
`otherwise placed into the stream of commerce the APAP Products. These actions were under the
`
`ultimate control and supervision of Defendants.
`
`99.
`
`In advertising, marketing, and promoting the APAP Products to consumers, like
`
`Plaintiff Mother, Defendants expressly warranted that the APAP Products were safe for use and
`
`reasonably fit for their intended purposes. In advertising, marketing, and otherwise promoting the
`
`APAP Products, Defendants intended for pregnant consumers to rely upon their representations
`
`regarding safety and fitness, in an effort to induce them to purchase and consume the APAP
`
`Products during pregnancy to relieve pain.
`
`100. Defendants expressly warranted to Plaintiff Mother and pregnant consumers that
`
`the APAP Products were safe for ingestion during pregnancy.
`
`101. Defendants had a duty to exercise reasonable care in the research, development,
`
`design, testing, packaging, manufacture, inspection, labeling, distributing, marketing, promotion,
`
`sale, and release of the APAP Products, including a duty to:
`
`
`
`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 16 of 28
`
`16
`
`

`

`a. ensure that the APAP Products did not cause users and their unborn children
`
`unreasonably dangerous side effects;
`
`b. warn of dangerous and potentially incurable side effects; and
`
`c. disclose adverse material facts, such as the true risks associated with the use of and
`
`exposure to APAP during pregnancy, when making representations to users,
`
`consumers, and the general public, including Plaintiff Mother.
`
`102. Defendants had the ability to properly disclose the risks associated with APAP
`
`usage during pregnancy through multiple channels, not just labeling.
`
`103. At all relevant times, Defendants expressly represented and warranted to the
`
`purchasers of the APAP Products, by and through statements made by Defendants in labels,
`
`publications, brochures, and other written materials intended for consumers and the general public,
`
`that the APAP Products were safe to human health and the environment, effective, fit, and proper
`
`for their intended use. Defendants advertised, labeled, marketed, and promoted the APAP
`
`Products, representing the quality to consumers and the public in such a way as to induce their
`
`purchases or use, thereby making an express warranty that the APAP Products would conform to
`
`the representations.
`
`104. The representations about the APAP Products, as set forth herein, contained or
`
`constituted affirmations of fact or promises made by the seller to the buyer, which related to the
`
`goods and became part of the basis of the bargain, creating an express warranty that the goods
`
`would conform to the representations.
`
`105. Defendants breached express representations and warranties made to Plaintiff
`
`Mother, with respect to the APAP Products, including the following:
`
`
`
`Case 4:22-cv-00366-DGK Document 1 Filed 06/01/22 Page 17 of 28
`
`17
`
`

`

`a. Defendants represented through their labeling, advertising, and marketing materials
`
`that the APAP Products were safe, and intentionally withheld and concealed
`
`information about the risks of serious injury associated with use of APAP and by
`
`expressly limiting the risks associated with use within its warnings and labels; and
`
`b. Defendants represented that the APAP Products were safe for use and intentionally
`
`concealed information that demonstrated that APAP carries the significantly
`
`increased risk of causing neurodevelopmental disorders in children through
`
`prenatal exposure to APAP, and that the APAP Products, therefore, were not safer
`
`than alternatives available on the market.
`
`106. Plaintiff Mother detrimentally relied on the express warranties and representations
`
`of Defendants concerning the safety and/or risk profile of APAP in deciding to purchase the APAP
`
`Products. Plaintiff Mother reasonably relied upon Defendants to disclose known defects, risks,
`
`dangers, and side effects of APAP. Plaintiff Mother would not have purchased or used the APAP
`
`Products had Defendants properly disclosed the risks associated with the APAP Products, either
`
`through advertising, labeling, or any other form of disclosure.
`
`107. Plaintiff Mother had no knowledge of the falsity or incompleteness of Defendants’
`
`statements and representations concerning the APAP Products.
`
`108. Plaintiff Mother used and/or was exposed to APAP as researched, developed,
`
`designed, tested, manufactured, inspected, labeled, distributed, packaged, marketed, promoted,
`
`sold, or otherwise released into the stream of commerce by Defendants.
`
`109. Had the warnings, labels, advertisements, or promotional material for the APAP
`
`Products accurately and adequately set forth the true risks associated with the use of such Products,
`
`including Plaintiffs’ injuries, rather than expressly excluding such information and warranting that
`
`
`
`

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