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`Case 3:22-cv-05070-SK Document 1 Filed 09/07/22 Page 1 of 27
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`
`
`LAW OFFICES OF
`WALKUP, MELODIA, KELLY & SCHOENBERGER
`A PROFESSIONAL CORPORATION
`
`650 CALIFORNIA STREET, 26TH FLOOR
`SAN FRANCISCO, CALIFORNIA 94108-2615
`T: (415) 981-7210 · F: (415) 391-6965
`
`
`KHALDOUN A. BAGHDADI (State Bar #190111)
`kbaghdadi@walkuplawoffice.com
`
`MIKAL C. WATTS (Pro Hac Vice Forthcoming)
`Texas State Bar No. 20981820
`mcwatts@wattsguerra.com
`ALICIA D. O’NEILL (Pro Hac Vice Forthcoming)
`Texas State Bar No. 24040801
`aoneill@wattsguerra.com
`WATTS GUERRA LLC
`5726 W. Hausman Dr., Suite 119
`San Antonio, Texas 78249
`Direct: (210) 447-0500
`
`ATTORNEYS FOR PLAINTIFFS
`
`
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`OAKLAND DIVISION
`
`
`
`
`
`
`
`Ingrid Moran, Individually and as
`)
`Guardian Ad Litem to M.B., a minor,
`)
`and I.B., a minor,
`)
`
`)
`Plaintiffs,
`)
`
`)
`v.
`)
`
`)
`CVS Pharmacy, Inc.,
`)
`
`)
`Defendant
`
`Civil Action No.:
`
`ORIGINAL COMPLAINT
`
`
`
`
`DEMAND FOR JURY TRIAL
`
`PLAINTIFFS’ ORIGINAL COMPLAINT AND JURY DEMAND
`Plaintiff Ingrid Moran and Plaintiff M.B., a minor, and Plaintiff I.B., a minor, pursuant
`to Fed. R. Civ. P. 17(c)(1)(A), by and through their undersigned counsel, bring this Complaint
`for damages against Defendant CVS Pharmacy, Inc. (hereinafter, “Defendant”) and in support,
`state the following:
`This is an action brought on behalf of Plaintiffs, Ingrid Moran (hereinafter,
`1.
`“Plaintiff Mother”), the natural and general guardian and mother of M.B., a minor, and I.B., a
`minor (hereinafter, “Plaintiff Child” or “Plaintiff Children”), arising out of the failure of
`
`
`
`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
`
`
`
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`

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`Case 3:22-cv-05070-SK Document 1 Filed 09/07/22 Page 2 of 27
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`Defendant to warn about the dangers of prenatal exposure to Paracetamol, also known as
`Acetaminophen (hereinafter “APAP”). As a result, Plaintiffs have suffered permanent injuries
`and 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.
`Defendant entirely failed its duty to adequately warn of the hazards of prenatal
`2.
`exposure to APAP, which was a direct and proximate cause of Plaintiffs’ injuries and associated
`damages.
`
`STATEMENT OF PARTIES
`At all material times Plaintiffs have been citizens and residents of Alameda
`3.
`County, California, and the United States.
`CVS Pharmacy, Inc. is incorporated in Delaware with its principal place of
`4.
`business in Woonsocket, Rhode Island.
`CVS Pharmacy, Inc. is involved in the research, development, testing,
`5.
`manufacture, labeling, production, marketing, promotion, and/or sale of APAP through its over-
`the-counter store brand, acetaminophen (hereinafter, the “APAP Products”).
`CVS Pharmacy, Inc. is individually, and jointly and severally liable to Plaintiffs
`6.
`for damages they suffered, arising from Each Defendant’s design, manufacture, marketing,
`labeling, distribution, sale, and placement of the defective APAP Products into the market,
`effectuated directly and indirectly through its agents, servants, employees, and/or owners, all
`acting within the course and scope of its agencies, services, employments, and/or ownership.
`CVS Pharmacy, Inc. is vicariously liable for the acts and/or omissions of its
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`employees and/or agents, who were at all material times acting on behalf of CVS Pharmacy,
`Inc. and within the scope of its employment or agency.
`VENUE, JURISDICTION, and DIVISIONAL ASSIGNMENT
`This Court has subject-matter jurisdiction under 28 U.S.C. § 1332(a), based on
`8.
`complete diversity of citizenship between Plaintiffs and Defendant. See supra ¶¶ 3–4.
`The amount in controversy exceeds $75,000.
`9.
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`Case 3:22-cv-05070-SK Document 1 Filed 09/07/22 Page 3 of 27
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`Venue is proper in this Court pursuant to 28 U.S.C. § 1391 because the events or
`10.
`omissions giving rise to Plaintiffs’ claims occurred in this judicial district.
`Divisional Assignment: this case should be assigned to the Oakland division of
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`this district pursuant to Local Rule 3-2(c) because a substantial part of the events or omissions
`giving rise to this action occurred in Alameda, California.
`Defendant has and continues to conduct substantial business in the State of
`12.
`California and in this District, distributes the APAP Products in this District, receives
`substantial compensation and profits from sales of the APAP Products in this District, and has
`made material omissions and misrepresentations and breaches of warranties in this District and
`caused injuries in this District to Plaintiffs, among others, so as to subject Defendant to in
`personam jurisdiction in this District. It was foreseeable at all times that Defendant could be
`haled into court in the State of California for its conduct that caused injuries to citizens of
`California, like Plaintiffs in this action. An exercise of in personam jurisdiction by this Court
`over Defendant comports fully with due process and does not offend traditional notions of fair
`play and substantial justice.
`Defendant is registered to transact business in California.
`13.
`FACTS COMMON TO ALL COUNTS
`APAP Is Marketed as the Safe Pain Reliever
`for Pregnant Women, but APAP Can Cause ASD/ADHD in Children
`APAP is widely used by pregnant women to relieve pain or discomfort during
`14.
`the term of their pregnancy.
`APAP was initially discovered in the late 1800’s.
`15.
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`APAP was introduced to the US market in 1955 as the first aspirin-free pain
`reliever. APAP was originally marketed and sold as a product to reduce fever in children,
`packaged like a red fire truck with the slogan, “for little hotheads.”
`Billions of units of APAP are sold annually in North America alone.
`17.
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`APAP has long been marketed as the safest, and the only appropriate, over-the-
`counter pain relief drug on the market for pregnant women.
`
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`Forty to 65% of pregnant women in the United States use APAP during
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`19.
`pregnancy.
`Based upon information and belief, a majority of women who use APAP during
`20.
`pregnancy do so electively for the treatment of headaches, muscle pain, back pain, and
`discomfort.
`These pregnant women electively choose to take APAP because Defendant has
`21.
`marketed APAP as a safe pain reliever for pregnant women.
`However, scientific and epidemiological research shows that prenatal exposure
`22.
`to APAP alters fetal development significantly increasing the risks of neurodevelopmental
`disorders, including but not limited to, autism spectrum disorder (“ASD”) and attention-
`deficit/hyperactivity disorder (“ADHD”).
`Undisturbed development of the human brain in utero is vital to the health and
`23.
`wellness of a child’s development. The human brain is vulnerable and extremely sensitive in
`utero. During this sensitive time-period in utero, certain chemicals have been found to cause
`permanent brain injury at low exposure levels.
`Once ingested by the mother, APAP is known to readily cross the placenta and
`24.
`blood-brain barrier.
`ASD is a serious neurological and developmental disorder that affects how
`25.
`people interact with others, communicate, learn, and behave.
`There are three functional levels of ASD, with Level 1 requiring support with
`26.
`activities of daily living, Level 2 requiring substantial support with activities of daily living, and
`Level 3 requiring very substantial support with activities of daily living.
`Treatments for ASD include behavioral management therapy, cognitive behavior
`27.
`therapy, joint attention therapies, medications, occupational therapy, physical therapy, social
`skill training, and speech-language therapy. Treatment for ASD lasts a lifetime, as there is no
`cure.
`
`ADHD is a chronic neurodevelopmental disorder resulting in attention difficulty,
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`hyperactivity, and impulsiveness.
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`ADHD begins in childhood and persists through adulthood. ADHD contributes
`29.
`to low self-esteem, troubled relationships, and difficulty with school, work, and familial
`relationships.
`Treatments for ADHD, include, but are not limited to, chronic medication usage
`30.
`and various therapies. Treatment for ADHD lasts a lifetime, as there is no cure.
`In or around 2018, the Center for Disease Control and Prevention (“CDC”)
`31.
`found that 1 in 44 (2.3%) 8-year-old children have been diagnosed with ASD.
`This represents an increase from a prior CDC finding that 1 in 68 U.S. children
`32.
`born in 2002 have ASD, which already represented a more than a 100% increase compared with
`children born a decade prior.
`As of 2019, 8.8% of children had been diagnosed with ADHD, or roughly
`33.
`325,000 children per year.
`Parental awareness and changes in diagnoses do not account for the rapid rise in
`34.
`these diagnoses.
`Rather, neurotoxic exposures, such as prenatal APAP exposure, explain a
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`trending increase in diagnosis.
`For years, the scientific community has published studies showing that prenatal
`36.
`ingestion of APAP can cause ASD and ADHD.
`For instance, since 2013, there have been six European birth cohort studies,
`37.
`examining over 70,000 mother-child pairs, showing the association between prenatal use of
`APAP and ASD and ADHD.
`The overall body of scientific evidence has shown that prenatal use of APAP can
`38.
`cause ASD and ADHD in the child.
`During all relevant times herein, Defendant was engaged in the business of
`39.
`manufacturing and selling the APAP Products in the United States, and the weight of the
`scientific evidence available showed prenatal exposure to APAP significantly increases the risk
`of neurodevelopmental disorders in children exposed to APAP prenatally, including but not
`limited to ASD and ADHD.
`
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`At the time Plaintiff Mother was pregnant with Plaintiff Child the scientific
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`evidence regarding the risks of in utero exposure of APAP was available to Defendant, and
`Defendant knew or should have known that prenatal use of APAP can cause ASD or ADHD.
`Based on information and belief, Defendant has concealed the prenatal APAP
`41.
`exposure-neurodevelopmental link from consumers, like Plaintiff Mother. .
`42. Moreover, despite knowing that prenatal use of APAP can cause ASD or ADHD,
`Defendant continued, and continues, to market APAP Products as safe pain relievers for
`pregnant women, making mothers believe they are choosing a safe drug for even minor aches,
`pains, and headaches.
`Plaintiff Mother Took APAP Products while Pregnant,
`and It Caused ASD in Plaintiff Child M.B.
`Plaintiff Mother began using the APAP Products when she was pregnant with
`
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`her Plaintiff Child M.B.
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`Over the course of her pregnancy, Plaintiff Mother took the APAP Products for
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`pain relief approximately three times a week as needed for pain.
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`Plaintiff Mother believed it was safe for her to take the APAP Products during
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`her pregnancy.
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`Indeed, Plaintiff Mother was instructed to not take ibuprofen or aspirin while
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`pregnant, but was informed she could take APAP freely and without risk.
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`There is no warning on the APAP Products’ labels specifically addressing the
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`risks of ASD if a mother ingests APAP while pregnant.
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`Had Plaintiff Mother known of the risk of taking APAP while pregnant,
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`specifically that it could cause ASD in her child, she would not have taken the APAP Products.
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`Plaintiff Child M.B. was born on July 28, 2012.
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`Plaintiff Mother started to have concerns about Plaintiff Child M.B.’s
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`development due to developmental delays when she was a toddler.
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`Plaintiff Child M.B. was diagnosed with ASD when she was three years old.
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`Plaintiff Child M.B. has sensitivity to sound and has experienced difficulty
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`walking and talking.
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`Plaintiff Child M.B. is being provided an individualized education plan for ASD
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`from her school, including speech and occupational therapy.
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`Plaintiff Child M.B. requires an immense amount of assistance to complete the
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`normal tasks of her daily life.
`Plaintiff Child M.B.’s ASD puts an incredible strain on Plaintiff Mother and their
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`family.
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`Plaintiff’s Mother fears for Plaintiff Child M.B. and experiences substantial
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`stress and anxiety due to the challenges associated with Plaintiff Child M.B.’s ASD.
`
`Plaintiff Mother Took APAP Products while Pregnant,
`and It Caused ASD in Plaintiff Child I.B.
`Plaintiff Mother began using the APAP Products when she was pregnant with
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`her Plaintiff Child I.B.
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`Over the course of her pregnancy, Plaintiff Mother took the APAP Products for
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`pain relief approximately two times a week as needed for pain.
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`Plaintiff Mother believed it was safe for her to take the APAP Products during
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`her pregnancy.
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`Indeed, Plaintiff Mother was instructed to not take ibuprofen or aspirin while
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`pregnant, but was informed she could take APAP freely and without risk.
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`There is no warning on the APAP Products’ labels specifically addressing the
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`risks of ASD if a mother ingests APAP while pregnant.
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`Had Plaintiff Mother known of the risk of taking APAP while pregnant,
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`specifically that it could cause ASD in her child, she would not have taken the APAP Products.
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`Case 3:22-cv-05070-SK Document 1 Filed 09/07/22 Page 8 of 27
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`Plaintiff Child I.B. was born on June 4, 2015.
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`Plaintiff Mother started to have concerns about Plaintiff Child I.B.’s
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`development due to developmental delays when he was a baby.
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`Plaintiff Child I.B. was diagnosed with ASD when he was two years old.
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`Plaintiff Child I.B. has sensitivity to sound, is easily frightened or triggered by
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`outside stimuli, has intense and uncontrollable mood swings, and displays compulsive behaviors
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`like scratching himself.
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`Plaintiff Child I.B. is being provided an individualized education plan for ASD
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`from his school, including speech and occupational therapy.
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`Plaintiff Child I.B. requires an immense amount of assistance to complete the
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`normal tasks of his daily life.
`Plaintiff Child I.B.’s ASD puts an incredible strain on Plaintiff Mother and their
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`family.
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`Plaintiff’s Mother fears for Plaintiff Child I.B. and experiences substantial stress
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`and anxiety due to the challenges associated with Plaintiff Child I.B. ’s ASD.
`
`ESTOPPEL AND TOLLING OF STATUTE OF LIMITATIONS
`Due to Defendant’s acts of fraudulent concealment, Defendant is estopped from
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`relying on any statutes of limitations or repose. Such acts include Defendant’s intentional
`concealment from Plaintiff Mother and the general public that APAP is defective when there is
`prenatal exposure, while continuing to market the APAP Products with the adverse effects
`described in this Complaint.
`Given Defendant’s affirmative actions of concealment by failing to disclose
`72.
`information about the defects known to it but not the public—information over which
`Defendant had exclusive control—and because Plaintiff Mother could not reasonably have
`known that the APAP Products were defective, Defendant is estopped from relying on any
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`Case 3:22-cv-05070-SK Document 1 Filed 09/07/22 Page 9 of 27
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`statutes of limitations that might overwise be applicable to the claims asserted in this
`Complaint.
` CLAIMS FOR RELIEF
`COUNT I: STRICT LIABILITY – FAILURE TO WARN
`Plaintiffs restate, reallege, and incorporate by reference the allegations set forth
`73.
`in the rest of this Complaint as if fully set forth herein.
`At the time of Plaintiffs’ injuries, the APAP Products were defective and
`74.
`unreasonably dangerous to foreseeable consumers using the APAP Products in a foreseeable
`manner during pregnancy, including Plaintiff Mother, because they lacked an adequate warning.
`At all relevant times, Defendant engaged in the business of testing, developing,
`75.
`designing, manufacturing, marketing, labeling, selling, distributing, and promoting the APAP
`Products, which were defective and unreasonably dangerous to consumers, including Plaintiff
`Mother, because they did not contain adequate warnings or instructions concerning the
`dangerous characteristics of ingesting APAP during pregnancy. These actions were under the
`ultimate control and supervision of Defendant. At all relevant times, Defendant registered,
`researched, manufactured, distributed, marketed, labeled, promoted, and sold the APAP
`Products within this District and aimed the marketing at the ultimate consumer. Defendant was
`at all relevant times involved in the retail and promotion of the APAP Products marketed and
`sold in this District.
`Defendant had a duty to warn of the risks associated with the use of the APAP
`76.
`products during pregnancy.
`The APAP Products ingested by Plaintiff Mother during pregnancy were in the
`77.
`same or substantially similar condition as they were when they left possession of Defendant.
`Defendant expected and intended the APAP Products to reach users such as
`78.
`Plaintiff Mother in the condition in which the APAP Products were sold.
`Plaintiff Mother did not materially alter the APAP Products prior to ingestion.
`79.
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`Plaintiff Mother ingested the APAP Products during pregnancy as indicated on
`the APAP Products’ labels.
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`Plaintiff Mother was unaware of the defects and dangers of the APAP Products
`81.
`during pregnancy and was specifically unaware that prenatal exposure increases the risk of brain
`and behavioral development of children in utero.
`The labels on the APAP Products to consumers lack any warning specific to
`82.
`pregnant women. The information that Defendant did provide or communicate to consumers
`failed to contain relevant warnings, hazards, and precautions that would have enabled
`consumers such as Plaintiff Mother to utilize the products safely and with adequate protection
`during pregnancy, or to decide to not use or ingest the APAP Products at all.
`This alleged failure to warn is not limited to the information contained on the
`83.
`APAP Products’ labeling. Defendant was able, in accord with federal law, to comply with
`relevant state law by disclosing the known risks associated with exposure to or use of APAP
`during pregnancy through other non-labeling mediums, including, but not limited to, promotion,
`advertisements, public service announcements, and/or public information sources. But
`Defendant did not disclose these known risks through any medium.
`At all relevant times, Defendant had a duty to properly test, develop, design,
`84.
`manufacture, inspect, package, label, market, promote, sell, distribute, maintain, and supply the
`APAP Products; provide proper warnings for the APAP Products; and take such steps as
`necessary to ensure the APAP Products did not cause users and consumers, and their children,
`to suffer from unreasonable and dangerous risks. Defendant had a continuing duty to warn
`Plaintiff Mother of dangers associated with exposure to or use of APAP during pregnancy.
`Defendant, as a manufacturer, seller, and/or distributor of pharmaceutical medication, is held to
`the knowledge of an expert in the field.
`At the time of manufacture, Defendant could have provided the warnings or
`85.
`instructions regarding the full and complete risks of the APAP Products during pregnancy
`because Defendant knew or should have known of the unreasonable risks of ASD and ADHD
`associated with prenatal exposure to and/or the use of such products.
`At all relevant times, Defendant failed and deliberately refused to investigate,
`86.
`study, test, or promote the safety of the APAP Products, or to minimize the dangers to
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`consumers of the APAP Products and to those who would foreseeably use or be harmed by the
`APAP Products, including Plaintiffs.
`Defendant failed to adequately warn consumers, like Plaintiff Mother, about the
`87.
`significant increased risk of neurodevelopmental disorders in children exposed to APAP
`prenatally, including but not limited to ASD and ADHD.
`Defendant failed to adequately inform reasonably foreseeable consumers, like
`88.
`Plaintiff Mother, of the proper usage of the APAP Products.
`Even though Defendant knew or should have known that APAP posed a grave
`89.
`risk of harm to Plaintiff Child, Defendant failed to exercise reasonable care to warn of the
`dangerous risks associated with use and prenatal exposure.
`Plaintiff Mother was exposed to the APAP Products during pregnancy without
`90.
`knowledge of their dangerous characteristics.
`At all relevant times, Plaintiff Mother used and/or was exposed to the use of the
`91.
`APAP Products while using them for their intended or reasonably foreseeable purposes during
`pregnancy, without knowledge of their dangerous characteristics.
`Plaintiff Mother could not have reasonably discovered the defects and risks
`92.
`associated with the APAP Products prior to or at the time of Plaintiff consuming APAP during
`pregnancy. Plaintiff Mother relied upon the skill, superior knowledge, and judgment of
`Defendant to know about and disclose serious health risks associated with using the APAP
`Products.
`If Plaintiff Mother had been properly warned of the defects, dangers, and risks
`93.
`associated with prenatal exposure to APAP, Plaintiff Mother would have utilized the APAP
`Products safely and with adequate protection during pregnancy or would have decided to not
`ingest the APAP Products at all. Defendant’s failure to properly warn of those defects, dangers,
`and risks associated with prenatal exposure to APAP was a substantial factor in causing
`Plaintiffs’ injuries and damages.
`Defendant is liable to Plaintiffs for injuries caused by Defendant’s negligent or
`94.
`willful failure, as described above, to provide adequate warnings or other relevant information
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`and data regarding the appropriate use of the APAP Products and the risks associated with the
`use of APAP.
`As a direct and proximate result of Defendant placing defective APAP Products
`95.
`into the stream of commerce, and Plaintiff Mother’s foreseeable use and ingestion of the APAP
`Products during pregnancy, Plaintiff Child was exposed to APAP prenatally, causing him to
`develop ASD and ADHD.
`As a direct and proximate result of Defendant placing defective APAP Products
`96.
`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 II: NEGLIGENCE
`Plaintiffs restate, reallege, and incorporate by reference each of the allegations
`97.
`set forth in the rest of this Complaint as if fully set forth herein.
`Although Defendant had a duty to use reasonable care in testing, developing,
`98.
`designing, manufacturing, marketing, labeling, selling, distributing, promoting, and preparing
`written instructions and warnings for the APAP Products, Defendant failed to do so.
`Defendant, directly or indirectly, caused the APAP Products to be sold,
`99.
`distributed, packaged, labeled, marketed, promoted, and/or used by Plaintiff Mother. At all
`relevant
`times, Defendant registered, researched, manufactured, distributed, marketed,
`promoted, and sold the APAP Products within this district and aimed at a consumer market
`within this district.
`100. Defendant knew, or in the exercise of reasonable care should have known, that
`the APAP Products were defectively and unreasonably designed and/or manufactured, and/or
`marketed, and were unreasonably dangerous and likely to injure persons that were prenatally
`exposed to them. Defendant knew or should have known that Plaintiff Mother was unaware of
`the dangers and defects inherent in the APAP Products when she was ingesting them during her
`pregnancy with Plaintiff Child.
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`101. At all relevant times, Defendant had a duty to exercise reasonable care in the
`marketing, advertisement, promotion, and sale of the APAP Products. Defendant’s duty of care
`owed to consumers and the general public included providing accurate, true, and correct
`information concerning the risks of using APAP during pregnancy and appropriate, complete,
`and accurate warnings concerning the potential adverse effects of APAP and, in particular, the
`significantly increased risk of causing neurodevelopmental disorders in children through
`prenatal exposure to APAP.
`102. At all relevant times, Defendant knew or, in the exercise of reasonable care,
`should have known of the hazards and dangers of APAP ingestion while pregnant and,
`specifically, the significantly increased risk of causing neurodevelopmental disorders in
`children through prenatal exposure to APAP.
`103. Defendant failed to provide any kind of warning to pregnant consumers, like
`Plaintiff Mother, about the significantly increased risk of causing neurodevelopmental disorders
`in children through prenatal exposure to APAP.
`104. Accordingly, at all relevant times, Defendant knew or, in the exercise of
`reasonable care, should have known that use of the APAP Products during pregnancy could
`cause Plaintiffs’ injuries, and thus, create a dangerous and unreasonable risk of injury to the
`users of these products, including Plaintiffs.
`105. As such, Defendant breached its duty of reasonable care and failed to exercise
`ordinary care in the design, research, development, manufacture, testing, marketing, labeling,
`supply, promotion, advertisement, packaging, sale, and distribution of the APAP Products, in
`that Defendant manufactured and produced defective APAP Products, which carry the
`significantly increased risk of causing neurodevelopmental disorders in children through
`prenatal exposure to APAP; knew or had reason to know of the defects inherent in the APAP
`Products; knew or had reason to know that a user’s or consumer’s use of the APAP Products
`during pregnancy created a significant risk of harm and unreasonably dangerous side effects;
`and failed to prevent or adequately warn of these risks and injuries.
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`106. Defendant had a duty to disclose the truth about the risks associated with
`exposure to or use of APAP during pregnancy in its promotional efforts outside of the context
`of labeling. Defendant was negligent in its promotion of APAP outside of the labeling context
`by failing to disclose material risk information as part of its promotion and marketing of the
`APAP Products, including through the internet, television, and print advertisements.
`107. Despite Defendant’s ability and means to investigate, study, and test the APAP
`Products and to provide adequate warnings regarding use during pregnancy, Defendant failed to
`do so. Indeed, Defendant wrongfully concealed information and further made false and/or
`misleading statements concerning the safety and use of APAP.
`108. Defendant’s negligence included:
`creating,
`formulating,
`promoting,
`producing,
`a. Manufacturing,
`developing, designing, selling, and/or distributing the APAP Products
`while negligently and/or intentionally concealing and failing to disclose
`the results of trials, tests, and studies of APAP and the significantly
`increased risk of causing neurodevelopmental disorders in children
`through prenatal exposure to APAP, and, consequently, the risk of
`serious harm associated with human use of APAP during pregnancy;
`b. Failing to undertake sufficient studies and conduct necessary tests to
`determine whether or not the APAP Products were safe for its intended
`consumer use and unborn children; and
`c. Failing to provide adequate instructions, guidelines, and safety
`precautions to those persons Defendant could reasonably foresee would
`use the APAP Products during pregnancy; and
`d. Failing to disclose to Plaintiff Mother, users, consumers, and the
`general public that use of APAP during pregnancy presents severe risks
`of neurodevelopmental disorders in children exposed to APAP
`prenatally; and
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`CIVIL COMPLAINT FOR DAMAGES AND JURY DEMAND
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`e. Failing to warn Plaintiff Mother, users, consumers, and the general
`public that the APAP Products’ risk of harm was unreasonable and that
`there were safer and effective alternative medications or treatments
`available to Plaintiff Mother and other users and/or consumers; and
`f. Representing that the APAP Products were safe for their intended
`purposes for pregnant women when, in fact, Defendant knew or should
`have known the APAP Products were not safe for their intended
`purposes; and
`g. Declining to make or propose any changes to the APAP Products’
`labeling or other promotional materials that would alert users,
`consumers, and the general public of the risks of APAP, including to
`pregnant women; and
`h. Advertising, marketing, and recommending the use of the APAP
`Products during pregnancy, while concealing and failing to disclose or
`warn of the dangers known by Defendant to be caused by the use of or
`exposure to APAP; and
`i. Continuing to disseminate information to its consumers and the general
`public, which indicates or implies that the APAP Products are not
`unsafe for pregnant consumer use; and
`j. Continuing the manufacture and sale of the APAP Products with the
`knowledge that the APAP Products were unreasonably unsafe and
`dangerous.
`109. Defendant knew and/or should have known that it was foreseeable that children
`such as Plaintiff Child would suffer injur