throbber
Case: 1:22-cv-00539 Document #: 1-1 Filed: 01/31/22 Page 1 of 31 PageID #:10
`Case: 1:22-cv-00539 Document M2-Rersem Jarg1/22 Page 1 of 31 PagelD.#:10
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`FILED
`1/26/2022 4:52 PM
`IRIS Y. MARTINEZ
`CIRCUIT CLERK
`IN THE CIRCUIT COURT OF COOK COUNTY,ILLINOIS Goo COUNTYIL
`COUNTY DEPARTMENT,LAW DIVISION
`16458002
`
`ELLEN BEASLEY,
`
`Plaintiff,
`
`v.
`
`20221000833
`‘CauseNo.
`
`“Hearing Date:3/29/2022 10:00 AM
`
`ACTAVIS LLC f/k/a ACTAVIS INC.,
`ACTAVIS PHARMA,INC., AND
`SAGENT PHARMACEUTICALSINC,,
`
`: Plaintiff Demands a
`: Trial by Jury
`
`Defendants.
`
`COMPLAINTATLAW
`
`NOW COMESPlaintiff ELLEN BEASLEY, by and throughherattorneys, Kelleher +
`
`Holland, LLC, and for her Complaint against defendants Actavis LLC f/k/a Actavis Inc.,
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`Actavis Pharma,Inc. and Sagent Pharmaceuticals Inc.(collectively “Defendants”), alleges
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`as follows:
`
`A. Plaintiff
`
`PARTIES
`
`1, Plaintiff is an individual residing in Southside, Alabama whoreceived Docetaxel
`
`Injection as part of a weekly chemotherapy regimen after being diagnosed with breast
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`cancer at Hematology & Oncology Associates of Alabama in Gadsden, Alabama.
`
`B. Defendants
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`2. Defendant Actavis LLC f/k/a Actavis Inc. is a pharmaceutical limited liability
`
`

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`company organized and existing underthe lawsof the State of Delaware with a principal
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`place of business at 60 Columbia Road, Building B, Morristown, New Jersey 07960 and
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`400 Interpace Parkway, Parsippany, New Jersey 07054.
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`3. Defendant Actavis Pharma Inc. is a pharmaceutical company organized and
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`existing under the laws of State of Delaware with a principal place of business at 400
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`Interpace Parkway, Parsippany, New Jersey 07054, In 2016, Teva Pharmaceuticals, Ltd.
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`Acquired Defendant Actavis PharmaInc.Prior to 2016, Actavis PharmaInc. was a wholly
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`owned subsidiary of Defendant Actavis LLC f/k/a Actavis Inc.
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`4, Defendant Sagent Pharmaceuticals, Inc. (“Sagent”) is incorporated underthe laws
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`of Delaware and maintains its principal place of business at 1901 N. Roselle Road, Ste.
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`700, Schaumburg, [linois 60195,
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`5. Defendants transacted and conducted business throughout the United States and
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`in thestate of Illinois.
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`6. Defendants derived substantial revenue from goods and products designed,
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`manufactured, marketed, advertised, promoted, sold and distributed throughout the
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`United States.
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`7. At all relevant times, Defendants were in the business of designing, testing,
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`manufacturing, labeling, advertising, marketing, promoting, selling and/or distributing
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`Docetaxel Injection approved by the FDA under NDA #203551.
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`8. The proprietary name for Defendants’ branded drug is Docetaxel Injection
`
`

`

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`Concentrate,
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`9, Defendants expected that Docetaxel Injection would be sold, purchased, and used
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`throughout the United States.
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`10, Defendant Actavis filed NDA #203551 on March 14, 2012 under Section 505(b)(2)
`
`of the Federal Food Drug and Cosmetic Act. Its application relied for its approval on
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`FDA'sfindings of safety and effectiveness for the reference listed drug Taxotere. Sagent
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`also sold this product (NDCs: 25021-222-01, 25021-222-04, and 25021-222-07) manufactured by
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`Actavis under Actavis’ NDA
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`11, Defendants one-vial formulation, however, was different from Taxotere’s one-vial
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`formulation becauseit is offered at an additional 140 mg dosage form, contains excipients
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`citric acid and Kollidor 12 PF (Povidone k12), and uses reduced ieveis of polysorbate 80.
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`After Actavis’ initial Docetaxel Injection approval, a 160 mg dosage form was also
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`introduced.
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`JURISDICTION AND VENUE
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`12. As a citizen of Wlinois, Defendant Sagentis subject to personal jurisdiction in this
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`Court, and venue is proper here under 735 ILCS 5/2-101. This case is not removable to
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`federal court because Plaintiff sues Sagent in its homestate.
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`13. Defendants Actavis LLC and Actavis Pharma,Inc. regularly conduct business in
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`the state and are subjectto its jurisdiction.
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`14, Because venue is properas to Sagent, venue is properfor all Defendants underthe
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`

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`tules of permissive joinder.
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`FACTUAL ALLEGATIONS
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`I. Development and Approval of Docetaxel Injection
`
`15. Taxotere and Docetaxel Injection are drugs used in the treatmentof various forms
`
`of cancer, including breast cancer, and are a part of a family of cytoxic drugs referred to
`
`as taxanes. Taxanes are derived from yew trees, and unlike other cytoxic drugs, taxanes
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`inhibit the multiplication of cancer cells by over-stabilizing the structure of a cancer cell,
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`which prevents the cell from breaking down and reorganizing for cell reproduction. They
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`are widely used as chemotherapy agents.
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`16. The FDAfirst approved Taxotere on May 14, 1996 for limited use—namely,for the
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`treatment of patients with locally advanced or metastatic breast cancer that hadeither (1)
`
`progressed during anthracycline-based therapy or (2) relapsed during anthracycline-
`
`based adjuvant therapy.
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`17. In August, 2004, the manufacturer of Taxotere obtained FDA approval for an
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`expandeduse of the drug “in combination with doxorubicin and cyclophosphamide for
`
`the adjuvant treatment of patients with operable node-positive breast cancer.” This
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`resulted in a greater number of patients being treated with Taxotere.
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`18. As the universe of patients taking Taxotere expanded to include patients with a
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`higher survivability rate, more cancer survivors taking Taxotere would now experience
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`a permanent disabling (but preventable) condition—namely, permanent damageto the
`
`

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`lacrimal system.
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`19, On March 14, 2012, Actavis filed NDA application #203551 to marketits Docetaxel
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`Injection under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“FDCA”),
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`codified at §21 U.S.C. 355(b)(2).
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`20. Actavis received FDA approval for NDA #203551 on April 12, 2013 and began
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`marketing these dosage forms on July 1, 2013.
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`21. Since approval, Actavis has submitted multiple Changes Being Effected
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`Supplemental New Drug Applications (“CBE sNDA”) to updateits labeling.It submitted
`
`a CBE sNDA (5-001) on May 14, 2013, which was approved on November4, 2013. It also
`
`submitted a “Prior Approval” sNDA (5-002) on March 21, 2014, which was approved on
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`September 17, 2014. Neither submission, however, updated its labeling concerning
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`permanent damageto the lacrimal system.
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`22. Docetaxel Injection is not purchased by patients at a pharmacy; rather, patients’ use
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`of this drug occurs via administration through injection and/or intravenously at a
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`physician’s office or medical treatmentfacility.
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`

`

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`Ii,
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`Anatomy of Lacrimal System
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`23. The following image depicts the anatomyofthe lacrimal system.
`
`ee
`‘
`eeHere th
`aR sips
`4
`eerie
`
`td pitt
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`24, Docetaxel Injection is secreted in the tear film, thereby causingfibrosis in areas of
`
`the lacrimal system, including the lacrimal punctum, canaliculi and/or nasolacrimal duct.
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`This scarring can cause permanent occlusion, causing an inability for tears to drain
`
`naturally through the lacrimal system. Because the eyes are constantly producingtears,
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`this results in persistent epiphora.
`
`Hil.
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`Docetaxel Injection’s Labeling
`
`25. At the time Plaintiff was administered Docetaxel Injection Concentrate,its
`
`labeling stated in relevant part under Post-Marketing Experiences:
`
`Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or without conjunctivitis. Excessive tearing which may be
`attributable to lacrimal duct obstruction has been reported. Rare cases oftransient visual disturbances(flashes,flashing lights,
`scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions have been reported, These were
`
`reversible upon discontinuation ofthe infusion.
`
`

`

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`and under Patient Counseling Information:'
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`* Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site
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`reactions, and hair loss are associated with docetaxel administration.
`
`26, Additionally, in the Patient Information section of the label, Defendants include
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`“redness of the eye, excess tearing” among “the most commonside effects of Docetaxel
`
`Injection.” Id. Defendants’ inclusion ofthis potentially permanentside effect in a laundry
`
`list of common, but notably transitory, side effects effectively misrepresents the risk of
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`harm associated with tearing. By failing to fully inform patients and physicians of the
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`potential for serious permanent damage to the lacrimal system, Defendants downplay
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`the significance of the underlying injury causing epiphora.
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`27. Defendants’ labeling informationat ail times relevant to this lawsuit, and even to
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`date, does not identify the risk of stenosis as a cause of excessive tearing, the rapid onset
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`at which stenosis can occur, the potentially permanent nature of the injury, the need to
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`refer patients to a lacrimal specialist, nor does it identify the condition as preventable
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`with timely intervention during chemotherapy.
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`28, Defendants did not provide such adequate notice to oncologists. To the contrary,
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`the labeling leads oncologists, like Plaintiff's, to believe that excessive tearing is merely a
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`transitory side effect and will end after the cessation of chemotherapy. This failure to
`
`provide notice resulted in thousands of women, like Plaintiff, suffering daily from a
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`\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551s0011bl.pdf
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`

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`permanent condition that could have easily been prevented with adequate warning.
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`IV.
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`Defendants’ Duty to Monitor and Update Labeling
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`29. The primary responsibility for timely communicating complete, accurate, and
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`current safety and efficacy information related to Docetaxel Injection rests with
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`Defendants because they have superior, and in many cases exclusive access to the
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`relevant safety and efficacy information, including post-market complaints and data.
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`30. To fulfill its essential responsibilities, Defendants must vigilantly monitor all
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`reasonably available information. It must closely evaluate the post-market clinical
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`experience of its drugs and timely provide updated safety and efficacy information to the
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`healthcare community and to consumers.
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`31. When monitoring and reporting adverse events, as required by both federal
`
`regulations and state law, timeis of the essence. The purpose of monitoring a product's
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`post-market experience is to detect potential safety signals that could indicate to drug
`
`sponsors and the medical community that a public safety problem exists.
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`32. If, for example, a manufacturer was to delay reporting post-market information,
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`that delay could mean that researchers, FDA, and the medical community are years
`
`behind in identifying a public safety issue associated with the drug.
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`33.In the meantime, more patients are harmed by using the product without
`
`knowing, understanding, and acceptingits true risks, which is why drug sponsors must
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`not only completely and accurately monitor,
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`investigate and report post-market
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`

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`experiences, but must also report the data in a timely fashion.
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`34, A drug is “misbranded” in violation of the FDCA whenits labeling is false and
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`misleading or does not provide adequate directions for use and adequate warnings. See
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`21 U.S.C. §§ 321(n); 331(a),
`
`(b),
`
`(Kk); 352(a),
`
`(f). A drug’s labeling satisfies federal
`
`requirements if it gives physicians and pharmacists sufficient information—including
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`indications for use and “any relevant hazards, contraindications, side effects, and
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`precautions” —to allow those professionals “to use the drug safely and for the purposes
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`for which it is intended.” 21 C.F.R. § 201.100(c)(1).
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`35. As part oftheir responsibility to monitor post-marketclinical experiences with the
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`drug and provide updatedsafety and efficacy information to the healthcare community
`
`and to consumers, each approved NDA applicant “must promptly review all adverse
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`drug experience information obtained or otherwise received by the applicant from any
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`source, foreign or domestic, including information derived from commercial marketing
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`experience,
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`post
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`marketing
`
`clinical
`
`investigations,
`
`post
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`marketing
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`epidemiological/surveillance studies, reports in the scientific literature, and unpublished
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`scientific papers.” 21 C.F.R. § 314.80(b).
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`36, Any report of a “serious and unexpected” drug experience, whether foreign or
`
`domestic, must be reported to the FDA within 15 days and must be promptly investigated
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`by the manufacturer. 21 C.F.R. § 314.80(c)(1)(i-ii).
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`37. Most other adverse event reports must be submitted quarterly for three years after
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`

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`the application is approved and annually thereafter. 21 C.F.R. § 314,80(c)(2)(i). These
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`periodic reports must include a “history of actions taken since the last report because of
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`adverse drug experiences (for example, labeling changesor studiesinitiated),” 21 CF.R.
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`§ 314.80(c)(2)(ii).
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`38. Federal law requires labeling to be updated as information accumulates: “labeling
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`must be revised to include a warning abouta clinically significant hazard as soon as there
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`is reasonable evidence of a causal association with a drug; a causal relationship need not
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`have been definitely established.” 21 C.F.R. § 201.57(c)(6)(i). Thus, for example, drug
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`manufacturers must warn of an adverse effect where there is “somebasis to believe there
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`is a causal relationship between the drug and the occurrence of the adverse event.” 21
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`C.E.R, § 201.57(c)(7).
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`39. All changes to drug labels require FDA assent, 21 C.F.R. § 314.70(b)(2)(v)(A).
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`Brand-name drug sponsors may seek to change their approved labels by filing a
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`supplemental application. 21 C.F.R. § 314.70,
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`40. One regulation,
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`the “Changes Being Effected” (CBE) regulation, permits a
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`manufacturer to unilaterally change a drug label to reflect “newly acquired information,”
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`subject to later FDA review and approval. 21 C.F.R. § 314.70(c)(6)(iii). Newly acquired
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`information includes “new analyses of previously submitted data.” 21 C.F.R. § 314.3(b).
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`41, Thus, for instance, if a drug sponsor determined that a warning was insufficient
`
`based on a new analysis of previously existing data, it could submit a CBE and changeits
`
`

`

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`labeling.
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`42, The longer a drug sponsor delays updatingits labeling to reflect currentsafety
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`information, the more likely it is that medical professionals will prescribe the drug
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`without advising patients of harmful adverse reactions, and the morelikely it is that
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`patients will suffer harmful side effects without the opportunity to evaluate risks for
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`themselves.
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`VY. Defendants Knew That Docetaxel Injection Can Cause Permanent Nasolacrimal
`Duct Obstruction
`
`43. After Defendants submitted their NDA for approval to the FDA, accumulating
`
`data demonstrated that the warning advising of “lacrimal duct obstruction” failed to
`
`adequately communicate to oncologists the severity and permanency of Docetaxel
`
`Injection-related epiphora. This accumulating data highlighted concernsof the increased
`
`frequency and severity of docetaxel-induced permanent stenosis in cancer patients, the
`
`increased need for monitoring, and the lack of awareness among oncologists and their
`
`patients regarding the true nature of the damage caused. The following excerptsare just
`
`a sampling of the accumulating data:
`
`The second most common adverse event [of docetaxel
`®
`
`administration] was watery and_tearingeyes
`
`(epiphora), affecting 55 patients (50.9%)in the one week
`group... this side effect was very specific for the weekly
`regimen and the frequency increased for every
`
`1]
`
`

`

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`consecutive treatment cycle.?
`
`*
`
`In conclusion,it is important for oncologists to be aware
`of this adverse event, and ophthalmologists should be
`consulted in cases in which tears appear during
`docetaxel therapy.
`
`44, Following the approval of Defendants’ NDA, published studies highlighted an
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`ongoing problem that oncologists did not appreciate the seriousness of potential
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`permanent damageto the lacrimal system as a result of Docetaxel Injection. Despite the
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`prevalence of accumulating data, Defendants took no efforts to analyze this data and
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`take measures to add a stronger warning to the oncological community.
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`45, Defendants’ decision to willfully ignore this data resulted in an increase of cases
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`of permanentinjuries to the end usersof its product.
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`46. Defendants had ample opportunity to utilize the CBE process and unilaterally
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`strengthen its label to raise awareness among oncologists as recommended by the
`
`studies. Of note, in 2018 Defendants utilized the CBE process to change their warning
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`label regardingthe side effects of alopecia. Specifically, Defendants soughtto strengthen
`
`the warning to include the word “permanent” with regard to alopecia.
`
`* Sorbe, Bengt, et al., A Study ofDocetaxel Weekly or Every Three Weeks in Combination with
`Carboplatin as First Line Chemotherapy in Epithelial Ovarian Cancer: Hematological and Non-
`Hematological Toxicity Profiles, 5(4) ONCOLOGY LETTERS 1140-1148 (2013).
`
`3'Yamagishi, T., Ochi, N., Yamane, H.et al. Epiphora in Lung Cancer Patients Receiving
`Docetaxel: A Case Series, 7 BMC Res NOTES 322 (2014).
`
`

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`47. Medical literature is clear that: (1) the onset of damageto the lacrimal system can
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`be rapid uponinitiation of Docetaxel Injection administration; (2) immediate referral to
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`a lacrimalspecialist for monitoring is essential; (3) damageto the lacrimal system can be
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`permanent; (4) this side effect is preventable, and (5) oncologists are not aware of the
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`severity of this side effect. Unfortunately this lack of awareness often results in
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`oncologists counseling their patients that their tearing is a temporary side effect and will
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`eventually subside.
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`VI. Docetaxel Injection Caused Plaintiff’s Permanent Nasolacrimal Duct Obstruction
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`48, Plaintiff was diagnosed with breast cancer and wasinitially given chemotherapy
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`with Defendants’ Docetaxel Injection. However, during her ten rounds of Docetaxel
`
`Injection, she developed tearing and exhaustion and was switched to Taxolfor herfinal
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`two chemotherapy treatments.
`
`49, Plaintiff completed chemotherapy and wasexcited to be cancerfree and rid of all
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`of the side effects she suffered as a result of the cancer treatment. Amongthese, Plaintiff
`
`looked forward to no longer suffering from constantly irritated, watering eyes. But as
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`the effects of chemotherapy wore off,
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`the epiphora continued; however Plaintiff
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`remained hopeful that it would eventually resolve, To her dismay,it never has.
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`50, Plaintiff continues to experience persistent tearing and a disruption oflife. As a
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`direct and proximate result of Defendants’ conduct in connection with the design,
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`development, manufacture,
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`testing, packaging, promotion, advertising, marketing,
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`

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`distribution, labeling, warning, and sale of Docetaxel Injection, Plaintiff suffers from
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`epiphora due to permanent nasolacrimal duct obstruction. This condition is a known
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`permanentside effect of taking Docetaxel Injection concentrate.
`
`51. As a result of this permanent side effect, Plaintiff has struggled to return to
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`normalcy even after surviving cancer, because she continues to suffer from persistent
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`tearing on a daily basis, interfering with her ability to perform basic activities and enjoy
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`life. This permanent change hasaltered Plaintiff's self-image, negatively impacted her
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`relationships, and others’ perceptions of her, leading to social isolation and depression
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`even longafter fighting cancer.
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`52. Plaintiff's tearing impacts all aspects of her daily life. Prior to developing
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`permanent nasolacrimal duct obstruction, Plaintiff was self-confident and enjoyed social
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`interactions with other people, Now she lacks the confidence she previously enjoyed.
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`Plaintiff is anxious aboutsocial interactions because she fears people will perceive her
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`as sad and crying. Hertears spill out over her cheeks, making her skin irritated and she
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`is unable to keep makeup on herface. She is aware of the concerned looks from well-
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`intentioned friends and strangers whoperceive her to be emotional and upset.
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`53. Due to the nasolacrimal duct obstruction Plaintiff feels as though most daily
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`activities are more trouble than they are worth. Plaintiff has difficulty watching
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`television, driving, and reading as a result of the tearing. In particular, reading has
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`become so difficult that Plaintiff needs a line marker and magnifying glass. The only
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`

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`time that Plaintiff does not feel discomfort from the tearing is when her eyes are shut.
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`Simply put, Plaintiff's tearing has negatively impacted her whole wayoflife.
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`54, Plaintiff has undergone multiple surgeries to repair her lacrimal system and
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`alleviate the persistent epiphora. Nevertheless, Plaintiff continues to suffer from painful
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`and debilitating tearing.
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`55. Plaintiff's injuries could have been prevented had Defendants simply warnedthat
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`permanent nasolacrimal duct obstruction is a common but preventable side effect of
`
`Docetaxel
`
`Injection concentrate. Specifically, had Defendants properly warned
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`Plaintifi’s oncologist of the rapid onset of permanent damage, her oncologist would
`
`have advised her to inform him immediately at the onset of her symptomsandreferred
`
`her to the appropriate lacrimal specialist. Plaintiff thus seeks recovery for her mental
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`and physical suffering stemming from permanent, but easily preventable, lacrimal duct
`
`obstruction.
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`Vil. Tolling of the Statue of Limitations
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`56. Alternatively, Plaintiff files this lawsuit within the applicable statute of limitations
`
`period of first suspecting that Defendants’ wrongful conduct caused the appreciable
`
`harm shesustained.
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`57. Due to Defendants’ fraudulent concealmentof the true nature of “excessive tearing
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`which may beattributable to lacrimal duct obstruction,” Plaintiff could not, by the
`
`exercise of reasonable diligence, have discovered that Defendants wrongfully caused her
`
`15
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`

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`injuries since she was unawareof the severity and permanency of herinjury.
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`98. Specifically in its warning label, which Defendants intended for oncologists to read
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`and rely on, Defendants fraudulently concealed (1) the rapid onset at which stenosis can
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`occur, (2) the potentially permanentnature of the injury, (3) the need to immediately refer
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`patients to a lacrimal specialist and (4) that the condition is highly preventable with
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`timely intervention during chemotherapy.
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`59. As a result, Plaintiff was unaware that Defendants knew of the devastating and
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`permanent consequencesof stenosis, or that Defendants concealed this information from
`
`her oncologist. Because Plaintiffs oncologist was unaware of the permanent nature of
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`this side effect, Plaintiff was also unawarethat her condition was permanent.
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`60. Defendants to this day do not warn that Docetaxel Injection can cause permanent
`
`obstruction of the lacrimal system. Therefore Plaintiff did not suspect, nor did she have
`
`reason to suspect, that she had been permanently injured. Furthermore, Plaintiff did not
`
`and could not suspect the tortious nature of the conduct causing her injuries until a date
`
`beforefiling this action that is less than the applicable limitations periodforfiling suit.
`
`61. Upon presentation of tearing, Plaintiff was advised that tearing was a commonside
`
`effect of chemotherapy that, like most otherside effects of chemotherapy, would resolve.
`
`Following completion of chemotherapy treatment, Plaintiff advised her oncologist of
`
`persistent epiphora. Subsequently Plaintiff was referred to an ophthalmologist who
`
`diagnosed her with bilateral nasolacrimal duct obstruction.
`
`

`

`Case: 1:22-cv-00539 Document#: 1-1 Filed: 01/31/22 Page 17 of 31 PagelD #:26
`Case: 1:22-cv-00539 Document #: 1-1 Filed: 01/31/22 Page 17 of 31 PageID #:26
`
`62, Plaintiff first became aware that the manufacturers of Taxotere and Docetaxel
`
`Injection Concentrate knew that
`
`their chemotherapy drug could cause permanent
`
`damageto the lacrimal system after seeing a blog post on the website of the law firm of
`
`Hotze Runkle, PLLC.
`
`63, When Plaintiff read that Defendants hid the risk of permanent canalicular stenosis
`
`from doctors and their patients, only then did she discover that the manufacturers of
`
`Taxotere were aware of this permanentside effect, but they intentionally withheld this
`
`information from healthcare practitioners and consumers.
`
`64, Plaintiff could not have discovered Defendants’ wrongdoingearlier, because to this
`
`date, Defendants’ warning fails to fully advise of the nature of the injury, resulting in
`
`oncologists and their patients remaining in the dark. Plaintiff was only able to discover
`
`that her tearing was never going to go away after Hotze Runkle published these facts on
`
`the internet.
`
`65. Additionally, Plaintiff was prevented from discovering this information at an
`
`earlier date because Defendants: (1) misrepresented to the public, the FDA, and the
`
`medical profession the permanent nature of “lacrimal duct obstruction;” (2) failed to
`
`disclose to the public, the FDA, and the medical profession its knowledge of the risk of
`
`permanentbutreversible side effects; (3) failed to disclose to the public, the FDA, and the
`
`medical profession its knowledge that these side effects were preventable with early
`
`intervention during chemotherapy; (4) fraudulently concealed facts and information that
`
`

`

`Case: 1:22-cv-00539 Document#: 1-1 Filed: 01/31/22 Page 18 of 31 PagelD #:27
`Case: 1:22-cv-00539 Document #: 1-1 Filed: 01/31/22 Page 18 of 31 PageID #:27
`
`could haveled Plaintiff to discover Defendants’ liability; and (5) still has not disclosed to
`
`the public, the FDA, and the medical profession that Docetaxel Injection concentrate can
`
`cause permanent punctal, canalicular and nasolacrimal duct stenosis which can be
`
`prevented with early intervention during chemotherapy.
`
`COUNT I — STRICT PRODUCTS LIABILITY (FAILURE TO WARN)
`
`66. Plaintiff incorporates by reference the above paragraphsasif set forth herein.
`
`67. At all relevant times, Defendants were in the business of designing, researching,
`
`manufacturing,
`
`testing,
`
`promoting, marketing,
`
`selling,
`
`and/or
`
`distributing
`
`pharmaceutical products, including the Docetaxel Injection used by Plaintiff.
`
`68. The Docetaxel Injection designed, formulated, produced, manufactured, sold,
`
`marketed, distributed, supplied and/or placed into the stream of commerce by
`
`Defendantsfailed to provide adequate warnings to users and their healthcare providers,
`
`including Plaintiff and her healthcare providers,of the risk of side effects associated with
`
`the use of Docetaxel Injection, particularly the risk of developing disfiguring, permanent
`
`nasolacrimal duct obstruction, or the measures that could have been taken to preventit.
`
`The Docetaxel Injection designed, formulated, produced, manufactured, sold, marketed,
`
`distributed, supplied and/or placed into the stream of commerce by Defendants and
`
`ultimately administered to Plaintiff lacked such warnings when it left Defendants’
`
`control.
`
`69. The risks of developing disfiguring, permanent nasolacrimal duct obstruction were
`
`

`

`Case: 1:22-cv-00539 Document#: 1-1 Filed: 01/31/22 Page 19 of 31 PagelD #:28
`Case: 1:22-cv-00539 Document #: 1-1 Filed: 01/31/22 Page 19 of 31 PageID #:28
`
`known to or reasonably knowable by Defendants at the time the Docetaxel Injection left
`
`Defendants’ control.
`
`70, A reasonably prudent company in the sameor similar circumstances would have
`
`provided a warning that communicated the dangers and safe use of Docetaxel Injection.
`
`71, Any warnings actually provided by Defendanis did not sufficiently and/or
`
`accurately reflect the symptoms, type, scope, severity, and/or duration of these side
`
`effects, particularly the risks of developing disfiguring, permanent nasolacrimal duct
`
`obstruction or how it could have been prevented during administration of
`
`the
`
`chemotherapy.
`
`72. Without adequate warning of these side effects, Docetaxel Injection is not
`
`reasonably fit, suitable, or safe for its reasonably anticipated or intended purposes.
`
`73. Plaintiff was a reasonably foreseeable user of Docetaxel Injection who used the
`
`drug in a reasonably anticipated manner.
`
`74. Plaintiff would have taken preventative measures during the course of her
`
`chemotherapy to prevent nasolacrimal duct obstruction had she (and her physicians)
`
`been provided an adequate warning by Defendantsof the risk of these side effects.
`
`75. As a direct and proximate result of Defendants’ failure to warn of the potentially
`
`severe adverse effects of Docetaxel Injection, Plaintiff suffered and continues to suffer
`
`serious and dangerousside effects, severe and personalinjuries that are permanent and
`
`lasting in nature, and economic and non-economic damages, harms, and_losses,
`
`

`

`Case: 1:22-cv-00539 Document#: 1-1 Filed: 01/31/22 Page 20 of 31 PagelD #:29
`Case: 1:22-cv-00539 Document #: 1-1 Filed: 01/31/22 Page 20 of 31 PageID #:29
`
`including, but notlimited to: past and future medical expenses; past and future loss and
`
`impairment of earning capacity; permanentdisfigurement, including nasolacrimal duct
`
`obstruction; mental anguish; severe and debilitating emotionaldistress; increased risk of
`
`future harm; past, present, and future physical and mental pain, suffering, and
`
`discomfort; and past, present, and future loss and impairment of the quality and
`
`enjoymentoflife.
`
`WHEREFORE, Plaintiff respectfully requests judgment in her favor and against
`
`Defendants in an amount that exceeds $75,000, plus the costs of this suit and any other
`
`and furtherrelief this Court deems just and proper.
`
`COUNT H— STRICT PRODUCTS LIABILITY (MISREPRESENTATION)
`
`76. Plaintiff incorporates by reference the above paragraphs asif set forth herein.
`
`77. Defendants sold the Docetaxel Injection that Plaintiff’s healthcare providers
`
`prescribed for Plaintiff and that Plaintiff used.
`
`78, Defendants were engaged in the business of selling the Docetaxel Injection for
`
`resale, use, or consumption.
`
`79. Defendants misrepresented facts as set forth herein concerning the character or
`
`quality of the Docetaxel Injection that would be material to potential prescribers and
`
`purchasers or users of the product.
`
`80. Defendants’ misrepresentations were made to potential prescribers and/or
`
`purchasers or users as membersof the public atlarge.
`
`20
`
`

`

`Case: 1:22-cv-00539 Document#: 1-1 Filed: 01/31/22 Page 21 of 31 PagelD #:30
`Case: 1:22-cv-00539 Document #: 1-1 Filed: 01/31/22 Page 21 of 31 PageID #:30
`
`81. As purchasersorusers, Plaintiff and/or her healthcare providers reasonably rel

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