Case 3:22-cv-00672-MPS Document 1 Filed 05/17/22 Page 1 of 44
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`IN THE UNITED STATES DISTRICT COURT
`DISTRICT OF CONNECTICUT
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`
`MATTHEW MIRTO and JENNIFER MIRTO
`
`
`v.
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`Plaintiffs,
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`
`
`
`
`
`
`:
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`:
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`Case No.: 22cv672
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`
`
`BAYER HEALTHCARE PHARMACEUTICALS, :
`INC.; BAYER CORPORATION;
`
`
`:
`JOHNSON & JOHNSON SERVICES, INC.;
`:
`JANSSEN RESEARCH & DEVELOPMENT, LLC;:
`And JANSSEN PHARMACEUTICAL COMPANY:
`
`Defendants
`
`_________________________________________
`
`
`May 17, 2022
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`COMPLAINT
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`Plaintiffs Matthew Mirto and Jennifer Mirto sue Defendants Bayer Healthcare
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`Pharmaceuticals, Inc., Bayer Corporation, (collectively referred to as the “Bayer
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`Defendants”), Johnson & Johnson Services, Inc., Janssen Research & Development, LLC,
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`Janssen Pharmaceutical Company (collectively referred to as the “J&J Defendants”), and
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`states:
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`INTRODUCTION
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`1.
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`This is a product liability case that involves the prescription fluoroquinolone
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`
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`antibiotic drugs Cipro (ciprofloxacin), Avelox (moxifloxacin) and Levaquin (levofloxacin)
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`(collectively referred to as “FLQ drugs”).
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`2.
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`Cipro is designed, developed, manufactured, tested, packaged, promoted,
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`marketed, advertised, distributed, labeled, and/or sold by the Bayer Defendants.
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`3.
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`Avelox is designed, developed, manufactured, tested, packaged, promoted,
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`marketed, advertised, distributed, labeled, and/or sold by the Bayer Defendants
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`4.
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`Levaquin is designed, developed, manufactured, tested, packaged, promoted,
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`Case 3:22-cv-00672-MPS Document 1 Filed 05/17/22 Page 2 of 44
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`marketed, advertised, distributed, labeled, and/or sold by the J&J Defendants.
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`5.
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` Plaintiffs maintain Cipro, Avelox and Levaquin are defective, dangerous to human
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`health, unfit and unsuitable to be marketed and sold in commerce to treat infections for which they
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`were not required, and lacked proper warnings and directions as to the dangers associated with
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`their all of their uses including the adverse health conditions associated with irreversible
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`neurogenic pain, collagen toxicity, tendinopathy, and aortic disease.
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`PARTIES
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`At all material times, Mr. Mirto and Mrs. Mirto were married and resided together
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`6.
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`in Wallingford, Connecticut.
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`7.
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`By reason of Defendants’ acts and omissions and as a direct and proximate result of
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`being prescribed and ingesting Defendants’ FLQ drugs, Mr. Mirto sustained personal injuries including
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`irreversible neurogenic pain, collagen toxicity, tendinopathy, and aortic disease that resulted in an
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`aortic aneurysm and dilated aortic root that destroyed his aortic valve requiring replacement and
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`permanently damaging his heart function, physical pain and mental anguish, including diminished
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`enjoyment of life, physical impairment, expenses for hospitalization and medical treatment, and
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`loss of earnings, among other damages.
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`8.
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`Defendant Bayer HealthCare Pharmaceuticals, Inc. (“Bayer Healthcare”) is a
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`foreign for profit corporation with its principal place of business at 100 Bayer Boulevard, in
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`Whippany, New Jersey 07981 and with a Connecticut Registered Agent to wit: Corporation
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`Service Company, Goodwin Square 225 Asylum St., 29th Floor, Hartford, CT, 06103.
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`9.
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`In January 2008, Bayer Pharmaceuticals Corporation was merged into Bayer
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`Healthcare and at all material times was involved in the labeling, supplying, selling, and
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`distribution of pharmaceutical products, including Cipro and Avelox, throughout in the United
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`States and the State of Connecticut including Wallingford, Connecticut.
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`10. Defendant Bayer Corporation (“Bayer Corp.”) is foreign for profit corporation with
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`its principal place of business at 100 Bayer Boulevard, in Whippany, New Jersey 07981 and with
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`a Connecticut Registered Agent to wit: Corporation Service Company, Goodwin Square 225
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`Asylum St., 29th Floor, Hartford, CT, 06103.
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`11.
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`Bayer Corp., formerly known as Miles, Inc., is an American subsidiary of a German
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`parent Bayer AG headquartered in Leverkusen, North Rhine-Westphalia, Germany who is one of
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`the largest pharmaceutical companies in the world and the researcher, producer, and manufacturer
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`of Cipro and Avelox, and was engaged in the business of testing, manufacturing, distributing,
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`marketing, advertising, labeling, and selling Cipro in the United States.
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`12.
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` Upon information and belief, the Bayer Defendants did act together to design, sell,
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`advertise, manufacture and/or distribute Cipro and Avelox with full knowledge of its dangerous
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`and defective nature.
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`13. Defendant Johnson & Johnson Services, Inc. (“J&J”) is a foreign for-profit
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`corporation with its principal place of business at One J&J Plaza, New Brunswick, New Jersey
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`08933 and with a Connecticut Registered Agent to wit: CT Corporation System, 67 Burnside Ave.,
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`East Hartford, CT, 06128-3408.
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`14.
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`J&J, and its “Family of Companies,” is involved in the research, development,
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`sales, and marketing of pharmaceutical products, including Levaquin.
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`15. Defendant Janssen Research & Development, LLC (“Janssen R&D”), formerly
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`known as Johnson & Johnson Pharmaceutical Research & Development, LLC, is a limited liability
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`company organized under the laws of the State of New Jersey, with its principal place of business
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`at 920 Route 202 South, P.O. Box 300, Mail Stop 2628, Raritan, New Jersey.
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`16.
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` At all times material hereto, Janssen R&D conducted research, development, and
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`testing on Levaquin and is part of the J&J “Family of Companies.”
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`17. Defendant Janssen Pharmaceutical Company (“Janssen Pharma”), formerly known
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`as Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a foreign for profit corporation with its
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`principal place of business at 1125 Trenton-Harbourton Rd., Titusville, New Jersey 08560.
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`18. At all times material hereto, Janssen Pharma was the responsible U.S. entity for the
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`design, manufacture, labeling, distribution, marketing, and sale of the drug Levaquin in the United
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`States.
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`19. Defendant Janssen Pharma is a wholly owned subsidiary of J&J.
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`20. Upon information and belief, the J&J Defendants did act together to design, sell,
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`advertise, manufacture and/or distribute Levaquin with full knowledge of its dangerous and
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`defective nature.
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`JURISDICTION AND VENUE
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`21.
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`This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332 because
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`the amount in controversy exceeds $75,000, exclusive of interest and costs, and because there is
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`complete diversity of citizenship between Plaintiffs and Defendants.
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`22. Defendants purposefully availed themselves of the privilege of conducting business
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`activities within the State of Connecticut through the marketing, distribution, and sale of FLQ
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`drugs, including to Mr. Mirto, thus invoking the benefits and protections of its laws.
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`23. Defendants have significant contacts in the State of Connecticut such that they are
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`subject to the personal jurisdiction of the court in this state.
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`24. A substantial part of the events and omissions giving rise to Plaintiffs’ causes of
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`action occurred in the District of Connecticut. Pursuant to 28 U.S.C. § 1391(a), venue is proper.
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`FACTUAL ALLEGATIONS
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`25. At all relevant times, Defendants were in the business of and did design, research,
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`manufacture, test, advertise, promote, market, sell, distribute, and/or have acquired and are
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`responsible for Defendants who have designed, researched, manufactured, tested, advertised,
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`promoted, marketed, sold, and distributed the FLQ drugs Cipro, Avelox, and Levaquin.
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`26.
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`The Bayer Defendants are a “product seller” engaged in the business of selling their
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`FLQ drugs Cipro and Avelox as defined by CPLA, Conn. Gen. Stat. § 52-572m(a).
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`27.
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`The J&J Defendants are a “product seller” engaged in the business of selling their
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`FLQ drug Levaquin as defined by CPLA, Conn. Gen. Stat. § 52-572m(a).
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`28.
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`FLQ drugs are broad-spectrum synthetic antibacterial agents marketed and sold in
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`oral tablet, IV solution, and ophthalmic solution, used to treat certain bacterial infections. They are
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`members of the quinolone class of antibiotics.
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`29.
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`Cipro was approved by the United States Food and Drug Administration (“FDA”)
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`in October 1987 for use in the United States and is the brand name for the antibiotic ciprofloxacin.
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`30. Avelox was approved by the United States Food and Drug Administration (“FDA”)
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`in December 1999 for use in the United States and is the brand name for the antibiotic
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`moxifloxacin.
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`31.
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`Levaquin was approved by the FDA on December 20, 1996, for use in the United
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`States and is the brand name for the antibiotic levofloxacin.
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`32.
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`Cipro and Avelox have long been associated with serious side effects including but
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`not limited to tendinopathy, aortic aneurysm, rupture, and dissection.
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`33.
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`Similar to Cipro, the scientific evidence has established a clear association between
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`Levaquin and an increased risk of tendinopathy, aortic aneurysm, rupture and dissection, no matter
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`whether the FLQ drugs are stopped once symptoms develop or not.
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`34.
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`Prior to applying to the FDA for and obtaining approval of their FLQ drugs,
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`Defendants knew or should have known that consumption of FLQ drugs were associated with
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`and/or would cause chronic and/or permanent collagen toxicity, tendinopathy, and aortic disease
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`including aneurysm, rupture, and dissection.
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`35. Defendants failed to appropriately and adequately inform and warn Mr. Mirto and
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`his prescribing physicians of the serious and dangerous risks associated with the use of FLQ drugs,
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`as well as other severe and personal injuries that they cause, which are permanent and/or long-
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`lasting in nature, cause significant physical pain and mental anguish, physical impairment,
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`diminished enjoyment of life, and the need for medical treatment, monitoring and/or medications.
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`36.
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`The warning labels for Cipro from April 2006 to August 2008 misled and
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`deceived Mr. Mirto and his treating physicians by incorrectly advising them the known side effects
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`and/or injuries associated with Cipro were “rare” and could be avoided by discontinuing the drug
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`upon the onset of certain symptoms. The truth, however, is that the onset of these symptoms and/or
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`injuries is often rapid, and discontinuation of the drug will not ensure that the conditions are
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`reversible. The Bayer Defendants misled patients (and physicians) by omitting any mention of the
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`possibility that Cipro use could result in these conditions.
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`37.
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`The warning labels for Avelox from January 2007 through March 2007 misled
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`and deceived Mr. Mirto and his treating physicians by incorrectly advising them the known side
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`effects and/or injuries associated with Avelox were “rare” and could be avoided by discontinuing
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`the drug upon the onset of certain symptoms. The truth, however, is that the onset of these
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`symptoms and/or injuries is often rapid, and discontinuation of the drug will not ensure that the
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`conditions are reversible. The Bayer Defendants misled patients (and physicians) by omitting any
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`mention of the possibility that Avelox use could result in these conditions.
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`38.
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`The warning labels for Levaquin from November 2003 through March 2015
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`misled and deceived Mr. Mirto and his treating physicians by incorrectly advising them the known
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`side effects and/or injuries associated with Levaquin were “rare” and could be avoided by
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`discontinuing the drug upon the onset of certain symptoms. The truth, however, is that the onset
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`of these symptoms and/or injuries is often rapid, and discontinuation of the drug will not ensure
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`that the conditions are reversible. The J&J Defendants misled patients (and physicians) by omitting
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`any mention of the possibility that Levaquin use could result in these conditions.
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`39.
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`Further, Defendants failed to disclose the serious and dangerous side effects
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`when promoting Cipro, Avelox and Levaquin to physicians and patients, despite the fact several
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`studies conducted over a number of decades confirmed those side effects.
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`40.
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`The FDA first added a Black Box warning to FLQ drugs in July of 2008 for the
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`increased risk of tendinitis and tendon rupture. In August of 2013, the FDA required updates to
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`the labeling to describe the potential for irreversible peripheral neuropathy. In 2016 the FDA
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`enhanced warnings about the association of FLQ drugs with disabling and potentially permanent
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`side effects involving tendons, muscles, joints, nerves, and the central nervous system which
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`included a statement that FLQ drugs should be reserved for use in patients who have no alternative
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`treatment options. In December of 2018, the FDA issued a warning that FLQ drugs can increase
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`the occurrence of serious events of ruptures or tears in aorta, aortic dissections, or ruptures of an
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`aortic aneurysm, which can lead to dangerous bleeding or death.
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`41.
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`The Bayer Defendants and J&J Defendants each had a duty of care in disseminating
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`product information extends to those patients, such as Mr. Mirto, who have been injured by generic
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`ingestion of any FLQ drugs as a result of prescriptions written in reliance on Defendants’ product
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`information for such drugs.
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`42. Defendants knew or should have known that prescribing physicians would rely
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`upon the warnings or product labeling disseminated by the Defendants for Cipro, Avelox and/or
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`Levaquin in prescribing brand-name or generic ciprofloxacin, moxifloxacin, and/or levofloxacin
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`for patients, such as Mr. Mirto.
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`43. Mr. Mirto was prescribed FLQ drugs, including from physicians practicing in
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`Connecticut and lawfully obtained the drugs from pharmacies in Connecticut.
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`44.
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`Specifically, Mr. Mirto was prescribed and took as directed the following FLQ
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`drugs to treat suspected bacterial infections:
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`a. Cipro – twice: April 2006 and August 2008
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`b. Avelox – twice: January 2007 and March 2007
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`c. Levaquin: eight times: November 2003; December 2005; August 2008;
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`February 2009; March 2009; July 2009; October 2009, and March 2015.
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`45.
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`In May 2004, Mr. Mirto began to experience pain in his tendons and connective
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`tissues in several joints. After taking Levaquin in December 2005, he again experienced joint and
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`connective tissue pain. In late 2009 and early 2010, he began to experience sever leg pains from
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`his calf down to his feet. He was seen by rheumatologists, neurologists, and infectious disease
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`specialists with normal findings. In 2016 and 2017, he had another neurology work-up for the
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`ongoing leg pain. In April 2016, he was diagnosed with neurogenic pain. Otherwise, no definitive
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`diagnosis and only normal findings that did not account for the pain in his feet and legs. Past
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`history of Lyme disease did not account for the continued bilateral leg pain. The slightest force
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`upon his legs caused pain and he would experience sudden onset of calf pain followed by a ”pop”
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`and bruising throughout the calf that he noted to be worse after taking Levaquin. In late November
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`2017, he was thought to be allergic to Levaquin.
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`46.
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`Irreversible injuries suffered by Mr. Mirto include neurogenic pain, collagen
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`toxicity and tendinopathy as a direct result of his use of Defendants’ FLQ drugs.
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`47.
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`In November 2017, Mr. Mirto was referred to a cardiologist and an Echocardiogram
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`was taken that found a dilated ascending aorta and dilated aortic root that was also confirmed by
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`CT in January 2018.
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`48.
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`Thereafter, Mr. Mirto came under the care of cardio-thoracic specialists at Yale
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`New Haven Hospital. On May 22, 2019, Mr. Mirto underwent cardio-thoracic surgery due to an
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`expanding ascending aortic aneurysm and dilated aortic root and during surgical exploration found
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`the aorta, root and valve were far more diseased than expected and that only something unusual could
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`cause the extensive degree of harm given Mr. Mirto had no risk factors for such disease and genetic
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`testing found no variants in his genes that were associated with his condition. As a result, the
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`ascending aorta, aortic root, and valve had to be replaced.
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`49.
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`The aortic aneurysm and dilated aorta as well as the damage to Mr. Mirto’s ascending
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`aorta, root and valve are a direct result of his use of Defendants’ FLQ drugs.
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`APPLICATION AND TOLLING OF THE STATUTE OF LIMITATIONS
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`50. Mr. Mirto had no knowledge and in the exercise of reasonable care could not have
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`discovered that the injuries to his ascending aorta, aortic root and valve were caused by
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`Defendants’ FLQ drugs until after the May 22, 2019 surgery.
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`51. Mr. Mirto had no knowledge and in the exercise of reasonable care could not have
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`discovered that neurogenic pain, collagen toxicity and tendinopathy injuries were caused by
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`Defendants’ FLQ drugs until after the May 22, 2019 surgery.
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`52.
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`The harm to Mr. Mirto by Defendants FLQ drugs occurred after taking the drugs
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`and during the useful life of the drugs as prescribed.
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`53.
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`By Executive Order, Governor of Connecticut Ned Lamont suspended the running
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`of the statute of limitations for civil claims during the time period from March 9, 2020 until March
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`21, 2021 due to the Covid-19 pandemic. See Executive Order 10A dated February 8, 2021.
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`Accordingly, this additional time is added to the applicable running of the statute of limitations for
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`Mr. Mirto’s claims asserted herein.
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`54.
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`The running of any statute of limitations has also been tolled by reason of
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`Defendants’ fraudulent concealment. Defendants, through their affirmative misrepresentations and
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`omissions, actively concealed from Mr. Mirto and his treating physicians the true risks associated
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`with Defendants’ FLQ drugs, including the actual incidence of FLQ-induced collagen toxicity,
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`tendinopathy, neurogenic pain, and aortic aneurysms, the progressive and disabling nature of these
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`injuries, and the irreversibility of these injuries.
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`55.
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`The time, place and substance of the Defendants’ alleged fraud is set forth as
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`follows. Between 1995 and 2002, FLQs became the most commonly prescribed class of
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`antibiotics to adults in the United States. The explosive increase in FLQ prescriptions was a direct
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`result of Defendants’ deliberate decision to reframe FLQ drugs from a “big gun” antibiotic that
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`should be reserved for serious infections to a “first choice” antibacterial that is appropriate for a
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`wide range of mild infections.
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`56.
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`Beginning in at the late 1990s, Defendants aggressively marketed FLQ drugs while
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`at the same time concealing, through misrepresentations or omissions, the risks associated with
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`FLQ drugs. They did this by focusing on the incidence of relatively benign side effects, such as
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`headaches or dizziness, while concealing the equally common but far more serious symptoms of
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`tendinopathy and damages to the aorta.
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`57. As the J&J Defendants explained in their 2003 Levaquin brand plan: “In late 2000
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`through mid-2001, after extensive market research and segmentation analysis, the LEVAQUIN
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`brand team made the decision to reposition LEVAQUIN from a ‘big gun’ anti-infective used in
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`serious/recalcitrant infections, to a product that is effective in fighting more common infections
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`where growth potential was the greatest…”1 The Bayer Defendants likewise marketed Cipro for
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`routine infections even though they knew that FLQs should be reserved for more serious
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`conditions.
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`58. One key obstacle to Defendants’ re-branding scheme was their awareness of the
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`nature and extent of collagen toxicity that manifest in tendinopathy and likely aortic aneurysm that
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`could result from taking FLQ drugs. Defendants had long been on notice that FLQ drugs were
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`associated with serious nerve and tendon injuries. For example, by the mid-1990s the J&J
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`Defendants knew from their own post-marketing experience that the most frequently reported
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`adverse events concerned the central nervous system (“CNS”). The most common CNS adverse
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`events were “dizziness, paresthesia and headache.”
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`59.
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`Beginning in at the late 1990s, Defendants aggressively marketed FLQ drugs while
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`at the same time concealing, through misrepresentations or omissions, the risk of peripheral
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`neuropathy and collagen toxicity. They did this by focusing on the incidence of relatively benign
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`side effects, such as headaches or dizziness, while concealing the equally common but far more
`
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`1 See Linder, JA. et al. Fluoroquinolone prescribing in the United States: 1995 to 2002. Am J
`Med. 2005 Mar;118(3):259-68 (“Fluoroquinolone prescribing increased threefold in
`outpatient clinics and emergency departments in the United States from 1995 to 2002.
`Fluoroquinolones became the most commonly prescribed class of antibiotics to adults in
`2002.”).
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`serious symptoms of peripheral neuropathy and collagen toxicity.
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`60.
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`For more than a decade, Defendants have known that paresthesia and other
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`symptoms associated with peripheral neuropathy and collagen toxicity in the form of tendinopathy
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`were among the most common side effects of FLQ drugs, and more recently Defendants knew that
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`FLQ significantly increase the occurrence of aortic aneurysms – yet they have fraudulently
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`concealed these facts from the public, for years.
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`61.
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`In failing to update their labels and marketing materials, Defendants intended that
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`that the misinformation contained in the label would be relied upon by Mr. Mirto and his
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`prescribing physicians, which it was.
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`62. As a direct result of Mr. Mirto and his prescribing physician’s reliance on the false
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`information contained within the FLQ drug labels, Mr. Mirto was prescribed and took Defendants’
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`FLQ drugs and experienced collagen toxicity that manifest as tendinopathy and later as an
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`ascending aortic aneurysm and dilated heart valve.
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`63.
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`The nature of Mr. Mirto’s injuries and the relationship of such injuries to FLQ drugs
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`were inherently undiscoverable prior to the full dissemination of the FDA disclosure of risk
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`information that began in 2013 and most recently with respect to the risk of aortic dissection, in
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`December 2018.
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`64. Accordingly, the discovery rule should be applied to toll the running of the statute
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`of limitations until Plaintiffs knew, or through reasonable care and diligence should have known,
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`of his claims against Defendants, and in any event such tolling should continue until at least the
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`date of FDA’s disclosure of risk information in December 2018 and after Mr. Mirto’s May 22,
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`2019 surgery when he first learned his aortic and valve disease were far worse than expected that
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`could be due to his use of Defendants’ FLQ drugs.
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`65.
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`Plaintiffs did not discover, and through the exercise of reasonable care and due
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`diligence should not and could not have discovered, his illnesses and injuries or their relationship
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`to the FLQ drugs until after the surgery on May 22, 2019, surgery. Plaintiff’s suit is filed well
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`within the applicable statute of limitations period under appropriate application of this state’s
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`“discovery rule.”
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`66.
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`In the alternative, the facts of Mr. Mirto’s claims made it impossible for him to
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`discover the true nature of his injuries and/or causes of action within the applicable limitations
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`period. In particular, Defendants’ misrepresentations and omissions constituted active
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`concealment regarding the true nature of the risks associated with their FLQ drugs prevented Mr.
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`Mirto from discovering the wrongful acts on which their causes of action are based.
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`COUNT I – PRODUCT LIABILITY AGAINST BAYER DEFENDANTS
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`(CPLA, Conn. Gen. Stat §§ 52-572m, et seq.)
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`67. Mr. Mirto re-alleges all prior allegations of the Complaint, except paragraphs 13
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`through 20 and 27, as if set out here in full.
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`68.
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`The Bayer Defendants are product sellers and liable to Plaintiff under the CPLA,
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`Conn. Gen. Stat. § 52-572m et seq. for failure to provide adequate warnings to Mr. Mirto and his
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`physicians about the risks associated with taking FLQ drugs Cipro/Avelox and for placing an
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`unreasonably dangerous product into the stream of commerce including claims for product liability
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`for: strict liability in tort; negligence, breach of warranty, express or implied; breach of failure to
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`discharge a duty to warn or instruct, whether negligent or innocent; misrepresentation or
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`nondisclosure, whether negligent or innocent.
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`Strict Liability in Tort
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`69.
`
`The FLQ drugs Cipro/Avelox manufactured, marketed, supplied and/or distributed
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`by the Bayer Defendants were defective at the time of manufacture, development, production,
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`testing, inspection, endorsement, prescription, sale and distribution in that warnings, instructions
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`and directions accompanying such labels failed to warn of the dangerous risks they posed,
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`including the risk of developing irreversible peripheral neuropathy, collagen toxicity,
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`tendinopathy, and aortic disease.
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`70. At all times alleged herein, the drugs Cipro/Avelox manufactured, marketed,
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`supplied, and/or distributed by the Bayer Defendants were defective.
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`71.
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`The Bayer Defendants knew their drugs Cipro/Avelox would be used by consumers
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`without inspection for defects.
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`72. Moreover, Mr. Mirto, his prescribing physicians neither knew nor had reason to
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`know at the time of his use of the drugs Cipro/Avelox of the aforementioned defects. Ordinary
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`consumers would not have recognized the potential risks for which Defendants failed to include
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`the appropriate warnings.
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`73. At all times alleged herein, the Bayer Defendants’ drugs Cipro/Avelox were
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`prescribed to and used by Mr. Mirto as intended by the Bayer Defendants and in a manner
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`reasonably foreseeable to them.
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`74.
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`The design of Bayer Defendants’ FLQ drugs Cipro/Avelox were defective in that
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`the risks associated with using the drugs as a first-line therapy for infections that did not dictate
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`the use of a FLQ drug outweighed any benefits of their design. Any benefits associated with the
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`use of the FLQ drugs in such situations were either relatively minor or nonexistent and could have
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`been obtained by the use of other, alternative treatments and products that could equally or more
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`effectively reach similar results but without the increased risk of developing irreversible injuries
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`such as those suffered by Mr. Mirto.
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`Case 3:22-cv-00672-MPS Document 1 Filed 05/17/22 Page 15 of 44
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`75.
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`The defect in design existed when the drugs Cipro/Avelox left the Bayer
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`Defendants’ possession.
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`76. At the time the Cipro/Avelox drugs left the control of the Bayer Defendants, they
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`knew or should have known of the risks associated with ingesting such drugs.
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`Negligence
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`77. At all times material hereto, the Bayer Defendants had a duty to exercise reasonable
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`care to consumers, including Mr. Mirto, in the design, development, manufacture, testing,
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`inspection, packaging, promotion, marketing, distribution, labeling, and/or sale of the FLQ drugs
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`Cipro/Avelox.
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`78.
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`The Bayer Defendants breached their duty of reasonable care to Mr. Mirto in that
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`they negligently promoted, marketed, distributed, and/or labeled the drugs Cipro/Avelox.
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`79. Mr. Mirto’s injuries and damages alleged herein were and are the direct and
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`proximate result of the carelessness and negligence of the Bayer Defendants, including, but not
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`limited to, one or more of the following particulars:
`
`a.
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`In the design, development, research, manufacture, testing, packaging,
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`promotion, marketing, sale, and/or distribution of Defendants’ FLQ drugs Cipro/Avelox;
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`b.
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`In failing to warn or instruct, and/or adequately warn or adequately
`
`instruct, users of the subject product, including Mr. Mirto herein, of the dangerous and
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`defective characteristics of Cipro/Avelox;
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`c.
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`In the design, development, implementation, administration, supervision,
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`and/or monitoring of clinical trials for Cipro/Avelox;
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`d.
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`In promoting Cipro/Avelox in an overly aggressive, deceitful, and
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`fraudulent manner, including as a first-line therapy to treat infections for which they were
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`
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`Case 3:22-cv-00672-MPS Document 1 Filed 05/17/22 Page 16 of 44
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`not required despite evidence as to the drug’s defective and dangerous characteristics due
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`to its propensity to cause irreversible neurogenic pain, collagen toxicity, tendinopathy, and
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`aortic disease and other severe side effects;
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`e.
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`In representing that Cipro/Avelox were safe for the intended use when,
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`in fact, the drugs were unsafe for their intended use;
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`f.
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`g.
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`h.
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`Failure to perform appropriate pre-market testing of Cipro/Avelox;
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`Failure to perform appropriate post-market surveillance of Cipro/Avelox;
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`Failure to adequately and properly test Cipro/Avelox before and after
`
`placing it on the market;
`
`i.
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`Failure to conduct sufficient testing on Cipro/Avelox which, if properly
`
`performed, would have shown that it had the serious side effects;
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`j.
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`Failure to adequately warn Mr. Mirto and his healthcare providers that the
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`use of Cipro/Avelox carried a risk of developing irreversible neurogenic pain, collagen
`
`toxicity, tendinopathy, and aortic disease and other severe side effects;
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`k.
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`Failure to provide adequate post-marketing warnings or instructions after
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`the Bayer Defendants knew or should have known of the significant risk of severe side
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`effects associated with the use of Cipro/Avelox; and
`
`l.
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`Failure to adequately and timely inform Mr. Mirto and the healthcare
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`industry of the risk of serious personal injury, from Cipro/Avelox ingestion as described
`
`herein.
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`80.
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`The Bayer Defendants knew or should have known that consumers, such as Mr.
`
`Mirto, would foreseeably suffer injury as a result of Defendants’ failure to exercise reasonable and
`
`ordinary care.
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`Case 3:22-cv-00672-MPS Document 1 Filed 05/17/22 Page 17 of 44
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`Breach Of Express Warranty
`Before Mr. Mirto was first prescribed the Bayer Defendants’ FLQ drugs
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`81.
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`Cipro/Avelox and during the period in which he used it, said Defendants expressly warranted
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`Cipro/Avelox were safe.
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`82.
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`The Bayer Defendants’ FLQ drugs Cipro/Avelox did not conform to these express
`
`representations because it was not safe and had an increased risk of serious side effects, whether
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`taken individually or in conjunction with other therapies.
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`83. Mr. Mirto, individually and through his prescribing physicians, reasonably relied
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`upon the express warranty of the Bayer Defendants.
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`84. Mr. Mirto was prescribed, purchased, and used Cipro/Avelox for their intended
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`purpose.
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`85.
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`The Bayer Defendants breached
`
`their express warranty associated with
`
`Cipro/Avelox.
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`Breach Of Implied Warranty
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`86. At all times mentioned herein, the Bayer Defendants manufactured, compounded,
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`packaged, distributed, recommended, merchandised, advertised, promoted, supplied, and/or sold
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`their FLQ drugs Cipro/Avelox.
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`87.
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`Before Cipro/Avelox were prescribed to Mr. Mirto, the Bayer Defendants impliedly
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`warranted to Mr. Mirto that these drugs were of merchantable quality and safe and fit for the
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`intended use.
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`88. Mr. Mirto, individually and through his prescribing physicians, reasonably relied
`
`upon the skill, superior knowledge, and judgment of the Bayer Defendants.
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`89. Mr. Mirto was prescribed, purchased, and used Cipro/Avelox for their intended
`
`
`
`17
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`Case 3:22-cv-00672-MPS Document 1 Filed 05/17/22 Page 18 of 44
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`purpose.
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`90. Due to the Bayer Defendants’ wrongful conduct as alleged herein, Mr. Mirto could
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`not have known about the nature of the risks and side effects associated with the subject products
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`until after he used