Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 1 of 63 PageID 1
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`UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
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`
`
`
`Plaintiff,
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`PATRICIA VOSBURGH,
`
`
`
`v.
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`ACELLA PHARMACEUTICALS, LLC
`and WALGREEN CO.
`
`Defendants.
`
`__________________________________/
`
`
`
`
`
`
` Civil Action:
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`
`
`
`
`
`
`
`
`
`
`COMPLAINT AND DEMAND FOR A JURY TRIAL
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`
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`Plaintiff, Patricia Vosburgh hereby sues Acella Pharmaceuticals, LLC, and
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`Walgreen Co., and would respectfully show this Court as follows:
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`Parties
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`1.
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`Plaintiff, Patricia Vosburgh (“Plaintiff”), is and at all times relevant
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`to this action has remained, a citizen and resident of Pinellas County, Florida. At
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`all times relevant, Plaintiff has maintained a Florida’s driver’s license. At all
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`times relevant, Plaintiff purchased NP Thyroid in Pinellas County, Florida.
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`2.
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`Upon information and belief, Plaintiff, Patricia Vosburgh, consumed
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`and regularly used Defendant Acella Pharmaceuticals, LLC’s NP Thyroid
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`product.
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`3.
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`Defendant Acella Pharmaceuticals, LLC (“Acella”) is a Limited
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`Liability Corporation with its principal place of business at 1880 McFarland
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`
`
`1
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`
`
`UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
`
`
`
`
`Plaintiff,
`
`PATRICIA VOSBURGH,
`
`
`
`v.
`
`ACELLA PHARMACEUTICALS, LLC
`and WALGREEN CO.
`
`Defendants.
`
`__________________________________/
`
`
`
`
`
`
` Civil Action:
`
`
`
`
`
`
`
`
`
`
`
`COMPLAINT AND DEMAND FOR A JURY TRIAL
`
`
`
`Plaintiff, Patricia Vosburgh hereby sues Acella Pharmaceuticals, LLC, and
`
`Walgreen Co., and would respectfully show this Court as follows:
`
`Parties
`
`1.
`
`Plaintiff, Patricia Vosburgh (“Plaintiff”), is and at all times relevant
`
`to this action has remained, a citizen and resident of Pinellas County, Florida. At
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`all times relevant, Plaintiff has maintained a Florida’s driver’s license. At all
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`times relevant, Plaintiff purchased NP Thyroid in Pinellas County, Florida.
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`2.
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`Upon information and belief, Plaintiff, Patricia Vosburgh, consumed
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`and regularly used Defendant Acella Pharmaceuticals, LLC’s NP Thyroid
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`product.
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`3.
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`Defendant Acella Pharmaceuticals, LLC (“Acella”) is a Limited
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`Liability Corporation with its principal place of business at 1880 McFarland
`
`
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`1
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`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 2 of 63 PageID 2
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`Parkway, Suite 110-B, Alpharetta, Georgia 30005. At all pertinent times, Acella
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`Pharmaceuticals, LLC did business in the State of Florida. Acella
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`Pharmaceuticals, LLC may be served with process of this Court via service on its
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`registered agent, located at 1880 McFarland Parkway, Suite 110-B, Alpharetta,
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`Georgia 30005.
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`4.
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`Defendant Walgreen Co. (“Walgreens”) is a Delaware corporation
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`with its principal place of business located at 108 Wilmot Road, Deerfield, Illinois
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`60015. Walgreen Co. is a citizen of Delaware and Illinois. At all pertinent times,
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`Walgreens was registered to do business in the State of Florida as a Florida Profit
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`Corporation and did business in Florida. At all times relevant, Walgreens
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`marketed, advertised, sold and/or distributed to Plaintiff, NP Thyroid in various
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`locations throughout the State of Florida, which proximately caused injury to
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`Plaintiff, Patricia Vosburgh. Walgreens may be served with process of this Court
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`via service on its registered agent, Prentice-Hall Corporation System, Inc. located
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`at 1201 Hays Street, Suite 105, Tallahassee, FL 32301.
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`5.
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`Hereinafter, Acella and Walgreens will collectively be called
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`“Defendants.”
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`(Intentionally Left Blank)
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`2
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`Jurisdiction and Venue
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`6.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §
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`1332(a). There is complete diversity among the Plaintiff and the Defendants, and
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`the amount of controversy exceeds $75,000.00, exclusive of interest and costs.
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`7.
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`This Court has supplemental jurisdiction over the remaining
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`common law and state claims pursuant to U.S.C. § 1367.
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`8.
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`A substantial part of the events, actions, or omissions giving rise to
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`Plaintiff’s causes of action occurred within the Middle District of Florida.
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`Plaintiff also purchased NP Thyroid within the Middle District of Florida.
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`Therefore, venue is proper in the Middle District of Florida under 28 U.S.C. §
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`1391(a).
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`9.
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`Defendants have significant contacts with the Middle District of
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`Florida, such that they are subject to the personal jurisdiction of the Court.
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`10. At all relevant times, Defendants marketed, labeled, packaged,
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`handled, distributed, stored, and/or sold NP Thyroid within the Middle District
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`of Florida and targeted the consumer market within this district.
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`11. At all times alleged herein, Defendants were authorized to conduct
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`or engage in business within the State of Florida and supplied NP Thyroid
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`within the State of Florida. Defendants received financial benefit and profits as a
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`3
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`result of designing, testing, marketing, labeling, packaging, handling,
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`distributing, storing, and/or selling NP Thyroid within the State of Florida.
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`12. Defendants have derived revenue from the sale of NP Thyroid in the
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`State of Florida. This Court has jurisdiction, as Defendants committed tortious
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`acts within the State of Florida and within the Middle District of Florida.
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`Introduction
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`13.
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`This is a personal injury action, arising from Plaintiff’s use of
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`Defendant Acella’s dangerously defective prescription drug, NP Thyroid.
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`14. Defendant Acella sold NP Thyroid as a product intended to treat a
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`disease or condition, therefore the NP Thyroid product is a drug as defined in
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`Section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21
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`U.S.C. 321(g).
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`15. NP Thyroid is a thyroid tablet, manufactured by Acella
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`Pharmaceuticals, LLC and is sold as a safe and effective method to treat
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`hypothyroidism. NP Thyroid tablets are composed of levothyroxine and
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`liothyronine, and are prescribed for the treatment of hypothyroidism. The
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`medication is designed to replace or supplement a thyroid hormone, which is
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`normally produced by the thyroid gland.
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`16. Acella designed, marketed, and distributed NP Thyroid in the
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`United States, including Florida. Defendants failed to provide adequate
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`4
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`warnings to patients, the healthcare community, and the medical community of
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`the risks associated with NP Thyroid. Defendants knew or should have known
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`that significant risks, due to improper dosage and/or excessive levels of
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`liothyronine and levothyroxine, yet Defendants failed to timely disclose these
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`risks and/or improper dosing to the medical and healthcare community, Food
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`and Drug Administration, to Plaintiff, and/or the public in general. Further,
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`Defendants failed to disclose the true risk, and serious link, between NP Thyroid
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`use and atrial fibrillation, hypertension, chest pain, rapid heart rate or heart
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`rhythm disturbances, weight loss, heat intolerance, fatigue, muscle weakness,
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`and negative maternal and fetal outcomes including miscarriage and/or
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`impairment to fetal development. Excessive levels of liothyronine, as found in
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`Acella’s NP Thyroid, when given to patients suffering from hypothyroidism, can
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`lead to unintentional weight loss, tachycardia, arrhythmia, heart palpitations,
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`nervousness, anxiety, irritability, tremors, sweating, changes in menstrual
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`patterns, increased sensitivity to heat, changes in bowel patterns, an enlarged
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`thyroid gland, fatigue, difficulty sleeping, skin thinning, and brittle hair.
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`17. On May 22, 2020, the Food and Drug Administration (“FDA”)
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`announced that Acella Pharmaceuticals issued a voluntary nationwide recall to
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`the consumer level of certain lots of NP Thyroid due to superpotency. Testing
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`found these certain lots to be superpotent, containing up to 115.0% of the labeled
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`5
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`amount of liothyronine (T3). Patients being treated for hypothyroidism, who
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`receive superpotent NP Thyroid, may experience signs and symptoms of
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`hypothyroidism which include, but are not limited to, hypertension, chest pain,
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`rapid heart rate, or heart rhythm disturbances, weight loss, heat intolerance, and
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`fatigue and muscle weakness. Pregnant women who take superpotent NP
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`Thyroid may also experience negative maternal and fetal outcomes including
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`miscarriage and/or impairment to fetal development.
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`18. Nearly four months later, on September 17, 2020, the FDA
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`announced that Acella issued another recall of NP Thyroid due to sub potency
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`causing patients to experience signs and symptoms of hypothyroidism.
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`19.
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`In April 2021, Acella issued its third recall within a year by recalling
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`35 (thirty-five) commercial lots and three sample lots of NP Thyroid because
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`testing found these lots had less than 90% of the active ingredients liothyronine
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`and/or levothyroxine as claimed on the bottle labels.
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`20. Acella’s methods, facilities, or controls for manufacturing,
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`processing, packing, or holding resulted in significant violations of current good
`
`manufacturing practice (CGMP) regulations for finished pharmaceuticals. The
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`NP Thyroid drug product sold to, and ingested by, Plaintiff was adulterated
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`within the meaning of Section 501(a)(2)(B) of the FD&C Act, 21 U.S.C.
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`351(a)(2)(B). Additionally, Acella’s NP Thyroid drug product, sold to and
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`6
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`ingested by Plaintiff, was adulterated under section 501(b) of the FD&C Act, 21
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`U.S.C. 351(b), for failure to conform to compendial standards for strength,
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`quality, or purity.
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`21. Acella distributed NP Thyroid, a biological product, to consumers
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`without FDA approval or a valid biologics license.
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`22.
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`Throughout the time Acella marketed NP Thyroid, Acella withheld
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`the potential for consumer exposure to superpotent and/or improper doses of
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`NP Thyroid, resulting in serious adverse events from the public, the medical
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`community and the FDA. Acella failed to disclose the serious link between the
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`defective product, and these adverse health consequences, ultimately placing
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`patients, including Plaintiff, at risk and harmed Plaintiff as a result of this
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`misleading conduct.
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`23.
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`Plaintiff brings this action for personal injuries as a result of
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`Defendants’ sale, design, manufacture, testing, marketing, labeling, packaging,
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`handling, distribution, storage, and/or sale of NP Thyroid. In effect, the NP
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`Thyroid product was akin to a Trojan Horse that smuggled dangerously high
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`levels of liothyronine (T3) and/or levothyroxine (T4) into the bodies of
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`consumers, including Plaintiff.
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`Factual Allegations
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`24.
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`In 2009, Defendant Acella launched NP Thyroid. Since that time,
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`Acella has manufactured, marketed, and distributed the drug in the United
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`States, including Florida.
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`25. NP Thyroid tablets are composed of levothyroxine and liothyronine,
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`and are prescribed for the treatment of hypothyroidism. Acella sold or
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`otherwise made available NP Thyroid through capsules. Acella designed,
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`manufactured, tested, marketed, labeled, packaged, handled, distributed, stored
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`and/or sold NP Thyroid by prescription.
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`26. NP Thyroid is a drug used to treat hypothyroidism, a condition
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`where the thyroid gland does not produce enough thyroid hormone. NP
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`Thyroid is also used in the treatment and prevention of normal functioning
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`thyroid goiters, such as thyroid nodules, Hashimoto’s thyroiditis, multinodular
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`goiter, and in the management of thyroid cancer.
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`27.
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`The thyroid is an endocrine gland located at the base of the neck.
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`The thyroid produces two crucial hormones called T3 and T4 that, in addition to
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`regulating the body’s temperature, helps control other bodily functions such as
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`heart rate, metabolization of food, hair growth, and nail growth.
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`Hypothyroidism is a condition where the thyroid gland fails to produce enough
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`T3 and T4 for the body to run properly.
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`8
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`28. Defendant Acella marketed NP Thyroid to “Bring Natural Balance
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`to Thyroid Therapy” touting “batch-to-batch testing to ensure consistent T4 and
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`T3.”
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`29.
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`Each bottle of NP Thyroid represents to the consumer a precise
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`amount of micrograms liothyronine (T3) and levothyroxine (T4) that is contained
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`therein.
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`30. Defendant Acella, through their webpage, warns patients to avoid
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`large doses of NP Thyroid because “Large doses of NP THYROID may cause
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`serious or life threatening side effects, including chest pain, increased pulse rate,
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`rapid, strong, irregular heartbeat, and excessive sweating.”
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`31.
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`In May of 2020, Defendant Acella recalled thirteen lots of NP
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`Thyroid tablets due to superpotency. The NP Thyroid tablets, manufactured by
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`Acella, had more than the labeled amount of liothyronine within the product.
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`Testing by the FDA found that those thyroid tablets had up to 115% of the
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`labeled amount of liothyronine, or T3.
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`a. FDA Testing Discovers Superpotent NP Thyroid, Leading to a Nationwide
`Recall.
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`32. On May 21, 2020, Acella Pharmaceuticals voluntarily recalled a total
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`of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid to the consumer level. Acella
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`issued a statement on its website that the products were being recalled because
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`9
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`testing found these lots to be superpotent. The product may have up to 115.0%
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`of the labeled amount of liothyronine (T3).
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`33. On May 22, 2020, the FDA announced the recall. The FDA further
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`issued a Risk Statement, advising: “Patients being treated for hypothyroidism
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`(underactive thyroid), who receive superpotent NP Thyroid, may experience
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`signs and symptoms of hyperthyroidism (overactive thyroid) which include but
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`are not limited to, weight loss, heat intolerance, fatigue, muscle weakness,
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`hypertension, chest pain, rapid heart rate, or heart rhythm disturbances.
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`Pregnant women who take superpotent NP Thyroid may also experience
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`negative maternal and fetal outcomes including miscarriage and/or impairment
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`to fetal development.”
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`34.
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`Plaintiff references federal law herein not in any attempt to enforce
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`it, but only to demonstrate that her state-law tort claims do not impose any
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`additional obligations on Defendants, beyond what is already required under
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`federal law.
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`b. Acella Made False Statements in the Labeling of NP Thyroid
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`35. A manufacturer is required to give adequate directions for use of a
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`pharmaceutical drug such that a “layman can use a drug safely and for the
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`10
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`purpose for which it is intended,”1 and conform to the requirements governing
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`the appearance of the label.2
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`36.
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`“Labeling” encompasses all written, printed or graphic material
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`accompanying the drug or device,3 and therefore broadly encompasses nearly
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`every form of promotional activity, including not only “package inserts” but also
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`advertising.
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`37.
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`“Most, if not all, labeling is advertising. The term ‘labeling’ is
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`defined in the FDCA as including all printed matter accompanying any article.
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`Congress did not, and we cannot, exclude from the definition printed matter
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`with constitutes advertising.”4
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`38. All drug manufacturers (brand and generic) are also responsible for
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`conducting stability testing, which must be “designed to assess the stability
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`characteristics of drug products.”5 Manufacturers must adopt a written testing
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`program that includes “(1) Sample size and test intervals based on statistical
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`criteria for each attribute examined to assure valid estimates of stability; (2)
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`storage conditions for samples retained for testing; (3) Reliable, meaningful, and
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`specific testing methods; (4) Testing of the drug product in the same container-
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`
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`1 21 C.F.R. § 201.5.
`2 Id. §201.15.
`3 Id.; 65 Fed. Reg. 14286 (Mar. 16, 2000).
`4 United States v. Research Labs., 126 F.2d 42, 45 (9th Cir. 1942).
`5 21 C.F.R. §211.166(a)
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`11
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`closure system as that in which the drug product is marketed; (5) Testing of drug
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`products for reconstitution at the time of dispensing (as directed in the labeling)
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`as well as after they are reconstituted.”6
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`39.
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`The purpose of stability testing is, in part, to determine “the
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`appropriate storage conditions and expiration dates.”7 And, expiration dates, in
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`turn, must be set to “assure that a drug product meets applicable standards of
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`identity, strength, quality and purity at the time of use.”8 An expiration date is
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`“related to any storage conditions stated on the labeling, as determined by
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`stability studies listed in §211.166.”9
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`40. After a drug is approved, a manufacturer (brand or generic) can
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`make changes to its drug application. To do so, manufacturers must comply
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`with the requirements of §§ 314.70 and 314.71.10
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`41.
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`The FDA has encouraged manufacturers of non-synthetic thyroid
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`medications to apply for FDA approval, as required by law. Acella has failed to
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`do so. As a result, Acella breached its duties to consumers by failing to
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`implement proper testing, which resulted in NP Thyroid consumers ingesting a
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`product which failed to meet Acella’s representations of safety, effectiveness or
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`
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`6 Id.
`7 Id.
`8 Id. §211.137(a).
`9 Id. §211.137(b).
`10 See id. §§ 314.70, 314.97(a) (requiring generics to comply).
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`12
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`quality. If Acella had elected to submit NP Thyroid for drug approval, then
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`Acella would have been subject to some of the requirements in those regulations
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`require a brand or a generic manufacturer of an approved drug to obtain FDA
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`approval before implementing a label change.11
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`42. A manufacturer, therefore, need not seek FDA pre-approval to make
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`changes to its stability studies to identify the appropriate expiration date—which
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`must “assure that a drug product meets applicable standard of identity, strength,
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`quality, and purity at the time of use”12—or to ensure that the drug is shipped
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`and stored under appropriate conditions.
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`c. Current Good Manufacturing Practices
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`43. Under federal law, a manufacturer must manufacture, store,
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`warehouse and distribute pharmaceutical drugs in accordance with “Current
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`Good Manufacturing Practices” (“CGMPs”) to ensure they meet safety, quality,
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`purity, identity, and strength standards.13
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`44.
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`The U.S. Pharmacopeia Convention (hereinafter “USP”) sets forth
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`industry standards applicable—in relevant part—to repackagers and
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`distributors. Chapter 1079, entitled “Good Storage and Shipping Practices,”
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`specifies that
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`11 Id. § 314.70(b)
`12 21 C.F.R. § 211.137(a).
`13 21 U.S.C. § 351(a)(2)B).
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`13
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`Good storage and distribution practices apply to all organizations and
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`individuals involved in any aspect of the storage and distribution of all drug
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`products, including but not limited to the following:
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`• Repackaging operations in which the drug product may be owned
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`by an organization other than the primary manufacturer Pharmacies
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`including but not limited to retail, compounding, specialty, mail
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`order, hospital, and nursing home pharmacies…
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`• Wholesale distributors: distribution companies involved in
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`automobile, rail, sea, and air services.
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`
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`45. USP 1079 further states that the drug product manufacturer (in the
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`case of many OTSs, where there is no application) and the repackager bear
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`primary responsibility and accountability including but not limited to the
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`following:
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`• Drug product stability profiles or the associated stability
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`information from the holder, inclusive of distribution conditions and
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`excursion that may be allowable should they occur. These stability
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`profiles include the approved storage conditions for the shelf life of
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`the drug product and, where applicable, supporting data for the
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`distribution conditions, if they differ from the storage conditions.
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`14
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`d. Acella’s Warranties to Plaintiff
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`46.
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` By presenting consumers with a label, Acella made representations
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`and express or implied warranties to consumers, like Plaintiff, that their product
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`was consistent with the safety, quality, purity, identity and strength
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`characteristics reflected in the labels and/or were not adulterated or misbranded.
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`47.
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`In addition, Defendant Acella affirmatively misrepresented and
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`warranted to physicians and patients like Plaintiff through their website,
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`brochure, and other marketing or informational materials that their liothyronine
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`containing product, NP Thyroid, complied with CGMP and contained the
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`ingredient levels identified on the products’ labels.
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`48. Acella willfully, recklessly, or negligently failed to ensure their
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`products’ labels and other advertising or marketing statements accurately
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`conveyed information about their product and the true level of liothyronine and
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`levothyroxine contained therein.
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`49. At all relevant times, Defendant Acella has also impliedly warranted
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`that NP Thyroid was merchantable and fit for its ordinary purposes.
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`50. The presence of excessive levels of liothyronine in Acella’s product,
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`NP Thyroid, resulted in the product being non-merchantable and not fit for its
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`ordinary purposes, breaching Acella’s implied warranty of merchantability
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`and/or fitness for ordinary purposes.
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`15
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`51. From December 17, 2019 to January 7, 2020, the U.S. Food and Drug
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`Administration conducted a facility inspection of Defendant Acella
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`Pharmaceuticals, LLC at 1880 McFarland Parkway, Suite 110-B, Alpharetta
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`Georgia. The FDA inspection found significant violations of current good
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`manufacturing practice (CGMP) regulations for finished pharmaceuticals. The
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`FDA, in its warning letter to Acella, determined that Acella’s methods, facilities
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`or controls for manufacturing, processing, packing or holding do not conform to
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`CGMP and that their drug product is adulterated within the meaning of the
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`FD&C Act. The FDA further determined “your NP Thyroid drug products are
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`adulterated under section 501(b) of the FD&C Act, 21 U.S.C. 351(b), for failure to
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`conform to compendial standards for strength, quality, or purity.”
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`52. As result of the December 17, 2019 to January 7, 2020 FDA facility
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`inspection of Acella, the FDA investigators found specific violations including
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`but not limited to the following: Acella “failed to establish laboratory controls
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`that include scientifically sound and appropriate specifications, standards,
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`sampling plans, and test procedures designed to assure that components, drug
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`product containers, closures, in-process materials, labeling, and drug products
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`conform to appropriate standards of identity, strength, quality, and purity. (21
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`CFR 211.160(b).” The FDA also cited an additional violation: “Your firm (Acella)
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`failed to establish an adequate quality control unit with the responsibility and
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`16
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`authority to approve or reject all components, drug product containers, closures,
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`in-process materials, packaging materials, labeling and drug products (21 CFR
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`211.22(a)).”
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`53. Acella distributed NP Thyroid, a biological product, without FDA
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`approval or a valid biologics license.
`
`54. For these and other reasons, Acella’s NP Thyroid products are
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`adulterated and/or misbranded, and it was unlawful for Acella to have
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`introduced misbranded, improperly labeled, and defective bottles of NP Thyroid
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`into commerce in the United States.14
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`e. Patricia Vosburgh’s Use of NP Thyroid
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`55. Plaintiff, Patricia Vosburgh, was prescribed and/or ingested NP
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`Thyroid as part of her treatment for hypothyroidism.
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`56. Plaintiff, Patricia Vosburgh, consistently used NP Thyroid on a daily
`
`basis. Plaintiff ingested the NP Thyroid product, in accordance with the
`
`instructions for use and in a reasonably foreseeable manner. Plaintiff purchased
`
`the product from Walgreens.
`
`57. Plaintiff, Patricia Vosburgh, used the NP Thyroid product, which is
`
`designed, manufactured, tested, marketed, labeled, packaged, handled,
`
`distributed, stored and/or sold by Acella. NP Thyroid, unbeknownst to
`
`
`14 See 21 U.S.C. §§ 331(a), 351(a)(2)(B), 331(g).
`
`
`
`17
`
`
`
`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 18 of 63 PageID 18
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`Plaintiff, contained dangerous levels of liothyronine and/or improper dosing,
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`resulting in a superpotent dose, which consequently resulted in multiple
`
`hospitalizations and adverse health effects to Plaintiff. Plaintiff developed atrial
`
`fibrillation, tachycardia, shortness of breath, elevated heart rate, chest pain and
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`hypertension, and suffered the effects and sequelae therefrom, as a direct and
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`proximate result of the unreasonably dangerous and defective nature of NP
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`Thyroid, and Defendants’ wrongful and negligent conduct in the research,
`
`development, testing, manufacture, production, promotion, distribution,
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`marketing and sale of NP Thyroid.
`
`58. As a result of consuming Defendant’s NP Thyroid product, Plaintiff
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`developed severe and permanent injuries consisting of: atrial fibrillation,
`
`tachycardia, shortness of breath, elevated heart rate, chest pain and
`
`hypertension. These injuries, as a result of her consumption of NP Thyroid,
`
`required multiple hospitalizations. These are some, but not all, of the injuries
`
`sustained by Plaintiff. Plaintiff seeks damages for all NP Thyroid related injuries
`
`within the medical records.
`
`59. As a result of her use of NP Thyroid, Plaintiff suffered significant
`
`bodily injury, pain and suffering, mental anguish, disfigurement,
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`embarrassment, inconvenience, loss of earnings and earning capacity and have
`
`and will incur past and future medical expenses.
`
`
`
`18
`
`
`
`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 19 of 63 PageID 19
`
`60. Based on the prevailing scientific evidence, exposure to excessive
`
`amounts of liothyronine, in individuals suffering from hypothyroidism can lead
`
`to atrial fibrillation, hypertension, chest pain, rapid heart rate, or heart rhythm
`
`disturbances, weight loss, heat intolerance, fatigue, muscle weakness, negative
`
`maternal and fetal outcomes including miscarriage and/or impairment to fetal
`
`development. Excessive levels of liothyronine in patients suffering from
`
`hypothyroidism can lead to unintentional weight loss, tachycardia, arrhythmia,
`
`heart palpitations, nervousness, anxiety, irritability, tremors, sweating, changes
`
`in menstrual patterns, increased sensitivity to heat, changes in bowel patterns, an
`
`enlarged thyroid gland, fatigue, difficulty sleeping, skin thinning and brittle hair.
`
`61. At all relevant times, Acella knew or should have known that there
`
`was a significant increased risk for severe adverse health consequences to
`
`consumers ingesting superpotent doses of NP Thyroid.
`
`62. Had Defendant Accella informed consumers of the true amount of
`
`liothyronine contained in NP Thyroid and the severe health consequences
`
`associated with the superpotent dose of liothyronine contained in Acella’s
`
`product, NP Thyroid, then:
`
`•
`
`Plaintiff’s prescribing physicians would not have prescribed NP
`
`Thyroid to Plaintiff;
`
`
`
`19
`
`
`
`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 20 of 63 PageID 20
`
`•
`
`•
`
`Plaintiff’s physicians would have changed the way in which they
`
`treated Plaintiff’s relevant conditions;
`
`Plaintiff’s physicians would have changed the way they warned
`
`Plaintiff about the signs and symptoms of serious adverse effects of
`
`NP Thyroid;
`
`•
`
`Plaintiff’s physicians would have discussed with Plaintiff the true
`
`risks of NP Thyroid; and
`
`•
`
`Plaintiff would not have ingested NP Thyroid.
`
`
`
`63. Upon information and belief, Patricia Vosburgh’s physicians were
`
`unaware of the increased risk associated with the use of NP Thyroid they
`
`prescribed to her and, if they had been informed of the true dose of liothyronine,
`
`would have used and prescribed alternative therapies to Plaintiff.
`
`64. Further, Plaintiff would not have taken NP Thyroid had she known
`
`of or been fully and adequately informed by Defendant of the true increased
`
`risks and serious dangers of taking the drug.
`
`65. As a direct result and proximate result of Defendants’ conduct,
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`Plaintiff suffered serious and/or permanent injuries, and adverse effects as set
`
`forth in this Complaint, which resulted in damages to Plaintiff in sums in excess
`
`of the jurisdictional limits of the Court.
`
`
`
`20
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`
`
`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 21 of 63 PageID 21
`
`TOLLING
`
`66.
`
` Plaintiff asserts all applicable statutory and common law rights and
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`theories related to the tolling or extension of any applicable statute of limitations,
`
`including equitable tolling, delayed discovery, discovery rule and/or fraudulent
`
`concealment.
`
`67. The discovery rule applies to toll the running of the statute of
`
`limitations until Plaintiff knew, or through the exercise of reasonable care and
`
`diligence, should have known, of facts that Plaintiff had been injured, the cause
`
`of the injury, and the tortious nature of the wrongdoing that caused the injury.
`
`68. The nature of Plaintiff’s injures, damages, or their causal
`
`relationship to Defendants’ conduct was not discovered, and through reasonable
`
`care and due diligence could not have been discovered until a date within the
`
`applicable statute of limitation for filing Plaintiff’s claims.
`
`69. Plaintiff brings this action within the applicable statute of
`
`limitations. Specifically, Plaintiff brings this action within the prescribed time
`
`limits following Plaintiff’s injuries and Plaintiff’s knowledge of the wrongful
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`cause. Prior to such time, Plaintiff did not know and had no reason to know of
`
`her injuries and/or the wrongful cause of those injuries.
`
`70. Because Plaintiff could not have reasonably known that Acella’s NP
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`Thyroid product failed and was defective, Defendants are estopped from relying
`
`
`
`21
`
`
`
`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 22 of 63 PageID 22
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`on any statute of limitations or repose that might otherwise be applicable to the
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`claims asserted herein.
`
`COUNT I
`
`Strict Product Liability – Failure to Warn as to all Defendants
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`71. Plaintiff re-alleges and incorporates by reference each and every
`
`preceding paragraph as though fully set forth herein.
`
`72. At all pertinent times, Defendant Acella was engaged in the
`
`manufacturing, marketing, testing, promotion, selling and/or distributing NP
`
`Thyroid in the regular course of business.
`
`73. At all pertinent times, Defendant Acella knew or should have
`
`known that the use of improperly dosed NP Thyroid by consumers increases the
`
`risk of severe adverse health consequences to consumers.
`
`74. At all pertinent times, Defendant Walgreens was in the business of
`
`selling NP Thyroid nationwide, including in the State of Florida and Pinellas
`
`County.
`
`75. At all pertinent times, Walgreens knew or should have known that
`
`the use of NP Thyroid would significantly increase the risk of adverse health
`
`consequences (including but not limited to: atrial fibrillation, hypertension, chest
`
`pain, rapid heart rate, or heart rhythm disturbances, weight loss, heat
`
`intolerance, fatigue, muscle weakness, negative maternal and fetal outcomes
`
`
`
`22
`
`
`
`Case 8:21-cv-02519-SDM-AEP Document 1 Filed 10/27/21 Page 23 of 63 PageID 23
`
`including miscarriage and/or impairment to fetal development) to consumers,
`
`including Plaintiff, and those suffering from hypothyroidism.
`
`76. At all pertinent times, including the time of sale to Plaintiff and
`
`consumption of NP Thyroid by Plaintiff, NP Thyroid was unreasonably
`
`dangerous and in a defective condition because it failed to warn of the dangers
`
`associated with the foreseeable use of the NP Thyroid product, regarding the risk
`
`of adverse health consequences (including but not limited to: atrial fibrillation,
`
`hypertension, chest pain, rapid heart rate, or heart rhythm disturbances, weight
`
`loss, heat intolerance, fatigue, muscle weakness, negative maternal and fetal
`
`outcomes including miscarriage and/or impairment to fetal development),
`
`given those risks were known or knowable in light of the generally recognized
`
`and prevailing best scientific and medical knowledge. The label failed to warn
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`of these risks by failing to ensure NP Thyroid’s labels made apparent the
`
`potential harmful consequences of use of the product. This includes, but is not
`
`limited to, the failure to warn of the true levels of liothyronine and levothyroxine
`
`contained within NP Th
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