Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 1 of 8
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`Exhibit A
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`Exhibit A
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`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 2 of 8
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`21-—2-00711-29
`CMP
`2
`HAL
`a0
`¥
`eb AE
`Complaint
`SKAGIT COUETY, 84
`11484637
`OU
`MUINEC ~2 PH 218
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`
`
`
`SUPERIOR COURT OF THE STATE OF WASHINGTON
`IN AND FOR SKAGIT COUNTY
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`Cause Number:
`ul Z 00] |
`:
`.
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`| 24
`_
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`COMPLAINT
`
`EILEEN HOLLAND,
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`Plaintiff,
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`Vv.
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`ACELLA PHARMACEUTICALS, LLC;
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`SAFEWAY,INC., d/b/a: HAGGEN #3436;
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`HH LEGACY,INC., d/b/a: HAGGEN FOOD
`& PHARMACY#15; and
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`DOE 1 — DOE 25.
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`Defendants.
`
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`I.
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`INTRODUCTION
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`1. Buyer beware is not the law in the State of Washington.
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`2. To lawfully sell pharmaceutical drugs to consumers in Washington, the drugs must
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`conform to national pharmaceutical standards for strength, quality, and purity.
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`3. For pharmaceutical drugs to conform to compendial standards of strength, quality, and
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`purity, laboratory controls must be scientifically sound and designed to assure that
`22
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`COMPLAINT
`SULLIVAN LAW GROUP, PLLC
`PAGE I
`2932 Hoyt Avenue, Everett WA 98201
`Tel: (425) 322-1076 ~ Fax: (425) 609-3760a
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`A sa!
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`AMaree thi
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`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 3of8
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`components, materials, labeling, and the actual drugs conform to standards.
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`Acella Pharmaceuticals, LLC failed to conform to these standards, and sold Acella NP
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`Thyroid® tablets that had excessive amounts of Liothyronine (T3), a man-made form
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`of thyroid hormone.
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`A Haggen grocery store in Burlington, Washington purchased the defective Acella NP
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`Thyroid® tablets and re-sold them to Eileen Holland.
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`Eileen Holland took the NP THYROID®asordered by her doctor.
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`Asdirected in the Acella Pharmaceuticals NP Thyroid® Important Safety Information
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`Sheet, Eileen did not stop or change the amount she took, or how often she took it, until
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`eventually told to do so by her medical provider.
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`This was unfortunately not until after Eileen had suffered effects of excessive
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`Liothyronine which resulted in her physical and emotional injuries which shall be
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`provedattrial.
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`Il.
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`PARTIES
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`Acella Pharmaceuticals, LLC is pharmaceutical company in Forsyth County, Georgia.
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`10.
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`Safeway, Inc. owns the Haggen grocery store in Burlington, Washington (Haggen
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`#3436) where Eileen purchased the defective Acella NP Thyroid® tablets.
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`11.
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`Aspart of Safeway Inc.’s businessit either operates or leases space to other pharmacies
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`at someofits stores; that is the case with Haggen #3436.
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`12.
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`HH Legacy, Inc., does business as Haggen Food & Pharmacy #15, and operates the
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`pharmacy at Haggen #3436.
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`13.
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`Safeway, Inc.; Haggen #3436; HH Legacy,Inc.; and Haggen Food & Pharmacy #15 are
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`COMPLAINT
`PAGE 2
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`SULLIVAN LAW GROUP, PLLC
`2932 Hoyt Avenue, Everett WA 98201
`Tel: (425) 322-1076 - Fax: (425) 609-3760
`
`
`
`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 4of8
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`hereinafter collectively referred to as “Safeway.”
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`14.
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`Doe | through Doe 25 are persons or business who were involved in the manufacture,
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`oversight, or transaction of defective Acella NP Thyroid® tablets.
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`I.
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`JURISDICTION AND VENUE
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`15.
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`The Court has personal jurisdiction overall the parties.
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`16.
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`Venueis appropriate in Skagit County Superior Court, where the defective product was
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`sold to Eileen Holland.
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`Iv.
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`FACTS
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`17.
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`Acella Pharmaceuticals, LLC claimsthat its NP Thyroid® tablets are, “Made with the
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`highest quality standards under cGMP,” which is the Current Good Manufacturing
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`Practices for drugs, per Section 21 of the US Code of Federal Regulations
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`Parts 210 and 211.!
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`18.
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`Acella Pharmaceuticals, LLC claimsthat its NP Thyroid® tablets are subject to Batch-
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`to-batch testing to ensure consistent T4 & T3.””
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`19.
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`Regardless of these claims, Acella Pharmaceuticals, LLC failed to conform to Current
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`Good Manufacturing Practices for drugs and sold Acella NP Thyroid® tablets that had
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`excessive amounts of Liothyronine (T3), a man-made form of thyroid hormone.
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`20.
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`The risk and cost of injuries when pharmaceuticals do not conform to Current Good
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`Manufacturing Practices for drugs substantially outweighs the cost
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`for Acella
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`Pharmaceuticals, LLC to make pharmaceuticals that are within standards.
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`' https://npthyroid.com/about/
`? https://npthyroid.com/about/
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`COMPLAINT
`PAGE 3
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`SULLIVAN LAW GROUP, PLLC
`2932 Hoyt Avenue, Everett WA 98201
`Tel: (425) 322-1076 - Fax: (425) 609-3760
`
`
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`
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`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page5of8
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`21.
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`Ordinary consumers would not be aware that their pharmaceutical drugs contain up to
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`115% ofthe labeled amountof active ingredient without conducting testing that is cost-
`prohibitive to the ordinary consumer.
`.
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`22.
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`Consumers do not and would not recognize hormone drugs as safe when they contain
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`up to 115% of the labeled amount of an active ingredient, as was the case with the
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`defective Acella NP Thyroid® tablets.
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`23.
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`Acella’s NP Thyroid® tablets did not contain adequate warnings or instructions,
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`including that the drug as actually manufactured may not be FDA approved, nor being
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`sold with a valid biologics license.’
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`24.
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`Acella Pharmaceuticals LLC’s sale of its defective NP Thyroid® tablets breached
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`warranties both express and implied.
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`25.
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`On May 22, 2020, the FDA published Acella Pharmaceuticals LLC recall of 30-mg NP
`Thyroid® tablets based on a warning of super potency and the receipt of at least two
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`adverse events knownto berelated to the recall.
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`26.
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`Nonetheless, on June 13, 2020, the Safeway defendants sold Eileen 30-mg NP Thyroid®
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`tablets from the recalled lot of defective drugs.
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`27.
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`The defective NP Thyroid® tablets purchased by Eileen were a direct and proximate
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`cause of her injuries that will be provenattrial.
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`28.
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`Doe 1
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`through Doe 25 have not yet been identified, but were involved in the
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`manufacture, oversight, or transaction of defective Acella NP Thyroid® tablets.
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`3 See https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
`investigations/warning-letters/acella-pharmaceuticals-llc-604438-08 142020
`
`
`COMPLAINT
`PAGE 4
`
`SULLIVAN LAW GROUP, PLLC
`2932 Hoyt Avenue, Everett WA 98201
`Tel: (425) 322-1076 - Fax: (425) 609-3760
`
`
`
`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 6 of8
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`V.
`
`CLAIM FOR DAMAGES UNDER THE
`WASHINGTON PRODUCTLIABILITY ACT
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`29. PlaintiffEileen Holland restates and reincorporates each ofthe preceding paragraphs.
`30. Defendant Acella Pharmaceuticals, LLC manufactured and supplied a product that was
`not reasonably safe in construction at the time the productleft its control because it did
`not conform to the manufacturer's express warranty.
`31. Defendant AcellaPharmaceuticals, LLC supplied aproduct thatwas not reasonably safe
`in construction at the time the productleft its control because it did not conform to its
`design.
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`32. Defendant Acella Pharmaceuticals, LLC supplied a product that was not reasonably safe
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`in construction at the time the productleft its control because it did not have adequate
`warnings
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`33. The defective pharmaceuticals sold to Eileen Holland were the direct and proximate
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`cause ofher injuries and damages.
`34. The collective Safeway defendants were negligent in selling Eileen Holland a recalled
`drug that wasrecalled for its super potency.
`35. Noneofthe collective Safeway defendants warned Eileen Holland that the drugsit sold
`her had beenrecalled for super potency.
`VI.
`CLAIM FOR DAMAGES UNDER THE CONSUMER PROTECTION ACT
`36. PlaintiffEileen Holland restates and reincorporates each ofthe preceding paragraphs.
`37. It was deceptive or unfair for Acella Pharmaceuticals, LLC to advertise that its drugs
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`were made under the “highest quality standards under cGMP,” when the drugs as
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`
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`COMPLAINT
`PAGE 5
`
`SULLIVAN LAW GROUP, PLLC
`2932 Hoyt Avenue, Everett WA 98201
`Tel: (425) 822-1076 - Fax: (425) 609-3760
`
`
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`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 7 of8
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`manufactured did not conform to design.
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`38.
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`It was deceptive and unfair for the Safeway defendants to sell pharmaceutical drugs that
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`were subject to an outstanding drug recall without notifying the buyer before purchase.
`The deceptive and unfair acts of Acella Pharmaceuticals, LLC and the Safeway
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`39.
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`defendants injured Eileen in her property: the money she spent on drugs that had been
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`recalled.
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`40.
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`The deceptive and unfair acts of Acella Pharmaceuticals, LLC and the Safeway
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`defendants caused Eileen’s injury because she would not have taken the drugs but for
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`the deceptive and unfair acts of the defendants.
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`Vil.
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`CLAIM FOR DAMAGES FROM NEGLIGENCE
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`41.
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`Plaintiff Eileen Holland restates and reincorporates each of the preceding paragraphs.
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`42.
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`The Safeway defendants were negligentin selling drugs that were subject to FDArecall.
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`43.
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`The Safeway defendants were negligentfor failing to tell Eileen that the drugs they were
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`selling her were subject to FDArecall.
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`44.
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`The negligence of the Safeway defendants caused Eileen’s injuries and damages
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`because she would not have taken the drugs but for them selling them to her.
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`VU.
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`PRAYER FOR RELIEF
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`45,
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`Wherefore, Plaintiff prays for judgment as follows:
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`46.
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`For her economic losses that were caused by the related injuries;
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`47.
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`For her non-economic losses that were causedbythe related injuries;
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`48.
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`For attorney fees and costs, as determined by the Court;
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`For jury consideration of trebling damages;
`49.
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`COMPLAINT
`SULLIVAN LAW GROUP, PLLC
`PAGE6
`2932 Hoyt Avenue, Everett WA 98201°
`Tel: (425) 322-1076 - Fax: (425) 609-3760
`
`
`
`Case 2:22-cv-00002 Document 1-1 Filed 01/03/22 Page 8 of8
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`50. For exemplary and/or punitive damagesas authorized bythe lawsofthe State of
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`Georgia
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`51. For any otherrelief the Court believes ifjust and appropriate.
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`Dated this 30" day of November 2021.
`
`By:_/s/ Brian M. Sullivan
`Brian M.Sullivan, WSBA #38066
`SULLIVAN LAW GROUP, PLLC
`2932 Hoyt Avenue
`Everett, WA 98201
`Tel: 425.322.1076
`Fax: 425.609.3760
`brian@sullivanpllc.com
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`Attorneyfor PlaintiffEileen Holland
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`COMPLAINT
`PAGE 7
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`SULLIVAN LAW GROUP, PLLC
`2932 Hoyt Avenue, Everett WA 98201
`Tel: (425) 322-1076 - Fax: (425) 609-3760
`
`
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