Case 2:22-cv-01014-MHH Document 1 Filed 08/10/22 Page 1 of 25
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` FILED
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` 2022 Aug-10 AM 10:51
`U.S. DISTRICT COURT
`N.D. OF ALABAMA
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` FILED
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` 2022 Aug-10 AM 10:51
`U.S. DISTRICT COURT
`N.D. OF ALABAMA
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`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 2 of 25
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`INTRODUCTION
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`1.
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`The Alabama State Board of Pharmacy has filed charges against
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`Oxford (an Alabama-licensed drug manufacturer) seeking to revoke Oxford’s
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`Alabama license and assess significant disciplinary penalties against it, based on
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`the Board’s claim that Oxford violated the federal Food, Drug, and Cosmetic Act
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`(the Act) when the U.S. Food and Drug Administration made certain observations
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`during a May 2019 inspection of Oxford’s facility. After the inspection, however,
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`the FDA concluded that the observations did not warrant any regulatory or
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`enforcement action and that Oxford had, in fact, minimally complied with current
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`good manufacturing practice, which is the same as being compliant
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`in FDA
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`parlance. Five months after the FDA’s determination, the Board itself inspected
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`Oxford’s facility and found it to be fully compliant.
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`2.
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`Now, more than three years later, the Board has brought these charges
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`against Oxford, and the hearing on the charges is set for August 16, 2022. The
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`Board’s Statement of Charges claims that the Board seeks to hold Oxford liable for
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`violating section 501(a)(2) of the Act, see 21 U.S.C. § 351(a)(2)(B). After Oxford
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`explained to the Board that only the FDA has authority to enforce the Act, the
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`Board told Oxford that it was really alleging that Oxford violated “USP 797,” a
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`non-binding pharmacypolicy related to compounding pharmacies. (Oxfordis not a
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`compounding pharmacy;
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`it
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`is licensed as manufacturer.) One day after that
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`explanation from the Board, however, the Board said that it actually was charging
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`that Oxford violated current good manufacturing practice (CGMP), based entirely
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`on the FDA’s May 2019 inspection observations—even though no Alabama law
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`applicable to Oxford requires such cGMP compliance, even though the Boarditself
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`found Oxford’s facility compliant one month after the FDA’s inspection, and even
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`though the FDA itself concluded that Oxford was cGMP compliant. Thus, at the
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`end of the day, the Board’s charges against Oxford continue to be expressly based
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`on the allegation that Oxford violated section 501(a)(2) of the Act, predicated
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`solely upon the form 483 issued by the FDA following its inspection of Oxford
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`more than three years ago.
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`3.
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`Oxford brings this lawsuit to obtain a declaration that the FDA’s
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`findings from the May 2019 inspection do not justify any enforcement or
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`disciplinary action against Oxford, as the FDA concluded. The allegations made by
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`the Board threaten to inflict severe damage on Oxford’s reputation, and thereby to
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`cause imminent and irreparable harm to Oxford. In addition, if the Board succeeds
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`and disciplines Oxford at the upcoming August 16 hearing, Oxford (which is
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`licensed in all fifty states) will have to report that discipline in most, if not all, of
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`those states and face potential disciplinary actions from the boards in thosestates.
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`Such a cascade of events would have a debilitating impact on Oxford’s business
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`and severely damage its reputation in the industry. The harm from the Board’s
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`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 4 of 25
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`continued pursuit of these baseless charges and its efforts to sanction Oxford is
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`impossible to calculate.
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`4,
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`Oxford also seeks a declaration that
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`the Board does not have
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`authority to enforce the Act against it (only the FDA has the authority to enforce
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`the Act) and that Oxford is not subject to an enforcement or disciplinary action
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`under the Act based on the FDA’s May 2019 inspection during which Oxford was
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`deemed to be minimally compliant. In addition, Oxford asserts a procedural due
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`process claim based on the Board’s continually-changing theories of liability
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`against Oxford. Oxford has no adequate notice of the charges against it. As a
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`result, in addition to compensatory damages and attorneys’ fees, Oxford asks the
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`Court to enjoin the upcoming August 16, 2022 hearing on the Board’s Statement of
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`Charges unless and until the Board provides adequate notice of the charges to
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`Oxford and ceasesits putative attempts to enforce the Act.
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`5.
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`Oxford has commencedthis action to clear its name in light of the
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`baseless charges brought by the Board. Because the FDAhasexclusive authority to
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`enforce the applicable provisions of the federal Food, Drug, and Cosmetic Act, the
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`FDAis a necessary party to this declaratory judgmentaction.
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`JURISDICTION AND VENUE
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`6.
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`This Court has jurisdiction pursuant to 28 U.S.C. § 1331 and § 1367.
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`7,
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`Venue is proper in this District because the acts and transactions
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`occurred here.
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`PARTIES
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`8.
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`Oxford is a Delaware limited liability company that manufactures
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`drugs and holds an Alabama manufacturer’s license from the Alabama State Board
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`of Pharmacy.
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`9.
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`The Alabama State Board of Pharmacy is an Alabamastate agency.
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`10.
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`Chris Phung is the President of the Alabama State Board of Pharmacy
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`and a citizen of Alabama.
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`11.
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`Rob Colburn is the Vice President of the Alabama State Board of
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`Pharmacy and a citizen of Alabama.
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`12.
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`Christy K. Garmon is the Treasurer of the Alabama State Board of
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`Pharmacyand a citizen of Alabama.
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`13.
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`Gary Mount is a member of the Alabama State Board of Pharmacy
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`and a citizen of Alabama.
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`14.
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`Thomas Cobb is a memberof the Alabama State Board of Pharmacy
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`and a citizen of Alabama.
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`15. Donna C. Yeatman is the Executive Secretary for the Alabama State
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`Board of Pharmacy and a citizen of Alabama.
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`16.
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`The United States Food and Drug Administration is an agency of the
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`federal government of the United States.
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`FACTUAL ALLEGATIONS
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`17. Oxford is a Birmingham, Alabama-based pharmaceutical company
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`that manufactures generic prescription drug products.
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`18. Oxford manufactures its products in a 120,000 square-foot facility in
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`Birmingham, which it completed in 2016.
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`19.
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`In January 2017, Oxford applied for a manufacturer’s license from the
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`Alabama State Board of Pharmacy (the Board).
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`20.
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`The Board inspected Oxford’s facility “pre-licensure” and determined
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`that
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`it was “compliant” with Alabama requirements. (A copy of the Board’s
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`January 18, 2017 inspection report is attached as Exhibit A.)
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`21.
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`The Board concluded at that inspection that all drugs were “stored at
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`appropriate temperatures and under appropriate conditions” and that Oxford had
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`established and maintained “inventories and records” concerning its drugs, among
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`other things. (/d.)
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`22.
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`The Board then issued Oxford a manufacturer
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`license (License
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`#195189).
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`23.
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`Before Oxford started manufacturing and shipping its products,
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`however, federal law required that the U.S. Food and Drug Administration (the
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`FDA) inspect Oxford’s facility.
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`24.
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`So, Oxford requested such a pre-approval inspection from the FDA.
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`The FDA’s May 2019 Pre-Approval Inspection of Oxford
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`25.
`The FDA’s pre-approval inspection occurred over seven days in May
`(A copy of the FDA’s Establishment Inspection Report is attached as
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`2019.
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`Exhibit B.)
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`26.
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`The FDA observed some “minor questionable instances,” but Oxford
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`immediately corrected them to the FDA’s satisfaction. (Ud. at 5, 12.)
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`27.
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`It also observed and reported to Oxford some conditions that it opined
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`violated the federal Food, Drug, and Cosmetic Act (the Act). Ud. at 7 (“I told the
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`company representatives that
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`the inspection revealed objectionable conditions
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`which I had included on an FDA-483, Objectional Conditions. 1 stated that those
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`conditions and practices,
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`in my opinion, represented violations of the FD&C
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`Act.”).)
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`28.
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`One of those observations (Observation #2) related to Oxford’s
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`purified water generation system and the FDA’s concerns about maintenance
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`procedures on the system and the UV lampsusedfor the system. (/d. at 10-11.)
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`29.
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`The other observation (Observation #3) related to the FDA’s concern
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`that Oxford deviated from certain written specifications and test procedures. (/d. at
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`11-12.)
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`30. At the end of the seven-day inspection, however, the FDA noted that
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`it appreciated Oxford’s “cooperation with the inspection” and its “expeditious
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`reactions to [the FDA’s] request of documents and interviews.” (/d. at 13.)
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`31.
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`The FDAthen issued report, known as a FDA Form 483, that detailed
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`its observations. (See generally Ex. B.)
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`32. Oxford responded in writing to the FDA’s Report, explained how it
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`planned to resolve the FDA’s observations, and reiterated its commitment to
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`ensuring compliance with all FDA requirements. (A copy of Oxford’s June 6, 2019
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`responseis attached as Exhibit C.)
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`33.
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`The FDA then concluded that Oxford’s facility was “in a minimally
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`acceptable state of compliance with regards to current good manufacturing
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`practice” and that it would “not take or recommend regulatory or enforcement
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`action” against Oxford. (A copy of the FDA’s July 11, 2019 letter is attached as
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`Exhibit D.)
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`34. After that, Oxford submitted products to the FDA and began receiving
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`approvals to manufacture and distribute drugs.
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`35.
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`For overthe next two years, Oxford had no incidents.
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`36.
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`For instance,
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`it passed the Board’s October 2019 inspection with
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`flying colors.
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`(A copy of the Board’s October 24, 2019 inspection report is
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`attached as Exhibit E.)
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`37.
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`At that inspection (less than six months after the FDA’s pre-approval
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`inspection),
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`the Board determined that Oxford properly stored its drugs and
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`medicines,
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`that its temperature equipment (like its UV lamps) were properly
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`utilized, and that it satisfied all record-keeping requirements, among other things.
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`(See generally id.) In 2021, the Board reaffirmed this conclusion and renewed
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`Oxford’s license through December 2022.
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`The Board’s 2022 Statement of Charges under § 501(a) of the Act
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`38.
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`But in May 2022—almost three years after the FDA’s May 2019 pre-
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`approval inspection and the FDA’s conclusion that no enforcement action should
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`be brought against Oxford because it complied with current good manufacturing
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`practice—Oxford received a Statement of Charges from the Board based on the
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`FDA’s Observations from its May 2019 inspection. (A copy of the Statement of
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`Charges is attached as Exhibit F.)
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`39.
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`In the Statement of Charges, the Board alleges that Oxford violated
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`Alabama Code § 34-23-92(11) by violating “Section 501(a)(2)(B) of the Federal
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`Food Drug and Cosmetic Act based upon Observations 2 and/or 3 of the FDA 483
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`issued on May 22, 2019.” Ud. at Count One.)
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`40. Alabama Code § 34-23-92(11)—the provision on which the Board
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`relies to bring its Statement of Charges—is simply an enumeration of some of the
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`Board’s powers; it does not in any way purport to apply to Oxford or any other
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`licensee:
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`(11) To enforce the state barbiturate act, the state amphetamine act, the state narcotic law, andall other laws ofthe state which
`pertain to the practice of pharmacy, the examination of applicants, the licensing ofpharmacists, the manufacture, packaging,
`repackaging, production, sale, or distribution of drugs, chemicals, and poisons, and all laws pertaiming to standards for their
`strength and purity. The board may work in conjunction with other law enforcement agencies to enforce any law pertaining
`to the practice of phanmacy. Nothing in this section shall be construed to deprive the State Board of Health ofany powers or
`duties otherwise presenbed by law including the enforcement of the narcotic law.
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`41.
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`The Board seeks sanctions against Oxford, including civil monetary
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`penalties and the suspension, probation, or revocation of Oxford’s manufacturer’s
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`license. Ud. at 1 (stating that a hearing will occur “to determine why the [license]
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`to operate Oxford Pharmaceuticals, LLC as a Manufacturer should not be subject
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`to any ofthe sanctions set out in Code of Alabama (1975), § 34-23-92(12)”).)!
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`The Board’s Shifting Explanations of its Charges
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`42.
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`The Statement of Charges alleges that Oxford violated section
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`501(a)(2)(B) of the Act based on the FDA’s Observations #2 and #3 in its 2019
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`inspection and violated Alabama Code § 34-23-92(11) as a result of those
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`Observations. (See Ex. F at Count One.)
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`
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`' Alabama Code § 34-23-92(12) allows the Board to “revoke, suspend, or probate any license”
`and “invoke penalties not to exceed the sum of one thousand dollars ($1,000) for each violation,”
`among other things.
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`10
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`43.
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`But § 34-23-92(11) allows the Board to enforce only (i) Alabama’s
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`barbiturate act; (ii) Alabama’s amphetamine act; (iii) Alabama’s narcotic law;
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`(iv) any Alabama law relating to pharmacy and the manufacturing of drugs; and
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`(v) “all laws pertaining to standards for [drug] strength in purity.” See Ala. Code
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`§ 34-23-92(11).
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`44,
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`Section 34-23-92(11) contains no standards for manufacturing.
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`45. And the Board makesnoallegation that Oxford violated any state law.
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`46.
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`The Board claimsonly that Oxford violated the Act.
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`47.
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`But the FDA hasexclusive authority to enforce the Act. See 21 U.S.C.
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`§ 337(a) (“Except as provided in subsection (b), all such proceedings for the
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`enforcement, or to restrain violations, of this chapter [the Act] shall be by and in
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`the name ofthe United States.” (emphasis added)).
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`48.
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`The only actions that a state agency—like the Board—may bring
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`relate to food, not the manufacture of drugs. See 21 U.S.C. § 337(b) (“A State may
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`bring in its own name and within its own jurisdiction proceedings for the civil
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`enforcement of [sections 341 and 343] of this Title if the food that is the subject of
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`the proceedingsis located in the State.”).
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`49. As a result, Oxford explained to the Board that the Board lacked
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`authority and jurisdiction to enforce the Act and asked the Board to dismiss its
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`Statement of Charges. (A copy of a June 25, 2022 email explaining Oxford’s
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`position is attached as Exhibit G.)
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`50.
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`In response, the Board’s counsel stated that the Board’s position is
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`actually that Oxford violated “USP 797”:
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`
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`You need to explain it to me because
`the federal agency that has exclusive
`jurisdiction over the statute said no
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`action was indicated.
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`Today 8:41 PM
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`Makesno difference. A violation of
`USP 797is a violation that can be
`sanctioned. States can enforce when
`violates
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`Not exclusive to feds. You know that
`bad acts can violate both federal and
`state law. Violation of FDCA and 797
`violation of state law too
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`Your complaint doesn't mention USP
`797. It only mentions section 501.
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`(A copy of the text message from the Board’s counselis attached as Exhibit H.)
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`51.
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`The USP is a wide range of pharmacy policies and procedures issued
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`by the U.S. Pharmacopeia Convention, a non-governmental, scientific body
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`responsible for setting voluntary standards for pharmacies.
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`52.
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`The U.S. Pharmacopeia Convention is not an enforcement body.
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`53. No Alabama statute or Board regulation references USP 797, which
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`addresses the compoundingof drugs.
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`54.
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`Two Board regulations reference the USP generally, but those concern
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`compounding pharmacies and pharmacists. See Ala. Admin. Code r. 680-X-2-
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`1
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`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 13 of 25
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`43.01; id. r. 680-X-2-.46(1).’
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`55. Oxford is not a pharmacist or a compounding pharmacy.
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`56. And Oxford does not compounddrugs.
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`57.
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`The day after the Board’s counsel said that the Board was pursuing
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`Oxford for violating USP 797, that same counsel said that the Board was, in fact,
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`pursuing Oxford for
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`failing to comply with “cGMP,” or
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`current good
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`manufacturing practices, based on the FDA’s May 2019 inspection.
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`58.
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`There are only two mentions of cGMP in Alabama statutory or
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`regulatory law.
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`59.
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`Both come in the definition of a “private label distributor,” which
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`defines such a distributor as “[a] firm that does not participate in the manufacture
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`or processing of a drug but instead markets and distributes under its own trade
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`name, and labels a drug product made by someoneelse. A private label distributor
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`is responsible for the products it
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`introduces into interstate commerce and for
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`compliance with federal Food, Drug, and Cosmetic Act requirements and Current
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`
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`* Alabama Administrative Code r. 680-X-2-.43.01 requires “All pharmacies that engage in the
`compounding of drugs or drug products shall comply with all applicable and current regulations
`of United States Pharmacopeia-National Formulary (USP)-NF.” (emphasis added). Regulation
`680-X-2-.46(1) similarly requires that pharmacists must ensure that the “[s]torage, use and
`administration of any sterile product used in the administration of immunizations meets the
`United States Pharmacopeia (USP) requirements, as well as those of the Centers for Disease
`Control and any applicable provision of the Alabama Pharmacy Practice Act and/or any rules of
`the Board now in effect or which may becomeeffective in the future.”
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`13
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`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 14 of 25
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`Good Manufacturing Practices regulations.” Ala. Code § 34-23-1(26) (emphasis
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`added); see also Ala. Admin. Code r. 680-X-2-.23(1)(h).
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`60.
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`The Board does not allege that Oxford is a private label distributor.
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`61. Oxford is not a private label distributor because it manufactures—not
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`distributes—drugs.
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`62.
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`The federal Act does, however, mention cGMP—it deems a drug
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`adulterated when the methods used to manufacture the drug do not conform “with
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`current good manufacturing practice to assure that
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`such drugs meet
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`the
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`requirements of this chapteras to safety.” See 21 U.S.C. § 351(a)(2)(B).
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`63.
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`Thus,
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`the Board apparently seeks to enforce the Act’s cGMP
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`requirements against Oxford based on the FDA’s May 2019 pre-approval
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`inspection after which the FDA determined that Oxford did, in fact, meet cGMP
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`requirements.
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`64.
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`Inresponse to Oxford’s discovery requests, the Board reiterated that it
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`relies solely on the May 2019 inspection report (what the Board calls the “FDA
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`483”) to bring its charges, stating that “[t]he charges in this case are based upon
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`Observations 2 and/or 3 of the above referenced FDA 483.” (A copy of the Board’s
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`August 8, 2022 discovery responsesare attached as Exhibit L.)
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`65.
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`The hearing on the Board’s Statement of Charges against Oxford is
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`scheduled for August 16, 2022.
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`14
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`66.
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`But Oxford still does not understand the nature of the charges against
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`it, which continue to change based on conversations with the Board.
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`67.
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`Since Oxford received the Statement of Charges,
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`the Board has
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`offered no less than three underlying theories for its Statement of Charges.
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`68.
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`First, the Statement of Charges claims only that Oxford violated the
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`Act. (See Ex. F.)
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`69.
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`Second, after Oxford explained that only the FDA can enforce the
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`Act, the Board said that Oxford actually had violated USP 797—a non-binding
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`pharmacypolicy related to compounding. (See Ex. H.)
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`70. And third, the Board claims that Oxford violated cGMP in relation to
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`the FDA’s pre-approval May 2019 inspection, even though no Alabama law
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`applicable to Oxford requires such cGMP compliance, even though the Board itself
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`concluded that Oxford satisfied all inspection criteria less than six months after the
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`FDA’s inspection (see Ex. E), and even though the FDA already determined that
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`Oxford did, in fact, meeting cGMP standards (see Ex. D).
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`71.
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`The Board has pointed to no Alabama-law standards that it complains
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`Oxford violated.
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`72. Oxford therefore has no idea to which standards it must comply. In
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`fact,
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`the only statutory standards that
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`the Board’s charges assert
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`is section
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`501(a)(2)(B) of the Act.
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`15
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`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 16 of 25
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`73.
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`The Board has pointed to the Act (see, e.g., Ex. TI), but the FDA has
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`exclusive authority to enforce the Act.
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`74.
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`The FDA hasalready determined that it would not bring any action
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`against Oxford for allegedly violating the Act and also determined that Oxford
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`sufficiently complied with all cGMP requirements. (See Ex. D.)
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`75.
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`Either way—whether the Board seeks to sanction Oxford based on
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`some non-existent Alabama law or to enforce the Act—Oxford (and the healthcare
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`industry generally) is harmed.
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`76.
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`It has no notice of the specific charges againstit.
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`77. Nor doesit have notice of the standards with which the Board expects
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`it to comply.
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`78.
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`The Board’s actions have caused irreparable harm to Oxford for
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`which there is no adequate remedy of law.
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`79.
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`80.
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`The Board hassignificantly disrupted Oxford’s business.
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`The Board’s pursuit of revoking Oxford’s manufacturer’s license, if
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`successful, would totally shut down Oxford’s business.
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`81.
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`The Board’s actions have harmed and will continue to significantly
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`harm Oxford’s reputation and goodwill, which have taken Oxford years to
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`cultivate in the pharmaceutical manufacturing industry.
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`16
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`82.
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`In addition, if the Board is successful in disciplining Oxford based on
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`the FDA’s Observations (observations on which the FDA itself declined to pursue
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`in any enforcement or regulatory action), Oxford will have to report
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`that
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`disciplinary action to most, if not all, of the states in which it is licensed.
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`83.
`
`84.
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`Oxford is licensed in all fifty states.
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`Furthermore, some of these states may themselves decide to impose
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`disciplinary action against Oxford should the Board discipline, and Oxford would
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`have to defend against each of those actions.
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`85. Having to report and defend against these disciplinary actions will
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`debilitate Oxford, and the harm to Oxford’s business and its reputation will be
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`irreparable.
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`COUNT ONE
`(Declaratory Judgment)
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`86.
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`There exists between Oxford,
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`the Board (its members and its
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`executive secretary), and the FDA an actual justiciable controversy with respect to
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`the matters set forth herein, as to which Oxford is entitled to have a declaration of
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`rights and further relief as set forth herein.
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`87.
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`Specifically, the Board contends that it has authority to enforce the
`
`Act against Oxford and that Oxford violated the Act based on the Observations by
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`the FDAin its May 2019 inspection of Oxford’s facilities. (See Exs. F-I.)
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`88.
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`The FDA, however,
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`concluded after
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`its
`
`inspection that
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`its
`
`Observations did not warrant the FDA taking any regulatory or enforcement
`
`actions against Oxford and that Oxford’s facility was “in a minimally acceptable
`
`state of compliance with regards to current good manufacturing practice (CGMP).”
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`(See Ex. D.)
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`89. Under federal law, the United States (i.e., the FDA) has exclusive
`
`authority to enforce the Act. See 21 U.S.C. § 337(a).
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`90. Oxford contends that the FDA—not the Board—is the only agency
`
`that can enforce the Act against Oxford and that it has already determined not to
`
`enforce the Act against Oxford based on its May 2019 inspection.
`
`91.
`
`Therefore, Oxford requests this Court to enter a judgment declaring:
`
`a.
`
`That the United States through the FDA has exclusive authority to
`
`enforce the Act against Oxford;
`
`b.
`
`That the Board does not have authority or jurisdiction to enforce the
`
`Act against Oxford;
`
`C.
`
`That the findings set forth in the FDA’s inspection report do not
`
`justify any enforcementor disciplinary action against Oxford for violating the Act,
`
`and
`
`d.
`
`That Oxford is not subject to an enforcement or disciplinary action
`
`under the Act based on the FDA’s May 2019 Observations.
`
`18
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 19 of 25
`
`COUNT TWO
`(Violation of 42 U.S.C. § 1983)
`
`92. Oxford has a Constitutional right under the Fourteenth Amendment to
`
`a full and fair hearing before the Board can sanction it by revoking, suspending, or
`
`probating its Alabama manufacturer’s license or by assessing civil monetary
`
`penalties againstit.
`
`93.
`
`Part of having a full and fair hearing is the Board provide reasonable
`
`notice of the claims asserted against a defendant.
`
`94.
`
`Here, as explained above, the Board (a state actor) has failed to
`
`provide fair and adequate notice of the charges against Oxford.
`
`95.
`
`The Board’s theories and claims against Oxford continually change,
`
`and none is based on any Alabamalaw applicable to Oxford.
`
`96.
`
`These shifting theories prove the arbitrary and capricious nature of the
`
`Board’s charges against Oxford.
`
`97.
`
`The Board has denied Oxford due process of law becauseit has failed
`
`to provide Oxford with fair and adequate notice of the charges against Oxford.
`
`98.
`
`The Board’s processis constitutionally inadequate.
`
`99.
`
`Therefore, Oxford requests:
`
`a.
`
`b.
`
`The injunctive relief set out in Count 3 of this complaint; and
`
`Attorneys’ fees pursuant to 42 U.S.C. § 1988.
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 20 of 25
`
`COUNT THREE
`(Temporary Restraining Order and Preliminary Injunction)
`
`100. The Board, under colorof state law, unlawfully seeks to proceed with
`
`meritless and unclear charges against Oxford based on the FDA’s May 2019
`
`inspection.
`
`101. The Board asks
`
`for
`
`sanctions
`
`against Oxford,
`
`including the
`
`revocation, suspension, or probation ofits license and civil monetary penalties.
`
`102. The hearing on the Board’s chargesis set for August 16, 2022.
`
`103. The Board’s constitutionally-inadequate process and the upcoming
`
`August 16 hearing on the Board’s Statement of Charges at which the Board seeks
`
`to revoke, suspend, or probate Oxford’s license and impose monetary fines have
`
`caused and will cause irreparable harm to Oxford.
`
`104. The Board’s actions are immediate and, absent relief from this Court,
`
`Oxford will never be capable of obtaining an adequate remedy at law and will be
`
`irreparably harmed,for the reasons explained in this complaint.
`
`105. Oxford has a substantial likelihood of success on the merits of its
`
`claim that
`
`the Board violated its due process rights and on its claim for a
`
`declaratory judgment that the FDA has exclusive jurisdiction over claims that a
`
`drug manufacturer (like Oxford) has violated the Act.
`
`106. The harm to Oxford if the Board’s hearing proceeds outweighs any
`
`harm that the Board could or would suffer.
`
`20
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 21 of 25
`
`107. The Board brings these charges based on an inspection that occurred
`
`more than three years ago.
`
`108. And the Board has previously continued hearings against Oxford for
`
`these very alleged violations.
`
`109,
`
`Injunctive relief to Oxford would serve the public interest.
`
`110. To allow the Board to seek sanctions against Oxford without
`
`providing constitutionally-adequate notice (including, notice of the specific law
`
`that the Board claims Oxford violated) injects uncertainty into the healthcare
`
`industry because the Board provides no uniform standards for drug manufacturers.
`
`111. Restraining the Board’s unlawful actions will serve to preserve the
`
`status quo pending a hearing on this cause and a ruling as to the legality of the
`
`Board’s attempt to enforce the Act against Oxford.
`
`112. Granting the requested injunctive relief will not disserve the public
`
`interest.
`
`113. To the contrary, granting the requested relief will actually serve the
`
`public interest by allowing the Court to consider and declare that the FDA has
`
`exclusive jurisdiction over claims based on the Act, which in turn will promote
`
`uniform standards in the drug-manufacturing industry.
`
`114. Oxford therefore asks
`
`for
`
`a temporary restraining order and
`
`preliminary injunction prohibiting the Board from proceeding with the August 16
`
`21
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 22 of 25
`
`hearing unless and until the Board provides adequate notice of the charges against
`
`Oxford and until this Court rules on Oxford’s request for a declaratory judgment.
`
`PRAYER FOR RELIEF
`
`Oxford requests the followingrelief:
`
`a.
`
`A judgment declaring that that the United States through the FDA has
`
`exclusive authority to enforce the Act against Oxford; that the Board does not have
`
`authority or jurisdiction to enforce the Act against Oxford; and that Oxford is not
`
`subject to an enforcementor disciplinary action under the Act based on the FDA’s
`
`May 2019 Observations;
`
`b.
`
`A temporary restraining order and preliminary injunction prohibiting
`
`the Board from proceeding with the August 16 hearing unless and until the Board
`
`provides adequate notice of the charges against Oxford and until this Court rules
`
`on Oxford’s request for declaratory relief;
`
`Attorneys’ fees pursuant to 42 U.S.C. § 1988; and
`
`Such other and further
`
`relief that
`
`this Court deems just and
`
`c.
`
`d.
`
`appropriate.
`
`Respectfully submitted on this the 10th day of August, 2022.
`
`/s/ William G. Somerville
`WILLIAM G. SOMERVILLE
`JADEE. SIPES
`Attorneys for Oxford Pharmaceuticals, LLC
`
`22
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 23 of 25
`
`OF COUNSEL:
`BAKER, DONELSON, BEARMAN,
`CALDWELL & BERKOWITZ, PC
`420 20th Street North, Suite 1400
`Birmingham, Alabama 35203
`Telephone (205) 328-0480
`Facsimile (205) 322-8007
`wsomerville@bakerdonelson.com
`jsipes@bakerdonelson.com
`
`THESE DEFENDANTS TO BE SERVED VIA PRIVATE PROCESS
`SERVER:
`
`The Alabama State Board of Pharmacy
`c/o Donna C. Yeatman, Executive Secretary
`111 Village Street
`Birmingham, Alabama 35242
`
`Chris Phung
`604 Keeneland Court
`Montgomery, Alabama 36109
`
`Robert M. Colburn
`930 Arundell Street
`Tuscaloosa, Alabama 35406
`
`Christy Garmon
`425 Brookview Drive
`Talladega, Alabama 35160
`
`Gary Mount
`P.O. Box 3073
`Auburn, Alabama 36831
`
`Thomas Cobb
`1725 Pine Street
`Montgomery, Alabama 36101
`
`Donna C. Yeatman
`111 Village Street
`
`23
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 24 of 25
`
`Birmingham, Alabama 35242
`
`THESE DEFENDANTSTO BE SERVED VIA CERTIFIED MAIL:
`
`The United States Food and Drug Administration
`c/o the Civil Process Clerk at the United States Attorney’s Office
`for the Northern District of Alabama
`1801 4th Avenue North
`Birmingham, Alabama 35203
`
`The United States Food and Drug Administration
`c/o U.S. Department of Justice
`950 Pennsylvania Avenue, NW
`Washington, D.C. 20530-0001
`
`In addition, a copy of this document has been sent by U.S. Mail and electronic
`mail to the following:
`
`James S. Ward, Esq.
`Ward & Cooper, LLC
`2100 South Bridge Parkway, Ste. 580
`Birmingham, Alabama 35209
`jward@wardcooperlaw.com
`
`Elizabeth Dickinson, Esq.
`Senior Associate Deputy General Counsel
`United States Food and Drug Administration
`10903 New Hampshire Ave
`Silver Spring, Maryland 20993
`elizabeth.dickinson@fda.hhs.gov
`
`24
`
`
`
`Case 2:22-cv-01014-MHH Document1 Filed 08/10/22 Page 25 of 25
`
`VERIFICATION
`
`With full authority, the undersigned, John Schultz, who is the President of
`Oxford Pharmaceuticals, LLC andis personally familiar with the allegations of the
`complaint, hereby declares under penalty of perjury that paragraphs 3, 75-85, and
`103-104 of this complaint are true and correct. Executed on August 9, 2022.
`
`
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