Louisiana AG sues GSK, says it ‘schemed’ to stop generic versions of Flonase

By Jessica M. Karmasek | Feb 10, 2015

NEW ORLEANS (Legal Newsline) - Louisiana Attorney General James “Buddy” Caldwell has filed a lawsuit in state court against the maker of the prescription nasal spray Flonase for allegedly scheming to keep generic versions of the drug off the market.


Caldwell filed his 24-page complaint in the 19th Judicial District Court, Parish of East Baton Rouge in December. GlaxoSmithKline is the named defendant.


The attorney general alleges in his lawsuit that GSK employed a so-called “brand maturation strategy” designed to prevent or delay a less expensive generic version of Flonase, or fluticasone propionate, from entering the market.


That strategy, he alleges, included four tactics:


  • Improperly influencing the Food and Drug Administration’s bioequivalence guidance process;

  • Filing successive objectively and subjectively “baseless” citizen petitions with the FDA;

  • Drafting a fluticasone propionate monograph for submission to the U.S. Pharmacopeia, which lists test, procedures and acceptance criteria in order to set standards for quality, purity, strength and consistency of the pharmaceutical ingredients in an approved drug; and

  • Supplementing its original New Drug Application in an attempt to delay the FDA from approving any Abbreviated NDAs before approving GSK’s supplements.

“As a result of its unlawful ‘brand maturation’ scheme to keep generic versions of Flonase off the market, and in violation of Louisiana antitrust and unfair competition laws, GSK: (a) illegally maintained monopoly power in the market for fluticasone propionate in the United States for at least 20 months and sold more than $1 billion of Flonase during that time; (b) maintained the price of Flonase at supra-competitive levels; and (c) overcharged Plaintiff millions of dollars by depriving it of the benefits of unrestricted competition and access to less expensive generic versions of fluticasone propionate,” Caldwell wrote in his complaint.


The attorney general claims that as a result of GSK’s actions, the state has paid “unlawfully inflated prices.”

Caldwell is seeking restitution and treble damages in an undisclosed amount.


The attorney general has hired Baton Rouge law firm Shows Cali & Walsh LLP, Natchitoches firm Salim-Beasley LLC, New Orleans firm Meade Law LLC, Opelousas firm Morrow Morrow Ryan & Bassett, New Orleans firm Kanner & Whiteley LLC, Baton Rouge firm Hammonds Sills Adkins & Guice LLP and New Orleans firm Usry, Weeks & Mathews APLC to help represent the state.


According to a search on FollowTheMoney.org, Shows Cali & Walsh -- also known as Shows Cali Berthelot & Walsh -- and attorney E. Wade Shows, who is listed on the complaint, made donations to Caldwell’s campaign, $160 and $5,000 respectively.


Robert L. Salim of Salim-Beasley also donated $6,000 to Caldwell’s campaign; Morrow Morrow donated $11,000; attorney Pat Morrow donated $5,000; Hammonds Sills Adkins & Guice attorney Alejandro Perkins donated $200; Usry Weeks & Mathews donated $10,000; and attorney T. Allen Usry donated $10,000.


Salim, Morrow, Perkins and Usry each were listed as attorneys for the state on Caldwell’s complaint.


GSK could not immediately be reached for comment on the lawsuit.


However, the company has taken action, asking that the lawsuit be moved to federal court.


GSK filed its notice of removal with the U.S. District Court for the Middle District of Louisiana Wednesday.


The company argues that the lawsuit should be moved because it involves a federal agency.


“This action is distinguishable from other actions brought by the State of Louisiana in which the court granted motions to remand, because in those actions the alleged conduct of the pharmaceutical companies was directed primarily at Louisiana patients and doctors, and the State’s Medicaid agency,” lawyers for GSK wrote.


“In contrast, this action centers on alleged conduct by GSK directed at a federal agency as well as actions by the federal agency that allegedly led to a delay in approving generic competition.”


New Orleans firm Irwin Fritchie Urquhart & Moore LLC is representing GSK.


From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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