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Merck Eprova AG v. Brookstone Pharmaceuticals, LLC
2013 U.S. Dist. LEXIS 13616
S.D.N.Y.
2013
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Background

  • Merck alleges Acella mislabeled folate products (Xolafin/Xolafin-B) to mimic Merck's Metafolin, causing database links and improper substitution.
  • Merck’s Metafolin is a substantially pure L-5-MTHF; Acella’s products are D,L-methylfolate mixtures with L and D forms.
  • Databases (e.g., First DataBank) linked Acella products to Merck’s products to promote substitution and broaden market share.
  • Merck presented consumer surveys showing pharmacists/physicians believed Acella products contained substantially pure L-5-MTHF.
  • Merck seeks Lanham Act false advertising and contributory false advertising claims, plus NY Deceptive Trade Practices; Acella seeks declaratory relief and asserts counterclaims.
  • Court finds Acella liable for false advertising and contributory false advertising; NY claims fail; damages awarded with trebling; injunctive relief ordered.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Lanham Act false advertising Merck argues Acella mislabeled Xolafin products as L-methylfolate to imply purity and sameness to Metafolin. Acella contends labeling reflects active L-isomer with D-isomer as impurity and is not literally false. Acella liable for implied false advertising; literal falsity not proven.
Materiality and deception Mislabeling was material; databases linked products and physicians/pharmacists were misled. Any deception was not material or was not proven to influence decisions. Labels were material and likely to affect purchasing decisions.
Contributory false advertising Acella induced databases to describe Acella as pharmaceutically equivalent to Metafolin products. No direct inducement to false advertising alleged. Merck prevails on contributory false advertising; Acella liable.
State-law claims (NY GBL 349/350) Claims allege consumer-oriented deceptive practices harming the public; reliance shown. Insufficient public-harm and reliance proof; competitive context weakens claims. Section 349/350 claims fail.
Individual liability of Deas and Bryant Officers were the moving forces behind labeling and marketing decisions. Liability should be limited to corporate actions. Deas and Bryant individually liable under the Lanham Act.

Key Cases Cited

  • S.C. Johnson & Son, Inc. v. Clorox Co., 241 F.3d 232 (2d Cir. 2001) (elements and reliance in Lanham Act false advertising; injury proof)
  • Time Warner Cable, Inc. v. DIRECTV, Inc., 497 F.3d 144 (2d Cir. 2007) (literal falsity vs. implied falsity framework; extrinsic evidence requirements)
  • Johnson & Johnson Merck Consumer Pharm. Co. v. Smithkline Beecham Corp., 960 F.2d 294 (2d Cir. 1992) (standard for implied falsity and consumer confusion; presumption where egregious conduct)
  • Resource Developers, Inc. v. Statue of Liberty-Ellis Island Found., Inc., 926 F.2d 134 (2d Cir. 1991) (presumption of deception when defendant acts with egregious intent)
  • George Basch Co. v. Blue Coral, Inc., 968 F.2d 1532 (2d Cir. 1992) (discretion in granting/limiting profits in Lanham Act cases; deterrence and windfall considerations)
Read the full case

Case Details

Case Name: Merck Eprova AG v. Brookstone Pharmaceuticals, LLC
Court Name: District Court, S.D. New York
Date Published: Jan 31, 2013
Citation: 2013 U.S. Dist. LEXIS 13616
Docket Number: No. 09 Civ. 9684(RJS)
Court Abbreviation: S.D.N.Y.