Healthcare Industry News: OPANA
News Release - November 10, 2015
Hi-Tech Pharmaceuticals Files Lawsuit Against IronMag Labs and Robert Dimaggio Over Racketeer Influenced and Corrupt Organizations (RICO) and Patent InfringementATLANTA, Nov. 10, 2015 -- (Healthcare Sales & Marketing Network) -- A lawsuit has been brought over Racketeer Influenced and Corrupt Organizations (RICO) and patent infringement allegations involving IronMag Labs ("IronMag") bodybuilding products, Super DMZ 4.0 and their Super Andro series of products. The lawsuit alleges that IronMag Labs and its owner Robert Dimaggio were engaged in a scheme to defraud Hi-Tech Pharmaceuticals out of sales and profits though IronMag's infringement of Hi-Tech's IP. The lawsuit alleges that IronMag and Dimaggio conducted fraudulent activities and deceived consumers as to the Super DMZ 4.0 product's content, quality, characteristics, and/or ingredients, and caused and enabled consumers to purchase IronMag's products instead of Hi-Tech products.
The lawsuit also alleges, "In furtherance of this scheme, IronMag used the Internet to disseminate its false product claims to consumers across the United States, and to enable consumers to purchase IronMag's Super DMZ 4.0 product online. It also used the U.S. Mail and/or other interstate carriers to ship Super DMZ 4.0 and other DHEA derivatives, the basis for the patent infringement allegations, to consumers throughout the United States in violation of 18 U.S.C. Section 1341." The suit further alleges, "Defendants have conspired to conduct and participate in the conduct of the affairs of the enterprise through a pattern of racketeering activity. That conduct constitutes conspiracy to violate Racketeer Influenced and Corrupt Organizations (RICO) 18 U.S.C. Section 1962(c), in violation of 18 U.S.C. Section 1962(d)." Passed the year after The Godfather was published, RICO is part of a 1970 law designed to allows plaintiffs to bring civil lawsuits against organizations whose members allegedly committed crimes.
The lawsuit alleges that IronMag Labs and Dimaggio have and had direct firsthand knowledge of the Patents in Suit since at least May of 2012. Furthermore, the lawsuit alleges that IronMag Labs and Dimaggio willfully and knowingly decided to infringe the Patents in Suit despite knowledge of the patent's existence and its knowledge of the Infringing Products infringements of the claims of the Patents in Suit.
Hi-Tech Pharmaceuticals lawsuit also alleges that IronMag and Dimaggio Defendants have made deliberate and misleading representations regarding the IronMag Labs' Super DMZ 4.0™ and Osta Rx™ products. These products are marketed as being natural supplements, when, in fact, they contain an illegal unapproved new drug known as Ostarine, or (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylprOPANAmide, which is a selective androgen receptor modulator for which substantial clinical investigations have been instituted and made public with regard to treatment of cancer cachexia, or muscle wasting.
The suit also alleges, Super DMZ 4.0™ and Osta Rx™ are not dietary supplements. According to section 201(ff)(3)(B)(i) of the FDCA [21 U.S.C. Section 321 (ff)(3)(B)(i)], a dietary supplement may not include an article that is approved as a new drug under section 505 of the FDCA [21 U.S.C. Section 355(a)] unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. According to section 201(ff)(3)(B)(ii) of the FDCA [21 U.S.C. Section 321 (ff)(3)(B)(ii)], a dietary supplement also may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug. In addition, the suit alleges that IronMag and Dimaggio have purposely made false and misleading descriptions of fact concerning the nature, characteristics and qualities of its "nutritional supplements" DMZ 4.0™ and Osta Rx™, by failing to tell the consumers that these products actually contain pharmaceutical drugs – (2S)-3-(4-cyanophenoxy) -N- [4-cyano-3- (trifluoromethyl)phenyl] -2 hydroxy -2- methylprOPANAmide) which is an unapproved new drug and is untested on humans and potentially dangerous. Defendants' marketing of such misbranded and falsely-labeled substances has the tendency to deceive a substantial segment of the public into believing that they are purchasing a product with different characteristics and that it has been proven safe.
Ostarine, FDA cautioned, is not a dietary supplement. In a Dec. 11, 2014 warning letter to a supplement company known as Biogenix USA LLC, FDA characterized Ostarine as a SARM "for which substantial clinical investigations have been instituted and made public with regard to treatment of cancer cachexia, or muscle wasting." FDA referenced 2007 clinical trials by Memphis, Tennessee-based Gtx Inc., which said on its website that Enobosarm (Ostarine) is its "lead product candidate" that is being developed to treat breast cancer.
The lawsuit alleges that Ironmag and Dimaggio have, and continue to do so, literally and directly infringed, or directly infringed under the doctrine of equivalents one or more claims of United States Patent No. 8,084,446 (hereinafter: "the '446 Patent") by making, using, offering to sell, and/or selling in the United States, and/or importing into the United States the Infringing Products, or any one of those products. Hi-Tech is the Exclusive Licensor of the following United States Patents: a) US Patent No. 8,084,446, entitled "Use of DHEA Derivatives for Enhancing Physical Performance" ("the '446 patent'"); and b) US Patent No. 8,338,399 entitled "Use of DHEA Derivatives for Enhancing Physical Performance" ("the '399 patent'").
"Hi-Tech has continued to put up such a strong fight against these type of 'bad actors' that cause the dietary supplement industry to get a black eye. The most direct way to address these types of companies is to directly make their activities illegal, by passing a federal law making sure that these type of 'players' are not involved in the dietary supplement business. However, until Congress passes such a law Hi-Tech will continue to fight back, Hi-Tech will continue to enforce its Intellectual Property and establish that it deserves all the money this illegal enterprise generated," says Jared Wheat, President of Hi-Tech. "We will also continue to vigorously pursue all available avenues to protect our intellectual property trademarks and licenses for DHEA derivatives," said Wheat.
About Hi-Tech Pharmaceuticals
Hi-Tech Pharmaceuticals (hitechpharma.com/index.htm) is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) Pharmaceuticals and dietary supplements. Since 1979, Hi-Tech Pharmaceuticals, Inc. and its sister company, Hi-Tech Nutraceuticals, LLC. have been providing quality custom manufacturing services to the pharmaceutical, dietary supplement and beverage industries. Hi-Tech Pharmaceuticals is a cGMP certified company that operates out of Four (4) US Production facilities and (2) Warehouses, totally over 400,000 sq. ft. The two Georgia based production facilities are both located outside Atlanta in the Norcross and Suwanee Advanced Technology areas. Hi-Tech also has Two (2) facilities located outside State College, Pennsylvania. Hi-Tech holds a Drug Manufacturing License issued by the State of Pennsylvania Food and Drug Branch and is registered as a Food and Drug Establishment with the FDA in Pennsylvania. Hi-Tech Pharmaceuticals has a diverse portfolio of brands including: APS Nutrition, ALR Industries, LG Sciences, Formutech Nutrition, Sports One, Innovative Laboratories, and iForce Nutrition. Hi-Tech'sstable of brands is one of the world's leading branded sports nutrition companies, providing products to customers throughout the world. The company maintains one of the industry's broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. Hi-Tech Pharmaceuticals has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. The company ranks among the top companies in dietary supplements and has among the largest capacity of U.S.-based manufacturers.
Source: Hi-Tech Pharmaceuticals
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