Federal Criminal Defense Blog : Georgia Federal Criminal Defense Lawyer & Attorney : Gillen Withers & Lake Law Firm : White Collar Crime, RICO, Trial : Atlanta, Savannah, GA

Ortho-McNeil, a unit of Johnson and Johnson, entered a guilty plea on Tuesday in the U.S. District Court for the District of Massachusetts to a misdemeanor for alleged illegal promoting of Topamax, a drug designed to treat epilepsy, for uses not approved by the Food and Drug Administration, according to PR Newswire. The government alleged that Ortho-McNeil used a promotional program called the "Doctor for a Day Program" to promote Topamax for psychiatric uses, allegedly paying physicians, including psychiatrists, to accompany sales representatives on sales calls. The government claimed that Ortho-McNeil never applied for approval to use Topamax to treat psychiatric conditions and that there were no reliable clinical trials demonstrating that Topamax is safe and effective to treat psychiatric conditons.

The Court imposed a $6.14 million criminal fine on Ortho-McNeil. An affiliate of Ortho-McNeil, Janssen Pharmaceuticals, has agreed to pay $75 million to settle claims under the False Claims Act that it illegally promoted Topamax for psychiatric purposes and submitted alleged false claims to Medicare. Ortho-McNeil and Jassen also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

"Promotion" of drugs by manufacturers for off-label uses is prohibited by the Food Drug and Cosmetic Act, 21 U.S.C. 331, 333. Physicians can, and frequently do, prescribe drugs for unapproved uses. In addition to epilepsy, Topamax has been prescribed for uses such as the treatment of headaches and for weight loss.

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Yesterday, after a five week trial, a jury in the U.S. District Court for the District of Massachusetts found Zhen Zhou Wu, a/k/a Alex Wu; Yufeng Wei, a/k/a Annie Wei; and Chitron Electronics, Inc., a corporation based in Shenzhen, China, with an office in Walthan, Massachusetts, guilty of conspiring to violate U.S. export laws and illegally exporting electronic equipment from the United States to the Peoples' Republic of China, according to a press release by the Boston Office of the Federal Bureau of Investigation.

From 2004 to 2007, Chitron purchased equipment used in electronic warfare; military radar, guidance and control equipment; satellite communications, including global positioning systems; and fire control and exported the equipment to China through Hong Kong. The equipment is primarily used in military phased array radar, electronic warfare, military guidance systems, and military satellite communications. The defendants sent the equipment to Chinese military entities and research institutes, including China Electronics Technology Group Corporation. The equipment was shipped without export licenses from the Department of Commerce, in violation of the U.S. arms embargo against China which has been in place since 1990. The press release notes that the equipment could make a significant contribution to weapons systems and fighting capabilities of adversaries of the U.S.

Source: chinalawandpolicy.com/page/2/

Wu and Wei were also convicted of filing false shipping documents with the U.S. Department of Commerce, and Wei was convicted of immigration fraud for using a U.S. Permanent Resident Card which she allegedly knew had been procured by making false and fraudulent statements to immigration officials in order to enter the U.S. A co-defendant, Bo Li, a/k/a Eric Lee, previously pled guilty to making false statements on shipping documents.

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Once again demonstrating the massive potential for crime created by our digital age, 28 year-old Albert Gonzalez pled guilty to two counts of conspiracy to gain unauthorized access to payment card networks last week in the U.S. District Court for the District of New Jersey according to a DOJ press release. Gonzalez was charged with hacking into the computer networks of major financial and retail organizations and stealing data on tens of millions of credit cards and debit cards, in one of the largest data breaches in U.S. history. He gained unauthorized access to the payment card networks of New Jersey-based, Heartland Payment Systems; Texas-based convenience store chain 7-Eleven; and Hannaford Brothers Co. Inc., a Maine-based supermarket chain. He was indicted in New Jersey in August 2009. In September 2009, Gonzalez also pled guilty in the U.S. Distric Court for the District of Massachusetts to 19 counts of conspiracy, computer fraud, wire fraud, access device fraud and aggravated identity theft for hacking into retailers including TJX Companies, BJ’s Wholesale Club, OfficeMax, Boston Market, Barnes & Noble and Sports Authority. In the same month, he pled guilty to a count of conspiracy to commit wire fraud for hacking into the system of Dave and Buster's, a restaurant chain, in the U.S. District Court for the Eastern District of New York.

Gonzalez had several servers, or "hacking platforms," and would give access to the servers to other hackers. Gonzalez and others would use the platforms to store malicious software, or "malware," in launching attacks on their victims. Gonzalez's plea agreement states that it was forseeable that Gonzalez and his co-conspirators would have used the malware to steal tens of millions of credit and debit card numbers, affecting more than 250 financial institutions.

Gonzalez tested malware by running multiple anti-virus programs in an attempt to ascertain if the programs detected the malware. According to information in the plea agreement, it was foreseeable to Gonzalez that his co-conspirators would use malware to Gonzalez was indicted in New Jersey in August 2009 for this criminal conduct. His plea agreement provides for a sentence of imprisonment between 17 and 25 years. He is scheduled to be sentenced in the Massachusetts, New York and New Jersey cases in March.

The charges against Gonzalez are staggering in their scope. They also demonstrate that would-be cybercriminals should consider their online aliases carefully, as they may resurface in a Federal indictment, as in the case of Albert Gonzalez a/k/a "j4guar17" a/k/a "soupnazi," etc.

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