Serono Guilty of 3rd Largest Health Fraud Case in US History

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PRESS RELEASE

Serono Guilty of 3rd Largest Health Fraud Case in US History

 

SERONO TO PAY $704 MILLION FOR

THE ILLEGAL MARKETING OF AIDS DRUG

 

Boston, MA... Swiss corporation SERONO, S.A., together with its U.S.

subsidiaries, SERONO, INC., SERONO HOLDING, INC., SERONO

LABORATORIES, INC. and related entities ("SERONO") have agreed to

pay a total of $704,000,000 to resolve criminal charges and civil

liabilities in connection with several illegal schemes to promote,

market and sell its drug, Serostim, used to treat AIDs wasting, a

condition involving profound involuntary weight loss in AIDS

patients. Today's global resolution is the third largest health care

fraud recovery by the United States.

 

Attorney General Alberto Gonzales; Assistant Attorney General for

the Department of Justice's Civil Division Peter D. Keisler; United

States Attorney for the District of Massachusetts Michael J.

Sullivan; United States Attorney for the District of Maryland Rod J.

Rosenstein; and United States Attorney for the District of

Connecticut Kevin J. O'Connor, announced that SERONO LABS will pay a

$136,935,000 criminal fine and a total of $567,065,000 to settle

civil liabilities. Today's global resolution also ensures that the

federal Medicaid program and each of the State Medicaid agencies who

paid any claims for Serostim during the time frame of the

investigation, 1996 through 2004, will recoup every dollar paid.

 

"Americans who need medical care depend on health care companies to

have their medical devices and drugs thoroughly evaluated and

approved before use," said Attorney General Alberto R.

Gonzales. "Serono abused the system of testing and approval, and put

its desire to sell more drugs above the interest of patients.

Today's settlement will repay with interest the losses to federal

and state Medicaid programs incurred by Serono's conduct, and would-

be wrongdoers are on notice that we will not tolerate attempts to

profit at the expense of the ill and needy in our society."

 

"The American people, as both taxpayers and consumers, expect our

health care system to be free from fraud and corruption," stated

U.S. Attorney Michael J. Sullivan for the District of

Massachusetts. "The pharmaceutical industry has an obligation to

ensure that all rules, regulations and laws are complied with. To do

less erodes public confidence, compromises the patient physician

relationship and adds costs to important government programs.

Without the assistance of concerned citizens illegal conduct on

government programs would go undetected."

To resolve the criminal charges, SERONO LABORATORIES, INC. ("SERONO

LABS") has agreed to plead guilty to two counts of criminal

conspiracy and to pay the $136,935,000 criminal fine. As a result of

its criminal conviction, SERONO LABS will be excluded from all

federal health care programs for at least five years. SERONO, INC.

and all other U.S. subsidiaries of SERONO, S.A., will also be

subject to a stringent Corporate Integrity Agreement for the next

five years.

 

SERONO has also agreed to settle its federal civil False Claims Act

liabilities for a total of $567,065,000. Specifically, SERONO will

pay $305,077,000, plus interest, to the United States in civil

damages for losses suffered by the federal portion of the Medicaid

program, the Veteran's Administration, the Department of Defense and

the Federal Employees Health Benefits program as a result of SERONO

LABS' fraudulent drug promotion and marketing misconduct. SERONO

will also pay a total of $261,988,000, plus interest, to settle its

civil liabilities to the fifty states and the District of Columbia

for losses the state Medicaid programs suffered.

 

"This plea agreement and settlement reflect an exemplary coordinated

use all of the appropriate anti-fraud weapons available to us," said

Assistant Attorney General Peter Keisler of the Department's Civil

Division. "This settlement sends the unequivocal message to the

health care industry that American taxpayers should not pay for

prescriptions induced by unproven medical tests and improper

payments to doctors and pharmacies."

 

In 1996, the FDA granted accelerated approval for SERONO's drug

Serostim solely for use in treating AIDS wasting, which at the time

was the leading cause of death among AIDS patients. Serostim came on

the market at the same time as protease inhibitor drugs. These

drugs, when used in combination with one another as an "AIDS

cocktail," dramatically curtailed the proliferation of the AIDS

virus. As a result, the incidence and prevalence of AIDS wasting

began to markedly decline among those AIDS patients taking the AIDS

cocktail drugs. In turn, the demand for Serostim began to drop

significantly immediately following its launch in the Fall of 1996.

SERONO LABS then began engaging in a multifaceted marketing and

sales campaign to redefine AIDS wasting and create a market for

Serostim.

 

The first Conspiracy count to which SERONO LABS will plead guilty

charges that, from as early as September 1996, through at least

January 2002, SERONO LABS conspired with medical device manufacturer

RJL Sciences, Inc., ("RJL") to introduce on the market bioelectrical

impedance analysis ("BIA") computer software packages for use in

calculating body cell mass and diagnosing AIDS wasting. The software

devices were adulterated in that approval from the FDA had not been

obtained for these uses before the software was disseminated. SERONO

LABS conspired with RJL to increase the market for the body cell

mass calculation devices/software, which in turn, would increase the

market for Serostim. Additionally, SERONO LABS employees directly

administered BIA tests to patients to induce doctors to prescribe

Serostim and to get Medicaid agencies and other payors to reimburse

for the drug. RJL and its president, Rudolph J. Liedtke, pled guilty

to their roles in the conspiracy in April 2005, and are awaiting

sentencing.

 

 

SERONO LABS will plead guilty to a second Conspiracy count charging

that, from March 1999, through December 1999, SERONO LABS conspired

to pay illegal remuneration to physicians to induce them to

prescribe Serostim for which payments were made by the Medicaid

program. In March and April 1999, in an attempt to reverse the

severe short fall in sales of Serostim, SERONO LABS offered

physicians an all expenses paid trip to a medical conference in

Cannes, France in return for the physicians writing up to 30 new

prescriptions of Serostim. The sales strategy was part of a campaign

referred to as the "$6m-6 Day Plan." Each prescription encompassed a

twelve week course of therapy that cost $21,000, thus the value of

30 scripts to be written by each doctor was $630,000. The SERONO

LABS marketing department announced within the company that 10

physicians were "U.S. Invitees" to the Cannes conference with all

expenses paid for them and a guest to attend. The 30 prescriptions

each doctor was expected to write meant a total value of

approximately $6.3 million in sales.

 

In December 2004, the Regional Director for Sales in New York, pled

guilty to his role in the marketing Conspiracy. He is scheduled to

be sentenced in January 2006. In April 2005, four SERONO LABS sales

and marketing executives were indicted on charges of Conspiracy and

Offering to Pay Illegal Remunerations. These charges are still

pending.

 

The civil settlement resolves allegations that SERONO knowingly

caused the submission of false and/or fraudulent claims for Serostim

that were not eligible for reimbursement. These included claims, (1)

based on testing using the unapproved BIA software devices; (2) for

treating supposed loss of body cell mass; and (3) for treating

lipodystrophy, a separate condition involving weight gain in the mid-

section and weight loss in the extremities. The civil settlement

also resolves allegations that SERONO knowingly caused the

submission of false and/or fraudulent claims by inducing pharmacies

to sell Serostim by paying rebates and discounts to those

pharmacies. Finally, the civil settlement resolves allegations that

SERONO knowingly caused the submission of false and/or fraudulent

claims to federal programs for Serostim by inducing physicians to

prescribe the drug by giving them free BIA devices and software,

free trips to Cannes, France and other kickbacks.

 

The investigation leading to today's global resolution was commenced

in the District of Massachusetts in 2001 after a former SERONO LABS

employee filed a civil False Claims Act ("FCA") suit as a result of

her concerns about the illegal marketing practices of the company.

Four other employees with similar concerns filed civil suits in

Maryland and Connecticut. The civil FCA provides that the Government

is entitled to recover up to treble damages on any fraudulent claims

filed. The FCA also provides that private individuals who file

whistleblower suits can share in recoveries of any successful

resolution of their claims. As a part of today's resolution, the

five whistleblowers will share in approximately 17% of the civil

recovery, or approximately $51.86 million.

 

"Today's announcement should send a strong message to the health

care industry and to those who conduct business with it that the OIG

will continue to zealously investigate any allegations of illegal

conduct. Serono's improper conduct ultimately affected the pockets

of the American taxpayer and the recipients of Federal programs and

cannot be tolerated," said Health and Human Services Inspector

General Daniel R. Levinson.

 

"When drug and device manufacturers deceive physicians into

providing a drug to patients based upon unapproved diagnostic tests,

they inadvertently subject their patients to all of the drug's risks

without any assurance that a benefit will be provided," stated

Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory

Affairs. "This places patient safety secondary to the desire to sell

more drugs."

 

 

The investigation was conducted by the Federal Bureau of

Investigation; the Food and Drug Administration's Office of Criminal

Investigations; the Department of Health and Human Services' Office

of Inspector General, Office of Investigations; the Department of

Labor's Employee Benefits Security Administration, Boston Regional

Office; and the U.S. Postal Service's Office of Inspector General.

Assistance in the investigation was also provided by Patrick

Lupinetti, Director of the New York State Attorney General's Special

Projects and Medicaid Fraud Control Unit who coordinated the

National Medicaid Fraud Units; Mark Thomas, Chief Deputy Attorney

General and David Lewis, Senior Deputy Attorney General of the

Medicaid Fraud Control Unit in Florida's Attorney General's Office,

John Krayniak, Supervising Deputy Attorney General and Chief of the

Medicaid Fraud Section of the New Jersey Attorney General's Office;

and Suzanne Giorgi, Deputy Attorney General in the California

Department of Justice. The investigation and settlement were handled

by Assistant U.S. Attorneys Mary Elizabeth Carmody, Jennifer Boal

and Patricia Connolly of the District of Massachusetts, and

Department of Justice Trial Attorneys Sondra Mills and Suzette

Smikle in the Office for Consumer Litigation and Carol Wallack in

the Fraud Section of the Civil Division. Assistant U.S. Attorneys

Roann Nichols of the District of Maryland and Richard Molot of the

District of Connecticut also assisted in the investigation. The

Corporate Integrity Agreement was negotiated by Senior Counsel Mary

Riordon in the Office of General Counsel in the Department of Health

and Human Services, Office of Inspector General.

 

Press Contact: Samantha Martin, (617) 748-3139

 

 

PRESS RELEASE

 

FORMER EXECUTIVES FOR SERONO, INC.

CHARGED WITH CONSPIRACY AND OFFERING KICKBACKS TO DOCTORS

 

Boston, MA... Four former top executives in sales and marketing for

Serono Laboratories, Inc. were indicted today by a federal grand

jury in connection with a conspiracy to offer and pay kickbacks to

doctors in the form of an all expenses paid trip for the doctors and

their guests to attend a medical conference in Cannes, France in

return for writing prescriptions of a drug manufactured and sold by

Serono Laboratories, Inc.

 

United States Attorney Michael J. Sullivan; Peter D. Keisler,

Assistant Attorney General of the U.S. Department of Justice's Civil

Division; Kenneth W. Kaiser, Special Agent in Charge of the Federal

Bureau of Investigation in New England; Kim A. Rice, Special Agent

in Charge of the Metro-Washington Field Office of the U.S. Food and

Drug Administration's Office of Criminal Investigations; Joseph C.

Moraski, Special Agent in Charge of the Boston Regional Office of

Investigations for the Department of Health and Human Services'

Office of Inspector General; James M. Benages, Regional Director of

the U.S. Department of Labor's Employee Benefits Security

Administration; and Joseph Finn, Special Agent in Charge of the

Boston Field Office of the U.S. Postal Service's Office of Inspector

General, announced the charges today.

 

Named in the Indictment are:

 

1. JOHN BRUENS, age 48, of 11504 Nantucket Parkway, San Diego,

California;

2. MARY STEWART, age 44, of 58 Union Street, North Andover,

Massachusetts;

3. MELISSA VAUGHN, age 43, of 673 West Harthorn Street, Louisville,

Colorado; and

4. MARC SIROCKMAN, age 41, of 15 Covered Bridge Road, Flemington,

New Jersey.

 

All of the defendants are charged in the Indictment with Conspiracy.

Additionally, BRUENS and STEWART are charged with seven counts of

Offering to Pay Illegal Remunerations, and VAUGHN and SIROCKMAN are

charged with two such counts.

 

According to the Indictment in 1999, BRUENS, STEWART, VAUGHN and

SIROCKMAN all worked for Serono, an international pharmaceutical and

bio-technology company with corporate headquarters in Geneva,

Switzerland and U.S. headquarters at the time in Norwell, now in

Rockland, Massachusetts. BRUENS was the Vice-President of Marketing;

STEWART was the Vice-President for Sales; VAUGHN was the Regional of Sales for the Southeast Region, including Florida; and

SIROCKMAN was the Regional Director for Sales for the Northeast

Region, including New Jersey. The defendants were responsible for

sales and marketing of the drug Serostim, the propriety name or

trademark of the generic drug, "somatropin," a form of recombinant

human growth hormone. Serono obtained accelerated approval from the

U.S. Food and Drug Administration ("FDA") in 1996 for Serostim to

treat AIDS wasting, also known as "cachexia," a condition involving

profound involuntary weight loss in AIDS patients. At the time FDA

approved Serostim, AIDS wasting was an AIDS defining condition that

constituted the leading cause of death among AIDS patients.

 

The Indictment alleges that Serostim came on the market concurrently

with the advent of protease inhibitor drugs. These drugs, often

referred to as Highly Active Anti-Retroviral Therapy, dramatically

curtailed, in the United States, the proliferation of the AIDS virus

itself, particularly when used in combination with one another

(commonly referred to as "AIDS cocktails"). Given the decreased

viral loads in HIV patients taking these drugs, the incidence and

prevalence of the AIDS wasting syndrome began to markedly decline

among AIDS patients. Consequently, the demand for Serostim began to

drop significantly immediately following its launch in the Fall of

1996.

 

According to the Indictment, by February, 1999, the Serono business

unit responsible for selling Serostim, Metabolic & Immune Therapy

("M&IT"), was falling short of its sales goals. At that time, the

sales force was lead by six Regional Directors, including VAUGHN and

SIROCKMAN.

 

According to the Indictment, in March, 1999, BRUENS, STEWART and

another identified in the Indictment as Executive X, a top executive

in M&IT, summoned the six Regional Directors, including VAUGHN,

SIROCKMAN and Adam Stupak, Regional Director for New York City, to a

meeting in Boston, Massachusetts, where they were told that they

were falling far short of their sales goals and needed to "dig their

way out"of this fiscal crisis. The Indictment alleges that BRUENS,

STEWART and Executive X ordered the Regional Directors to target

select doctors to induce them to write more prescriptions related to

a sales plan called the "$6m-6 Day Plan" - meaning that each

Regional Director, including VAUGHN, SIROCKMAN and Stupak, were

required to identify the highest prescribing physicians or "thought

leaders" in their regions and target those physicians with financial

incentives in order to get the required number of prescriptions to

achieve the sales goal of $6 million in 6 days.

 

The Indictment alleges that part of the "$6m-6 Day Plan" was to

offer key high prescribing doctors an all-expenses paid trip for the

doctor and a guest to attend the 3rd International Conference on

Nutrition and HIV Infection being held in Cannes, France for three

days in April, 1999, in return for writing additional prescriptions,

up to thirty, of Serostim. The cost of each prescription of Serostim

induced by the offer of the trip to Cannes was for a twelve-week

course of treatment valued at approximately $21,000, thus the market

value of thirty scripts written by each doctor was $630,000.

 

According to the Indictment, in March, 1999, BRUENS and STEWART

caused VAUGHN to direct Serono sales representatives in her district

to visit the offices of Dr. "RL" and Dr. "P," each of whom practiced

medicine in Florida and treated patients who were HIV positive

and/or suffering from AIDS. It is alleged that the sales

representatives, at the direction of VAUGHN, offered the trip to the

Cannes Conference to the doctors in return for their writing

additional prescriptions of Serostim. The Indictment alleges that

VAUGHN reported to BRUENS, STEWART, SIROCKMAN, Stupak and others

that Dr. RL reacted negatively to the offer of the trip for scripts

and told the sales representative that this program was "unethical

and the very thing that the FDA looks for." According to the

Indictment, VAUGHN told BRUENS, STEWART, SIROCKMAN, Stupak and

others that "we won't be doing this program in the South." After

this message, VAUGHN nevertheless reported to BRUENS and STEWART

that Dr. P would attend the Cannes Conference from Florida. BRUENS

directed that Serono would pay for the doctor's flight.

 

Similarly, the Indictment alleges that in March, 1999, BRUENS and

STEWART caused SIROCKMAN to direct a Serono sales representatives in

his district to offer a New Jersey physician an all-expenses paid

the trip to the Cannes conference in return for the doctor gaining

clinical experience with at least thirty Serostim patients. The

Indictment further alleges that BRUENS and STEWART caused SIROCKMAN

to visit the office of another New Jersey doctor and to offer him

the Cannes trip in return for writing additional prescriptions of

Serostim. According to the Indictment, BRUENS, STEWART, and

SIROCKMAN caused the doctor's airline tickets to the Cannes

Conference as well as private limo service to be paid for by Serono.

 

The Indictment further alleges that BRUENS and STEWART caused

Stupak, together with other Serono sales representatives, to visit

the offices of three New York physicians. It is alleged that during

these meetings, that Stupak offered the doctors the trip to the

Cannes Conference in return for the doctors writing at least 10

additional prescriptions of Serostim.

 

It is alleged that during a presentation at Serono's National Sales

meeting held later in the month of March, 1999, BRUENS announced the

names of ten physicians who were "US Invitees" to the Cannes

Conference. The Indictment further alleges that BRUENS authorized

and caused personal gifts and entertainment to be provided to the

physicians and their guests at the Cannes Conference.

 

If convicted on these charges, BRUENS, STEWART, VAUGHN and SIROCKMAN

each face up to 5 years' imprisonment on each count, to be followed

by 3 years of supervised release, and a $250,000 fine per count.

 

In December, 2004, Adam Stupak, the former Regional Director for New

York City, pleaded guilty in federal court in Boston to three counts

of Offering to Pay Illegal Remunerations to doctors in his sales

territory in connection with his involvement in the kick-back scheme.

 

The investigation is continuing.

 

The case was investigated by the Federal Bureau of Investigation;

the U.S. Food and Drug Administration's Office of Criminal

Investigations; the Department of Health and Human Services' Office

of Inspector General, Office of Investigations; the U.S. Department

of Labor's Employee Benefits Security Administration; and the U.S.

Postal Service's Office of Inspector General. It is being prosecuted

by Assistant U.S. Attorney Mary Elizabeth Carmody in Sullivan's

Health Care Fraud Unit and Trial Attorney Sondra L. Mills in the

Department of Justice's Office of Consumer Litigation.

 

The details contained in the Indictment are allegations. The

defendants are presumed innocent unless and until proven guilty

beyond a reasonable doubt in a court of law.

 

Press Contact: Samantha Martin, (617) 748-3139

 

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-----------

FOR IMMEDIATE RELEASE

MONDAY, OCTOBER 17, 2005

WWW.USDOJ.GOVCIV

(202) 514-2007

TDD (202) 514-1888

 

 

SERONO TO PAY $704 MILLION FOR THE ILLEGAL MARKETING OF AIDS DRUG

WASHINGTON, D.C. - Swiss corporation, Serono, S.A., together with

its U.S. subsidiaries and related entities, has agreed to pay $704

million to resolve criminal charges and civil allegations in

connection with illegal schemes to promote, market and sell its

drug, Serostim, the Justice Department announced today. Serostim is

used to treat AIDS wasting, a condition involving profound

involuntary weight loss in AIDS patients. Under the settlement,

Serono Laboratories has agreed to pay a $136.9 million criminal fine

and its affiliate companies a total of $567 million to settle civil

liabilities. Today's global resolution, the third largest health

care fraud recovery by the U.S., also ensures that the Medicaid

program and each of the state Medicaid agencies which paid for

Serostim during the time frame of the investigation, 1996 through

2004, will recoup all monies paid based on Serono's illegal activity.

 

"Americans who need medical care depend on health care companies to

have their medical devices and drugs thoroughly evaluated and

approved before use," said Attorney General Alberto R.

Gonzales. "Serono abused the system of testing and approval, and put

its desire to sell more drugs above the interest of patients.

Today's settlement will repay with interest the losses to federal

and state Medicaid programs incurred by Serono's conduct, and would-

be wrongdoers are on notice that we will not tolerate attempts to

profit at the expense of the ill and needy in our society." Serono

Labs has agreed to plead guilty to charges that the company

conspired with medical device manufacturer RJL Sciences to market

bioelectrial impedance analysis (BIA) computer software packages for

use in calculating body cell mass and diagnosing AIDS wasting. The

device has not been approved by the Food and Drug Administration for

these uses. Serono Labs conspired with RJL to increase the market

for the devices/software in order to increase the market for

Serostim. Serono Labs employees also directly administered BIA tests

to patients to induce doctors to prescribe Serostim and to get

Medicaid agencies and other payers to reimburse for the drug. RJL

and its president, Rudolph J. Liedtke, pleaded guilty to their roles

in the conspiracy in April of this year and are awaiting sentencing.

Additionally, Serono Labs agreed to plead guilty to offering

physicians an all expense-paid trip to a medical conference in

Cannes, France in return for the doctors writing up to 30 new

prescriptions of Serotism, which cost $21,000 per course of

treatment, for a total value of $630,000 per doctor. As a result of

its criminal conviction, Serono Labs will be excluded from all

federal health care programs for at least five years. Serono's U.S.

subsidiary, Serono Holding and all U.S. affiliates will also be

subject to a stringent Corporate Integrity Agreement for the next

five years. "This plea agreement and settlement reflect an exemplary

coordinated use all of the appropriate anti-fraud weapons available

to us," said Assistant Attorney General Peter Keisler of the

Department's Civil Division. "This settlement sends the unequivocal

message to the health care industry that American taxpayers should

not pay for prescriptions induced by unproven medical tests and

improper payments to doctors and pharmacies." Under the federal

civil settlement, Serono will pay $305 million plus interest to the

U.S. for losses suffered by the federal portion of the Medicaid

program, the Veteran's Administration, the Department of Defense and

the Federal Employees Health Benefits program. Under separate civil

settlement agreements with the states, the company will also pay

nearly $262 million plus interest to state Medicaid programs. The

civil settlement resolves allegations that Serono knowingly

submitted false and fraudulent claims for Serostim that were not

eligible for reimbursement because they were for the unnecessary

and/or off label use of Serostim and because the claims were for

prescriptions induced by kickbacks. The FDA granted accelerated

approval for Serostim in 1996 solely for use in treating AIDS

wasting, which at the time was one of the leading causes of death

among AIDS patients. Serostim came on the market at the same time as

protease inhibitor drugs, which when used in combination with one

another as an "AIDS cocktail," dramatically curtail the progress of

the AIDS syndrome. As a result, the incidence and prevalence of AIDS

wasting began to markedly decline and the demand for Serostim

dropped significantly immediately following its launch. Serono Labs

then began engaging in a marketing and sales campaign to redefine

AIDS wasting and create a market for Serostim. "The American people,

as both taxpayers and consumers, expect our health care system to be

free from fraud and corruption," stated U.S. Attorney Michael J.

Sullivan of the District of Massachusetts. "The pharmaceutical

industry has an obligation to ensure that all rules, regulations and

laws are complied with. To do less erodes public confidence,

compromises the patient physician relationship and adds costs to

important government programs. Without the assistance of concerned

citizens illegal conduct on government programs would go

undetected." The investigation leading to today's global resolution

was initiated in 2000 in Massachusetts after a former Serono Labs

employee filed a False Claims Act suit. Four other employees filed

similar suits in Maryland and Connecticut. As a result of the

settlement, the private individuals who filed the whistleblower

suits will share in approximately $51.8 million. Under the

whistleblower provisions of the False Claims Act, private parties

can file an action on behalf of the United States and receive a

portion of the proceeds of a settlement or judgment awarded against

a defendant. The investigation was conducted by the Federal Bureau

of Investigation; the Food and Drug Administration's Office of

Criminal Investigations; the Department of Health and Human

Services' Office of Inspector General, Office of Investigations; the

Department of Labor's Employee Benefits Security Administration,

Boston Regional Office; and the U.S. Postal Service's Office of

Inspector General. Assistance in the investigation was also provided

by the New York State Attorney General's Special Projects and

Medicaid Fraud Control Unit; the Medicaid Fraud Control Unit in

Florida's Attorney General's Office; the Medicaid Fraud Section of

the New Jersey Attorney General's Office; and the California

Department of Justice. The Corporate Integrity Agreement was

negotiated by the Office of Inspector General at the Department of

Health and Human Services.

 

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