Navigation Links
Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million
Date:5/21/2010

BOSTON, May 21 /PRNewswire-USNewswire/ -- Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.

U.S. Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, announced today that Ortho-McNeil was sentenced by U.S. Magistrate-Judge Robert B. Collings to pay a criminal fine of $6.14 million.

At the plea hearing, the prosecutor told the court that had the case proceeded to trial, the government's evidence would have proven that Ortho-McNeil used a promotional program called the "Doctor for a Day Program" as a tool to promote its epilepsy drug, Topamax, for uses which had never been approved by the U.S. Food & Drug Administration (FDA). Through the "Doctor for a Day Program," Ortho-McNeil paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists. On these sales calls, through the Doctor for a Day, Ortho-McNeil promoted Topamax to psychiatrists, including some in Massachusetts, for psychiatric uses. However, Ortho-McNeil had never applied to the FDA for any approval for Topamax to treat any psychiatric disorders and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.

"This case should send a strong reminder that the off-label promotion of pharmaceuticals is illegal, whether it is done directly by company employees, or through programs such as the 'Doctor For A Day Program,'" said U.S. Attorney Carmen M. Ortiz. "We will remain vigilant in our enforcement of these laws regardless of what form the conduct takes," Ortiz concluded.

An affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals Inc. will also pay $75.37 million to resolve civil allegations under the False Claims Act that it illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. Also as part of the settlement, Ortho-McNeil-Janssen Pharmaceuticals entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

The criminal case was prosecuted by Assistant U.S. Attorneys Jeremy Sternberg and Susan Winkler of the U.S. Attorney's Office for the District of Massachusetts and Jill Furman of the Justice Department's Office of Consumer Litigation. It was investigated by the U.S. Department of Veterans Affairs, Office of Inspector General; Boston Resident Agency, Criminal Investigations Division; the U.S. FDA's Office of Criminal Investigations, Boston Resident Office; and the FBI's Boston Field Office.

The civil investigation and settlement was handled by Assistant U.S. Attorney Zachary A. Cunha of the U.S. Attorney's Office in Massachusetts and Trial Attorney Colin M. Huntley of the Commercial Litigation Branch of the Justice Department's Civil Division. The Corporate Integrity Agreement was negotiated by the Office of Inspector General for the Department of Health and Human Services. Assistance was provided by the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resolves Investigation of Past TOPAMAX(R) Marketing and Promotional Activities
2. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Agrees to $75 Million Settlement for Topamax(R) False Claims Lawsuit
3. AUDIO from Medialink and Ortho-McNeil-Janssen Pharmaceuticals Inc.: Getting Ready for Cold and Flu Season
4. Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Type 2 Diabetes Drug Candidate in Partnership with Ortho-McNeil-Janssen Pharmaceuticals
5. Isis Earns $5 Million Milestone Payment From Ortho-McNeil, Inc. for Initiation of Phase 1 Study of ISIS 325568
6. Shengtai Pharmaceutical, Inc. Reports Financial Results for the Third Quarter and the First Nine Months of Fiscal Year 2010
7. Shengtai Pharmaceutical, Inc Announces Appointment of New Chief Financial Officer
8. National Pharmaceutical Council Welcomes New Member, Otsuka America Pharmaceutical, Inc.
9. Tianyin Pharmaceutical, Co. Announces Cash Dividend to Common Shareholders - Record Date October 30, 2009
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Houston-Area Durable Medical Equipment Company Owner Pleads Guilty to Fraud Scheme Involving Nutrition Supplies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... 22, 2017  As the latest Obamacare repeal effort ... Cassidy (R-LA) and Lindsey Graham (R-SC) ... medical device industry is in an odd place.  The ... 2.3% excise tax on medical device sales passed along ... covered patients, increased visits and hospital customers with the ...
(Date:9/19/2017)... medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed sound energy ... ... Jim Bertolina, PhD ... Tom Tefft ... executive Josh Stopek , PhD, who has led R&D and business development teams at ...
(Date:9/18/2017)... , Sept. 18, 2017  PMD Healthcare of ... Pharmacy of Kalamazoo, Mich. , have ... service that expedites and streamlines patient and provider access ... 2.0, and wellness management services.  ... used to measure lung function for a variety of ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & ... and special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to ... with elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco dentists, ... cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated to ... breathing. Oral appliances can offer significant relief to about 75 percent of people ...
(Date:10/12/2017)... ... 2017 , ... The American College of Medical Informatics (ACMI) will present the ... Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... a pioneer in the field of medical informatics, this prestigious award is presented to ...
Breaking Medicine News(10 mins):