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
'/>"/>

SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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:12/15/2014)... 2014 Research and Markets ( http://www.researchandmarkets.com/research/bf3b6l/electrocardiogram ... (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018" ... http://photos.prnewswire.com/prnh/20130307/600769 Global Electrocardiogram Devices (ECG) ... The North America accounts for ... Europe claims approximately 27% (2018). ...
(Date:12/15/2014)... December 15, 2014 BerGenBio AS, ... aggressive drug resistant cancers, today announces that it has ... placing from new and existing investors. BerGenBio ... the development of its pipeline of innovative cancer therapeutics, ... lead drug candidate, BGB324, a first-in-class selective Axl kinase ...
(Date:12/15/2014)... and BRIDGEWATER, N.J. , Dec. ... and Sanofi US (EURONEXT: SAN and NYSE: SNY) are ... to launch Cholesterol Counts , an awareness program ... their numbers, and the risks associated with high LDL-C ... www. CholesterolCounts .com to take a brief poll ...
Breaking Medicine Technology:Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 2Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 3Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 4BerGenBio Completes NOK90 Million Fundraising 2Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 2Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 3Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 4Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 5Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 6
... , FREMONT, Calif., Nov. 16 Vermillion, Inc. ... Chairperson, will be presenting at the Lazard Capital Markets Sixth ... is scheduled for Tuesday, November 17, 2009 at 5:10 p.m. ... The OVA1 Test is a qualitative serum test that combines ...
... ANGELES, Nov. 16 The Los Angeles Zoo announced ... treatment for skin cancer using a breakthrough cancer treatment ... to cancer sites with minimal radiation exposure to surrounding ... Randa was recently diagnosed with recurrent squamous cell carcinoma ...
Cached Medicine Technology:L.A. Zoo Announces Successful Cancer Treatment of Rhinoceros With Electronic Brachytherapy 2L.A. Zoo Announces Successful Cancer Treatment of Rhinoceros With Electronic Brachytherapy 3
(Date:12/19/2014)... Diet Doc strives to continue to ... weight loss by combining scientific fast weight ... the company understand that remaining committed to a diet ... carbohydrates and sugars from the diet can cause patients ... weight loss goals. , For this reason, Diet ...
(Date:12/19/2014)... December 19, 2014 B. E. Smith, ... healthcare providers, has been retained to lead a national ... Medical Center in Estes Park, Colo. The top executive ... has recently placed more than 900 healthcare executives into ... a 25-bed, not-for-profit critical access hospital and level IV ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 The ... shifting, capital equipment market that is saturated with ... safety and efficacy as well as non-invasive nature, ... were first introduced to the healthcare market. Rapid ... development of MRI safe technologies have greatly expanded ...
(Date:12/19/2014)... Hands On Mobile Spa, has announced they now have a ... been transformed into a utopia for the Long Island community ... The Virtual Tour showcases the beauty of the Spa On ... more. , The Virtual Tour shows viewers each of the ... overhauled Winnebago. Marla Kaplan-Pelle, Director states " It's hard to ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 If you ... having difficulty breathing, you probably wished you had an ... asthma, COPD, cystic fibrosis, and other breathing disorders. Currently, ... medications and avoiding triggers, but other common treatments do ... Educators conference in San Antonio, TX, 34 asthma educators ...
Breaking Medicine News(10 mins):Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 2Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 3Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 4Health News:Estes Park Medical Center Retains B. E. Smith to Recruit New Chief Financial Officer 2Health News:Estes Park Medical Center Retains B. E. Smith to Recruit New Chief Financial Officer 3Health News:Magnetic Resonance Imaging Systems Market Analysis and Forecast to 2020 Report at RnRMarketReserach.com 2Health News:Magnetic Resonance Imaging Systems Market Analysis and Forecast to 2020 Report at RnRMarketReserach.com 3Health News:Magnetic Resonance Imaging Systems Market Analysis and Forecast to 2020 Report at RnRMarketReserach.com 4Health News:A Virtual Tour Of Hands On Mobile Massage Spa Is Now Available 2Health News:A Virtual Tour Of Hands On Mobile Massage Spa Is Now Available 3Health News:Harmonica Techs, Inventors of the Pulmonica®, Unveil New Findings on Complementary Treatments for Asthma 2Health News:Harmonica Techs, Inventors of the Pulmonica®, Unveil New Findings on Complementary Treatments for Asthma 3
... in Huntingtons disease take place earlier in cell life ... Medicine in Houston in a report that appears in ... research provides evidence of toxicity by huntingtin (the protein ... said Dr. Juan Botas, associate professor of molecular and ...
... study finds, , , WEDNESDAY, Jan. 9 (HealthDay News) -- It ... such as schizophrenia and bipolar disorder, very early in the ... five factors that were often present prior to the diagnosis ... high risk of such disorders. When three or more of ...
... Time for the Holiday ... ... 50%,of his yearly weight gain during the Holiday Season. That,s not good ... http://www.metabothin.net ), the herbal weight loss formula,from American Generic Laboratories, specifically designed ...
... Margolin Named President of Blue Cross of California, ... today announced that Brian A. Sassi has been ... Consumer Business Unit, which,includes the Individual, Senior and ... of Blue Cross of California, replaces Joan,Herman, who ...
... on Ice Skating Admission Through ... the End of the Season, PHILADELPHIA, ... and head outdoors this weekend for the,Healthy Kids Fest at the Blue ... for families to enjoy the winter,months, the skating season is in full ...
... 9. 2008 -- Two Hebrew University of Jerusalem researchers, ... awarded the 2008 Wolf Prize in Medicine for their ... cancer research. , Minister of Education Prof. Yuli ... the $100,000 prize, often referred to as Israels Nobel ...
Cached Medicine News:Health News:5 Factors Help Predict Psychosis in Children 2Health News:5 Factors Help Predict Psychosis in Children 3Health News:Metabothin B56 with Ephedra Extract Now Available 2Health News:WellPoint Appoints Brian A. Sassi as President and CEO of the Company's Consumer Business Unit 2Health News:WellPoint Appoints Brian A. Sassi as President and CEO of the Company's Consumer Business Unit 3Health News:Families Encouraged to Enjoy Healthy Kids Fest January 12 at the Blue Cross RiverRink 2Health News:Families Encouraged to Enjoy Healthy Kids Fest January 12 at the Blue Cross RiverRink 3Health News:2 Hebrew University scientists awarded Wolf Prizes 2
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Deflected large type, opening width 8.0 mm and length 5 mm....
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Deflected large type, opening width 10.0 mm and length 10 mm....
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Deflected large type, opening width 8.0 mm and length 5 mm....
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Standard crankshaft-type 1/1 (mm), opening width 7.0 mm and length 5 mm....
Medicine Products: