Link To ::
Former Executives of International Medical Device Maker Sentenced to Prison in Unlawful Clinical Trials Case. US Department of Justice Press Release 2011-11-21: http://www.justice.gov/usao/pae/News/2011/Nov/synthesexecs_release.pdf
Michael D. Huggins Criminal No. 09CR00403 USDC PA Eastern Judgment 2011-11-21: http://www.circare.org/lex/09cr00403_judghug_20111121.pdf
Michael D. Huggins Criminal No. 09CR00403 USDC PA Eastern Sentencing Hearing Audio File 2011-11-21:http://www.circare.org/lex/09cr00403_doc181_audio.pdf
Thomas B. Higgins Criminal No. 09CR00403 USDC PA Eastern Judgment 2011-11-21:http://www.circare.org/lex/09cr00403_20111122_tbh_judg.pdf
Thomas B. Higgins Criminal No. 09CR00403 USDC PA Eastern Sentencing Hearing Audio File 2011-11-21:http://www.circare.org/lex/09cr00403_doc185_audio.pdf
John J. Walsh Criminal No. 09CR00403 USDC PA Eastern Judgment 2011-11-21:http://www.circare.org/lex/09cr00403_judgwalsh_20111121.pdf
John J. Walsh Criminal No. 09CR00403 USDC PA Eastern Sentencing Hearing Audio File 2011-11-21:http://www.circare.org/lex/09cr00403_doc187_audio.pdf
International Medical Device Maker And Four Executives Charged In Connection With Unlawful Clinical Trials. United States Department of Justice Press Release 2009-06-16: http://www.usdoj.gov/usao/pae/News/Pr/2009/jun/synthesrelease.pdf
Synthes, Inc., Norian Corporation, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner, and John J. Walsh Criminal No. 09CR00403 USDC Eastern PA Indictment 2009-06-16: http://www.circare.org/lex/synthes/09cr00403_indictment.pdf
Norian Corporation, Synthes, Inc. Criminal No. 09CR00403 USDC Eastern PA Superseding Information 2010-10: http://www.circare.org/lex/synthes/synthesnorian_supersedinginformation.pdf
Norian Corporation, Synthes, Inc. Criminal No. 09CR00403 USDC Eastern PA Amended Superseding Information 2010-10-22: http://www.circare.org/lex/synthes/09cr00403_114_20101022.pdf
Norian Corporation, Synthes, Inc. Criminal No. 09CR00403 USDC Eastern PA Corporate Integrity Agreement Undated: http://www.circare.org/lex/synthes/synthes_cia.pdf
Norian Corporation, Synthes, Inc. Criminal No. 09CR00403 USDC Eastern PA Divestiture Agreement 2010-09-23: http://www.circare.org/lex/synthes/synthes_divestitureagrmt.pdf
Norian Corporation, Synthes, Inc. Criminal No. 09CR00403 USDC Eastern PA Settlement Agreement 2010-09-23: http://www.circare.org/lex/synthes/synthesnorian_settlementagreement.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA Government's Amended Presentence Memorandum 2010-03-30: http://www.circare.org/lex/synthes/09cr00403_94_20100330.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA United States' Consolidated Response to Defendants' Objections to the Presentence Reports 2011-04-22: http://www.circare.org/lex/synthes/09cr00403_138_20110422.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA United States' Consolidated Response to Defendants' Objections to the Presentence Reports, Exhibit 3 New Product Market Introduction Approval 2011-04-22: http://www.circare.org/lex/synthes/09cr00403_138-8_20110422.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA United States' Consolidated Response to Defendants' Objections to the Presentence Reports Exhibit 4 Product Complaint Report 2011-04-22: http://www.circare.org/lex/synthes/09cr00403_138-9_20110422.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA United States' Consolidated Response to Defendants' Objections to the Presentence Reports Exhibit 7 Synthes Spine Strategic Planning Meeting 2011-04-22: http://www.circare.org/lex/synthes/09cr00403_138-12_20110422.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA United States' Consolidated Response to Defendants' Objections to the Presentence Reports Exhibit 19 XR IDE Proposal 2011-04-22: http://www.circare.org/lex/synthes/09cr00403_138-24_20110422.pdf
Michael D. Huggins et al. Criminal No. 09CR00403 USDC Eastern PA United States' Consolidated Response to Defendants' Objections to the Presentence Reports Exhibit 20 Norian XR 2011-04-22: http://www.circare.org/lex/synthes/09cr00403_138-25_20110422.pdf
FDA Warning Letter to Synthes, Inc. (CDRH) 2004-11-05: http://www.circare.org/fdawls2/synthes_20041105.pdf
FDA Issues For Cause Inspection Following Reports of Three Patient Deaths Associated with Norian XR Device FDA Enforcement Story 2004(43): http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091455.pdf
MAUDE Adverse Event Report Norian Corporation (Synthes) Norian XR Calcium Phosphate Bone Void Filler 2004-01-24: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=510337
MAUDE Adverse Event Report Norian Corporation Norian XR Bone Void Filler (Follow Up) 2004-02-19: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=517339
Synthes (USA) Norian SRS Bone Void Filler 10CC Sterile (Follow Up) 2003-01-13: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=554520
MAUDE Adverse Event Report Norian Corporation (Synthes) Norian XR Calcium Phosphate Bone Void Filler 2003-09-19: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=518074
MAUDE Adverse Event Report Norian Corporation Norian XR Bone Void Filler 2004-12-17: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=565996
FDA MAUDE Adverse Event Report Search: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
MAUDE Adverse Event Report Kyphon Inc. Kyphx HV-R Bone Cement High Viscosity, Radiopaque Bone Cement 2009-01-02: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1847585
Prison terms sought for 4 over deadly medical tests. David Sell Philadelphia Inquirer 2011-06-05: http://www.philly.com/philly/business/123187273.html
Synthes' relationship with surgeons questioned. Miriam Hill. The Philadelphia Inquirer 2009-06-23: http://www.philly.com/philly/business/48839522.html
Synthes, Medical Device Maker, Accused of Improper Marketing. Barry Meier. The New York Times 2009-06-17: http://www.nytimes.com/2009/06/17/business/17device.html
Indictment says W. Chester firm tested cement on patients. Miriam Hill and Sam Wood. The Philadelphia Inquirer 2009-06-17: http://www.philly.com/philly/business/48233472.html
Manufacturer pleads guilty to improper use of bone cement. Bob Fernandez. Philadelphia Inquirer 2010-10-05: http://www.philly.com/philly/business/homepage/20101005_Manufacturer_pleads_guilty_to_improper_use_of_bone_cement.html
SpineMark Corporation Acquires Majority Ownership of Texas Back Institute; New Entity to Be Leader in Spine Research. PR Newswire 2006-04-27: http://goliath.ecnext.com/coms2/gi_0199-5468839/SpineMark-Corporation-Acquires-Majority-Ownership.html
Barton L. Sachs, M.D. Curriculum Vitae 2010-10: http://www.muschealth.com/cvs/FY11/SachsB_bls21_CV2010_scrubbed.pdf
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