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Special notice to effected entities: if there has been a substantive change in matters described in public court documents posted on the CIRCARE website we will gladly update our information. Please use the Webmaster email link at the bottom of this page to contact us.

Please review our Terms of Use for important information about material on the CIRCARE website.

2010-02-03: I'm (still) attempting to reorganize the cases into (hopefully) sensible categories. Your patience is appreciated. Cases are in (approximately) reverse chronological order.

(Tanezumab trial) Candace Melissa Stewart Civil No. 1206-07852 OR Circuit Court Multinomah County. Complaint 2012-06-20: http://www.circare.org/lex/1206-07852_complaint_20120620.pdf

(Guatemalan plaintiffs RE: US Public Health Service STD research) Manuel Gudiel Garcia et al. Civil No. 11CV00527 USDC D. of Columbia 2011-03-14 Class Action Complaint for Injunctive Relief and Damages 2011-03-14: http://www.circare.org/lex/11cv00527_complaint_20110314.pdf

Manuel Gudiel Garcia et al. Civil No. 11CV00527 USDC D. of Columbia First Amended Class Action Complaint for Injunctive Relief and Damages 2010-11-10: http://www.circare.org/lex/11cv00527_amendedcomp_20101110.pdf

Manuel Gudiel Garcia et al. Civil No. 11CV00527 USDC D. of Columbia The United States' Motion to Dismiss and Memorandum of Points and Authorities 2012-01-09: http://www.circare.org/lex/11cv00527_20120109.pdf

Manuel Gudiel Garcia et al. Civil No. 11CV00527 USDC D. of Columbia Indivual Federal Defendants' Motion to Dismiss and Memorandum of Points and Authorities 2012-01-09: http://www.circare.org/lex/11cv00527_20120109a.pdf

(Stem cell fraud) Lawrence Stowe, Francisco Morales Criminal No. 11CR00803 USDC Southern Dist. TX Indictment 2011-11-09: http://www.circare.org/lex/11cr00803_indictment.pdf

Francisco Morales et al. Criminal No. 11CR00783 USDC Southern Dist. TX Indictment 2011-11-09: http://www.circare.org/lex/11cr00783_indictment.pdf

Stem Cell Fraud: A 60 Minutes Investigation 2012-01-08: http://www.cbsnews.com/video/watch/?id=7394380n

Immunosyn Corporation Company and Case Information. Stanford Law School Securites Class Action Clearinghouse. 2009-08-24: http://securities.stanford.edu/1043/IMYN00_01/

Norian Corporation, Synthes Inc., Criminal No. 09CR00403 USDC Eastern PA. Follow this link for case documents: http://www.circare.org/lex/synthes/synthes.htm

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

Richard Aiken et al. Civil No. 11CVS4721 General Court of Justice Superior Court Division Durham County, NC Complaint 2011-09-07: http://www.circare.org/lex/11cvs4721_complaint.pdf [courtesy of ABC News, WTVD, Durham]

Robert Zeman Civil No. 11CV10204 USDC MA Amended Complaint 2011-04-11: http://www.circare.org/lex/zeman_11cv10204.pdf

Lisa Sharp and Wayne Spencer, M.D. Criminal No. 11CR40042 USDC KS Indictment 2011-06-01: http://www.circare.org/lex/11cr40042_20110601.pdf

Spectranetics Corporation Criminal No. 08CR05232 USDC CO Application and Affidavit for Search Warrant and Seizure 2008-09-02: http://www.circare.org/lex/08cr05232_searchwarrant.pdf

Colorado-based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical Devices. U.S. Department of Justice Press Release. 2009-12-29 : http://www.justice.gov/opa/pr/2009/December/09-civ-1385.html

Scott Reuben, M.D. Criminal No. 10CR30003 USDC MA Information 2010-01-14: http://www.circare.org/lex/10cr30002_1_20100114.pdf

Stryker Biotech, LLC, Mark Philip, William Heppner, David Ard, Jeffrey Whitaker. Criminal No. 09CR10330 USDC MA Indictment. 2009-10-28: http://www.circare.org/lex/09cr10330_20091028.pdf

Immunosyn Corporation Company and Case Information. Stanford Law School Securites Class Action Clearinghouse. 2009-08-24
URL: http://securities.stanford.edu/1043/IMYN00_01/

Frederic Harris Corbin, M.D. According to the U.S. Department of Justice Dr. Corbin implanted unlawful French-made silicone gel breast implants. Defendant caused these implants to be illegally smuggled into the United States from Mexico. Later, defendant used his position as a physician-investigator on an FDA-authorized breast implant research study (the Implant Study) to obtain silicone gel implants from Mentor Corporation (Mentor), a breast implant manufacturer and sponsor of the Implant Study. Defendant fraudulently qualified women for the Implant Study and concealed his illegal conduct by creating false medical records. (Motion of 2007-05-21, p. 3, linked below.) Subsequently Dr. Corbin pleaded guilty to four counts of violating 21 U.S.C. 331(e), Introduction of Adulterated Device Into Interstate Commerce. On 2009-02-20 he entered into a stipulated agreement with the Medical Board of California to settle charges arising from the federal case.

Before the Medical Board of California In the Matter of the First Amended Accusation Against Frederic Harris Corbin, M.D. Decision. 2009-02-20: http://www.circare.org/pd/corbin_20090220.pdf

Frederic Harris Corbin, M.D. Criminal No. 06CR00022 USDC Central District of California [Supplemental Information] 2007-09-25: http://www.circare.org/lex/06cr00022_information.pdf

Frederic Harris Corbin, M.D. Criminal No. 06CR00022 USDC Central District of California [Government's Opposition to Defendent Frederic H. Corbin's Motion to Dismiss Indictment] 2007-05-21: http://www.circare.org/lex/06cr00022_20070521.pdf

Frederic H. Corbin, M.D. Criminal No. 06CR00022 USDC Central District of California [Judgment] 2008-08-02 http://www.circare.org/lex/06cr00022_20080802.pdf

Frederic Harris Corbin, M.D. Medical Board of California Physician Profile [disciplinary and malpractice history]. Accessed on 2009-07-04 at: http://www2.dca.ca.gov/pls/wllpub/WLLQRYNA$LCEV2.QueryView?P_LICENSE_NUMBER=41325&P_LTE_ID=790

USA v. Palazzo. Appellate No. 07-31119 [2009, 5th Circuit]: http://www.circare.org/lex/palazzo_0731119.pdf

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letter to Maria Carmen Palazzo, M.D., Ph.D. 2003-12-03: http://www.circare.org/fdawls3/palazzo_20031203.pdf

Local Psychiatrist Indicted for Fraud Associated with Mentally Ill Patients and Children in Clinical Trials. U.S. Department of Justice Press Release. 2007-06-14: http://neworleans.fbi.gov/dojpressrel/2007/no061407a.htm

Maria Carmen Palazzo M.D., Ph.D. Criminal No. 05CR00266. USDC Eastern District of Louisiana. 2005-08-25: http://www.circare.org/lex/palazzo_indictment.pdf

Maria Carmen Palazzo M.D., Ph.D. Criminal No. 05CR00266. USDC Eastern District of Louisiana (Superseding Indictment). 2007-06-14: http://www.circare.org/lex/05cr00266_20070614.pdf

Louisiana State Board of Medical Examiners In the Matter of Maria Carmen Palazzo, M.D. Consent Order. 2009-02-19: http://www.circare.org/pd/palazzo_20090219.pdf

Clinical Investigators and Criminal Liability: The Legal Landscape After U.S. v. Palazzo. FDA Law Blog. 2009-04-05. Accessed on 2009-04-07 at: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/04/clinical-investigators-and-criminal-liability-the-legal-landscape-after-us-v-palazzo.html

740 F.2d 734 US vs. Ronald C. Smith, Robert Miltimore, and Donald F. Mitchell. No. 83-5200 USCA, 9th Cir. 1984-08-13: http://bulk.resource.org/courts.gov/c/F2/740/740.F2d.734.83-5200.html

Former Medical Device Company Manager Pleads Guilty to Felony Misbranding. US Department of Justice Press Release. 2009-04-14: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Apr2009/DoyleShanePR.html

Shane Doyle Criminal No. 09CR10035 USDC MA Information. 2009-02-06: http://www.circare.org/lex/09cr10035_20090206.pdf

Shane Doyle Criminal No. 09CR10035 USDC MA Agreed Statement of Facts. 2009-03-16: http://www.circare.org/lex/09cr10035_20090316.pdf

Shane Doyle Criminal No. 09CR10035 USDC MA Plea Agreement. 2009-03-26: http://www.circare.org/lex/09cr10035_20090326.pdf

Second Stryker sales rep pleads guilty. Eric Convey. Boston Business Journal. 2009-02-10.
URL: http://boston.bizjournals.com/boston/stories/2009/02/09/daily29.html

Former Medical Device Company Manager Pleads Guilty to Felony Misbranding. U.S. Department of Justice Press Release. 2009-02-10.
URL: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Feb2009/DemmingPleaPR.html

Justin Demming. Criminal No. 08CR10379, USDC, MA. (Agreed Statement of Facts in U.S.A. v Justin Demming.) Available from: http://www.circare.org/lex/08cr10379_20090210.pdf

Ex-Stryker sales rep. pleads guilty. Eric Convey. Boston Business Journal. 2008-11-19.
URL: http://boston.bizjournals.com/boston/stories/2008/11/17/daily36.html

Former Medical Device Company Manager Pleads Guilty to Making a False Statement and Felony Misbranding. U.S. Department of Justice Press Release. 2008-11-18.
URL: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Nov2008/MartinDarnellPleaPR.html (Ed.: the false statement was a falsified IRB approval.)

Darnell Martin. Criminal No. 08CR10338, USDC, MA. (Criminal Information in U.S.A. v Darnell Martin.) Available from: http://www.circare.org/lex/08cr100338_20081107.pdf

Boivin, WS. FDA Warning Letter to Stryker Biotech. 2008-04-28: http://www.circare.org/fdawls2/strykerbiotech_20080425.pdf

FDA CDRH Humanitarian Device Exemption. H020008-OP-1 Putty. Stryker Biotech. 2004-04-07. Accessed on 2009-07-04 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H020008

FDA CDRH Humanitarian Device Exemption. H010002-OP-1 ™ Implant. Stryker Biotech. 2001-10-17. Accessed on 2009-07-04 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H010002

FDA CDRH Humanitarian Device Exemptions Overview. Accessed on 2009-07-04 at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm

Orthopaedic and Rehabilitation Devices Panel. Notice of Meeting (2009-03-31), Agenda, Roster, Briefing Information, and Questions re: Premarket Approval Application (PMA) for OP-1 Putty, sponsored by Stryker Biotech. Accessed on 2009-07-04 at: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm148781.htm

05-4863-cv (L), 05-6768-cv (CON) Rabi Abdullahi v. Pfizer, Inc. United States Court of Appeals for the Second Circuit. 2009-01-30: http://www.circare.org/lex/05-4863-cv_opn.pdf

Yale University to Pay $7.6 Million to Resolve False Claims Act and Common Law Allegations. U.S. Department of Justice News Release. 2008-12-28. Accessed on 2009-02-03 at: http://www.usdoj.gov/usao/ct/Press2008/20081223-1.html

Bruce Perlowin pleads guilty to sale of Energy Wellness machine, an unapproved medical device. U.S. Department of Justice News Release. 2008-01-29: http://www.usdoj.gov/usao/cas/press/cas80129-Perlowin.pdf

United States of America v. Mitchell V. Kaminski (05-3823); Marilyn A. Coleman (05-3826); and Ovimmune, Inc. (05-4509). Appeal from the United States District Court for the Southern District of Ohio at Columbus. No. 02-00130. 2007-08-31: http://www.ca6.uscourts.gov/opinions.pdf/07a0356p-06.pdf

Masiello SA. FDA Warning Letter to Marilyn A. Coleman and Ovimmune. 2001-07-19: http://www.circare.org/fdawls2/ovimmune_20010719.pdf

Restitution Ordered for Victims of Unapproved Clinical Trials. FDA Enforcement Story. 2005: http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091079.pdf

Ovimmune Informed Consent: use of egg yolk containing natural antibodies against candida albicans/tropicalis. Undated: http://www.circare.org/FOIA/ovimmune_consent.pdf

Marilyn A. Coleman and Ovimmune, Inc. v. Sally W. Wiley et al. Case No. 2002CV0048. Common Pleas Court Union County, Ohio. Complaint. 2002-02-21: http://www.circare.org/FOIA/2002cv0048_complaint.pdf

Egg Powder Key Ingredient in Legal Fight. David Lore. The Columbus Dispatch. 2002-11-11: http://pro-networkers.com/bbs/messages/10116.html

James A. Holland, M.D. Criminal No. 07CR202, USDC, N.D. of N.Y. (Criminal Information) 2007-04-24: http://www.circare.org/lex/07cr202_20070424.pdf

James A. Holland, M.D. Criminal No. 07CR202, USDC, N.D. of N.Y. (Plea Agreement) 2007-04-24: http://www.circare.org/lex/07cr202_plea.pdf

James A. Holland, M.D. Criminal No. 07CR202, USDC, N.D. of N.Y. (Sentencing Memorandum) 2008-03-17: http://www.circare.org/lex/07cr202_20080317.pdf

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letter to James A. Holland, M.D. 2004-09-22: http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143715.pdf

Form FDA 483 Issued to James A. Holland M.D. Stratton VA Medical Center. 2003-01-02. Available from http://www.bioethicswatch.org/foia/strattonva483_20030102.pdf

On 2008-08-25 FDA disqualified Dr. Holland from participation in research subject to agency jurisdiction. FDA Disqualified/Totally Restricted List for Clinical Investigators. Accessed on 2009-07-04 at: http://www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/ucm131681.htm#holland

United States of America v. Meredith Rigdon Lentz. Case No. 05CR00046. United States District Court for the Middle District of Tennessee Nashville Division. Plea Agreement. 2006-01-06: http://www.circare.org/lex/05cr00046_30_20060106.pdf

FDA Warning Letter to Meredith Rigdon Lentz, M.D. 2001-08-21: http://www.circare.org/fdawls3/lentz_20010821.pdf

Clinical Investigator Fails to Obtain IRB Approval. FDA Enforcement Story 2006: http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM090866.pdf

Widow sues doctor, claims he gave her husband false hope about recovery. Associated Press. 1998-04-27: http://web.archive.org/web/19990220030716/http://www.oakridger.com/stories/042798/aps_widow.html

Use of stem cells in autistic child: Scott Reid v. David Steenblock, D.O. Petition for Order to Show Cause RE Appearance and Testimony Pursuant to Investigational Subpoena. Case No. 07CC00725. Superior Court of California for the County of Orange. 2007-04-05: http://www.circare.org/lex/steenblock_20070405.pdf

Medicare and research fraud: United States of America vs. Richard Fleming. Case No. 07CR3005. United States District Court for the District of Nebraska. Indictment. 2007-01-18: http://www.circare.org/lex/07cr3005_indictment_20070118.pdf

Counts 11 and 12 are for Mail Fraud related to research contracted by Aaron Tabor, M.D., CEO of Physicians Pharmaceutical, Inc., and CEO and Medical Research Director of Revival Soy: http://www.revivalsoy.com/. So the soy chip food product mentioned in the indictment (p. 7).

Biopharmaceutical Company InterMune, Inc. To Pay Nearly $37 Million for Unlawful Marketing of Actimmune. U.S. Department of Justice Press Release. 2006-10-26. Accessed on 2006-12-02 at http://web.archive.org/web/20070319041200/http://www.usdoj.gov/usao/can/press/2006/2006_10_26_InterMune.Deferred.prosecution.agreement.press.html

United States v. InterMune Inc. Case No. 06CR0707. United States District Court Northern District of California San Francisco Division. Deferred Prosecution Agreement. 2006-10-26. Accessed on 2006-12-02 at http://www.usdoj.gov/usao/can/press/press_documents/Intermune%20Def%20Pros%20Agrmt.PDF

United States v. InterMune Inc. Case No. 06CR0707 United States District Court Northern District of California San Francisco Division. Information. 2006-10-24. Accessed on 2006-12-02 at http://www.usdoj.gov/usao/can/press/press_documents/Intermune%20Information.PDF

United States v. James W. Forsythe. Case No. 06CR00147. United States District Court District of Nevada. Indictment. 2006-09-27. Available from http://www.circare.org/lex/06cr00147_indict_20060927.pdf

James Forsythe, M.D. In the Matter of the search of the residence located at 2660 West Lake Shores Reno, Nevada and business Century Wellness Center at 521 Hammill Lane Reno, Nevada. 06CR00147. 2006-09-27. Available from http://www.circare.org/lex/06cr00147doc7-1_20060926.pdf

Maverick doctor under fire. Jaclyn O'Malley. Reno Gazette-Journal. 2006-10-08. Accessed on 2007-02-16 at: http://faculty.uml.edu/sgallagher/ForsytheMaverick_doctor.htm

NB: Not all articles remain available online. Doctor indicted in drug scandal. Jaclyn O'Malley. Reno Gazette-Journal. 2006-09-29. Accessed on 2006-11-30 at: http://news.rgj.com/apps/pbcs.dll/article?AID=/20060929/NEWS/609290418/1049/SPORTS02

The Case. Jaclyn O'Malley. Reno Gazette-Journal. 2006-10-08. Accessed on 2006-11-30 at: http://news.rgj.com/apps/pbcs.dll/article?AID=/20061008/NEWS/610080485

Choosing between the medicines is personal, ethicist says. Jaclyn O'Malley. Reno Gazette-Journal. 2006-10-08. Accessed on 2006-11-30 at: http://news.rgj.com/apps/pbcs.dll/article?AID=/20061008/NEWS/610080483

Some call him hero; others have harsher words for Dr. Forsythe. Jaclyn O'Malley. Reno Gazette-Journal. 2006-10-08. Accessed on 2006-11-30 at: http://news.rgj.com/apps/pbcs.dll/article?AID=/20061008/NEWS/610080482

Indicted Reno doctor under fire for alternative treatments. Reno AP. 2006-10-08. Accessed on 2006-11-30 at: http://web.archive.org/web/20071022082842/http://lasvegassun.com/sunbin/stories/nevada/2006/oct/08/100810724.html

Arthur Krigsman M.D. v. Lenox Hill Hospital and the Members, Directors, and Individuals constituting the Institutional Review Board and the Medical Board of Lenox Hill Hospital. Index No. 15921/03. Supreme Court / State of New York. Order Granting Defendents' Motion to Dismiss. 2004-05-03. Available from http://www.circare.org/lex/krigsman15921-03_20040503.pdf

Related:McNeilly PJ. Office for Human Research Protections Determination Letter to Lenox Hill Hospital. 2006-11-08. Accessed on 2006-11-25 at: http://www.hhs.gov/ohrp/detrm_letrs/YR06/nov06a.pdf

Indian Tribe Wins Fight to Limit Research of Its DNA. Amy Harmon. The New York Times. 2010-04-21.
URL: http://www.nytimes.com/2010/04/22/us/22dna.html

Havasupai Tribe Win Nice Settlement From ASU In Scandalous Blood-Sample Case. Paul Rubin. Phoenix New Times. 2010-04-22: http://blogs.phoenixnewtimes.com/valleyfever/2010/04/havasupai_tribe_finally_win_ni.php

Havasupai Tribe Civil No. 1 CA-CV 07-0454, 1 CA-CV 07-0801 (Consolidated) Court of Appeals State of AZ Div. 1. Opinion 2008-11-28 http://www.azcourts.gov/Portals/89/opinionfiles/CV/CV070454.pdf

Tilousi et al. Civil No. 1 CA-CV 07-0801 Court of Appeals State of AZ Div. 1. Plaintiffs Appellants Opening Brief. 2008-01-07: http://turtletalk.files.wordpress.com/2008/12/tilousi-opening-brief.pdf

Tilousi et al. Civil No. 04 CV1290 USDC AZ Order. 2005-03-03: http://www.whoownsyourbody.org/havasupai-arizona.pdf

Arizona's Broken Arrow. Jana Bommersbach. Phoenix Magazine. November 2008: http://www.phoenixmag.com/lifestyle/200811/arizona-s-broken-arrow/web-exclusive--bouns-material

DKT International, Inc. v. United States Agency for International Development et al. Case No. 05CV1604. USDC District of Columbia [Memorandum Opinion]. 2006-05-18: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2005cv1604-34

Abigail Alliance for Better Access to Developmental Drugs and The Washington Legal Foundation v. Andrew von Eschenbach in His Official Capacity as Acting Commissioner, Food and Drug Administration, et al. No. 04-5350. United States Court of Appeals for the District of Columbia Circuit. 2006-05-02. Available from http://pacer.cadc.uscourts.gov/docs/common/opinions/200605/04-5350a.pdf. Accessed 2006-05-03.

Judge Limbaugh Rules in Favor of Washington University in Washington University v. William J. Catalona. Case No. 4:03 cv 01065 SNL. Washington University School of Medicine information page. Undated. Available from http://prostatecure.wustl.edu/

The Washington University v. William J. Catalona M.D., et al. Case No. 03CR01065. Order. 2006-03-31. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_order.pdf

The Washington University v. William J. Catalona M.D., et al. Case No. 03CR01065. Opinion. 2006-03-31. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_opinion.pdf

The Washington University v. William J. Catalona M.D., et al. Case No. 03CR01065. Complaint. 2003-08-04. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_complaint.pdf

The Washington University v. William J. Catalona M.D., et al. Case No. 03CR01065. Plaintiff's Pre-hearing Brief. 2005-04-04. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_pltfprehearingbrief.pdf

The Washington University vs. William J. Catalona M.D., et al. Case No. 03CR01065. Plaintiff's Proposed Findings of Fact and Conclusions of Law. 2005-06-15. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_pltffindingsoffact.pdf

The Washington University v. William J. Catalona M.D., et al. Case No. 03CR01065. Plaintiff's Post-trial Brief. 2005-06-15. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_pltfposttrialbrief.pdf

The Washington University v. William J. Catalona M.D., et al. Case No. 03CR01065. Plaintiff's Post-hearing Reply. 2005-07-05. United States District Court Eastern District of Missouri, Eastern Division. Available from http://www.circare.org/lex/03cv01065_pltfposthearingreply.pdf

Psychiatrist Charged with Conspiracy to Illegally Market the Prescription Medication Xyrem, Also Known as Ghb, for Unapproved Medical Uses on Behalf of its Manufacturer. U.S. Department of Justice Press Release. 2006-04-05. Available from http://www.usdoj.gov/usao/nye/pr/2006/2006apr05.html

The People of the State of New York v. Guidant Corporation. Supreme Court of the State of New York, County of New York. Index No. 403656/05. Complaint. 2005-11-02. Available from http://www.oag.state.ny.us/media_center/2005/nov/complaint%20-%20stamped%20&%20signed.pdf

United States Attorney Patrick L. Meehan today announced the filing of a two count Information charging Harold F. Farber, M.D., PC and Harold F. Farber, M.D. U.S. with false statements to the United States and illegal possession of controlled substances, in violation of 18 U.S.C. § 1001 and 21 U.S.C. § 844 respectively. U.S. Department of Justice Press Release. 2005-07-25. Available from http://web.archive.org/web/20080126181510/http://www.usdoj.gov/usao/pae/News/Pr/2005/jul/farber.html

Criminal Information as to Harold F. Farber M.D. Available from http://www.usdoj.gov/usao/pae/News/Pr/2005/jul/farber.pdf. Accessed 2006-04-22.

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Deborah Henshall v the General Medical Council. United Kingdom Supreme Court (Civil Division) [2005] EWCA Civ 1520. December 13, 2005. Accessed on 2007-12-07 at: http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWCA/Civ/2005/1520.html

Clinical Study Coordinator for Pediatric Drug Charged with Fraud. U.S. Department of Justice Press Release. 2005-05-25. Accessed on 2006-03-09 at: http://tinyurl.com/lv5c3

Clinical Study Coordinator for Pediatric Drug Study Sentenced for Fraud. U.S. Department of Justice Press Release. 2005-09-16. Accessed on 2006-03-09 at: http://tinyurl.com/hu8oy

United States of America v. Anne Butkovitz. Case No. 05CR10128. Criminal Information as to Anne Butkovitz. United States District Court, District of Massachusetts. 2005-05-26: http://www.circare.org/lex/ci_butkovitz.pdf

United States of America v. Anne Butkovitz. Case No. 05CR10128. Plea Agreement. United States District Court, District of Massachusetts. 2005-04-28: http://www.circare.org/lex/butkovitz_plea.pdf

Ann L. Butkovitz; Debarment Order. 71 FR 61061. 2006-10-16. Accessed on 2009-07-04 at: http://www.fda.gov/downloads/ICECI/EnforcementActions/FDADebarmentList/UCM138388.pdf

Related: FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain to Eugenia Marcus, M.D. 2004-04-22: http://www.circare.org/fdawls3/marcus_20040422.pdf

U.S. Department of Justice Press Release — Dr. Eric T. Poehlman. 2005-03-17: http://ori.hhs.gov/misconduct/cases/press_release_poehlman.shtml (Courtesy of The Office of Research Integrity.)

Voluntary Exclusion and Settlement Agreement between the United States Department of Health and Human Services (HHS), through the Public Health Service (PHS) and Eric T. Poehlman Ph.D. 2005-03-09. Available from http://ori.hhs.gov/documents/vea_2.pdf. (Courtesy of the Office of Research Integrity.)

70 FR 56 [Notices] March 24, 2005. Pages 15092-15095. Available from http://ori.hhs.gov/misconduct/cases/poehlman_notice.shtml (Courtesy of the Office of Research Integrity.)

List of Retracted / Corrected Publications [Updated March 23, 2005]. Available from http://ori.hhs.gov/documents/pubmed_list.pdf (Courtesy of the Office of Research Integrity.)

In the Matter of Eric T. Poehlman Ph.D. Investigation Report. University of Vermont College of Medicine. 2002-04-18. Available from http://ori.hhs.gov/documents/uvm_report.pdf (Courtesy of the Office of Research Integrity.)

United States of America v. Eric T. Poehlman. Case No. 05CV66. Settlement Agreement and Stipulation for Entry of Judgment. 2005-03-21. United States District Court, District of Vermont. Available from http://ori.hhs.gov/documents/poehlman_settlement_agreement_final.pdf (Courtesy of Office of the Research Integrity.)

Paul H. Kornak pled guilty today, in United States District Court in Albany, to making a false statement, mail fraud, and criminally negligent homicide. Kornak, 53, resides in Clifton Park. U.S. Department of Justice Press Release. 2005-01-18: http://web.archive.org/web/20060203101242/http://www.usdoj.gov/usao/nyn/NewsReleases/2005/2005-02/200502031553.htm

United States of America v. Paul H. Kornak. Case No. 03CR436. Plea (and cooperation) agreement. 2005-01-19. United States District Court, Northern District of New York. Available from http://www.circare.org/lex/03cr436.pdf

NOT-OD-06-042 Findings of Scientific Misconduct (Paul H. Kornak). Department of Health and Human Services (DHHS). 2006-02-24. Available from http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-042.html

See also information about James A. Holland, M.D., principal investigator and Kornak's supervisor

Jayne Steubing, individually and as Personal Representative of Carl Steubing, and all others similarly situated v. Paul Kornak and James Holland M.D. Case No. 03CV0332. Complaint and Motion for Class Action. 2003-03-18. United States District Court, Northern District of New York. Available from http://www.circare.org/lex/03cv0332complaint_20030318.pdf

[Steubing] Consent Form for study titled Open Label, Randomized, Multicenter, Phase I/III Study of Docetaxel in Combination with Cisplatin (CDDP) or Docetaxel in Combination with 5-fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients with Metastasis or Locally Recurrent Gastric Cancer Previously Untreated with Chemotherapy for Advanced Disease. Available from http://www.sskrplaw.com/gene/steubing/vaconsent.html (Courtesy of Alan Milstein, SSKR & P, Attorneys At Law.)

Former VA psychiatrist sentenced to 15 years in jail. Office of Inspector General Department of Veterans Affairs (VAOIG) Press Release. 1998-10-09. Available from http://www.va.gov/oig/51/press99/borison-pr.htm

Researcher pleads guilty in massive fraud. Office of Inspector General Department of Veterans Affairs (VAOIG) Press Release. 1997-12-16. Available from http://www.va.gov/oig/51/press98/diamondpr.htm

Attorney General Announces Guily Plea in Medical College of Georgia Fraud Case. State of Georgia Attorney General Press Release. 1998-10-09. Available from http://www.state.ga.us/ago/press/press.cgi?prfile=PR.19981009.01

Attorney General Announces Guily Plea in Medical College of Georgia Fraud Case. State of Georgia Attorney General Press Release. 1997-12-16. Available from http://www.state.ga.us/ago/press/press.cgi?prfile=PR.19971216.01

Richard L. Borison; Debarment Order. 68 FR 56298. 2003-09-30. Accessed on 2009-07-04 at: http://www.fda.gov/downloads/ICECI/EnforcementActions/FDADebarmentList/UCM138379.pdf

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Karen Lenahan v. The University of Chicago et al. Nos. 1-02-2513 & 1-02-2867:Cons. 2004-03-31: http://www.state.il.us/court/Opinions/AppellateCourt/2004/1stDistrict/March/Html/1022513.htm

Abdullahi v. Pfizer Inc. Case Nos. 02-9223 (L), 02-9303 (XAP). United States Court of Appeals for the Second Circuit. 2003-10-08: http://www.circare.org/lex/02-9223_so.pdf

Audrey M. Snow Civil No. 03CV00474 USDC Southern District of Alabama Complaint. 2003-06-25. Available in PACER or by request. Use the Webmaster link at the bottom of this page and we'll send you a copy via email attachment.

Purported Informed Consent Agreement signed by Ms. Snow to enroll in the clinical trial of Stimulated Autologous Immune Serum conducted by Dr. Page. 1999-02-25: http://www.circare.org/foia2/cv_03_2238_icf.pdf

A laboratory analysis conducted on 2002-11-04 revealed that the serum, for which the research subject Ms. Snow was charged $9,500, contained water, lactic acid, and no protein material. It's believed that the Stimulated Autologous Immune Serum was manufactured by Amscot Medical Laboratory, a company owned and operated by GLCCM IRB member George Kindness. Kindness was indicted in US federal district court on 22 criminal counts arising from his actions in clinical trials testing several cancer vaccines.

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letter to Roy C. Page, M.D. 2000-04-06. Accessed on 2009-07-04 at: http://www.circare.org/fdawls3/page_20000406

FDA Notice of Opportunity for Hearing (NOOH) Letter to Roy C. Page, M.D. 2002-01-08. Accessed on 2009-07-04 at: http://www.circare.org/fdawls3/page_20020108.pdf

Roy C. Page; Debarment Order 73 FR 71008. 2008-11-24. Accessed on 2009-07-04 at: http://www.circare.org/fdawls3/page_debarment.pdf

Before the Tennessee Board of Medical Examiners in the Matter of Roy C. Page, M.D. Amended Agreed Order. 2008-02-24. Accessed on 2009-07-04 at: http://www.circare.org/pd/page_20080124.pdf

Susan Darke, Individually and as Executrix of the Estate of Roger J. Darke, Plaintiff v. Estate of Dr. Jeffrey M. Isner, M.D., Jeffrey M. Isner, M.D. P.C., Dr. James Symes, Douglas Losordo, Vascular Genetics, Inc. and CA. Docket No. 02-2194. Memorandum of Decision and Order on Motion for Partial Summary Judgment by Defendants Caritas ST. Elizabeth's Medical Center and the Estate of Dr. Jeffrey M. Isner, M.D. 2004-06-03. Massachusetts Superior Court, Suffolk County. Social Law Library web site. Available at:   http://www.socialaw.com/slip.htm?cid=14025&sid=121

Related: FDA Warning Letter to Jeffrey M. Isner, M.D. 2000-04-28. Available from http://www.circare.org/fdawls3/isner_20000428.pdf

Evelyn Heinrich, on behalf of her husband, George Heinrich, and Henry M. Sienkewicz, on behalf of his mother, Eileen Rose Sienkewicz Jr., Plaintiffs, Appellants, Cross-Appellees, Rosemary Gualtieri, on behalf of her father, Joseph Mayne, and Walter Carl Van Dyke, Representative of the Estate of Walter Carmen Van Dyke, Plaintiffs, Appellants, v. Elizabeth Dutton Sweet and Frederick H. Grein Jr., Representatives of the Estate of William H. Sweet, M.D., and Massachussets General Hospital, Defendants, Appellees, Cross-Appellants, Unites States of America, Defendant, Appellee, Estate of Lee Edward Farr, Associated Universities, Inc., and Massachussets Institute of Technology, Defendants. Case no. 002553. 2002-08-27. United States Court of Appeals For the First Circuit. Available from http://laws.lp.findlaw.com/getcase/1st/case/002553&exact=1 (Oninion courtesy of FindLaw.com.)

Evelyn Heinrich, on behalf of her husband, George Heinrich, and Henry M. Sienkewicz, on behalf of his mother, Eileen Rose Sienkewicz Jr., Plaintiffs, Appellants, Cross-Appellees, Rosemary Gualtieri, on behalf of her father, Joseph Mayne, and Walter Carl Van Dyke, Representative of the Estate of Walter Carmen Van Dyke, Plaintiffs, Appellants, v. Elizabeth Dutton Sweet and Frederick H. Grein Jr., Representatives of the Estate of William H. Sweet, M.D., and Massachussets General Hospital, Defendants, Appellees, Cross-Appellants, Unites States of America, Defendant, Appellee, Estate OF Lee Edward Farr, Associated Universities, Inc., and Massachussets Institute of Technology, Defendants. Case no. 002553v2. 2002-10-03. United States Court of Appeals For the First Circuit. Available from http://laws.lp.findlaw.com/getcase/1st/case/002553v2&exact=1 (Opinion courtesy of FindLaw.com.)

Evelyn Heinrich, on behalf of her husband, George Heinrich, and Henry M. Sienkewicz, on behalf of his mother, Eileen Rose Sienkewicz Jr., Plaintiffs, Appellants, Cross-Appellees, Rosemary Gualtieri, on behalf of her father, Joseph Mayne, and Walter Carl Van Dyke, Representative of the Estate of Walter Carmen Van Dyke, Plaintiffs, Appellants, v. Elizabeth Dutton Sweet and Frederick H. Grein Jr., Representatives of the Estate of William H. Sweet, M.D., and Massachussets General Hospital, Defendants, Appellees, Cross-Appellants, Unites States of America, Defendant, Appellee, Estate of Lee Edward Farr, Associated Universities, Inc., and Massachussets Institute of Technology, Defendants. Case no. 002553v3. 2002-10-17. United States Court of Appeals For the First Circuit. Available from http://laws.lp.findlaw.com/getcase/1st/case/002553v3&exact=1 (Opinion courtesy of FindLaw.com.)

Linda A. Ande, Charles Ande, C.E.A., a minor, and C.L.A., a minor, Plaintiffs-Appellants, v. Michael Rock, Norman Fost et. al. Case no. 01-1009. 2002 WI App 136. 2002-05-16. Available from http://www.wicourts.gov/html/ca/01/01%2D1009.htm

William C. Hamlet, Plaintiff, v. Genentech Inc., Xoma LTD., Western Institutional Review Board Inc., Parexel International LLC., Mark S. Fradin M.D., Chapel Hill Dermatology PA, Defendants. Case no. 03CVS1161. Complaint. North Carolina, Orange County in the General Court of Justice, Superior Court Division. Available from http://www.sskrplaw.com/gene/hamletcomplaint.pdf (Case courtesy of Alan Milstein, SSKR & P, Attorneys At Law.)

Erica Grimes v. Kennedy Krieger Institute et. al., Myron Grimes v. Kennedy Krieger Institute et. al. 366 Md. 29. (Nos. 128 and 129. Court of Appeals of Maryland. Circuit Court for Baltimore City Case nos. 24-C-99-000925 and 24-C-95066067/CL 193461.) 2001-08-16: http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf

William Lee Wright, Sr., individually and as Personal Representative of the Estate of Becky Wright; Peggy Draheim, individually and as Personal Representative of the Estate of Dr. John Draheim; and all others similarly situated, Plaintiff, v. The Fred Hutchinson Cancer Research Center; Dr. E. Donnall; Thomas and Jane Doe Thomas, and the marital community comprised thereof; Dr. John A. Hansen and Jane Doe Hansen, and the marital community comprised thereof; Dr. Paul J. Martin and Jane Doe Martin and the marital community comprised thereof; Dr. Robert Day and Jane Doe Day, and the marital community comprised thereof; and Genetic Systems Corporation and its Presently Unknown Successor Corporation, Defendants. Case no. 01-2-008376. First Amended Complaint for Damages and Class Action. 2001-03-29. Kitsap County Superior Court in and for the State of Washington. Available from http://www.sskrplaw.com/gene/wright/complaint1.html. (Courtesy of Alan Milstein, SSKR & P, Attorneys At Law.)

John Gelsinger, as administrator and personal representative of the estate of Jesse Gelinsinger, and Paul Gelsinger, in his own right, Plaintiffs, v. The Trustees of the University of Pennsylvania, & James Wilson M.D. Ph.D., Genovo Inc., Steven Raper M.D., Mark Batshaw M.D., William Kelley M.D., Children's Hospital of Philadelphia, Children's National Medical Center, and Arthur Caplan Ph.D., Defendants. Complaint. Court of Common Pleas, Philadelphia County. Trial Division Term, 2000. Available from http://www.sskrplaw.com/links/healthcare2.html (Courtesy of Alan Milstein, SSKR & P, Attorneys At Law.)

Beverly H. Scheer v. James F. Burke, M.D., Michael J. Duzy, D.O., Susan Heaney, R.N., Joseph T. Conroy, D.O., Mainline Hospitals, Inc., Lankenau Hospital, Lankenau Institute for Medical Research, George Reichard, Jr., Ph.D., Mainline Hospitals Institutional Review Board. No.: 000375. Complaint. Court of Common Pleas, Philadelphia County. July Term, 2003. Available from http://www.circare.org/lex/scheer000375.pdf

Related: Borror KC. Office for Human Research Protections Determination Letter to Lankenau Medical Research Center. 2002-11-14: http://www.hhs.gov/ohrp/detrm_letrs/YR02/nov02a.pdf

ALLHAT Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (study web site). Available from http://allhat.sph.uth.tmc.edu/

National Heart, Lung, and Blood Institute (NHLBI) Information on ALLHAT. Available from http://www.nhlbi.nih.gov/health/allhat/index.htm

** Robertson v. McGee et al. Complaint. United States District Court for the Northern District of Oklahoma. Available from http://www.sskrplaw.com/gene/robertson/complaint-new.html (Courtesy of Alan Milstein, SSKR & P, Attorneys At Law)

Related: Ruth H. Creech, Plaintiff-Appellee, Cross-Appellant, v. Oral Roberts, Richard Roberts, City of Faith Hospital, Oral Roberts Evangelistic Association, Brent Bennett, M.D., Michael Laughlin, M.D., Defendants, City of Faith Medical and Research Center, Michael McGee, M.D., Defendants-Appellants, Cross-Appellees. Nos. 88-4180, 89-3096. United States Court of Appeals, Sixth Circuit. Argued March 12, 1990. Decided July 13, 1990. Rehearing Denied Sept. 6, 1990. Rehearing En Banc Denied Sept. 7, 1990. Available from http://www.circare.org/lex/creechvsmcgee.pdf

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letter to J. Michael McGee, M.D. 2001-06-21: http://www.circare.org/fdawls3/mcgee_20010621.pdf

FDA Notice of Opportunity for Hearing (NOOH) Letter to J. Michael McGee, M.D. 2002-05-21: http://www.circare.org/fdawls3/mcgee_20020521.pdf

J. Michael McGee, M.D. 2009-R-0036 Notice of Denial of Hearing and Disqualification of Eligibility to Receive Investigational Drugs. 2009-01-08: http://www.circare.org/fdawls3/mcgee_20090108.pdf

United States of America, Appellee, v. Writers & Research, Inc., Defendant, Charles R. Pixley, Defendant-Appellant. No. 834. Docket No. 96-1476. United States Court of Appeals for the Second Circuit. 1997-05-07: http://caselaw.lp.findlaw.com/scripts/printer_friendly.pl?page=2nd/961476.html (Opinion courtesy of FindLaw.com.)

29 F.3d 451 US vs. Barry Garfinkel No. 93-3160 USCA 8th Cir. 1994-07-13: http://bulk.resource.org/courts.gov/c/F3/29/29.F3d.451.93-3160.html

Barry D. Garfinkel, M.D.; Debarment Order 162 FR 1573 1997-04-02: http://www.fda.gov/downloads/ICECI/EnforcementActions/FDADebarmentList/ucm063081.pdf

740 F.2d 734 US vs. Ronald C. Smith, Robert Miltimore, and Donald F. Mitchell. No. 83-5200 USCA, 9th Cir. 1984-08-13: http://bulk.resource.org/courts.gov/c/F2/740/740.F2d.734.83-5200.html

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Interesting Cases :: Food and Drug Law

Stem Cell Treatment Fraud Case Indicted. U.S. Department of Justice Press Release. 2006-03-29: http://www.usdoj.gov/usao/gan/press/2006/03-29-06.pdf

United States of America v. Laura Brown and Stephen Mark van Rooyen aka Mark Dehavillan. Case No. 06CR153. Indictment. 2006-03-28. United States District Court, Northern District of Georgia, Atlanta Division. Available from http://www.circare.org/lex/06cr1534_indictment.pdf

Local Doctor Indicted in Health Care Fraud Scheme Involving Injections of Unapproved and Misbranded Drugs [Totada R. Shanthaveerappa M.D. aka T.R. Shantha M.D.]. U.S. Department of Justice Press Release. 2005-12-20: http://www.usdoj.gov/usao/gan/press/2005/12-20-2005b.html

United States of America v. Totada R. Shanthaveerappa M.D. and Dan U. Bartoli. Case No. 05CR00612. Indictment. United States District Court for the Northern District of Georgia Atlanta Division. 2005-12-20: http://www.circare.org/lex/05cr00612_indictment.pdf

United States of America v. Totada R. Shanthaveerappa M.D. and Dan U. Bartoli. Case No. 05CR00612. Government's Response to Defendants' Motion to Supress. United States District Court for the Northern District of Georgia Atlanta Division. 2006-05-10: http://www.casewatch.org/doj/shantha/motion.pdf

State of Florida Department of Health v. Discovery Experimental and Development, Inc. 2003-04-18 (NB case documents posted to docket) : http://tinyurl.com/3es6mn

United States of America v. Michael Forrest. Case No. 04CR00232. Plea Agreement. United States District Court, Eastern District of Wisconsin. 2005-08-02: http://www.circare.org/lex/04cr00232pleaagreement_20050802.pdf

Federal Trade Commission. In the Matter of Michael Forrest, individually and doing business as Jaguar Enterprises of Santa Ana. File No. 012 3091, Docket No. C-4020. 2001-08-03 and 2001-06-14: http://www.ftc.gov/os/caselist/c4020.shtm

Poag v. Atkins 2005 NYSlipOp 51445(U). 2005-09-12: http://www.nycourts.gov/reporter/3dseries/2005/2005_51445.htm (Exculpatory agreement in consent form offends public policy; express assumption of risk dependent upon specific information disclosed to plaintiff.)

Poag v. Atkins 2004 NYSlipOp 50524(U). 2004-06-07: http://www.nycourts.gov/reporter/3dseries/2004/2004_50524.htm (Granting plaintiff's motion for leave to renew and leave to amend the complaint to assert a cause of action for wrongful death.)

Osman v. Opthalmic Innovations Intl., Inc. 2004 NYSlipOp 51405(U). 2004-10-24: http://www.nycourts.gov/reporter/3dseries/2004/2004_51405.htm (Damages arising from use of unapproved class III medical device; phakic intraocular lenses.)

United States of America v. George Kindness and Amscot Medical Labs Inc. (a corporation). Case no. 03CR20433. Indictment. United States District Court Western District of Tennessee Western Division. 2003-11-19: http://www.bioethicswatch.org/foia/03_20433BV.pdf (Kindness was a member of the Great Lakes College of Clinical Medicine Institutional Review Board. Follow this link for more information on the Great Lakes College of Clinical Medicine Institutional Review Board.)

United States of America v. George Kindness and Amscot Medical Labs Inc. Case No. 03CR20433. Plea Agreement. United States District Court Western District of Tennessee Western Division. 2005-07-06: http://www.circare.org/lex/03cr20433_20050706.pdf

Securities and Exchange Commission v. Secure Investment Services, Inc., American Financial Services, Inc., Lyndon Group, Inc., Donald F. Newhaus, and Kimberly A. Snowden. Case No. 07CV01724. United States District Court Eastern District of California Sacramento Divison. Complaint. 2007-08-23: http://www.sec.gov/litigation/complaints/2007/comp20252.pdf

Redding man, daughter accused of Ponzi scheme. Dale Kasler. The Sacramento Bee. 2007-08-24: http://www.sacbee.com/103/story/342116.html

Premium of America, LLC v. Amscot Medical Labs, Inc., Amscot Medical Labs – Hamilton, Inc., George Kindness et al. Adversary Proceeding No: 04-10454. United States Bankruptcy Court District of Columbia (Washington, D.C.). 2004-11-19: http://www.circare.org/foia2/02_2358.pdf. (Kindness and Amscot Medical Labs, Inc. provided life expectancy estimates for one or more companies selling viatical investments; the life expectancy estimates are alleged to be erroneous.)

Scheck Investments, et al. v. Viatical Benefactors, et al. Case No. 04CV21160. United States District Court Southern District of Florida (Miami). 2004-05-17. (The case is available to subscribers through PACER. If you don't use PACER you can access many of the case documents on the web site set up by the receiver for Mutual Benefit Incorporated at http://mbcreceiver.com/updates.html.)

Division of Securities of the Arizona Corporations Commission Docket No. S-03445A-01-0000. Notice to Cease and Desist etc. to Accelerated Success Inc., Integrity Assured Life Settlements, Inc. et al. 2001-04-10: http://www.azcc.gov/divisions/securities/enforcement/Actions/2001/apr10-01.pdf

Division of Securities of the Arizona Corporations Commission: Docket No. S-03445A-01-0000. Decision No. 64245. Order To Cease And Desist, Order of Restitution, Order for Administrative Penalties and Consent to Same to Accelerated Success Inc., Integrity Assured Life Settlements, Inc. et al. 2001-11-29: http://www.azcc.gov/divisions/securities/enforcement/Orders/2001/nov29-01b.pdf

George J. Kindness; Debarment Order 73 FR 71007. 2008-11-24. Accessed on 2009-07-04 at: http://www.fda.gov/downloads/ICECI/EnforcementActions/FDADebarmentList/UCM138392.pdf

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United States v. Endovascular Technologies Inc. Case No. CR020179. Criminal Information. 2003-06-09. United States District Court, Northern District of California, San Francisco Division. Available from http://www.bioethicswatch.org/lex1/02cr0179_criminalinformation.pdf

United States v. Endovascular Technologies Inc. Case No. CR020179. Plea Agreement. 2003-06-12. United States District Court, Northern District of California, San Francisco Division. Available from http://web.archive.org/web/20030809175617/http://www.usdoj.gov/usao/can/press/assets/applets/2003_06_12_Endovascular_plea.pdf

Company Touting Unproven Cancer Treatment Agrees to Settle FTC Charges. United States Federal Trade Commission Press Release. 2002-07-24. [Biopulse International Inc.] Available from http://www.ftc.gov/opa/2002/07/biopulse2.shtm

United States Federal Trade Commission v. Biopulse International Inc. et al. Case No. 02CV03511. Complaint For Permanent Injunction And Other Equitable Relief. 2002-06-23. United States District Court Northern District of California. Available from http://www.ftc.gov/os/2002/07/biopulse2cmp.pdf

United States Federal Trade Commission v. Biopulse International Inc. et al. Case No. 02CV03511. Stipulated Final Judgment and Order RE: And Order Re Biopulse International, Inc., Biopulse, Inc., and Loran Swenson. United States District Court Northern District of California. 2002-07-24. Available from http://www.ftc.gov/os/2002/07/biopulse2stip2.pdf

United States Federal Trade Commission v. Biopulse International Inc. et al. Case No. 02CV03511. Stipulated Final Judgment and Order RE: Jonathan Neville. United States District Court Northern District of California. 2002-07-24. Available from http://www.ftc.gov/os/2002/07/biopulse2stip.pdf

Schiff v. Prados. 92 Cal.App.4th 692, 112 Cal.Rptr.2d 171, 157 Ed. Law Rep. 264. Cal.App. 1 Dist. 2001. Available from http://biotech.law.lsu.edu/cases/consent/schiff_v_prados.htm. (Courtesy of The Medical and Public Health Law Site at http://biotech.law.lsu.edu/index.htm.)

Richards E. Discussion of Schiff v. Prados. Available from http://biotech.law.lsu.edu/cases/consent/schiff_v_prados_brief.htm. Accessed 2006-05-03. (Courtesy of Professor Edward Richards and The Medical and Public Health Law Site.)

Schneider v. Revici, 817 F.2d 987 (2nd Cir. 1987). Available from http://biotech.law.lsu.edu/cases/consent/Revici.htm. Accessed 2006-02-28. (Case courtesy of Professor Edward Richards, The Medical and Public Health Law Site, and Versuslaw Inc.)

United States v. Rutherford, 442 U.S. 544 (1979). Accessed on 2006-11-10 at: http://caselaw.lp.findlaw.com/scripts/printer_friendly.pl?page=us/442/544.html. (Opinion courtesy of FindLaw.com.)

In the Supreme Court of the United States U.S. v. Glen L. Rutherford et al. No. 78-605, October Term, 1978. April 5, 1979. Brief of Amicus Curiae American Academy of Medical Preventics in Support of Respondents. Accessed on 2006-11-10 at: http://www.circare.org/foia2/acam_rutherford.pdf

People v. Privitera, 23 Cal. 3d 697, 591 P.2d 919, 153 Cal. Rptr. 431 (Cal. 1979). Accessed on 2006-11-10 at: http://biotech.law.lsu.edu/cases/research/people_v_privitera.htm. (Courtesy of The Medical and Public Health Law Site at http://biotech.law.lsu.edu/index.htm and Versuslaw Inc.)

U.S. Food and Drug Administration Postscript on Laetrile. 1987-06-18. Accessed on 2006-11-10 at: http://web.archive.org/web/19970506021729/http://www.fda.gov/bbs/topics/ANSWERS/ANS00309.html

State Bd. of Med. Examiners v. Burzynski, 917 S.W.2d 365 (Tex. App. 1996). Accessed 2006-05-03 at: http://www.3rdcoa.courts.state.tx.us/opinions/HTMLopinion.asp?OpinionID=847

Trustees of the Northwest Laundry and Dry Cleaners Health & Welfare Trust Fund, Plaintiff-Appellee, v. Stanislaw R. Burzynski, Defendant-Appellant. No. 93-2071. United States Court of Appeals, Fifth Circuit. 1994-07-28. Accessed 2006-05-03 at: http://www.circare.org/pd/burzynski_932071.pdf

Stanislaw R. Burzynski M.D., and Burzynski Research Institute Inc., Plaintiffs-Appellants, v. Aetna Life Insurance Company, et al., Defendants-Appellees. No. 91-2385. United States Court of Appeals, Fifth Circuit. 1992-08-11. Accessed 2006-05-03 at: http://www.ca5.uscourts.gov/opinions%5Cpub%5C91/91-2385.0.wpd.pdf

United States of America, Appellee, v. Pascal Ballistrea, Defendant-Appellant. No. 56. 1996-11-25. United States Court of Appeal, Second Circuit. Accessed on 2006-02-18 at: http://caselaw.lp.findlaw.com/scripts/printer_friendly.pl?page=2nd/951578.html (Opinion courtesy of FindLaw.com.)

Therial L. Bynam, M.D. Revocation of Registration. FR Vol. 61, No. 23. 3948. 1996-02-02: http://www.circare.org/lex/bynum_fr_19960202.pdf

Baxter S, Segal M. Docs lose licenses after 'secret cure' scam – Tennessee physicians advocated alleged AIDS cure. FDA Consumer 1992;26:(9):40-1. Accessed on 2009-04-01 at: http://findarticles.com/p/articles/mi_m1370/is_n9_v26/ai_12859869/?tag=content;col1

Jacques E. Chelly, Plaintiff-Appellant, v. Knoll Pharmaceuticals, Defendent-Respondent, and Edward B. Kirsten, Defendent. A-6453-94T5. Superior Court of New Jersey Appellate Division. 1996-12-02. Accessed on 2006-05-08 at: http://lawlibrary.rutgers.edu/decisions/appellate/a6453-94.opn.html (Opinion courtesy of Rutgers University School of Law.)

United States v. An Article of Drug*** Diso-tate, et al. United States District Court for the Eastern Division of Louisiana. No. 75-1790. September 28, 1976. Vincent A. Kleinfeld, Alan H. Kaplan & Stephen A. Weitzman. Federal Food, Drug, and Cosmetic Act Judicial Record 1975-1977 (FDLI, Washington, DC 1979): http://www.circare.org/tact/17-1790_19760928.pdf

2006-02-09: The complaint and settlement agreement in the case against Boston Scientific have been moved; we're attempting to update the links. We apologize for any inconvenience.

Boston Scientific Agrees to Pay $74 Million to Resolve Allegations That it Shipped Adulterated and Misbranded Medical Devices. U.S. Department of Justice Press Release (courtesy of PR NewsWire). 2005-06-24. Accessed on 2006-03-09 at: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-24-2005/0003938030&EDATE=

Boston Scientific Corporation Inc. Civil Complaint 2005-06-24. [dead link]

Boston Scientific Corporation Inc. Settlement Agreement 2005-06-24. [dead link]

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Qui Tam False Claims

UCONN Agrees to Pay $2.5 Million to Settle False Claims Allegations. U.S. Department of Justice Press Release. 2006-01-09. Available from http://www.usdoj.gov/usao/ct/Press2006/20060109.html

The Weill Medical College of Cornell University Pays $4,385,696 to Settle Federal Civil Grant Fraud Charges. U.S. Department of Justice Press Release. 2005-06-21. Available from http://web.archive.org/web/20061005063638/http://www.usdoj.gov/usao/nys/Press+Releases/June+2005/Cornell+Settlement+PR.pdf

Parent Organization of Mayo Clinic Pays U.S. $6.5 Million to Settle Grant Fraud Investigation. U.S. Department of Justice Press Release. 2005-05-26. Available from http://www.usdoj.gov/opa/pr/2005/May/05_civ_292.htm

University of Alabama–Birmingham to Pay U.S. $3.39 Million to Resolve False Billing Allegations. U.S. Department of Justice Press Release. 2005-04-14. Available from http://web.archive.org/web/20060116034424/http://www.usdoj.gov/usao/aln/Docs/April+2005/Apr14UAB.htm

U.S. Settles Case of Gene Therapy Study That Ended With Teen's Death. U.S. Department of Justice Press Release. 2005-02-19. Available from http://web.archive.org/web/20050415173519/http://www.usdoj.gov/usao/pae/News/Pr/2005/feb/UofPSettlement+release.html

Related: U.S. Department of Justice Settlement Agreements with James Wilson M.D., Ph.D., Steven Raper M.D., The University of Pennsylvania, Mark Batshaw M.D., and Childrens National Medical Center. 2005-02-09. Available from http://www.circare.org/foia3/ihgtdocs.htm#settlements

U.S. Department of Justice Settlement Agreement with Harvard University And Beth Israel Deaconess Medical Center. [Harvard And Beth Israel Deaconess Medical Center Pay $ 2.4 Million To Settle Allegations Of False Claims To NIH.] U.S. Department of Justice Press Release. 2004-03-16: http://www.circare.org/lex/harvardbidmc_settl20040316.pdf

Settlement Agreement with Johns Hopkins University & Bayview Medical Center settling allegations under the False Claims Act related to federally sponsored research. U.S. Department of Justice Press Release. 2004-02-26: http://web.archive.org/web/20040324121701/http://www.usdoj.gov/usao/md/press_releases/press04/JHUsettlePR.pdf

Columbia University Pays $480,000 to Settle Federal Civil Health Care Fraud Charges. U.S. Department of Justice Press Release. 2003-10-01. Available from http://web.archive.org/web/20041227084756/http://www.usdoj.gov/usao/nys/Press+Releases/October03/columbiaunivsettlepr.pdf

UIC Medical Center Pays $2 Million to United States and State of Illinois to Settle Liver Transplant Fraud Suit. U.S. Department of Justice Press Release. 2003-11-17. Available from http://www.usdoj.gov/usao/iln/pr/chicago/2003/pr111703_01.pdf

Northwestern University Will Pay $5.5 Million to Resolve False Claims Act and Common Law Allegations. U.S. Department of Justice Press Release. 2003-02-06. Available from http://www.usdoj.gov/opa/pr/2003/February/03_civ_076.htm

Cook County, Illinois v. United States ex rel. Chandler. No. 01-1572. Certiorari to the United States Court of Appeals for the Seventh Circuit. 2003-03-10. Available from http://caselaw.lp.findlaw.com/scripts/printer_friendly.pl?page=us/000/01-1572.html. Accessed 2006-03-05. (Opinion courtesy of Findlaw.com.)

Unites States of America ex rel. Janet Chandler, Ph.D., v. Cook County, Illinois. Nos. 00-4110 and 01-1810. United States Court of Appeals For the Seventh Circuit. 2002-01-22. Available from http://www.ca7.uscourts.gov/fdocs/docs.fwx?caseno=00-4110&submit=showdkt&yr=00&num=. Accessed 2006-03-05.   (Briefs for No. 00-4110: http://www.ca7.uscourts.gov/briefs.htm.)

United States of America ex rel. Sanford Gross v. AIDS Research Alliance-Chicago et. al. No. 04-2566. 2005-07-06. United States Court of Appeals For the Seventh Circuit. Available from http://www.ca7.uscourts.gov/fdocs/docs.fwx?caseno=04-2566&submit=showdkt&yr=&num= (Briefs for No. 04-2566: http://www.ca7.uscourts.gov/briefs.htm.)

United States of America, ex rel. by Jeffrey Gorumba v. Cancer Treatment Centers of America Professional Corporation of Washington, P.C., A Washington Corporation, doing business as Seattle Cancer Treatment and Wellness Center. Case No. 02CV02257. Complaint and Jury Demand. 2002-11-04. United States District Court Western District of Washington. Available from http://www.bioethicswatch.org/lex1/02cv02257_complaint.pdf

United States of America, ex rel. by Jeffrey Gorumba v. Cancer Treatment Centers of America Professional Corporation of Washington, P.C., A Washington Corporation, doing business as Seattle Cancer Treatment and Wellness Center. Case No. 02CV02257. Declaration of Jeffrey Gorumba P.A. United States District Court Western District of Washington. 2002-11-04. Available from http://www.bioethicswatch.org/lex1/02cv02257_gorumbadeclaration.pdf

Related: Companies That Purport to Successfully Treat Cancer Agree To Settle FTC Charges Over Their Claims. Cancer Treatment Centers of America Inc. United States Federal Trade Commission Press Release. 1996-03-13. Available from http://www.ftc.gov/opa/1996/03/cancer.shtm

University of Minnesota Pays $32 Million to Settle Allegations of Selling an Unlicensed Drug and Mishandling Grant Funds. U.S. Department of Justice Press Release. 1998-11-17. Available from http://www.usdoj.gov/opa/pr/1998/November/549civ.htm

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A. I. Dupont Children's Hospital

Robert Daddio et al. v. The A.I. Dupont Hospital for Children et al. Case No. 05CV00441. Complaint. United States District Court for the Eastern District of Pennsylvania. 2005-01-02. Available from http://www.circare.org/lex/daddio_05cv00441complaint.pdf

Teague Conway et al. v. A.I. duPont Hospital for Children and Nemours Foundation et al. Case no. 04CV04862. Complaint. United States District Court for the Eastern District of Pennsylvania. 2004-10-15. Available from http://www.circare.org/lex/conwaycomplaint_04cv04862.pdf

Catherine B. Laag. et al. v. Edward J. Cullen Jr. DO et al. Case No. 04cv1306. United States District Court. District of Delaware. Complaint. 2004-02-10. Available from http://www.circare.org/lex/laag_04cv1360complaint.pdf

Follow this link for more information about research with unapproved medical devices at A.I. Dupont Hospital for Children.

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Raising the Dead: Propounding (barely) Experimental Interventions for Terry Schiavo

In re: the Guardianship of Maria Theresa Schiavo, Incapacitated. Robert Schindler and Mary Schindler, Appellants, v. Michael Schiavo, as Guardian of the person of Theresa Marie Schiavo, Appellee. Case No. 2D01-3626. Order. District Court of Appeal of Florida, Second District. 2001-10-17. Accessed on 2006-02-18 at: http://www.2dca.org/opinion/October%2017,%202001/2d01-3626.pdf

Affidavit of Fred Webber D.O. Re: Terry Schiavo. 2001-06. Accessed on 2006-02-18 at: http://judgegeorgegreer.com/docs/Affidavit%20Webber.doc

Dr. Webber commends Hammesfahr therapy for Ms. Schiavo. For one opinion on the intervention propounded by William Hammesfahr M.D., see Novella S. Ultrasound Monitoring of Stroke Patients. Quackwatch web site. 2000-02-14. Accessed on 2006-02-18 at: http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/tcd.html

Additional opinions on Dr. Hammesfahr can be retrieved through the links provided in the following: News outlets ignored questions about doctor who claimed Schiavo can be helped. Media Matters for America. 2005-03-21. Accessed on 2006-02-18 at: http://mediamatters.org/research/200503220002

Report of William Hammesfahr M.D. Re: Terry Schiavo. 2002-09-12. Accessed on 2006-02-18 at: http://judgegeorgegreer.com/docs/Hammesfahr%20Report%20%20091202.pdf

Deposition of William Hammesfahr M.D. 2002-09-30. In re: The Guardianship of Theresa Marie Schiavo, Incapacitated. Michael Schiavo, as Guardian of the person of Theresa Marie Schiavo, Petitioner, v. Robert Schindler and Mary Schindler, Respondents. Case No. 90-2908-GB-003. Order. In the Circuit Court in and for Pinellas County, Florida. Sixth Judicial Circuit. Accessed on 2006-02-18 at: http://judgegeorgegreer.com/docs/Hammesfahr%20Depo%20transcript.txt

Affidavit of William Neubauer M.D. Re: Terry Schiavo. 2001-05. Accessed on 2006-02-18 at: http://judgegeorgegreer.com/docs/DrNeubauerAffidavit.htm

In re: The Guardianship of Theresa Marie Schiavo, Incapacitated. Michael Schiavo, as Guardian of the person of Theresa Marie Schiavo, Petitioner, v. Robert Schindler and Mary Schindler, Respondents. Case No. 90-2908-GB-003. Order. 2002-11-22. In the Circuit Court in and for Pinellas County, Florida. Sixth Judicial Circuit. Accessed on 2006-02-18 at: http://abstractappeal.com/schiavo/trialctorder11-02.txt

In re: Theresa Marie Schiavo, Incapacitated. Report to Jeb Bush and the 6th Florida Judicial Circuit. Jay Wolfson, as Guardian ad litem to Theresa Marie Schiavo. 2003-12-01. Accessed on 2006-02-18 at: http://web.archive.org/web/20051031052523/http://www.miami.edu/ethics/schiavo/wolfson's+report.pdf

Stuff I Haven't Found a Heading For Yet

Michael J. Friedrich, Petitioner v. Louis W. Sullivan, Secretary of Health and Human Services. No. 89-1879. In The Supreme Court Of The United States, October Term, 1990. On Petition For A Writ Of Certiorari To The United States Court Of Appeals For The Sixth Circuit. Brief For The Respondent In Opposition. Accessed on 2007-09-21 at: http://www.usdoj.gov/osg/briefs/1990/sg900951.txt

California Dental Association, Petitioner v. Federal Trade Commission. No. 97-1625. In the Supreme Court of the United States, October Term, 1998. On Writ of Certiori to the United States Court of Appeals for the Ninth Circuit. Brief for the Respondent. Accessed on 2007-09-21 at: http://www.usdoj.gov/osg/briefs/1998/3mer/2mer/97-1625.mer.pdf

American College for Advancement in Medicine, File No. 962 3147, Docket No. C-3882. Accessed on 2007-09-21 at: http://www.ftc.gov/os/caselist/c3882.shtm

Off The Wall Cases

Statewide Grand Jury Charges Ring Of Identity Thieves Abusing Information Collected During Medical Study. Office of the Florida Attorney General Press Release. 2001-10-31. Available from http://myfloridalegal.com/newsrel.nsf/$$swp/BE0B53393801CB9E85256AF600579B72

Six people have been arrested and two others are expected to be brought into custody on charges that they assumed the identities of individuals participating in a medical study and used them to fraudulently obtain nearly $300,000 in merchandise, Statewide Prosecutor Melanie Ann Hines, Florida Department of Law Enforcement (FDLE) Commissioner James T. Moore and Orlando Police Chief Jerry Demings announced today. … According to officials, an employee of the Nemours Children's Clinic in Orlando obtained social security numbers and other identifying information of 18 individuals from around the country who participated in a study concerning cystic fibrosis and whose children suffer from the disease.

General Information

U.S. Department of Justice Press Releases 1994-

United States Attorneys Offices (USAO web sites.)


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Last Updated: 2012-07-11

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