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Medical Device Manufacturer Pleads Guilty to Healthcare Crime; Agrees to Pay Multi-Million Dollar Fine for Failure to Obtain FDA Approval. U.S. Department of Justice Press Release. 2007-07-30. Accessed on 2007-09-03 at: http://www.usdoj.gov/usao/de/press/2007/7-30-07%20Medical%20Device%20Manufacturer%20Pleads%20Guilty.pdf
USA vs. NuMED, Inc. et al. Case No. 07CR00128. United States District Court for the District of Delaware (Wilmington). Information. 2007-07-27: http://www.circare.org/lex/07cr00128_information_20070727.pdf
USA vs. NuMED, Inc. et al. Case No. 07CR00128. United States District Court for the District of Delaware (Wilmington). Memorandum of Plea Agreement. 2007-07-30: http://www.circare.org/lex/07cr00128_20070730.pdf
USA vs. NuMED, Inc. et al. Case No. 07CR00128. United States District Court for the District of Delaware (Wilmington). Memorandum of Plea Agreement Exhibit A, Corrective Action Plan for Allen J. Tower, Sr. and NuMED, Inc. 2007-07-30: http://www.circare.org/lex/07cr00128_20070730_exhibita.pdf
Update 2009-07-14: FDA Warning Letter to Richard E. Ringel, M.D. 2009-05-20: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm164618.htm
Coarctation of the Aorta Stent Trial (COAST). Clinialtrials.gov. Accessed on 2009-07-10 at: http://www.clinicaltrials.gov/ct2/show/NCT00552812
Ulatowski TA. FDA Warning Letter to John P. Cheatham, M.D. 2004-06-01: http://www.circare.org/fdawls3/cheatham_20040601.pdf
Bailey DJ. Alfred I. duPont Hospital for Children letter to FDA re: Cheatham Platinum (CP) Stent. 2004-03-30: http://www.circare.org/lex/nemoursfda_20040330.pdf
Holman BJ. FDA Warning Letter to Allen J. Tower, President, Numed Inc. 2000-02-03: http://web.archive.org/web/20061006081424/http://www.fda.gov/foi/warning_letters/m3403n.pdf
FDA Enforcement Report for 2003-07-23: http://web.archive.org/web/20031004090507/http://www.fda.gov/bbs/topics/enforce/2003/ENF00805.html
PRODUCT: CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with azigpattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths. Recall # Z-0983-03.
CODE: All lots produced.
RECALLING FIRM/MANUFACTURER: Numed Inc., Hopkinton, NY, by letters dated June 26, 2003. FDA initiated recall is ongoing.
REASON: Lacks a 510k clearance for marketing.
VOLUME OF PRODUCT IN COMMERCE: 169 units.
Delaware Office of Health Facilities Licensing and Certification. Statement of Deficiencies and Plan of Correction RE: Alfred I duPont Hospital for Children. 2004-11-02: http://www.circare.org/lex/delawaredupontreport.pdf (Courtesy of Eaton & McClellan, Attorneys at Law.)
The Alfred I. duPont Hospital for Children and Nemours Children's Clinic also have announced the following: Dr. Christian Pizarro, director of Nemours Cardiac Center and chief cardiothoracic surgeon, has been named 2005 Physician of the Year. The Delaware News Journal. 2006-01-24.
Big Pharma's Shameful Secret. David Evans, Michael Smith, and Liz Willen. Bloomberg News. 2005-11-05.
Baby Steps. Darshak Sanghavi. The Boston Globe. 2005-05-29.
John Murphy Named Chief of Cardiology at St. Christopher's Hospital for Children. St. Christopher's Hospital for Children Press Release. 2005-01-31.
DuPont center sued over death of baby girl. Jennifer Goldblatt. The Delaware News Journal. 2004-08-17.
Cardiac center sees new problems. Jennifer Goldblatt and Adam Taylor. The Delaware News Journal. 2004-07-23.
Use of Unapproved Device Lands Hospital in Trouble. Food and Drug Regulation Newsletter. Thompson Inc. 2004-06.
Did Dr. Norwood Go Too Far? (Part One). Jason Fagone. Philadelphia Magazine. June 2004 (p. 94).
Did Dr. Norwood Go Too Far? (Part Two). Jason Fagone. Philadelphia Magazine. June 2004 (p. 94).
Dismissed trio sues duPont hospital. Adam Taylor and Laura Ungar. The Delaware News Journal. 2004-05-22.
Surgeons balance risks, rules. Laura Ungar, Adam Taylor, and Jennifer Goldblatt. The Delaware News Journal. 2004-04-11.
Former A.I. duPont cardiologist cleared. Adam Taylor, Laura Ungar, and Jennifer Goldblatt. The Delaware News Journal. 2004-04-08.
Cardiologist cleared of consent complaint. Susan FitzGerald and Karl Stark. The Philadelphia Inquirer. 2004-04-07.
Board of medical practice clears physician. Jennifer Goldblatt, Laura Ungar, and Adam Taylor. The Delaware News Journal. 2004-04-07.
State faults hospital for use of stent. Adam Taylor, Laura Ungar, and Jennifer Goldblatt. The Delaware News Journal. 2004-04-07.
Hospital asked to explain dismissals. Jennifer Goldblatt, Laura Ungar, and Adam Taylor. The Delaware News Journal. 2004-04-01.
Colleagues support dismissed doctors. Adam Taylor and Jennifer Goldblatt. Delaware News Journal. 2004-03-27.
Related: Letter of Concern in support of Drs. Norwood and Murphy from physicians at the Nemours Cardiac Center. Available from http://www2.delawareonline.com/newsjournal/local/2004/03/pdf/27letter.pdf. 2004-03-10. Posted online 2004-04-27 by the Delaware News Journal.
Hospital dispute centers on consent forms. Adam Taylor, Laura Ungar and Jennifer Goldblatt. Delaware News Journal. 2004-03-26.
3rd man lost duties at duPont hospital. Adam Taylor and Jennifer Goldblatt. Delaware News Journal. 2004-03-13.
Doctors' removal alarms parents. Adam Taylor and Jennifer Goldblatt. Delaware News Journal. 2004-03-04.
Two doctors lose duties at hospital. Jennifer Goldblatt. Delaware News Journal. 2004-03-02.
Tending to tiny hearts. Jane Harriman. The Delaware News Journal. 1998-02-22.
Children are the focus of a history-making heart surgery. Mike Grogan. Jacksonville Business Journal. 2001-02-02.
New heart procedure done by Nemours surgeon. Mike Grogan. Jacksonville Business Journal. 2000-10-09.
Catherine B. Laag. et al. vs Edward J. Cullen Jr. DO et al. Civil No. 04cv1306. USDC District of DE. 2004-02-10 [Complaint]: http://www.circare.org/lex/laag_04cv1360complaint.pdf
Teague Conway et al. vs A.I. duPont Hospital for Children and Nemours Foundation et al. Civil no. 04CV04862. USDC Eastern District of PA. 2004-10-15 [Complaint]: http://www.circare.org/lex/conwaycomplaint_04cv04862.pdf.
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Civil No. 05CV00441. USDC Eastern District of PA. 2005-01-02 [Complaint]: http://www.circare.org/lex/daddio_05cv00441complaint.pdf
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Civil No. 05mc00120. USDC Middle District of FL (Orlando). 2005-06-10 [Response in opposition to motion by Robert Daddio et al. Exhibit D: Letters and Deposition Concerning William I. Norwood]: http://www.circare.org/lex/daddio_05mc00120exibitd.pdf (NB: if you get blank pages open the file with Adobe® Reader.)
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Civil No. 05CV00441. USDC Eastern District of PA. 2005-07-20 [Deposition of William I. Norwood, M.D., Ph.D., Pt. 1, pp. 2-164]: http://www.circare.org/lex/norwooddeposition_20050720_pt1.pdf
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Civil No. 05CV00441. USDC Eastern District of PA. 2005-07-20 [Deposition of William I. Norwood, M.D., Ph.D., Pt. 2, pp. 170-215 plus index]: http://www.circare.org/lex/norwooddeposition_20050720_pt2.pdf
William I. Norwood M.D. Ph.D. et al. vs Nemours Foundation. Superior Court of the State of Delaware in and for New Castle County. 2004-05-22 [Complaint]: http://www2.delawareonline.com/newsjournal/local/2004/05/pdf/norwoodsuit.pdf (Courtesy of the Delaware News Journal.)
2008-0228: Guinan v. A.I. Dupont Hospital 04/07/2008: http://www.paed.uscourts.gov/documents/opinions/08D0406P.pdf
2008-0228: Guinan v. A.I. Dupont Hosp. for Children 02/06/2009: http://www.paed.uscourts.gov/documents/opinions/09D0135P.pdf
2008-0228: Guinan v. A.I. Dupont Hosp. for Children 02/09/2009: http://www.paed.uscourts.gov/documents/opinions/09D0137P.pdf
2008-0229: Hess v. A.I. Dupont Hosp. 03/06/2009: http://www.paed.uscourts.gov/documents/opinions/09D0246P.pdf
2006-0595: Murphy v. A.I. Dupont Hospital 03/30/2007: http://www.paed.uscourts.gov/documents/opinions/07D0417P.pdf
2006-0743: Workman v. Nemours Foundation 07/27/2007: http://www.paed.uscourts.gov/documents/opinions/07D0880P.pdf
2005-0417: Svindland v. A.I. Dupont Hosp. 05/05/2006: http://www.paed.uscourts.gov/documents/opinions/06D0565P.pdf
2005-0417: Svindland v. A.I. Dupont Hosp. 11/03/2006: http://www.paed.uscourts.gov/documents/opinions/06D1370P.pdf
2005-0417: Svindland v. Nemours Foundation 05/19/2009: http://www.paed.uscourts.gov/documents/opinions/09D0578P.pdf
2005-0441: Daddio v. A.I. Dupont Hospital 05/05/2006: http://www.paed.uscourts.gov/documents/opinions/06D0566P.pdf
2005-0441: Daddio v. A.I. Dupont Hosp. 05/19/2009: http://www.paed.uscourts.gov/documents/opinions/09D0579P.pdf
2005-0661: Reger v. A.I. Dupont Hospital 05/05/2006: http://www.paed.uscourts.gov/documents/opinions/06D0567P.pdf
2005-0674: Watson v. A.I. Dupont Hospital 03/30/2007: http://www.paed.uscourts.gov/documents/opinions/07D0418P.pdf
2005-0719: Newkirk v. A.I. Dupont Hospital 06/05/2006: http://www.paed.uscourts.gov/documents/opinions/06D0689P.pdf
2005-3002: Faustino v. The A.I. Dupont Hosp. for Children 11/06/2006: http://www.paed.uscourts.gov/documents/opinions/06D1377P.pdf
2005-3002: Faustino v. Dupont Hospital 05/01/200 : http://www.paed.uscourts.gov/documents/opinions/08D0487P.pdf
2005-3003: Papacoda v. The A.I. Dupont Hosp. for Children 06/27/2006: http://www.paed.uscourts.gov/documents/opinions/06D0782P.pdf
2005-3003: Papacoda v. The A.I. Dupont Hosp. for Children 10/25/2006: http://www.paed.uscourts.gov/documents/opinions/06D1326P.pdf
2005-3004: Everwine v. The Nemours Foundation 04/05/2006: http://www.paed.uscourts.gov/documents/opinions/06D0421P.pdf
2005-5496: Rhoads v. A.I. Dupont Hospital 05/22/2006: http://www.paed.uscourts.gov/documents/opinions/06D0628P.pdf
2004-3877: Farrell v. A.I. Dupont Hospital 05/05/2006: http://www.paed.uscourts.gov/documents/opinions/06D0564P.pdf
2004-3877: Farrell v. A.I. Dupont Hospital 07/19/2006: http://www.paed.uscourts.gov/documents/opinions/06D0888P.pdf
2004-4862: Conway v. A.I. Dupont Hospital for Children 02/14/2007: http://www.paed.uscourts.gov/documents/opinions/07D0207P.pdf
2004-4862: Conway v. A.I. Dupont Hosp. for Children 01/06/2009: http://www.paed.uscourts.gov/documents/opinions/09D0026P.pdf
004-4862: Conway v. A.I. duPont Hosp. for Children 05/26/2009: http://www.paed.uscourts.gov/documents/opinions/09D0612P.pdf
Galantowicz M, Cheatham JP. Lessons learned from the development of a new hybrid strategy for the management of hypoplastic left heart syndrome. Pediatr Cardiol. 2005;26(3):190-9. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16179977&query_hl=42&itool=pubmed_docsum
Cheatham JP. Stenting of coarctation of the aorta. Catheterization and Cardiovascular Interventions. 2001;54 (1);112-125. Available from http://dx.doi.org/10.1002/ccd.1249
Pizarro C, Mroczek T, Malec E, Norwood WI. Right Ventricle to Pulmonary Artery Conduit Reduces Interim Mortality After Stage 1 Norwood for Hypoplastic Left Heart Syndrome. Ann Thorac Surg. 2004;78(6):1959-63. Available from http://dx.doi.org/10.1016/j.athoracsur.2004.06.020.
Pizarro C, Malec E, Maher KO, Januszewska K, Gidding SS, Murdison KA, Baffa JM, Norwood WI. Right Ventricle to Pulmonary Artery Conduit Improves Outcome After Stage I Norwood for Hypoplastic Left Heart Syndrome. Circulation. 2003;108 Suppl 1:II155-60. Available from http://circ.ahajournals.org/cgi/content/full/108/10_suppl_1/II-155
Maher KO, Pizarro C, Gidding SS, Januszewska K, Malec E, Norwood WI Jr, Murphy JD. Hemodynamic profile after the Norwood procedure with right ventricle to pulmonary artery conduit. Circulation. 2003;108(7):782-4. Epub 2003 Aug 11. Available from http://circ.ahajournals.org/cgi/content/full/108/7/782
Pizarro C, Norwood WI. Right ventricle to pulmonary artery conduit has a favorable impact on postoperative physiology after Stage I Norwood: preliminary results. Eur J Cardiothorac Surg. 2003;23(6):991-5. Available from http://dx.doi.org/10.1016/S1010-7940(03)00158-1
Moore JW, Norwood JB, Kashow KM, Murphy JD. Closure of atrial septal defects in the cardiac catheterization laboratory: early results using the Amplatzer Septal Occlusion Device. Del Med J. 1998 Dec;70(12):513-6. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9885415&dopt=Abstract.
Transcatheter closure of fenestrations and excluded hepatic veins after Fontan: Versatility of the Amplatzer device. Am Heart J. 2000;140:534-40: http://www.ahjonline.com/article/PIIS000287030018531X/abstract
Of Interest: AGA Medical Amplatzer Septal Occluder System P000039. Approval Date: December 5, 2001. FDA Labeling, Approval Order, and Summary of Safety and Efficacy Data: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P000039
FDA Circulatory System Devices panel. September 10, 2001. P000039 AMPLATZER® Septal Occluder and Delivery System. Briefing Information: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3790b1.htm
FDA Application Integrity Policy List [AGA Medical added on 2004-03-30; removed on 2005-10-26]: http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134453.htm
FDA Circulatory System Devices panel. October 24, 1997. Transcript: http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3354t1.pdf
Lang P. The Norwood Procedure: Advancing Treatment of Congenital Cardiovascular Malformations. Heart Murmurs. Fall/Winter 2003. Available from http://www.childrenshospital.org/heartmurmurs/fall_winter2003/art2.html.
Jonas RA. The Norwood Procedure Updated. Heart Murmurs. Fall/Winter 2003. Available from http://www.childrenshospital.org/heartmurmurs/fall_winter2003/art3.html
Jaquiss R. A new wrinkle for hypoplastic left heart syndrome patients. Heart Matters. 2004;7(2). Available from http://www.chw.org/display/router.asp?DocID=30008#a30009
Department of Pediatric Cardiac Surgery. Polish-American Children's Hospital, Collegium Medicum. Jagiellonian University. Undated. Available from http://www.kardiochirurgiadziecieca.cm-uj.krakow.pl/index_en.php?art=history
Nemours Foundation 2000 Annual Report: http://web.archive.org/web/20060630040706/http://nemours.org/no/filebox/pdf/2000annualreport.pdf
Or try the Foundation Center's 990 Finder: http://tfcny.fdncenter.org/990s/990search/esearch.php
Last Updated: 2009-07-14
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