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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: (External) 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
Ulatowski TA. FDA Warning Letter to John P. Cheatham, M.D. 2004-06-01: (External) http://www.fda.gov/foi/warning_letters/archive/g4751d.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: (External) http://www.fda.gov/foi/warning_letters/archive/m3403n.pdf
FDA Enforcement Report for 2003-07-23. Available from (External) 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 a
zigpattern. 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.
DISTRIBUTION: Nationwide.
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 (External) Eaton & McClellan, Attorneys at Law. )
Health Notables.
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.
URL: (External)
http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20060124/HEALTH/601240305/-1/NEWS12
Parents of Babies Who Died in Delaware Tests Weren't Warned. David Evans and Liz Willen. Bloomberg News. 2005-11-05.
URL: (External)
http://www.bloomberg.com/apps/news?pid=specialreport_index2&sid=a13F_Mo6vzAs&refer=news
Baby Steps. Darshak Sanghavi. The Boston Globe. 2005-05-29.
URL: (External)
http://www.darshaksanghavi.com/columns/babysteps.htm
John Murphy Named Chief of Cardiology at St. Christopher's Hospital for Children. St. Christopher's Hospital for Children Press Release. 2005-01-31.
URL: (External)
http://www.stchristophershospital.com/CWSContent/stchristophershospital/Archive/newsAndArticles/NewChiefofCardiology.htm
DuPont center sued over death of baby girl. Jennifer Goldblatt. The Delaware News Journal. 2004-08-17.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/08/17dupontcentersue.html
Cardiac center sees new problems. Jennifer Goldblatt and Adam Taylor. The Delaware News Journal. 2004-07-23.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/07/23cardiaccenterse.html
Use of Unapproved Device Lands Hospital in Trouble. Food and Drug Regulation Newsletter. Thompson Inc. 2004-06.
URL: (External)
http://www.thompson.com/libraries/fooddrug/clin/samplenews/clin0406.html
Did Dr. Norwood Go Too Far? (Part One). Jason Fagone. Philadelphia Magazine. June 2004 (p. 94).
URL: (External)
http://www.phillymag.com/index.cfm/fuseaction/article.view/articleID/f8ff0fee-193e-445b-bc04-9216bb0c154b
Did Dr. Norwood Go Too Far? (Part Two). Jason Fagone. Philadelphia Magazine. June 2004 (p. 94).
URL: (External)
http://www.phillymag.com/index.cfm/fuseaction/article.view/articleID/30371304-9b6c-4ecc-8f7d-cd1e77202820
Dismissed trio sues duPont hospital. Adam Taylor and Laura Ungar. The Delaware News Journal. 2004-05-22.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/05/22dismissedtriosu.html
Surgeons balance risks, rules. Laura Ungar, Adam Taylor, and Jennifer Goldblatt. The Delaware News Journal. 2004-04-11.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/04/11surgeonsbalance.html
Former A.I. duPont cardiologist cleared. Adam Taylor, Laura Ungar, and Jennifer Goldblatt. The Delaware News Journal. 2004-04-08.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/04/08formeraidupontc.html
Cardiologist cleared of consent complaint. Susan FitzGerald and Karl Stark. The Philadelphia Inquirer. 2004-04-07.
URL: (External)
http://web.archive.org/web/20040715191947/http://www.philly.com/mld/inquirer/living/health/8384502.htm?1c
Board of medical practice clears physician. Jennifer Goldblatt, Laura Ungar, and Adam Taylor. The Delaware News Journal. 2004-04-07.
URL: (External)
http://www2.delawareonline.com/updates/Boardofmedicalp.html
State faults hospital for use of stent. Adam Taylor, Laura Ungar, and Jennifer Goldblatt. The Delaware News Journal.
2004-04-07.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/04/07statefaultshosp.html
Hospital asked to explain dismissals. Jennifer Goldblatt, Laura Ungar, and Adam Taylor. The Delaware News Journal.
2004-04-01.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/04/01hospitalaskedto.html
Colleagues support dismissed doctors. Adam Taylor and Jennifer Goldblatt. Delaware News Journal. 2004-03-27.
URL: (External)
http://www.delawareonline.com/newsjournal/local/2004/03/27colleaguessuppo.html
Related: Letter of Concern in support of Drs. Norwood and Murphy from physicians at the Nemours Cardiac Center. Available from (External) 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.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/03/26hospitaldispute.html
3rd man lost duties at duPont hospital. Adam Taylor and Jennifer Goldblatt. Delaware News Journal. 2004-03-13.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/03/133rdmanlostdutie.html
Doctors' removal alarms parents. Adam Taylor and Jennifer Goldblatt. Delaware News Journal. 2004-03-04.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/03/04doctorsremovala.html
Two doctors lose duties at hospital. Jennifer Goldblatt. Delaware News Journal. 2004-03-02.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2004/03/02twodoctorslosed.html
Tending to tiny hearts. Jane Harriman. The Delaware News Journal. 1998-02-22.
URL: (External)
http://www2.delawareonline.com/newsjournal/local/2001/01/022298dupont.html
Children are the focus of a history-making heart surgery. Mike Grogan. Jacksonville Business Journal. 2001-02-02.
URL: (External)
http://www.bizjournals.com/jacksonville/stories/2001/02/05/focus2.html?jst=s_rs_hl
New heart procedure done by Nemours surgeon. Mike Grogan. Jacksonville Business Journal. 2000-10-09.
URL: (External)
http://www.bizjournals.com/jacksonville/stories/2000/10/09/newscolumn5.html?jst=s_rs_hl
Catherine B. Laag. et al. vs Edward J. Cullen Jr. DO et al. Case No. 04cv1306. United States District Court. District of Delaware. Complaint. 2004-02-10: http://www.circare.org/lex/laag_04cv1360complaint.pdf
Teague Conway et al. vs A.I. duPont Hospital for Children and Nemours Foundation et al. Case no. 04CV04862. United States District Court for the Eastern District of Pennsylvania. Complaint. 2004-10-15: http://www.circare.org/lex/conwaycomplaint_04cv04862.pdf .
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Case No. 05CV00441. United States District Court for the Eastern District of Pennsylvania. Complaint. 2005-01-02: http://www.circare.org/lex/daddio_05cv00441complaint.pdf
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Case No. 05mc00120. United States District Court. Middle District of Florida (Orlando). Response in opposition to motion by Robert Daddio et al. Exhibit D: Letters and Deposition Concerning William I. Norwood. 2005-06-10: 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. Case No. 05CV00441. United States District Court for the Eastern District of Pennsylvania. Deposition of William I. Norwood, M.D., Ph.D., Pt. 1, pp. 2-164. 2005-07-20: http://www.circare.org/lex/norwooddeposition_20050720_pt1.pdf
Robert Daddio et al. vs The A.I. Dupont Hospital for Children et al. Case No. 05CV00441. United States District Court for the Eastern District of Pennsylvania. Deposition of William I. Norwood, M.D., Ph.D., Pt. 2, pp. 170-215 plus index. 2005-07-20: http://www.circare.org/lex/norwooddeposition_20050720_pt2.pdf
William I. Norwood M.D. Ph.D. et al. vs Nemours Foundation. Complaint. Superior Court of the State of Delaware in and for New Castle County. 2004-05-22: (External) http://www2.delawareonline.com/newsjournal/local/2004/05/pdf/norwoodsuit.pdf (Courtesy of the Delaware News Journal.)
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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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. Available from (External) http://www.ahjonline.com/article/PIIS000287030018531X/abstract
Related: AGA Medical Amplatzer Septal Occluder System P000039. Approval Date: December 5, 2001. FDA Labeling, Approval Order, and Summary of Safety and Efficacy Data. Available from (External) http://www.fda.gov/cdrh/pdf/p000039.html .
Food and Drug Administration. Circulatory System Devices panel. September 10, 2001. Briefing Information: P000039 AMPLATZER® Septal Occluder and Delivery System. Available from (External) http://www.fda.gov/ohrms/dockets/ac/01/briefing/3790b1.htm
Food and Drug Administration. Circulatory System Devices panel. September 10, 2001. Transcript. Available from (External) http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3790t1.htmFood and Drug Administration. Circulatory System Devices panel. October 24, 1997. Transcript. Available from (External) 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 (External) http://www.childrenshospital.org/heartmurmurs/fall_winter2003/art2.html .
Jonas RA. The Norwood Procedure Updated. Heart Murmurs. Fall/Winter 2003. Available from (External) 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 (External) 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 (External) http://www.kardiochirurgiadziecieca.cm-uj.krakow.pl/index_en.php?art=history
Nemours Foundation 2000 Annual Report. Available from (External) http://nemours.org/no/filebox/pdf/2000annualreport.pdf . Undated.
Last Updated: 2008-03-31
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