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| With all the enemies you've made and people you have maimed and killed Dave, I think you'd be safer in jail. Why don't you be smart and confess everything? |
http://medcitynews.com/2012/02/fda-fines-orthopedic-device-ceo-for-distributing-products-without-approval/
GLOBUS MEDICAL INC (Form: S-1/A, Received: 05/08 ...
www.nasdaq.com/markets/ipos/filing.ashx?filingid=8212778
May 8, 2012 - Following this offering, David C. Paul, our Chief Executive Officer and Chairman, ...... U.S. federal and state laws pertaining to healthcare fraud and abuse,...... may distribute prospectuses by electronic means, such as e-mail.
NASDAQ
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
UNITED STATES OF AMERICA
v.
DAVID C. PAUL
DIANE F. FLANNERY
CRIMINAL NO.
DATE FILED:
VIOLATIONS:
18 U.S.C. § 1341 (mail fraud - 2 counts)
18 U.S.C. § 2 (aiding and abetting)
Contact Globus Medical, Inc.
Globus Medical, Inc. is the largest privately held spinal implant manufacturer in the world and is based in Audubon, PA. The company was founded in 2003 by an experienced team of spine professionals with a shared vision to create products that enable spine surgeons to promote healing in patients with spinal disorders. Additional information can be accessed at www.globusmedical.com.Contacts
Valley Forge Business Center
2560 General Armistead Avenue
Audubon, PA 19403
phone: (610) 930-1800
fax: (610) 930-2042
fax: (610) 930-2042
The company was fined $550,000 for marketing its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance, according to a statement from the U.S. Food and Drug Administration.
The settlement was reached following a civil complaint filed by the FDA in November 2011.
Globus Medical Inc., an Audubon, Pennsylvania-based company near Philadelphia,had sought approval for its NuBone device in January 2009, but the FDA did not grant it after finding the device was not substantially equivalent to other products on the market. Globus Medical distributed the device anyway, despite receiving a letter turning down the product in December 2009, the statement said.
The move to fine the medical device company’s CEO reflects a toughened stance against companies that violate its policies. The FDA has a number of enforcement tools to hold corporate officials accountable, particularly at pharmaceutical companies, for off-label use.
Dara A. Corrigan, associate commissioner for regulatory affairs, said in the statement: “This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices. By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices.”
MITCHELL v. GLOBUS MEDICAL, INC.
as 2:2012cv02747
Plaintiff: M. DAVID MITCHELL
Defendant: GLOBUS MEDICAL, INC.
Cause Of Action: Diversity-Contract Dispute
Bianco MD vs Globus Medical Inc
as 2:2012cv00147
Plaintiff: Sabatino Bianco MD
Defendant: Globus Medical Inc
Cause Of Action: Patent Infringement
Globus Medical, Inc. v. Lazenby et al
as 6:2011cv01330
Plaintiff: Globus Medical, Inc.
Defendants: Tim Lazenby and Innovasis, Inc.
Cause Of Action: Diversity-Breach of Contract
Globus Medical, Inc. v. Froehlich et al
as 8:2011cv00340
Plaintiff: Globus Medical, Inc.
Defendants: Stephen Froehlich and Peter F. Williams
Cause Of Action: Breach of Contract
Rachiotek, LLC et al v. Globus Medical, Inc.
as 1:2011cv11481
Plaintiffs: Rachiotek, LLC and Yale University
Defendant: Globus Medical, Inc.
Cause Of Action: Patent Infringement
Synthes USA, LLC et al v. Globus Medical Inc.
as 1:2011cv00652
Plaintiffs: Synthes USA, LLC , Synthes USA Products LLC and Synthes USA Sales LLC
Defendant: Globus Medical Inc.
Cause Of Action: Patent Infringement
NuVasive, Inc. v. Globus Medical, Inc.
as 1:2011cv02196
Plaintiff: NuVasive, Inc.
Defendant: Globus Medical, Inc.
Movant: William C. Tally
NuVasive, Inc. v. Globus Medical, Inc.
as 1:2011mi00050
Plaintiff: NuVasive, Inc.
Defendant: Globus Medical, Inc.
Movant: William C. Tally
Nuvasive Inc. et al v. Globus Medical Inc
as 4:2011mc00003
Plaintiff: Nuvasive IncÂ
Defendant: Globus Medical Inc
Movant: John D. DorchakÂ
Nuvasive, Inc. v. Globus Medical, Inc.
as 3:2011cv01370
Plaintiff: Nuvasive, Inc.
Defendant: Globus Medical, Inc.
Movant: Choll W. Kim, M.D.
Cause Of Action: Fed. Question
SEAVEY et al v. GLOBUS MEDICAL, INC. et al
as 1:2011cv02240
Plaintiffs: MATTHEW SEAVEY and KORRIN SEAVEY
Defendants: GLOBUS MEDICAL, INC. , MARK A. TESTAIUTI, M.D., COASTAL SPINE, P.C. and FELLOWSHIP SPINE SURGERY CENTER
Cross_claimant: FELLOWSHIP SPINE SURGERY CENTER
Cross_defendants: COASTAL SPINE, P.C., GLOBUS MEDICAL, INC. and MARK A. TESTAIUTI, M.D.
Cause Of Action: Diversity-Product Liability
NuVasive Inc. v. Globus Medical Inc.
as 1:2010cv00849
Plaintiff: NuVasive Inc.
Defendant: Globus Medical Inc.
Cause Of Action: Patent Infringement
N Spine Inc. et al v. Globus Medical inc.
as 1:2010cv00300
Plaintiffs: N Spine Inc. and Synthes USA Sales LLC
Defendant: Globus Medical Inc.
Cause Of Action: Patent Infringement
Medtronic Sofamor Danek USA,, et al v. Globus Medical, Inc.
as 09-6144
Defendant: GLOBUS MEDICAL, INC.
Movant - Appellants: ANDREW R. CARR, Esq. and BOBBIE VADEN
Plaintiff - Appellees: MEDTRONIC SOFAMOR DANEK USA, INC., WARSAW ORTHOPEDIC, INC., MEDTRONIC PUERTO RICO OPERATIONS COMPANY, MEDTRONIC SOFAMOR DANEK DEGGENDORF and GMBH
WARSAW ORTHOPEDIC V GLOBUS MEDICAL
as 09-1525
Defendant-appellant: Globus Medical, Inc.
Plaintiff-appellees: Medtronic Puerto Rico Operations Company, Medtronic Sofamor Danek Deggendorf, gmbH, Medtronic Sofamor Danek USA, Inc. and Warsaw Orthopedic, Inc.
WARSAW ORTHOPEDIC V GLOBUS MEDICAL
as 09-1517
Defendant/cross Appellant: Globus Medical, Inc.
Plaintiff-appellants: Medtronic Puerto Rico Operations Company, Medtronic Sofamor Danek Deggendorf, gmbH, Medtronic Sofamor Danke USA, Inc. and Warsaw Orthopedic, Inc.
Vertos Medical, Inc. v. Globus Medical, Inc.
as 3:2009cv01411
Plaintiff: Vertos Medical, Inc.
Defendant: Globus Medical, Inc.
Cause Of Action: Federal Question
Medtronic Sofamor Danek USA, Inc. et al v. Globus Medical, Inc.
as 2:2008mc00028
Plaintiffs: Medtronic Sofamor Danek USA, Inc., Warsaw Orthopedic, Inc., Medtronic Puerto Rico Operations Company, Medtronic Sofamor Danek Deggendorf and GMBH
Defendant: Globus Medical, Inc.
Movants: Andrew R. Carr and Bobbie Vaden
Globus Medical, Inc. v. Reeder
as 2:2008cv00893
Plaintiff: Globus Medical, Inc.
Defendant: Michael Reeder
Cause Of Action: Diversity
GLOBUS MEDICAL, INC. v. SPINE SQUAD, INC.
as 2:2008cv02273
Plaintiff: GLOBUS MEDICAL, INC.
Defendant: SPINE SQUAD, INC.
Cause Of Action: Diversity
