- Posted January 17, 2014 by
- FDA Issues Warning Letter to Edwards Lifesciences, for misbranding of Myxo ETlogix annuloplasty Ring
- Northwestern University 5pm ET Deadline Today to Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation
- Grassley not satisfied with the responses, continues to press the issue
- Medical Institutions Identified in Secret Testing in Senate Investigation FDA not Responding: Part I
- Part II: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
Cook County Denies Motion to Intervene to retrieve Northwestern University Authorization to Waive Patient's Rights Regarding Illegal Human Experimentation and surgical placement of Non-FDA approved Medical devices in their hearts during open heart surgery
Motion denied to retrive Authorization to waive patients rights to have full informed consent regarding the use of the echo data from the clinical testing of the IMR ETlogix and the Myxo ETlogix from 2004-2007.
Waiver IRB number 1532-004
1 STATE OF ILLINOIS
2 COUNTY OF COOK
IN THE CIRCUIT COURT OF COOK COUNTY , ILLINOIS
4 COUNTY DEPARTMENT , LAW DIVISION
6 MAUREEN OBERMEIER,
7 Plaintiff ,
8 vs . No . 08 L 012426
9 NORTHWESTERN MEMORIAL HOSPITAL; THE NORTHWESTERN
10 MEDICAL FACULTY FOUNDATION ; PATRICK McCARTHY , M .D .; and
11 EDWARDS LIFESCIENCES,
12 Defendants .
13 Report of proceedings had at the hearing in
the above-entitled cause before the HONORABLE WILLIAM E .
14 GOMOLINSKI, Judge of said Court , conunencing at 12 :11 p .m . on January 6, 2014 .
16 APPEARANCES :
17 LAW OFFICES OF MICHAEL J. BURNETT , by MR . MICHAEL J BURNETT
18 On behalf of the Plaintiff ;
19 ANDERSON, RASOR & PARTNERS , LLC, by MS . AMY PLEUSS
20 On behalf of the Defendants Northwestern Memorial Hospital , The Northwestern Medical
21 Faculty Foundation , and Patrick McCarthy , M .D.;
EICHORN & EICHORN , LLP, by
23 MR . KIRK BAGROWSKI
On beha lf of the Defendant Edwards
24 Lifesources, LLC .
1 THE COURT: All right . For the record ...
2 MS. PLEUSS : Good afternoon , your Honor.
3 Amy Pleuss on behalf of Northwestern Memorial Hospital ,
4 Northwestern Medical Foundation, and Dr . McCar thy.
5 MR. BAGROWSKI: Kirk Bagrowski on behalf of Edwards
7 MR. BURNETT : Michael Burnett on behalf of the
8 petitioner , Dr. Maureen Rajamannan .
9 THE COURT : All right. This comes before us on
10 Dr. Rajamannan 's petition for leave to intervene as of
11 right or in the alternative to leave to intervene by
12 permission .
13 Counsel has provided to me a six-page petition
14 and a five-page memorandum of law . I've read it in
15 great detail. I've gone through it page by page , step
16 by step . I noticed different things in here. Your
17 mot ion to -- petition to leave to intervene is denied .
18 It 's denied for the following reasons: The sole basis
19 for your intervention is based upon an alleged cause of
20 act ion that Dr . Rajamannan may or may not have regard ing
21 defamation of character , fraud, misrepresentation , some
22 other things , some other causes of action which may or
23 may not be directed against Dr . McCarthy .
24 your claim that based upon the IRB, the Institutional
1 Review Board , it 's your allegation that Dr . McCart hy
2 made misrepresentations to the institutional review
3 board which resulted in a waiver as opposed to an actual
4 consent document that was given from the IRB. As a
5 result of the waiver , the consent form was unnecessary ,
6 according , and based upon a motion to quash a subpoena
7 that was granted to Northwes tern Univers ity . You are
8 coming in now asking for me to provide the waiver
9 document that I previously found may or may not be
10 privileged under the Medical Studies Act.
11 In your context , I 'm not sure if it is or it's
12 not . It may or may not be. It 's a separate hearing at
13 a separate date and separate time .
14 Dr. Rajamannan 's request , as you term her to be a
15 whistle blower , to be able to obtain this information
16 which would so to speak clear her name in the medical
17 community , but those all go to damages also in the
18 separate lawsuits which you may or may not have . You 're
19 free to file those lawsuits any time you want to . I 'm
20 not sure that they 'd be part and parcel with what we 're
21 doing in this case,