Johnson v. C R Bard Incorporated et al

Filing 276

ORDER on Deposition Designations as to Gin Schulz. Signed by District Judge William M. Conley on 6/5/2021. (nks)

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IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WISCONSIN NATALIE JOHNSON, Plaintiff, ORDER v. 19-cv-760-wmc C.R. BARD INC. and BARD PERIPHERAL VASCULAR INC., Defendants. Before the court is the parties’ request for ruling on objections to certain deposition designations as to Gin Schulz. DEPONENT Schulz, Gin 01/30/2014 PL AFFIRM DEF OBJECTIONS PL RESPONSE TO OBJECTIONS COURT RULING Bard objects to the playing of this deposition under Rules 401, 402 and 403. Ms. Schulz was formerly a quality assurance employee who left Bard in 2011, before the Meridian filter was available for commercial distribution. Her testimony does not address the Meridian filter. Bard chose to market the Meridian filter using the 510(k) process which relied upon the Recovery filter as the predicate. All G2 filter platform filters, including the Meridian trace their design history to the Recovery filter and the defects in the Meridian design only can be understood only in the context of the entire filter-line development. Testimony regarding the Recovery filter’s complications, testing, warnings and design is relevant and is not OVERRULED 1 outweighed by any prejudicial effect. Judge Campbell agreed with this position in Jones v. Bard. [MDL Order No. 10819]. The design history and failure modes are relevant to the assessment of the defects in the design of the filter whether a particular failure mode has occurred and Bard's past conduct is relevant to the claims of negligence. The testimony is relevant and not unfairly prejudicial. Schulz, Gin 01/30/2014 13:17-13:18 Schulz, Gin 01/30/2014 101:23102:12 Schulz, Gin 01/30/2014 104:14105:03 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. This testimony does not invovled any particular filter, bust instead devices in general. Testimony discusses the needs of the device OVERRULED Schulz, Gin 01/30/2014 109:13110:01 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. Testimony involves migration, which is at issue here and the testimony is not device specific. OVERRULED Schulz, Gin 01/30/2014 110:04111:19 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value Testimony involves migration, which is at issue here and the testimony is not device specific. OVERRULED 2 outweighed by prejudicial effect. Schulz, Gin 01/30/2014 120:22121:10 Schulz, Gin 01/30/2014 121:13121:15 Schulz, Gin 01/30/2014 125:05125:10 Schulz, Gin 01/30/2014 130:22131:01 Schulz, Gin 01/30/2014 131:04131:07 Schulz, Gin 01/30/2014 204:17204:20 Schulz, Gin 01/30/2014 206:03206:07 Schulz, Gin 01/30/2014 206:15206:22 Schulz, Gin 01/30/2014 207:24208:19 Schulz, Gin 01/30/2014 227:04227:13 Late addition of 125:02125:04 is confusing and should not be included as it references an answer that is not designated. The designation of 125:05-125:110 as indicated clarifies the testimony. OVERRULED Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. Rules 401, 402, 403 – Testimony relates to irrelevant and prejudicial evidence regarding Bard’s conduct related to the Recovery Filter. Irrelevant and any probative value outweighed by prejudicial effect. Rules 601/602 & The witness had direct involvement with the issue being discussed and it was part of her duties at Bard to be aware of the needs of physicians. Ms. Johnson's filter fractured. The Recovery is relevenat to the Meridian as ruled by the MDL Court. OVERRULED 3 612. Witness does not have personal knowledge of document Witness was shown a document, was not familiar with it and testified that he/she does not have personal knowledge about it or the circumstances. See testimony at 227:23 228:02. Schulz, Gin 01/30/2014 228:07228:19 Schulz, Gin 01/30/2014 417:09417:11 Schulz, Gin 01/30/2014 417:14417:17 Schulz, Gin 01/30/2014 417:19418:03 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. Rules 401, 402, 403 – Testimony relates to irrelevant and prejudicial evidence regarding Bard’s conduct related to the Recovery Filter. Irrelevant and any probative value outweighed by prejudicial effect. Rules 601/602 & 612. Witness does not have personal knowledge of document Witness was shown a document, was not familiar with it and testified that he/she does not have personal knowledge about it or the circumstances. Rules 801/802. Testimony is hearsay. 4 The witness had direct involvement with the issue being discussed and it was part of her duties at Bard to be aware of the needs of physicians. Ms. Johnson's filter fractured. The Recovery is relevenat to the Meridian as ruled by the MDL Court. OVERRULED Schulz, Gin 01/30/2014 418:06418:07 Schulz, Gin 01/30/2014 418:09418:22 Schulz, Gin 01/30/2014 419:01 Schulz, Gin 01/30/2014 419:03419:08 Schulz, Gin 01/30/2014 419:11419:24 Schulz, Gin 01/30/2014 420:02420:06 Schulz, Gin 01/30/2014 420:09420:11 Schulz, Gin 01/30/2014 422:18422:21 Schulz, Gin 01/30/2014 422:24423:02 Schulz, Gin 01/30/2014 431:14431:17 Schulz, Gin 01/30/2014 431:20431:20 Schulz, Gin 01/30/2014 431:22432:05 Schulz, Gin 01/30/2014 434:19434:20 Schulz, Gin 01/30/2014 435:04436:05 Schulz, Gin 01/30/2014 442:06442:14 Schulz, Gin 01/30/2014 446:14447:06 5 Schulz, Gin 01/30/2014 447:09447:11 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. Rules 601/602 & 612. Lacks foundation, witness does not have personal knowledge of subject matter, calls for speculation by the witness. Tilting and penetration are at issue in this case. The witness is allowed to explain her understanding. OVERRULED Schulz, Gin 01/30/2014 447:13447:19 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. Ms. Johnson's filter fractured and embolized to her right ventricle. The witness is allowed to explain her understanding. OVERRULED Schulz, Gin 01/30/2014 448:09448:13 Schulz, Gin 01/30/2014 448:16 Schulz, Gin 01/30/2014 448:18 Schulz, Gin 01/30/2014 448:21 Schulz, Gin 01/30/2014 448:23449:18 Schulz, Gin 01/30/2014 449:21449:23 DEPONENT DEF COUNTER PL OBJECTIONS DEF RESPONSE TO OBJECTIONS COURT RULING Schulz, Gin 01/30/2014 24:11-24:17 6 Schulz, Gin 01/30/2014 31:05-31:07 Schulz, Gin 01/30/2014 31:16-47:09 Schulz, Gin 01/30/2014 49:04-49:07 Schulz, Gin 01/30/2014 56:04-56:07 at Do you Schulz, Gin 01/30/2014 56:14-57:04 FRE 611(b) - beyond the scope of the direct examination. OVERRULED Schulz, Gin 01/30/2014 58:12-58:17 FRE 611(b) - beyond the scope of the direct examination. OVERRULED Schulz, Gin 01/30/2014 59:01-59:12 FRE 611(b) - beyond the scope of the direct examination; FRE 106 optional completeness - the witness's clarification and answer at lines 58:20-24 ought to be included. OVERRULED except ADD 58:20-58:24 Schulz, Gin 01/30/2014 59:23-60:03 at According FRE 611(b) - beyond the scope of the direct examination. OVERRULED Schulz, Gin 01/30/2014 60:06-60:19 FRE 611(b) - beyond the scope of the direct examination. OVERRULED Schulz, Gin 01/30/2014 77:22-78:01 Schulz, Gin 01/30/2014 90:20-91:09 Schulz, Gin 01/30/2014 101:23103:03 Schulz, Gin 01/30/2014 103:06104:12 ? 7 Schulz, Gin 01/30/2014 117:12119:09 Schulz, Gin 01/30/2014 123:13123:20 Schulz, Gin 01/30/2014 131:11133:01 Schulz, Gin 01/30/2014 135:01135:04 Schulz, Gin 01/30/2014 135:07136:02 Schulz, Gin 01/30/2014 145:11145:20 Schulz, Gin 01/30/2014 Schulz, Gin 01/30/2014 (133:21-133:1) FRE 401/402 (relevance); further, the designated lines are a statement by counsel, not a question, and do not constitute evidence. Plaintiff's counsel asked the question. The testimony is relevant to show how Bard evaluates its filters. SUSTAIN, strike 132:21133:1 145:23147:19 (147:20-149:21) Nonresponsive - objection & motion to strike at 149:22-23. That testimony is not designated MOOT 151:02151:07 (1) FRE 402, 403 objection to evidence of FDA lack of enforcement for the reasons set forth in Plaintiff's Motion in Limine on this topic. (2) FRE 402, 403: objection to evidence of advocacy organization guidelines, for reasons stated in Plaintiff's Omnibus Motion in Limine; (3) FRE 602, 802: speculative & hearsay: witness lacks foundation to testify about FDA's intent/state of mind as to the SIR guidelines or as an expert on the legal requirements established by FDA; to extent witness is reporting that FDA There is no testimony on FDA enforcement designated. Objection makes no sense. RESERVE 8 represented or acknowledged in meetings that SIR guidelines or Bard failure rates were acceptable, the testimony is inadmissible hearsay. (4) FRE 402, 403: further, any probative value is outweighed by the danger of undue prejudice and confusion of the issues because (a) SIR has issued multiple guidelines and the testimony does not identify which ones were allegedly ""acknowledged"" or accepted by FDA. and (b) testimony implies that FDA found the failure rates for the Meridian filter ""to be acceptable,"" suggesting (improperly and without foundation) that FDA evaluated Ecplise filter for compliance with a Federal regulatory standard." Schulz, Gin 01/30/2014 154:20154:24 (1) FRE 402, 403 objection to evidence of FDA lack of enforcement for the reasons set forth in Plaintiff's Motion in Limine on this topic. (2) FRE 402, 403: objection to evidence of advocacy organization guidelines, for reasons stated in Plaintiff's Omnibus Motion in Limine; (3) FRE 602, 802: speculative & hearsay: witness lacks foundation to testify about FDA's intent/state of mind as to the SIR guidelines or as an expert on the legal requirements established by FDA; to extent witness is 9 SUSTAIN reporting that FDA represented or acknowledged in meetings that SIR guidelines or Bard failure rates were acceptable, the testimony is inadmissible hearsay. (4) FRE 402, 403: further, any probative value is outweighed by the danger of undue prejudice and confusion of the issues because (a) SIR has issued multiple guidelines and the testimony does not identify which ones were allegedly ""acknowledged"" or accepted by FDA. and (b) testimony implies that FDA found the failure rates for the Meridian filter ""to be acceptable,"" suggesting (improperly and without foundation) that FDA evaluated Ecplise filter for compliance with a Federal regulatory standard." Schulz, Gin 01/30/2014 155:03157:13 (1) FRE 402, 403 objection to evidence of FDA lack of enforcement for the reasons set forth in Plaintiff's Motion in Limine on this topic. (2) FRE 402, 403: objection to evidence of advocacy organization guidelines, for reasons stated in Plaintiff's Omnibus Motion in Limine; (3) FRE 602, 802: speculative & hearsay: witness lacks foundation to testify about FDA's intent/state of mind as to the SIR guidelines or as an expert on the legal requirements established by 10 SUSTAIN FDA; to extent witness is reporting that FDA represented or acknowledged in meetings that SIR guidelines or Bard failure rates were acceptable, the testimony is inadmissible hearsay. (4) FRE 402, 403: further, any probative value is outweighed by the danger of undue prejudice and confusion of the issues because (a) SIR has issued multiple guidelines and the testimony does not identify which ones were allegedly ""acknowledged"" or accepted by FDA. and (b) testimony implies that FDA found the failure rates for the Meridian filter ""to be acceptable,"" suggesting (improperly and without foundation) that FDA evaluated Ecplise filter for compliance with a Federal regulatory standard." FDA does not establish safety through the 510K process. Schulz, Gin 01/30/2014 185:18185:22 at Most Schulz, Gin 01/30/2014 186:08186:12 Schulz, Gin 01/30/2014 208:24209:04 Schulz, Gin 01/30/2014 209:07209:10 Schulz, Gin 01/30/2014 215:14215:23 11 Schulz, Gin 01/30/2014 216:02216:08 Schulz, Gin 01/30/2014 217:21218:04 Schulz, Gin 01/30/2014 218:07218:19 (218:12-17): FRE 602/702: the witness lacks personal knowledge of whether filters "took the recurring PE rate down" and is not qualified to offer evidence on this topic. FRE 402/403: as explained in Plaintiffs' Omnibusa Motion in Limine, testimony that filters "prevent PEs" ought to be excluded because no such evidence exists for Bard's retrievable filter line. Further the testimony is non-responsive. Schulz, Gin 01/30/2014 227:23228:02 FRE 106 - Optional completeness; the remainder of the witness's answer at 228:4-6 ought to be included. SUSTAIN as to completeness only; add 228:4-228:6. Schulz, Gin 01/30/2014 285:02285:09 at Given subject to objection Schulz, Gin 01/30/2014 285:13285:23 subject to objection Schulz, Gin 01/30/2014 290:13290:16 subject to objection Optional completeness: the complete question, beginning at 290:2, ought to be included, as the omission of th question makes it unclear what the SUSTAIN as to completeness only; add 290:2-290:9. 12 The MIL was denied. This testimony is directly relevant to the risk benefit analysis performed by Bard. OVERRULED witness is actually begin asked. Schulz, Gin 01/30/2014 290:19291:06 subject to objection FRE 402/403: The witness's testimony that she believed the Bard personnel who made decisions were qualified is not relevant to any matter at issue, including, but not limied to, the issue of consumer expectations. OVERRULED Schulz, Gin 01/30/2014 351:19352:21 Schulz, Gin 01/30/2014 394:24395:07 Lack of foundation. Witness does not know if the "product" was improved with every iteration. OVERRULED Schulz, Gin 01/30/2014 395:10395:18 Lack of foundation. Witness does not know if the "product" was improved with every iteration. OVERRULED Schulz, Gin 01/30/2014 406:17406:19 Lack of foundation. Witness cannot speak for the entire medical community. SUSTAIN Schulz, Gin 01/30/2014 406:22407:02 Lack of foundation. Witness cannot speak for the entire medical community. SUSTAIN Schulz, Gin 01/30/2014 414:23414:24 vague and confusing question. Lack of foundation. Relevant is not clear in the question or based on the answer. SUSTAIN Schulz, Gin 01/30/2014 415:03415:09 vague and confusing question. Lack of foundation. Relevant is not clear in the question or based on the answer. SUSTAIN 13 Schulz, Gin 01/30/2014 432:20432:22 Speculation. The witness cannot speak for Dr. Ciavarella and what he did and did not understand. OVERRULED Schulz, Gin 01/30/2014 433:01433:05 Speculation. The witness cannot speak for Dr. Ciavarella and what he did and did not understand. OVERRULED Schulz, Gin 01/30/2014 437:06437:21 Counsel if testifying. The document speaks for itself. Plaintiff's counsel is asking the question. SUSTAIN Schulz, Gin 01/30/2014 438:05438:11 Counsel if testifying. The document speaks for itself. Plaintiff's counsel is asking the question. SUSTAIN Schulz, Gin 01/30/2014 440:07440:11 Schulz, Gin 01/30/2014 443:07443:20 Schulz, Gin 01/30/2014 444:16444:22 Non responsive. The witness did not answer the quesiton. Speculations, the witness cannot speak for what physicians believed to be the tradeoffs of retrievable filters. No objection to responsiveness was made at the time of the question. OVERRULED Schulz, Gin 01/30/2014 445:01445:08 Non responsive. The witness did not answer the quesiton. Speculations, the witness cannot speak for what physicians believed to be the tradeoffs of retrievable filters. No objection to responsiveness was made at the time of the question. OVERRULED Schulz, Gin 01/30/2014 452:04452:13 This is an answer without a question. Plainitff designated the question without the answer. The answer is necessary for comleteness. SUSTAIN, plaintiff did not designate the question. Schulz, Gin 01/30/2014 452:19452:22 14 Schulz, Gin 01/30/2014 453:01453:03 Schulz, Gin 01/30/2014 465:12465:20 Schulz, Gin 01/30/2014 466:06466:09 DEPONENT DEF AFFIRM Schulz, Gin 01/30/2014 24:04-24:10 begin at “Can” Schulz, Gin 01/30/2014 26:11-26:13 Schulz, Gin 01/30/2014 30:12-30:16 begin at “you” end at through “1990” Schulz, Gin 01/30/2014 30:21-31:04 begin at “And” Schulz, Gin 01/30/2014 31:08-31:15 begin at “when” Schulz, Gin 01/30/2014 49:08-50:24 Schulz, Gin 01/30/2014 52:22-53:24 begin at “And” Schulz, Gin 01/30/2014 54:01-55:10 begin at “Now” PL OBJECTIONS 15 DEF RESPONSE TO OBJECTIONS COURT RULING Schulz, Gin 01/30/2014 123:21124:03 begin at “if” Schulz, Gin 01/30/2014 124:06124:20 (124:06-20): Nonresponsive. (124:18-20): FRE: 602 & 702: Lack of foundation; speculative: witness is not qualified or properly designated to testify as an expert about what "FDA looks at…on the approval of the devices." Also, FRE: 403: any probative value of reference to what FDA considers in "approval of the devices" is outweighed by the danger of undue prejudice and confusion of the issues because the device at issue was never "approved" and the FDA made no risk/benefit analysis of the device at issue although testimony implies that occurred. The witness is testifying from her extensive personal experience. She was asked extensively about these issues by Plaintiff's counsel who apparently believed she had the pertinent background and experience to testify as to these issues -- otherwise, Plaintiff's counsel would not have asked. Any confusion regarding "approval" or "clearance" can be easily cured by inclusion of 124:22-23. SUSTAIN as to 124:18-124:20, otherwise OVERRULED Schulz, Gin 01/30/2014 125:11125:22 begin at “And” FRE 602, 702: Lack of foundation: witness has no personal knowledge and is neither qualified nor properly designated as an expert to testify about how an implanting physician makes risk/benefit decisions in using the device at issue. Further, FRE 106: the rule of optional completeness requires the answer (at line 125:16) if this excerpt is permitted because the question is designated without the witness's answer and gives the improper impression that the answer given at lines The witness is testifying from her extensive personal experience. She was asked extensively about these issues by Plaintiff's counsel who apparently believed she had the pertinent background and experience to testify as to these issues -- otherwise, Plaintiff's counsel would not have asked. Defendants do not object to the inclusion of 125:16. OVERRULED 16 126:1 and following is an answer to the designated question, rather than line 16. Schulz, Gin 01/30/2014 126:01127:06 (126:01-06): FRE 106: under the rule of optional completeness the jury should hear the question at lines 125:17-22 ( rather than the question at lines 125:11-15) since that is the actual question this witness is answering in the designated testimony. (Highlighted transcript includes lines 126:7-127:6, to which Plaintiffs have additional objections. Plaintiffs assume that this chart presents the correct intended designations). Defendants do not object to the icnlusion of 125:17-22. Plaintiffs do not articulate what their "additional objections" are. MOOT Schulz, Gin 01/30/2014 147:20149:21 (147:20-149:21): Nonresponsive. (147:20-150:13): (1) FRE 402, 403 - objection to evidence of FDA lack of enforcement for the reasons set forth in Plaintiff's Motion in Limine on this topic. (2) FRE 402, 403: objection to evidence of advocacy organization guidelines, for reasons stated in Plaintiff's Omnibus Motion in Limine; (3) FRE 602, 802: speculative & hearsay: witness lacks foundation to testify about FDA's intent/state of mind as to the SIR guidelines or as an expert on the legal The witness is testifying from her extensive personal experience. She was asked extensively about these issues by Plaintiff's counsel who apparently believed she had the pertinent background and experience to testify as to these issues -- otherwise, Plaintiff's counsel would not have asked. Plaintiff's objection to this testimony on the basis that Ms. Schulz began with Bard in 2005 and the timeframe at issue is 2013 (Plaintiff errantly identifies the SUSTAIN 17 requirements established by FDA; to extent witness is reporting that FDA represented or acknowledged in meetings that SIR guidelines or Bard failure rates were acceptable, the testimony is inadmissible hearsay. (4) FRE 402, 403: testimony is irrelevant because the witness went to work at Bard in 2005 and did not explain when such meetings occurred, thus the testimony is not shown to pertain to the G2X filter or to the time frame at issue (2010), further, any probative value is outweighed by the danger of undue prejudice and confusion of the issues because (a) SIR has issued multiple guidelines and the testimony does not identify which ones were allegedly "acknowledged" or accepted by FDA. and (b) testimony implies that FDA found the failure rates for the G2X filter "to be acceptable," suggesting (improperly and without foundation) that FDA evaluated G2X filter for compliance with a Federal regulatory standard. 18 filter at issue in this case as the G2X and the germane time frame as 2010) runs counter to Plaintiff's own actions, as she has designated a significant amount of testimony from this and other witnesses regarding events and circumstances from the 2003-2005, etc. timeframe. Plaintiff cannot have it both ways. Either the pertinent time period is 2013, or both parties can present evidence from this earlier time period. Defendants incorporate their responses to Plaintiff's motions in limine. Schulz, Gin 01/30/2014 150:02150:13 Non-responsive. The witness is testifying from her extensive personal experience. She was asked extensively about these issues by Plaintiff's counsel who apparently believed she had the pertinent background and experience to testify as to these issues -- otherwise, Plaintiff's counsel would not have asked. Plaintiff's objection to this testimony on the basis that Ms. Schulz began with Bard in 2005 and the timeframe at issue is 2013 (Plaintiff errantly identifies the filter at issue in this case as the G2X and the germane time frame as 2010) runs counter to Plaintiff's own actions, as she has designated a significant amount of testimony from this and other witnesses regarding events and circumstances from the 2003-2005, etc. timeframe. Plaintiff cannot have it both ways. Either the pertinent time period is 2013, or both parties can present evidence from this earlier time period. Defendants incorporate their responses to Plaintiff's motions in limine. 19 SUSTAIN DEPONENT PL COUNTERS DEF OBJECTIONS PL RESPONSE TO OBJECTIONS COURT RULING Schulz, Gin 01/30/2014 150:22151:01 Schulz, Gin 01/30/2014 109:22110:01 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. This is not within the scope of Defendant's designations; this is not a "counter-designation." Ms. Shultz was the VP of Quality assurance and is now the VP of Quality Operations for Bard. The testimony is clearly with in experience, her knowledge and the scope of responsibilities for Bard. Bard has used this witness to discuss complication rates and what should or should not be told to physicians about complications. See 148:01-150:13. This testimony is clearly within the scope of Bard’s direct. Also the testimony concerns migration and Mrs. Johnson experience migration of her filter. The testimony is relevant and is not unfairly prejudicial OVERRULED, but also already designated Schulz, Gin 01/30/2014 110:04110:14 Rules 401, 402, 403. Testimony does not involve filter at issue and/or failure modes at issue; Irrelevant and any probative value outweighed by prejudicial effect. This is not within the scope of Defendant's designations; this is not a "counter-designation." Ms. Shultz was the VP of Quality assurance and is now the VP of Quality Operations for Bard. The testimony is clearly with in experience, her knowledge and the scope of responsibilities for Bard. Bard has used this witness to discuss OVERRULED, but also already designated 20 complication rates and what should or should not be told to physicians about complications. See 148:01-150:13. This testimony is clearly within the scope of Bard’s direct. Also the testimony concerns perforation and fracture and Mrs. Johnson experience perforation and fracture of her filter. The testimony is relevant and is not unfairly prejudicial. Accordingly, IT IS ORDERED that the parties’ request for rulings on objections to certain designations is GRANTED, and the objections are sustained in part and overruled in part as provided above. Entered this 5th day of June, 2021. BY THE COURT: /s/ __________________________________ WILLIAM M. CONLEY District Judge 21

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