PACER Documents

Searchable, OCR-transcribed court filings from the litigation surrounding the Kennedy Krieger Institute’s childhood-lead-research programs. Featherstone and DeShields concern the NIEHS-funded TLC trial (Treatment of Lead-Exposed Children; Contract N01-ES-35362); Covington, Wallace, and Armstrong concern the related KKI Repair-and-Maintenance lead-paint abatement study (the Grimes v. KKI lineage). Most are federal filings from PACER (Public Access to Court Electronic Records), where document numbers correspond to docket entries; a few are Maryland state-court records, noted as such. Each document has been processed into a searchable text layer.

Featherstone v. Kennedy Krieger InstituteTLC

Case 1:07-cv-01120-WMN • U.S. District Court, District of Maryland • Filed 05/01/2007

Doc 1 Notice of Removal — Original notice of removal to federal court
Doc 1-2 Exhibit I — Davoli Affidavit — Co-investigator Cecilia Davoli, M.D. attests NIEHS controlled all TLC decisions via Rogan
Doc 1-4 Exhibit A — Complaint & Election for Jury Trial — 89 paragraphs, 8 counts: negligence, misrepresentation, civil conspiracy, breach of fiduciary duty ($2M per count per plaintiff)
Doc 1-6 Exhibit D — NIEHS Contract N01-ES-35362 — Full TLC contract: $5.76M, 60-month term, SOW, abatement prohibition (Art. B.4.g), IND sponsorship, Rogan as PO, govt furnishes drug/placebo
Doc 1-7 Exhibit E — Contract Award Transmittal Letter — NIEHS Hardee to KKI Sorensen: 5-day return deadline under threat of FY93 funding forfeiture (Jun 25, 1993)
Doc 1-8 Exhibit F — HHS Memorandum: Appointment of Project Officer — Walter Rogan appointed PO with “complete surveillance” authority; Beth Ragan alternate; signed 6/29/93 by Rogan and KKI
Doc 3 Answer to Complaint — Passas defendants’ general denial; 4 affirmative defenses
Doc 17 Affidavit of Service — Service on defendant Thomas R. Hendrix at Chestertown, MD
Doc 18 Affidavits of Service — Service on Cornblath, Lietman, Braine, Becker (deposition subpoenas)
Doc 21 Answer to Complaint — Marc Medin answer in related case Elmore v. GBP; 12 defenses
Doc 22 Defendants’ Motion to Dismiss / Join NIEHS
Doc 22-1 Memorandum of Law — KKI memo: NIEHS controlled all aspects of TLC, must be joined as party
Doc 22-2 Request for Hearing — KKI requests hearing on motion to dismiss/join NIEHS
Doc 22-3 Proposed Order — Proposed order granting dismissal or requiring NIEHS joinder
Doc 22-4 Exhibit List — Index of 9 exhibits (A–I) supporting KKI motion re NIEHS joinder
Doc 28-2 Memorandum in Support of Plaintiffs’ Opposition
Doc 28-3 Table of Contents — TOC for plaintiffs’ opposition brief
Doc 28-4 Exhibit List
Doc 28-6 Exhibit 2 — NIEHS Contract excerpt
Doc 28-8 Exhibit 4 — KKI Technical Plan (Nov 23, 1992)
Doc 28-9 Exhibit 5 — NIEHS Contract pp. 9–10 — Background, Statement of Work, “independently” clause
Doc 28-10 Exhibit 6 — NIEHS Contract p. 11 — Patient population, eligibility, source ID, clean-up
Doc 28-11 Exhibit 7 — NIEHS Contract pp. 11–12 — Nutrition, lab, drug therapy, safety monitoring
Doc 28-12 Exhibit 8 — NIEHS Contract p. 12 — Nutrition, safety, retention (duplicate of 28-11 p. 2)
Doc 28-13 Exhibit 9 — Iron supplementation stoppage
Doc 28-15 Exhibit 11 — Informed Consent Form (Keona Featherstone) — Plain-text transcript
Doc 28-16 Exhibit 15 — Hendrix to Chisolm (Feb 10, 1993) — JHU IRB approval letter
Doc 28-17 Exhibit 13 — KKI Summary of TLC — Baltimore DHCD loan program, cleaning, NEJM results
Doc 28-18 Exhibit 14 — McNutt Deposition pp. 46–49 — Interventions not abatement; KKI directed; 3 price-cap levels
Doc 28-19 Exhibit 15 — McNutt Deposition pp. 38–41 — TLC used same specs as R&M; field notes from KKI
Doc 28-20 Exhibit 19 — IRB submission (Dec 7, 1994)
Doc 28-21 Exhibit 20 — IRB concerns re: untreated controls (Jan 2, 1996)
Doc 28-22 Exhibit 21 — Rogan to Chisolm (Jul 1, 1994)
Doc 28-23 Exhibit 22 — Brophy to Bhargava (Sep 28, 1995)
Doc 28-24 Exhibit 23 — Medical records (Shayonna Featherstone)
Doc 28-25 Exhibit 21 — BCHD Record (Keona Featherstone) — Flaking paint, hand-to-mouth activity documented
Doc 28-26 Exhibit 25 — BCHD records (Keona Featherstone)
Doc 28-27 Exhibit 26 — KKI Technical Plan p. 25
Doc 28-27 TLC Technical Plan — Safety Monitoring excerpt — KKI Trace Metal Lab blood-lead methods (GFAA / anodic stripping; CDC proficiency testing) and safety-monitoring procedures for drug side effects and continued lead exposure
Doc 28-29 Exhibit 25 — McNutt Deposition pp. 46–53 — Cleaning did not remove hazards; KKI controlled specs
Doc 28-30 Exhibit 26 — Arc Environmental XRF Survey — 2418 Jefferson: window sill 8.0 mg/cm² (2005)
Doc 28-31 Exhibit 27 — McNutt Deposition pp. 42–45 — KKI field notes directed all work; ERI had no discretion
Doc 28-32 Exhibit 28 — Chisolm to Hendrix (Jan 25, 1993) — RFA response; DMSA investigational; side effects discussed
Doc 28-33 Exhibit 29 — McNutt Deposition p. 37 — R&M transitioned into TLC; same contractor
Doc 28-37 Exhibit 33 — McNutt Deposition pp. 34–37 — R&M/TLC crossover; KKI developed specs with Farfel
Doc 28-38 Exhibit 34 — Davoli Affidavit (duplicate) — NIEHS controlled every aspect of TLC (04/19/07)
Doc 28-39 Exhibit 35 — Davoli Deposition pp. 166–169 — “not primary treatment,” “participating in a study”
Doc 28-40 Exhibit 36 — Davoli Deposition pp. 174–177 — “we” meant KKI; sat through 20–100+ consent meetings
Doc 28-41 Exhibit 37 — Davoli Deposition pp. 178–181 — 3 clinical sites; relocation list; enrollment process
Doc 28-42 Exhibit 38 — Davoli Deposition pp. 198–201 — “We Kennedy Krieger draw the blood”
Doc 28-43 Exhibit 39 — Davoli Deposition pp. 198–201 — Duplicate of 28-42 (different exhibit label)
Doc 28-44 Exhibit 40 — TLC Protocol p. 3 — Steering Committee (7 members, NIEHS ex officio); DSMB composition
Doc 29 Court Order — Judge Legg Discovery Order (Deshields) — KKI must produce all TLC documents
Doc 30 Answer — Passas defendants deny all cross-claim allegations by KKI/JHU
Doc 32 Reply Brief — KKI reply: NIEHS conceived/funded/controlled TLC, is indispensable party
Doc 32-1 Exhibit 1 — NIEHS Contract N01-ES-35362 (Full, 62 pages)
Doc 32-3 Exhibit 3 — NIEHS Press Release — Succimer does not improve test scores; Olden quote
Doc 32-5 Exhibit 5 — KKI Lead Clinic Intake (Shayonna Featherstone) — 23 months old, BLL 32, flaking paint, pica
Doc 33-4 Plaintiffs’ Exhibit List (39 exhibits)
Doc 33-20 Exhibit 16 — TLC Study Procedures & NEJM Results Summary
Doc 33-23 Exhibit 19 — IRB Protocol Form, PI Judith Rubin (Dec 7, 1994)
Doc 33-24 Exhibit 20 — U. of Maryland IRB Concerns re: Untreated Controls
Doc 33-25 Exhibit 21 — Rogan (NIEHS) to TLC PIs re: IRB Clearance & Consent
Doc 35 Reply Brief — KKI re: Protective Order (Deshields) — TLC documents already produced in six bankers’ boxes
Doc 37 Defendants’ Opposition to Plaintiffs’ Motion to Remand — Argues TLC ≠ R&M Study
Doc 37-1 Memorandum of Law — Federal Officer Removal — 35-page brief on § 1442(a)(1) and Boyle defense
Doc 37-2 Proposed Order Denying Remand
Doc 37-3 Exhibit A — Notice of Removal (refiled) — 44-paragraph notice: NIEHS control, causal nexus chart
Doc 37-4 Exhibit D — RFP Amendment (Oct 22, 1992) — Amendment 01 to RFP NIH-ES-92-31; preproposal conference Q&A on ethics, placebo, abatement, blinding, iron deficiency
Doc 37-6 Exhibit F — Contract Award Letter (Jun 25, 1993) — NIEHS Hardee to KKI Sorensen re: Contract N01-ES-35362
Doc 37-8 Exhibit H — Brophy to Hardee re: taxi reimbursement
Doc 37-10 Exhibit L — MD State Blood Lead Reports (1994–1995) — Levels 20–23 ug/dL
Doc 39 Stipulation of Dismissal with Prejudice (Deshields, 02-CV-3694)
Doc 41-7 Exhibit 5 — Cosky Deposition (Lead Abatement Loans) — Re: Farfel spending tracking and loan programs
Doc 41-8 Exhibit 6 — Farfel Memo & HUD Letter (Aug 1993) — Linking succimer trial to abatement support
Doc 44 Memorandum and Order (Nov 6, 2007) — Judge Nickerson grants remand; 2007 U.S. Dist. LEXIS 107338

DeShields v. Kennedy Krieger InstituteTLC

Case 1:02-cv-03694-BEL • U.S. District Court, District of Maryland • Chief Judge Benson E. Legg • Discovery over TLC research records (NIEHS Contract N01-ES-35362)

Doc 20-1 Memorandum to Counsel & Order — Motion to Withdraw — Judge Legg order on KKI counsel’s withdrawal; sets a Rule 16(b) conference across the consolidated KKI lead-study cases (Martin, DeShields, Higgins) (Jan 14, 2003)
Doc 25 KKI Disclosure of Corporate Affiliations & Financial Interests — Rule 7.1 statement; KKI a non-stock corporation insured by OHIC (Mar 2003)
Doc 27 Memorandum to Counsel / Order — Discovery Conference — Judge Legg sets the discovery schedule ahead of plaintiffs’ remand motions (Apr 8, 2003)
Doc 30 Motion for Protective Order & Memorandum in Support — KKI moves to bar dissemination of confidential TLC research records, invoking NIEHS Contract N01-ES-35362 and FOIA Exemption 5 deliberative-process privilege (Aug 8, 2003)
Doc 30-1 Exhibit A — Counsel Letter & Proposed Confidentiality Order — Apr 10, 2003 letter from KKI counsel (Iverson) to plaintiffs’ counsel (Thalenberg) and a proposed Local Rule 104.13 stipulated order over the research documents
Doc 36 Order Granting Motion for Protective Order — Judge Legg limits the study discovery documents to this litigation (Mar 29, 2004)
Doc 38 Memorandum to Counsel — Scheduling Order — Discovery due 7/30/2004; dispositive motions by 8/15/2004; no new parties (May 17, 2004)

Covington v. Kennedy Krieger Institute

Case 1:07-cv-01761-WMN • U.S. District Court, District of Maryland • Re: KKI Repair-and-Maintenance (R&M) lead-paint abatement study (Grimes lineage)

Doc 24-5 Index of Exhibits to Plaintiffs’ Memorandum — 25 exhibits: OHRP findings, KKI R&M abatement-study records, Farfel depositions/affidavits, Grimes v. KKI materials (2007)
Doc 26-3 Index of Exhibits to Plaintiffs’ Memorandum — 28 exhibits tying the KKI R&M study to OHRP human-subjects findings, Farfel depositions, and the Lead-Based Paint Abatement QA Project Plan (2007)
Removal Exhibits to Notice of Removal (Index A–U) — KKI-Battelle subcontract, Farfel affidavit, KKI progress reports, EPA Baltimore R&M abatement-study findings

Wallace v. Kennedy Krieger Institute

Case 1:07-cv-01140-WMN (D. Md.), removed from Baltimore City Circuit Court 24-C-07-002026 • Re: KKI lead-paint abatement study

Doc 1 Notice of Removal (34 pp) — KKI/Farfel/JHU remove the Wallace lead-study suit to federal court under federal-officer jurisdiction over the EPA-sponsored Baltimore R&M abatement study (May 1, 2007)
Doc 1-1 Civil Cover Sheet (JS-44) — Removal action; parties and counsel (May 1, 2007)
Doc 41-1 Memorandum ISO Plaintiffs’ Reply on Motion to Remand — Argues Farfel’s 2000 and 2007 affidavits conflict on EPA control of the KKI R&M study; addresses Grimes/Higgins (2007)
State Maryland Judiciary Case Search — Case Detail (138 pp) — State docket for Wallace v. KKI (Balt. City Circuit Ct. 24-C-07-002026): parties, hearings, a $1,280,645 judgment (Jan 15, 2010) later vacated (May 6, 2010)

Armstrong v. Kennedy Krieger Institute

Circuit Court for Baltimore City (Maryland state court) • Filed 09/14/2011 • Re: KKI Repair-and-Maintenance lead-paint abatement study

Complaint Class Action Complaint & Jury Demand (38 pp) — Putative class action alleging KKI nontherapeutically exposed children to lead dust in the R&M abatement study without informed consent (Sep 14, 2011)