human tissue
DESCRIPTION
Human Tissue and Funeral Home Litigation Update from Anapol Schwartz.TRANSCRIPT
Anapol Schwartz | Attorneys at Law
Human Tissue Products Liability Litigation
Human Tissue Cases 3
Transmission 10
Literature 16
The Debate 21
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Mdl CommitteesCo-Lead
Lawrence R.Cohan–Anapol Schwartz Weiss Cohan Feldman & Smalley, P.C.
Ron Motley–Motley Rice
JonCuneo–Cuneo, Gilbert & LaDucca
Medical Monitoring
CounselArnold Levin –Levin,Fishbein,Sedran&Beran
Local Liaison Counsel
JosephDePalma–Lite DePalmaGreenberg & Rivas, LLC
State Liaison Counsel
ChristopherPlacitella-Cohen,Placitella& Roth
Executive Committee
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Number of Human Tissue CasesRecipient Cases
365 MDL
512 State Courts
Donor Cases
50 State Courts
5 MDL
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Status of the MDL Donor CasesDefendant’s Motion for Summary Judgment
Immunity Clause of the NY Anatomical Gift Act
A person who acts in good faith in accord with the terms of this article or with the anatomical gift laws of another state is not liable fordamages in any civil action or subject to prosecution in any criminal proceeding for his act. 43 NY CLS Pub Health §4306(3).
Limited Discovery
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Status of the State Court Donor CasesNew Jersey
Several individual cases
New York
Consolidated in Richmond County
Stay pending criminal proceedings
Pennsylvania
Consolidated in Philadelphia County
Discovery ongoing
Dec Action
NY
PA
NJ
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Donor Cases-Theories of LiabilityFuneral Home Defendants Breach of Contract Professional Negligence (PA Funeral Directors Law) Pa Unfair Trade Practices + Consumer Protection Law Fraud/Deceit Intentional/Negligent Misrepresentation Emotional Distress Damages
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Donor Cases-Theories of LiabilityHarvesting Defendants
Negligence Fraud/ Deceit Emotional Distress Damages
Tissue Processing Defendants
Negligence Civil Conspiracy Fraud/Deceit Emotional Distress Damages
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Status of the State Court Recipient CasesFlorida
Transfer to Alachua County
Defendant’s Motions to Dismiss
Negligence
Intentional Misrepresentation
Negligent Infliction of Emotional Distress
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Status of the MDL Recipient CasesScience Motions
8 days in September
Daubert Hearings
Oral Argument on Summary Judgment Motions
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Transmission Of Disease By Human Tissue
AAJ 2008 ANNUAL CONVENTION
Lawrence R. Cohan, Esquire Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C. 1710 Spruce StreetPhiladelphia, PA 19103
(215) 790-4567 (215) 875-7702
[email protected] WWW.ANAPOLSCHWARTZ.COM
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. Read more online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 | 146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability Litigation
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
IN THE COURT OF COMMON PLEASFIRST JUDICIAL DISTRICT OF PENNSYLVANIA
CRIMIAL TRIAL DIVISON
IN RECOUNTY INVESTIGATING
GRAND JURY XXI
MISC. NO. 05-011487
C-10
REPORT OF THE GRAND JURY
LYNNE ABRAHAMDistrict Attorney
:::
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
The Grand Jury Report:
“…death certificates revealed the “donors” died of cancer and sepsis…and one deceased had both HIV and hepatitis”
“…in the alley a sparrow was perched on a cadaver’s head…”
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
The Grand Jury Report:
“…the same blood was often submitted for more than one body…”
“…they harvested two hundred bodies…even those with cancer or where rigor mortis had set in…”
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Donor Acceptance Criteria
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Recipients At Risk For:Hepatitis B & C
HIV
Syphilis
Sepsis/Infection
“Bad Bones”
Cancer, prions??
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
World’s Literature7 Articles
17 Reported Cases Of Disease Transmission
Vast Body Of Literature:Disease Survival On Surfaces
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
10 6
10 8
10 4
10 2
10 -2
0 10 20 30Days
Regression of van Bueren Data (Figure 2)HIV Dried onto Glass Coverslips Stored at Room Temperature
Initial Titer Reduced 100 - Fold
40 50 60
1
HIV
Tit
er (
TCID
)5
0
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
The Matrix Is The Key
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Frozen Human Tissue Retains and can transmit disease
Human Tissue Implanted Within 30 Days of harvest can transmit disease
DEFENDANT’S CONCEDE:
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. Read more online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 | 146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability Litigation
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
THE DEBATE:Survivability of Disease in Bone Stored at room temperature for over 30 days
Whether Freeze Drying preserves or destroys disease
MORE DEBATE:Do “Sterilization techniques” eliminate disease?”
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Key DefinitionsSterile: free of viable microorganisms
Sterilization: validated processused to render a product free of viable microorganisms
Sterility assurance level: probability of a single viable microorganism occurring on an item after sterilization
Log10reduction: a 10-fold decrease in viable microorganisms
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
STILL MORE DEBATE:Can we eliminate confounding variables to prove causation in victims?
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
THE BATTLEGROUND:U.S. District Court MDL –Newark, N.J.
September 2008 –Hearings
Medicine/Science General Causation
Daubert issues re experts
CDC Investigation Ongoing
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
Bad bones–aged, osteoporosis
Rights of victims with no confirmed disease
Medical monitoring
Compensation to “unknowing” donor families
NOT YET ADDRESSED ANYWHERE:
Prepared by Lawyers at Anapol Schwartz. © 2008 All Rights Reserved. More information online at anapolschwartz.com.1710 Spruce Street Philadelphia, PA 19103 | 1040 Kings Hwy N Cherry Hill, NJ 08034 | 334 W Front St Media, PA 19063 |146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101
Human Tissue Products Liability LitigationAnapol Schwartz | Attorneys at Law
THE FUTURENew Regulation
Industry Oversight
Donor Screening Criteria
Testing Recipient Population