human tissue

26
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 08034 334 W Front St Media, PA 19063 | 146 N 6th St Reading, PA 19601 | 209 State St Harrisburg, PA 17101

Upload: anapol-schwartz

Post on 21-Jan-2015

986 views

Category:

Health & Medicine


3 download

DESCRIPTION

Human Tissue and Funeral Home Litigation Update from Anapol Schwartz.

TRANSCRIPT

Page 1: Human Tissue

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

Page 2: Human Tissue

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

Page 3: Human Tissue

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

Page 4: Human Tissue

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

Page 5: Human Tissue

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

Page 6: Human Tissue

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

Page 7: Human Tissue

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

Page 8: Human Tissue

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

Page 9: Human Tissue

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

Page 10: Human Tissue

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

Page 11: Human Tissue

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

:::

Page 12: Human Tissue

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…”

Page 13: Human Tissue

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…”

Page 14: Human Tissue

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

Page 15: Human Tissue

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??

Page 16: Human Tissue

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

Page 17: Human Tissue

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

Page 18: Human Tissue

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

Page 19: Human Tissue

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:

Page 20: Human Tissue

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

Page 21: Human Tissue

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?”

Page 22: Human Tissue

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

Page 23: Human Tissue

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?

Page 24: Human Tissue

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

Page 25: Human Tissue

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:

Page 26: Human Tissue

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