Product Liability fall 2015 updated November 18, 2015
George W. Conk
Good background/overview: Principles of Products Liability, Geistfeld (2006)
Syllabus (evolving)
Week 1 -
Chapter 1. The Big Picture -
Casebook pp. 1 - 22
Discussion slides:
Punctuated Equilibrium
Product Stewardship
Conk, Punctuated Equilibrium: Why Section 402A Flourished and the Product Liability Restatement Languished (2007)
Noah, Platitudes About Product Stewardship in Torts (2009)
The Future of Drug Safety - Action Steps for Congress IOM/National Academy of Sciences
FDA Drug Safety Communication: Strengthen Warnings - NSAIDS can cause heart attacks and strokes (July 9, 2015)
FDA Slides for Thrombotic Cardiovascular Events and NSAID Use (for 2014 Joint Meeting of Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee
FDA Panel Rejects ClaimNaproxen Safer than other NSAIDS
Background:
industry and speakers' slides for 2014 Joint Advisory Committee Meeting on NSAIDS
FDA considers treating Naproxen differently
Cox 2 Selective and NSAIDS - balancing Gastrointestinal and cardiovascular risks (BMC 2007)
Rand report on asbestos litigation costs and compensation (2000)
Week 2
Chapter 2. Doctrinal Foundations of Strict Product Liability - Casebook pp. 23-67
Discussion slides
Section 3 - Circumstantial Evidence - Product Liability Restatement
Background: Jed Shugerman, The Floodgates of Strict Liability: Bursting Reservoirs and the Adoption of Fletcher v. Rylands in the Gilded Age
Chapter 3. The Substantive Rationale for Strict Products Liability -
Casebook pp. 69-115
Discussion slides
Weeks 3 and 4
The concept of product defect - the heart of the matter
Chapter 4. Construction or Manufacturing Defects - pp. 117-138
Background: Restatement of the Law, 3rd: Products Liability § 1 Liability of Commercial Seller or Distributor for Harm Caused by Defective Products
§ 4 Noncompliance with product safety statutes or regulations
Chapter 5. Design Defects - pp. 139- 183
Discussion slides - design defect
§ 2 Categories of Product Defect, Products Liability Restatement (black letter and comments)
Saw Stop - Osorio v. One World and the Proposed Rulemaking by the Consumer Product Safety Commission (Read post on Torts Today)
Read Osorio - full text of 1st Circuit opinion - link at post above.
CPSC Table saw page
SawStop: How it works - videos
Bosch Jobsite Reaxx saw = A competitor emerges ($1,499)
SawStop sues to block Bosch
complaint
Powerpoint Slides Saw Stop
Hinojo v. NJM, 353 N.J. Super 261 (App. Div. 2002)
NJ Model Civil Jury Charge -
Design Defect 5.40D
Proximate Cause 6.10-6.14 Background:
Compared to What? Instructing the Jury on Product Defect Under the Products Liability Act and the Restatement (Third) of Torts: Products Liability
George W Conk, 30 Seton Hall L. Rev. 273 (1999)
Week 5
Chapter 6. Warning Defects - pp. 217-289
Powerpoint slides
Restatement 3rd, Product Liability, Section 2 - comments and Reporters Notes on Failure to Warn
Drug product liability warning cases
Restatement 2d - Torts, 402A, comment k
Victor Schwartz, Unavoidably Unsafe Products, Clarifying the Meaning and Policy Behind Comment k (1985)
Informed choice: In Re Diet Drug - Judge Charles Walsh, NJ Super (2005)
Vioxx - Cox 2 inhibitors -NSAIDS and Cardiac Risk
FDA considers treating Naproxen differently
Cox 2 Selective and NSAIDS - balancing Gastrointestinal and cardiovascular risks (BMC 2007)
McDarby v. Merck, 401 NJ Super 10 (NJ App. Div. 2008) (download and read excerpted opinion at link above)
Slideshow - the Vioxx story
Lanier closing (excerpt)
Jury charge
The demise of New Jersey Product Liability Law
Read blog post and Bailey v. Wyeth (NJ App. 2008)
Presumptions - discussion slides
Proximate Cause and Scope of Liability for Damages
Chapters 11 & 12 -pp 449 - 502
discussion slides
On medical monitoring - compare Donovan (p. 489) with Caronia v. Philip Morris, NY Ct. of Appeals - available HERE.
(foreseeability - Stazenski, In re September 11; backward-looking tests - Union Pump; reprise of duty - Jeld-Wen; pure economic loss East River Steamship, Pfizer; medical monitoring - Donovan v. Philip Morris and Caronia v. Philip Morris)
Expert testimony - proving causation of harm
Ref. Manual on Scientific Evidence - discussion slides
discussion slides - expert testimony
Federal Rules of Evidence 702 - Testimony by Expert Witnesses
Daubert v. Merrell Dow Pharmaceuticals (9th Circuit 1991)
Landrigan v. Celotex (N.J.1992)
Daubert v. Merrell Dow Pharmaceuticals 509 U.S. 579 (1993)
Joiner v. General Electric (1997) standard of review
Kumho Tire v. Carmichael, 526 U.S. 137 (1999)
Circumstantial evidence: Differential etiology
Cooper v. Takeda (Cal. App. 2015)
Background
Amicus Brief of Bayer, et al. -Daubert
Against the Odds: Proving Causation of Disease with Epidemiological Evidence (1995) George Conk
Reference Guide on Scientific Evidence (3rd edition) Federal Judicial Center
Admissibility of expert evidence -Margaret Berger
How Science Works - David Goodstein
Reference Guide on Epidemiology - Michael Green
Week 10 Preemption: Vaccines, Drugs, and Devices in the high court
Chapter 8 - pp. 319-332
Discussion slides: preemption of medical devices under Riegel Devices: Premarket Approval 21 USC 360e
FDA Devices page FDA: PMA Supplements and Approvals
Devices
Preemption: 21 USC 360k
Riegel v. Medtronic (U.S. 2007)(read opinion and dissent)
Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Ariz. 2013)
Are parallel claims a viable option?
Week 11 Generics
Review: Levine v. Wyeth (U.S. 2009) (opinions)
Oyez page
Wyeth discussion slides
Discussion slides - generics
* Mutual Pharmaceutical v. Bartlett, 570 U.S. ___ (2013) [majority and dissents)
21 USC 355 New Drugs
21 CFR 314.70 Supplements and other changes to approved labels
FDA Response to Bartlett v. Mutual Pharma
* FDA Notice of Proposed Rule-making (November 13, 2013) (post-Mutual Pharma.)
FDA Docket
Pro：
* Comments on FDA proposed rule - by Alberto Bernabe and George Conk
The empire strikes back on generics - FDA reopens comment period
Contra:
* FDA should be in charge of labels - Ralph Neas, Generic Pharmaceutical Ass'n
Generics and Pharma joint response - Proposal for Expedited Agency Action
Proposed rule may violate statute, drive up costs -Washington Legal Foundation
Background
FDA Glossary of Terms
FDA Adverse Effects Reporting System (FAERS)
Conk, Is there a design defect in the Restatement of Torts, 3rd: Product Liability? (2000:
Cornett v.J&J, 211 N.J. 362 (2012) (omit Kentucky law issue)
Wolfman, Brian and King, Anne Warren, Mutual Pharmaceutical Co. v. Bartlett and Its Implications (November 5, 2013). The United States Law Week (BNA), Vol. 82, pp. 1-18, 2013.
Week 12 - Settling the Mass Tort Claim
DePuy Hip Implant Settlement
slides: key elements of the DePuy ASR Product Liability Settlement
DePuy ASR settlement official website
********
DePuy ASR MDL docket page
DePuy ASR Resource Page - Torts Today
Background
Fallon, Grabill, Wynne, Bellwether Trials in Multi-district Litigation (2008)
Hellerstein, Henderson, Twerski - Managerial Judging: the 9/11 Responders Litigation
Hellerstein, et. al., The 9/11 Litigation Database: A Recipe for Judicial Management, 90 Wash. U.L. Rev. 653 (2013)
Week 13 European Union Product Liability Law
Chapter 16 pp. 609-631
A and others v. National Blood Authority - excerpted (2001)
discussion slides
European Product Liability Directive
AOK Sachsen v. Boston Scientific, European Court of Justice (March 5, 2015)
Opinion of the Advocate General - Boston Scientific v. AOK Sachsen
DJL v. Armour Pharmaceuticals (NJ Super 1997)
Background
Comparing U.S. and European Medical Device Processes
Audio - NEJM
German company apologizes for thalidomide
Week 14 Vaccines - products virtually removed from the tort system
Vaccines
discussion slides - vaccines
National Vaccine Injury Program - DHHS
Bruesewitz v. Wyeth, LLC (U.S. 2011) (read opinion and dissents)
Background
The Salk-Sabin Polio Vaccine Debate
Harvard Crimson - 1963
Jonas Salk Obituary
GAO 1987 Safety and use of Polio Vaccines
CDC 1999 Notice: Revised Recommendations for Polio Immunization
US DHHS ACIP Recommended Immunization Schedule (current)
George W. Conk
Adjunct Professor of Law & Senior Fellow
Stein Center for Law & Ethics
Fordham Law School
Room 8-122
Room 8-122
gconk@law.fordham.edu
**
3 credits
Tuesday and Thursday afternoons
4:00 - 5:25 PM | Room 4-03
Prof. George W. Conk
gconk@law.fordham.edu
Room 8-122
Course materials are often linked on this the Syllabus page of the Course blog: Torts Today
I have posted hypertext links for much of the materials. Slides will be posted on Scribd, as are some other materials. Some readings are linked to Westlaw via Dropbox links (If successful I will expand use of that method). Others are linked to SSRN. If you don't have an SSRN account, register. It's free and they don't spam you.
Office hours :
By appointment on the hour and half hour. Please make appointments by email.
Attendance is required.
If you are unable to attend class please drop me a note with brief explanation before class.
Discussion leaders:
I will generally make assignments of discussion leaders for each class 6 days before the class meeting. The assignments will usually be groups of four, in alphabetical order, starting week two.
Topics must be approved by me in advance of filing.
Friday, October 9, 5:00 PM - outlines due
November 6, 5:00 PM - rough drafts due
November 30, 5:00 PM - final papers due
Term papers (if elected in lieu of exam)
Term paper topic proposals due: Friday, October 9, 5:00 PM
November 6, 5:00 PM - rough drafts due
November 30, 5:00 PM - final papers due
(page references are to the Geistfeld casebook)**
3 credits
Tuesday and Thursday afternoons
4:00 - 5:25 PM | Room 4-03
Prof. George W. Conk
gconk@law.fordham.edu
Room 8-122
Course materials are often linked on this the Syllabus page of the Course blog: Torts Today
I have posted hypertext links for much of the materials. Slides will be posted on Scribd, as are some other materials. Some readings are linked to Westlaw via Dropbox links (If successful I will expand use of that method). Others are linked to SSRN. If you don't have an SSRN account, register. It's free and they don't spam you.
Office hours :
By appointment on the hour and half hour. Please make appointments by email.
Attendance is required.
If you are unable to attend class please drop me a note with brief explanation before class.
Discussion leaders:
I will generally make assignments of discussion leaders for each class 6 days before the class meeting. The assignments will usually be groups of four, in alphabetical order, starting week two.
Accountability: Final exam (take-home - 48 hours) OR term paper (15 + pp well supported) OR Upper Class Writing Requirement paper (25 pp.)
Good and regular attendance is mandatory.
Class participation is a substantial factor in grading.
There is no anonymous grading in this seminar class.
Stylistic principles: Rhetoric: Aristotle, RBG, and the art of persuasion
Upper Class writing requirement:
Notice of intent must be filed with Registrar within two weeks of start of semester Good and regular attendance is mandatory.
Class participation is a substantial factor in grading.
There is no anonymous grading in this seminar class.
Stylistic principles: Rhetoric: Aristotle, RBG, and the art of persuasion
Upper Class writing requirement:
Topics must be approved by me in advance of filing.
Friday, October 9, 5:00 PM - outlines due
November 6, 5:00 PM - rough drafts due
November 30, 5:00 PM - final papers due
Term papers (if elected in lieu of exam)
Term paper topic proposals due: Friday, October 9, 5:00 PM
November 6, 5:00 PM - rough drafts due
November 30, 5:00 PM - final papers due
I will make assignments of discussion leaders for each class 6 or 7 days before the class meeting.
Take home final
due no later than December 18
(48 hour download)
Take home final
due no later than December 18
(48 hour download)
Required casebook:
Product Liability Law - Mark Geistfeld
Good background/overview: Principles of Products Liability, Geistfeld (2006)
Syllabus (evolving)
Week 1 -
Chapter 1. The Big Picture -
Casebook pp. 1 - 22
Discussion slides:
Punctuated Equilibrium
Product Stewardship
Conk, Punctuated Equilibrium: Why Section 402A Flourished and the Product Liability Restatement Languished (2007)
Noah, Platitudes About Product Stewardship in Torts (2009)
The Future of Drug Safety - Action Steps for Congress IOM/National Academy of Sciences
FDA Drug Safety Communication: Strengthen Warnings - NSAIDS can cause heart attacks and strokes (July 9, 2015)
FDA Slides for Thrombotic Cardiovascular Events and NSAID Use (for 2014 Joint Meeting of Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee
FDA Panel Rejects ClaimNaproxen Safer than other NSAIDS
Background:
industry and speakers' slides for 2014 Joint Advisory Committee Meeting on NSAIDS
FDA considers treating Naproxen differently
Cox 2 Selective and NSAIDS - balancing Gastrointestinal and cardiovascular risks (BMC 2007)
Rand report on asbestos litigation costs and compensation (2000)
Week 2
Chapter 2. Doctrinal Foundations of Strict Product Liability - Casebook pp. 23-67
Discussion slides
Section 3 - Circumstantial Evidence - Product Liability Restatement
Background: Jed Shugerman, The Floodgates of Strict Liability: Bursting Reservoirs and the Adoption of Fletcher v. Rylands in the Gilded Age
Chapter 3. The Substantive Rationale for Strict Products Liability -
Casebook pp. 69-115
Discussion slides
Weeks 3 and 4
The concept of product defect - the heart of the matter
Chapter 4. Construction or Manufacturing Defects - pp. 117-138
Background: Restatement of the Law, 3rd: Products Liability § 1 Liability of Commercial Seller or Distributor for Harm Caused by Defective Products
§ 4 Noncompliance with product safety statutes or regulations
Chapter 5. Design Defects - pp. 139- 183
Discussion slides - design defect
§ 2 Categories of Product Defect, Products Liability Restatement (black letter and comments)
Saw Stop - Osorio v. One World and the Proposed Rulemaking by the Consumer Product Safety Commission (Read post on Torts Today)
Read Osorio - full text of 1st Circuit opinion - link at post above.
CPSC Table saw page
SawStop: How it works - videos
Bosch Jobsite Reaxx saw = A competitor emerges ($1,499)
SawStop sues to block Bosch
complaint
Powerpoint Slides Saw Stop
Hinojo v. NJM, 353 N.J. Super 261 (App. Div. 2002)
NJ Model Civil Jury Charge -
Design Defect 5.40D
Proximate Cause 6.10-6.14 Background:
Compared to What? Instructing the Jury on Product Defect Under the Products Liability Act and the Restatement (Third) of Torts: Products Liability
George W Conk, 30 Seton Hall L. Rev. 273 (1999)
Week 5
Chapter 6. Warning Defects - pp. 217-289
Powerpoint slides
Restatement 3rd, Product Liability, Section 2 - comments and Reporters Notes on Failure to Warn
Drug product liability warning cases
Restatement 2d - Torts, 402A, comment k
Victor Schwartz, Unavoidably Unsafe Products, Clarifying the Meaning and Policy Behind Comment k (1985)
Informed choice: In Re Diet Drug - Judge Charles Walsh, NJ Super (2005)
Vioxx - Cox 2 inhibitors -NSAIDS and Cardiac Risk
FDA considers treating Naproxen differently
Cox 2 Selective and NSAIDS - balancing Gastrointestinal and cardiovascular risks (BMC 2007)
McDarby v. Merck, 401 NJ Super 10 (NJ App. Div. 2008) (download and read excerpted opinion at link above)
Slideshow - the Vioxx story
Lanier closing (excerpt)
Jury charge
The demise of New Jersey Product Liability Law
Read blog post and Bailey v. Wyeth (NJ App. 2008)
Presumptions - discussion slides
Proximate Cause and Scope of Liability for Damages
Chapters 11 & 12 -pp 449 - 502
discussion slides
On medical monitoring - compare Donovan (p. 489) with Caronia v. Philip Morris, NY Ct. of Appeals - available HERE.
(foreseeability - Stazenski, In re September 11; backward-looking tests - Union Pump; reprise of duty - Jeld-Wen; pure economic loss East River Steamship, Pfizer; medical monitoring - Donovan v. Philip Morris and Caronia v. Philip Morris)
Expert testimony - proving causation of harm
Ref. Manual on Scientific Evidence - discussion slides
discussion slides - expert testimony
Federal Rules of Evidence 702 - Testimony by Expert Witnesses
Daubert v. Merrell Dow Pharmaceuticals (9th Circuit 1991)
Landrigan v. Celotex (N.J.1992)
Daubert v. Merrell Dow Pharmaceuticals 509 U.S. 579 (1993)
Joiner v. General Electric (1997) standard of review
Kumho Tire v. Carmichael, 526 U.S. 137 (1999)
Circumstantial evidence: Differential etiology
Cooper v. Takeda (Cal. App. 2015)
Background
Amicus Brief of Bayer, et al. -Daubert
Against the Odds: Proving Causation of Disease with Epidemiological Evidence (1995) George Conk
Reference Guide on Scientific Evidence (3rd edition) Federal Judicial Center
Admissibility of expert evidence -Margaret Berger
How Science Works - David Goodstein
Reference Guide on Epidemiology - Michael Green
Week 10 Preemption: Vaccines, Drugs, and Devices in the high court
Chapter 8 - pp. 319-332
Discussion slides: preemption of medical devices under Riegel Devices: Premarket Approval 21 USC 360e
FDA Devices page FDA: PMA Supplements and Approvals
Devices
Preemption: 21 USC 360k
Riegel v. Medtronic (U.S. 2007)(read opinion and dissent)
Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Ariz. 2013)
Are parallel claims a viable option?
Week 11 Generics
Review: Levine v. Wyeth (U.S. 2009) (opinions)
Oyez page
Wyeth discussion slides
Discussion slides - generics
* Mutual Pharmaceutical v. Bartlett, 570 U.S. ___ (2013) [majority and dissents)
21 USC 355 New Drugs
21 CFR 314.70 Supplements and other changes to approved labels
FDA Response to Bartlett v. Mutual Pharma
* FDA Notice of Proposed Rule-making (November 13, 2013) (post-Mutual Pharma.)
FDA Docket
Pro：
* Op-Ed - Boumil & Curfman New England Journal of Medicine (read article not just blog post)
Public Citizen* Comments on FDA proposed rule - by Alberto Bernabe and George Conk
The empire strikes back on generics - FDA reopens comment period
Contra:
* FDA should be in charge of labels - Ralph Neas, Generic Pharmaceutical Ass'n
Generics and Pharma joint response - Proposal for Expedited Agency Action
Proposed rule may violate statute, drive up costs -Washington Legal Foundation
Background
FDA Glossary of Terms
FDA Adverse Effects Reporting System (FAERS)
Conk, Is there a design defect in the Restatement of Torts, 3rd: Product Liability? (2000:
Cornett v.J&J, 211 N.J. 362 (2012) (omit Kentucky law issue)
Wolfman, Brian and King, Anne Warren, Mutual Pharmaceutical Co. v. Bartlett and Its Implications (November 5, 2013). The United States Law Week (BNA), Vol. 82, pp. 1-18, 2013.
Week 12 - Settling the Mass Tort Claim
DePuy Hip Implant Settlement
slides: key elements of the DePuy ASR Product Liability Settlement
Review the trial slides (sent by email), the settlement agreement, the statutory provisions and the proposed FDA Order
21 USC 360(k) [FDCA 510(k)
21 USC 515(b) - Order to require premarket approval
FDA proposed order on premarket approval
510(k) cleanrances - substantial equivalence
FDA proposed order on premarket approval
510(k) cleanrances - substantial equivalence
DePuy ASR settlement official website
DePuy ASR MDL docket page
DePuy ASR Resource Page - Torts Today
Background
Fallon, Grabill, Wynne, Bellwether Trials in Multi-district Litigation (2008)
Hellerstein, Henderson, Twerski - Managerial Judging: the 9/11 Responders Litigation
Hellerstein, et. al., The 9/11 Litigation Database: A Recipe for Judicial Management, 90 Wash. U.L. Rev. 653 (2013)
Week 13 European Union Product Liability Law
Chapter 16 pp. 609-631
A and others v. National Blood Authority - excerpted (2001)
discussion slides
European Product Liability Directive
AOK Sachsen v. Boston Scientific, European Court of Justice (March 5, 2015)
Opinion of the Advocate General - Boston Scientific v. AOK Sachsen
DJL v. Armour Pharmaceuticals (NJ Super 1997)
Background
Lucas Bergkamp, Is There A Defect in the European Court's Defect Test? Musings About Acceptable Risk, 6 Eur. J. Risk Reg. 309 (2015)
Audio - NEJM
German company apologizes for thalidomide
Week 14 Vaccines - products virtually removed from the tort system
Vaccines
discussion slides - vaccines
National Vaccine Injury Program - DHHS
Bruesewitz v. Wyeth, LLC (U.S. 2011) (read opinion and dissents)
Background
The Salk-Sabin Polio Vaccine Debate
Harvard Crimson - 1963
Jonas Salk Obituary
GAO 1987 Safety and use of Polio Vaccines
CDC 1999 Notice: Revised Recommendations for Polio Immunization
US DHHS ACIP Recommended Immunization Schedule (current)
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