Product Liability Syllabus - fall 2015

Product Liability fall 2015                             updated  November  18, 2015

George W. Conk
Adjunct Professor of Law & Senior Fellow
Stein Center for Law & Ethics
Fordham Law School  
Room 8-122
3 credits
Tuesday and Thursday afternoons
4:00 - 5:25 PM | Room 4-03
Prof. George W. Conk 
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  
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)
Required casebook: Product Liability Law - Mark Geistfeld 
(page references are to the Geistfeld casebook)

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

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

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)

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

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


* 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

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


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
Understanding 510(k) 1976-2010 Institute of Medicine
FDA proposed order on premarket approval 
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

DePuy ASR settlement official website

DePuy ASR  MDL docket page
DePuy ASR Resource Page - Torts Today

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)

 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 

discussion slides - vaccines

National Vaccine Injury Program - DHHS
Bruesewitz v. Wyeth, LLC  (U.S. 2011) (read opinion and dissents)

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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