Warnings-Based Claims in Product Liability Navigating U.S. Standards for Warnings; Leveraging the Requirements in Litigation

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Warnings-Based Claims in Product Liability Navigating U.S. Standards for Warnings; Leveraging the Requirements in Litigation WEDNESDAY, APRIL 25, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Phoebe A. Wilkinson, Partner, Chardbourne & Parke, New York, Of Counsel, Bowman and Brooke, Minneapolis The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

2 Conference Materials If you have not printed the conference materials for this program, please complete the following steps: Click on the + sign next to Conference Materials in the middle of the lefthand column on your screen. Click on the tab labeled Handouts that appears, and there you will see a PDF of the slides for today's program. Double click on the PDF and a separate page will open. Print the slides by clicking on the printer icon.

3 Continuing Education Credits FOR LIVE EVENT ONLY For CLE purposes, please let us know how many people are listening at your location by completing each of the following steps: In the chat box, type (1) your company name and (2) the number of attendees at your location Click the SEND button beside the box

4 Tips for Optimal Quality Sound Quality If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory and you are listening via your computer speakers, you may listen via the phone: dial and enter your PIN -when prompted. Otherwise, please send us a chat or sound@straffordpub.com immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Quality To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again.

5 Warnings and Instructions: Law and Standards Bowman and Brooke LLP April 25, 2012

6 Defects in Warnings Definition: Defective if reasonably foreseeable risks could have been reduced by providing reasonable instructions or warnings and omission renders product not reasonably safe 6

7 Defects in Warnings Exception: Not required for risks and risk avoidance measures that should be obvious to reasonably foreseeable product users Only required for reasonably foreseeable users and risks Sellers down chain are liable if predecessors labels are inadequate 7

8 Warnings Must Be Provided If... The product is hazardous The manufacturer knows or should know the product is hazardous The hazard is not obvious to the user The hazard will exist during reasonably foreseeable use or misuse 8

9 Restatement 2d Read and heed presumption Where a warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning... is not... defective... Used by Ps and Ds. Not accepted in Restatement 3d. 9

10 Safety Hierarchy Eliminate hazard and risk from design Add guard, barrier, or interlock Add safety labels Provide for training and instruction Recommend personal protection 10

11 Reasonable Foreseeability Harm and person injured must have been reasonably foreseeable. Misuse, alteration and modification do not make manufacturer liable unless they are reasonably foreseeable. 11

12 Obvious Hazards Warning not required for obvious hazard Because product user will or should already know of its existence. Not necessary, diminish impact of other warnings Decided by trier of fact Rationale: How to determine? Related to reasonably foreseeable Probability and severity also obvious 12

13 What is an adequate warning in the U.S. It is in a form that could reasonably be expected to catch the attention of a reasonably prudent person in the circumstances of the product s use; The content is of such a nature as to be comprehensible to the average user; and It conveys a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person 13

14 Content of adequate warnings (law and standards) Description of hazard Probability of hazard occurring Severity if occurs How to avoid hazard 14

15 U.S. Labeling Standards ANSI Z535 (all products where no product specific standard applies) ANSI Z400.1/Z (hazardous industrial chemicals) Europe ISO 3864 (all products except chemicals and where law requires different label) Product specific European Directives 15

16 Label elements Signal word Danger, Warning or Caution Description of hazard Description of consequences (severity) Description of probability How to avoid (precautions) 16

17 ANSI Z535.4 Format 17

18 18

19 Z535 Signal Words Danger will cause serious injury or death Warning could cause serious injury or death Caution will or could cause moderate or minor injury and property damage NOTICE property damage only 19

20 Sufficiency of Warnings Description of hazard - words, pictorial Probability of hazard occurring - signal word, words Severity if hazard occurs - signal word, pictorial, words How to avoid hazard - words, pictorial 20

21 Illiterate and non- English reading users Some courts in U.S. have held that a manufacturer may be liable if the reasonably foreseeable users are illiterate or do not read English and the label does not have pictograms or text that are readily understood by such users No U.S. cases requiring foreign language on labels 21

22 Multi-lingual dilemma But some customers (e.g. retailers) require multi-lingual labels and you have no choice. Population is growing increasingly non- English speaking and reading. And there are more advertisements in foreign languages in TV, radio, print. 22

23 Multi-lingual in U.S. Do very carefully which languages? Don t diminish conspicuity of English labels Put burden on employer or customer to ask for languages other than English More pictorials instead of words? Should instructions be in foreign language? Use of website to offer other languages 23

24 Goal of some manufacturers No text labels Pictorial only Use worldwide But what about instructions 24

25 Pictorials in U.S. Not required generally by most standards Some courts have encouraged use of pictorials in addition to text where some users are illiterate or speak another language Labels with pictorials and no text are vulnerable unless they clearly transmit entire message 25

26 26

27 ISO Safety Labeling Standards ISO 3864 Part 2 Product Safety Labels Accepts symbol-only formats ISO incorporated by reference in 2007 ANSI Z

28 3864-Part 2 Accepts Various Formats 28

29 ISO

30 Content of adequate warnings If lack of space on product, may be acceptable to use just Signal Word and reference to instruction manual Good idea to have label offering replacement manual by mail or on website But, what must go on label and what can be in manual? What about verbal labels: 30

31 31

32 Safety Label Issues Other standards U.S. and Europe Size Placement Material Adhesion 32

33 U.S. Law re Instructions A court has held that warnings, standing alone, may have no practical relevance without instructions and that instructions without warnings may not be adequate. In discussing the adequacy of instructions, the cases only say that manuals should be adequate, accurate and effective and clear, complete and adequately communicated. 33

34 U.S. Law re Instructions Whether warning goes on product or in manual is decided on a case by case basis What about multi-lingual no case law 34

35 ANSI Z goals address the applicability of elements of other ANSI Z535-series standards to collateral materials establish a uniform and consistent visual layout for safety information in collateral materials for a wide variety of products minimize the proliferation of designs for safety information in collateral materials 35

36 State Of The Art Instructions Label on product referring to manual Incorporate safety information into manual Warning on cover to read manual Safety information consistent with labels, ads Reproduce labels in product manual Written for intended audience Delivered to customer 36

37 Other instruction issues Delivery to customer how to prove, how to keep with product Hard copy vs. electronic? Instruction videos/cds Websites interactive web-based training (with or without CD-Rom) Test comprehension? 37

38 Recommendations Comply with U.S. law and ANSI Z535 and other product specific standards if possible. Avoid multi-lingual labels unless absolutely necessary. Use pictorials in lieu of foreign languages. Avoid testing pictorials if possible. Consider multi-lingual in instructions and website. 38

39 Recommendations Now is good time to evaluate manuals and labels and update when appropriate. Consider updating to new Z535.4 standard when revising labels. Generally, no need to discard current inventory or offer new labels to prior customers unless prior labels very bad. Z535.6 provides guidelines. Confirms best practices. No need to throw out current manuals unless terrible. Incorporate when revising manuals. 39

40 For more information: 40

41 Warnings-Based Claims in Product Liability Phoebe A. Wilkinson (212) April 25, 2012

42 High Stakes Motivation of Plaintiffs To Aggregate Litigation Create Settlement Pressure Makes Plaintiff s Case Easier Focus on Defendant Not Plaintiff Influence Court Generate Publicity 42

43 Shift In Theories? Increasingly difficult to have personal injury classes certified Too many individual issues Those individual issues predominate Absent certification, little interest Shift to consumer protection act lawsuits to prosecute warnings-based claims 43

44 Consumer Fraud Act Claims Theories Disavow all personal injury claims I didn t get what I paid for The price was inflated Unfair treatment towards consumers I never would have purchased this product had I known Diminished re-sale value 44

45 Consumer Fraud Act Claims Attractive Recovery Possibilities Treble damages Attorneys fees and costs Punitive damages Statutory minimum damage awards 45

46 Be Aggressive in Exploring Bases To Fight Back Regulated Industry? Abstention Primary Jurisdiction Have Administrative Remedies Been Properly Exhausted? 46

47 Be Aggressive in Exploring Bases To Fight Back Equitable Abstention Particularly appropriate where claims raised by the lawsuit involve scientific and public policy issues E.g., in Pharmaceutical/Medical Device industries, doctrine recognizes that judgment regarding safety and efficacy rests with FDA and not court system Legislature regulates conduct through FDCA 47

48 Be Aggressive in Exploring Bases To Fight Back Doctrine of Primary Jurisdiction Questions within an administrative agency s area of expertise are more appropriately handled by the agency in question, and a court can refer the matter to that agency 48

49 Be Aggressive in Exploring Bases To Fight Back Exhaust Administrative Remedies What is the proper procedure to challenge an agency s determination? Have they been exhausted such that judicial review is timely? 49

50 Be Aggressive in Exploring Bases To Fight Back The Consumer Fraud Act Itself Is there a statutory exemption for manufacturers in a regulated industry? Is there a notice requirement? Is the plaintiff a proper plaintiff? Does the Act permit prosecution through class actions? 50

51 Be Aggressive in Exploring Bases To Fight Back Don t Forget Civil Procedure/Common Law Does the Plaintiff Have Standing? Is the plaintiff actually injured? Does the Complaint Satisfy Pleading Requirements? Iqbal-Twombly Has fraud been plead with requisite particularity? Do the Alleged Warnings-based Claims Really Constitute Nothing More than Sales Puffery? Choice of Law Analysis on Motion to Dismiss 51

52 Q&A To ask a question from your touchtone phone, press *1. To exit the queue, press *1 again. You may also use the Chat function to ask questions, or questions to litigation@straffordpub.com CLE CODE: TXWKPD

53 Tell us how we did! After you complete a brief survey of this program, we'll send you a free $5 Starbucks Gift Card. Look for our 'Thank You' (which you should receive shortly) for details and the survey link!

54 Thanks. Please join us for our next legal conference, CPSC Mandatory Disclosures of Potentially Dangerous Product Defects- Meeting Reporting Requirements, Leveraging Internal Compliance Programs, and Managing Future Litigation, scheduled on Tuesday, May 22, 2012 starting at 1pm EDT. Strafford Publications, Inc