Warnings-Based Claims in Product Liability Navigating U.S. Standards - - PowerPoint PPT Presentation

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Warnings-Based Claims in Product Liability Navigating U.S. Standards - - PowerPoint PPT Presentation

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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, 2012 1pm Eastern | 12pm Central

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Warnings-Based Claims in Product Liability

Navigating U.S. Standards for Warnings; Leveraging the Requirements in Litigation

Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

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have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.

WEDNESDAY, APRIL 25, 2012

Presenting a live 90-minute webinar with interactive Q&A

Phoebe A. Wilkinson, Partner, Chardbourne & Parke, New York Kenneth Ross, Of Counsel, Bowman and Brooke, Minneapolis

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Warnings and Instructions: Law and Standards

Kenneth Ross 952.933.1195 kenrossesq@comcast.net Bowman and Brooke LLP April 25, 2012

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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

14 Kenneth Ross

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Labeling Standards

U.S.

 ANSI Z535 (all products where no product

specific standard applies)

 ANSI Z400.1/Z129.1-2010 (hazardous

industrial chemicals)

Europe

 ISO 3864 (all products except chemicals

and where law requires different label)

 Product specific European Directives

15 Kenneth Ross

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Label elements

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

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ANSI Z535.4 Format

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Z535 Signal Words

Danger – will cause serious injury or death Warning – could cause serious injury or death Caution – will or could cause moderate

  • r minor injury and property damage

NOTICE – property damage only

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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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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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

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

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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 Kenneth Ross

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ISO Safety Labeling Standards

ISO 3864 Part 2 Product Safety Labels Accepts symbol-only formats

ISO 3864-2 incorporated by reference in 2007 ANSI Z535.4

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3864-Part 2 Accepts Various Formats

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ISO 3864

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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: www.vesstech.com

30 Kenneth Ross

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Safety Label Issues

Other standards – U.S. and Europe Size Placement Material Adhesion

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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 Kenneth Ross

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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 Kenneth Ross

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ANSI Z535.6 - goals

address the applicability of elements of

  • ther 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 Kenneth Ross

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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 Kenneth Ross

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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 Kenneth Ross

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Recommendations

Comply with U.S. law and ANSI Z535 and

  • ther 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 Kenneth Ross

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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 Kenneth Ross

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For more information:

www.productliabilityprevention.com

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Warnings-Based Claims in Product Liability

Phoebe A. Wilkinson

pwilkinson@chadbourne.com (212) 408-1157 April 25, 2012

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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
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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

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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
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Consumer Fraud Act Claims

  • Attractive Recovery Possibilities
  • Treble damages
  • Attorneys’ fees and costs
  • Punitive damages
  • Statutory minimum damage awards
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Be Aggressive in Exploring Bases To Fight Back Regulated Industry?

  • Abstention
  • Primary Jurisdiction
  • Have Administrative Remedies Been Properly

Exhausted?

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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
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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

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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?

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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?

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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

Be Aggressive in Exploring Bases To Fight Back

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Q&A

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Thanks.

Strafford Publications, Inc. 1-800-926-7926 www.straffordpub.com

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 .