If You Label It, They Will Come Kasey Mitchell Adams Butler Snow - - PowerPoint PPT Presentation

If You Label It, They Will Come

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Kasey Mitchell Adams Butler Snow LLP

COMMON PRODUCT LIABILITY CLAIMS

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Negligence Design Defect Manufacturing Defect Strict Liability Failure to Warn

FAILURE TO WARN

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Requires the Plaintiff to show that the manufacturer (i) failed to warn of the risks of the products and (ii) the failure to warn caused the Plaintiff’s injury.

FAILURE TO WARN

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General Causation Specific Causation Adequacy General Causation Proximate Causation

LEARNED INTERMEDIARY DOCTRINE

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No causation on failure to warn if: (i) Physician did not rely on warnings provided by manufacturer; (ii) Physician knew the risks and decided to use the product anyway; (iii) Physician would not alter decision if he/she had known of the risks.

INNOVATOR LIABILITY

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What is it and why does it matter to me?

WARNING SIGNS

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FDA Warning Letter Label Change Literature General Causation News Reports Investigations Complaints Citizens’ Petition Advertisements

PRELIMINARY RISK ASSESSMENT

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Litigation Hold Interviews Competitor Labels General Causation Regulatory Review Document Decisions Collaborate Track Advertisements Communicate

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LEGAL DEFENSES TO LABELING CLAIMS

Statute of Limitations No Failure to Warn

Available Accessible Accurate Accepted

Preemption

EVIDENCE

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Company Documents Regulatory Story Literature/Reports General Causation Competitor Labeling

BEST PRACTICES

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Call Notes Communication Practices Stick to the Facts Proper Documentation Follow Policy

QUESTIONS? Kasey.Adams@butlersnow.com

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THANK YOU

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