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

If You Label It, They Will Come Kasey Mitchell Adams Butler Snow LLP BUTLER SNOW | 1

COMMON PRODUCT LIABILITY CLAIMS Manufacturing Negligence Design Defect Defect Strict Liability Failure to Warn BUTLER SNOW | 2

FAILURE TO WARN 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. BUTLER SNOW | 3

FAILURE TO WARN General Causation General Causation Specific Causation Adequacy Proximate Causation BUTLER SNOW | 4

LEARNED INTERMEDIARY DOCTRINE 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. BUTLER SNOW | 5

INNOVATOR LIABILITY What is it and why does it matter to me? BUTLER SNOW | 6

WARNING SIGNS Citizens’ Petition FDA Warning Letter General Causation Label Change Investigations Literature Complaints News Reports Advertisements BUTLER SNOW | 7

PRELIMINARY RISK ASSESSMENT Track Advertisements Litigation Hold General Causation Interviews Document Decisions Competitor Labels Collaborate Regulatory Review Communicate BUTLER SNOW | 8

LEGAL DEFENSES TO LABELING CLAIMS Statute of Preemption Limitations No Failure to Warn Available Accessible Accurate Accepted BUTLER SNOW | 9

EVIDENCE Company Documents General Causation Regulatory Story Literature/Reports Competitor Labeling BUTLER SNOW | 10

BEST PRACTICES Follow Policy Call Notes Communication Practices Stick to the Facts Proper Documentation BUTLER SNOW | 11

QUESTIONS? Kasey.Adams@butlersnow.com BUTLER SNOW | 12

THANK YOU BUTLER SNOW | 13