Kubicki ex rel. Kubicki v. Medtronic, Inc.

KETANJI BROWN JACKSON, United States District Judge

TABLE OF CONTENTS

I. INTRODUCTION...139

II. FACTS RELATED TO CAROLINE AND HER INJURIES...141

A. The Hypoglycemic Event...141

B. The Medtronic Paradigm Insulin Pump Model MMT-522 And The Medtronic MiniMed Paradigm Quick-set Infusion Set, Model MMT-396...143

1. The Design And Operation Of These Medical Devices...143

2. The Approval, Manufacturing, And Marketing Of These Medical Devices...145

C. Infusion Set Recalls In 2009 And 2013...146

1. 2009 Return And Replace Recall Of The "Lot 8" Batch...146

2. 2013 Paradigm Infusion Set Recall...146

3. 2013 FDA…