Kubicki ex rel. Kubicki v. Medtronic, Inc.

293 F.Supp.3d 129

John KUBICKI & Karen Kubicki, ON BEHALF OF Caroline KUBICKI, Plaintiffs,

v.MEDTRONIC, INC., et al., Defendants.

Civil No. 12–cv–734 (KBJ)

United States District Court, District of Columbia.

Signed February 5, 2018

Michelle Adrien Parfitt, Drew LaFramboise, L. Palmer Foret, Ashcraft & Gerel, LLP, Alexandria, VA, Adam R. Leighton, Cohen & Cohen, P.C., Washington, DC, Kevin Haverty, Pro Hac Vice, Williams Cuker Berezofsky LLC, Cherry Hill, NJ, for Plaintiffs.

Eric Lawrence Alexander, Jesse J. Ash, Reed Smith LLP, Kelly Marie Lippincott, Paul J. Maloney, Carr Maloney, P.C., Washington, DC, Keiko L. Sugisaka, Pro Hac Vice, Nicole E. Narotzky, Pro Hac Vice, Steven L. Schleicher, Pro Hac Vice, Maslon LLP, Minneapolis, MN, Michael K. Brown, Reed Smith, LLP, Los Angeles, CA, Leslie J. Suson, Pro Hac Vice, Zoe I. Martinez, Thompson Hine LLP, Atlanta, GA, for Defendants.

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 Warning Letter...148

III. PROCEDURAL HISTORY...149

A. The Initial Pump–Related Legal Action The Plaintiffs Brought Against Medtronic Alone...149

B. Plaintiffs' Amended Complaint, Which Adds Unomedical And Claims That Relate Specifically To The Infusion Set...150

C. Medtronic's And Unomedical's Motions For Summary Judgment...151

IV. LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT...152

V. RULING ON CAUSATION...152

A. The Record Evidence Thus Far Submitted Is Not Sufficient To Warrant Granting Summary Judgment To Defendants On Causation Grounds...153

B. The Parties Will Be Permitted To Revisit The Causation Question After Expert Discovery Is Completed...156

VI. RULING ON TIMELINESS...157

A. The Law Pertaining To Timeliness: Statutes Of Limitations, The Discovery Rule, And The Relation Back Doctrine...157

1. The Discovery Rule...158

2. The Relation Back Doctrine...158

B. Plaintiffs Could Have Discovered Their Claims Against Unomedical Regarding The MMT–396 Infusion Set Near The Time Of Caroline's Injury; Therefore, The Infusion Set Claims That Plaintiffs Belatedly Asserted Against Unomedical Are Untimely...159

1. Caroline's Insulin–Delivery Device Is A Multifaceted Medical Product, And The Manufacturers Of The Various Components Are Clearly Identified...160

2. Plaintiffs Rely On Dissimilar Cases To Support Their Contention That Their Infusion Set Claims Accrued In 2013...162

3. The Relation Back Doctrine Does Not Save The Infusion Set–Related Claims Against Unomedical...164

C. Plaintiffs' Infusion Set Claims Against Medtronic Relate Back To Their Preexisting MMT–522 Pump Claims Against That Defendant, And Thus Are Deemed Timely...166

VII. RULING ON PREEMPTION...167

A. The Law Pertaining To Classification Of Medical Devices And The Express And Implied Preemption Of State Law Claims Under The Medical Device Amendments To The Food, Drug And Cosmetics Act...168

1. The MDA's Device–Classification Scheme...168

2. Express Preemption Of State Law Claims Under the MDA...170

3. Implied Preemption Of State Law Claims Under the MDA...172

B. With One Exception, The MDA Expressly Preempts All Of The Kubickis' MMT–522 Pump Claims...173

1. State Law Claims Pertaining To The MMT–522 Pump Are Subject To The MDA's Express Preemption Provision Because That Device Was Approved Pursuant To The FDA's Premarket Approval Process...174

2. Plaintiffs Have Not Established That Their Pump–Related State Law Claims Are Genuinely Equivalent To Specific Federal Law Requirements...176

a. The CGMPs and general labeling and instruction regulations that Plaintiffs cite are insufficient to support a parallel state law claim asserting a design, manufacturing, or labeling defect, or a breach of warranty...178

b. Plaintiffs have not identified a genuinely equivalent parallel state law claim pertaining to Medtronic's failure to report events to the FDA...182

C. The Implied Preemption Doctrine Does Not Bar Plaintiffs' Claims Against Medtronic For The Allegedly Negligent Design, Manufacture, And Labeling Of The MMT–396 Infusion Set, And The Claims Based On Medtronic's Alleged Failure To Warn Consumers About That Product Also Survive...185

VIII. RULING ON THE LEARNED INTERMEDIARY DOCTRINE, THE KUBICKIS' INFUSION SET WARRANTY CLAIM, AND PUNITIVE DAMAGES...188

A. Medtronic Is Not Entitled To Summary Judgment With Respect To The Failure To Warn Claims On The Basis Of The Learned Intermediary Doctrine...188

B. Medtronic Is Entitled To Summary Judgment On Plaintiffs' Breach Of Express Warranty Claim Because The Statements On Which Plaintiffs Rely Do Not Create An Actionable Warranty...190

C. While Medtronic Is Entitled To Summary Judgment On Plaintiffs' Stand–Alone Punitive Damages Claim, It Is Premature To Foreclose Punitive Damages As A Remedy...192

IX. CONCLUSION...193

MEMORANDUM OPINION

I. INTRODUCTION

This complex products-liability action arises out of a tragic event in the life of Caroline Kubicki, a Type–I diabetic who began using a mechanical pump and an associated infusion set to administer the insulin necessary to manage her diabetes when she was 12 years old. Caroline was 19 and a sophomore at George Washington University ("GW") in early September of 2007, when she experienced severe hypoglycemia in her dormitory room and suffered a traumatic brain injury as a result of the low blood sugar levels. Caroline currently resides in a group home in a persistent vegetative state, and her parents, John and Karen Kubicki ("Plaintiffs" or "the Kubickis"), have filed the instant lawsuit against the company that designed and manufactured the insulin pump and a component of the associated infusion set that Caroline was using at the time of the incident—Medtronic, Inc.—along with certain of its subsidiaries, Medtronic Diabetes and Medtronic MiniMed, Inc. (collectively, "Medtronic"). The Kubickis have also sued Unomedical Devices SA de CV, the manufacturer and assembler of the infusion set, and one of that company's affiliates, Unomedical A/S (collectively, "Unomedical").

The Kubickis' amended complaint contains 25 state law claims that concern two medical devices: the Medtronic MiniMed Paradigm® Insulin Pump Model MMT–522 ("the MMT–522 Pump") and the Medtronic MiniMed Paradigm® Quick-set Infusion Set, Model MMT–396 ("the MMT–396 Infusion Set"). (See Second Am. Compl. ("2nd Am. Compl."), ECF No. 124, ¶¶ 6, 20.) The complaint's myriad claims can generally be grouped into five categories. The first five counts (hereinafter referred to as "the negligence claims") generally allege that the defendants committed common law negligence with respect to the design and manufacturing of both the MMT–522 Pump and the MMT–396 Infusion Set, and that defendants breached both the duty to provide adequate consumer instructions, labels, and warnings with respect to these devices, and the duty to take "reasonable care in documenting, logging, investigating, and reporting to the FDA" public complaints about these devices. (Id. ¶ 91; see id. ¶¶ 88–117 (Counts I–V).) Counts VI through X cast similar allegations as common law "strict liability" claims (see, e.g., id. ¶ 149 (contending that defendants "sold the [insulin-delivery devices] to Ms. Kubicki in a defective condition what was unreasonably dangerous to consumers"); see also id. ¶¶ 118–152 (Counts VI–X) ), while Counts XI through XV (hereinafter the "express warranty claims") assert that each defendant breached an express warranty upon which Caroline, her parents, and her physicians relied (see id. ¶¶ 153–203). The final two groups of claims in the complaint (the "failure to warn" claims) allege that the defendants failed to warn users and the FDA "of the foreseeable harm associated with the use" of the insulin-delivery devices (id. ¶ 205; see id. ¶¶ 204–253 (Counts XVI–XX) ), and that the Kubickis are entitled to "punitive damages" because each defendant company "acted maliciously, willfully, wantonly, and recklessly without regard to the safety of others" (id. ¶ 262; see id. ¶¶ 254–263 (Counts XXI–XXV) ). To date, the parties have completed fact discovery—but not expert discovery—in this matter, and Plaintiffs have pared down the charges against Unomedical, such that the only claims remaining against the Unomedical defendants are the failure to warn claims that appear in the complaint both as separate claims and as part of the negligence and strict liability theories. (See Mot. Hr'g Tr., ECF No. 152, at 5:5–6:1 (Nov. 3, 2016).)

Before this Court at present are two motions for summary judgment that Medtronic and Unomedical have filed. (See Medtronic Mot. for Summ. J. or, in the Alternative, for Partial Summ. J. ("Medtronic's MSJ"), ECF No. 133; Unomedical Mot. for Summ. J. ("Unomedical's MSJ"), ECF No. 134.)¹ Plaintiffs oppose these motions, but have not cross-moved for summary judgment. (See Pls.' Opp'n to Defs.' Mots. for Summ. J. ("Pls.' Opp'n"), ECF No. 141.) Medtronic first argues that Plaintiffs cannot establish the requisite causation because, among other things, the existing record evidence definitively establishes that Caroline was not wearing her insulin pump at the time of the hypoglycemic incident.² In addition, Medtronic also maintains that the Kubickis' common law tort and express warranty claims are entirely preempted and/or barred by the applicable statutes of limitations (see Mem. in Support of Medtronic's Mot. for Summ. J. or, in the alternative, for Partial Summ. J. ("Medtronic's Mem."), ECF No. 133–1, at 31–62), and Medtronic further contends that, because the record contains no evidence...