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Paul Bentzley v. Medtronic

November 28, 2011

PAUL BENTZLEY PLAINTIFF,
v.
MEDTRONIC, INC., ET AL., DEFENDANTS.



The opinion of the court was delivered by: Eduardo C. Robreno, J.

MEMORANDUM

TABLE OF CONTENTS

I. BACKGROUND................................................ 3

A. Premarket Approval of Model MMT-522 Paradigm Real-Time Insulin & Glucose Monitoring System.................. 3

B. Plaintiff's MMT-522 System........................... 6

C. Procedural History................................... 9

II. DISCUSSION............................................... 10

A. Standard of Review.................................. 11

B. Preemption.......................................... 12

1. The Federal Government Established Requirements Applicable to the MMT-522 System............... 13

2. Whether Plaintiff's Claims are Based on Parallel Federal Requirements........................... 18

a. Strict products liability and negligence claims.................................... 20

b. Breach of implied warranty claims......... 23

c. Breach of express warranty claim.......... 24

C. Failure to Meet Summary Judgment Standard........... 26

1. Manufacturing Defects.......................... 26

2. Failure to Warn................................ 28

a. Prescription for device................... 29

b. FDA-required warnings..................... 34

III. CONCLUSION............................................... 39

Before the Court is Defendants' Motion for Summary Judgment on Plaintiff's products liability, negligence, and breach of warranty claims under Pennsylvania law. The issue before the Court is whether the Medical Device Amendments of 1976 ("MDA") expressly preempt certain state law claims. For the reasons that follow, the Court will grant Defendants' motion on all of Plaintiff's claims except for the claim for breach of express warranty.

I.BACKGROUND

A. Premarket Approval of Model MMT-522 Paradigm Real-Time Insulin & Glucose Monitoring System Medtronic, Inc., and Medtronic Minimed, Inc. ("Defendants") manufacture and distribute the Model MMT-522 Paradigm Real-Time Insulin & Glucose Monitoring System ("MMT-522 System").*fn1 That system provides continuous glucose monitoring and consists of three components: a real-time continuous glucose sensor, a radio frequency transmitter, and a "smart" insulin pump. Am. Compl. ¶¶ 14-15. The system delivers insulin "automatically and continuously 24-hours a day." Paradigm 522 and 722 Insulin Pumps User Guide 1, ECF No. 36-5 (hereinafter "User Guide"). The MMT-522 System is a Class III medical device approved by the U.S. Food and Drug Administration ("FDA"). Faillace Decl. ¶ 5, ECF No. 36-3.

Medical devices intended for human use fall into three classes based on their risk to consumers. See 21 U.S.C. § 360c(a)(1);*fn2 Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Class I devices are subject only to "general controls," which involve the lowest level of oversight. § 360c(a)(1)(A); Riegel, 552 U.S. at 316. Class II devices are subject to "special controls," such as performance standards and post-market surveillance measures. § 360c(a)(1)(B); Riegel, 552 U.S. at 317. And Class III devices are subject to the highest level of federal oversight. § 360c(a)(1)(C). "In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is 'purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,' or 'presents a potential unreasonable risk of illness or injury.'" Riegel, 552 U.S. at 317 (quoting § 360c(a)(1)(C)(ii)). A new Class III device must receive premarket approval from the FDA.*fn3 Id.

Upon receiving premarket approval, a manufacturer may not change any aspect of the device that would affect its safety or effectiveness without first receiving FDA approval by "supplemental application." § 360e(d)(6)(A)(i). A supplemental application is "evaluated under largely the same criteria as an initial application." Riegel, 552 U.S. at 319 (citing § 360e(d)(6); 21 C.F.R. § 814.39(c)).

Defendants received premarket approval pursuant to a supplemental application for the MMT-522 System. On June 15, 1999, the FDA approved Defendants' premarket application for the Minimed Continuous Glucose Monitoring System. Faillace Decl. ¶ 6.*fn4 The FDA advised Defendants that the appropriate pathway to market approval for the MMT-522, the modified system, would be by supplemental application for premarket approval, not the § 510(k) notification process.*fn5 Id. ¶ 7. Defendants filed the supplemental application and, on April 7, 2006, after a six-month review process, the FDA approved the requested modifications to the original device "to enable the pump to accept data from the sensor, and to enable the sensor to communicate directly to the pump." Id. Ex. A.

B. Plaintiff's MMT-522 System

Paul Bentzley ("Plaintiff") suffers from Type One diabetes, which requires him to infuse insulin into his body to control his blood-sugar levels.*fn6 Barilla Dep. 8:20-25, Mar. 1, 2011, ECF No. 36-4. Plaintiff's physician, Dr. Donald Barilla, prescribed the MiniMed 507c insulin pump in 1998. Letter from Dr. Barilla 2 (Oct. 13, 1998), ECF No. 36-4. In 2003, Dr. Barilla prescribed the MMT-512 pump, the predecessor to the ...


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