Debra v. Medtronic, Inc.

63 F. Supp. 3d 1050, 2014 U.S. Dist. LEXIS 164980
CourtDistrict Court, D. Arizona
DecidedNovember 24, 2014
DocketNo. 2:14-cv-0385-HRH
StatusPublished
Cited by7 cases

This text of 63 F. Supp. 3d 1050 (Debra v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Arizona primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Debra v. Medtronic, Inc., 63 F. Supp. 3d 1050, 2014 U.S. Dist. LEXIS 164980 (D. Ariz. 2014).

Opinion

ORDER

H. RUSSEL HOLLAND, District Judge.

Motion to Strike; Motion to Dismiss

Defendants move to dismiss1 plaintiffs’ first amended complaint. This motion is opposed.2 In the alternative, defendants move to strike portions of plaintiffs’ first amended complaint.3 The motion to strike is opposed.4 Oral argument was requested and has been heard on both motions. Background

Plaintiffs are Debra and Patrick Martin. Defendants are Medtronic, Inc. and Med-tronic Sofamor Danek USA, Inc.

Defendants manufacture and sell a Class III medical devise known as Infuse® Bone Graft/LT-Cage Lumbar Tapered Fusion Device. The “Infuse® product consists of (1) a metallic spinal fusion cage (the LT-CageTM); (2) Infuse® Bone Graft kit which comes with a vial of liquid rhBMP-2 and absorbable collagen sponges (ACS), which serve as carriers for the rhBMP-2 when the two are placed inside the LT-Cage.”5 The Infuse® device went through the FDA’s Premarket Approval process and was approved for use on July 2, 2002, for anterior lumbar interbody (ALIF) spinal fusion surgeries.6

“On or about July 14, 2010, the [p]laintiff Debra Martin underwent a posterolateral lumbar fusion at L4-5 and L5-1. To achieve fusion, [Debra’s] surgeon, Dr. Yadship Pannu, performed an unapproved procedure by utilizing a posterolateral approach and, by packing Atlas vertebral cages with Infuse® Bone Graft and placing the cages into multiple levels of [Debra’s] spine.”7 Plaintiffs allege that “the Atlas vertebral cage was not designed for use with a biologic, like rhBMP-2[,]” but that Dr. Pannu “was induced by Medtronic’s misrepresentations to perform this procedure[.]”8 Plaintiffs allege that

a. [defendants] fraudulently concealed and misrepresented the health and safety hazards, symptoms, constellation of symptoms, diseases and/or health problems associated with the unapproved uses of Infuse®;
b. [defendants] fraudulently concealed and misrepresented their practice of promoting and marketing to physicians, including Plaintiffs physicians, the practice of using Infuse® without an LT-[1054]*1054Cage™ and/or the practice of using unapproved cages instead, like the cage used in [Debra’s] surgery, and placing it via a posterolateral approach; [and]
c.[defendants] fraudulently concealed and misrepresented information about the known comparative risks and benefits of the use of Infuse® and the relative benefits and availability of alternate products, treatments and/or therapies.9

More specifically, plaintiffs allege that

a. Dr. Pannu completed his residency at Loyola University in Baltimore, Maryland from 1997 through 2003, when Infuse® Bone Graft was just being introduced to physicians. At that time, Loyola was what Dr. Pannu termed a “Medtronic facility,” meaning that the hospital received various educational grants from Medtronic.
b. Dr. Pannu’s professors at Loyola first taught him how to use Infuse® Bone Graft. Dr. Pannu was told that Infuse® was safer and more effective than ICBG or donor bone (allograft). It was at this time that Dr. Pannu said he learned about the safety and efficacy profile of Infuse.
c. In addition to his training that he received from Loyola, Dr. Pannu relied heavily upon the medical literature that he read on Infuse® Bone Graft. Specifically, Dr. Pannu recalls reading a number of articles through the “journal club” he was a part of, where he and other physicians read and reviewed articles on Infuse® Bone Graft, none of which disclosed any adverse events. Dr. Pannu recalled reading the 2004 article by Dr. Haid,[10] wherein the results of the 1999 PLIF study ... were published in a distorted, false, and misleading manner.
d. Dr. Pannu relied upon this and other articles to ascertain how safe Infuse® Bone Graft was for his patients like Debra Martin.
e. After completing his residency, Dr. Pannu began working at Midwest Neu-rosciences in 2003, where he continues to work today. While there, Dr. Pannu continued to educate himself on Infuse®. Specifically, Dr. Pannu relied upon information he received from his colleagues, particularly Dr. Arvind Ahu-ja. Dr.' Ahuja, according to a published article in The Milwaukee Journal Sentinel, [11] similarly relied upon the medical literature on Infuse® Bone Graft to ascertain the safety and efficacy profile of the product and was likewise misled by the false statements contained therein.
f. Dr. Pannu’s Medtronic sales representative was Kris Boetcher. Mr. Boetcher was frequently in the operating room with Dr. Pannu, and during these procedures, he would assist Dr. Pannu and his nurses with the appropriate doses for unapproved procedures, such as Debra Martin’s. Dr. Pannu believed that the unapproved procedures he was performing were safe, because Mr. Boetcher was helping to- ensure patients received a proper dose of rhBMP-2.
[1055]*1055g. Ultimately, Dr. Pannu decided to use Infuse® on Debra Martin, because he believed that it was safer and more effective than ICBG, based upon the misrepresentations outlined herein.[12]

Plaintiffs allege that “on or around August 2013, [Debra] was diagnosed with bony overgrowth at L5-S1. A CT-scan also revealed the formation of a cyst near the cage, which had become displaced. As a result, [Debra] has required extensive medical treatment.”13 Plaintiffs further allege that Debra “continues to suffer daily, disabling pain that prevents her from performing many basic activities of daily living.”14 In short, plaintiffs allege that defendants’ misrepresentations led to Dr. Pannu’s off-label use of the Infuse® device, which led to bony overgrowth in Debra’s spine, which has caused her debilitating pain.

On February 27, 2014, plaintiffs commenced this action. In their original complaint, Debra asserted seven state law causes of action against defendants: 1) fraudulent misrepresentation/fraud in the inducement, 2) strict products liability—failure to warn, 3) strict products liability—design defect, 4) strict products liability—misrepresentation, 5) product liability—negligence, 6) breach of express warranty, and 7) violation of Arizona’s Consumer Protection statutes. Debra’s claims were based on her contention that defendants “should not have violated federal law by falsely and misleadingly promoting and marketing new designs and uses for a product that were never considered or approved by the FDA.”15 Patrick asserted a loss .of consortium claim.

Defendants moved to dismiss plaintiffs’ original complaint, and on July 23, 2014, 32 F.Supp.3d 1026, 2014 WL 3635292 (D.Ariz.2014), the court granted that motion and all of plaintiffs claims were dismissed.16 The majority of Debra’s claims were dismissed because they were preempted by the Medical Device Amendments of 1976. “A state law claim will be expressly preempted ...

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Related

Myers v. County of Fresno
E.D. California, 2023
Angeles v. Medtronic, Inc.
863 N.W.2d 404 (Court of Appeals of Minnesota, 2015)
Jones v. Medtronic
89 F. Supp. 3d 1035 (D. Arizona, 2015)

Cite This Page — Counsel Stack

Bluebook (online)
63 F. Supp. 3d 1050, 2014 U.S. Dist. LEXIS 164980, Counsel Stack Legal Research, https://law.counselstack.com/opinion/debra-v-medtronic-inc-azd-2014.