United States District Court, D. Arizona
Decided November 21, 2014
[Copyrighted Material Omitted]
For Debra Martin, Patrick Martin, Plaintiffs: Adam T Funk, LEAD ATTORNEY, Branch Law Firm, Albuquerque, NM; Deborah S Kerr, LEAD ATTORNEY, Goldberg & Osborne, Phoenix, AZ; Marlene J Goldenberg, LEAD ATTORNEY, Goldenberg Law PLLC, Minneapolis, MN; Stuart L Goldenberg, LEAD ATTORNEY, Goldenberg Law PLLC, Minneapolis, MN; Turner Williamson Branch, LEAD ATTORNEY, Branch Law Firm, Albuquerque, NM; Margaret M Branch, Branch Law Firm, Albuquerque, NM.
For Medtronic Incorporated, Medtronic Sofamor Danek USA Incorporated, Defendants: Kathleen Kelly Kahn, LEAD ATTORNEY, Lewis Roca Rothgerber LLP - Phoenix Office, Phoenix, AZ; Michael Kevin Brown, LEAD ATTORNEY, Reed Smith LLP, Los Angeles, CA; Stephen M Bressler, LEAD ATTORNEY, Lewis Roca Rothgerber LLP - Phoenix Office, Phoenix, AZ.
ORDER Motion to Strike; Motion to Dismiss
H. Russel Holland, United States District Judge.
Defendants move to dismiss plaintiffs' first amended complaint. This motion is opposed. In the alternative, defendants move to strike portions of plaintiffs' first amended complaint. The motion to strike is opposed. Oral argument was requested and has been heard on both motions.
Plaintiffs are Debra and Patrick Martin. Defendants are Medtronic, Inc. and Medtronic 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-Cage[TM]); (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."  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.
" 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."  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[.] 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 Plaintiff's physicians, the practice of using Infuse® without an LT-Cage[TM]
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.
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 ...