Eidson v. Medtronic, Inc.

• Decision Date: 03 October 2013
• Docket Number: Case Nos.: 13–CV–02049–LHK, 13–CV–01502–LHK
• Parties: Richard Eidson, Plaintiff, v. Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc., Defendants. Scott Bell and April Bell, Plaintiffs, v. Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc., Defendants.
• Court: U.S. District Court — Eastern District of California

981 F.Supp.2d 868

Richard Eidson, Plaintiff,

v.Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc., Defendants.

Scott Bell and April Bell, Plaintiffs,

v.Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc., Defendants.

Case Nos.: 13–CV–02049–LHK, 13–CV–01502–LHK

United States District Court, N.D. California.

San Jose Division

October 3, 2013

Khaldoun Baghdadi, Sara M. Peters, Walkup Melodia Kelly & Schoenberger, San Francisco, CA, for Plaintiffs.

Michael Kevin Brown, Mildred Segura, Reed Smith LLP, Los Angeles, CA, Courtland Carter Chillingworth, Reed Smith, Oakland, CA, for Defendants.

ORDER GRANTING DEFENDANTS' MOTION TO DISMISS SCOTT AND APRIL BELL'S COMPLAINT, AND GRANTING IN PART AND DENYING IN PART DEFENDANTS' MOTION TO DISMISS RICHARD EIDSON'S COMPLAINT

LUCY H. KOH, United States District Judge

Plaintiffs Scott and April Bell bring this action based on harmful side effects Scott Bell suffered after undergoing spinal surgery in which his surgeon used a medical device produced by Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, “Defendants”). ECF Bell No. 1 at 1 (“Bell Complaint”).¹ Plaintiff Richard Eidson also brings this action based on harmful side effects he suffered after undergoing spinal surgery in which his surgeon used the same product produced by Defendants. ECF Eidson No. 1 at 1(“Eidson Complaint”). The two cases have been related because they involve the same product and similar questions of law. ECF Bell No. 23. Defendants move to dismiss both complaints pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief may be granted. ECF Bell No. 10; ECF Eidson No. 9. This order addresses both motions to dismiss. Having considered the submissions of the parties, the relevant law, and the record in this case, the Court GRANTS IN PART AND DENIES IN PART Defendants' motion to dismiss Richard Eidson's complaint, and GRANTS Defendants' motion to dismiss Scott and April Bell's complaint without prejudice.

I. BACKGROUNDA. Factual Allegations

1. Infuse Device

Medtronic Sofamor Danek, USA, Inc. manufactures a medical device known as the Infuse Device which stimulates bone growth, obviating the necessity of harvesting bone from a patient's hip. Bell Complaint ¶¶ 2, 51; Eidson Complaint ¶¶ 2, 50. Doctors can use the Infuse Device in spinal fusion surgeries to form a bone graft. Id. ¶¶ 1–2; Id. ¶¶ 1–2. The Device consists of three components: (1) a metallic spinal fusion cage (the LT Cage), (2) the bone graft substitute, which consists of liquid rhBMP–2, and (3) a spongy carrier or scaffold for the protein that resides in the fusion cage. Id. ¶ 34; Id.¶ 33. The latter two components are collectively called the Infuse Bone Graft. Id. ¶ 58; Id. ¶ 57. During surgery, the doctor attaches the fusion cage to the diseased spinal region in order to stabilize the area, soaks the collagen sponge with the rhBMP–2, and applies it to the diseased region. Id. ¶¶ 35–36; Id. ¶¶ 34–35. Later, the sponge dissolves while the rhBMP–2 stimulates the spinal cells to grow new bone in place of the diseased area. Id.;Id.

2. Premarket Approval of the Infuse Device

The Infuse Device is a Class III device under the Federal Food, Drug, and Cosmetic Act of 1938 (“FDCA”), as amended by the Medical Device Amendments of 1976 (“MDA”). Id. ¶¶ 45, 54; Id. ¶¶ 44, 54. Class three devices are those that pose the greatest risk of death or complications. Id.Id. Defendants were required to obtain premarket approval (“PMA”) from the FDA before they could sell the Infuse Device. Id. ¶¶ 44, 46; Id. ¶¶ 43, 45.

In July 2002, the FDA granted the Infuse Device PMA for spinal fusion procedures. Id. ¶¶ 4, 56–57; Id. ¶¶ 4, 55–56. The FDA's approval letter stated that the Device may be implanted (1) from the anterior (front) abdomen, and (2) placed within lumbar spine levels L4 through S1. Id. ¶ 59; Id. ¶ 58. The FDA–approved labeling stated that the Infuse Bone Graft must not be used without the LT Cage. Id. ¶ 58; Id. ¶ 57. Any operation that uses the Infuse Device in a manner other than that which has been approved by the FDA is called an “off-label” use. Id. ¶¶ 60, 62. This includes posterior lumbar interbody fusion surgery (“PILF”) (approaching the spine from the back), posterolateral fusion surgery (also approaching the spine from the back), or surgeries without the LT Cage. Id. ¶¶ 4, 59, 62; Id. ¶¶ 4, 58, 61. As described below, Plaintiffs' claims stem from off-label uses of the device. Id. ¶¶ 1–3, 279; Id. ¶¶ 1–3, 278.

In 2011, off-label uses of the Infuse Device made up close to ninety percent of the $800 million dollars in revenue the Device generated for Defendants. Id. ¶ 110; Id. ¶ 109. Defendants spent large sums of money to promote off-label uses by establishing consulting/royalty agreements with physicians who advocated off-label uses. Id. ¶¶ 112–114, 118–119; Id. ¶¶ 111–113, 117–118. Yet Defendants knew that various studies showed that off-label use could produce severe side effects in patients. Id. ¶¶ 64–73, 96–97; Id. ¶¶ 63–64, 95–96. Specifically, PLIF surgery had resulted in excessive bone growth in the location where the bone protein component of the device was applied. Id. ¶¶ 64–65; Id. ¶¶ 63–64.

Defendants tried to suppress this information by funding studies that omitted mentions of risk and funding articles by opinion leaders that showed a lower incidence of off-label adverse effects. Id. ¶¶ 80, 98, 119–120, 172–177; Id. ¶¶ 79, 97, 118–119, 171–176. In addition, Defendants failed to report certain adverse events to the FDA. Id. ¶¶ 106, 129–132, 165, 278; Id. ¶¶ 105, 128–131, 164, 277. These activities led to investigations by the Department of Justice and to significant controversial media coverage in the Wall Street Journal and the New York Times. Id. ¶¶ 89, 115, 133–135, 148, 178, 185, 195; Id. ¶¶ 88, 114, 132–34, 147, 177, 184, 194.

3. Plaintiff Scott Bell's Surgery

In February 2005, Scott Bell underwent a decompression laminectomy and posterolateral fusion surgery. Bell Complaint ¶ 279. His physician used the Infuse Device in an off-label manner by implanting it by means of a posterior, not anterior, approach, and an LT Cage was not used. Id.

Bell alleges Defendants directly and indirectly encouraged his surgeon to use an off-label procedure. Id. ¶ 280. After the surgery, Bell was diagnosed with bony overgrowth and underwent corrective surgery, whereby his surgeon discovered large columns of extra bone. Id. ¶ 281. He now has severe bony overgrowth, debilitating leg pain, decreased sensation, weakness, and other injuries presently undiagnosed. Id. ¶ 282.

As a result, Plaintiffs Scott and April Bell brought six causes of action against Defendants in connection with the Infuse Device: (1) fraudulent misrepresentation and fraudulent inducement ( Id. ¶¶ 284–296); (2) strict products liability—failure to warn ( id. ¶¶ 297–3 10); (3) strict products liability—design defect ( id. ¶¶ 311–320); (4) strict products liability—misrepresentation ( id. ¶¶ 321–329); (5) products liability—negligence ( id. ¶¶ 330–340); (6) products liability negligence for loss of consortium on behalf of April Bell ( id. ¶¶ 341–343).

4. Plaintiff Richard Eidson's surgery

In November 2008, Plaintiff Richard Eidson underwent an L3–L4 and L2–3 multilevel posterior lumbar interbody fusion and posterolateral fusion surgery. Eidson Complaint ¶ 278. His physician performed the surgery in an off-label manner by implanting the Infuse Device by means of a posterior, not anterior, approach, by using a multi-level fusion, and an LT Cage was not used. Id.

Eidson alleges Defendants directly and indirectly encouraged his surgeon to use an off-label procedure. Id. ¶ 279. After the surgery, he began experiencing new pain in his back and bilateral legs, experienced onset of new leg weakness, decreased leg sensation, and decreased reflexes in his legs. Id. ¶ 280. He was diagnosed with fluid-filled cysts within the vertebral bodies where the surgery had taken place. Id. Eidson now has severe low back pain, buttock pain, bilateral leg pain, and reduced sensation, strength, and reflexes in his lower extremities. Id. ¶ 281. He has also suffered bone resorption and ectopic bone growth, or bone overgrowth. Id. ¶ 12, 73.

As a result, Eidson brought five causes of action against Defendants in connection with the Infuse Device: (1) fraudulent misrepresentation and fraudulent inducement ( Id. ¶¶ 283–95); (2) strict products liability—failure to warn ( id. ¶¶ 296–309); (3) strict products liability—design defect ( id. ¶¶ 310–319); (4) strict products liability—misrepresentation ( id. ¶¶ 320–328); and (5) products liability—negligence ( id. ¶¶ 329–339).

B. Procedural History

Plaintiffs Scott and April Bell filed their complaint on April 3, 2013. ECF Bell No. 1. Defendants filed a Motion to Dismiss the Complaint on May 14, 2013. ECF Bell No. 10 (“Bell MTD”). Plaintiffs filed an opposition to the Motion to Dismiss on July 1, 2013. ECF Bell No. 20 (“Bell MTD Opp”). Defendants filed a reply on July 22, 2013. ECF Bell No. 24.

Plaintiff Richard Eidson filed his complaint on May 6, 2013. ECF Eidson No. 1. Defendants filed a Motion to Dismiss the Complaint on May 28, 2013. ECF Eidson No. 9 (“Eidson MTD”). Plaintiff filed an opposition to the Motion to Dismiss on July 1, 2013. ECF Edison No. 18 (“Edison MTD Opp”). Defendants filed a reply on July 22, 2013. ECF Eidson No. 21. On August 21, 2013, Plaintiffs and Defendants filed separate notices of supplemental authorities. ECF Bell Nos. 29, 30; ECF Eidson Nos. 24, 25. On September 6, 2013, Plaintiffs filed a notice of supplemental authorities. ECF Bell No. 31; ECF Eidson No. 26. On September 27, 2013, Defendants filed a statement of recent decisions. ECF Bell No. 33; ECF Eidson No. 28. The Court has considered these supplemental authorities. The Court also reminds the parties that Local Rule 7.3(d)(2) prohibits argument in such notices and statements.

II. LEGAL STANDARDSA. Motion to ...