United States District Court, D. Hawaii
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For Karla Beavers-Gabriel, Plaintiff: Bruce H. Wakuzawa, LEAD ATTORNEY, The Law Office of Bruce H. Wakuzawa, ALC, Honolulu, HI; Marlene J. Goldenberg, Stuart L. Goldenberg, LEAD ATTORNEYS, PRO HAC VICE, GoldenbergLaw, PLLC, Minneapolis, MN.
For Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., Defendants: Corlis J. Chang, Thomas Benedict, LEAD ATTORNEYS, Goodsill Anderson Quinn & Stifel LLLP, Honolulu, HI; Lisa M. Baird, Michael K. Brown, LEAD ATTORNEYS, PRO HAC VICE, Reed Smith LLP, Los Angeles, CA.
J. Michael Seabright, United States District Judge.
ORDER GRANTING DEFENDANTS MEDTRONIC, INC. AND MEDTRONIC SOFAMOR DANEK USA, INC.'S MOTION TO DISMISS PLAINTIFF'S COMPLAINT PURSUANT TO Fed.R.Civ.P. 12(B)(6)
On December 16, 2013, Plaintiff Karla Beavers-Gabriel (" Plaintiff" ) filed this action against Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, " Medtronic" or " Defendants" ), asserting state law claims based on injuries she sustained after undergoing spinal surgery in which her surgeon used Defendants' Infuse(r) Bone Graft (the " Infuse Device" or " Infuse(r)" ), a Class III prescription medical device, in an off-label manner not approved by the Food and Drug Administration (" FDA" ).
Currently before the court is Defendants' Motion to Dismiss, in which they argue that Plaintiff's claims are expressly preempted by the Medical Device Amendments (" MDA" ) of the Federal Food, Drug, and Cosmetic Act (" FDCA" ), 21 U.S.C. § 360k(a), impliedly preempted by the " no private right of action clause" of the FDCA, 21 U.S.C. § 337(a), and in any event fail to assert plausible claims for relief or comply with Federal Rule of Civil Procedure 9(b). Based on the following, the court finds that Plaintiff's claims are preempted in part and otherwise fail to assert a plausible claim for relief and/or comply with Rule 9(b). The court therefore GRANTS Defendants' Motion to Dismiss,
with leave for Plaintiff to amend as to certain claims.
A. Factual Background
To properly frame the issues presented in Defendant's Motion to Dismiss, the court provides the following factual background based on the allegations of the Complaint, the judicially-noticed facts, as well as the statutes and caselaw explaining the FDA's approval process of Class III medical devices such as the Infuse Device.
1. FDA Approval and Oversight of Class III Medical Devices
Class III medical devices such as the Infuse Device are regulated by the FDA pursuant to the Medical Device Amendments of 1976 (the " MDA" ) of the FDCA. Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Of the three classes of medical devices, Class III medical devices pose the greatest risk of death or complications -- " 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.'" Id. (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)).
Class III medical devices are subjected to a " rigorous regime" of premarket approval (" PMA" ). Id. To obtain PMA, a manufacturer must submit a multi-volume application outlining, among other things, all studies and investigations of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a " full statement" of the device's " components, ingredients, and properties and of the principle or principles of operation; " " a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device; " samples or device components required by the FDA; and a specimen of the proposed labeling. Id. at 318 (citing 21 U.S.C. § 360e(c)(1)). The FDA will spend an average of 1,200 hours per application, and will grant PMA " only if it finds there is a
'reasonable assurance' of the device's 'safety and effectiveness,'" after weighing " 'any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.'" Id. (quoting 21 U.S.C. § § 360e(d) & 360c(a)(2)(C)).
FDA approval of a Class III medical device does not end oversight --" [o]nce a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Id. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). As a result, " [i]f the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application." Id. (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). The manufacturer also has continuing reporting duties to the FDA of any new studies of the device or incidents of adverse affects, and " [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling." Id. at 319-20 (citing 21 U.S.C. § 360e(e)(1)).
2. FDA Approval of the Infuse Device
On July 2, 2002, the FDA approved the Infuse Device " to treat degenerative disk disease, but only by means on one specific procedure, namely, anterior lumbar interbody fusion (" ALIF" ) surgeries on a single level between L4 and S1." Doc. No. 1, Compl. ¶ 74; see also Doc. No. 15-1, Defs.' Ex. A. The Infuse Device is approved only for use with the ALIF procedure, and is not approved for use in cervical spine surgery, any lumber surgery performed through the back or side of the body, or any back surgeries that use Infuse Bone Graft Component without the LT-Cage. Doc. No. 1, Compl. ¶ 4.
The Infuse Device consists of (1) a metallic cylindrical spacer used to keep the two vertebrae in place and to direct the development of new bone growth (the " LT-Cage" ); and (2) the Bone Graft Component, which includes a collagen sponge that acts as a carrier and scaffold for the active ingredient, rhBMP-2 protein, which promotes bone growth. Id. ¶ 72. The labeling for the Infuse Device, as approved by the FDA, provides: " These components must be used as a system. The Infuse(r) Bone Graft component must not be used without the LT-Cage(tm) Lumbar Tapered Fusion Device Component." Id. ¶ 75; see also Doc. No. 15-7, Defs.' Ex. G at 1.
The labeling further warns against using the Infuse Device in spinal surgeries beyond what is approved by the FDA:
The safety and effectiveness of the InFUSE Bone Graft component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established. When degenerative disc disease was treated by a posterior lumber interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances.
Doc. No. 15-7, Defs.' Ex. G at 4. An earlier Medtronic trial using rhBMP-2 in a posterior lumbar interbody fusion was halted in
December 1999 when uncontrolled bone growth developed, see Doc. No. 1, Compl. ¶ ¶ 81-82, and the FDA Advisory Committee Panel voiced concerns regarding the potential for off-label use and admonished Medtronic to guard against procedures beyond the specific ALIF procedure approved by the FDA. Id. ¶ ¶ 84-86.
3. Off-Label Use of the Infuse Device
Although the Infuse Device is approved only for the ALIF procedure and by using both of its components together, Medtronic sells the Bone Graft Component separately from the LT-Cage, and physicians may use FDA-approved medical devices " in any way they see fit" so long as the patient is fully informed of the off-label use. Id. ¶ ¶ 76, 79. Off-label uses of the Infuse Device account for 85 to 90 percent of all spine surgeries using the Infuse Device, id. ¶ 133, even though these off-label uses have resulted in many more reported adverse events than on-label uses. Id. ¶ 110. Adverse effects include severe uncontrolled or ectopic bone growth, severe inflammatory reaction, adverse back and leg pain events, radiculits, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement. Id. ¶ 115.
The Complaint asserts that Medtronic, aware of the heightened risks of off-label uses, nonetheless engaged in an aggressive campaign to promote off-label uses of the Infuse Device. For example, Medtronic funded studies which failed to accurately describe the adverse side effects of off-label uses, id. ¶ ¶ 115, 143, and ensured that adverse side effects were under-reported by writing and editing the published medical literature. Id. ¶ ¶ 153(d), 189-90, 253-54. The Complaint further asserts that Medtronic (1) used its sales representatives to promote off-label uses by assisting physicians during surgery, distributing false and misleading medical literature that was written and/or edited by Medtronic, recommending dosages, and referring physicians to paid Medtronic physicians; (2) used its distributors to purchase gifts for physicians and facilities to induce them to use the Infuse Device off-label; (3) and used " opinion leaders" and other paid physician consultants to promote off-label uses of the Infuse Device at conferences, VIP meetings, demonstrations, and to serve as resources for other physicians seeking information on off-label uses. Id. ¶ 153.
4. Plaintiffs Surgery
On April 17, 2008, Plaintiff underwent a transforaminal lumbar interbody fusion and posterolateral fusion at L5-S1 in Honolulu, Hawaii. Id ¶ 299. To achieve this fusion, Plaintiffs surgeon used the Infuse Device in an off-label manner by using a transforaminal and posterolateral approach as well as by placing rhBMP-2 both inside and outside of non-LT-Cages. Id The Complaint asserts that Plaintiff s surgeon was encouraged to engage in this off-label procedure by Medtronic's sales representatives and paid key opinion leaders. Id ¶ 300. After the surgery, Plaintiff was diagnosed with heterotopic bone growth, secondary to rhBMP-2 at the right neuroforamen of the S1 nerve root, requiring extensive medical treatment and additional surgery, and causing significant injuries to Plaintiff. Id ¶ ¶ 301-02.
B. Procedural History
Plaintiff s December 16, 2013 Complaint, containing 414 paragraphs, alleges
eight causes of action titled (1) Fraudulent Misrepresentation and Fraud in the Inducement; (2) Strict Products Liability -- Failure to Warn; (3) Strict Products Liability -- Design Defect; (4) Strict Products Liability -- Misrepresentation; (5) Products Liability -- Negligence; (6) Breach of Express Warranty; (7) Breach of Hawaii's Consumer Protection Statutes; and (8) Punitive Damages.
On February 4, 2014, Defendants filed their Motion to Dismiss. Doc. No. 14. On March 13, 2014, the parties stipulated to dismissal of Count 7 of the Complaint for Breach of Hawaii's Consumer Protection Statutes. Doc. No. 21. On March 14, 2014, Plaintiff filed her Opposition, Doc. No. 22, and Defendants filed their Reply on March 24, 2014. Doc. Nos. 26, 28. A hearing was held on April 7, 2014. At the April 7, 2014 hearing, Plaintiff's counsel conceded to dismissal of the " Strict Products Liability -- Misrepresentation" claim.
III. STANDARDS OF REVIEW
A. Rule 12(b)(6): Failure to State a Claim
Federal Rule of Civil Procedure 12(b)(6) permits a motion to dismiss a claim for " failure to state a claim upon which ...