Caplinger v. Medtronic, Inc.

• Decision Date: 08 April 2013
• Docket Number: Case No. CIV–12–630–M.
• Citation: 921 F.Supp.2d 1206
• Parties: Patricia CAPLINGER, Plaintiff, v. MEDTRONIC, INC., a Minnesota corporation, and Medtronic Sofamor Danek USA, Inc., a Tennessee corporation, Defendants.
• Court: U.S. District Court — Western District of Oklahoma

921 F.Supp.2d 1206

Patricia CAPLINGER, Plaintiff,

v.MEDTRONIC, INC., a Minnesota corporation, and Medtronic Sofamor Danek USA, Inc., a Tennessee corporation, Defendants.

Case No. CIV–12–630–M.

United States District Court, W.D. Oklahoma.

Feb. 6, 2013.

Order Denying Reconsideration April 8, 2013.

James W. Dobbs, Rhodes Dobbs & Stewart PLLC, Edmond, OK, for Plaintiff.

Mary B. Scott, Murray E. Abowitz, Abowitz Timberlake & Dahnke PC, Oklahoma City, OK, for Defendants.

ORDER

VICKI MILES–LaGRANGE, Chief Judge.

Before the Court is defendants' Motion to Dismiss Plaintiff's Amended Complaint, filed August 9, 2012. On September 4, 2012, plaintiff filed her response, and on September 20, 2012, defendants filed their reply.

I. Background

On August 25, 2010, plaintiff had a posterior lumbar interbody fusion surgery at the L5–S1 spine to correct a degenerative disc condition.¹ The Infuse® Bone Graft product (“Infuse Device”) was used in the surgery. In October and November 2010, plaintiff's symptoms returned and worsened and included a drop foot condition in her right leg allegedly resulting from exuberant bone growth caused by the use of the Infuse Device. In December 2010, plaintiff's drop foot condition caused a tear of the anterior cruciate ligament in her right knee, which required surgery in February 2011. Because of exuberant bone growth in plaintiff's lumbar spine, revision surgery was required on September 9, 2011. Exuberant bone growth is continuing and will likely require a second revision surgery.

The Infuse Device was made by defendants. It is a medical device consisting of three parts: (1) a recombinant human bone morphogenetic protein, (2) a collagen scaffold, and (3) an interbody fusion device (essentially, a cage). The Infuse Device is used for the treatment of degenerative disc disease in a surgical procedure known as spinal fusion. The Infuse Device is a Class III medical device approved by the Federal Drug Administration (“FDA”) through the Premarket Approval (“PMA”) process. The Infuse Device has been approved for use in lumbar surgery that is performed through the abdomen (anterior) but has not been approved for use in lumbar surgery that is performed through the back (posterior). The Infuse Device was initially approved on July 2, 2002. The FDA has since approved thirty-seven supplements to its PMA.

On June 4, 2012, plaintiff filed the instant action. On July 23, 2012, plaintiff filed an Amended Complaint. In her Amended Complaint, plaintiff alleges seven causes of action against defendants in connection with their Infuse Device: (1) fraudulent misrepresentation and fraud in the inducement, (2) constructive fraud, (3) strict products liability—failure to warn, (4) strict products liability—design defect, (5) breach of express and implied warranty, (6) negligence, and (7) negligent misrepresentation.

Pursuant to Federal Rule of Civil Procedure 12(b)(6), defendants now move this Court to dismiss plaintiff's Amended Complaint with prejudice. Defendants assert that plaintiff's claims are expressly preempted in their entirety by the Medical Device Amendments of 1976, 21 U.S.C. § 360(k), as interpreted by the Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), because they seek to impose state-law requirements on the design, manufacture, or labeling of the Infuse Device that are different from or in addition to the federal requirements imposed by the FDA. Moreover, defendants assert that to the extent plaintiff's claims seek to enforce the provisions of federal law governing the promotion of medical devices for “off-label” uses, they are impliedly preempted under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) and prohibited by the “no private cause of action” clause of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 337(a).

II. The Statutory and Regulatory Framework and the PMA Process

The Federal Food, Drug, and Cosmetic Act (“FDCA”), 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., has long required FDA approval for the introduction of new drugs into the market; however, the introduction of new medical devices was left largely for the states to supervise as they saw fit. See Riegel, 552 U.S. at 315, 128 S.Ct. 999. The regulatory landscape changed in the 1960's and 1970's, as complex devices proliferated and some failed, most notably the Dalkon Shield. See id. As a result, Congress stepped in with the passage of the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq., which swept back some state obligations and imposed a regime of detailed federal oversight. See id. at 316, 128 S.Ct. 999.

The new regulatory regime established various levels of oversight for medical devices, depending on the risks they present. Class I, which includes such devices as elastic bandages and examination gloves, is subject to the lowest level of oversight: “general controls,” such as labeling requirements. § 360c(a)(1)(A); FDA, Device Advice: Device Classes, http:// www. fda. gov/ cdrh/ devadvice/ 3132. html (all Internet materials as visited Feb. 14, 2008, and available in Clerk of Court's case file). Class II, which includes such devices as powered wheelchairs and surgical drapes, ibid., is subject in addition to “special controls” such as performance standards and postmarket surveillance measures, § 360c(a)(1)(B).

The devices receiving the most federal oversight are those in Class III, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, FDA, Device Advice: Device Classes, supra. 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.” § 360c(a)(1)(C)(ii).

Id. at 316–17, 128 S.Ct. 999.

The MDA established a rigorous regime of premarket approval for new Class III devices.

A manufacturer must submit what is typically a multivolume application. FDA, Device Advice—Premarket Approval (PMA) 18, http:// www. fda. gov/ cdrh/ devadvice/ pma/ printer. html. It includes, among other things, full reports of 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. § 360e(c)(1). Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, 21 CFR § 814.44(a) (2007), and may request additional data from the manufacturer, § 360e(c)(1)(G).

The FDA spends an average of 1,200 hours reviewing each application, [ Medtronic, Inc. v.] Lohr, [518 U.S. 470,] 477, 116 S.Ct. 2240[, 135 L.Ed.2d 700 (1996) ] ... and grants premarket approval only if it finds there is a “reasonable assurance” of the device's “safety and effectiveness,” § 360e(d). The agency must “weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” § 360c(a)(2)(C). It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives....

The premarket approval process includes review of the device's proposed labeling. The FDA evaluates safety and effectiveness under the conditions of use set forth on the label, § 360c(a)(2)(B), and must determine that the proposed labeling is neither false nor misleading, § 360e(d)(1)(A).

After completing its review, the FDA may grant or deny premarket approval. § 360e(d). It may also condition approval on adherence to performance standards, 21 CFR § 861.1(b)(3), restrictions upon sale or distribution, or compliance with other requirements, § 814.82. The agency is also free to impose device-specific restrictions by regulation. § 360j(e)(1).

If the FDA is unable to approve a new device in its proposed form, it may send an “approvable letter” indicating that the device could be approved if the applicant submitted specified information or agreed to certain conditions or restrictions.21 CFR § 814.44(e). Alternatively, the agency may send a “not approvable” letter, listing the grounds that justify denial and, where practical, measures that the applicant could undertake to make the device approvable. § 814.44(f).

Once 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. § 360e(d)(6)(A)(i). If 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. § 360e(d)(6); 21 CFR § 814.39(c).

After premarket approval, the devices are subject to reporting requirements. § 360i. These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of, 21 CFR § 814.84(b)(2), and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred, § 803.50(a). The FDA has the power to withdraw...