White v. Stryker Corp., Civil Action No. 3:10–CV–544–H.

• Decision Date: 25 March 2011
• Docket Number: Civil Action No. 3:10–CV–544–H.
• Citation: 818 F.Supp.2d 1032
• Parties: John WHITE, Plaintiff v. STRYKER CORPORATION, et al., Defendants.
• Court: U.S. District Court — Western District of Kentucky

818 F.Supp.2d 1032

John WHITE, Plaintiff

v.STRYKER CORPORATION, et al., Defendants.

Civil Action No. 3:10–CV–544–H.

United States District Court, W.D. Kentucky,at Louisville.

March 25, 2011.

Martin H. Kinney, Jr., Dolt, Thompson, Shepherd & Kinney PSC, Louisville, KY, for Plaintiff.

Jamie K. Neal, Robert M. Connolly, Stites & Harbison, PLLC, Louisville, KY, for Defendants.

MEMORANDUM OPINION

JOHN G. HEYBURN, II, District Judge.

Plaintiff, John White, filed this product liability action concerning injuries suffered from a medical device known as the Trident Hip Replacement System (the “Trident System”), which was surgically implanted on May 25, 2004, and removed five years later. Defendants, Stryker Corporation and How Medica Osteonics Corp. (“Stryker”), designed, manufactured and distributed the Trident System.

After Plaintiff filed his complaint in Jefferson Circuit Court, Stryker immediately removed to federal court and, a week later moved to dismiss on grounds that the Supreme Court has interpreted the Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (“MDA”), to the Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., as expressly preempting claims such as these. In response, on October 1, 2010, Plaintiff moved for leave to file an amended complaint.¹ Stryker replied that under the standards of Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), even the Amended Complaint fails to state with specificity any plausible claims that avoid federal preemption.

This case raises interesting questions about the scope of MDA express preemption and the specificity of pleading required to avoid it. However, the pleadings at issue here are so insufficient that, for the reasons that follow, the Court will sustain Stryker's motion and dismiss Plaintiff's claims.

I.

The actual pertinent allegations of the Amended Complaint, and those of the original complaint which is incorporated by reference, are extremely important.

The original complaint states that on May 25, 2004, Plaintiff underwent a total hip arthroplasty, a procedure that involves the implantation of the Trident System. More than five years later, on August 24, 2009, Plaintiff underwent additional surgery during which his physician discovered that certain ceramic component parts of the Trident System had failed. Paragraphs 7 through 14 of the original complaint make general allegations concerning the defectiveness and dangerousness of the design, manufacture, assembly, inspection, testing and marketing of the Trident System. No where does the original complaint make mention of federal regulations.

The Amended Complaint incorporates the factual allegations of the original and contains some new allegations. Paragraph 2 states that “defendants failed to manufacture [the Trident System] according to FDA approved standards and procedures for medical devices.” Subsequent paragraphs assert the original causes of action and then add the same generic allegations concerning FDA standards and procedures. Paragraph 3 sets forth a negligence claim; Paragraph 4 sets forth implied and express warranty claims; Paragraph 5 sets forth a merchantability claim; and Paragraph 6 sets forth a strict liability claim. The Amended Complaint neither cites any particular federal standard or procedure, nor does it generally state how the alleged defect deviated from a federal standard or procedure.

Only in the most general way possible does the Amended Complaint seek to limit its broad common law state claims to those circumstances founded upon alleged violations of “FDA approved standards.”

II.

The process by which the Food and Drug Administration (the “FDA”) approved the Trident System for manufacture and distribution is important because it provides the underpinning for the MDA's express preemption provision. The FDA exercises comprehensive authority over all medical devices intended for human use in the United States. See 21 U.S.C. § 360 et seq. The most comprehensive summary of the overarching regulatory structure for devices such as the Trident System can be found in Riegel v. Medtronic, Inc., 451 F.3d 104, 108–111 (2nd Cir.2006). Much of the following summary can be found there.

In 1976, Congress enacted the MDA in order to provide for the safety and effectiveness of medical devices intended for human use. Under the MDA's regulatory structure, medical devices are categorized into three classes, based on the level of risk that they pose. See 21 U.S.C. § 360c(a)(1). Those devices presenting minimal risks are placed in Classes I and II. See 21 U.S.C. § 360c(a)(1)(A) and (B). Those devices which either “present a potential unreasonable risk of illness or injury” or are “for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health” are classified as Class III devices. 21 U.S.C. § 360c(a)(1)(C). It is undisputed that the Trident System is a Class III device.

Prior to marketing and sale, a Class III device must undergo “premarket approval to provide reasonable assurance of its safety and effectiveness.” 21 U.S.C. § 360c(a)(1)(C). The premarket approval, or “PMA,” process is considered lengthy and rigorous. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (describing the PMA process as a “rigorous one,” and noting that the FDA spends an average of 1,200 hours on each PMA submission). The manufacturer must submit a detailed PMA application that contains: full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, ingredients, properties, and principles of operation of the device; a full description of the methods used in the manufacture and processing of the device; information about performance standards of the device; samples of the device; specimens of the proposed labeling for the device; and any other relevant information. See 21 U.S.C. § 360e(c).

The PMA process envisions significant interaction between the FDA and the manufacturer. Typically, the initial PMA application must include data from clinical investigations to establish the safety and effectiveness of the device, 21 C.F.R. § 814.20(b)(6)(ii); the manufacturer cannot conduct such a clinical investigation in the first place without FDA permission, 21 C.F.R. § 812.1(a). The results of these clinical investigations are included in the PMA application, along with other information. See 21 C.F.R. § 814.20; 21 U.S.C. § 360e(c). The FDA then reviews the submission to determine whether it is sufficiently complete to enable a substantive review. 21 C.F.R. § 814.42. If so, the FDA begins its own review, which may involve referring the application to an advisory committee. See 21 C.F.R. § 814.44. Indeed, the FDA referred the Trident System application to the Orthopedic and Rehabilitation Advisory Committee on July 20, 2000.²

Once the FDA has concluded its review, it decides whether or not to approve the device for marketing. This choice is not binary; the FDA has means to impose additional requirements. For example, the FDA can issue an “approvable letter” stating that the FDA believes it will be able to approve the application if specific conditions are agreed to by the applicant. See 21 C.F.R. § 814.44(e). In the end, once the FDA has approved a medical device through the PMA process, the applicant is required to comply with the standards in the PMA approval order. 21 C.F.R. § 814.80.

The standard FDA “Conditions of Approval” accompanying a PMA approval order state that continued approval of the PMA “is contingent on the submission of postapproval reports required under 21 C.F.R. 814.84 at intervals of 1 year from the date of approval of the original PMA.” ³ These reports must identify all manner of events and occurrences that could affect the device's safety or effectiveness. See 21 C.F.R. § 814.84(b)(1) and (2). The FDA also requires the manufacturer to submit an “Adverse Reaction Report” or “Device Defect Report” to the FDA concerning any occurrence adversely effecting the use, safety or maintenance of the device.⁴ The FDA may also impose other requirements it “determines are necessary to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness of the device.” 21 C.F.R. § 814.82(a).

It is not exactly clear when Stryker initiated the PMA process for the Trident System. However, it may have begun as early as 1999. After the FDA referred the Trident System application to the Orthopedic and Rehabilitation Advisory Committee on July 20, 2000, the Committee recommended denial of approval based on the lack of 24–month follow-up data from clinical trials.⁵ The FDA did not agree with the Committee's non-approval recommendation. Consequently, it either performed or required additional studies. After several more years, in February of 2003, the FDA communicated that it approved the PMA application of the Trident System and that Stryker could commence commercial distribution of the device in accordance with certain normal “Conditions of Approval.” ⁶

Upon issuance of PMA approval, the FDA made publicly available a document entitled “Summary of Safety and Effectiveness Data” concerning the Trident System.⁷ The document provides a significant amount of information concerning the Trident System, including the following: a description of the device; identification of certain contraindications, warnings and precautions necessary for the its use; a summary of the potential adverse effects from its use; a summary of all of the preclinical testing and studies of the device; conclusions regarding the risks and benefits of the device; and, finally, a summary of the FDA approval process. The report appears to be a comprehensive survey of the data surrounding and processes comprising the...