Riley v. Cordis Corp.

Decision Date05 June 2009
Docket NumberCase No. 08-CV-5031 (PJS/RLE).
Citation625 F.Supp.2d 769
PartiesMarlyn RILEY and Debra Riley, Plaintiffs, v. CORDIS CORPORATION and Johnson & Johnson, Defendants.
CourtU.S. District Court — District of Minnesota

Ronald S. Goldser and Stacy K. Hauer, Zimmerman Reed, P.L.L.P., for plaintiffs.

Tracy J. Van Steenburgh and Dana M. Lenahan, Halleland Lewis Nilan & Johnson, P.A., and John D. Winter, Patterson Belknap Webb & Tyler, LLP, for defendants.

MEMORANDUM OPINION AND ORDER

PATRICK J. SCHILTZ, District Judge.

Plaintiff Marlyn Riley was implanted with a stent manufactured by defendant Cordis Corporation, a subsidiary of defendant Johnson & Johnson (collectively "Cordis"). Riley later suffered a heart attack because of a blood clot that had formed at the site of his stent. Riley and his wife, Debra Riley, bring state-law claims of negligence, strict liability, breach of express and implied warranties, negligent misrepresentation, fraud, and loss of consortium against Cordis. This matter is before the Court on Cordis's motion for judgment on the pleadings. For the reasons set forth below, the Court dismisses all of plaintiffs' claims—some with prejudice because they are expressly or impliedly preempted by federal law, and others without prejudice because they are not pleaded sufficiently under the Federal Rules of Civil Procedure. The Court will give plaintiffs leave to replead the latter claims.

I. BACKGROUND

Cordis manufactures a drug-eluting stent sold under the brand name "Cypher." The Cypher stent is a tiny metal mesh tube that is implanted in a coronary artery for the purpose of opening the artery and improving blood flow through the heart. The Cypher stent is coated with the drug Sirolimus under a license from Wyeth Corporation. After implantation, the Cypher stent slowly releases Sirolimus to prevent the artery from being narrowed through restenosis (the build-up of new tissue). But the release of Sirolimus also slows the normal healing process; specifically, it slows the beneficial growth of a thin, slippery layer of endothelial cells over the stent and arterial wall. Before this healing process is complete, there is an increased risk of blood-clot formation. In order to prevent clotting, patients with drug-eluting stents are normally placed on antiplatelet drug therapy for a period of time after implantation.

The Cypher stent is a Class III medical device regulated by the Food and Drug Administration ("FDA") pursuant to the 1976 Medical Device Amendments ("MDA"), 21 U.S.C. §§ 360c et seq., to the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq. Class III devices are those devices that are "for a use in supporting or sustaining human life," that are "for a use which is of substantial importance in preventing impairment of human health," or that "present[] a potential unreasonable risk of illness or injury. . . ." 21 U.S.C. § 360c(a)(1)(C). Class III devices receive more extensive federal oversight than any other class of medical devices and are subject to a comprehensive and rigorous process known as "premarket approval" ("PMA"). See 21 U.S.C. § 360e; Riegel v. Medtronic, Inc., ___ U.S. ___, 128 S.Ct. 999, 1004-05, 169 L.Ed.2d 892 (2008) (describing the PMA process). During the PMA process, manufacturers must provide the FDA with, 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).

Riegel, 128 S.Ct. at 1004. The FDA grants PMA only if the agency has received "reasonable assurance" that the device is safe and effective under the conditions of use included on the label and has determined that the proposed labeling is not false or misleading. 21 U.S.C. § 360e(d)(2).

The Cypher stent received PMA on April 24, 2003. Goldser Aff. Ex. 4 at 1-1, Oct. 20, 2008 (hereinafter "PMA___").1 The PMA states that the Cypher stent "is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤30 mm in native coronary arteries with a reference vessel diameter of ≥2.5 to ≤3.5 mm." PMA 1-1. The PMA sets forth certain restrictions on the marketing and use of the Cypher stent. In particular, the PMA states that "[a]dvertising and other printed materials prepared by your firm or its distributors should not include indications or claims not included in the FDA-approved labeling for the device, e.g., use in diabetic patients small vessels (<2.5 mm in diameter), in-stent restenosis, bifurcation lesions, or patients with acute myocardial infarction." PMA 1-2. In addition, plaintiffs allege that the Cypher stent is not approved for implantation by "direct stenting," which occurs when the stent is implanted in an artery that has not first been predilated with a balloon catheter. Compl. ¶ 17.

Riley was implanted with a Cypher stent in late April 2003, about a week after the Cypher was approved by the FDA. The stent was placed in Riley's mid-left-anterior descending coronary artery using direct stenting at a site containing a bifurcation lesion (a lesion located at the intersection of two arteries). Following his doctor's instructions, Riley took Plavix, an antiplatelet drug, for twelve weeks after the surgery. Nearly two years later, in March 2005, Riley suffered a heart attack as a result of a thrombotic occlusion (blood clot) that had formed at the site of the stent. Riley now seeks to recover damages to compensate him for the injuries that he suffered as a result of the heart attack.

II. ANALYSIS
A. Standard of Review

In reviewing a motion for judgment on the pleadings under Fed. R. Civ. P. 12(c), a court applies the same standard used to address a motion to dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6). Ashley County v. Pfizer, Inc., 552 F.3d 659, 665 (8th Cir.2009). Under this standard, the court must accept as true all of the factual allegations in the complaint and draw all reasonable inferences in the plaintiff's favor. Id. Although the factual allegations in the complaint need not be detailed, they must be sufficient to "raise a right to relief above the speculative level...." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 1964-65, 167 L.Ed.2d 929 (2007).

Ordinarily, if the parties present, and the court considers, matters outside of the pleadings, the motion must be treated as a motion for summary judgment. Fed. R. Civ. P. 12(d). But the court may consider materials that are necessarily embraced by the complaint, as well as any exhibits attached to the complaint, without converting the motion into one for summary judgment. Mattes v. ABC Plastics, Inc., 323 F.3d 695, 697 n. 4 (8th Cir.2003). Here, the parties have submitted materials outside the pleadings, but the Court has not considered them. The Court therefore applies the standard of review applicable to Rule 12(c) motions.

B. Preemption
1. Express and Implied Preemption under the FDCA

The FDCA includes an express preemption clause that provides, in relevant part:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a).

The Supreme Court addressed the meaning of § 360k(a) in Riegel v. Medtronic, Inc., a recent case that, like this one, involved a Class III medical device that had received PMA. 128 S.Ct. 999 (2008). The Court first concluded that the PMA process imposes "requirement[s] applicable under this chapter to the device" for purposes of § 360k(a)(1). Riegel, 128 S.Ct. at 1007. As the Court noted, PMA is specific to individual medical devices. Id. A device that has received PMA must "be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness." Id. The Court further held that state common-law duties impose "requirement[s]" that, notwithstanding their general nature, are "with respect to" medical devices. Id. at 1007-10. As a result, to the extent that a state common-law duty imposes requirements "different from, or in addition to" the requirements imposed by the FDCA, those state common-law duties are expressly preempted by § 360k(a). Id.

To escape preemption by § 360k(a), then, a state-law claim must be premised on the breach of a state-law duty that is the same as a duty imposed under the FDCA (or one of its implementing regulations). Riegel, 128 S.Ct. at 1011 ("Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case `parallel,' rather than add to, federal requirements.").2 Put differently, the conduct that is alleged to give the plaintiff a right to recover under state law must be conduct that is forbidden by the FDCA. Thus, to determine whether Riley's claims are...

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