Foster v. St. Jude Medical, Inc.

229 F.R.D. 599, 2005 U.S. Dist. LEXIS 15143, 2005 WL 1773986
CourtDistrict Court, D. Minnesota
DecidedJuly 26, 2005
DocketNo. Civ. 04-135(RHK/AJB)
StatusPublished
Cited by4 cases

This text of 229 F.R.D. 599 (Foster v. St. Jude Medical, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Minnesota primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Foster v. St. Jude Medical, Inc., 229 F.R.D. 599, 2005 U.S. Dist. LEXIS 15143, 2005 WL 1773986 (mnd 2005).

Opinion

MEMORANDUM OPINION AND ORDER

KYLE, District Judge.

Introduction

Before the Court is Plaintiffs’ Motion For Class Certification. Plaintiffs are individuals who have had one of Defendant’s medical products implanted into their hearts during heart bypass surgery. Generally, Plaintiffs allege that they suffered complications as a result of the implantation of Defendant’s product. Currently, Plaintiffs have moved to [600]*600represent a class of persons who also have had one of Defendant’s products implanted into their hearts during heart bypass surgery. For the reasons set forth below, the Court will deny the Motion.1

Background

A. The Parties

Plaintiffs Ruby Foster and Kenneth Mager are the named plaintiffs in this case (together, “Plaintiffs”). Foster is a resident and citizen of Memphis, Tennessee. (First Am. Class Action Compl. (“FACAC”) 111.) In March 2002, she underwent a coronary artery bypass graft procedure, otherwise known as a heart bypass surgery, at which time a St. Jude Medical Symmetry Bypass Connector (“Bypass Device”) was implanted into her heart. (Id. H 2.) Mager is a resident and citizen of Lake Cormorant, Mississippi. (Id. 113.) In February 2002, he also underwent bypass surgery at which time a Bypass Device was implanted into his heart. (Id. 114.) Defendant St. Jude Medical, Inc. is a Minnesota corporation. (Id. H 5.) It designed, manufactured, and marketed the Bypass Device. (Id.)

B. Heart Bypass Surgery and the Bypass Device

Over time, some people develop coronary artery disease, which is a progressive condition caused by the build-up of plaque within the heart’s arteries (also known as atherosclerosis). In severe cases, the plaque buildup can restrict the flow of blood and damage heart tissue. Such restrictions in the arteries can produce chest pain, shortness of breath, and fatigue. The restrictions may also result in a heart attack, congestive heart failure, or death.

A heart bypass surgery is performed to improve blood flow through the coronary arteries to the heart muscle. The surgery essentially reroutes, or “bypasses,” blood around the clogged arteries. During a bypass surgery, the surgeon removes a portion of a blood vessel from a patient’s leg, arm, or chest and then uses that vessel as a conduit to bypass the obstructed coronary artery. After harvesting the bypass vein, the surgeon grafts one end to the aorta, which is the main artery that pumps fresh blood, and grafts the other end to the coronary artery at a point past the obstruction. The suturing of the graft to the aorta and the coronary artery (anastomosis) is usually the most difficult, time consuming, and critical part of the bypass procedure.

Surgeons perform bypass surgery either with or without the aid of a cardiopulmonary bypass machine (heart-lung machine). The majority of bypass surgeries are performed “on-pump,” with the heart-lung machine pumping blood during the operation. An “on-pump” procedure allows the surgeon to stop the heart during surgery and clamp off the aorta, thereby maintaining a still, bloodless surgical field to attach the bypass vessel. A minority of bypass surgeries are performed “off-pump,” with the patient’s heart continuing to beat. “Off-pump” surgeries are more technically complicated because of the challenges presented with suturing a beating heart.

Traditionally, the suturing is carried out by hand. In May 2001, St. Jude Medical introduced the Bypass Device, which is a mechanical anastomosis device that allows cardiac surgeons to attach the vein grafts to the aorta without suturing or clamping the aorta. Since its introduction, St. Jude’s Bypass Device has been implanted approximately 40,000 times. In late 2004, St. Jude discontinued the Bypass Device.

[601]*601C. Plaintiffs’ Complaint

Plaintiffs allege that as a result of the implantation of the Bypass Device they have suffered or are likely to suffer complications, including occlusions (a total blockage of the blood vessel) and stenosis (a narrowing of the blood vessel) of the bypass vein grafts. (See FACAC U 8.) Plaintiffs assert that they and the class members they seek to represent will require ongoing medical surveillance, among other things, due to those alleged complications. (See id. It 9.)

Plaintiffs allege five causes of action: strict liability; breach of implied warranty; breach of express warranty; negligence; and violations of Minnesota’s False Advertising Act, Consumer Fraud Act, Unlawful Trade Practices Act, and Uniform Deceptive Trade Practices Act. (See id. 111137-70.) Under each cause of action, the following relief is sought:

(a) an Order pursuant to Rule 23, F.R.C.P. permitting this action to be maintained as a class action as specified herein, appointing Plaintiffs as the representatives of the Class and Plaintiffs’ counsel as counsel for the class;
(b) a judgment and/or decree in favor of Plaintiffs and the Class against Defendant creating a trust fund paid for by Defendant which, under Court supervision, will design, pay for and manage the delivery of medical monitoring services, including, but not limited to, testing and preventative screening care of the adverse and latent conditions resulting from, or potentially resulting from, the implantation and use of defective medical products at issue in this suit;
(c) a judgment and/or decree in favor of Plaintiffs and the Class against Defendant creating a trust fund, paid for by Defendant, under Court supervision, to finance medical research on monitoring services, including, but not limited to, testing and preventative screening care of conditions resulting from, or potentially resulting from the defective medical products at issue in this suit;
(d) a judgment and/or order requiring Defendant to bear the cost of publication to members of the Class and the medical
community of advising and educating them of the need for appropriate medical screening and monitoring concerning the medical conditions that are at issue in this suit, the content, form and manner of such publication to be approved by the Court;
(e) a judgment in favor of Plaintiffs individually awarding all appropriate compensatory damages for any personal injuries Plaintiffs have suffered or are likely to suffer in the future; and
(f) such further relief as this Court deems necessary, just, and proper.

(FACAC ¶ 44; see id. ¶¶ 52, 58, 65, 70.)

Based on their claims, Plaintiffs seek to certify the following class:

All persons in the United States and its territories who have had a coronary artery bypass graft procedure utilizing the BYPASS DEVICE manufactured, developed, designed, fabricated, sold, distributed or otherwise placed into the stream of commerce by Defendant, St.

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Bluebook (online)
229 F.R.D. 599, 2005 U.S. Dist. LEXIS 15143, 2005 WL 1773986, Counsel Stack Legal Research, https://law.counselstack.com/opinion/foster-v-st-jude-medical-inc-mnd-2005.