In re Propulsid Products Liability Litigation

208 F.R.D. 133, 2002 WL 1187201
CourtDistrict Court, E.D. Louisiana
DecidedJune 4, 2002
DocketNo. MDL 135
StatusPublished
Cited by33 cases

This text of 208 F.R.D. 133 (In re Propulsid Products Liability Litigation) is published on Counsel Stack Legal Research, covering District Court, E.D. Louisiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Propulsid Products Liability Litigation, 208 F.R.D. 133, 2002 WL 1187201 (E.D. La. 2002).

Opinion

ORDER AND REASONS

FALLON, District Judge.

Before the Court is plaintiff Virginia Gail Jones’s motion filed in connection with her class action seeking certification of a nationwide class under Federal Rule of Civil Procedure 23(b)(2). For reasons set forth below the motion is DENIED.

I. BACKGROUND

A. Introduction

Propulsid is the trade name for a family of prescription drug products which contain the active pharmaceutical ingredient Cisapride. It was approved by the U.S. Food and Drug Administration (FDA) in 1993 to be used in treating the symptoms of nocturnal heartburn due to gastroesophageal reflux disease (GERD). Propulsid is manufactured by Janssen Pharmaceutica, Inc., which is a wholly owned subsidiary of Johnson & Johnson. Janssen Pharmaceutica’s United States headquarters is located in Titusville, New Jersey.

It is alleged that dangerous heartbeat irregularities develop when Propulsid is consumed by some individuals in certain circumstances and that as early as 1993 the defendants, through adverse drug reports, became aware of heart problems associated with the ingestion of Propulsid. Nevertheless, according to plaintiff, the defendants persisted in aggressively marketing Propul-sid by misleading potential consumers, physicians, and other healthcare providers concerning the safety, efficacy and risks associated with the use of the drug.

On March 23, 2000 Janssen announced its decision to end general distribution of Pro-pulsid in the United States as of July 14, 2000. The stated reason for the removal of the drug was that, despite clear label warnings regarding Propulsid’s adverse effects [136]*136when combined with contraindicated medicines and risk factors, the drug was being inappropriately prescribed by physicians. It is estimated that prior to its removal some thirty million U.S. residents had taken Pro-pulsid. Following its removal, thousands of claimants began filing suits against Johnson & Johnson and Janssen Pharmaceutiea in federal and state courts across the country.

On August 7, 2000, the Judicial Panel on Multidistrict Litigation (JPMDL) conferred multidistrict litigation status on the Propul-sid suits filed in the federal courts, and pursuant to Title 28, United States Code, Section 1407, transferred all federal Propulsid suits to this Court to coordinate discovery and to consolidate pretrial matters. Shortly thereafter, this Court appointed committees of counsel to represent the parties, and the litigation commenced. This multidistrict litigation, designated MDL-1355 and captioned In re Propulsid Products Liability Litigation, involves hundreds, perhaps thousands of individual claimants including over thirty class actions from some fifteen states, all alleging various tort and products liability claims against the manufacturers of Propul-sid.

After a period of discovery, the Plaintiffs’ Steering Committee filed the present motion for certification of a nationwide class under Federal Rule of Civil Procedure 23(b)(2). The pleadings allege various wrongful acts by the defendants and specify numerous theories of liability under both New Jersey law and the “laws of any state whose law may be found to be applicable to this case.” These theories of liability include: negligence; fraud; failure to warn; strict products liability; defective design; breach of express warranty; breach of implied warranty; and knowing concealment, suppression or omission of a material fact.

Plaintiffs’ Steering Committee requests equitable relief in the form of medical monitoring in addition to the establishment of a clinical study, the purpose of which is to examine the long-term effects of Propulsid. They also seek monetary reimbursement for the purchase of Propulsid.

The class representatives are Virginia Gail Jones and Patrick Luckman. Presently it is only the claims of Ms. Jones and those similarly situated that are the subject matter of this motion.1 The putative class consists of all such persons in the United States who purchased and/or used Propul-sid. Also included in the class are any other such persons asserting their right to sue the defendants independently or derivatively by reason of their personal relationship with persons who used Propulsid, including without limitation, spouses, parents, children, dependents, and other relatives or significant others.

B. Medical Background

Prior to any legal analysis of the certifia-bility of plaintiffs claims as a class action, a discussion of the pharmacology of Propulsid as well as the anatomy and electrical behavior of the human heart is helpful in understanding the issues raised in this case.

1. Pharmacology of Propulsid

Propulsid was developed to treat gastroe-sophageal reflux disease (GERD). GERD is the abnormal backflow (reflux) of stomach acids into the esophagus, the tube that leads from the throat to the stomach. This back-flow occurs because the valve between the lower end of the esophagus and the stomach (the lower esophageal sphincter) does not close tightly enough. The main symptom of GERD is frequent heartburn. Some drugs treat this condition by neutralizing acid in the digestive tract or by decreasing the amount of acid produced by the stomach.

[137]*137Propulsid is unique in that it is a prokinetic or motility agent. It treats GERD by increasing the rate at which the esophagus, stomach, and intestines move food during digestion. It also increases the rate at which the stomach empties into the intestines and increases the strength of the lower esophageal sphincter.

2. The Anatomy of the Heart

The human heart is a pear-shaped structure about the size of the possessor’s fist. It lies obliquely within the chest cavity just left of center, with the apex pointing downward. The heart is constructed of a special kind of muscle called myocardium and is enclosed in a double-layered, membranous sac known as the pericardium. A wall of muscle divides the heart into two cavities. The left cavity pumps blood throughout the body, while the right cavity pumps blood only through the lungs. Each cavity is in turn divided into two chambers, the upper ones are called atria, the lower ones, ventricles. Venous blood from the body, containing large amounts of carbon dioxide, returns to the right atrium. From there it enters the right ventricle, which contracts, pumping blood through the pulmonary artery to the lungs. Oxygenated blood returns from the lungs to the left atrium and enters the left ventricle, which contracts, forcing the blood into the aorta, from which it is distributed throughout the body.

3. The Electrical System of the Heart

In the normal heart, the heart beat (or heart contraction) originates in the natural pacemaker of the heart, the sinoatrial node (S.A.node) located high in the right atrium. The heart beat is caused by a special group of cells located in the S.A. node that have the ability to generate electrical activity by separating charged particles and leaking them into the extra-cellular space.

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Bluebook (online)
208 F.R.D. 133, 2002 WL 1187201, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-propulsid-products-liability-litigation-laed-2002.