In re Rezulin Products Liability Litigation

210 F.R.D. 61, 2002 WL 31031642
District Court, S.D. New York·Decided September 12, 2002·No. MDL No. 1348; Master File No. 00 Civ. 2843·Published·Cited by 54 cases

Opinion

MEMORANDUM OPINION

KAPLAN, District Judge.

Plaintiffs in this putative class action, which has been consolidated for pretrial purposes with hundreds of individual products liability actions, seek relief based upon their ingestion of the prescription drug Rezulin. The matter currently is before the Court on plaintiffs’ motion to certify (1) a class of all persons who ingested Rezulin and their spouses,1 and (2) a subclass of asymptomatic Rezulin users who have not manifested physical injury. The proposed class seeks, among other things, restitution of the revenues defendants realized from the sale of Rezulin and compensatory and punitive damages.2 The proposed subclass seeks to create and fund a medical monitoring mechanism for those exposed to Rezulin.3 For the reasons discussed below, the motion is denied.

I. The Introduction and Withdrawal of Rezulin 4

More than 15 million Americans suffer from Type II diabetes, commonly referred to as adult onset diabetes, a disease characterized by high blood-sugar levels which, if left untreated, can lead to coronary heart disease, blindness, kidney failure and limb amputation. Prior to 1996, treatment for this malady consisted primarily of multi-drug regimes and insulin injections.

In 1996, Warner-Lambert Company (“Warner-Lambert”) announced the development of Rezulin,4 5 a drug that it intended not only as a treatment for Type II diabetes, but also as a drug that might play a role in preventing the disease. The Food and Drug Administration (the “FDA”) agreed to consider approving Rezulin on a priority basis, or within six months of Warner-Lambert’s filing of a new drug-application.

[63]*63Rezulin ran into some obstacles in the course of its approval,6 but the FDA ultimately approved it for sale to consumers, for use in conjunction with insulin therapy, on January 29, 1997, and Warner-Lambert began to sell it in the United States that March.7 In August 1997, the FDA approved use of Rezulin as a monotherapy as well. Following the drug’s market introduction, however, Rezulin encountered a series of problems.

The first occurred several months after Rezulin was first marketed, when Warner-Lambert received reports of patients who had experienced liver failure resulting in death or transplant while on Rezulin. The FDA subsequently required, in October 1997, that Warner-Lambert change the Rezulin label to recommend liver enzyme testing within the first one to two months and then every three months during the first year of therapy, and periodically thereafter. In December 1997, following a report that the United Kingdom was considering a ban on the sale of Rezulin, Glaxo-Wellcome, the holder of rights to market Rezulin in Great Britain, withdrew it from the market. Also in December 1997, the FDA required a second labeling change to recommend monthly liver enzyme testing for the first six months of Rezulin therapy, followed by tests every two months for the remainder of the first year and periodically thereafter. Then, on May 17, 1998, a non-diabetic participant in a Rezulin study died of irreversible liver failure shortly after undergoing a liver transplant, and an NIH physician concluded that her death had “ ‘probably’ been caused by Rezu-lin,”8 although Warner-Lambert asserted that it was “apparently due to complications unrelated to” Rezulin.9

In July 1998, Warner-Lambert again was directed to revise the Rezulin label to recommend monthly liver testing for the first eight months of therapy, followed by a test every two months for the remainder of the first year and periodically thereafter. The FDA subsequently convened a second advisory committee to evaluate the safety of Rezulin, and in June 1999 the FDA adopted the committee’s recommendation that Rezulin be permitted to remain on the market, but that it be approved for use only in combination with insulin and other medications and that it no longer be used as an initial therapy for treating diabetes. A new label advising patients to undergo monthly liver-function testing for the first twelve months of use and quarterly for the second twelve months was required.

The final straw appears to have been a March 10, 2000, Los Angeles Times report that the FDA had linked Rezulin to eighty-nine cases of liver failure, including sixty-one that resulted in death.10 Twelve days later, Warner-Lambert withdrew Rezulin from the market.11

II. Plaintiffs ’ Allegations

A. The Substantive Claims Relating to Re-zulin

Plaintiffs here claim that Rezulin is both hepato- and eardiotoxic, i.e., that it is toxic to [64]*64the liver and the heart. Specifically, they assert that it is causally associated with a variety of liver and heart ailments, often asymptomatic, including (1) liver cell death and necrosis, (2) concomitant and chronic inflammation in the liver, (3) fibrosis, including bridging fibrosis, of the liver, (4) cirrhosis, (5) liver failure requiring transplant or resulting in death, (6) irreversible liver scarr-ring, (7) congestive heart failure, (8) fluid overload and retention in the cardiac muscle, (9) cardiomyopathy and (10) increased cardiac gross weight.12 But it is useful to place this assertion in context.

As plaintiffs acknowledge, “[h]epatotoxicity is a known complication of most prescribed drugs.”13 Other side effects also are common. And the claim is not that Rezulin caused liver or cardiopulmonary injury in all or even most who ingested it. On the contrary, even plaintiffs’ experts agree that “the controlled clinical studies of the drug Rezulin demonstrate that the vast majority of patients who were treated with Rezulin tolerated the drug well and had no elevated liver enzymes and had no liver injury as a result of the drug.”14 Thus, while nothing turns on the proposition at this stage of the proceedings, it appears that such injuries, if any, as Rezulin caused may well have been both rare and idiosyncratic,15 although this of course would not excuse any concealment of the risks of such injuries.

B. Class Allegations

The essence of the complaint is that the defendants failed adequately to disclose the risks of liver and cardiopulmonary complications.16 Had they done so, the complaint alleges, the plaintiffs and, presumably, the other class members would not have taken the drug.17 Having ingested Rezulin, however, plaintiffs and members of the class allegedly were damaged.18 Plaintiffs seek relief on the following theories:

1. Negligence: Defendants allegedly failed to exercise reasonable care in the manufacture, sale, testing, quality control, marketing and distribution of Rezulin and this failure allegedly created a high risk of unreasonable, dangerous side-effects.19

2. Fraud: Defendants allegedly knew or should have known that Rezulin was dangerous and not as effective for its purpose as they represented and that it posed risks greater than were disclosed.

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In re Rezulin Products Liability Litigation, 210 F.R.D. 61, 2002 WL 31031642 (S.D.N.Y. 2002).

210 F.R.D. 61 (In re Rezulin Products Liability Litigation) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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