In re Vioxx Products Liability Litigation

501 F.Supp.2d 776

In re: VIOXX PRODUCTS LIABILITY LITIGATION

This Document Relates to: Arnold v. Merck & Co., Inc., No. 05-2627.

Gomez v. Merck & Co., Inc., No. 05-1163.

No. MDL 1657.

United States District Court, E.D. Louisiana.

July 3, 2007.

COPYRIGHT MATERIAL OMITTED

ORDER & REASONS

FALLON, District Judge.

Before the Court is Merck & Co., Inc.'s Motion for Summary Judgment (Rec.Doc. 5842) in two individual Vioxx cases on federal preemption grounds. The Court heard oral argument and took this motion under submission. Because the Court finds that the plaintiffs' claims are not expressly nor impliedly preempted by virtue of the federal regulation of prescription drugs, Merck's motion is now DENIED.¹

I. BACKGROUND

Vioxx, known generically as rofecoxib, belongs to a general class of pain relievers known as non-steroidal anti-inflammatory drugs ("NSAIDs"). NSAIDs work by inhibiting 'cyclooxygenase ("COX"), an enzyme that stimulates synthesis of prostaglandins, which are chemicals produced in the body that promote certain effects. Traditional NSAIDs, such as Advil (ibuprofen), Aleve (naproxen), and Voltaren (diclofenac), have been longstanding treatment options for patients needing relief from chronic or acute inflammation and pain associated with osteoarthritis, rheumatoid arthritis, and other musculoskeletal conditions. This relief, however, has historically come with significant adverse side effects. Specifically, traditional NSAIDs greatly increase the risk of gastrointestinal perforations, ulcers, and bleeds ("PUBs"). This risk is further increased when high doses are ingested, which is often necessary to remedy chronic or acute inflammation and pain.

In the early 1990s, scientists discovered that the' COX enzyme had two forms — COX-1 and COX-2- — each of which appeared to have several distinct functions. Scientists believed that COX-1 affected the synthesis or production of prostaglandins responsible for protection of the stomach lining, whereas COX-2 mediated the synthesis or production of prostaglandins responsible for pain and inflammation. This belief led scientists to hypothesize that "selective" NSAIDs designed to inhibit COX-2, but not COX-1, could offer the same pain relief as traditional NSAIDs with a reduced risk of fatal or debilitating PUBs. In addition, scientists believed that such drugs might also prove beneficial for the prevention or treatment of other conditions, such as Alzheimer's disease and certain cancers, where evidence suggests that inflammation may play a causative role. In light of these scientific developments,. pharmaceutical companies began developing such drugs, which became known as "COX-2 inhibitors" or "coxibs." Merck developed a COX-2 inhibitor and named it Vioxx.

On November 23, 1998, Merck submitted a new drug application for Vioxx to the Food and Drug Administration ("FDA") and requested an expedited review of its application. Six months later, on May 20, 1999, the FDA approved Vioxx as safe and effective for treatment of osteoarthritic pain, primary dysmenorrhea (menstrual pain), and acute pain based on the data and label supplied by Merck. From its initial approval, Vioxx gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain.

Vioxx was subjected to a number of studies and tests both before and after its initial approval. In March of 2000, Merck received the preliminary results of the Vioxx GI Outcomes Research ("VIGOR") study. VIGOR was an 8,000-patient trial designed to assess the relative incidence of gastrointestinal PUBs in rheumatoid arthritis patients treated with Vioxx as compared to those treated with the drug naproxen. While VIGOR demonstrated that patients taking Vioxx suffered fewer serious gastrointestinal PUBs than patients taking naproxen, it also showed that patients on Vioxx suffered a statistically significant increase of serious cardiovascular thrombotic events compared to patients taking naproxen.²

In `light of the new data obtained in the VIGOR study, Merck submitted a proposed label change for Vioxx to the FDA in June of 2000. After approximately eighteen months of "negotiation" with Merck over the content and organization of a new Vioxx label, the FDA approved a revised label on April 11, 2002. The new label incorporated the VIGOR data and noted that such data "should be taken into consideration and caution should be exercised when Vioxx is used in patients with a medical history of ischemic heart disease." (Def.'s Mot. for Summ. J. Ex. 23.)

On September 23, 2004, an external safety board monitoring the results of a separate long-term study, known as APROVe, which was designed to assess whether Vioxx could help prevent the recurrence of precancerous colon polyps, informed Merck that the interim data from this study also showed a significantly increased rate of cardiovascular events in the Vioxx arm as compared to the placebo arm of the study. One week later, on September 30, 2004, Merck voluntarily withdrew Vioxx from the market.

Thereafter, thousands of individual lawsuits and numerous class actions were filed against Merck in state and federal courts throughout the country alleging various products liability, tort, failure-to-warn, fraud, and warranty claims. It is estimated that 105 million prescriptions were written for Vioxx in the United States between May 20, 1999 and September 30, 2004. Based on this estimate, it is thought that approximately 20 million patients have taken Vioxx in the United States. On February 16, 2005, the Judicial Panel on Multidistrict Litigation conferred multidistrict litigation status on Vioxx lawsuits filed in federal court and transferred all such cases to this Court to coordinate discovery and to consolidate pretrial matters pursuant to 28 U.S.C. § 1407. See In re Vioxx Prods. Liab. Litig., 360 F.Supp.2d 1352 (Jud.Pan.Mult.Lit.2005).³

II. PRESENT MOTION

On July 18, 2006, Merck filed the instant motion for summary judgment in the following two individual Vioxx cases:

• " Arnold v. Merck & Co.,Inc., No. 05-2627: Lene Arnold alleges that she used Vioxx between July 2003 and October 2004, and that she suffered a heart attack on December 28, 2003 as a result of taking the drug. She filed suit on June 27, 2005 directly in this Court pursuant to Pretrial Order No. 11, asserting strict liability, negligence, warranty, and fraud claims against Merck.

• " Gomez v. Merck & Co., Inc., No. 05-1163: Joe G. Gomez allegedly used Vioxx from November 21, 2002 until January 7, 2003, the day on which he suffered a fatal heart attack. His surviving spouse and children filed suit on January 7, 2005 in the United States District Court for the Western District of Texas, asserting strict liability, negligence, warranty, and fraud claims against Merck. Their case was subsequently transferred to this Court pursuant to 28 U.S.C. § 1407.

Merck argues that the plaintiffs' failure-to-warn claims in these cases are preempted, that is, precluded as a matter of law, because the Vioxx label was approved by the FDA. Specifically, Merck contends that a finding of implied preemption is appropriate because the federal regulatory scheme devised for regulating prescription drugs cannot function properly if juries applying state law are allowed to "force" drug manufacturers to add information to prescription drug labels beyond language that the FDA has approved. In support of its argument, Merck principally relies upon recent FDA statements to this effect accompanying new labeling regulations. See Requirements on Content and Format of Labeling for Human Prescription Drug and' Biological Products, 71 Fed.Reg. 3922 (Jan. 24, 2006) (hereinafter "2006 Final Rule"). In the preamble to the 2006 Final Rule, the FDA asserts that its requirements are "both a minimum `floor' and a maximum `ceiling' for the content and format" of prescription drug labels and that state-law failure-to-warn claims are, therefore, preempted. Id. at 3933-36. The FDA explains its reasoning as follows:

Given the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling under the act, additional requirements for the disclosure of risk information are not necessarily more protective of patients. Instead, they can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use. Exaggeration of risk could discourage appropriate use of a beneficial drug.

. . . . . .

State law actions also threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the general public-the central role of FDA-sometimes on behalf of a single individual or group of individuals. That individualized reevaluation of the benefits and risks of a product can result in relief-including the threat of significant damage awards or penalties-that creates pressure on manufacturers to attempt to add warnings that FDA has neither approved nor found to be scientifically required. This could encourage manufacturers to propose "defensive labeling" to avoid State liability, which, if implemented, could result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

Id. at 3935.

The Plaintiffs' Steering Committee ("PSC") opposes Merck's motion, contending that the FDA's current view on preemption is unpersuasive, inconsistent with its prior views, and thus not entitled to deference.⁴ Indeed, the PSC notes that state-law claims have coexisted with federal regulation of prescription drugs for decades and urges the Court to ensure that no claims in this multidistrict litigation are vanquished by what ...