Staples v. Merck & Co., Inc.

270 F. Supp. 2d 833, 2003 U.S. Dist. LEXIS 11318, 2003 WL 21529140
CourtDistrict Court, N.D. Texas
DecidedJuly 1, 2003
Docket3:03-cv-00180
StatusPublished
Cited by7 cases

This text of 270 F. Supp. 2d 833 (Staples v. Merck & Co., Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Staples v. Merck & Co., Inc., 270 F. Supp. 2d 833, 2003 U.S. Dist. LEXIS 11318, 2003 WL 21529140 (N.D. Tex. 2003).

Opinion

Memorandum Opinion and Order

LYNN, District Judge.

A number of cases, separately removed, were consolidated into this ease. In each Notice of Removal and/or Amended Notice of Removal, Defendant Merck alleged that jurisdiction is proper in this Court because Plaintiffs fraudulently joined two Texas defendants: Dr. Harvey Resnick, M.D., and R/D Clinical Research, Incorporated (collectively, “Clinical Researchers”). If the Clinical Researchers were not fraudulently joined, then this case is non-removable under 28 U.S.C. § 1441(b). In December 2002, the Plaintiffs filed ten actions in multiple district courts in Dallas County, Texas. The petitions asserted nearly identical claims against Defendants Merck & Co., Inc. (“Merck”), for a variety of causes of action, including negligence, fraud and conspiracy. Plaintiffs specifically named the Clinical Researchers only in the negligence count, but also implicated the Clinical Researchers in the fraud and conspiracy counts.

Merck answered on January 27, 2003. Two days later, Merck removed the suits and then, on February 6, 2003, filed an Amended Notice of Removal to correct a mistake as to the state court where one action was commenced. On February 11, 2003, this Court consolidated all Plaintiffs’ actions into the Staples action, Civil Action No. 3:03-CV-0180-M, and instructed the parties to file briefs concerning the issue of fraudulent joinder.

The Texas citizenship of the Clinical Researchers would ordinarily defeat removal jurisdiction under 28 U.S.C. § 1441(b). However, Merck contends that this Court may assert its removal jurisdiction because the Plaintiffs fraudulently joined the Clinical Researchers. For the reasons herein stated, this Court finds that the Plaintiffs fraudulently joined the Clinical Researchers. Thus, removal was proper, and this Court has jurisdiction over this action.

Factual Background

In May 1999, Merck received approval from the Federal Drug Administration and began distributing, marketing, and selling VIOXX®, an osteoarthritis and pain-relief drug. Plaintiffs received VIOXX® and now allege that they suffered adverse cardiovascular effects as a result of ingesting the drug. Specifically, the Plaintiffs allege that Merck, through its clinical studies, knew that VIOXX® caused adverse cardiovascular effects. Plaintiffs allege that, rather than disclosing such information, Merck negligently and fraudulently concealed it, instead marketing the drug as safe and effective. Plaintiffs further allege that the Clinical Researchers acted in concert with Merck, choosing not to report the drug’s adverse effects despite performing clinical studies during the development stage of VIOXX® that made them aware of possible side effects.

Where fraudulent joinder is alleged in removed cases, the Court must decide all disputed questions of fact and all ambiguities in favor of the non-removing party. 1 *836 Therefore, the Court must accept as true the fact that the Clinical Researchers’ studies showed a pattern of drug-related toxicity, but in light of undisputed critical facts, no viable claims can be pursued by Plaintiffs against the Clinical Researchers. Both parties have supplemented their pleadings with evidence. Merck has substantiated the facts it alleges with affidavits from Dr. Resnick, the Medical Director of R/D Clinical Research, and Dr. Robert E. Silverman, the Senior Director of Regulatory Affairs for Merck Research Laboratories, a division of Merck. Plaintiffs have included documents showing the results of the tests conducted by the Clinical Researchers.

Between 1993 and the present, Merck contracted with the Clinical Researchers to be “Primary Investigators” in six studies of VIOXX®. Customarily, the Clinical Researchers do not design their own clinical studies, but work according to protocols provided by the pharmaceutical companies with which they contract. Merck designed the protocols and provided the instructions via an Investigator’s Brochure. The Clinical Researchers conducted each protocol according to Merck’s instructions and then reported the results. Merck had Clinical, Medical, and Statistical Monitors who aided in determining what constituted an adverse effect, and sent employees to R/D Clinical Research multiple times to determine whether there was a pattern of drug-related toxicity. Merck did not authorize the Clinical Researchers to report the data to anyone other than Merck. The Clinical Researchers did not participate in the manufacture, composition, labeling, or any other aspect of marketing VIOXX®.

The studies that Merck designed for the Clinical Researchers to conduct were double-blind. Under this method, neither the Clinical Researchers nor the patients knew whether the patients received VIOXX®, a placebo, or a comparator drug. Only Merck had a code which allowed it to match a patient to the treatment he or she was receiving. Consequently, if one of the subjects suffered an adverse effect, the Clinical Researchers had no means of knowing whether the effect was related to VIOXX®. None of the Plaintiffs were subjects of the Clinical Researchers’ studies. The Clinical Researchers had no contact with the Plaintiffs prior to this litigation.

The Clinical Researchers were also not the only research company reporting data to Merck. Merck contracted with a number of other research companies. For instance, in one of the six studies in which the Clinical Researchers participated, Merck also contracted with more than 60 other “Primary Investigators” for the same study. In total, the Clinical Researchers screened and submitted data on less than five percent of the patients randomized in the six studies, or 154 out of a total of 3,638. Furthermore, Merck conducted, in all, 23 clinical studies encompassing approximately 28,000 patients; therefore, the Clinical Researchers submitted data on less than 0.6 percent of the patients that Merck evaluated in its development of VIOXX®.

Analytical Framework and Standard of Review

Under the concept of fraudulent joinder, “a federal court may assert diversity jurisdiction when a non-diverse defendant has been joined in state court simply to preclude removal.” 2 As the moving party, Merck bears the heavy burden of proving that the Plaintiffs fraudulently *837 joined the Clinical Researchers, by establishing that either (1) the Plaintiffs’ statement of the facts is utterly fraudulent, or (2) there is no possibility that the Plaintiffs could establish a cause of action in state court for any of the counts they have pleaded against the Clinical Researchers. 3 Merck based its Notice of Removal on a claim that Plaintiffs would be unable to establish liability against the Clinical Researchers under state law.

In evaluating the fraudulent joinder issue, the Court may choose to “pierce the pleadings” and view summary judgment-type evidence. 4 In this case, the parties have offered such evidence.

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Bluebook (online)
270 F. Supp. 2d 833, 2003 U.S. Dist. LEXIS 11318, 2003 WL 21529140, Counsel Stack Legal Research, https://law.counselstack.com/opinion/staples-v-merck-co-inc-txnd-2003.