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HEINDEL v. PFIZER INC.

June 7, 2004.

DOROTHY HEINDEL and JEAN KINMOTH Plaintiff,
v.
PFIZER INC., PHARMACIA CORP., MONSANTO CO., G.D. SEARLE & CO. and MERCK & CO., INC., Defendants.



The opinion of the court was delivered by: STANLEY CHESLER, Magistrate Judge

OPINION

This matter comes before the Court on the motion of Defendants, Pfizer, Inc., Pharmacia Corporation, the Monsanto Company, Searle & Co., and Merck & Co., Inc. for summary judgment. The Court has opted to adjudicate this motion on the papers, and renders this opinion without oral argument pursuant to Fed.R.Civ.P. 78. For the reasons set forth more fully below, Defendants' motion is granted, and summary judgment entered dismissing Plaintiff's complaint. I. INTRODUCTION

Plaintiffs in this matter are two consumers who suffer from pain associated with osteoarthritis and other conditions. Both took prescription drugs to treat their conditions and both got relief from the drugs they took. Though neither plaintiff suffered any physical injury from either of the drugs at issue, both now claim that they are entitled to damages for the "economic injuries" they suffered due to Defendants' failure to publicize the results of two clinical studies that revealed possible risks associated with the use of the drugs. Plaintiffs assert claims arising under the consumer fraud statutes of New Jersey or "other states," claims for breach of implied warranty of merchantability, and claims for injunctive/equitable relief requiring Defendants to issue revised advertising statements, marketing materials, and product packaging.*fn1

  For the reasons adduced more fully below, the Court finds that Plaintiffs' claims lack merit under the laws of Pennsylvania. Moreover, the Court finds that since the Plaintiffs suffered no injury, there is no theory under which they are entitled to recover, and that Defendants are therefore entitled to summary judgment as to all claims.

  II. BACKGROUND

  A. Facts

  The Defendants in this matter manufactured and marketed two prescription pain medications which belong to a class of medications known as "non-steroidal anti-inflammatory drugs," or "NSAIDs." Pfizer, Inc., Pharmacia Corporation, Monsanto Co., and G.D. Searle & Co. (collectively the "Celebrex Defendants") are (or were) the makers of Celebrex, while Vioxx is made by Merck & Co. ("hereinafter "Merck"). Non-steroidal anti-inflammatory drugs reduce pain by blocking the body's production of enzymes called cyclooxygenase, or "COX," of which there are two forms: COX-1 and COX-2. Most traditional NSAIDs, (such as ibuprofen) work by blocking the COX-1 enzyme, which reduces pain but may lead to gastrointestinal perforations and bleeds. Celebrex and Vioxx, it is believed, block the COX-2 enzyme that triggers pain and inflamation while sparing the (COX-1) enzyme that helps maintain normal stomach lining. Both drugs are indicated for, inter alia, treating the signs symptoms of osteoarthritis, and rheumatoid arthritis, management of acute pain in adults, and treatment of primary dysmenorrhea.

  Plaintiffs Heindel and Kinmonth both suffer from pain associated with osteoarthritis. Both women, who are citizens of Pennsylvania, were treated by the same rheumatologist, Dr. Lawrence Leventhal, and both were prescribed (and took) traditional NSAIDs. Among other things, Heindel had survived esophageal cancer by having part of her stomach removed (and her stomach thereby raised); and Kinmonth had a history of G.I. complications associated with her ingestion of other drugs used to treat her musculoskeltal aches and pains. These factors put both at risk for serious gastrointestinal side effects, including non-steroidal induced ulcers and ulcer complications because "people that are at risk for developing non-steroidal induced ulcers are: people over the age of 60, individuals with a history of G.I. bleed, [and] individuals with concomitant medical problems." (Deposition of Dr. Lawrence J. Leventhal (hereinafter "Leventhal Dep.) at p. 7-8; 24-26.)

  Plaintiff Heindel

  Heindel first took Celebrex in February of 1999 when Dr. Leventhal provided her with samples of the drug. (Deposition of Dorothy Heindel (hereinafter "Heindel Dep.") at 44-46; Leventhal Dep. at 14). Heindel responded favorably to Celebrex, which apparently gave her tremendous relief from her arthritis pain and other symptoms, and she did not experience any adverse side effects. (Heindel Dep. at 44-48). She continued to take Celebrex until July of 1999, when she read an article in a consumer newsletter that questioned the utility and safety of new drugs like Celebrex. (Heindel Dep. at 60-63, 99-100). Dr. Leventhal told Heindel that Celebrex was the best treatment for her, and advised her to continue using it. (Heindel Dep. at 63-64; Leventhal Dep. at 18-19). Thereafter she resumed taking Celebrex, and apparently used it until February 2001, when, at Dr. Leventhal's suggestion, she switched to Vioxx. (Heindel Dep. at 76-77; Leventhal Dep. at). Vioxx apparently caused her to experience stomach upset, and after a few months she switched back to Celebrex. (Heindel Dep. at 77; Leventhal Dep. at 55).*fn2 In February of 2002, Dr. Leventhal provided Heindel with another prescription drug, Bextra, to "see if it [was] better than Celebrex." (Heindel Dep. At 80). Finding that it was not, Heindel switched back to Celebrex in November of 2002. (Heindel Dep at 84). Heindel does not claim that she suffered ill effects from or was personally injured by Celebrex. It appears that, at least as of the filing of Defendants' motion for summary judgment, she was still taking Celebrex and planned to continue using it in the future. All of Heindel's treatment took place in Pennsylvania, where Dr. Leventhal is located, where she lives, and where she purchased Celebrex and Vioxx.

  Plaintiff Kinmonth

  Kinmonth was first prescribed Celebrex in May or June of 1999. (Deposition of Jean Kinmonth (hereinafter "Kinmonth Dep.") at 16-18, 95-96; Leventhal Dep. at 28). Some time in the spring of 2000, she switched to Vioxx, which Dr. Leventhal thought might provide her with a greater degree of relief. (Leventhal Dep. at 33-34). Though Vioxx initially provided Kinmonth with more complete relief from her symptoms than Celebrex had, its efficacy declined over time, and she eventually switched back to Celebrex.

  Kinmonth does not claim that she suffered ill effects from or was personally injured by Celebrex or Vioxx. It appears that, at least as of the time of her deposition, she was still using Celebrex. (It is not clear whether she was still taking Vioxx or had any plans to do so.) All of Kinmonth's treatment took place in Pennsylvania, where Dr. Leventhal is located, where she lives, and where she purchased Celebrex and Vioxx.

  B. Plaintiff's Claims

  Plaintiffs brought this consumer class action on behalf of the purchasers and users of Celebrex and Vioxx, claiming that they are entitled to recover economic damages they sustained due to Defendants' "unconscionable marketing conduct." Plaintiff's Brief (hereinafter "Pl.'s Br.") at 1. They are pursuing claims under the New Jersey Consumer Fraud Act (Count III) and for breach of implied warranty of merchantability (Count I).*fn3 Plaintiffs claim that Defendants knew, by 1998, that their "selective COX-2 inhibitors posed serious cardiovascular risks for anyone who took them," but nonetheless made a marketing decision to "push these drugs to market on claimed improvements in gastrointestinal safety while downplaying their cardiovascular dangers." Complaint at ¶¶ 23, 24. Plaintiffs contend that Defendants funded two significant clinical trials to justify their advertising claims and demonstrate that Celebrex and Vioxx had greater gastrointestinal safety than traditional NSAIDs — the Celecoxib Long-Term Arthritis Safety Study ("CLASS") and the Vioxx Gastrointestinal Outcomes Research Study ("VIGOR"). Complaint at ¶ 25.

  The CLASS study compared gastrointestinal toxicity in arthritis patients taking Celebrex, ibuprofen, and dicofenac. It included patients with heart problems, who were allowed to take low prophylactic doses of aspirin to reduce the risk of adverse cardiovascular events. The VIGOR study-which compared gastrointestinal toxicity in patients taking VIOXX with those taking naproxen to treat arthritis — excluded patients with heart problems. Complaint at ¶ 26, 27. Plaintiffs claim that Defendants' attention to cardiac factors establishes their "secret acknowledgment of the likelihood cardiovascular events." Id. at ¶ 28. Plaintiffs further allege that once the studies were concluded the Defendants tried to divert attention from cardiovascular risks by either not publishing cardiovascular data they had gathered or publishing partial information. (Presumably this allegation refers to publication in medical journals or other media traditionally used for the purpose of disseminating the results of clinical trials; it is not clear from the briefing.)

  The results of both studies were submitted to the FDA's Arthritis Drugs Advisory Committee ("the Committee") as part of requests to exempt Celebrex and Vioxx from gastrointestinal safety warning in their package inserts. Plaintiffs state that the Committee did not consider the cardiovascular safety of Celebrex, but they do not discuss whether this would have been a normal consideration given the scope of the exemption sought. They also state that, because patients in the VIGOR study suffered significantly more adverse cardiovascular events than those taking naproxen, the Committee suggested that "Merck add a warning to its package insert advising that Vioxx lacked the cardio-protective properties of traditional NSAIDs." Id. at 34. However, it is not clear what Merck's obligation was to warn of a protective quality that Vioxx did not have, as opposed to warning of side effects that may have affirmatively caused.

  Thereafter, Defendants "initiated extensive pre-release marketing campaigns" that emphasized Vioxx and Celebrex's efficacy without gastrointestinal side effects. This, Plaintiffs claim, was an attempt to "avoid negative publicity from the VIGOR report and the Committee's decisions. Id. at 36. Subsequently, Celebrex and Vioxx were approved by the FDA and released for sale. According to the Plaintiffs, Defendants should have (at this point), used their exponential profits to fund further studies to quantify cardiovascular risks, but instead poured money into advertising campaigns that emphasized the gastrointestinal safety of the drugs. As a "result of" these "misleading advertising campaigns, Celebrex and Vioxx were wildly successful." Id. at 42-44.

  Persistent concern within the medical community about possible links between COX-2 inhibitors and increased blood clotting (with related incidence of cardiovascular events) eventually led to further research and study. In 2001 independent doctors from the Cleveland Clinic published a meta-analysis of the CLASS and VIGOR trials that concluded that COX-2 inhibitors posed an increased risk of adverse cardiovascular events compared to naproxen. Defendants did not modify their package inserts to reflect the results of the Cleveland Clinic study. Though Plaintiffs contend that the FDA sent both Defendants cautionary letters reflecting its concern about their failure to include warn of cardiovascular side effects in direct-to-consumer advertising, it is far from clear that the FDA's letters addressed this issue. Vioxx and Celebrex have not been taken off the market, and remain popular treatments for osteoarthritis and other types of pain.

  Plaintiffs admit that they are not pursuing any claims for physical injury, either for themselves or for the two sub-classes they seek to represent. Rather, their claims are based on the economic injury that Defendants' marketing practices have allegedly caused them. (Pl.'s Br. at 2). Specifically, they posit that Defendants' "uniform failure to disclose known cardiovascular risks associated with Celebrex and Vioxx caused consumers to pay artificially inflated prices for them." Id. Plaintiffs seek to recover some or all of the purchase price consumers paid for these drugs. Pl.'s Br. at 4-5.

  Though this suit arises out of economic injuries allegedly suffered by the Plaintiffs, both Heindel and Kinmonth denied, when deposed, that they had suffered economic harm. Both plaintiffs also testified that they took Celebrex and Vioxx at the suggestion of their physicians, and did not rely on advertising or marketing materials created or distributed by Defendants.

  III. SUMMARY JUDGMENT STANDARD

  Summary judgment is appropriate only if all of the probative materials in the record, viewed in the light most favorable to the non-moving party, demonstrate that there is no genuine issue of material fact and that the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Brooks v. Kyler, 204 F.3d 102, 105, n. 5 (3d Cir. 2000); Celotex v. Catrett, 477 U.S. 317, 330 (1986) Todaro v. Bowman, 872 F.2d 43, 46 (3d Cir. 1989). An issue is "genuine" if a reasonable jury could possibly hold in the non-movant's favor with regard to that issue. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). A fact is "material" if it influences the outcome under the applicable law. Anderson, 477 U.S. at 248.

  The moving party bears the initial burden of demonstrating either (1) that there is no genuine issue of fact and that, as a matter of law, the moving party must prevail, or (2) that the non-moving party has not shown facts relating to an essential element of the issue for which he bears the burden of proof. Celotex, 477 U.S. at 331. Once either showing is made, the burden shifts to the non-moving party, who must demonstrate facts which support each element of the for which he bears the burden, and establish the existence of genuine issues of material fact. Id. To satisfy this burden, the non-moving party "may not rest on mere allegations or denial of his pleading." Fed.R.Civ.P. 56(e). Rather, he must produce sufficient evidence from which a reasonable jury might find in his favor, and may not simply create some metaphysical doubt as to material facts. Matsushita Elec. Indus. Co. V. Zenith Radio Corp., 475 U.S. 574 (1986).

  IV. CHOICE OF LAW

  The parties disagree as to which state's law this Court should apply in considering Plaintiff's claims. Plaintiffs claim that, because Defendants have failed to establish specific conflicts between the laws of New Jersey and Pennsylvania, the laws of this forum (New Jersey) should apply. They also contend that the objectives underlying the consumer warranty laws of New Jersey and Pennsylvania are identical, thus requiring the application of New Jersey law to Plaintiff's claims. Turning to the governmental interest analysis, Plaintiffs argue that New Jersey has the greatest interest in having its law govern these claims because (1) the New Jersey legislature has expressed a specific intent to protect the citizens of other states from the deceptive practices of businesses located within its boundaries (even if some aspect of the transaction took place outside New Jersey); (2) many of the corporate decisions and actions that form the basis for Plaintiff's claims — including the development, production, and marketing of Celebrex and Vioxxtook place in New Jersey; and (3) because "Defendants have other significant contacts with New Jersey that give this state an express interest in having its laws apply to their conduct." Among the contacts mentioned are Defendants' large corporate presence in the state, the considerable number of people it employs, the tax breaks it receives from New Jersey, and the number of lawsuits (unrelated to this one) filed by Defendants in New Jersey courts.

  The Defendants contend, for essentially the same reasons, that Pennsylvania law should apply. They stress that both Plaintiffs live in Pennsylvania; that the conduct alleged occurred in Pennsylvania; and that the alleged financial injuries were suffered in Pennsylvania. All Defendants argue that the mere fact of a corporate presence (a minimum threshold which some of these defendants do not even meet, since only one of the four Celebrex Defendants has headquarters in New Jersey) does not give New Jersey an interest in the adjudication of these claims which overrides that of the Plaintiffs' home state. Thus, they argue, New Jersey has neither sufficient contacts with this litigation nor the requisite governmental interest in having its laws applied.

  Federal courts sitting in diversity must apply the choice of law rules of the forum in which they sit. Klaxon Co. v. Stentor Electrical Manufacturing Co., 313 U.S. 487, 496 (1941); Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938). Accordingly, New Jersey's choice of law rules govern this Court's analysis. Chin v. Chrysler Corp., 182 F.R.D 448, 457 (D.N.J. 1998). New Jersey's rule "applies a flexible `governmental interest' standard, which requires application of the law of the state with the greatest ...


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