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Sinclair v. Merck & Co.

June 4, 2008

PHYLLIS SINCLAIR, JOSEPH MURRAY AND ROBBIE L. TRAYLOR, INDIVIDUALLY AND FOR ALL OTHERS SIMILARLY SITUATED, PLAINTIFFS-RESPONDENTS,
v.
MERCK & CO., INC., DEFENDANT-APPELLANT, AND JANE DOES DISTRIBUTORS (1-50), JILL DOES MANUFACTURERS (1-50), JACK DOES PHARMACEUTICAL ADVERTISERS (1-50), JAKE DOES SELLERS (1-50), JOHN DOES MARKETING PARTNERS (1-50) AND JOAN DOES PROMOTERS (1-50), DEFENDANTS.



On certification to the Superior Court, Appellate Division, whose opinion is reported at 389 N.J. Super. 493 (2007).

SYLLABUS BY THE COURT

(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in the interests of brevity, portions of any opinion may not have been summarized).

WALLACE, J., writing for a majority of the Court.

In this products liability case the Court considers whether plaintiffs may recover the costs of medical monitoring despite their failure to allege a physical injury.

This litigation arises from the use of Vioxx, a prescription drug manufactured and sold by Merck. On May 20, 1999, Vioxx was approved for sale by the United States Food and Drug Administration (FDA) for the relief of the signs and symptoms of acute pain, dysmenorrhea, and osteoarthritis. Five years later, on September 30, 2004, the FDA acknowledged the voluntary withdrawal from the market of Vioxx. The FDA explained that the withdrawal came after a board overseeing a long-term study of the drug recommended the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among patients taking Vioxx.

Since the withdrawal of Vioxx from the market, numerous plaintiffs have instituted lawsuits against Merck alleging cardiovascular injuries due to Vioxx. In November 2004, plaintiffs filed a class action complaint against Merck and various other parties. Plaintiffs alleged negligence, violation of the Products Liability Act (PLA), violation of the Consumer Fraud Act (CFA), breach of warranties, and unjust enrichment. Plaintiffs brought the action on behalf of a proposed national class of individuals who ingested Vioxx and who may suffer from serious silent or latent injury for which they may require medical monitoring.

In March 2005, an amended complaint redefined the class as consisting of individuals who ingested Vioxx for at least six consecutive weeks and who had not sought to recover damages for personal injuries caused by Vioxx. Plaintiffs also refined the factual allegations advanced in the complaint and alleged that as a result of the direct consumption of Vioxx, they are at enhanced risk of serious undiagnosed and unrecognized myocardial infarction, commonly referred to as "silent heart attack," and other latent and unrecognized injuries. In addition to seeking punitive damages, plaintiffs asserted that the cost of diagnostic testing designed to determine whether they have suffered unrecognized or serious latent injury represents an ascertainable economic loss for which they are entitled to medical monitoring relief paid for by defendants. They sought to have defendants fund a court-administered screening program to provide medical diagnostic tests for each member of the proposed class and follow-up with an epidemiologist. Plaintiffs did not allege that they have had an Electrocardiogram (EKG) since they began taking Vioxx or that they have suffered any known adverse effect as a result of taking Vioxx.

In April 2005, Merck moved to dismiss the amended complaint for failure to state a cognizable claim under New Jersey law. The trial court reviewed the standards governing pleadings and motions to dismiss, as well as the facts and holdings of several significant cases that addressed medical monitoring: Ayers v. Township of Jackson, 106 N.J. 557 (1987), Mauro v. Raymark Industries, Inc., 116 N.J. 126 (1989), and Theer v. Philip Carey Co., 133 N.J. 610 (1993). The trial court granted Merck's motion and dismissed plaintiffs' complaint. It found that the PLA limits compensation to harm as defined by N.J.S.A. 2A:58C-1b(2), and reasoned that medical monitoring has not been applied to a products liability action to which the PLA applies. Additionally, the trial court noted that the CFA only allows for recovery of economic damages, and medical monitoring is therefore an unavailable remedy under that act.

On appeal, the Appellate Division reversed and remanded for further proceedings. Sinclair v. Merck & Co, 389 N..J. Super. 493 (2007). The panel cautioned that it did not read the relevant cases to require dismissal without analysis of the scientific and other evidence relevant to plaintiffs' claims. It noted the lack of facts and expert testimony at this stage of the proceedings, and remanded for discovery and an evidentiary hearing. Although the panel explained that even though the PLA's requirement of harm, which is defined in relevant part as "personal physical illness, injury or death," may ultimately lead to the dismissal of plaintiffs' claims, they must be accorded an opportunity to demonstrate such harm before the portions of the suit premised on the PLA can be dismissed as legally insufficient. This Court granted Merck's petition for certification and also granted amicus curiae status to five entities.

HELD: The Products Liability Act, which is the sole source of remedy for plaintiffs' defective product claim, does not include the remedy of medical monitoring when no manifest injury is alleged.

1. This Court held in Ayers that a plaintiff can recover the cost of medical monitoring under the Tort Claims Act. In that case, a landfill operated by the defendant contaminated the plaintiffs' well water. The Court identified several factors to be considered in determining whether medical monitoring is an appropriate remedy, including the extent of exposure to chemicals, the toxicity of the chemicals, the seriousness of the diseases, relative increase in chance of onset of disease, and the value of early diagnosis. Two years later, in Mauro, the Court allowed damages that included future medical surveillance in a suit by a repairman employed at a state hospital against manufacturers of products containing asbestos. The complaint alleged plaintiff's injuries were sustained as a result of inhalation of asbestos fibers. The next case was Theer, where the widow of an asbestos worker brought a products liability action against manufacturers of asbestos products to recover for her husband's death and her risk of future injury due to her indirect exposure to asbestos through the handling of her husband's clothes. This Court determined that the remedy of medical surveillance was not available to the plaintiff in Theer, because that remedy applied only to persons who have been directly exposed to a hazardous substance. (pp. 9-13)

2. In 1987, the Legislature enacted the PLA to limit the liability of manufacturers so as to balance the interests of the public and the individual with a view towards economic reality. A product liability action is defined as "any claim or action brought by a claimant for harm caused by a product." N.J.S.A. 2A:58C-1b(3). "Harm" is defined as "personal physical illness, injury or death." N.J.S.A. 2A:58C-1b(2). Merck argues that the word "physical" modifies both "illness" and "injury," and because plaintiffs have no "physical" injury, their claims must fail. This Court reads the PLA to require a physical injury. In the definition, the word "injury" is surrounded by "physical illness," which explicitly requires something physical, and "death," which inherently is physical. The sense and reason of the definition is that the adjectives "personal physical" are intended to modify the words "illness," "injury," and "death." It is not disputed that plaintiffs do not allege a personal physical injury. Thus, the Court concludes that they cannot satisfy the definition of harm to state a product liability claim under the PLA, and their claim for medical monitoring must fail. (pp. 13-18)

3. Plaintiffs also seek to avoid the requirements of the PLA by asserting their claims as CFA claims. However, the Legislature expressly provided in the PLA that claims for harm caused by a product are governed by the PLA irrespective of the theory underlying the claim. The heart of plaintiffs' case is the potential for harm caused by Merck's drug. It is obviously a product liability claim. Consequently, plaintiffs may not maintain a CFA claim. (pp. 18-19)

The judgment of the Appellate division is REVERSED, and the matter is REMANDED to the Law Division to REINSTATE the judgment dismissing plaintiffs' complaint.

JUSTICE LONG filed a separate, DISSENTING opinion, expressing her disagreement with the majority's conclusion that plaintiffs did not suffer "harm" under the PLA, and her view that even if the majority is correct on that issue, plaintiffs are entitled to pursue their remedies at common law.

CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, RIVERA-SOTO and HOENS join in JUSTICE WALLACE's opinion. JUSTICE LONG filed a separate, dissenting opinion. JUSTICE ALBIN did not participate.

The opinion of the court was delivered by: Justice Wallace, Jr.

Argued October 22, 2007

In this products liability case we consider whether plaintiffs may recover the costs of medical monitoring despite their failure to allege a physical injury. The trial court granted defendant Merck & Co., Inc.'s (Merck) motion to dismiss, reasoning that medical monitoring is an uncommon remedy that should not be applied to plaintiffs who did not allege any manifest injury. The Appellate Division disagreed, concluding that our limited medical monitoring jurisprudence does not necessarily preclude plaintiffs' cause of action and remanded for discovery. We granted Merck's petition for certification, and now reverse.

We hold that the definition of harm under our Products Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11, does not include the remedy of medical monitoring when no manifest injury is alleged. We also hold that the PLA is the sole source of remedy for plaintiffs' defective product claim; therefore, the Consumer Fraud Act (CFA), N.J.S.A. 56:8-1 to -106, does not provide an alternative remedy.

I.

This litigation arises from the use of Vioxx, a prescription drug manufactured and sold by Merck. On May 20, 1999, Vioxx was approved for sale by the United States Food and Drug Administration (FDA) for the relief of the signs and symptoms of acute pain, dysmenorrhea, and osteoarthritis. Sequence of Events with VIOXX, since opening of IND, http://www.fda.gov/OHRMS/DOCKETS/AC/05/briefing/2005-4090B1_04_E-FDA-TAB-C.htm (last visited Mar. 20, 2008). Five years later, on September 30, 2004, the FDA "acknowledged the voluntary withdrawal from the market of Vioxx." FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product (Sept. 30, 2004), http://www.fda.gov/bbs/topics/news/2004/NEW01122.html [hereinafter FDA Release]. The FDA Release explained that the withdrawal came "after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo."

Since the withdrawal of Vioxx from the market, numerous plaintiffs have instituted lawsuits against Merck alleging cardiovascular injuries due to the use of Vioxx. In November 2004, plaintiffs Phyllis Sinclair and Joseph Murray filed a class action complaint against Merck and various fictitiously-named distributors, manufacturers, advertisers, sellers, marketing partners, and promoters. Plaintiffs alleged negligence, violation of the PLA, violation of the CFA, breach of express and implied warranties, and unjust enrichment. Plaintiffs brought the action on behalf of a proposed national class of individuals who ingested Vioxx during the period from when Vioxx was introduced in May 1999 through the period when it was withdrawn from the worldwide market in September 2004, and who may suffer from serious silent or latent injury for which they may require medical monitoring.

In March 2005, an amended complaint substituted plaintiff Robbie L. Traylor for plaintiff Sinclair and redefined the class sought to be certified as consisting of national or statewide individuals who ingested Vioxx for at least six consecutive weeks during the previously mentioned period who had not sought to recover damages for personal injuries caused by Vioxx. Plaintiffs also refined the factual allegations advanced in the complaint and alleged that as a result of their direct and prolonged consumption of Vioxx, they are at enhanced risk of serious undiagnosed and unrecognized myocardial infarction, commonly referred to as "silent heart attack," and other latent and unrecognized injuries. In addition to seeking punitive damages, plaintiffs asserted that the cost of diagnostic testing designed to determine whether they have suffered unrecognized or serious latent injury as a result of their direct exposure to Vioxx represents an ascertainable economic loss for which they are entitled to medical monitoring relief paid for by defendants. They sought to have defendants fund a court-administered screening program to provide medical diagnostic tests for each member of the proposed class and follow-up with an epidemiologist. Plaintiffs did not allege that they have had an Electrocardiogram (EKG) since they began taking Vioxx or that they have suffered any known adverse effect as a result of taking Vioxx.

Thereafter, in April 2005, Merck moved to dismiss the amended complaint for failure to state a cognizable claim under New Jersey law. In framing the issue, the trial court reviewed the standards governing pleadings and motions to dismiss, as well as the facts and holdings of several significant cases that addressed medical monitoring: Ayers v. Township of Jackson, 106 N.J. 557 (1987), Mauro v. Raymark Industries, Inc., 116 N.J. 126 (1989), and Theer v. Philip Carey Co., 133 N.J. 610 (1993). The court determined that Theer, as it related to Ayers and Mauro, limited the extent to which the Supreme ...


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