The Products Liability Act is the sole source of remedy for defective product claims; it does not include the remedy of medical monitoring where, as here, no manifest injury is alleged.

This products liability litigation arises from the use of Vioxx, a prescription drug manufactured and sold by Merck & Co. Inc. Vioxx was approved for sale in May 1999. It was voluntarily withdrawn from the market in September 2004 after a long-term study of the drug showed an increased risk of serious cardiovascular events, including heart attacks and strokes, among patients taking it.

In November 2004, plaintiffs Phyllis Sinclair and Joseph Murray filed a class-action complaint against Merck and other fictitiously named defendants alleging, inter alia, violation of the Products Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11, and the Consumer Fraud Act (CFA), N.J.S.A. 56:8-1 to -106. They filed the action on behalf of a proposed national class of those who, as a result of their direct and prolonged consumption of Vioxx, are at enhanced risk of serious undiagnosed and unrecognized myocardial infarction and other latent injuries. They did not allege any manifest injury. Plaintiffs sought to have defendants fund a court-administered medical monitoring program for each member of the proposed class.