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N.J. Appeals Court: Hormone Replacement Therapy Plaintiffs Didn't Rebut Label Adequacy

TRENTON, N.J. - (Mealey's) A New Jersey appeals court panel on Sept. 29 affirmed summary judgment in two hormone replacement therapy (HRT) cases in which the state's mass tort court found that the plaintiffs failed to present sufficient evidence to rebut the state's presumption that warnings approved by the Food and Drug Administration are adequate (Loretta DeBoard v. Wyeth, Inc., et al., No. A-6230-07T1, and Dora Bailey, et al. v. Wyeth, Inc., et al., No. A-6251-07T1, N.J. Super., App. Div.). 

In 1991, Loretta DeBoard and Dora Bailey each took Premarin, made by Wyeth, and Provera, made by Pharmacia & Upjohn Co., to treat menopausal symptoms.  In 1996, their doctors switched both of them to Prempro, made by Wyeth. 

Premarin's active ingredient is conjugated estrogen.  Prempro is a combination of estrogen and progestin.  Provera's active ingredient is progestin. 

DeBoard was diagnosed with breast cancer in 2001, and Bailey was diagnosed with the disease in 2002.  DeBoard sued Wyeth and Pharmacia & Upjohn in New Jersey state court, and their cases became part of the state's HRT mass tort docket in the Middlesex County Superior Court. 

The plaintiffs claimed that the defendants violated the New Jersey Products Liability Act by failure to warn, fraud and intentional and negligent misrepresentation and also violated the New Jersey Consumer Fraud Act. 

In 2008, Judge Jamie D. Happas granted summary judgment.  In addition to finding that the plaintiffs failed to rebut the state law presumption in favor of FDA-approved drugs, the judge said their consumer law claims are subsumed by the Product Liability Act. 

DeBoard and Bailey appealed to the Superior Court Appellate Division, arguing that the presumption cannot be applied prior to 1995 because the combined used of estrogen and progesterone constituted an off-label use of the drugs.  They also argued that Judge Happas misconstrued established law regarding the application of the presumption and that she failed to draw all favorable inferences from their evidence and the defendants' conduct. 

In a five-page published opinion, the panel said simply "we affirm substantially on the basis of the well-considered and exhaustive opinion of Judge Happas in the Bailey matter, which we have determined to be well supported by the evidence and legally unassailable." 

[Editor's Note:  Full coverage will be in the Oct. 6 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-111006-023Z.  For all of your legal news needs, please visit] 

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