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Wyeth Must Face Defective Drug Label Claims Over Fen-Phen Diet Pill, Says Court

The Pennsylvania Supreme Court has ruled that drug maker Wyeth must deal with products liability claims alleging that the warning labels on a popular diet drug were defective. In a 4-2 vote in Lance v. Wyeth, the majority rejected the claim that inadequate warnings and manufacturing defects are the only claims against pharmaceutical companies that are viable. Now, the Pfizer subsidiary will face negligent design and marketing allegations over the popular diet pill linked to the Fen-Phen craze.

It was during the 1990’s that Redux and Pondimin, two diet pills, were prescribed by weight-loss clinics. While the US Food and Drug Administration approved Redux but included a warning that pulmonary hypertension was a possible risk, both pills were pulled from the market in 1997 as they became increasingly inked to the risk of heart problems.

The plaintiff in this drug injury lawsuit is Patsy Lance, who is the administrator of her daughter Catherine Lance’s estate. Catherine took the diet drug Redux for a few months in 1997 and then died from primary pulmonary hypertension-related complications-it was later that year that the drug was taken off shelves.

Patsy Lance contends that Wyeth waited to disclose to the public that its diet drugs came with the risk of heart valve disease for long-term users. Redux, in particular, contains dexfenfluramine-the more potent portion of fenfluramine, which made up part of Fen-Phen, the popular drug cocktail. Both fenfluramine and dexfenfluramine are now illegal in the US.

The plaintiff argued that based on the Food and Drug Administration’s decision to take Redux off the market, there was no test for weighing the risks over the benefits that could have justified placing the drug in the marketplace, and Wyeth should have withdrawn the drug sooner than it did.

Although a judge previously dismissed Patsy’s drug injury case on the grounds that a seller cannot be held liable unless there is proof of an impurity or label inadequacy, an appellate panel revived her negligent design defect claim and brought the case to the state’s high court. Wyeth countered with the contention that Pennsylvania law only recognizes theories according to the adverse effects caused by prescription drugs and said that only drug injury claims having to do with inadequate warnings and manufacturing defect should be allowed.

This latest ruling is a partial reversal of the previous decision, and the court found there also may be a case for negligent marketing. Writing for the majority, Justice Thomas Saylor noted that a company that placed a drug into the marketplace that it knew or should have known was dangerous enough could be in violation of its duty of care either through “design or marketing.” He said that in the area of negligence, substantive allegations are more of import than labels.

In Massachusetts, please contact our Boston drug injury lawyers today.

Fen-Phen Defective Label Claim Revived by Court, Courthouse News Service, January 27, 2014
Drug makers may face liability for design defects, Pittsburgh Post-Gazette, January 27, 2014


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