Chief Justice Ronald Castille

HARRISBURG, Pa. (Legal Newsline) - The Pennsylvania Supreme Court has agreed to hear a case in which a pharmaceutical company is accused of breaching the standard of care in designing, developing, inspecting, testing and preparing a drug to sell.

The Court, in an order filed on March 15, granted an appeal in the case of Patsy Lance v. Wyeth.

Patsy Lance alleges that her daughter, Catherine Ruth Lance, ingested Wyeth's diet drug, Redux, from January 1997 to April 1997. The drug is prescribed to help treat cases of obesity.

The Food and Drug Administration approved Redux as "safe and effective" on April 29, 1996, and the FDA continued to approve Redux after Catherine Lance stopped using it.

Then, on Sept. 15, 1997, Wyeth voluntarily withdrew Redux from the market because of the risk that the drug may cause valvlular heart disease.

More than seven years later, in November 2004, Catherine Lance was diagnosed with Primary Pulmonary Hypertension, or PPH. At the time, she suspected that her ingestion of the diet drugs was related to her diagnosis.

Catherine Lance died in December 2004. The cause of her death is at issue in the case.

The issues to be considered include:

- Whether the superior court erred in creating a new claim for "negligent design defect" of a prescription drug, despite Lance's repeated waiver of that claim;

- Whether the superior court's creation of a new cause of action for "negligent design defect" conflicts with the Court's settled precedent limiting product liability cliams against manufacturers and sellers of prescription drugs; and

- Whether the superior court's creation of a new cause of action for "negligent design defect" should properly be argued before the Court because it may affect hundreds or thousands of cases and ignores that (a) plaintiffs in design defect cases must plead and prove a "feasible alternative design" and (b) there should be deference to regulatory authorities.

Also to be considered, according to the Court's order, are:

- Did the superior court err in holding, in an acknowledged conflict with the U.S. Court of Appeals for the Third Circuit's prediction of Pennsylvania law, that Pennsylvania law would not recognize a claim against a prescription drug manufacturer for negligent failure to test to discover a prescription drug's actual harmful side effects?

- Did the superior court err in holding that Pennsylvania law would not recognize claims against a manufacturer of a prescription drug, which the federal Food and Drug Administration ultimately ordered withdrawn from the market as too dangerous for any potential users, for negligently marketing that drug and for negligently failing to withdraw that drug from the market?

Lance alleges that Wyeth was negligent in placing "an unreasonably dangerous" prescription drug on the market and in failing to withdraw it after discovering that it was unsuitable for public consumption.

She also takes issue with the pharmaceutical company's design and development of the drug.

However, Wyeth says Lance did not assert a cognizable claim. In Pennsylvania, the company argues, a plaintiff can only recover from a drug manufacturer by proving either that the drug had a manufacturing defect or an inadequate warning.

Wyeth maintains that because Lance did not aver a manufacturing defect claim and admitted that her negligence claim was not based on a failure to warn, she failed to plead a valid cause of action.

On Sept. 19, 2008, a trial court granted summary judgment in favor of Wyeth. The court concluded as a matter of law that Lance failed to plead a cognizable cause of action.

The superior court, in its opinion filed in August, concluded that the trial court did not err in granting summary judgment against Lance on her claims of unreasonable marketing and unreasonable failure to remove the drug from the market.

The trial court, however, erred in granting summary judgment in favor of Wyeth on Lance's claim for "negligent design defect," the superior court said.

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