'Lance v. Wyeth': A New Cause Of Action In Pennsylvania?

Issuing an opinion over two years after oral argument, the Pennsylvania Supreme Court ruled last week in Lance v. Wyeth that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs. While the 4-2 majority opinion stated that Wyeth was asking for the court to impose "a new [restricted] duty regime" by ruling against such negligence claims, this decision actually expands the duty regime by allowing them.

BACKGROUND

In April 1996, the Food and Drug Administration ("FDA") approved Redux as a prescription weight-loss drug. The Redux packaging warned of an increased risk of pulmonary hypertension ("PPH"). By September 1997, Wyeth and the FDA announced that the drug would no longer be available in the United States following reports of an association between the medication and serious heart problems.

In the fall of 2006, Patsy Lance brought this case on behalf of her daughter, Catherine Lance, alleging that Catherine ingested Redux for several months in 1997. The complaint alleged that the drug caused Catherine to develop PPH, from which she died within a month after her diagnosis in 2004. Lance framed her claims as "Negligence—Unreasonable Marketing of a Dangerous Drug and Unreasonable Failure to Remove the Drug from the Market before January 1997." Lance disavowed any claim based upon inadequate labeling.

At the lower court level, Wyeth filed and won a motion for summary judgment, arguing that Lance failed to assert a cognizable cause of action. On appeal, the intermediate appellate court found that Lance should have been permitted to proceed with a claim of negligent design only. Wyeth and Lance cross-appealed to the Pennsylvania Supreme Court, "challenging, respectively...that pharmaceutical companies are not immune (under Pennsylvania law) from claims of negligent drug design, and that claims of negligent marketing, testing, and failure to withdraw are unviable."

THE SUPREME COURT'S DECISION

The majority of the Pennsylvania Supreme Court affirmed the intermediate court's ruling reinstating Lance's negligent design defect claim but reversed the part of the decision that disallowed other negligence-based theories, such as negligent marketing.

On appeal, Wyeth maintained that, under Pennsylvania precedent, claims against pharmaceutical companies were limited to manufacturing defects and inadequate warnings. But the Pennsylvania Supreme Court held that the case was a matter of first impression. The court...