By David Sell, Inquirer Staff Writer

WASHINGTON - Supreme Court justices questioned and debated Tuesday the proper reach and power of federal law in the regulation of generic drugs and whether a Philadelphia company is liable for $21 million in damages for horrific injuries suffered by a New Hampshire woman who took one of the company's medications.

Mutual Pharmaceuticals Co. asked the justices to overturn a jury decision in favor of Karen Bartlett, 53, who had a rare reaction to the painkiller sulindac, in which her skin essentially peeled away and she was left nearly blind.

"No warning label would have made a difference," lawyer David Frederick said, arguing on behalf of Bartlett that patients should be able to sue drugmakers in state courts on the ground that a badly designed drug can cause harm.

The Mutual generic was a copy of a previously branded drug. Bartlett and her attorneys argue that the drug was badly designed. Mutual contends it was legally bound to retain that design in its generic version.

The nine justices probably will decide by the end of June when and whether federal law trumps state law regarding generic-drug design, and their ruling could change the landscape for patients, drugmakers, and regulators.

Generic drugs account for 80 percent of prescriptions written in the United States. To get approval to sell a brand-name drug in the U.S., pharmaceutical companies must do clinical testing and divulge the ingredients to the Food and Drug Administration. Generic drugs are essentially copies of the original, and the FDA requires manufacturers to adhere to the label and the formula of the branded version. Without the front-end cost, generic companies can sell the drug for much less money.