Norplant maker has no duty to warn about side effects.

The manufacturer of the long-term contraceptive implant Norplant had no duty to warn women about possible side effects, according to a decision by the Fifth Circuit Court of Appeals. Plaintiff lawyers say the ruling hurts but that it's not fatal to the thousands of cases pending in courts across the country.

However, the decision, which upheld the learned intermediary doctrine as a defense for the manufacturer, brought to an abrupt halt the trial of five women who claimed Norplant caused headaches, nausea, irregular menstrual bleeding, mood swings, and depression. (In re: Norplant Contraceptive Products Liability Litigation, No. 97-40591 (5th Cir. Jan. 29, 1999).)

On the eve of the women's trial in 1997, U.S. District Judge Richard Schell granted Wyeth Laboratories, Inc.'s motion for summary judgment, finding that the learned intermediary doctrine applied to all claims filed by the women.

The doctrine holds that when a drug manufacturer properly warns a prescribing physician of the dangerous risks of its product, the manufacturer is excused from warning each patient who receives the drug. The doctor stands as a learned intermediary between the manufacturer and the consumer.

On appeal, the women argued that the doctrine cannot be applied to claims under the Texas Deceptive Trade Practices Act (DTPA) because it is a common law defense and inapplicable to a statute like the DTPA. The Fifth Circuit rejected their argument, agreeing instead with the manufacturer that the doctrine is a rule of law rather than a defense and, therefore, applicable to the DTPA.

The women also contended that the doctrine should not be allowed because the manufacturer marketed Norplant directly to the women. They said they had relied on this marketing, which included no warnings, rather than rely on their physicians' warnings.

The Fifth Circuit rejected that argument as well, finding that the plaintiffs failed to present evidence that they "actually saw, let alone relied on, any marketing materials" distributed by the manufacturer.

Houston lawyer Matt Rubin, who argued the women's appeal, said the case is over for them. However, more trials are scheduled to follow as part of the multidistrict litigation (MDL) over which Judge Schell presides in Beaumont, Texas. The judge has allowed for the creation of three groups of "bellwether plaintiffs" to determine whether class certification is appropriate in the thousands of cases that have been filed.

"I'm sure that the [learned intermediary doctrine] will be raised again in the rest of the cases that are pending for Texas plaintiffs in the Beaumont MDL litigation," Rubin said. "But [the Fifth Circuit decision] doesn't have much impact for anybody else because it's a very factually specific ruling.

"The court didn't address the issue of the adequacy of the warning or whether the product was defective," Rubin said. "All those issues remain to be litigated in Beaumont. This learned intermediary doctrine is just one more thing we've got to deal with, and we'll continue to do so."