Odds Rise for FDA Shield Against Drug Liability

-Wall Street Journal

04/07/2008 - Johnson & Johnson maintains that it can’t be sued by thousands of women who claim they were injured by the company’s birth control patch because the FDA approved the product as safe and effective.

The seemingly tautologous legal argument is called pre-emption. “After decades of being dismissed by courts, the tactic now appears to be on the verge of success,” attorneys for plaintiffs and drug makers tell the New York Times.

J&J’s Ortho Evra patch delivered much more of the hormone estrogen than regular oral contraceptives, the Times reports, potentially raising the risk of blood clots and strokes.

The Times says J&J obscured that fact, yet is still counting on the FDA’s approval of the patch to shield the company from liability claims. A J&J spokeswoman told the paper, “We have regularly disclosed data to the FDA, the medical community and the public in a timely manner.”

In February, the Supreme Court ruled that makers of medical devices can’t be sued over their products’ safety and effectiveness, if the devices received premarket approval from FDA. The court split on a Pfizer case that could have provided a step toward pre-emption for prescription drugs. That deadlock raised the stakes for Wyeth v. Levine, a case scheduled for the Supreme Court in the fall, that could make a broad pre-emption shield a reality for medicines.