Supreme Court to hear J&J pre-emption case

WASHINGTON Within the next couple of months, the Supreme Court could render a decision that could prove to be monumental for the pharmaceutical industry. The court will soon hear its third case on pre-emption. The pharmaceutical companies are hoping that the court states that the Food and Drug Administration has pre-emption status over state laws.

The new case involved Johnson & Johnson and its birth control patch Ortho Evra, according to The New York Times. Lawsuits have stated that the drug actually released more estrogen than standard birth control pills and as such put women at more of a risk for blood clots and strokes. Johnson & Johnson has admitted to providing faulty information in regard to the estrogen level and has said that it has taken care of it with the FDA, who amended the drug’s label. The lawsuits are seeking damages from the manufacturer for allowing the drug to be used even though they knew it was harmful. The company fights back stating that the FDA, who approved the drug is the only entity that can challenge and regulate the drug, therefore ruling out the need for a trial. The Bush administration has sided with the pharmaceutical companies.

The other two cases seeking pre-emption involve the manufacturers Wyeth and Pfizer. Wyeth’s case involved the anti-nauseas drug Phenergan and Pfizer’s case involves the drug Rezulan, which the company acquired when it bought Warner-Lambert.

Since the FDA released the new findings in 2005 showing that the patch was more powerful than original thought to be, prescription sales of the contraceptive have taken a nose-dive by 80 percent.

The Supreme Court is expected to hear the case regarding Wyeth in the fall, which could lead to a huge decision regarding the Johnson & Johnson case.