Pre-Emption Doctrine Would Make FDA Responsible For All Drug Problems, Shield Big Pharma From Lawsuits

Johnson & Johnson is waiting to hear whether or not a judge in Ohio will allow any lawsuits over its Ortho birth control patch to move forward, and the New York Times says lawyers on both sides think there’s a good chance he may find in the company’s favor based on the doctrine of pre-emption. The argument goes that it’s the FDA’s responsibility to monitor the safety and labeling of drugs that go to market, and therefore if something goes wrong, it’s the agency’s fault and not the pharmaceutical company’s.

The Ortho patch releases high levels of estrogen and can cause problems for some patients, but J&J says it’s the FDA’s fault for not requiring a label sooner:

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

“We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner,” Ms. Vanderham said. “Ortho Evra is a safe and effective birth control option for women when used according to the labeling.”

But Janet Abaray, a plaintiff’s lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

“Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said.

“Drug Makers Near Old Goal: A Legal Shield “ [New York Times] (Thanks to Beth!)