Drug Makers Near Old Goal: A Legal Shield

From the New York Times:
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. ...more

Blood clots, deaths linked to Evra

From the (University of Western Ontario) Gazette:
The Evra birth control patch may be more convenient than the pill for many Canadian women, but new evidence suggests it may also be more dangerous.

The January issue of Health Canada’s Canadian Adverse Reaction Newsletter documented 16 cases of blood clots and one heart attack in Evra patch users since its arrival on the Canadian market in 2004. Two of the 17 patients reported to Health Canada died as a result.

One documented case of death was that of a 16-year-old, and most of the 93 total adverse reactions Health Canada received were from women in their teens, 20s or early 30s.

The Evra patch, manufactured by Janssen-Ortho Inc., is a prescription-only contraception patch that adheres to the skin, delivering hormones into a woman’s body to prevent pregnancy.

According to IMS Health Canada, a market research company, between January and November 2007, 274,617 Evra prescriptions were dispensed from retail pharmacies.

So far, there has been no conclusive evidence linking the patch with an increased risk of health problems versus other contraception methods. ...more

Red flag for birth control patch

From the Globe and Mail:
Two Canadian women have died and numerous others have suffered blood clots, heart attacks and other medical problems in the span of about four years after using the well-known but increasingly controversial Evra birth-control patch, according to a Health Canada report.

Although medical research has not concluded there is a direct relationship between the Evra patch and reported problems, concerns have been great enough to raise questions about the product's safety and prompt government health officials to issue warnings in Canada and the United States.

Advocacy groups have also sounded the alarm, with some saying the product should not be on the market.

"[Women] shouldn't use it. It shouldn't be used because it's a new product with no unique advantage," said Sidney Wolfe, director of the health research group at Public Citizen, a U.S.-based consumer group founded by Ralph Nader. ...more