Adrianna Duffy was a healthy, active college freshman. When she decided to go on birth control, her doctor prescribed Ortho Evra, more commonly known as the birth control patch. On September 28, 2009, not long after she began using the patch, Duffy fell and died in her dorm room. "She just got up and collapsed in the doorway," said Leslie Niedner, Duffy's mother. "And she was gone instantly."
For users of Ortho Evra, which is manufactured by Johnson & Johnson, these incidents are alarmingly uncommon. Patient reports between 2002 and 2004 show that the patch was 12 times more likely to cause strokes and 18 times more likely to cause blood clots than the birth control pill. Duffy's death was caused by a blood clot.
The reason, according to experts, is that the patch delivers a continuous and high level of estrogen into the bloodstream for the entire week it is worn. The pill has 60 percent less estrogen and quickly dissolves into the system. "With the patch, there's no relief of the body from getting estrogen," said Dr. Sidney Wolfe, Medical Director of the watchdog group Public Citizen.
Recently uncovered internal documents show that Johnson & Johnson executives knew of this increased danger and did little to correct it or make it known to users. According to Dr. Wolfe, this was largely out of concern for the company's bottom line. "The company knew about much of it, if not all of it," he said. "They thought correctly that it wouldn't sell as well if you told people how dangerous it was."
More than 20 women have died and 2,400 injured as a result of Ortho Evra use. Johnson & Johnson has faced lawsuits, but has settled them quietly, paying out an estimated $68 million to victims, which pales in comparison to the $1.6 billion the company has made off sales of the drug. The patch was and continues to be FDA approved, although it has been under review for two years.
Leslie Niedner, who has filed a lawsuit against Johnson & Johnson, plans to use her daughter's death to force a change. "Before I take [a settlement] and know that other young women are going to die from this and other mothers are going to be in my situation, I'm going all the way to trial," she said. "I want them accountable for allowing this to happen."
Source: Today, "Did drugmaker hide birth control patch risks?", Jeff Rossen and Robert Powell, 22 September 2010