It was supposed to be the forgetful woman’s answer to birth control but now the Ortho Evra patch is the subject of an ongoing investigation and basis for numerous lawsuits against its manufacturer, New Jersey-based pharmaceutical company Johnson & Johnson. The question is whether or not Johnson & Johnson did enough to warn consumers about the higher risks associated with the patch. (1)
When it was first introduced in 2002, the patch was lauded as one of the year’s best inventions. But as popularity of the patch grew, so did evidence about the higher risks associated with the product. (1)
In 2005, the Food and Drug Administration (FDA) issued a warning to consumers that exposure to higher levels of estrogen put them at greater risks for serious side effects, including blood clots and strokes. A warning was then added to the label on the patch advising women that use of the product would expose them to approximately 60% more estrogen than if they used the pill. (2) Medical experts seem to think that is due to the fact that the patch delivers estrogen straight into the bloodstream on a continuous basis whereas, when in pill form, the hormone is dissolved and digested before entering the bloodstream in more diluted levels. (3)
Medical records from the period between 2002 and 2004 indicated that risks of strokes were higher than with the pill (by 12%), as were risks of blood clots (by 18%). Over 2,400 women have claimed injuries from the patch and about 24 deaths have been attributed to it. One of those who died was 17-year-old college freshman Adrianna Duffy. Her mother, Leslie Niedner, is currently involved with others in a lawsuit against Johnson & Johnson. Reports estimate that Johnson & Johnson already has paid an estimated $68 million in settlements to victims of the patch. Niedner vows not to settle but instead to see the case to trial. (1)
Separately, a former Johnson & Johnson vice-president, Dr. Joel Lippman, is suing the company for unlawful termination, claiming that he was fired after “blowing the whistle” on the product even before it was put on the market. (1)
Whether Johnson & Johnson’s warnings about the potential dangers of the patch were clear enough is now a question for the courts to answer.