Johnson & Johnson has spent over 65 million dollars to settle hundreds of birth-control-patch related lawsuits
Bloomberg reports that the maker of Ortho Evra birth control products has received at least 562 complaints, with the majority of users alleging the patch caused deep-vein thrombosis, pulmonary embolisms, heart attacks or strokes. 20 deaths have been alleged. Over 5 million women have used the patch since 2002, and its warning label was strengthened in 2005, 2006 and 2008. The current warning tells women that the patch exposes them to sixty percent more estrogen than the typical birth control pill, and that higher estrogen levels results in increased health risks.
Sales of the patch have reportedly declined substantially since the change in warnings. Many of the lawsuits brought by victims alleged that Johnson & Johnson had deliberately misled women about the associated risks. The FDA refuses to answer questions about why it has not removed the patch from the market, given the unique risks it poses to users and the availability of effective medications that do not expose the user to such high levels of estrogen. Bloomberg News identifies several young women who have died of blood-clot related complications, but found that the attorneys for these victims were unable to discuss the cases, due to confidentiality agreements demanded by Johnson & Johnson. The victims described ranged in age from 14 to 41, with a number of otherwise healthy young women identified. The Supreme Court of the U.S. is currently considering a Bush Administration-recommended preemption case that would deny these women (or any injured victims) the right to sue over a medication approved by the FDA.