Johnson & Johnson's Ortho Birth Control Patch was supposed to provide the same amount of estrogen as birth control pills. At least that's what Johnson & Johnson told the U.S. FDA (Food and Drug Administration) at first.
Years later, documents have surfaced showing that J&J's Ortho Evra birth control patch actually delivers much more estrogen than birth control pills and has an increased risk of causing blood clots and strokes. Injured women have sued J&J, but the manufacturer is simply pointing its corporate finger at the FDA.
Catch 22?
The FDA is responsible for consumer safety regarding foods, drugs and medical devices. In many cases, manufacturers are not held responsible for their products if the FDA takes responsibility for approval – regardless of whether the product is later found to be dangerous or cause injuries. It's a catch 22 known as preemption.
Preemption
Preemption prohibits consumers from filing lawsuits against manufacturers. However, consumer advocate groups say that the FDA actually relies on manufacturers' data in approving many products – especially drugs. In fact, the FDA has said as much itself and claims that it does not have the resources to adequately protect consumers. Industry analysts say that manufacturers know this and use it to their advantage – then claim that consumers are preempted from suing them. Unfortunately, this claim has been upheld.
Supreme Court upholds preemption
The U.S. Supreme Court, the nation's highest court, recently upheld a preemption argument earlier this year. In February 2008, the Court ruled that consumers could not sue medical device manufacturers if the FDA was responsible for approving the device. The Court will hear another case later this year concerning preemption and drug manufacturers and only time will tell how the Court will rule.