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.
More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.
Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.
Companies can lie to the FDA to get their drug approved, and then once it’s approved, continue lying to the public about the dangers of the drug, and suffer no harm as a result, because the FDA approved the drug, even though the approval was based on dishonestly collected and presented information. Conservatives don’t want governmental agencies funded well enough to do their jobs properly, and don’t want citizens harmed, even killed, by corporate wrongdoing to have recourse to the courts. We are gradually headed for a corporatocracy, where corporations will be entirely exempt from the laws and expectations that the rest of us deal with, where even their most egregious wrongdoing will be blamed on the government and the citizens stupid enough to trust products made by companies (this ties in with the conservative fetish for “personal responsibility”). That such a situation will inevitably break down the trust and confidence that people have in the system, and so break down the system itself, is besides the point. Companies want it, and with this Supreme Court, what companies want, companies will get.