Drug Makers Continue to Seek Legal Shield From Civil Lawsuits
Time and time again, we have run into the same story of drug manufacturers covering up known dangers regarding drugs they develop in order to get FDA approval. One recent example: The Ortho Ebra birth Control Patch.
According to recent newspaper accounts, Johnson & Johnson obscured evidence for years 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 in the U.S. Supreme Court, lawyers for plaintiffs and drug companies say.
According to a recent article in the New York Times, 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 lied and reduced the numbers by 40 percent.Despite this egregious behavior, however, Johnson & Johnson may be allowed to simply walk away from the harm it caused without any liability whatsoever. The pre-emption doctrine being argued for by the drug companies and Republicans holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. This would be the case even when the company obtained FDA approval by lying to the agency. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
This means that the hundreds of women that have been injured due to Johnson & Johnson's conduct (and the families of the 50 women whose death has been directly associated with the drug) would have no legal recourse.
Source: New York Times
