- Mar 12, 2002
Even if they knowingly lie to the FDA, doctors, and patients? Looks like that's about to happen:
Whole article here: NYT
Responsibly??? More like predictably.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 companys 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.
The F.D.A. did not warn the public of the potential risks until November 2005 six years after the companys own study showed the high estrogen releases. At that point, the products label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.
Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.
Of course, becauseThis 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.
The Bush administration has argued strongly in favor of the doctrine, which 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. 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.
Now I'm for shielding everyone from frivolous lawsuits and going after the plaintiffs, but this would seem to be something other. Rather than defending J&J's position here, given the facts as they're spelled out in the article, a rational person might think it's time to overhaul the approval process and put in penalties for falsifying data submitted with such applications or prosecute those caused the falsifying, but that's just me...The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. These are scientists, not cops, said David Vladeck, a professor at Georgetown Law School.
Whole article here: NYT