Legal strategy boosts drug makers
FDA oversight seen as shield from liability
NEW YORK - 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 say 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 preemption. 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 FDA 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 preemption 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.
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.
The FDA did not warn the public of the potential risks until November 2005, six years after the company's own study showed the high estrogen releases. At that point, the product's 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.
"We have regularly disclosed data to the FDA, the medical community, and the public in a timely manner," Vanderham said. "Ortho Evra is a safe and effective birth control option for women when used according to the labeling."
But Janet Abaray, a plaintiff's lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.
"Johnson & Johnson knew that FDA does not have the funding or the manpower to police drug companies," Abaray said.
A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient, and short of money.
In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be "adequate to regulate the food and drugs of the 21st century."
The FDA 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.
For years, top officials at the agency acknowledged that lawsuits could aid the agency's oversight of safety issues. In the last decade, suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid, and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs.
But now, the agency says a proliferation of lawsuits could lead to an overlapping patchwork of rules that would burden companies and might discourage patients from taking useful medicines.
The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the FDA about potential problems with its medicines. 