New York Times Examines Johnson And Johnson's Pre-Emption Defense Over Safety Of Birth Control Patch

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 09 Apr 2008 - 2:00 PDT

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The New York Times on Sunday examined Johnson & Johnson's use of the legal doctrine of preemption to defend against claims that the birth control patch Ortho Evra causes blood clots or other adverse effects. Under this legal argument, if a product's safety has been approved through a federal regulatory agency such as FDA, then its safety cannot be questioned in individual lawsuits. According to the Times, J&J is arguing that the company should be exempt from lawsuits because FDA approved the drug and its label in 2001 and its decisions should not be second guessed by the courts.

Lawyers for plaintiffs and pharmaceutical companies said that courts have dismissed the preemption argument for decades, but the strategy might be "on the verge of success," the Times reports. The U.S. Supreme Court in February ruled that suits against makers of medical devices like pacemakers are preempted. The court is scheduled to rule on another case that could make pre-emption a legal standard for drug cases, the Times reports. The Bush administration has argued in favor of pre-emption.

According to the Times, Ortho Evra's old label inaccurately described the amount of estrogen the patch released, and more than 3,000 women and their families have sued J&J, arguing that users of the patch suffered heart attacks, strokes and death in 40 cases. A J&J clinical trial of Ortho Evra completed in 1999 originally showed that the patch delivered "far more" estrogen daily than low-dose birth control pills, but the study's author applied a "correction factor" that claimed the patch delivered 40% less estrogen than the trial showed, the Times reports. The correction factor was not in the study protocol submitted to FDA. However, Bob Tucker, an attorney representing J&J, said the agency was aware of the adjustment. Two other studies, one completed in 1999 and one in 2003, confirmed that the patch releases more estrogen than low-dose pills. FDA changed Ortho Evra's warning label in November 2005, and an epidemiological study has since shown that women using the patch can have up to double the risk of developing blood clots as women taking the pill.

Gloria Vanderham, a J&J spokesperson, 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, adding, "Ortho Evra is a safe and effective birth control option for women when used according to the labeling." Janet Abaray, an attorney representing a plaintiff suing the company, said J&J took advantage of FDA, which was overwhelmed by its responsibilities. The company "knew that FDA does not have the funding or the manpower to police drug companies," Abaray said. FDA Commissioner Andrew von Eschenbach acknowledged that the agency faces a crisis and might not be "adequate to regulate the food and drugs of the 21st century" (Harris/Berenson, New York Times, 4/6).

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