Johnson & Johnson hid or altered data on the health risks of its Ortho Evra birth-control patch and flaws in the manufacturing of the device, lawyers for women suing the company claim in court papers.
Lawsuits on behalf of 2,400 women claim high levels of estrogen released by the patch caused strokes, heart attacks, and blood clots. J&J, the world's largest maker of health-care products, misled the Food and Drug Administration about estrogen levels before and after patch sales began in 2002, according to a filing April 3 in federal court in Toledo, Ohio.
Manufacturing defects made the patch unstable and the dosage unpredictable, according to the filing. Tests showed in 2003 that the patch produced 60 percent more estrogen than oral contraceptives, it said. A company pharmacologist, Dr. Larry Abrams, applied a ``correction factor'' to lower estrogen results given to the FDA by 60 percent, according to the filing.
``Through a sleight of hand, and altering of numbers,'' Abrams ``presented a truly misleading picture of the amount of estrogen delivered by the patch,'' the filing said. ``The import of this misrepresentation is enormous, given the tenet that the greater the dose, the greater the poison.''
The filing, in response to 1,500 federal lawsuits consolidated in Toledo, offers the most detailed look to date at evidence previously deemed confidential. Plaintiffs responded to a company motion to dismiss the cases that argued that FDA approval of the device and its label supersedes, or preempts, the ability of patients to seek damages under state laws.
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