Attorney Howard L. Nations of Houston filed a lawsuit on behalf of Helen Chandler Faretta in the U.S. District Court in Johnstown.
Nations said Wednesday that hundreds of lawsuits have been filed against Ortho McNeil Inc. of Raritan, N.J., a subsidiary of Johnson & Johnson, also in New Jersey, because of its birth control patch, Ortho Evra. He said the patch has caused blood clots, heart attacks, strokes and even death in women nationwide.
The case will be transferred to the federal district court in Toledo, Ohio, where all of the Ortho Evra cases are being heard, Nations said.
He said the product, advertised as a convenient way to prevent pregnancy, was approved by the Federal Drug Administration Nov. 20, 2001.
It was made available to the public in April 2002, and within a 17-month period, the FDA received 9,116 reports from women experiencing problems.
Ortho McNeil did not respond to a message requesting comment Wednesday.
Nations said the product remains on the market with FDA approval because the company has attached a warning label about the possible side effects of using Ortho Evra, particularly when smoking.
Nations said Ortho Evra is marketed worldwide. He said FDA-equivalent agencies in Canada, Great Britain and Japan refused to allow the drug on the market because of its high output of estrogen.
He said the pharmaceutical company altered the product in those nations to make them safe, but the FDA only requires a warning label.
According to the lawsuit in Johnstown, Faretta was prescribed the product from July through August 2004.
On Aug. 27, 2004, she experienced severe leg pain and was diagnosed with a blood clot in the leg. She was immediately taken off the patch.
“Had the [company] properly disclosed the risks associated with the subject product, [Faretta] would not have used it,” the lawsuit stated.
Nations is seeking damages on nine counts, including a charge that the company violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Act.
The lawsuit also seeks punitive damages.
Johnson & Johnson, its pharmaceutical research company and Ortho McNeil were named as defendants.
Nations said only a few of the lawsuits were settled so far, including one involving a death.
