by Sandra Cassidy, Associate Corporate Counsel for Counsel Financial Services
March 4, 2008
Johnson & Johnson will pay $1.25 million for the death of a 14-year-old who suffered blood clots in her lungs after using the Ortho Evra birth control patch. Five million women have used the patch since it came on the market in 2002, and Johnson & Johnson now faces lawsuits from 2,400 victims. Twenty-three deaths have been linked to the use of the patch, but the total number of deaths is believed to be higher because 90 percent of adverse events are unreported. Of the 23 deaths, 18 of the victims suffered blood clots and five suffered a heart attack or stroke.
From April 2002 to December 2004, 28,000 users reported side effects from the patch. In 2005, the first death was publicly linked to the patch by a medical examiner after a college student with a headache and leg pain died on her way to the hospital. The autopsy revealed that a blood clot in her leg had migrated to her lungs. The first nationwide class-action lawsuit against manufacturer Ortho-McNeil and parent company Johnson & Johnson was then launched.
Most of the pending suits claim that Johnson & Johnson did not properly test the patch or sufficiently warn of the associated safety concerns. The lawsuits claim the manufacturers knew about health concerns from negative clinical trial results published well before the patch went to market but downplayed the risks.
Johnson & Johnson and Ortho-McNeil deny knowledge about health and safety problems related to the patch. CBS News, however, reported in November 2005 that internal corporate records from April 2002 to December 2004 demonstrate that Johnson & Johnson had knowledge of approximately 500 incidents of serious side effects associated with the patch.
In recent months, Johnson & Johnson has been settling cases and seeking court approval to seal the court records pursuant to confidentiality orders. In May 2006, a corporate attorney announced that the company is prepared to settle with all plaintiffs who were hospitalized for adverse effects from the patch.
Women of all ages are at risk, but women between the ages of 14 and 35 have the greatest chance of stroke or death. There does not appear to be any predictable duration of use before manifestation of negative side effects. Some victims used the patch for several months while others used it for only a few weeks.
The Ortho Evra patch is a 1 ¾-inch, multilayer square contraceptive that adheres to the skin and releases the hormones progestin and estrogen into the blood stream. The patch became popular because of its convenient once-a-week application; however, the synthetic estrogen released by the patch is known to increase blood coagulation.
In 2005, the Food and Drug Administration warned that the patch’s delivery method may cause clots and that it delivers 60 percent more estrogen than the birth control pill. The Associated Press reported in November 2005 that an internal Ortho-McNeil memo written in 2003 showed that the corporation refused to pay for a comparative study of the relative safety between different methods of delivery because there was too high of a chance that the study would be negative on the patch over the pill.
The clots reported typically form in the calves then break loose and travel to other parts of the body where they lodge and eventually cut off the blood supply. The FDA forced Ortho-McNeil to use the highest “black box” warning, a warning that means the product is capable of causing severe or fatal side effects. The federal government has not yet been persuaded to issue a recall; however, many doctors are recommending that women stop using the Ortho Evra patch.