Johnson & Johnson is being sued by more women in the USA who claim Ortho Evra, its contraceptive patch product, is responsible for injuries including blood clots and even death.
In the latest development, 40 women filed lawsuits in a San Francisco court claiming J&J subsidiary Ortho McNeil and drug distributor McKesson of failing to investigate the safety of Ortho Evra (norelgestromin/ethinyl estradiol) properly and deceiving the public about the severity of side effects. They join well over 500 other women who have sued the company in other jurisdictions.
The action comes a little over a year after the US Food and Drug Administration (FDA) added new warnings to Ortho Evra’s labelling indicating that it delivered a higher dose of oestrogens that would normally be delivered using oral contraceptives.
The warning stated that women are likely to be exposed to about 60% more oestrogen with the patch compared to a typical birth control pill, which in turn may raise the risk of side effects such as blood clots in the legs and lungs and strokes. The FDA updated the warning last month after results of a new study found woman using the patch were twice as likely to develop blood clots, than those taking birth control pills.
In its second-quarter results filing, J&J said it is expecting s significant decline in contraceptive sales this year because of “labelling changes and negative media concerning product safety.” The company has already chosen to settle with a number of plaintiffs out of court, according to news reports.