Johnson & Johnson has paid out more than $68 million to settle hundreds of lawsuits by women who allege they have been harmed by the company’s contraceptive patch Ortho Evra, it has been reported.

Documents obtained and reviewed by Bloomberg News detail that the drug giant spent at least $68.7 million settling lawsuits claiming Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) caused blood clots, heart attacks and stroke. The patch has also been linked to the deaths of 20 women, while studies have showed the patch doubles the risk of blood clots compared with the pill.

According to the documents, J&J did not go to trial but rather settled the suits privately and failed to release the financial details to investors.

Ortho Evra was first launched in 2002, but in 2005 the US Food and Drug Administration added new warnings to the patch’s label indicating that higher doses of oestrogens were delivered via the patch than traditional contraceptives, which might increase the risk of side effects such as blood clots and strokes.

The warning label was further strengthened in 2006 and again earlier this year. The prescribing information now warns that women are exposed to 60% higher levels of oestrogen than other contraceptives.

About 4000 complaints have been filed against the company, alleging J&J failed to investigate the safety of the drug properly and deceived the public about the severity of the side effects.

According to attorney Janet Abaray, reported in Bloomberg, “several hundred individual cases” had been settled by 31 March, though the details of how much was paid out for each case were not indicated on court documents, she said.

The financial details were based on a fund that finances lawyers who gather evidence for attorneys who sue the company, Bloomberg said.

The company has defended the contraceptive patch but declined to comment on any settlements.

The FDA is currently reviewing a petition to ban the patch.