A lawsuit filed in Ohio is claiming that Johnson & Johnson kept under wraps information on the potential cardiovascular risks of using its contraceptive patch Ortho Evra.
Furthermore, the suit is claiming that the company misled US regulators as it altered information on the amount of oestrogen being supplied by the patch, and that this higher amount is responsible for heart attacks, strokes and blood clots experienced by some women using the product, according to media reports.
Documents filed in the federal court allege that the dose of oestrogen supplied by Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) was unstable. They point to the fact that, following its market launch, tests showed that the patch was actually delivering a substantial 60% more than oestrogen oral contraceptives, but that a company trial investigator had applied a “correction factor” to lower results provided to the Food and Drug Administration before its approval, Bloomberg reports.
But a spokeswoman for J&J told Bloomberg that the company “regularly and properly disclosed data to the FDA, the medical community and the public in a timely manner,” and she insisted that “Ortho Evra is a safe and effective hormonal birth control option for women when used in accordance with the FDA-approved labelling.”
Label warnings
Ortho Evra first hit the market in 2002, but in 2005 the FDA added new warnings to the patch’s labelling indicating that it delivered a higher dose of oestrogens than would normally be delivered using oral contraceptives, which may raise the risk of side effects such as blood clots in the legs and lungs and strokes. This sparked a spate of legal challenges by women claiming to have suffered serious side effects from using the patch.
And aside from defending the product’s safety profile, the company is also reportedly arguing in the Supreme Court that claimants shouldn’t be allowed to such file lawsuits in the first place, as Ortho Evra has been approved by the FDA.
