Over 4000 lawsuits have been filed by women who say they have suffered serious Ortho Evra side effects, which reportedly include blood clots in the legs and lungs, heart attacks and strokes.

Manufacturer Downplays Risk of Patch Side Effects

The lawsuits claim that Ortho-McNeil Pharmaceutical knew about higher levels of estrogen released with the Ortho Evra patch in 2002, but failed to warn users that the patch carries an increased risk of potentially life threatening blood clots, which is three times higher than the risk associated with the use of traditional birth control pills.

The product’s initial warning label indicated that the patch carried similar risks to other hormonal contraceptives, but the safety information was based on studies of birth control pills and was contrary to data collected during the clinical studies for the patch.

Manufacturer Placed Profits Above Consumer Safety

Ortho Evra was introduced as Ortho-McNeil Pharmaceutical was about to lose the exclusive patent for their best-selling birth control pill, Ortho Tri-Cyclen. The new birth control patch was a top priority for Ortho-McNeil, since they needed to offset the anticipated lost income from Ortho Tri-Cyclen.

Patch Warning Label Amended but Product Not Recalled

In November 2005, the warning label was amended to indicate that the dose of estrogen was 60% higher than delivered by birth control pills. In September 2006, further warnings were added indicating a potential increased risk of blood clots. Both Ortho-McNeil Pharmaceutical and the FDA still maintain that the medication is as safe as any other pill-form birth control, claiming that the benefits of the drug outweighs the risks associated with it.

Many experts believe that the warnings remain inadequate and some have called for the product to be removed from the market.