The mother of an Ortho Evra birth control patch user is calling for the drug to be removed from the market, following her daughter’s sudden death from a pulmonary embolism.

Adrianna Niedner, 17,  had just begun her freshman year at Trinity College when she collapsed in her dorm room.  According to the Boston Globe, Leslie Niedner began to suspect that Ortho Evra played a role in her daughter’s death when someone asked if Adrianna had used it.  An internet search quickly revealed dozens of similar stories.  Leslie is now convinced that Ortho Evra caused the blood clot that killed her daughter.  (more…)

Johnson & Johnson, the maker of the Ortho Evra birth control patch, doesn’t want to be held accountable for blood clots and other injuries caused by the defective contraceptive.  To that end, the company is trying to convine courts that the mere fact that Ortho Evra was approved  by the Food & Drug Administration (FDA) shields it from product liability lawsuits.  Johnson & Johnson is making this argument even though it is becoming increasingly clear that Johnson & Johnson withheld vital Ortho Evra safety information from the FDA for years.

According to The New York Times, this legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success. Earlier this year, the US Supreme Court agreed with Medtronic Inc. that FDA approval of a medical device prevented people from suing in state courts if they sustained an injury from the devce. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. (more…)

Information received from a second study that revealed a higher risk of blood clots for users of Ortho Evra compared with birth-control pills will be included in the patch’s packaging, according to a statement from U.S Food & Drug Administration (FDA). In 2006, the prescribing instructions for the Ortho Evra patch were revised to include information about a study warning that women could face a doubling of blood clot risks when using the patch. Previous to that study, Johnson & Johnson had touted a study that inidcated that Ortho Evra’s blood clot risks were equal whether one took the Pill or wore the contraceptive patch.

The most recent study of women ages 15 to 44 also found blood clots—also known as venous thromboembolisms or VTEs—were about twice as likely to develop in women who used the patch versus women who took birth control pills, the FDA said. Yet despite the increasing evidence of a high blood clot risk, the agency said it believes “Ortho Evra is a safe and effective method of contraception, when used according to the labeling.” The Ortho Evra Patch’s labeling recommends that those women with concerns or risk factors for serious blood clots speak with their doctors before wearing the patch. “Women should discuss with their health-care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily,” the FDA said.

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The Ortho Evra label was once again updated to include a second blood clot warning, following a study that showed it carried double the risk of potentially fatal blood clots compared with oral birth control pills. Despite mounting evidence that the Ortho Evra Birth Control Patch is extremely dangerous, it is still being called a “safe and effective” contraceptive by the Food & Drug Administration (FDA). Instead, users of Ortho Evra were told by the FDA to “thoroughly discuss with their health care providers the risks and benefits involved ” before using the patch.

Not surprisingly, the FDA’s conduct in regards to Ortho Evra is not setting well with critics, who would like to see the patch pulled from the market all together. “This is crazy. Risk/Benefit ratio? Compared to what?” asked Jerrold Parker, a partner in the law firm Parker Waichman Alonso, LLP, which is representing many Ortho Evra plaintiffs. “It is the most dangerous contraceptive on the market! Why should anyone take the greatly enhanced risk?” (more…)

Ortho Evra Birth Control Patch studies that proved the contraceptive patch exposed women to dangerously high levels of estrogen where either altered or withheld by Johnson & Johnson before the medication was approved by the Food & Drug Administration (FDA), according to court papers file by lawyers for women suing the patch maker in Ohio.   Johnson & Johnson is being sued by 2,400 women nationwide who claim the defective Ortho Evra Birth Control Patch caused them to suffer strokes, heart attacks, and blood clots in the legs and lungs.

When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives. But in 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60% more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

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