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Ruling Moves Local Woman's Case Against NuvaRing Forward

Court Ruling: FDA Approval Does Not Shield Drug Makers

POSTED: 1:34 pm PDT March 13, 2009
UPDATED: 3:05 pm PDT March 16, 2009

Kristina Buckner of Chula Vista appears fit, healthy, an attractive young woman.

Her appearance gives no clue as to the physical shock to her body three years ago.

"I will never move on with my life," she says.

Diana Levine of Vermont is older and her injury shows plain as day -- she's missing part of her left arm.

"I want my arm back," she says, "And I wish I could trade this money for my arm, but I can't."

The two woman are complete strangers living on opposite sides of the country. But they are linked by medical mishap and a recent ruling by the U.S. Supreme Court.

Buckner says her injury came from NuvaRing, a vaginal form of birth control she used in 2006. She suffered potentially fatal blood clots, a side effect listed on NuvaRing's label.

"I'm very lucky I went to the hospital when I did," she told the I-Team three years ago, when she was hospitalized for 12 days with the blood clots. Since then her medical bills continue to mount, she suffers pain from scar tissue and faces a lifelong threat of the blood clots reappearing.

"What goes on in my head, am I going to be as lucky next time, that's how I live," says Buckner.

She is among more than 200 plaintiffs who say they were injured by NuvaRing, including six deaths. They are suing the drug maker, Organon, now merged with Shering-Plough.

But Buckner's lawsuit was on hold while the U.S. Supreme Court debated a case involving Levine.

"It's been nine years of reclaiming my sense of self," Levine says.

It was 1999 when Levine's medical injury happened. At that time, she was a professional musician who sought treatment for migraines. A nurse injected her by IV with an FDA approved anti-nausea medication made by Wyeth Pharmaceuticals.

"My headache was gone, but the arm hurt, so she took a look at it, and it felt really weird," says Levine.

It was gangrene, a side effect.

Two months later, her arm was amputated. Her award of $6 million was appealed all the way to the U.S. Supreme Court.

Wyeth argued their medication and label were FDA approved and therefore they were shielded from liability lawsuits. The court ruled last week.

"The Supreme Court just held that even if the Food and Drug Administration has approved a label, it doesn't stop people from suing," says Shaun Martin, Professor of Law at the University of San Diego.

"The Supreme Court said that there are eleven thousand different drugs on the market, and the ability of the FDA to effectively make sure that all of the labels are adequate is minimal," Martin says.

"My first reaction was, 'Yes!'" Buckner says, holding her hands up in victory.

After the Supreme Court ruling, NuvaRing's maker dropped its petition to dismiss Buckner's lawsuit under the same FDA shield argument that didn't work for Wyeth. Buckner's case is now moving forward.

"It shouldn't have happened to me. I'm a normal healthy woman," she says.

She wants stronger warnings about NuvaRing's potential side effects. She's even set up a website about it.

"Win or lose in this suit, I want women to know, don't think you're safe. You need to read up on things. It can happen to you."

Scherling-Plough and Organon say they have "acted responsibly, providing women and their doctors with clear and important safety information" about Nuvaring. Both their label and the information they give to doctors have been updated since Buckner used NuvaRing in 2006.

Here is the full statement:
Organon and Shering-Plough have received a number of lawsuits in the U.S. relating to NuvaRing and alleged blood clots and other vascular problems. The majority of these lawsuits allege that Organon failed to warn physicians and patients of the risk of blood clots.

Prior to its approval, NuvaRing was evaluated by the FDA and other regulatory agencies, and was approved as a safe and effective method of contraception when used in accordance with the labeling. Blood clots have long been known as a rare risk associated with all combined hormonal contraceptives. The FDA-approved patient and physician package labeling includes this important safety information. There are also numerous other risk factors associated with blood clots, such as pregnancy, smoking, obesity, and prolonged immobilization.

Patient safety is our top priority at Schering-Plough. The Company continually evaluates the safety of all of its marketed products and reports adverse patient experiences to the FDA and to other regulatory agencies around the world.

Shering-Pough and Organon have acted responsibly, providing women and their doctors with clear and important safety information about our product, which has been approved by the FDA, and this is the position that we will continue to take in these lawsuits.
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