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Did drugmaker hide birth control patch risks?

According to private internal documents obtained by NBC News, pharmaceutical giant Johnson & Johnson may have known about deadly risks of its birth control patch Ortho Evra years ago, but kept the product on the market anyway.
/ Source: NBC News

Pharmaceutical giant Johnson & Johnson may have known years ago about the deadly risks of its birth control patch Ortho Evra, according to internal documents obtained by NBC News.

Patient reports between 2002 and 2004 show that Ortho Evra was 12 times more likely to cause strokes and 18 times more likely to cause blood clots than the conventional birth control pill, NBC News' TODAY show revealed Wednesday.

When Ortho Evra first hit the market in 2002, it was a big hit. "Time" magazine called it one of the best inventions of the year and doctors have written nearly 40 million prescriptions for it. But as sales surged, so did claims of injury and even death.

Some experts say the patch is problematic because it delivers a continuous and high level of estrogen — 60 percent more estrogen than the pill. When a birth control pill is swallowed, it quickly dissolves into the system. But with the patch, estrogen keeps flowing into the bloodstream for an entire week.

"With the patch… there's no relief of the body of the woman from getting estrogen," Dr. Sidney Wolfe, Medical Director of watchdog group Public Citizen, told NBC.

Warnings ignored
Concern over the patch has led to high-level resignations at Johnson & Johnson.

In 2005, Johnson & Johnson Vice President Dr. Patrick Caubel suddenly quit, saying in his resignation letter, "I have been involved in the safety evaluation of Ortho Evra since its introduction on the market. … The estrogenic exposure [of the patch] was unusually high, as was the rate of fatalities."

His letter, which was obtained by NBC, said the research was "compelling evidence" that the company ignored. Therefore, he wrote, "it became impossible for me to stay in my position as VP."

NBC's investigation also found a lawsuit by another Johnson & Johnson vice president, Dr. Joel Lippman, who is suing the company for unlawful termination after he says he blew the whistle on the patch's dangerously high levels of estrogen, even before it came to market.

The company, he says, "disregarded his concerns and launched the product anyway."

"The company knew about much of it, if not all of it," said Dr. Wolfe. "They thought correctly that it wouldn't sell as well if you told people how dangerous it was."

Wolfe petitioned the FDA two years ago to pull the patch off the market, but the FDA has yet to make a decision.

In the meantime, Johnson & Johnson continues settling lawsuits quietly. According to Bloomberg, the company has paid out an estimated $68 million to victims, a small number compared to the $1.6 billion they have made on sales of the patch.

'She was gone instantly'
Adrianna Duffy was a freshman in college, a top student athlete and in perfect health when she started on the patch. She had a serious boyfriend and told her mother that she wanted to be responsible and avoid pregnancy, so Duffy's doctor prescribed Ortho Evra.

But one night in her dorm room, on September 28, 2009, the girl who had been the picture of health fell to the floor and died. Duffy's family said that was when they learned the patch may be to blame.

"She just got up and collapsed in the doorway. And she was gone instantly," Leslie Niedner, Duffy's mother, told NBC. "This is a Johnson & Johnson product — it's the most trusted brand for baby products, so why would I question their birth control patch?"

More than 2,400 women claim Ortho Evra hurt them as well. Lawsuits claim more than two dozen have died, many from blood clots, which was what killed Duffy. Her family and others are now suing Johnson & Johnson.

"It's outrageous, it's horrifying," Duffy's mother said. "How many other young women have to die from using this product before it's off the market?"

Roopal Luhana of Chaffin Luhana LLP is the attorney for Leslie Niedner, Duffy's mother. "They're making a significant profit on this product, off the backs of people like Adrianna," she told NBC.

Consumer's responsibility?
In 2006, Johnson & Johnson did make changes to the patch's inside label, warning in fine print about the increased levels of estrogen, and outlining its own study showing a doubling of the risk of serious blood clots.

"There is nothing in that warning that could help me understand that a patch would kill a healthy young 17-year-old woman," Duffy's mother said.

Despite these concerns, NBC's investigation found several doctors who continue to prescribe Ortho Evra. They said it was FDA approved and, although the risks are higher than the pill, they are still relatively small and worth it to protect women from becoming pregnant.

Dr. Wolfe, however, says that Ortho Evra is not only riskier but also has a higher dropout rate than the pill and is no better at preventing pregnancy.

"We don't ask the FDA to ban anything unless we think it's quite clear that the risks outweigh the benefits," he said.

NBC asked the FDA why it has still not made a decision, two years later, about whether to pull the product off the market. A spokeswoman said it was a complicated issue that takes time to review.

Johnson & Johnson declined NBC's request for an interview. In an email, the company also declined to answer any questions about the patch, citing "ongoing litigation."

The company also said it has "regularly disclosed scientific data regarding Ortho Evra to the FDA, the medical community and the public in a timely manner, and when used according to the FDA-approved label, Ortho Evra [is] safe and effective."

But Adrianna Duffy's mother says she wants it off the market for good, which is why she's unlikely to settle her lawsuit.

"There is no amount of money that's going to give me back my daughter," she said.

"And before I take money and know that other young women are going to die from this and other mothers are going to be in my situation, I'm going all the way to trial. I want them accountable for allowing this to happen."

Editor's note: Experts say women should never stop using birth control, including the patch, without talking to their doctor.