The numbers keep adding up for the Ortho Evra birth-control patch. Not sales, those are down sharply, but the docket of product liability cases filed against Johnson & Johnson, the maker of the one-of-a-kind contraceptive.
In its latest update last month, J&J said more than 2,400 Ortho Evra lawsuits are queued up in state and federal courts. Some 400 are New Jersey cases that have been consolidated in the Middlesex County Courthouse in New Brunswick, just a few blocks from the health-care conglomerate's headquarters.
Most of the lawsuits have a common theme: J&J allegedly knew the skin patch had greater safety risks than birth-control pills, particularly in the incidence of harmful blood clots that could develop in women's legs and lungs. But it chose to aggressively market the contraceptive in ads featuring supermodel Naomi Campbell and others, and soft-pedaled the dangers.
J&J denies the claims, and says Ortho Evra is a "safe and needed" contraceptive if used according to its label.
But the company's defense has a complication: Two former executives have said they raised red flags about the patch's safety but were ignored.
One is Joel Lippman, a medical officer whose claims about problems with Ortho Evra and other products were first made public in a state whistleblower suit last year. The other is a J&J vice president who decided to resign from a job overseeing the "benefit risk and safety evaluation" of reproductive products — including the patch — after being unable to properly "exercise this responsibility," according to a recently unsealed document in the New Jersey litigation.
The latter filing is an October 2005 letter addressed to J&J Chief Executive William Weldon by the executive, whose name and exact job title were redacted by the court. The officer said he or she had left the company the previous month in part because Ortho Evra's risks had been downplayed, despite "compelling evidence" to the contrary.
"My discomfort on the issues mentioned above was and is still shared by many of my former colleagues, and several of them asked me to be more open on the reasons for my resignation," the person wrote.
J&J said the former employee, who tracked adverse reactions to the patch after it was on the market, vouched for its safety to both the company and the Food and Drug Administration while working there.
More than 4 million women used Ortho Evra after it was approved for sale in the United States in 2001. It's biggest selling point is convenience — slap the patch on for a week, and you're set. But having a hormonal contraceptive delivered through the skin turns out to be a different proposition than digesting it in a daily pill.
In 2005, the FDA and J&J agreed to make a change in Ortho Evra's label that said users of the patch could be exposed to 60 percent more estrogen than women who used the pill.
Oral contraceptives have been linked to some risk of harmful side effects, such as deep-vein thrombosis or pulmonary embolism, a potentially fatal condition in which clots form in the body and make their way to the lungs. To the women suing J&J, greater estrogen exposure from the patch means greater risk of death or injury.
"They should have warned about that, and they didn't," said Andres Alonso, a partner with Parker & Waichman, which represents more than 600 Ortho Evra plaintiffs.
Another plaintiff attorney, Gary Douglas, said Johnson & Johnson had data showing the different rates of exposure before the drug was approved. Douglas is scheduled to try the first Ortho Evra case, a wrongful death suit brought by the estate of 18-year-old college student Zakiya Kennedy, this fall in New York.
"Johnson & Johnson not only knew their product delivered more estrogen than the pill, but deliberately manipulated the numbers and results of the clinical trials to reflect that it delivered the same amount as the pill," Douglas said.
Lippman has already been deposed in the New Jersey litigation, according to his lawyer. The executive, who helped oversee clinical trials for the patch, said he raised questions about the "dangerously high levels of estrogen" emitted by Ortho Evra in the late 1990s but was ignored. J&J has said Lippman's allegations are untrue, and that he was fired from another post in 2006 for conduct unrelated to his safety claims.
An FDA medical reviewer cited the potential for clot-related problems with Ortho Evra in 2001, and said post-market studies would be necessary. But the patch was ultimately approved by the agency, and the revised label says "it is not known" if the patch's different profile of estrogen exposure leads to more serious health problems than the pill.
Preliminary data from two, large J&J-funded studies last year were a mixed bag. One showed a twofold increase in events involving clots with Ortho Evra users compared with women who took oral contraceptives. Another showed no difference at all.
Both epidemiological studies are ongoing, and the full results could be critical to the outcome of the litigation. No trial date is set yet for the New Jersey cases, but jury selection for the Kennedy case is expected to commence on Nov 19. The first federal suit is expected to go on trial in June next year in Cincinnati, Ohio, where U.S. District Court cases have been pooled.
The vice president who wrote Weldon said the company chose to publicize early study data that showed comparable safety results between the patch and the pill, even though J&J was aware of more than 20 deaths that had been tied to Ortho Evra after it hit the market.
"It was decided to quickly try to communicate in priority on these partial and incomplete results, despite compelling evidence that the estrogenic exposure was unusually high compared to an oral product, and that the reporting rate of fatalities and of various thromoboembloic disorders was out of range for this class of products," the executive wrote in the letter.
Weldon did not respond to the executive, but the head of the former employee's business unit arranged a meeting to discuss the concerns soon afterwards, said Gloria Vanderham, a spokeswoman for Ortho Women's Health & Urology, the J&J unit that sells the birth-control patch.
Saddled with inconclusive results from studies, doctors are prescribing other contraceptives. Peak sales of Ortho Evra were $416 million in 2005, but fell 45 percent last year and were off another 39 percent in the first six months of this year, according to IMS Health. In the past year, the patch has been eclipsed by Organon's NuvaRing and an uptick in oral contraceptives.
Still, Wall Street hasn't taken much notice of the Ortho Evra litigation yet. Investors have bigger concerns about J&J, such as the coming patent expirations of several major drugs and the slump in sales of drug-coated coronary stents, said Les Funtleyder, a health-care analyst with Miller Tabak.
"It's sort of on the radar screen, but it's way, way down," Funtleyder said.