Johnson & Johnson improperly claimed its Ortho Evra birth-control patch posed a low safety risk to women, a product-safety executive told Chief Executive Officer William Weldon in a 2005 letter, court records show.

J&J, the world’s largest maker of health-care products, faces lawsuits by more than 1,500 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company hasn’t publicly identified reserves for the Ortho Evra litigation.

The author investigated an “unusually high number” of blood clots caused by the patch and cited more than 20 reported deaths, according to the letter, made public on Aug. 25 by a New Jersey judge who oversaw some of the lawsuits. J&J is based in New Brunswick, New Jersey.

The executive, whose name was removed from the letter, said J&J conducted two studies and emphasized “partial and incomplete” results of the one that found the patch no riskier than birth control pills. The writer resigned because the company’s conduct undermined his ability to evaluate product safety, the letter said.

“I was faced lately with what I considered an inability to exercise this responsibility, which led me to consider a job opportunity outside the company,” the writer said in the letter dated Oct. 31, 2005, after he left the company.

Protective Order

New Jersey Superior Court Judge Bryan Garruto, who oversaw 309 Ortho Evra lawsuits, made the two-page letter public after ordering lawyers to black out portions of the text and the author’s name. At the request of plaintiffs’ lawyers, Garruto removed the letter and other documents from a protective order covering evidence gathered for Ortha Evra cases around the U.S.

The company confidentially settled dozens of Ortho Evra cases, records show.

The writer was a vice president who spent seven years at Johnson & Johnson, overseeing benefit and safety risk analysis in reproductive medicine and oncology, according to the letter.

During his tenure, the author “continuously communicated that Ortho Evra was safe and effective when used as labeled and communicated this to the company and the Food and Drug Administration,” said Gloria Vanderham, a spokeswoman for Ortho Women’s Health & Urology unit, a division of J&J’s Ortho-McNeil Pharmaceutical Inc.

“This determination was made after his review of all the information he had available to him,” she said.

Inside Investigation

Vanderham said Weldon, who also is J&J’s chairman, didn’t see the letter. Another senior executive investigated the claims, pursuant to company policy, she said.

“The senior executive that received and reviewed the letter took prompt action to have an in-person meeting with this former employee to discuss and understand his concerns,” she said.

The letter said J&J had “compelling evidence” that estrogen levels were “unusually high” compared with those associated with the pill, and deaths and blood clots were “out of range” for that type of product. The FDA warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives.

Johnson & Johnson put too much emphasis on a preliminary study showing that Ortho Evra posed no more risk for clotting than birth-control pills, according to the letter. In February 2006, another study found a twofold increase in the risk of clots compared with women who took oral contraceptives.

Vanderham said that study, which the company made public, “adds to the body of knowledge” about the patch.

‘Scientific Debate’

“Whether Ortho Evra does or does not increase the risk is a subject of scientific debate, and it’s something we continue to study,” she said in an interview.

Following the Feb. 16, 2006, disclosure, made after U.S. markets closed, J&J shares rose 9 cents to $59.07 the next day. Company shares rose 89 cents today to $63.83 in New York Stock Market composite trading.

Les Funtleyder, an analyst with Miller Tabak & Co., said it was difficult to gauge the potential impact of the litigation on company finances.

“The fact that they haven’t taken litigation reserves yet means it’s not bad yet, but that doesn’t mean it couldn’t get bad for them,” Funtleyder said in a telephone interview.

Some of the cases involved “young women who were generally healthy and then used this patch and died,” he said. “If there turns out to be a smoking gun where memos show the CEO knew about this, this could explode into a huge problem for J&J.”

J&J Reserves

Johnson & Johnson does not detail any reserves for Ortho Evra cases. It said in an Aug. 8 regulatory filing that it faces numerous product liability cases and believes any liability “will be substantially covered by existing amounts accrued in the company’s balance sheet and, where available, by third-party liability insurance.”

Gary Douglas, an attorney who sued J&J on behalf of Ortho Evra users, said in an interview that the executive”`was told by someone on behalf of Bill Weldon that when they got the letter it was shredded and never seen by Bill Weldon.”

Douglas said the senior executive who mentioned the shredding to the letter writer was deposed in pretrial discovery and denied the account.

“This person was deposed and denied that he ever said it was shredded,” said Douglas. “He claims that it was lost.”

Vanderham disputed the Douglas account.

“The letter was not shredded,” she said. “When they met, the senior executive requested another copy of the letter because he had inadvertently misplaced it.”

‘Normal Procedure’

Vanderham said Weldon never saw the letter “because normal procedure is that when correspondence is received, it’s given to the head of the business unit that it falls under.”

Last month, Garruto ruled in New Brunswick, New Jersey, on the confidential designation of the letter and several other documents that are among thousands in the case.

Garruto, who was coordinating the New Jersey cases, has been reassigned. Another judge, Jamie Happas, is now overseeing the Ortho Evra litigation. Several hundred federal lawsuits also are being coordinated by U.S. District Judge David Katz in Ohio.

No Ortho Evra case has gone to trial. The first is slated to begin in state court in Manhattan on Nov. 19. Survivors of Zakiya Kennedy, who was 19, blame her death on April 2, 2004, on her use of the patch.

“This is a product that never should have been brought to market,” said Douglas, the family’s attorney and a partner at Douglas and London in New York. “It’s unreasonably dangerous.”

Vanderham said the company defends against claims “except where settlement is deemed appropriate.”


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