The drugmaker improperly claimed its Ortho Evra birth-control patch posed a low safety risk to women, a product-safety executive wrote in a letter two years ago to ceo Bill Weldon, Bloomberg News reports. But Weldon supposedly never saw his copy because it allegedly wound up in the company shredder.

The exec investigated an “unusually high number” of blood clots caused by the patch, and cited more than 20 reported deaths, according to the letter, which was made public last month by a New Jersey judge overseeing some of the more than 1,500 lawsuits filed by women who used the patch. Most claim they suffered strokes or clots in their legs or lungs.

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

“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 exec wrote in the Oct. 31, 2005, letter, following his departure. The letter writer was a vp, who spent seven years at J&J overseeing benefit and safety risk analysis in reproductive medicine and oncology, Bloomberg reports.

NJ Superior Court Judge Bryan Garruto, who oversees 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 US.

The company confidentially settled dozens of Ortho-Evra cases, records show, although J&J has no reserves for the litigation.

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

“This determination was made after his review of all the information he had available to him.” And she adds that Weldon never saw the letter, although another exec investigated the claims. “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 adds.

The letter said J&J had “compelling evidence” that estrogen levels were “unusually high” compared 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.

J&J 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 argues the study, which the company made public, “adds to the body of knowledge” about the patch. “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 says.

Some of the cases involved “young women who were generally healthy and then used this patch and died,” says Les Funtleyder, an analyst with Miller Tabak. “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.”

Gary Douglas, an attorney who sued J&J on behalf of Ortho-Evra users, says the exec “was told by someone on behalf of Bill Weldon that when they got the letter it was shredded and never seen by Bill Weldon.” He adds the senior executive who mentioned the shredding to the letter writer was deposed in pre-trial discovery and denied the account. “This person was deposed and denied that he ever said it was shredded,” Douglas says. “He claims that it was lost.”

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

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,” says Douglas, the family’s attorney. “I’s unreasonably dangerous.”

“We continue to defend against claims except where settlement is deemed appropriate,” Vanderham retorts.