Johnson & Johnson agreed to pay $1.25 million to settle a lawsuit over the death of a 14-year-old girl who used the company's Ortho Evra birth-control patch, according to court records.
The confidential agreement involved Alycia Brown, a resident of LaCrosse, Wisconsin, who suffered two blood clots in her lungs on May 7, 2004, after using the patch for several weeks. J&J, the world's largest maker of health-care products, faces lawsuits by 2,400 of the 5 million women who used the patch.
Most claim they suffered strokes or clots in their legs or lungs. The company settled dozens of cases before trial without releasing financial details. The Brown agreement offers the first glimpse into how much money the company paid to resolve a case and avoid a trial that might air details of the company's safety concerns about the drug before it came to market in 2001.
"Johnson & Johnson is finally starting to realize that the value of these cases and the toll they've taken on people is quite considerable," said New York attorney Hunter Shkolnik, whose firm has filed Ortho Evra lawsuits. "They initially took the position that their conduct cannot be defended and there was low value to these cases."
The Brown agreement, dated April 21 and entered in federal court in Ohio, was in the file of another Ortho Evra case in state court in Manhattan and made available to Bloomberg News by a court clerk. The 12-page document states that the company denied that Ortho Evra caused Brown's death, and it acknowledged the uncertainty of litigation as a reason for settling.
Company spokeswoman Gloria Vanderham said the company could not discuss the case because of a confidentiality order. She said the company does not discuss how many cases it settled.
"The company is defending against these claims, except where settlement is deemed appropriate," said Vanderham, a spokeswoman for Ortho Women's Health & Urology unit, a division of Ortho-McNeil Pharmaceutical Inc., a J&J subsidiary. "Settlement is not an admission of fault or that the company caused the event."
The Brown agreement was in the file of a lawsuit by survivors of Zakiya Kennedy, who was 18 when she died on April 2, 2004, after using the patch. Court records show that a confidential settlement was reached in that case on Oct. 11.
Her case was scheduled for Nov. 19 and would have been the first to go to trial. The next scheduled trial involves the death of Ashley Lewis, who was 17 when she died in late 2003. It is slated for state court in St. Louis on Feb. 11.
Brown attorney Janet Abaray and Kennedy lawyer Gary Douglas declined to comment.
Those suing J&J claim the company failed to heed warning signs about the patch, which delivers the hormones progestin and estrogen through the skin into the bloodstream. The plaintiffs claim the company, based in New Brunswick, New Jersey, knew that the patch, which went on the market in 2002, caused more blood clots and deaths than the birth-control pill.
The Food and Drug Administration warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with women who took the pill.
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."