J&J Hid Safety Risk Data on Birth-Control Device, Women Claim

By David Voreacos

April 5 (Bloomberg) -- Johnson & Johnson hid or altered data on the health risks of its Ortho Evra birth-control patch and flaws in the manufacturing of the device, lawyers for women suing the company claim in court papers.

Lawsuits on behalf of 2,400 women claim high levels of estrogen released by the patch caused strokes, heart attacks, and blood clots. J&J, the world's largest maker of health-care products, misled the Food and Drug Administration about estrogen levels before and after patch sales began in 2002, according to a filing April 3 in federal court in Toledo, Ohio.

Manufacturing defects made the patch unstable and the dosage unpredictable, according to the filing. Tests showed in 2003 that the patch produced 60 percent more estrogen than oral contraceptives, it said. A company pharmacologist, Dr. Larry Abrams, applied a ``correction factor'' to lower estrogen results given to the FDA by 60 percent, according to the filing.

``Through a sleight of hand, and altering of numbers,'' Abrams ``presented a truly misleading picture of the amount of estrogen delivered by the patch,'' the filing said. ``The import of this misrepresentation is enormous, given the tenet that the greater the dose, the greater the poison.''

The filing, in response to 1,500 federal lawsuits consolidated in Toledo, offers the most detailed look to date at evidence previously deemed confidential. Plaintiffs responded to a company motion to dismiss the cases that argued that FDA approval of the device and its label supersedes, or preempts, the ability of patients to seek damages under state laws.

`Safe and Effective'

``We regularly and properly disclosed data to the FDA, the medical community and the public in a timely manner,'' said Gloria Vanderham, a spokeswoman for Ortho Women's Health & Urology unit, a division of Ortho-McNeil Pharmaceutical Inc., a J&J subsidiary. ``Ortho Evra is a safe and effective hormonal birth control option for women when used in accordance with the FDA-approved labeling.''

The company settled scores of lawsuits without allowing any to go to trial or releasing financial details. Last year, Johnson & Johnson agreed to pay $1.25 million to settle a lawsuit over the death of a 14-year-old girl who used the patch, according to a document left in a court file reviewed by Bloomberg News.

J&J strengthened its warning label three times since 2005 to inform doctors about estrogen levels released by the patch and their potential association with injuries, including blood clots in the legs and lungs.

The FDA 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 use of the pill.

Warning Signs

More than five million women have used Ortho Evra since 2002. The patch is designed to release continuous levels of progestin and estrogen through the skin and into the bloodstream for seven-day periods. The women claim the company ignored warning signs as early as 1998.

J&J was ``desperate'' to get Ortho Evra on the market because it was losing patent protection in 2003 on its best- selling birth control pill, according to the filing. J&J initially told the FDA that it expected the patch to release less estrogen than the pill.

The filing details a clinical trial in 1999, known internally as PHI-014, that measured the amount of ethinyl estradiol, or EE as the estrogen component is called, released into the bloodstream every 24 hours. The company said the study proved the level was 20 micrograms.

`Correction Factor'

The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the filing. Abrams, who is now retired, applied his ``correction factor'' to lower the results, and the company obscured his method in reports to the FDA.

Abrams said in a pre-trial interview that the ``correction factor'' related to the rate at which users of the pill cleared estrogen from the body, the filing said.

J&J learned in June 1999, through a study known as PHI-017, that the patch delivered two times more estrogen than one form of the pill, the filing said. It also delivered three times more estrogen than two other types of the pill, it said. J&J didn't give the full results to the FDA until October 2001, it said.

One J&J scientist, Dr. Patrick Caubel, urged the company in 2003 to conduct epidemiology studies because of ``an abnormally high number of `spontaneous cases' of clotting disorders, as well as death,'' associated with the patch, the filing said. His request was disregarded, according to the filing.

Manufacturing Problems

Johnson & Johnson had manufacturing problems at its facility in Redwood City, California, that caused variations in the rate of release of estrogen from the patch, the filing said. The company also couldn't replicate in its commercial patch the results obtained in clinical trials, it said. The levels of estrogen also varied from batch to batch, it said. The company hid those problems from the FDA, it said.

An attorney for the company, John Winter, said the use of the ``correction factor'' was proper, well documented, and disclosed to the FDA. He said FDA inspectors reviewed J&J's manufacturing facilities in Redwood City and Puerto Rico.

``We have always adhered to our manufacturing and quality- control procedures, which were reviewed and approved,'' said Winter, of Patterson Belknap Webb & Tyler, in an interview. ``Our quality-control procedures are top-notch.''

Disputed Claims

Winter disputed claims that the company ignored safety concerns raised by Caubel, saying the filing was ``completely inaccurate'' in that regard.

``The company did not ignore information relating to the safe and effective use of Ortho Evra,'' Winter said. ``Nothing was ignored.''

U.S. District Judge David Katz has designated some women as ``bellwether'' plaintiffs for trials later this spring. They include Sienna Tomko, who was 14 when she suffered a deep vein thrombosis in 2005.

Johnson & Johnson rose 46 cents yesterday to $65.73 in New York Stock Exchange composite trading.

The case is In re Ortho Evra Products Liability Litigation, 06-cv-40000, U.S. District Court, Northern District of Ohio (Toledo).

If you or someone you love has used the Ortho Evra Birth Control Patch and has experienced side effects such as: heart attack, stroke, blood clots, or deep vein thrombosis (DVT) you need to know your legal rights. Call our Ortho Evra side effects lawyers for a free legal consultation or to ask questions about a possible Ortho Evra lawsuit or Ortho Evra recall.