Lawsuit alleges Johnson and Johnson Hid Health Risks of Ortho-Evra Patch

Lawyers say company did not tell FDA about high estrogen levels

Johnson and Johnson, maker of the Ortho Evra birth-control patch, is being sued by 1,500 women who claim the company knew about potential health risks of the patch in 1999, but deliberately withheld the information from the Food and Drug Administration when the company was seeking approval to market the patch in 2001.

Ortho Evra patches were found to expose women to 60 percent more estrogen than oral contraceptives. The high levels of hormones found in the patch were found to cause clotting disorders in the legs and lungs, including deep vein thrombosis and pulmonary embolism.

Lawyers for the women filing the lawsuit said the company “withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels of estrogen than oral contraceptives,” and allege the FDA would not have approved the drug had it been aware of the withheld information.

The case has been filed in federal court in Toledo, Ohio. A November 20 motion filed by the plaintiffs asks U.S. District Judge David Katz to dismiss some of the company’s defenses, and outlines new disclosures about the drug’s development.

Source: David Voreacos, “J&J Altered Birth-Control Patch Data to Hide Risks,” Bloomberg.com, November 29, 2007.

Johnson and Johnson Settles Brown Ortho-Evra Patch Lawsuit

Settlement of $1.25 million for death of 14 year old

On October 24, 2007, the maker of the Ortho-Evra Patch, Johnson & Johnson, agreed to settle a lawsuit for $1.25 million over the death of a teenager who used the company’s birth control patch.

Fourteen year old Alycia Brown suffered two blood clots in her lungs in May 2004 after several weeks of use of the Ortho Evra Patch.

The world’s largest manufacturer of health-care products, Johnson & Johnson, is facing more than 2,400 lawsuits from woman who used the patch. Many suffered strokes or developed clots in their legs or lungs after use of the patch.

The Brown settlement is the first to disclose an actual sum Johnson & Johnson will pay to avoid a trial that could have made public details of the company’s safety concerns over Ortho-Evra Patch since its debut in 2001.

In November 2005, the U.S. Food and Drug Administration (FDA) warned users that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. The patch works by delivering the hormones progestin and estrogen through the skin into the bloodstream. In February 2006, another study found a twofold increase in the risk of clots as compared to women who took birth control in pill form.

Alycia Brown’s attorney said, “They initially took the position that their conduct cannot be defended and there was low value to these cases.”

“Settlement is not an admission of fault or that the company caused the event,” said company spokeswoman Gloria Vanderham.

The Brown agreement was found in another pending lawsuit that involves 18-year-old Zakiya Kennedy. She died on April 2, 2004 after using the patch. Kennedy’s case would have been the first trial scheduled but court records show that a confidential settlement was reached.

The next scheduled trial is set for February 11, 2008 concerning the death of Ashley Lewis, who was 17 years old when she died in 2003.

Source: David Voreacos and Patricia Hurtado, “J&J Pays $1.25 Million to Settle Suit Over Death of 14-Year-Old,” Bloomberg.com, October 24, 2007.

Johnson & Johnson Faces Thousands of Ortho Evra Lawsuits

Blood clot risk, thrombosis

Johnson & Johnson is now facing more than 2,400 Ortho Evra lawsuits, with 400 in New Jersey alone. Plaintiffs allege that Johnson & Johnson knew the heightened safety risks of their Ortho Evra patch compared to birth-control pills. Injuries specifically targeted by plaintiffs are potentially harmful blood clots forming in women’s legs and lungs.

Hormonal contraceptives delivered through the skin, such as those delivered via the Ortho Evra patch, result in exposure to 60 percent more estrogen than their oral counterparts. This heightened estrogen exposure may increase the risk of injury. Oral contraceptives have been linked to harmful side effects such as deep-vein thrombosis and/or pulmonary embolism. Pulmonary embolism is a potentially fatal affliction in which clots form in the body and travel to the lungs.

In 2001, an FDA medical reviewer warned of the blood clot risk with Ortho Evra and the drug should undergo more studies. Two former Johnson & Johnson executives questioned the safety of the drug, but were ignored by the company.

Source: “J&J faces thousands of Ortho lawsuits,” NJ.Com, September 19, 2007.

Women Using Contraceptive Patch at Higher Risk for Blood Clots

Colorado Women suing over deep venous thrombosis, pulmonary embolisms resulting from use of patch

According to report published in the February 2007 edition of The Journal of Obstetrics and Gynecology, women using the Ortho Evra contraceptive patch experience a 2.2 times higher incidence of deep venous thrombosis than women using oral contraception of the same dosage. The study compared 49,000 women using the patch to 200,000 who used oral contraception between April 2002 and December 2004.

Pulmonary embolism, a possible result of deep venous thrombosis, occurs when a peripheral blood clot comes loose and is carried back through the arteries to lodge in the blood vessels of the lungs. Pulmonary embolisms cause respiratory distress and, if large enough, can cause sudden death.

Six Colorado women have said they experienced blood clots while wearing the patch and are now filing personal injury lawsuits as a result. Three of the women developed pulmonary embolisms. All six stated they were not informed about the risks of deep venous thrombosis associated with the Ortho Evra patch.

In a recent claim for wrongful termination, Dr. Joel Lippman, former chief medical officer with Ortho-McNeil, a subsidiary of Johnson & Johnson and manufacturer of the Ortho Evra patch, said he had warned the company the patch could cause serious health problems in women. Johnson & Johnson has denied Lippman’s assertions.

Dr. Lippman said the patch “released dangerously high levels of estrogen into patients.” His complaint also stated that he advised Ortho-McNeil that the company should “conduct further research to understand the impact of the hormones released by the patch.” Lippman said that Ortho-McNeil disregarded his concerns and launched the product.

Last September, the FDA required Ortho-McNeil to provide better warnings to consumers about the risks of deep vein thrombosis.

Sources: “Contraceptive patch may raise blood clot risk,” Reuters Health, February 19, 2007; J. Alexander Cole, et.al, “”Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users(abstract),” Journal of Obstetrics and Gynecology 109 (February 2007); “Exclusive: Women Claim Birth Control Patch’s Risks Undisclosed,” DenverChannel.com, February 9, 2007.

FDA Updates Labeling for Ortho Evra Contraceptive Patch

The FDA approved updated labeling for the Ortho Evra contraceptive patch, in order to warn healthcare providers and patients that the patch exposes women to higher levels of estrogen than most birth control pills. In general, increased estrogen exposure may increase the risk of blood clots and strokes in some patients, although the FDA has been hesitant to state definitively whether there is a greater risk of these adverse events in women using the Ortho Evra patch.

The new bolded product label warning states that women who use Ortho Evra are exposed to about 60% more total estrogen in their blood than if they were taking a typical birth control pill containing 35 mcg. of estrogen. The FDA has stated that it will continue to monitor safety reports for the Ortho Evra patch. Ortho McNeil, manufacture of the Ortho Evra patch, is conducting additional safety studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills. Several women have developed serious blood clots, leading to strokes and other adverse events, while using the Ortho Evra patch.

Source: FDA Release, November 10, 2005.