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.

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 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.

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.

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.

A lawsuit has been filed in New York on behalf of a woman who was using the Ortho Evra patch for seven months and suffered a pulmonary embolism. Recent reports have indicated that the risk of developing blood clots, strokes, heart attack, and pulmonary embolism might be significantly higher in women who use the Ortho Evra path than with other oral contraceptives.

The lawsuit alleges Ortho-McNeil was aware of the risk to women who use the Ortho Evra patch and failed to adequately warn patients of the possible danger.

Source: “Contraceptive patch focus of lawsuit,” Kansascity.com, September 14, 2005.

The deaths of 13 elderly patients taking the prescription drug Reminyl (galantamine hydrobromide) for treatment of symptoms related to Alzheimer’s disease have prompted a change to the precautions section of the drug’s labeling. Reminyl is approved for the treatment of mild-to-moderate Alzheimer’s disease. Two clinical trials were conducted to research the use of Reminyl for mild cognitive impairment in which one group of patients received Reminyl and one group received a placebo. There were 13 deaths in the group of patients receiving Reminyl compared to one in the placebo group.

Ortho-McNeil issued a “Dear Healthcare Professional” letter on April 5, 2005, warning that information about the deaths in the studies will be added to the section of the drug’s labeling called “Precautions.” In addition, the company has changed the drug’s brand name to Razadyne to avoid confusion of the drug with the diabetes drug Amaryl. The U.S. Food and Drug Administration has received several reports of prescribing and dispensing errors between Reminyl and Amaryl. Approximately 2 million patients have been treated with Reminyl since its introduction.

Source: Daniel DeNoon, “Reminyl Deaths Prompt Warning,” Webmd.com, April 5, 2005.

On November 1, 2006, more than 40 women sued the makers of Ortho Evra, claiming the contraceptive caused serious health problems, including blood clots and stroke. Ortho Evra, manufactured by Ortho-McNeil Pharmaceutical Company, is one of the fastest-growing forms of contraception in the United States.

The lawsuits, filed against Ortho-McNeil, claim that the company didn’t properly investigate the product’s safety and deceived the public about the seriousness of potential side effects. Similar patch lawsuits have been filed on behalf of nearly 400 women worldwide.

Ortho Evra was approved by the Food and Drug Administration (FDA) in 2001. It is a birth control patch that delivers hormones, estrogen and progestin, directly into the bloodstream through the skin.

One complaint alleges that Kelly Bracken, 25 , of Maryland, died of severe blood clots in her lungs and legs after she started wearing the skin patch. Another claimant says she developed potentially life-threatening blood clots in her lungs and suffered a miscarriage after using the patch.

The FDA warned consumers in September 2006 that their risk of blood clots in the legs and lungs may be higher if they use the patch instead of the birth control pill. The product label was updated to say that women using the patch faced twice the risk of blood clots than women on the pill. The FDA has called for additional testing of the product.

Sources: Terence Chea, “43 women sue maker of birth-control patch,” Houston Chronicle, November 1, 2006; “New Ortho Evra cases show problems continue,” Yahoo News, November 2, 2006.

Johnson & Johnson and drug maker Ortho McNeil are being sued in federal court by a teen who developed a serious blood clot problem after using the popular birth control patch, Ortho Evra. The suit is one of hundreds filed nationwide.

According to the lawsuit, Katy McKellips Braman was 17 when she first began using the Ortho Evra patch in 2004 and had been using the patch for about a month when she noticed swelling in her left leg that worsened over several days.

Doctors diagnosed Braman with deep vein thrombosis. If a piece of the blood clot were to break off and travel into her bloodstream, it could become lodged in the lungs and block blood flow, which could prove fatal.

Braman was in the hospital for about four days and must now take several drugs daily to keep her blood from clotting. She is also unable to take estrogen-containing medications, including birth control pills or treatment of menopause or hormonal imbalance, for the rest of her life because of the condition.

The teen said in the lawsuit that Johnson & Johnson and Ortho-McNeil cleared the patch to consumers without adequate testing to make sure the product was safe and that the companies misinformed consumers into thinking the risks and benefits of the patch were the same as other birth control options.

The suit asks that the companies be ordered to pay damages and pay for Ms. Braman’s ongoing medical monitoring and treatment.

In September 2006, the Food and Drug Administration modified the Ortho-Evra birth control patch label to warn women about the elevated risk of blood clots in the legs and lungs if they use the patch instead of the pill. In 2005, an investigation found higher rates of blood clots in women using the patch.

Source: Rebecca Boone, “Woman sues drugmaker over blood clots,” October 17, 2006.

The U.S. Food and Drug Administration (FDA) has updated the safety precautions on the warning label for the Ortho Evra birth control patch to remind women that their risk of blood clots in the legs and lungs may be higher if they use Ortho Evra instead of birth control pills. The warning reflects the results of a study disclosed by Johnson & Johnson in February 2006 that found women using the Ortho Evra patch risked blood clots at a rate twice as high as women on birth control pills. Johnson & Johnson owns Ortho McNeil, the company that manufactures the Ortho Evra patch.

A second study cited by Johnson & Johnson found no difference in risk between the two different forms of birth control. However, using a birth control patch exposes a patient to as much as 60 percent more estrogen than using a traditional birth control pill. Studies on the safety and efficacy of the Ortho Evra patch versus birth control pills are expected to continue for another 18 to 24 months.

More than four million women are estimated to have used the Ortho Evra patch since it was approved for sale in the U.S. in 2002. About 500 people have filed product liability lawsuits against Ortho McNeil for personal injuries linked to blood clots while they were taking the patch.

Source: Andrew Bridges, “Warning added to birth control patch,” Associated Press, September 23, 2006.

A female resident of Atlanta, GA, 37, filed a personal injury lawsuit in the U.S. District Court for the District of New Jersey in Newark against Ortho-McNeil Pharmaceutical, Inc., the makers of the Ortho Evra birth control patch. The woman alleges Ortho-McNeil was aware of increased medical risks associated with the product before it was approved by the FDA and failed to adequately warn patients of those risks.

The woman had used the Ortho Evra birth control patch for just over a year when she was admitted to Piedmont Hospital in Atlanta for chest pain. Diagnostic tests revealed a bilateral pulmonary embolism for which she was treated with anticoagulation therapies. Her personal injury attorneys have indicated that there is a strong likelihood she will have to be on such therapies for the rest of her life. A pulmonary embolism is a sudden blockage in a lung artery that is usually caused by a blood clot. It can be fatal or result in pulmonary obstruction, pulmonary hypertension, heart attack or stroke.

In November 2005, Ortho-McNeil and the FDA issued a safety warning about the increased risks of blood clots and pulmonary events associated with the Ortho Evra patch. Women who use the product may be exposed to up to 60 percent more estrogen than they would be if they were taking a traditional birth control pill.

Source: “Ortho-McNeil sued on birth-control patch,” UPI, June 16, 2006, accessed June 19, 2006.

A new study has found that users of the Ortho Evra birth control patchhad twice the risk of venous thromboembolic events, or blood clots in the legs and lungs, as users of more traditional birth control pill methods. The results of the study were made public February 16, 2006, by the patch’s manufacturer, Ortho Women’s Health & Urology, a subsidiary of Johnson & Johnson. A second study made public by the manufacturer found no increased risk of clots in patch users.

Dr. Daniel Shames of the U.S. Food and Drug Administration says that the confidence intervals of the results for the two forms of contraceptive, the patch and the pill, overlap. Tere actually may be more than double the risk of blood clots from the patch as from the pill in most users. The normal risk of a nonfatal blood clot is about one per year per 10,000 women not using a contraceptive. For women on the pill, the risk rises to between three and five. In the study cited showing a risk, there were two reports of blood clots among only 3,000 women.

The FDA has urged concerned women to discuss the risks of the Ortho Evra patch with their doctors but has taken no action at this time to recall the patch.

Source: Randolph E. Schmid, “Study criticizes patch,” Associated Press, February 18, 2006.

22-year old Rachel Cook of Jackson, MO, began experiencing chest pains several months after her doctor prescribed the Ortho Evra birth control patch. The pains became so severe that she required three rounds of hospitalization. Her doctors took her off the patch, blaming the blood clots on her use of the patch, which is manufactured by Ortho-McNeil. Now Ms. Cook has brought a personal injury lawsuit against the company for failing to warn consumers of the danger of blood clots and strokes when using the patch.

The Ortho Evra patch was approved in 2001 but Ortho-McNeil was forced to update its labeling in November 2005 to include warnings that the product exposes women to higher levels of estrogen than most birth control pills. Users of the Ortho Evra patch are exposed to about 60 percent more estrogen in their blood than if they were taking a birth control pill. Any time a woman has an increased estrogen level, her risk of blood clots is greatly increased.

Source: Jennifer Freeze, “Health issues from birth control patch spark lawsuits from local women,” Southeast Missourian, January 31, 2006.

Seven product liability suits have been filed in U.S. District Court for the Southern District of Illinois against Ortho-McNeil, maker of the Ortho Evra birth control patch, and its parent company, Johnson & Johnson, on behalf of seven women who suffered injury while wearing the patch.

Among the injuries suffered by the plaintiffs stated in the suits are:

• Multiple blood clots
• Excessive bleeding
• Heart pain
• Miscarriage

The plaintiffs seek class action status for the significant harm, conscious pain and suffering, physical injury and bodily impairment including permanent physical effects as a result of wearing a dangerous and defective product. The suit claims that Ortho-McNeil’s own clinical studies show a higher rate of venous thromboembolism in women on the patch compared to those using the pill, but the company concealed those side effects from the public.

Source: Steve Gonzalez, ” Women claim contraceptive didn’t come with blood clot warning,” Madison-St. Clair Record, January 30, 2006.

10 women filed suit today in Hudson County, NJ, Superior Court against Johnson & Johnson and its subsidiary Ortho McNeil, marketer and manufacturer of the Ortho Evra birth control patch. They have suffered debilitating, long-term adverse health effects while using the patch, including strokes and blood clots. One plaintiff, 19-year-old Amanda Bianchi of Colorado Springs, CO, had developed a 10-inch blood clot in her brain that her doctors say is a direct result of the patch she used for just three months in 2004. She suffered two strokes and routinely gets debilitating migraine headaches.

An Associated Press report on July 17, 2005, derived from raw FDA data obtained under the Freedom of Information Act, indicated that about a dozen young women who had used the Ortho Evra patch died in 2004 from blood clots. The AP concluded that the risk of dying from a blood clot might be about three times higher when using the Ortho Evra patch than when using a form of oral contraceptive. The current lawsuit alleges that the Ortho Evra patch is defectively designed and unreasonably dangerous.

Current FDA warnings advise that patients already at risk for adverse health events, including blood clots and stroke, should not use the patch. Younger women who use birth control would ordinarily not be tested for such risk. The prevalence of stroke among women in the U.S. ages 20 to 34 is a mere 0.3%. Spokespersons for Ortho McNeil contend that none of the deaths reported by the AP can be directly attributable to their patch.

Sources: “Women sue birth control maker,” CNNMoney, July 25, 2005; Katrina Woznicki, “Birth Control Patch May Be Linked to Stroke Risk,” MedPage Today, July 19, 2005.

The Associated Press released a report today of its own study of more than 16,000 adverse events reported to the FDA by users of the Ortho Evra transdermal contraceptive patch. The patch, approved in November 2001 for the prevention of pregnancy, has been linked to deaths among a dozen women, most in their late teens and early 20s, who died last year from blood clots. Dozens more young women survived strokes and other clot-related problems, according to the reports, which are voluntarily sent to the FDA by the public.

The FDA warned of possible problems with the Ortho Evra patch when it was first approved. The patch is considered dangerous to patients already at risk for adverse cardiovascular events such as heart attack, blood clots and stroke. It has also been shown to cause birth defects in children whose mother wore the patch while pregnant. Blood clots are considered an “accepted risk” from hormonal birth control because estrogen promotes blood coagulation. Clots usually form in the legs and can become serious problems if they travel to a woman’s heart, lungs or brain.

Normal blood clot risk for women under 35 who use birth control pills but do not smoke is between 1 and 3 in 10,000. The risk of dying from such a clot for the same women, using the pill, is about 1 in 200,000. By contrast, the rate of nonfatal blood clots for women on the patch was about 12 out of 10,000 users, and the rate of deaths by blood clots while on the patch is about 3 in 200,000.

The AP report described several of the deaths. One woman, a fashion student from Manhattan, collapsed and died in a subway station in New York City in April 2004. Another woman, Sasha Webber, 25 and a mother of two from Baychester, NY, died of a heart attack after just six weeks on the Ortho Evra.

Kathleen Thoren, a 25-year old mother of three, died last fall after days of agonizing headaches. Admitted to intensive care because of pressure on her brain due to swelling, Ms. Thoren’s coroner’s report stated the swelling was due to hormones released into her system by the Ortho Evra patch.

Sources: “Risks seen with patch,” Associated Press, July 17, 2005; Katrina Woznicki, “Birth Control Patch May Be Linked to Stroke Risk,” MedPage Today, July 19, 2005.